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Based on observation, staff and patient interviews, medical record and document reviews, the hospital failed to effectively govern the activities and conduct of the hospital staff to provide safe and quality care to all patients as evidenced by:

A. The hospital failed to provide surgical services that were well organized and in accordance with acceptable standards of practice in order to ensure safe and high quality surgical care to all patients. (Refer to A 904).

B. The hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The hospital's infection control program and policies were not in accordance with nationally recognized infection control standards to effectively prevent, control, and minimize cross-contamination and risks for infections and communicable diseases. (Refer to A 0747).

C. The hospital failed to meet the emergency needs of patients in accordance with acceptable standards of practice. (Refer to A 0092 and A 1100).

D. The hospital failed to ensure Outpatient services were appropriately organized and integrated with inpatient services (Refer to A 1077 )

These failures (described in detail in Conditions of Participation A 747, A 940, and A 1100) resulted in a potential for increased infections, injuries and adverse outcomes for all patients. The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Governing Body.

Findings:

In an interview on 1/23/12 at 11:15 a.m. with the Chief Medical Officer (CMO), who served on the governing body advisory council and medical staff leadership committees, the CMO stated that the governing body was ultimately responsible for all hospital activities, operations, patient care processes, and management supervision.

Review of a document from a policy and procedure manual belonging to the hospital's owner and presented as the governing body bylaws, identified as Chapter 200 Organization and Management, Section 40, last revised 9/7/11, documented the rules, responsibilities, and organizational structure and hierarchy of reporting from various management groups up to the governing body. Item III-A-2 noted that the governing body was responsible for "fulfilling those responsibilities required by [The Joint Commission, Centers for Medicare and Medicaid] Conditions of Participation."
No other governance documents were presented to hold the Board responsible for the conduct of the hospital as an institution, to ensure hospital patients received quality care, and to furnish and maintain facilities for the proper care and safety of all patients, physicians, and employees.

The hospital failed to meet the emergency needs of patients in accordance with acceptable standards of practice as defined in 482.55. (Reference A 1100).

Based on observation, interview and record review, the hospital failed to to provide emergency medical services that were well organized and in the requirements of Centers for Medicare and Medicaid Services defined in federal regulation 482.55.

1. The hospital failed to establish policies, procedures and standards for emergency medical services.

2. The physicians failed to complete a Transfer Summary prior to the transfer of patients to an in-patient facility. .

3. The hospital failed to ensure adequate medical and nursing personnel provided the necessary care and services to meet the needs of patients who presented to the facility with an emergent medical condition.

4. The hospital failed to provide evidence of current competency for nurses in the triage areas.

Based on interview, record review and facility document review, the hospital failed to consistently measure, analyze and track episodes of hypoglycemia (low blood sugar) related to insulin (medication to lower bloods sugar) administration in accordance with their policy.

Findings:

According to Institute of Safe Medication Practices (ISMP), a nationally recognized organization that promotes the safe use of medication in healthcare facilities, insulin is considered a high-risk, high alert medication due to the heightened potential for significant patient harm. ISMP recommends healthcare facilities utilize special safeguards to reduce the risk of insulin adverse effects.

Lexi-Comp ONLINE, a nationally recognized drug information source, indicated that the most common adverse effect of insulin is hypoglycemia (low blood sugar). Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death.

According to the American Diabetes Association, normal fasting (before meals) blood sugar ranged from 70 - 130 mg/dL (milligrams per deciliter, unit of measure).

A list of patients who received reversal agents for hypoglycemia (low blood sugar) for the time period 1/16/12 through 1/23/12 was requested from and provided by Pharmacist 1 (Pharm 1).

During an interview on 1/23/12 at 2:10 p.m. Pharm 1 indicated the pharmacy generated a report daily for intensive care patients who have experienced a blood glucose less than 50 mg/dL and who have received a reversal drug such as 50% dextrose (sugar solution)injection. Pharm 1 further indicated the report had not yet been rolled out to the entire hospital.

A review of one current and one closed Electronic Medical Record (EMR) revealed the following issues in both of those records:

a. Clinical EMR review revealed Patient 36 was a 72 year-old trauma (motor vehicle collision) patient admitted to the facility on 12/16/11 with spinal injury and multiple fractures; medical history included Diabetes Mellitus II (non-insulin dependent). Patient 36 was receiving liquid nutrition enterally (through a feeding tube).

Review of Patient 36's Physician Orders included the following insulin orders: Lantus insulin (long-acting) 30 units subcutaneous (injected underneath the skin) daily at bedtime (ordered 1/8/12); regular (short-acting) insulin 4 units subcutaneous every 6 hours (ordered 1/9/12); and regular insulin sliding scale (amount to be administered subcutaneous based on assessed blood sugar results every six hours).

Further EMR review indicated Patient 36 underwent a surgical procedure on 1/18/12; enteral feedings were held after midnight on the same day.

Patient 36's EMR Medication Administration Record (MAR) revealed that on 1/18/12 at 6:15 a.m. 25 grams of dextrose was administered I.V. (infusion of liquid substances directly into a vein) by a licensed nurse for an assessed blood sugar of 53 mg/dL.

During an interview on 1/25/12 at approximately 2 p.m. a Nurse Manager (NM 2) verified Patient 36's clinical EMR findings.

During an interview on 1/25/12 at approximately 5:20 p.m. Pharm 7 confirmed that an online incident report had not been filed by licensed nursing staff or a pharmacist related to Patient 36's episode of hypoglycemia on 1/18/12.

Further review of Patient 36's EMR revealed an additional surgical procedure was performed on 1/20/12; enteral feedings were held on 1/19/12.

Patient 36's EMR MAR revealed that on 1/20/12 at 5:45 a.m. 25 grams of dextrose was administered I.V. by a licensed nurse for an assessed blood sugar of 44 mg/dL.

During an interview on 1/25/12 at approximately 2 p.m. Nurse Manager (NM) 2 verified Patient 36's clinical EMR findings. During a concurrent interview Pharm 3 acknowledged Patient 36's insulin regimen should have been evaluated due to his nutritional feedings being held to possibly avert the episodes of hypoglycemia.

Review of two pharmacists' EMR clinical notations revealed that on 1/18/12 at 3:06 p.m. a clinical pharmacist documented: "BS [blood sugar] of 53 this AM; TRM [trauma service] aware, will follow trend, if hypoglycemic will d/w [discuss with] team decreasing Lantus. On 1/20/12 at 2:42 p.m. Pharm 4 documented: "BG [blood glucose] this am 44 ....paged twice to inquire if can decr [decrease] lantus even if by just a few units. No call back ....pls f/u [follow up am stick [fingerstick blood sugar] tmrw [tomorrow]."

During an interview on 1/26/12 at 12:20 p.m. Pharm 4 confirmed the aforementioned documentation in Patient 36's EMR. Pharm 4 indicated being very busy with a high patient load and did not follow up; Pharm 4 further indicated she did not generate an online incident report related to Patient 36's two episodes of hypoglycemia.

During an interview on 1/26/12 at 12:20 p.m., Pharm 3 confirmed that an online incident report had not been filed by licensed nursing staff or a pharmacist related to Patient 36's episode of hypoglycemia on 1/20/12.

b. Closed EMR review revealed Patient 37 was a 65 year-old admitted to the facility on 1/16/12 with diagnoses including Diabetes Mellitus type II (non-insulin dependent) and squamous cell carcinoma (a type of skin cancer) of the head and neck. Patient 37 was receiving liquid nutrition through a gastrostomy tube (GT) (tube surgically placed in the stomach for the administration of liquid nutrition and medications).

Patient 37's Physician Orders included an order for regular insulin sliding scale and fingerstick blood sugar assessments every six hours (at 6 a.m., 12 noon, 6 p.m. and midnight).

Review of Patient 37's Internal Medicine Admission History and Physical EMR indicated a history of resection of the jaw and floor of the mouth; a flap of skin from Patient 37's fibula (back area of lower leg) had been grafted to the jaw area June 2011 and was poorly healing; ENT (ear, nose and throat physician) had planned for surgery on 1/23/12 to reconstruct the area.

Review of Patient 37's Glycemic Control EMR indicated on 1/21/12 she received GT feedings and on 1/22/12 the feedings were stopped in advance of the surgery [NPO status].

Review of Patient 37's EMR MAR indicated no sliding scale insulin had been administered from 1/16/12 through 1/21/12 due to stable fingerstick blood sugars. Patient 37's 1/22/12 EMR MAR revealed that at 12:27 a.m., a licensed nurse administered 2 units of regular insulin for an assessed fingerstick blood sugar of 193 mg/dL. The record further indicated that on 1/22/12 at 6:11 a.m. 25 grams of dextrose was given I.V. by licensed nursing staff for an assessed low blood sugar of 33 mg/dL; another 25 gram dose of dextrose was given I.V. at 11:55 a.m. for an assessed low blood sugar of 54 mg/dL.

During an interview on 1/26/12 at approximately 9:30 a.m. Pharm 8 indicated that patients with physician's order sets including dextrose I.V. for reversal of hypoglycemia may not be readily identified by pharmacists as an adverse drug reaction.

During an interview on 1/26/12 at approximately 12:15 p.m. NM 2 verified Patient 37's clinical EMR findings. During a concurrent interview, Pharm 3 confirmed that an online incident report had not been filed by licensed nursing staff or a pharmacist related to Patient 37's two episodes of hypoglycemia requiring I.V. dextrose administration on 1/22/12.

Review of the hospital policy 1633 Medication Related Event Management Program (revised 2/14/11) indicated under III. Definitions and Descriptions, item F: "ADVERSE DRUG REACTION (ADR): Any undesired response associated with the use of a medication that requires medical intervention or a significant alteration in therapy." The policy further indicated under IV. Medication Event Related Reporting, item B. Adverse Drug Reaction Reporting, number 1: "When a pharmacist or nurse becomes aware of an adverse reaction, he/she should immediately assure the responsible medical service is aware, initiate appropriate therapy adjustments with responsible physician and complete an online incident report."

During an interview on 1/26/12 at 12:20 p.m. Pharm 3 indicated that patients with standing orders (order sets) for dextrose I.V. for reversal of hypoglycemia may not be identified as adverse drug reactions by pharmacists unless they "stumbled" on them while doing clinical EMR reviews or on clinical rounds.

Based on medical record review, dietary staff interview and dietary document review the hospital failed to ensure a comprehensive performance improvement program for medical nutrition therapy as evidenced by lack of effective interventions to ensure the clinical performance monitoring indicator for medical nutrition therapy was improved and/or sustained after the identification of the problem. Failure to ensure comprehensive medical nutrition therapy may further compromise patient medical status and may result in increased length of hospitalization.

Findings:

During medical record review from 1/24-1/26/12 between the hours of 9 a.m. and 3 p.m. it was noted that multiple patients did not receive timely nutrition assessment and/or medical nutrition therapy (Cross Reference A630). In an interview on 1/26/12 beginning at 2:30 p.m., with RD 3 and 5 they were asked to describe the system for ensuring adequate coverage for clinical nutrition care. They stated that in 2009 the hospital identified that there was a decline in patients' medical nutrition therapy. At that time the hospital developed a plan to hire a relief dietitian, eliminate dietitian "back up" of screening patients at admission, rather relying on nursing staff to assess initial nutritional risk, create a brief follow up note and cross train dietitians to multiple areas of expertise. They also stated that while these interventions were put in place the department continued to struggle with adequate Registered Dietician (RD) staffing. She stated that while the hiring of a relief dietitian seemed to make the most impact this position was often required to provide long-term relief for RDs who were on extended leaves of absence and vacations rather than the intended purpose of the relief RD to cover regular days off. They additionally stated that the hospitals' clinical dietitians were routinely called upon to provide relief coverage for the outpatient children's clinic. They also stated that within the next several months she was anticipating additional vacancies due to retirements. The surveyors also asked what the expectation was for RDs in terms of patient load. They stated that depending on the acuity of patients a reasonable load would be an average of 8 patients/day. They also stated that currently it was not uncommon for the RD load to be greater than that and may be 10-14 patients/day depending on patient acuity.

Review of clinical nutrition schedules from 7/11-12/11 revealed that for any given month there were 2-4 RDs who were not working for 5 or greater consecutive days and consistently there were 2 or more RD's who were unavailable on the same work week.

In an interview on 1/26/12 at 3 p.m., with DDS (Dietary Service Manager) 1, who had overall responsibility for the department, was asked by the surveyors how he ensured adequate RD coverage. He stated that several years ago it was identified that patients were not receiving timely medical nutrition therapy. He also stated that he felt the addition of a relief dietitian solved the issue. He also stated that he felt the current staffing was adequate, that the department was reaching its goals and confirmed that the expected production of the RDs was to see approximately 8 patients/shift.

Review of performance improvement activity summary report 06/14/11 and submitted by DSM 1 on 1/30/12 revealed that for Fiscal Year (FY) 2009 through 2010 the department reached the benchmark of 90% compliance for January 2009 through April 2010; however the remaining 8 months the benchmark did not reach the desired goal, rather ranged from 79-89% compliance. Review of year to date statistics beginning July, 2011 through December, 2011 revealed that when utilizing the percentage of patients receiving intervention by the RD, the compliance ranged from 71-81%, with an acceptable benchmark of 90%. It was noted that the hospital also had a Registered Dietitian internship program. While utilization of internship hours increased compliance to 75-85% it did still not meet the hospital developed benchmark of 90%. While the use of student interns may benefit the staffing levels for hospital departments, students participating in the internship program were not registered by the Commission on Dietetic Registration (CDR) and would not possess the depth and breadth of expertise of a Registered Dietitian. Cumulative review of statistics provided by the nutrition department revealed that despite the development of a multi-faceted action plan the final outcome did not improve the percentage of patients seen from FY 2009 through 2010 that required medical nutrition therapy.

Based on interview, record review and facility document review, the hospital failed to develop a diabetic plan of care for one of 79 sampled patients (Patient 37).

Findings:

Closed Electronic Medical Record (EMR) review revealed Patient 37 was a 65 year-old admitted to the facility on 1/16/12 with diagnoses including Diabetes Mellitus type II (non-insulin dependent) and squamous cell carcinoma (a type of skin cancer) of the head and neck. Patient 37 was receiving liquid nutrition through a gastrostomy tube (GT-tube surgically placed in the stomach for the administration of liquid nutrition and medications).

Patient 37's Physician Orders included an order for regular insulin sliding scale and fingerstick blood sugar assessments every six hours (at 6 a.m., 12 noon, 6 p.m. and midnight).

Review of Patient 37's Internal Medicine Admission History and Physical EMR indicated a history of resection of the jaw and floor of the mouth; a flap of skin from Patient 37's fibula had been grafted to the jaw area June 2011 and was poorly healing; ENT (ear, nose and throat physician) had planned for surgery on 1/23/12 to reconstruct the area.

Review of Patient 37's Glycemic Control EMR indicated on 1/21/12 she received GT feedings and on 1/22/12 the feedings were stopped in advance of the surgery (NPO status).

Review of Patient 37's EMR MAR (Medication Administration Record) indicated no sliding scale insulin had been administered from 1/16/12 through 1/21/12. Patient 37's 1/22/12 EMR MAR revealed that at 27 minutes after midnight a licensed nurse administered 2 units of regular insulin for an assessed fingerstick blood sugar of 193. The record further indicated that on 1/22/12 at 6:11 a.m. 25 grams of dextrose (also known as glucose, or sugar) was given I.V. (infusion of liquid substances directly into a vein) by licensed nursing staff for an assessed low blood sugar of 33 mg/dL (milligrams per deciliter); another 25 gram dose of dextrose was given I.V. at 11:55 a.m. for an assessed low blood sugar of 54 mg/dL. According to the American Diabetes Association, normal fasting (before meals) blood sugar ranges from 70 - 130 mg/dL.

Lexi-Comp ONLINE, a nationally recognized drug information source, indicates that the most common adverse effect of insulin is hypoglycemia (low blood sugar). Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death.

During an interview on 1/26/12 at approximately 12:15 p.m. NM 2 verified Patient 37's clinical record findings and indicated that, due to Patient 37's NPO status and previously stable fingerstick blood sugars, a repeat blood sugar assessment should have been considered.

During an interview on 1/26/12 at 2:15 p.m. NM 2 confirmed a diabetic plan of care had not been initiated or developed in Patient 37's EMR to guide nursing staff in evaluating treatment.

Review of the hospital policy XVIII-02 EMR Plan of Care, revision date unknown, indicated under III. Process, item A: "The Plan of Care is initiated within the first 24 hours of the admission ...."

Based on observations, interviews, clinical records and documents review, the hospital failed to follow physician's orders for Patients 7 and 20 when:

1. Patient 7 received 350 mcg (micrograms) of Fentanyl (pain medication) when 200 mcg was ordered;
2. Patient 20 a) received propofol (medication frequently used to provide relaxation and loss of awareness in ventilator patients) at a starting rate of 10 mcg/kg/min (micrograms per kilogram per minute) when 5 mcg/kg/min was ordered; and b) Richmond Agitation-Sedation Scores (RASS, a tool for evaluating patient sedation on a scale of +4 to -5) in conjunction with propofol administration were not documented.

Findings:

1. On 1/23/12 at 1:45 p.m., a tour of the Tower 2, [burn unit], was conducted with Nurse Manager (NM 7). At 1:48 p.m., an interview was conducted with Registered Nurse (RN 7). RN 7 was providing care for Patient 7 and when questioned whether she charted the medications administered to Patient 7, RN 7 indicated she had not. RN 7 stated the medications administered were written on the glass door in Patient 7's room. Noted on the glass door was Fentanyl with a total dose of 250 mcg. RN 7 stated she gave an additional dose of Fentanyl of 50 mcg at 12:30 p.m., making the total dose 300 mcg.

On 1/24/12 at 3 p.m., the clinical records for Patient 7 were reviewed. Review of Patient 7's physician's orders contained the following dated 1/23/12 at 3:07 p.m.: "Fentanyl (Sublimaze) 25-200 mcg PREMED (pre-medication before procedure) Route: IV (intravenous -into the vein)" Another order dated 1/23/12 at 9:13 a.m. indicated the following: "Fentanyl 50 mcg/ml (microgram per milliliters) injection. Start: 1/23/12 0913 (9:13 a.m.) Standing Count: 1 Occurrences."

Review of Patient 7's January 2012 Medication Administration Record (MAR) indicated the Fentanyl was administered on 1/23/12 at 10 a.m. "200 mcg" total procedure dose. The next time this medication was documented as administered was at 9:30 p.m. The MAR did not contain documentation of the 50 mcg dose.

On 1/24/12 at 4:36 p.m., during an interview with Pharm 2, a request for the Pyxis system(medication delivery system) printout for Patient 7 was requested. This printout would show how much of Fentanyl was removed for Patient 7. The printout for Patient 7 indicated 4 vials of Fentanyl 100 mcg/ml was removed by RN 7 from the Pyxis (total of 400 mcg) on 1/23/12 at 9:13 a.m. (The printout indicated 50 mcg of Fentanyl was wasted.)

On 1/25/12 at 11:10 a.m., a follow-up interview was conducted with RN 7. RN 7 stated she removed 4 vials of the Fentanyl (totaling 400 mcg) and administered 350 mcg to Patient 7. RN 7 stated she gave the wrong dose of medication based on the physician orders for Patient 7.

According to the hospital policy "Medication Administration" revised 1/12/12 "All medications require a physician's order. The physician's order must include: 4. Dose (amount) of medication."


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2. In a review of Patient 20's medical record, propofol was noted as ordered to be started 1/23/12 at "5 mcg. per kg. per minute. Titrate [change the dose] to RASS -1 to +1."

Documentation indicated propofol was started in the Emergency Department (ED) at 5:47 a.m., 1/23/12 at 10 mcg./kg./min. (micrograms per kilogram per minute) The first RASS score was not noted until 9 a.m., 1/23/12, after the patient had been admitted to the Medical Intensive Care Unit.

In a 4:45 p.m., 1/24/12 interview with NM 9, she stated she "would have expected to see documentation from the nurse [starting the propofol] as to why it was started at 10 mcg." In addition, she "could not find [ED] RASS scores either. Nurses are trained to do these and they should have been done." At 1:35 p.m., 1/25/12, AM (assistant manager) 1 stated she too was unable to provide additional information regarding the absence of RASS scores or why propofol was started at a level higher than the physician ordered.

Review of the hospital "Medication Administration" policy, revised 1/12/12, reflected, "Administer medications according to the Five Rights: right patient, right medication, right dose, right time and right route....If PRN [as needed] medication administered, record...the patient's behavioral and physiological response within 60 minutes after administration...."

Based on observations, interviews and record reviews, the hospital failed to ensure that medications were administered in accordance with the physicians' orders, the manufacturer's specification, and the hospital policy and procedures as for seven of 80 sampled patients (28, 29, 30, 31, 32, 39, 66).

Findings:

1. During an observation of medication administration on 1/24/12, at 9:48 a.m., a Registered Nurse (RN 4) was observed to flush Patient 28's peripheral (placed in the arm vein) I.V. line with approximately 5 mL(milliliters, unit of measure) normal saline with a prefilled syringe; RN 4 then administered 2 mL of ondansetron (medication for nausea) (2 mg/mL, or a total of 4 mg in the prepared syringe) into the I.V. line over approximately 20 seconds, then flush with an additional 5 mL of normal saline.

Review of Patient 28's Electronic Medical Record (EMR) current Physician Orders on 1/24/12 revealed an order (dated 1/23/12) for ondansetron 4 mg every 12 hours if needed for nausea/vomiting. Review of the EMR MAR revealed the following instructions for administration: "IV push (undiluted) over 2 - 5 minutes."

Review of the hospital policy XIII-33, Administration of Adult and Pediatric IV Medications, revised 12/8/11, indicated under II. Procedure, item G, "Adult Inpatient and Outpatient Areas: Administration of IV Push Medications," 3. Procedure: "e. Attach prepared syringe and administer medication as ordered, not exceeding maximum dosage and rate specified in Attachments 1 and 2."

Review of the policy attachment (provided by Pharmacist (Pharm) 3), entitled "Guidelines for Intravenous Drug Administration for Adult Patients EXCEPT in Emergency Situations," updated 1/24/12, indicated ondansetron should be administered "Slow IV push 2 - 8 mg over 2 - 5 minutes."

During an interview on 1/24/12 at 9:50 a.m. RN 4 acknowledged administering Patient 28's I.V. push ondansetron over less than two to five minutes during the morning observation of medication administration; RN 4 further acknowledged potential risks of administering the medication too rapidly.

During an interview on 1/24/12 at 10:10 a.m. the Nurse Manager (NM 3) confirmed the expectation that licensed nursing staff administer I.V. push ondansetron in accordance with facility guidelines.

2. During an observation of medication administration on 1/24/12, at 12: 33 p.m., a Registered Nurse (RN 5) was observed to flush Patient 29's peripheral I.V. line with approximately 5 mL normal saline with a prefilled syringe; RN 5 then administered 8 mL of furosemide (diuretic) (10 mg/mL, or a total of 80 mg in the syringe prepared by RN 5) into the I.V. line over approximately 30 seconds, then flush with an additional 5 mL of normal saline.

Review of Patient 29's EMR current Physician Orders revealed an order (dated 1/24/12) for a one time dose of furosemide 80 mg I.V. Review of the EMR MAR revealed the following instructions for administration: "IV push (undiluted) over 1 - 3 minutes."

Review of the facility policy XIII-33, Administration of Adult and Pediatric IV Medications, revised 12/8/11, indicated under II. Procedure, item G, "Adult Inpatient and Outpatient Areas: Administration of IV Push Medications," 3. Procedure: "e. Attach prepared syringe and administer medication as ordered, not exceeding maximum dosage and rate specified in Attachments 1 and 2."

Review of the policy attachment (provided by Pharm 3), entitled "Guidelines for Intravenous Drug Administration for Adult Patients EXCEPT in Emergency Situations," updated 1/24/12, indicated furosemide should be administered "Slow IV push Max dose 80 mg over 1 - 3 minutes."

During an interview on 1/24/12 at approximately 12:40 p.m. RN 5 stated furosemide 80 mg I.V. should be administered over three minutes, and indicated belief that Patient 29's dosage had been administered according to facility guidelines. RN 5 acknowledged not checking her watch during the administration of Patient 29's I.V. furosemide to verify the actual administration rate.

During an interview on 1/24/12 at 4:15 p.m. NM 3 confirmed the expectation that licensed nursing staff administer I.V. push furosemide in accordance with facility guidelines.

3. During an observation of medication administration on 1/25/12, at approximately 8:58 a.m., a Registered Nurse (RN 6) was observed to withdraw Patient 39's solid tablet dosage from the Automatic Dispensing Cabinet (ADC) ; RN 6 then crushed each medication in the packaging. Several of Patient 39's medications included: isosorbide dinitrate 15 mg (indicated for heart disease); olanzapine 5 mg rapidly dissolving tablet (indicated for psychosis); carvedilol 25 mg (indicated for heart failure); famotidine 20 mg (indicated for gastric hyperacidity); hydralazine 30 mg (indicated for high blood pressure); and simvastatin 40 mg (indicated for high cholesterol). RN 6 then carried the medications to Patient 39's room, opened the packaging and mixed all of the medications together in a plastic dosing cup with approximately 30 mL of sterile water for irrigation. RN 6 then flushed Patient 39's NG (nasogastric, a flexible tube placed into the nose then stomach for the administration of liquid nutrition and medications) tube with approximately 20 mL of water in a plastic enteral syringe; administered the slurry of the six combined medications in water via the same syringe; then flushed the NG tube with approximately 50 mL of sterile water after the medications were administered.

Review of Patient 39's EMR current Physician Orders included orders for isosorbide dinitrate 15 mg NG three times daily; olanzapine 5mg rapidly dissolving tablet NG every morning; carvedilol 25 mg NG twice daily; famotidine 20 mg NG every morning; hydralazine 30 mg NG three times daily; and simvastatin 40 mg NG every morning.

Review of the facility policy VIII-11 Enteral Tube Feeding Management, revised 8/12/11, indicated under item D. Monitoring Feeding, 4. Tube Patency a: " ....If it is absolutely necessary to give medication through the feeding tube, use liquid medications when possible. Each medication should be given separately ....Consult the pharmacy for medication and formula administration compatibilities and flush between each medication. "

During an interview on 1/25/12 at 10:45 a.m. NM 4 confirmed medications given through a feeding tube, including an NG, should be administered separately.

During an interview on 1/25/12 at approximately 1:20 p.m. RN 6 acknowledged she should have administered Patient 39's morning meds separately through the NG tube. RN 6 indicated consideration of the potential for fluid overload with multiple medications and the need to flush the NG tube with water between each one. RN 6 further indicated Patient 39 did not have a Physician's Order to restrict the administration of fluids.


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4. During a medication pass observation on Nursing Unit 11 on 1/24/12 at 9:10 a.m. in the presence of a Nurse Manager (NM) 4, RN 16 was observed giving 5 milliliters (ml) of Nystatin (anitfungal medication) suspension to Patient 30, who was alert, oriented, and spoke English. Patient 30 had an order to "swish and swallow" with 5 ml of Nystatin four times a day to prevent mouth infection. At the time of observation, RN 16 gave to medication to the patient but did not emphasize the medication needed to be swished in the mouth for as long as possible before swallowing. As a result, the patient took the medication and immediately swallowed it, without swishing the medication in the mouth.

To date, Lexi-Comp, a nationally recognized drug information resource, indicates that Nystatin "should be swished about the mouth and retained in the mouth for as long as possible (several minutes) before swallowing."

During the same medication pass observation, RN 16 used a large syringe to flush the PEG tube with water before and after the administration of a medication. The syringe was not labeled nor dated. RN 1 was unable to tell the last time the syringe was changed and how often it should be changed.

On 1/25/12 at 9:15 a.m., Tower 11 Nurse Manager (NM 6) said the syringe used for enteral feeding and drug administration should be dated, labeled with the patient's name, and changed out daily and sooner if soiled or contaminated.

5. A review of Patient 30's EMR at Davis 11 RN 17, NM 4, and NM 6 on 1/24/12 at 9:45 a.m. revealed the patient came into the hospital due to a motor vehicle accident. She had a physician order for 10 ml to 20 ml of Lortab (hydrocodone and acetaminophen, a controlled medication for mild to moderate pain) liquid every 4 hours as needed. The record showed on 1/20/12 at 7:42 p.m., 15 ml of Lortab was given but there were no documented evidence pain score, pain location, and pain assessment were conducted before or around the time of medication administration in the EMR. The medical records lacked a baseline pain assessment at the time of the pain relief intervention.

In a concurrent interview and record review Patient 31's EMR revealed the patient came into the hospital for L4-5 (spine) decompression (back surgery for pain relief) and had a physician order for Norco (pain medication) one to two tablets every four hours as needed. The record showed two tablets were given on 1/23/12 at 2:06 p.m. but there were no documented evidence of pain assessment, pain location, and pain score before or at the time of the Norco administration. RN 17 said the nursing staff was required to document pain score, pain location, assessment, and any intervention any time an "as needed" pain medication was given.

Patient 32's EMR was reviewed with RN 8 and NM 4 on 1/24/12 at 11 a.m. The record showed on 1/24/12 at 7 a.m., the patient had a pain score of "7" (moderate-severe pain) and required one dose of oral morphine for pain relief. However, there was no documented re-assessment of the pain relief and intervention effectiveness within one hour of the morphine administration. Both RN 8 and NM 4 confirmed the finding.

The hospital's policy and procedure entitled "Pain Management and Pain Intensity Scale", revised 3/3/11, indicated, "Prior to providing pain relief intervention, it is necessary to obtain a baseline pain level. Between 15 and 60 minutes after providing any pain relief intervention, effectiveness of the pain relief measure is assessed and documented in the appropriate electronic medical record area."

6. A review of Patient 66's EMR in the ED with an ED registered nurse (RN 18), NM 4, and the pharmacy director (Pharm 1) was conducted on 1/24/12 at 4 p.m. Patient 66 was admitted to the hospital for a motor vehicle accident. While at the ED, she had a physician order for hydromorphone 0.2 milligram (mg) to 0.6 mg to be given intravenously every 2 hours as needed. The medication administration record indicated an ED nurse administered two doses of 0.6 mg each at 1:19 a.m. and 3:29 a.m. on 1/24/12. The Pyxis (automated dispensing cabinet) report indicated the same said nurse withdrew only one 1-ml vial of hydromorphone 2 mg/ml during this period and wasted the amount of 0.8 mg at 4:35 a.m. This information indicated two doses (1.2 mg total) were withdrawn and administered to the patient from one single-use vial. Pharm 1 said the hydromorphone 2 mg/ml 1 ml vials were for single-use only.

In an interview on 1/24/12 at 4:15 p.m., the ED Nurse Manager (NM 5) verified the finding and said that single dose vials were to be used one time only; the unused portion should have been wasted and not kept for multiple administrations.

The hospital's policy and procedure entitled "Medications/Solutions, Vaccines in Single and Multiple Dose Vials", revised 9/1/11, indicated, "1. Medication in a single dose vial (contains no preservatives) shall not be used for more than one dose, nor for more than one patient. 2. Any unused portion of the medication shall be appropriately discarded immediately."

The review of Patient 66's EMR also revealed that hydromorphone was not administered as ordered by the physician. The order indicated to give the medication every two hours as needed. The ED medication administration record indicated one dose was given at 11:58 p.m. on 1/23/12 and again at 1:19 a.m. on 1/24/12, 1 hour and 21 minutes apart.

The EMR also revealed when the patient was at the P3 Unit (nursing unit) on 1/24/12, the patient had a physician order for hydromorphone 0.2 mg to 0.4 mg every 2 hours as needed. The record indicated two consecutive doses were administered at 5:11 a.m. and 6:07 a.m., less than 1 hour apart. RN 3 and NM 4 verified the finding.

Based on staff interview, medical record and document review, the hospital failed to ensure that all medical records were accessible to care providers and accurately written to show the chronology of care delivery, in accordance with hospital policy, medical staff rules and regulations, and standards of practice. This failure occurred when shared and pended notes did not clearly identify the times and authors of all medical record entries for 3 of 3 sampled patients (Patients 31, 44 and 49). This failure posed a risk for errors from mis-information among care providers who rely on the clarity and accuracy of entries to reflect each patient's condition and the rationale for the care decisions, which are critical features for safe and continuous care.

Findings:

1. Concurrent review on 1/23/12 at 5:30 p.m. of the medical record for Patient 31 with MD 5, who supervised the provision of anesthesia care to Patient 31 for spine surgery earlier that day, indicated that a pre-surgical assessment was documented by a resident physician in training (MD 25). The surgery and anesthesia care were performed on 1/23/12 between 7:15 a.m. and 11:30 a.m. The pre-surgical assessment was signed by the resident physician on 1/23/12 at 1:57 p.m. (7 hours after the care was initiated rather than prior to the care), and signed by the supervising physician (MD 5) also on 1/23/12 at 1:57 p.m. MD 5 stated that MD 25 started the assessment note the day before surgery, but whatever was started was placed in a "pending" and "shared" status and not officially part of the legal medical record until it was signed. While in a shared status, multiple providers were able to add information to the initial note. MD 5 indicated that because the note was not signed until many hours after the pre-surgical assessment should have been performed, several portions of the note were added and downloaded into it (e.g. vital sign measurements and laboratory results obtained after surgery) and were not chronologically part of the pre-surgical assessment. Thus the pre-surgical note was not accurate and did not reflect the chronology of care provided. Neither front-line clinical provider staff nor health information technology staff were able to show when the pre-surgical note was started, when the patient examination (integral to the performance of the assessment) was performed, or when additional entries were made while the note remained in the shared or pended state (as care was being delivered), prior to entering the final signatures at 1:57 p.m.

Review of recommendations from the American Health Information Management Association (AHIMA) titled "Update: Maintaining a Legally Sound Health Record - Paper and Electronic," [source: AHIMA e-HIM Work Group on Maintaining the Legal HER, Journal of AHIMA 76, no. 10, November-December 2005] documented, "Authentication shows authorship and assigns responsibility for an act, event, condition, opinion, or diagnosis ... Each organization should establish a definition of a legally authenticated entry and establish rules to promptly authenticate every entry in the health record by the author responsible for ordering, providing, or evaluating the service furnished." AHIMA further directed that medical record entries should be made as soon as possible after an event or observation was made. An entry shall never be made in advance. The record must reflect the continuous chronology of the patient's healthcare. The chronology must be readily apparent in any given view. Every entry must include a complete date and time, accessible by the reviewer.

2. Concurrent review on 1/24/12 at 3:15 p.m. of the medical record for Patient 49 with RN 21, who specialized in health information technology for quality review purposes, indicated that Patient 49 was treated in the Emergency Department (ED) on 1/23/12 starting at 11:28 a.m. An ED physician assessment note was started by a supervising physician (MD 30) on 1/23/12 at 4:31 p.m. as a shared document. The electronic revision history for each identified "version" of the assessment note showed entries at 5:38 p.m. as an edit by MD 30, at 7:07 p.m. as an edit by a resident physician (MD 16), and 11:45 p.m. as signature by MD 30. RN 21 could not demonstrate the actual entries made at each encounter on the retrieved versions for each entry time. Only by putting each version side by side could it be determined that MD 16 changed a single phrase from "Utox ***" to "Utox negative" as the entry to his edit at 7:07 p.m. Information (laboratory test results) was added to the final version but that version was described as a signature, not as an addendum or edit plus signature. All early versions included MD 30's signature, even though it was not entered until 11:45 p.m. RN 21 could not produce the original entries from when the note was started.

In an interview on 1/26/12 at 3:20 p.m. with the Director of Health Information Management (HIM-2), HIM-2 stated that the shared assessment notes did not readily identify the authors for edits and added information by date and time of entry in the final legal version of the electronic medical record. The final version would be the document provided when requested by a patient or outside entity. To determine the content of entries provided by the authors listed in the revision history required digging into the "back side" of the system, which would not be produced (multiple versions) for a record request. HIM-2 claimed that the edit entries were identified by the appearance of bolded type. However, the 3 versions provided by RN 21 for Patient 49 showed bolded type for identical entries on each of the 3 versions (for statements under the physical examination portion of the assessment). The edit alteration made by MD 16 related to "Utox" did not appear in bolded type.

Review of the medical record for Patient 44 with HIM-1 on 1/26/12 at 3:20 p.m. showed bolded type entries (without identified date, time, author) on identical sections of each of 4 versions of a shared ED note for care provided to Patient 44 on 1/23/12 between 2:22 p.m. and 4:13 p.m.

3. Additional review on 1/24/12 at 5 p.m. of the medical record for Patient 49 with the Chief of Staff (COS), who served as a clinical director for the ED, indicated that the ED physician assessment note for Patient 49 documented the treatment plan was to transfer Patient 49 to an outside hospital. However, Patient 49 was not transferred to a hospital, but was discharged home (according to the nursing notes) on 1/24/12 at 1:57 p.m. No further edits, addendums, or separate notes by the ED physicians were made to reconcile the change in the treatment plan, finalized by MD 30 on 1/23/12 at 11:45 p.m. A separate note by a consulting specialist documented a recommendation to discharge home and not transfer. But the consultant was not listed as the ED attending physician and did not directly issue the treatment orders and instructions for Patient 49. No additional notes by ED physicians were documented to reconcile a change in the treatment plan (to show they were aware of the consultant's recommendation and to show they agreed with the consultant or not). Thus, the continuity and clear direction of care for Patient 49, by the physicians responsible for his care, was not documented.

Review of recommendations from the American Health Information Management Association (AHIMA) titled "Update: Maintaining a Legally Sound Health Record - Paper and Electronic," [source: AHIMA e-HIM Work Group on Maintaining the Legal HER, Journal of AHIMA 76, no. 10, November-December 2005] documented specific procedures to make changes or clarifications (corrections and amendments) to the electronic medical record. Previous information should not be deleted or written over. When information was not written in a timely manner, subsequent entries should be identified as late entries, with date, time and author identified. An addendum was considered a type of late entry that was used to provide additional information in conjunction with a previous entry. The addendum should be identified with date, time, author, reason for writing the addendum, and entered as soon as possible after the original note. Regarding the management of multiple document versions, "once documentation has been made available for patient care, it must be retained and managed regardless of whether the document was authenticated."

Review of policy 2307 titled "Medical Record Documentation Standards," revised 8/28/11, under item II-C noted that all entries in the medical record must be dated and timed, including progress notes, patient assessments, and history and physical examination assessments (e.g. pre-surgical assessments). Item II-F-3 documented that every entry in the medical record must be authenticated by the author (with certain exceptions that did not include anesthesia or ED notes). Item II-F-8 noted that documents with multiple entries or sections should have a method to identify the author of each section. Item II-H-2(a) noted that edits, corrections or addendums to any patient record must indicate the date, time, and name of the person making the revision. The original entry must still be accessible. Item II-H-3(c)(1) directed, "After editing a note, it should be signed and the encounter closed. If additional corrections are required after a note has been edited once, an addendum should be created. Residents may not edit notes by other staff." Contradicting this last part of the policy was item II-H-3(d) which permitted initial notes in the ED to be "shared" and edited multiple times (no limit) throughout the encounter until signed by the attending physician. Finally, item II-O-2 documented that medical information created within the electronic medical record must be reproducible in paper form.

In an interview with the COS on 1/23/12 at 1 p.m., the COS indicated the following processes: ED physicians documented their notes in a shared/pended portion of the electronic system that was not available to all staff, until the notes were signed and finalized. There was no limit for how long a shared/pended note may exist in that state. It was possible for ED patients to spend up to 24 hours (or longer) in the ED before a final version might be completed. Patients routinely were handed off from one physician to another, and to another after that, over the course of their stay. But there was no provision for the physician information to be shared and available to all provider staff involved with the care of ED patients. In interviews with clinical frontline staff on 1/23/12 in the post-surgical care unit, and on 1/24/12 with nursing staff, staff were not able to demonstrate how to validate the date, time and author of various entries in these shared notes, to show what was accessible and when, and to validate the chronology of care as documented.

Review of the July 2011 Medical Staff Rules and Regulations documented under item IX-A and IX-B that physician medical staff members were responsible to maintain each medical record as complete, accurate and current. "All entries to the medical record must be legible, complete, dated, timed and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided. All authenticators shall be clearly identified."

Based on medical record review and pharmacy staff interview the hospital failed to ensure enteral nutrition verbal orders developed by the pharmacist were authenticated within hospital specified parameters of 48 hours for 2 of 80 sampled patients (Patients 23 and 25).

Findings:

Patient 23 was admitted with diagnosis of cancer. Medical record review was conducted on 1/24/12 beginning at approximately 1:30 p.m. Admission physician order was NPO (nothing by mouth). On 1/4/12 the pharmacist completed a standardized order titled "Adult Parenteral Nutrition Orders." Parenteral nutrition provides nutrition through a vein (American Society of Enteral and Parenteral Nutrition, 2012). It was also noted that the pharmacist documented a verbal order from the physician for the initiation of feeding. There was no documentation that the physician signed the nutrition orders after verbally approving the feeding. Similarly the pharmacist completed additional parenteral nutrition orders dated 1/8, 1/10 and 1/19/12. The pharmacist also entered these orders into the electronic medical record. There was no authentication of any of the orders by the physician.

Similarly Patient 25 was admitted with symptoms of significant weight loss, poor intake and fatigue. Admission diet order dated 1/15/12 was NPO. On 1/19/12 the pharmacist filled out the parenteral nutrition order for and documented a verbal order from the nurse practitioner responsible for the care of the patient for initiation of feeding. There were additional verbal orders dated 1/20, 1/21 and 1/22/12, none of which were authenticated by the nurse practitioner responsible for the care of the patient.

In an interview on 1/26/12 at 9 a.m., with Pharmacist 3 she stated that once it was determined that a patient required parenteral feeding, the order form would be filled out and an order obtained, then the form would be faxed to the pharmacy. She also stated that the original form would be placed in the cart with the intention that the physicians authenticated the order at a later time. She also stated that the parenteral nutrition ordering process was the only pharmacy function that was not in the electronic medical record system. Pharmacist 3 also stated that the orders were entered as a "verbal" order since they were speaking with the physician on the phone. She also stated that when entering electronic orders there was a drop down menu that had 4 selections. She further stated that with respect to pharmacy orders the drop down selections were either a verbal order with readback or a transcribed order. There was no selection for telephone orders.

Hospital policy titled "Physician Orders" revised 5/11/2011 revealed that "1. Verbal orders are to be used infrequently and limited to those situations in which it is impossible or impractical for the ordering provider to enter the order in the EMR ...5. Verbal orders must be cosigned by the ordering provider within 48 hours from the date and time the order was entered ..."

Based on observation, interview and facility document review, the hospital failed to discard a medication in accordance with facility guidelines and accepted professional principles.

Findings:

On 1/24/12, at approximately 9 a.m. in the medication room, during the preparation of medications to be administered to Patient 39, RN 6 was observed to withdraw two isosorbide dinitrate (a medication indicated for heart disease) 10 mg tablets from the ADC. RN 6 cut one of the tablets in half and discarded the remainder ? tablet in the trash can.

During a concurrent interview, RN 6 confirmed the medication disposal in the trash can. RN 6 then summoned her supervisor to the medication room, who indicated the discarded medication should have been placed in the pharmaceutical waste container adjacent to the sink in the medication room.

Review of the hospital document (undated) posted on the medication room wall adjacent to the sink, "Managing Pharmaceutical/Drug Waste at [hospital name]" indicated a picture of a plastic blue and white labeled container. Adjacent to the picture was the following printed information: "Pharmaceutical Waste Container (white/blue) is for....Solid meds like pills." The document further indicated: "No Drug Waste to These Containers" above a picture of a trash can.

Based on staff interviews and record reviews, the hospital failed to ensure the process for medication reconciliation (a process of maintaining and communicating accurate medication information across the continuum of care) was conducted in a timely manner, resulting in a prescribing error for one of 80 Patients (70). Consequently, the patient suffered a narcotic (opioid) overdose and required two doses of Narcan (to reverse an opioid overdose). Also, the hospital pharmacist failed to intervene when there was a potential for overdose/increased adverse effects when two high-dose long-acting opioid medications (MS Contin and Oxycontin) were prescribed concomitantly for Patient 70. The failure to intervene resulted in the failure to identify a prescribing error.

Findings:

A review of Patient 70's Electronic Medical Record (EMR) was conducted on 1/25/12 at 2 p.m. with two clinical information service staff and Pharmacist (Pharm) 1.

Patient 70 was scheduled for a "right elbow revision arthroplasty" (surgical repair of the elbow) on 1/20/12. One day prior, she was seen by the Orthopaedic Clinic where an update of her current medications would have been obtained. The 1/19/12 history and physical (H&P) by the clinic documented her current pain medication included MS Contin (no indicated strength) only.

After being admitted to the hospital, she was prescribed Oxycontin 100 (80 mg and 20 mg) three times daily (300 mg total, a high dose of long-acting oxycodone, potent narcotic for pain) and MS Contin 100 mg orally twice daily (200 mg of long-acting morphine, a high dose) concomitantly on 1/20/12.

The EMR revealed the patient received two doses of Oxycontin on 1/20/12 at 3:40 p.m. and 9:52 p.m. and none of the MS Contin. The MS Contin was held due to the patient's
condition of "low blood pressure and somnolent" per nursing notes. She also received two "as-needed" doses of Fentanyl (short acting narcotic) 25 mcg for breakthrough pain on 1/20/12. On 1/21/12, the patient received two doses of Narcan, at 4:15 a.m. (about 6 hours after the last Oxycontin dose) and at 7 a.m. The 1/21/12 General Medicine Consult Note indicated the patient was "noted overnight to have low BP in the 80s systolic. Early this AM patient was somnolent and difficult to arouse. Patient was given a dose of Narcan and she woke up and began responding appropriately." Under assessment and plan, the Consult Note indicated the reason for "AMS" (altered mental status): "Likely 2/2 to narcotic overdose as patient woke up with Narcan."

The pharmacist's note on 1/21/12 at 10 a.m. (after Narcan doses had been given) indicated a pharmacist had discussed with the patient about the recent home medications and discovered she was no longer taking Oxycontin - she was only taking MS Contin prior to being admitted to the hospital; her Oxycontin was replaced with MS Contin due to insurance non-coverage. he pharmacist then "flagged for removal" of the Oxycontin from the pain medication regimen.

An interview with the chief medical officer (CMO) was conducted on 1/25/12 at 4:10 p.m. in the presence of Pharm1 and Pharm 2. He stated that although the H&P medication list was accurate, the specialist at the Orthopaedic Clinic failed to update the electronic home medication list, as required, on 1/19/12, thus resulting in an error. The home medication list, which includes the patient's past and current medications, is an electronic record accessible by the patient's care providers to assess medication use and to base their decision whether to continue/discontinue medications during the a particular visit. The home medication list included both MS Contin and Oxycontin as active orders when Oxycontin was no longer an active order. The failure to update the electronic home medication list led the hospital physician to prescribe both the MS Contin and Oxycontin. The CMO said, "it was a prescribing error" that both Oxycontin and MS Contin were prescribed.

The hospital policy and procedures on "Medication Reconciliation", revised 9/2/11, indicated, "All patients, upon presentation to the Medical Center (including inpatient, outpatient, emergency room and Home care service), should have medication reconciliation performed during relevant encounters and based on the clinical judgment of the the clinician" and "a record of the patient's most current medication therapy shall be communicated to or readily accessible by the next provider of care and original provider whenever a patient is referred or transferred to another setting, service, provider or level of care within or outside of the medical center."

On 1/25/12 at 4:15 p.m., during the interview as above, Pharm 1 said there were no documented evidence of any interventions by the pharmacist who reviewed the orders of MS Contin and Oxycontin for Patient 70. Pharm 2, a pain management pharmacist, said he would have questioned and consulted with the physician's about the concomitant use of such orders. Pharm 1 also said the pharmacist should have questioned the orders.

Lexi-Comp, a nationally recognized drug information resource, indicates that "adverse/toxic effect" of each medication would be enhanced when MS Contin and Oxycontin are used together.

Based on observation, interview and facility document review the hospital failed to segregate an expired I.V. (intravenous, through the vein) solution from current supplies in the CIVA (Central I.V. Admixture) pharmacy; and properly date two doses of injectable lorazepam (an anti-anxiety medication) to ensure stability outside of the refrigerator; and properly date one 50 mL minibag of 0.9% sodium chloride (normal saline) to ensure it did not exceed its stability date outside of the plastic overwrap pouch.

Findings:

1. An inspection of the CIVA pharmacy was conducted on 1/23/12 at approximately 12:10 p.m. Observation of a metal rack (with six bins used for storage of one liter bags of various types of I.V. solutions in their plastic outer wrap) revealed a 1000 mL (milliliter) bag of injectable 5% dextrose and 0.2% sodium chloride premixed with 20m Eq of potassium chloride (indicated for replacement of fluids and potassium, an essential element in body cells); the bag contained no plaster outer wrap and was affixed with a pharmacy patient label indicating a hand-written expiration date of 11/28/11 (57 days prior to the date of inspection).

During a concurrent interview, Pharm 6 verified the product's expiration date and stated, "That should not be in there." Pharm 6 confirmed the multi-bin storage area should contain I.V. solutions available for current patient use and should not contain expired products.

Review of the hospital policy 251:02 Pharmacy Area Inspections, dated 6/4/10, under III. Procedure, item A, indicated: "Each Pharmacy area shall be inspected approximately every thirty (30) days, and the questions on the Pharmacy Area Monthly inspection sheet will be answered by the responsible pharmacist....D. 1a. Drugs expire on the last day of the month unless labeling gives a specific date that includes a day."

Review of the CIVA Pharmacy Area Monthly Inspection document (dated 12/5/11 and signed by a pharmacy technician and pharmacist) indicated that no expired I.V. solutions were identified by the pharmacy technician who inspected that area during the prior month.

During an interview on 1/25/12 at 11:20 a.m. Pharm 5 verified a pharmacy technician had inspected the CIVA on 12/5/11 and did not identify an expired I.V. product.

2. An inspection of the T6 CICU (tower 6 cardiovascular intensive care unit) ADC (automated dispensing cabinet, a room temperature electronic device accessed by licensed nursing staff for medication dispensing) on 1/23/11 at approximately 3:45 p.m. An inspection of a cabinet pocket designated for injectable lorazepam (anti anxiety medication) 2 mg/mL (milligrams per milliliters) was conduction. The pocket contained multiple prefilled lorazepam 2 mg/mL syringes each affixed with paper adhesive labels designating stability/expiration dates of 3/3/12 , 2/29/11 and 3/21/12 [the adhesive labels designated when the lorazepam was removed from the refrigerator]. Also found were two loose prefilled syringes of lorazepam 2 mg/mL that did not have stability/expiration labels.

During a concurrent interview, NM 1 and Pharm 3 were unable to specify when the two loose prefilled syringes of lorazepam 2 mg/mL were removed from the refrigerator, which would determine their room temperature stability.

Review of the hospital document provided by Pharm 3 (dated 1/24/12) from the injectable lorazepam manufacturer indicated that refrigeration was "strongly recommended." The document further indicated that the manufacturer could support product potency when stored outside of the refrigerator (at room temperature) "up to 3 months."

Review of the hospital policy 251:01 Pharmacy Oversight of Medications Stored Outside Pharmacy Areas, dated 2/11/10, under II. Policy, item A, indicated: " Pharmacy is responsible for appropriate storage and use of medications throughout the Health System...."

3. An inspection of locked medication storage areas in OR (operating room) 23 on 1/24/12 at approximately 3:15 p.m. identified a multi-drawer metal supply cart containing surgery supplies and I.V. fluids. The contents of one drawer revealed a 50 mL minibag of 0.9% sodium chloride (normal saline) used for dilution of medications for I.V. administration; the minibag was not contained within the manufacturer's plastic overwrap pouch.

Review of the hospital document provided by Pharm 3 (dated 1/24/12) from the I.V. fluid manufacturer indicated: "The purpose of the overwrap pouch is to retard moisture evaporation ....[the product manufacturer] recommends only removing the overwrap from the [proprietary name] plastic container just before the drug or solution is to be administered....containers may be stored at room temperature for no more than the following time periods: 50 mL or less....15 days."

During a concurrent interview, NM 10 was unable to specify when the 50mL minibag of normal saline contained within the supply cart was removed from the overwrap pouch.

Based on interview, record review and facility document review, the hospital failed to immediately notify the physician regarding one episode of hypoglycemia (low blood sugar, an adverse drug reaction related to insulin) for one sampled patient (Patient 36); and report episodes of hypoglycemia to the hospital-wide QAPI program for two of 80 sampled diabetic patients receiving insulin (Patients 36 and 37) in accordance with their policy.

Findings:

1a. Clinical Electronic Medical Record (EMR) review revealed Patient 36 was a 72 year-old trauma (motor vehicle collision) patient admitted to the facility on 12/16/11 with spinal injury and multiple fractures; medical history included Diabetes Mellitus II (non-insulin dependent). Patient 36 was receiving liquid nutrition enterally (through a feeding tube).

Review of Patient 36's Physician Orders included the following insulin orders: Lantus insulin (long-acting) 30 units subcutaneously (injected underneath the skin) daily at bedtime (ordered 1/8/12); regular (short-acting) insulin 4 units subcutaneously every 6 hours (ordered 1/9/12); and regular insulin sliding scale (amount to be administered subcutaneously based on assessed blood sugar results every six hours).

Further EMR review indicated Patient 36 underwent a surgical procedure on 1/18/12; enteral feedings were held after midnight on the same day.

Patient 36's EMR MAR revealed that on 1/18/12 at 6:15 a.m. 25 grams of dextrose (sugar water solution) was administered I.V. by a licensed nurse for an assessed blood sugar of 53 mg/dL (milligrams per deciliter). Review of the licensed nurse's note indicated Patient 36's physician was not notified of the episode of low blood sugar.

Review of Patient 36's Patient Care Orders indicated: "Notify House Officer of hypoglycemia treatment of BG (blood glucose) less than 70 mg/dL."

During an interview on 1/25/12 at approximately 2 p.m. Nurse Manager (NM) 2 verified Patient 36's clinical EMR findings and that his physician was not notified of the low blood sugar and need to administer I.V. dextrose on 1/18/12.

During an interview on 1/25/12 at approximately 5:20 p.m. Pharmacist (Pharm) 7 confirmed that an online incident report had not been filed by licensed nursing staff or a pharmacist related to Patient 36's episode of hypoglycemia on 1/18/12.

1b. Further review of Patient 36's EMR revealed an additional surgical procedure was performed on 1/20/12; enteral feedings were held on 1/19/12.

Patient 36's EMR MAR (medication administration record) revealed that on 1/20/12 at 5:45 a.m. 25 grams of dextrose was administered I.V. by a licensed nurse for an assessed blood sugar of 44 mg/dL.

During an interview on 1/25/12 at approximately 2 p.m. NM 2 verified Patient 36's clinical EMR findings.

Review of the hospital policy 1633 Medication Related Event Management Program (revised 2/14/11) indicated under III. Definitions and Descriptions, item F: "ADVERSE DRUG REACTION (ADR): Any undesired response associated with the use of a medication that requires medical intervention or a significant alteration in therapy." The policy further indicated under IV. Medication Event Related Reporting, item B. Adverse Drug Reaction Reporting, number 1: "When a pharmacist or nurse becomes aware of an adverse reaction, he/she should immediately assure the responsible medical service is aware, initiate appropriate therapy adjustments with responsible physician and complete an online incident report."

Lexi-Comp ONLINE, a nationally recognized drug information source, indicated that the most common adverse effect of insulin is hypoglycemia (low blood sugar). Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death.

According to the American Diabetes Association, normal fasting (before meals) blood sugar ranged from 70 - 130 mg/dL.

During an interview on 1/26/12 at 12:20 p.m. Pharm 3 confirmed that an online incident report had not been filed by licensed nursing staff or a pharmacist related to Patient 36's episode of hypoglycemia on 1/20/12.

2. Closed EMR review revealed Patient 37 was a 65 year-old admitted to the facility on 1/16/12 with diagnoses including Diabetes Mellitus type II (non-insulin dependent) and squamous cell carcinoma (a type of skin cancer) of the head and neck. Patient 37 was receiving liquid nutrition through a gastrostomy tube (GT) (tube surgically placed in the stomach for the administration of liquid nutrition and medications).

Patient 37's Physician Orders included an order for regular insulin sliding scale and fingerstick blood sugar assessments every six hours (at 6 a.m., 12 noon, 6 p.m. and midnight).

Review of Patient 37's Internal Medicine Admission History and Physical EMR indicated a history of resection of the jaw and floor of the mouth; a flap of skin from Patient 37's fibula (leg bone) had been grafted to the jaw area June 2011 and was poorly healing; ENT (ear, nose and throat physician) had planned for surgery on 1/23/12 to reconstruct the area.

Review of Patient 37's Glycemic Control EMR indicated on 1/21/12 she received GT feedings and on 1/22/12 the feedings were stopped in advance of the surgery (NPO status).

Review of Patient 37's EMR MAR indicated no sliding scale insulin had been administered from 1/16/12 through 1/21/12. Patient 37's 1/22/12 EMR MAR revealed that at 12:27 a.m., a licensed nurse administered 2 units of regular insulin for an assessed fingerstick blood sugar of 193 mg/dL. The record further indicated that on 1/22/12 at 6:11 a.m. 25 grams of dextrose was given I.V. by licensed nursing staff for an assessed low blood sugar of 33 mg/dL; another 25 gram dose of dextrose was given I.V. at 11:55 a.m. for an assessed low blood sugar of 54 mg/dL.

During an interview on 1/26/12 at approximately 12:15 p.m. NM 2 verified Patient 37's clinical EMR findings. During a concurrent interview, Pharm 3 confirmed that an online incident report had not been filed by licensed nursing staff or a pharmacist related to Patient 37's two episodes of hypoglycemia requiring I.V. Dextrose administration on 1/22/12.

Based on food storage observations the hospital failed to ensure effective procedures to ensure that foods were:
1) stored per manufacturers' guidance and
2) expired spices were discarded.
The failures [effective food storage systems] had the potential of decreased palatability of meals and decreased dietary intake of patients in the acute setting.

Findings:

1) During initial tour on 1/23/12 beginning at 12:30 p.m., it was noted that in refrigerator RR3C there was a case of bagels as well as multiple bags of bread and English muffins that were in the refrigerator. It was noted that on the exterior of the box the manufactures' recommendation was to "Keep Frozen." In a follow up observation on 1/24/12 beginning at 10 a.m., it was noted that dietary staff continued to store bread in the refrigerator. In a concurrent interview with a Dietary Manager Staff (DMS 2) he stated that storage of opened bread items as well as the bagels was the regular storage method for staff. The recommended method for bread storage is either at room temperature of frozen. Scientific studies have shown refrigerated bread storage draws out the moisture and the bread becomes stale faster (University of Alaska-Food Storage, 2009).

2) During review of food storage practices in the cafeteria on 1/24/12 beginning at 3 pm, it was noted that there were greater than 10 containers of spices that were opened and undated. In addition it was noted that there was white pepper, baking soda and cumin with delivery dates ranging from 7/10 to 8/10. In a concurrent interview with DMS 2 he stated that the hospital policy was to discard items that were greater than 12 months old.

Based on observation, staff interviews, and document review, the hospital failed to ensure:
1. The nutritional needs of the patients were met in accordance with recognized dietary practices when menus were not analyzed to ensure they met Recommended Dietary Allowances or the Dietary Reference Intake (DRI) of the Food and Nutrition Board or the National Research Council for Fiber, Calcium, Iron, Vitamin D, Vitamin E, Biotin and Foliate;
2. The Renal diet did not meet the diet manual description.; and
3. Two of 80 sampled patients (22 and 77) and random patients (Patient 80 and 81) were not assessed in a timely manner according to hospital policy. This put patients at risk of menus not providing required nutrients and compromising medical care.

Findings:

Foodservice

1. Registered Dietitian 1 (RD 1) and RD 2 were asked for the nutrient analysis of the menus. Review of the regular menu indicated the daily average of dietary fiber was 12.9 grams (g) per day; calcium was 795 milligrams (mg); and 8.79 mg of iron. Further review of the regular menu indicated there were minimal levels of Vitamin D; one day indicated only 0.7 micrograms (mcg); 3.55 mg of Vitamin E; 185 mcg of Foliate; and no values for Biotin. Review of the low fat and low cholesterol menu indicated there was 17.3 g of fiber per day.

Review of the Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes for Elements, indicated for Calcium that males and females between 19 through 50 years of age to receive 1,000 mg; females between the age of 51 though 70 to receive 1,200 mg; and females and males greater than 70 years of age is 1,200 mg. The DRIs for Calcium are dated 1997. The hospital menu was inadequate in Calcium depending on the age and gender by 205 through 405 mg. It indicated for Iron that for females between 19 through 50 years of age to receive 18 mg. The DRIs for Iron are dated 2001. The hospital menu is inadequate for Iron by 9.21 mg.

Review of the Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes for Vitamins, indicated for Vitamin D that females and males between 19 and 70 years of age is 15 mcg; and females and males greater than 70 years of age is 20 mcg. The DRIs for Vitamin D are dated 2011. The hospital menu is inadequate in Vitamin D depending on age and gender by 14.3 through 19.3 mcg. It indicated for Vitamin E that males and females between 19 through greater than 70 years of age are to receive 15 mg. The DRIs for Vitamin E are dated 2000. The hospital menu is inadequate for Vitamin E by 11.45 mg. It indicated for Foliate for males and females between 19 through greater than 70 years of age are to receive 400 mcg. The DRIs for Folate are dated 1998. The hospital menu is inadequate by 215 mcg. It indicated for Biotin for males and females between 19 through greater than 70 years of age are to receive 30 mcg. The DRIs for Biotin are dated 1998. The hospital menu is completely inadequate for Biotin.

Review of the DRI for Macronutrients, dated 2002/2005, indicated total fiber for males 19 through 50 years of age is 38 g; and 50 through greater than 70 years of age is 30 g; females nine through 18 years of age is 26 g; 19 through 50 years of age is 25 g; 50 through greater than 70 years of age is 21 g. The hospital menu is inadequate in Fiber depending on the age and gender by 8.1 through 25.1 g.

On 1/26/12 at 1:35 p.m. an interview was conducted with RD 1 and RD 2 regarding the analysis of the menus. RD 1 stated when they analyzed the menus they looked at the macronutrients which were carbohydrate, protein, and fat to make sure they were meeting the appropriate amounts. RD 2 stated depending on the diet they would look at micronutrients, like the renal diet for potassium, sodium, phosphorus. RD 1 stated when they did the menu they also made sure there was a daily serving of Vitamin C and two to three servings of calcium. RD 1 stated for the pediatric and OB (pregnant or lactating patients) menu they had three servings of calcium to meet the recommended intakes. When asked, RD 1 stated they analyzed their menus using a computerized nutrition software program. RD 1 stated that depending on the product they may not have all the nutritional information input into the program. RD 1 stated sometimes they use a nutrition label not the information from the USDA (United States Department of Agriculture) database which would make the analysis not completely accurate. RD 1 stated they could probably go back and re-analyze the menus and pull more items from the USDA database to get a more accurate analysis. RD 1 and RD 2 acknowledged that their non-select menu should meet the DRIs.

The menu analysis could not ensure the quantifiable amounts of these nutrients were provided for the diets.

2. Review of the diet manual indicated the renal diet provided approximately 80 grams (g) of protein, two g of potassium, two g of sodium and less than 1200 milligrams of phosphorus per day.

Review of the renal menu indicated on Fridays's the patients would receive 111.8 g of protein and on Saturday the patients would receive 87 g. The daily average showed the renal diet provided 86.3 g of protein.

On 1/26/12 at 1:35 p.m. an interview was conducted with RD 1 and RD 2 regarding the analysis of the renal menu. RD 1 stated when they analyzed the menus they looked at the macronutrients which were carbohydrate, protein, and fat to make sure they were meeting the appropriate amounts. RD 2 stated depending on the diet they would look at micronutrients, like the renal diet for potassium, sodium, phosphorus. RD 1 and RD 2 were not aware that the protein levels were that high on those days and acknowledged those levels were not in accordance with their diet manual.

Clinical Nutrition

3. Review of the clinical record for Patient 22 was initiated on 1/25/12. Patient 22 was admitted on 1/14/12 with diagnoses of cellulitis and sepsis (severe illness in which the bloodstream is overwhelmed by bacteria). Patient 22 had a medical history which included hepatitis C (an infectious disease affecting primarily the liver, caused by the hepatitis C virus), liver disease, and right lower extremity ulcerations (sores). Review of the physician's orders dated 1/14/12 indicated a regular diet. Review of the physician's orders dated 1/17/12, indicated an order for a multivitamin, folic acid and thiamine. Review of the physician's orders dated 1/24/12 indicated an order for Ensure Clinical Strength (oral nutrition supplement with extra calories and protein).

Review of the wound care consult note dated 1/18/12, indicated Patient 22 had 2 right lower extremity leg wounds. The anterior leg wound was measured as 7.5 by 5.5 centimeters (cm); and the posterior leg wound was measured as 7 by 4.5 cm. The plan included to maximize nutrition and hydration.

Review of the nutrition flow sheet dated 1/14/12 at 8:38 a.m. through 1/25/12 at 1:00 p.m. indicated Patient 22 had no documented intakes for percent meal intake for 7 of those meals. It also indicated Patient 22 ate 50 % or less of her meal 15 times out of the 28 documented meal intakes. Approximately 53% of the time, Patient 22 ate fair to poor. It indicated that Patient 22 ate 25% or less of her meal 12 out of the 28 documented meal intakes. Approximately 43% of the time, Patient 22 ate poor.

Further review of Patient 22, indicated there was no nutritional assessment or note in the record.

On 1/25/12 at 2:09 p.m. an interview was conducted with RD 4. RD 4 stated the patient had a nasty wound and they should have seen the patient by day nine of admission since nothing else would have brought them in to see her any sooner. RD 4 stated they would use clinical judgment to determine if this patient was at nutritional risk. When asked, RD 4 stated he did not know why the patient was receiving a nutrition supplement.

Review of the policy titled " Nutrition Screening/Level of Care " dated 9/11 revealed that All patients not identified "at nutrition risk" at time of admission will be re-evaluated by the Dietitian, within 7-9 days, to determine if any acute issues have arisen during length of stay. The policy also guided that decreased intake and the development of pressure ulcers would indicate nutritional risk.

Based on observation, staff interviews and document review, the hospital failed to ensure the overall environment was developed and maintained in such a manner that assured the safety and well-being of the patients when the Director of Food and Nutrition Services failed to maintain:
1. A detailed disaster menu and food plan for patients and staff;
2. An adequate amount of bottled water on hand in case of a disaster for patients and staff; 3. A disaster menu for staff; and
4. Enough food on hand to feed staff in the event of a disaster.

Findings:

During an observation and review of the hospital's disaster food plan and supplies, the inventory list of disaster food on hand was reviewed on 1/23/12 at approximately 4:00 p.m. with the Dietary Service Manager 3 (DSM). In a concurrent interview, when asked; DSM 3 stated the person who was responsible for the disaster plan was off today so he was unsure how many patients and staff the disaster menu would feed. DSM 3 stated the kitchen was responsible for the drinking water only. Review of the inventory list indicated there was no bottled water. In a concurrent observation, there were 392 cases of bottled water counted.

On 1/24/12 at 10:20 a.m. an interview was conducted with a Registered Dietician (RD) 2 regarding the disaster menu. RD 2 stated they were responsible for the drinking water and they planed to have three liters per patient on hand. RD 2 stated at this time they were unsure of what the staff number would be.

On 1/24/12 at 3:35 p.m. an interview was conducted with RD 1, RD 2, DSM 2, and the Emergency Planner (EP) regarding the disaster plan. RD 2 stated there was no nutrient analysis of the disaster menu and they were currently trying to figure out how many patients and staff they need to feed in the event of a disaster. RD 2 acknowledged there was no detail of the disaster food plan and they did not have a staff menu in place to be able to feed the staff during a disaster. EP stated the plan was to be sustainable for 96 hours. EP stated there was a plan to utilize two wells that could be used as potable water but the first method would be the bottled water. When asked, EP stated no one from the Nutrition Department was on the emergency preparedness committee.

On 1/25/12 at approximately 4:30 p.m., an interview was conducted with RD 1, RD 2, and DSM 2. RD 2 stated they were short by 33 cases of water currently. RD 2 stated they would need to provide food for 3,200 staff for four days and they currently did not have any food supplies for this on hand but would be getting it.

Based on observation, interview and document review, the hospital failed to provide adequate oversight of medical gas contract services to ensure an acceptable level of patient safety when three unsecured compressed gas cylinders were observed to be unsecured during transfer from a cart to a truck on 1/26/12 at 10:27 a.m.

Findings:

At 10:27 a.m., 1/26/12, a medical gas delivery truck was observed parked on the hospital property. The delivery driver was transferring 'H' cylinders (metal cylinders for holding compressed gas) from a cart to the hydraulic lift gate of a truck. Three gray cylinders were observed standing side by side unsecured on their flat bases. The driver loaded each cylinder onto the lift gate individually. As one cylinder was moved to the tailgate, a cylinder next to it was observed to teeter slightly from the movement.

In a 12:25 p.m., 1/26/12 interview, with the Central Distribution Supervisor (CDS 1), he stated, "Vendors pick up and return cylinders. There is a requirement that they [compressed gas cylinders] be secured."

Review of hospital policy "Hazardous Gases/Handling and Storage of Compressed Gas Cylinders, revised 3/1/10, reflected, "Hazardous gases include: All gases in compressed gas cylinders or tanks ...All compressed gas cylinders (empty or full) must be stored in approved holders in an upright position ...."

Review of the medical gases contract finalized 11/21/07 reflected, "The seller shall take all reasonable precautions ...to protect the health and safety of employees and members of the public and to minimize danger from all hazards to life and property, and shall comply with all health, safety, and fire protection regulations and requirements."

Review of "Cylinder Handling" information on the vender website revealed, "Transporting compressed gas cylinders is hazardous ...Even cylinders that are empty by your definition are still considered hazardous materials by the DOT [Department of Transportation] because of the small amount of residual gas they contain ....Secure your cylinders ...Cylinders that can move can open accidentally ....Safety must always be your number one consideration when using compressed gas cylinders ...."

Based on observations, staff interviews, and document review, the hospital failed to maintain the relative humidity, temperature, and air exchange in the perioperative areas such as operating rooms (ORs), sterile storage, sterile processing area, decontamination room and the GI Lab (Gastrointestinal Laboratory - a department offers a variety of services for patients with digestive concerns) in accordance with nationally recognized infection control guidelines (The Association of perioperative Registered Nurses -AORN).

These failures had the potential for putting the patients at risk due to a) posing a fire hazard in an oxygen-enriched environment; or b) conducing bacterial growth which would compromise the integrity of wrapped sterile items and cause infection; or c) interrupting airflow patterns within the operative settings which could cause contamination of the sterile field, increasing the risk of surgical site infection.

Findings:

During observations in the ORs on 1/23/12 from 2:15 p.m. to 2:30 p.m., the temperatures displayed on the thermostats in the OR 36, 46, and 48 were 73.7 degrees Fahrenheit (F), 73.5 degrees F, and 73.7 degrees F respectively.

During an interview on 1/23/12 at 2:25 p.m. with the Administrative Nurse of Surgeries (RN 2), RN 2 stated the normal range of the OR temperature was 68 degrees F to 72 degrees F; the normal range of the OR humidity level was 20% (percent) to 60 %. RN 2 also stated the Plant Operations and Maintenance (POM) staff were responsible for the OR temperature and humidity monitoring and they would notify the OR staff if the temperature and humidity were out of normal range.

During an interview with RN 1 on 1/23/12 at 2:35 p.m., RN 1 stated the OR staff did not monitor the OR temperature and humidity; the OR staff would not notice the difference if only a few degrees above or below the normal range. RN 1 also stated the POM staff would call the OR staff if the temperature and humidity alarm went off.

During an interview with the Manager of Central Processing (MCP) in the clean core of Pod 40 on 1/23/12 at 2:15 p.m., the MCP stated the temperature and humidity of the perioperative areas were monitored and controlled by the POM department. The MCP stated that the hospital used the AORN (Association of periOperative Registered Nurses) and the AAMI (Association for the Advancement of Medical Instrumentation) guidelines as references for the OR infection control practices.

During an interview with the Assistant OR Manager (RN 1) in the OR suite on 1/23/12 at 4:55 p.m., RN 1 stated the hospital used the AORN guidelines as references for the OR infection control practices and acknowledged that the current published (2011 edition) AORN guidelines indicated the relative humidity within the perioperative suite should be maintained between 30% and 60%.

On 1/26/12 the 2011 Perioperative Standards and Recommended Practices, published by the AORN, were reviewed. On page 218, under Recommendation V.b., direction was given that, "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area...endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas." On page 219, under Recommendation V.c., direction was given that, "Temperature should be monitored and recorded daily..." Under recommendation V.c.1., direction was given that, "Temperature should be maintained between 68 degrees F (Fahrenheit) to 73 degrees F within the operating room suite and...in sterile processing." Under Recommendation V.c.2., direction was given that, "The decontamination area temperature should be maintained between 60 degrees F to 65 degrees F." Under Recommendation V.d., direction was given that, "The air-exchange rate in the perioperative area should be carefully controlled." Under Recommendation V.d.1. The minimum rate of total air exchanges per hour should be maintained at a constant level as follows...Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges...Postanesthesia care unit: Six air exchanges per hour...Sterile storage area: four air exchanges per hour. Under Recommendation V.e. Air-flow patterns within the perioperative setting should be controlled and uninterrupted."

On 1/26/12 at 2:45 p.m., the hospital's temperature and humidity log of 23 ORs (OR 21, 23, 24, 25, 26, 27, 28, 31, 32, 33, 34, 35, 36, 37, 38, 41, 42, 43, 44, 45, 46, 47, and 48) for 1/25/12 was reviewed with the Assistant Manager of the Plant Operations and Maintenance;(AMPO). The aforesaid document indicated the temperatures were out of the range of 68 degrees F and 73 degrees F in OR 21, 23, 25, 32, 33, 44, 45, 46, and 48; the humidity level of OR 48 was 28.2 % (percent) which was below 30%. The AMPO stated the AORN standard was only the goal and the staff should follow the parameters set by the hospital. The AMPO further stated the hospital's OR humidity standard was 20% to 60% and the hospital's OR temperature standard was 65 degrees F to 76 degrees F, which were different from the AORN standard.

Observations and staff interviews showed that the hospital also failed to maintain the relative humidity, temperature, and air exchange in the sterile storage, sterile processing area, decontamination room and the GI Lab, as evidenced by:

During an observation and a concurrent interview in the sterile storage of the Central Processing department on 1/24/12 at 3:30 p.m., there was no device displaying the temperature and humidity. The MCP confirmed that there was no device for monitoring temperature and humidity in the sterile storage and the sterile processing area; the POM staff were responsible for the temperature, humidity, and air exchanges monitoring.

During an observation and a concurrent interview in the decontamination room of the Central Processing department on 1/23/12 at 5 p.m., there was no device displaying the temperature and humidity. The MCP confirmed that there was no device for monitoring temperature and humidity in the decontamination room and the POM staff was responsible for the temperature, humidity, and air exchanges monitoring.

During an observation and a concurrent interview in the GI Lab on 1/25/12 at 11:25 a.m., there was no device displaying the temperature and humidity. The GI Lab manager (NM 13) confirmed that there was no device for monitoring temperature and humidity in the GI Lab and the POM staff was responsible for the temperature, humidity, and air exchanges monitoring.

During an interview with the APOM on 1/26/12 at 2:45 p.m., the APOM stated GI lab was not considered as a surgical area, so the temperature and humidity and air exchanges were not being monitored. The APOM confirmed there was no humidity control in the Central Processing department and the GI Lab. The APOM also stated the POM staff set the OR temperature range from 65 degrees F to 76 degrees F and the OR humidity range from 25% to 60%, which were different from the AORN standard; the alarms would not go off if the temperature and humidity were within the POM settings. The APOM also stated the OR staff had a choice to adjust the OR temperature between 68 degrees F and 73 degrees F. The APOM further indicated that the temperature setting for OR 48 was from 65 degrees F to 85 degrees F because it was the OR where surgical procedures for burn patients were performed. When asked if there was any document showing the air exchanges monitoring for the perioperative area, the APOM stated no annual report was available, but random checking had been done.

On 1/26/12 at 3:15 p.m., a review of the hospital's policy and procedure titled "Energy Management and Conservation" dated 7/25/10 indicated the parameters of the temperature in the ORs, Central Processing Areas, and Supply Storage Areas are 68 -72 degrees F, 70-76 degrees F, and 68-78 degrees F respectively; the parameters of the relative humidity in the ORs, Central Processing Areas, and Supply Storage Areas are 50%-60%, 30%-50%, and 30%-60% respectively. The aforesaid document also indicated an exception in the OR's temperature parameters was "65 degrees F to 80 degrees F depending on procedure." No other document regarding the temperature, humidity, air exchange control and monitoring in the operating suite, the GI lab, and other perioperative areas was provided upon request.

On 1/26/12 at 4 p.m., a review of an undated memo titled "Policies" indicated "The Environmental Monitoring Policy requested was not relevant to procedure rooms that are not licensed as operating rooms. There is environmental monitoring that occurs, including temperature; however, the standards are not the same as the monitoring done for the operating rooms."

The hospital's policies and procedures on the temperature, humidity, and air exchange control and monitoring in operating suites, the GI lab, and other perioperative areas as well as the documentation of air exchange monitoring were not provided upon request.

Based on observations, interviews and record review, the hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The hospital's infection control program and policies were not in accordance with nationally recognized infection control standards to effectively prevent, control, and minimize cross-contamination and risks for infections and communicable diseases (Reference A 0747).

1. The hospital failed to ensure Infection control practices where invasive procedures were performed were in accordance with nationally established standards for surgical attire, traffic patterns, equipment cleaning, environmental cleaning, clean linen storage and handwashing. (Refer to A 0749)

2. The hospital failed to ensure staff were knowledgeable of information and precautions for chemical hazards. (Refer to 0749)

3. The hospital failed to provide evidence physicians performed and authenticated a daily assessment of the need for a central line (a tube placed in a large vein in the neck, chest, or arm to give fluids, blood, or medications or to do certain medical tests quickly) (Refer to A 0749)

4. The hospital failed to proved Tuberculosis screening for physicians and staff in accordance with nationally accepted standards. (Refer to A 0749)

5. The hospital failed to ensure food was stored, prepared and served in safe, sanitary conditions. (Refer to A 0620)

The cumulative effect of these systemic problems resulted in the hospital's inability to comply with the statutorily-mandated condition for infection control.

Surveyor: Bender-Porter, Dagma


Surveyor: Craig, Deborah

Based on observations, interviews and record review, the hospital failed to develop an effective system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel when:

1. Surgical infection control standards in areas where invasive procedures were performed in in-patient and out-patient services were not in accordance with nationally accepted infection control standards for:
a) Surgical attire including personal protective equipment (PPE), traffic patterns
b) Cleaning of surgical equipment
c) Environmental cleaning
d) Handwashing
2) Staff were unable to access information on chemical hazards and precautions.
3) Biohazard waste was not secured.
4) Tuberculosis screening of employees was not in accordance with nationally recognized infection control guidelines.
5) There was no evidence of the physicians daily assessment of the need for a central line.
6) Food was not stored, prepared and served in safe, sanitary conditions.
7) Glucometers were not being cleaned according to infection control standards.

Findings:

1a) Surgical Attire/PPE:
i. During a tour in the Operating Rooms (ORs) with the Infection Control Practitioner (ICP 1) and the OR Assistant Manager (AM 2) on 1/23/12 from 1:50 p.m. through 4:30 p.m., ICP 1 was observed wearing turtle neck clothing under her scrub suit. Approximately 1 inch of the turtle neck clothing was not completely covered by the warm-up jacket. ICP 1 accompanied the surveyor walking through the perioperative areas, including the operating rooms, the hallway...and the clean cores.

During an interview with AM 2 in the hallway of the operating suite on 1/23/12 at 4:05 p.m., AM 2 stated it was acceptable for staff members to wear personal clothing not completely covered by surgical attire in the operating rooms.

ii. During an observation in the anesthesia board runner room (Room 3P648) on 1/23/12 at 2:02 p.m., Anesthesiologist (MD 27) was observed wearing white personal clothing under the scrub suit. About 2 inches of the white clothing was not covered by the scrub suit at the V-neck area.

During an interview with ICP 1 on 1/24/12 at 9 a.m., ICP 1 stated the anesthesia board runner room was a semi-restricted area and staff members were required to wear surgical attire appropriately.

iii. During an interview with the GI Laboratory Manager (NM 13) on 1/25/12 at 11:25 a.m., NM 13 stated staff were not required to wear surgical attire in the decontamination room if there was no instrument processing in the room, that was, wearing street clothes was allowed in the decontamination area in the GI Lab.

During an interview with a Registered Nurse (RN 8) in a tour of the GI Lab on 1/26/12 at 9:30 a.m., RN 8 stated staff were not required to wear surgical attire and a hair cover if there was no patient or procedure set up in the room (that was, the staff could wear street clothes in the procedure room). When asked the types of procedures were performed in the procedure room, RN 8 stated the procedures performed included colonoscopy (the visualization of the colon [portion of the large intestine] with a long, flexible instrument that consists of a tube and a light), EGD (Esophagogastroduodenoscopy or upper endoscopy - a procedure that enables the examiner to examine the swallowing tube, stomach, and the first portion of small bowel using a thin flexible tube that can be looked through on a monitor), liver biopsy (the removal of a small piece of living tissue from the liver for microscopic examination), and biopsy (the removal of a small piece of living tissue from an organ or other part of the body for microscopic examination). RN 8 stated biopsy was the removal of "a little bit of tissue" and she did not consider biopsy as a type of surgery.

On 1/26/12 at 10 a.m., in an interview with the Nurse Manager (NM 13) and RN 8, a review of the definition of surgery developed by the American College of Surgeons dated 4/2007 was conducted. The definition of surgery indicated "Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or diseases processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles......All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel" NM 13 and RN 8 acknowledged that biopsy was a procedure performed for the purpose of structurally altering the human body by the incision or destruction of tissues. NM 13 also confirmed there was no defined restricted or semi-restricted areas in the GI laboratory and the staff were not required to follow the surgical attire as practiced in the operating suite.


iv. During an observation in the decontamination room of the GI Laboratory on 1/26/12 at 11 a.m., the Gastrointestinal Procedure Technician (GI T 1) was observed handling the soiled endoscope and the high-level disinfectant without wearing a mask.

During an interview with the NM 13 on 1/26/12 at 12:50 p.m., the NM 13 stated the staff should have worn a mask during the decontamination process.

On 1/26/12 at 1:30 p.m., a review of the hospital's policy and procedure titled "Personal Protective Equipment (PPE)" dated 7/30/10 indicated "Decontamination area: To protect staff members against biological and chemicals hazards, the following...must be worn when working in the decontamination area...mask."

In a review of the hospital's Policy and Procedure titled "Dress Code - Standards for Operating Room Wearing Apparel", dated 1/7/12, there was stipulation "All persons entering the semi-restricted and restricted areas of the surgical suites are required to wear clean surgical scrubs...Semi-restricted area: Includes peripheral support areas of the surgical suite, storage, scrub sinks, hallway...Restricted area: Includes OR rooms, clean cores, substerile rooms...All personal clothing should be completely covered by the surgical attire. Clothing that cannot be covered by the surgical attire should not be worn."


In a review of the 2011 Perioperative Standards and Recommended Practices, published by the Association of periOperative Registered Nurses (AORN), Page 57, Recommendation Practices for Surgical Attire, direction was given that, "These recommended practices are intended as guidelines adaptable to various practice settings. These practice settings include traditional ORs, ambulatory surgery centers, physicians' offices, cardiac catheterization laboratories, endoscopy suites, radiology departments, and all other areas where surgery and other invasive procedures may be performed." Under Recommendation II, direction was given that, "Clean surgical attire, including shoes, head covering, masks, jackets, and...should be worn in the semi-restricted and restricted areas of the surgical or invasive procedure setting." On page 95, under Recommendation I.1., direction was given that, "...The sequestrated area includes the peripheral support areas of the surgical suite...Personnel are required to wear surgical attire and cover all head and facial hair. The restricted area includes ORs, procedure rooms, and the clean core area. Surgical attire and hair coverings are required..."

1b) Cleaning of Surgical Equipment:
i. Flash Sterilization:
During an interview with the Manager of Central Processing (MCP) in the clean core of Pod 40 in the Operating Suite on 1/23/12 at 2:15 p.m., the MCP stated the hospital used the AORN (Association of periOperative Registered Nurses) and the AAMI (Association for the Advancement of Medical Instrumentation) guidelines as references for the OR infection control practices. When asked the reasons for flash sterilization in the hospital, the MCP stated there were only 2 sets of dental instruments therefore flash sterilization would be done for the subsequent surgery.

Continuing the interview, the MCP stated that chemical indicators were used during flash sterilization of instruments and biological indicators were not required.

On 1/23/12 at 3 p.m., the flash sterilization record of Pod 20 dated 10/11 was reviewed with an OR Registered Nurse (RN 3) in the operating suite. The aforesaid document indicated flash sterilization was performed 138 times for 8 ORs' (OR 21 through OR 28) use in October 2011 due to "Not up sterile." The RN 3 stated "Not up sterile" was meant there were not enough instruments available for the specified surgery. The information regarding the number of flash sterilization for Pod 30 (OR 31 through OR 38) and Pod 40 (OR 41 through OR 48) was not provided upon request.

During an interview with a Registered Nurse (RN 1) in the OR suite on 1/23/12 at 3:20 p.m., RN 1 stated a flash-sterilized implant could be used prior to the rapid-action BI result was known.

During an interview with the Assistant OR Manager (RN 1) on 1/24/12 at 10:10 a.m., RN 1 stated flash sterilization was required if the physicians had the same preferences on a specific model of the instruments.

During an interview with the MCP on 1/24/12 at 3:30 p.m., the MCP acknowledged the hospital should have bought more instruments in order to use flash sterilization for urgent use only.

In a review of the hospital policy titled "Flash Sterilization", dated 12/5/11, there was direction to use: "References...Recommended Practices for Sterilization in the Perioperative /setting. In: Perioperative Standards and Recommended Practices...AORN...2011: 463 - 485." for infection control standards.

A review of the hospital policy "Flash Sterilization", dated 12/5/11, indicated to use "References...Recommended Practices for Sterilization in the Perioperative /setting. In: Perioperative Standards and Recommended Practices...AORN...2011: 463 - 485." for infection control standards.

In review of the 2011 Perioperative Standards and Recommended Practices, published by AORN, page 467, under Recommendation IV.a., direction was given that, "Flash sterilization should not be used as a substitute for sufficient instrument inventory." On page 468, under Recommendation IV.c.3., direction was given that, "Biological (BI) and chemical indicators should be used to monitor sterilizer efficacy and assess compliance of monitoring standards established for gravity-displacement and dynamic air-removal sterilizers..." On page 469, under Recommendation IV.h.1., direction was given that, "The implant should be quarantined on the back table and should not be released until the rapid-action BI provides a negative result."

ii. Central Processing:
During an observation and a concurrent interview with the Sterile Processing Technician (SP 1) in the decontamination room of the Central Processing Department on 1/23/12 at 4:25 p.m., the SP 1 was mixing the enzymatic detergent for soaking the soiled instruments. When asked how to mix the enzymatic detergent, SP 1 stated she put 2.5 ounces (oz.) Asepti-Zyme in the sink and turned the water faucet on. SP 1 also stated she would turn the water faucet off when the water reached the line in the sink which indicated the 5 gallon level.

The soiled instruments in the sink were not completely submerged in the enzymatic solution. The enzymatic solution level was approximately one inch below the 5-gallon-line in the sink. The Sterile Processing Technician (SP 2) visually checked the soiled instruments; removed the soiled instruments from the sink; and got ready to transfer the soiled instruments to the washer. No rinsing was observed during the entire process.

The printed label on the container of the Asepti-Zyme was reviewed and indicated "For presoak...Add 0.5 US (United States) fluid ounce of Asepti-Zyme Instrument Presoak and Detergent to 1 US fluid ounce per US gallon of water..."

During an interview with the ICP 1 in the decontamination room on 1/23/12 at 4:50 p.m., ICP 1 confirmed the enzymatic solution level did not reach the 5-gallon-line level indicated in the sink. ICP 1 acknowledged that the staff did not mix the enzymatic detergent in the correct concentration.

During an interview with the MCP in the decontamination room on 1/23/12 at 4:55 p.m., the MCP acknowledged that the concentration of the enzymatic solution would not be correct if the solution level did not meet the 5-gallon-line level in the sink.

In an observation of the decontamination room in Central Processing on 1/23/12 at 4:30 p.m., a cleaning brush was observed by the sink. The SP 2 stated the brush was used for brushing the soiled suction tubes. When asked how to handle the brush after each use, SP 2 stated she washed the brush with water after use and the brush was ready to be used on the following sets of soiled instruments.

A review of the manufacturer's information on the cleaning brushes indicated the brush was reusable after autoclaving.

During an observation and a concurrent interview with a Sterile Processing Staff Member (SP 2) in the decontamination room of the Central Processing Department on 1/23/12 at 4:30 p.m., a 60-ml (milliliter) syringe was observed by the sink. SP 2 stated the 60-ml syringe was used for flushing the soiled suction tubes. When asked how to handle the syringe after each use, SP 2 stated she washed the syringe with water after use and the syringe was ready to be used on the following sets of soiled instruments throughout the day. SP 2 also stated she would throw the syringe away at the end of the day.

A review of the manufacturer's information indicated "the 60-ml syringe was for single use."

The ICP 1, in an interview on 1/25/12 at 9:10 a.m., stated single use was meant for one time use only.

During an observation and a concurrent interview with the MCP in the sterile storage area of the Central Processing Department on 1/24/12 at 3:45 p.m., 67 pairs of scissors of various types in the closed position in sealed peel pouches (self-sealable pouches that contain surgical instruments during the sterilization process) were observed. The MCP confirmed the scissors blades were in the closed position in peel pouches. The MCP further stated he could not ensure the scissors with blades closed were effectively sterilized.

In review of the 2011 Perioperative Standards and Recommended Practices, published by AORN, page 438, under Recommendation XII, direction was given that, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces." Under Recommendation XII.c., direction was given that, "Instruments with hinges should be opened..." Under Recommendation XII.c.1., direction was given that, "Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments."


Endoscope processing:
During an observation and a concurrent interview in the endoscope processing room of GI Lab on 1/25/12 at 11:55 a.m., three endoscopes were observed to be coiled on a towel on a cart close to the door. The Endoscopy Technician (GIT 2) stated the endoscopes on the towel were processed and ready to be transported to the storage area.

During an observation and a concurrent interview in the GI lab clean supply room on 1/25/12 at 12:02 p.m., three storage carts and two storage cabinets with clean supplies were seen. The clean supply items included syringes, gloves, shoe covers, gowns, cups, bottles of water, toothpaste...etc. Ten upper endoscopes were observed hanging against the wall; the lower portion of the storage was enclosed by plexi glass and the upper portion was not closed. On the bottom of the endoscope storage area, scattered visible grayish black particles, a piece of plastic-like item, a syringe cap, a packet of IV cap...were seen. The ends of two endoscopes were wrapped with paper. GI T 2 confirmed that the endoscopes were the processed endoscopes ready for use; the two endoscopes with the wrapped ends were the cultured endoscopes that needed to be reprocessed before use and the culture report were pending. GI T 2 also confirmed the scattered grayish black particles were dust.

During an observation and a concurrent interview in the lower endoscope storage room on 1/25/12 at 12:16 p.m., 17 lower endoscopes were observed hanging against the wall; the lower portion of the storage was enclosed by plexi glass and the upper portion was not closed. On the bottom of the endoscope storage area, scattered visible grayish black particles, a piece of swab stick were observed. ICP 1 confirmed the scattered gray particles were dust. There were clean supplies, a box of reusable forceps...stored in the same room.

During an interview NM 13 in the lower endoscope storage room on 1/26/12 at 9:05 a.m., when asked how often the staff clean the endoscope storage area, NM 13 stated the hospital had no system to clean the endoscope storage room.

In review of the 2011 Perioperative Standards and Recommended Practices, published by AORN, page 420, under Recommendation IX., direction was given that, "Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes microbial contamination." Under Recommendation IX.a., Flexible endoscopes should be stored in a closed cabinet with...sufficient space for storage of multiple endoscopes without touching..." On page 422, under Recommendation IX.c. Flexible endoscopes should be reprocessed before use if evidence of improper drying exists (e.g., evidence of discoloration, wet spots, or stains, or soil in the storage cabinet)..." Under Recommendation IX.d., direction was given that, "Storage cabinets should be cleaned and disinfected with an EPA-registered disinfectant when visibly soiled and on a weekly or monthly schedule..."

During an interview with GIT 1 in the processing room of the GI Lab on 1/26/12 at 12:15 p.m., the GIT 1 stated a processed endoscope was put on the towel on the cart upon removal from the AER. When asked how often the towel was changed, the GIT 1 stated the towel was changed at least once a day and as needed.

During an interview with ICP 1 on 1/26/12 at 12:50 p.m., ICP 1 stated a processed endoscope should not have been placed on the towel and instead should have been transported to the storage area upon removal from the AER.

In a review of the hospital's policy and procedure titled "Scope Cleaning and Processing" dated 1/24/12 there was stipulation: "Once the cleaning cycle is complete...and dry using forced air...remove from processor and carry to clean utility room...hand vertically, with ports open to dry."

During an observation and a concurrent interview with NM 13 in the lower endoscope storage room on 1/26/12 at 9:10 a.m., the processed lower endoscopes were hanging in the the storage area and there were no labels showing the processing dates of the processed endoscopes. When asked how to identify the processing date of the processed endoscopes, NM 13 stated that she was not able to determine the processing dates of the processed endoscopes in the storage area. When asked if the hospital had a system to reprocess the endoscopes before use if unused for more than five days, the NM 13 stated the hospital used the ASGE (the American Society for Gastrointestinal Endoscopy) standard, that was, to reprocess the endoscopes before use if not used for more than 14 days.

In review of an undated hospital document titled "Disinfection of Endoscope Instruments" there was stipulation: "References...Association of Perioperative Registered Nurses. AORN Standards, Recommended Practices and Guidelines, 2011."

In a review of the 2011 Perioperative Standards and Recommended Practices, published by AORN, page 421, under Recommendation IX.b., direction was given that, "Flexible endoscopes should be reprocessed before use if unused for more than five days...flexible endoscopes cleaned and processed as recommended and stored by hanging in closed cabinets have been shown to grow organisms after five days of no use..."

During an observation of the endoscope decontamination process in the decontamination room of the GI Lab on 1/26/12 at 11:55 a.m., GIT I brushed the exterior portion of the soiled endoscope with a toothbrush under the enzymatic solution and then put the toothbrush in the container by the sink. There were three toothbrushes in the container.

During an interview with the GIT 1 in the decontamination room of the GI Lab on 1/26/12 at 12:35 p.m., when asked how to handle the brush after use, the GI T 1 stated he would reprocess the toothbrush if he "brushed a lot"; he did not reprocess the toothbrush because he had "brushed a little bit."

In a review of the hospital policy titled "Cleaning Instruments and Scopes Prior to Cold Sterilization/High Level Disinfection", dated 7/14/10, there was stipulation "Cleaning brushes should be disposable; if reusable, they must be thoroughly cleaned and then high-level disinfected or sterilized after each use."

During further observation of the endoscope processing procedure in the GI Lab on 1/26/12 at 12:10 p.m., GIT 1 used test strip (Cidex OPA [ortho-Phthalaldehyde] test strip) to test the high level disinfectant solution (Cidex OPA) for minimum effective concentration and stated "pass" right away and documented in the log book. GIT 1 did not read the result at 90 seconds.

In a review of the manufacturer's printed instruction on the vial of Cidex OPA test strip there was stipulation to read result at 90 seconds.

During an interview in the decontamination room of the GI Lab on 1/26/12 at 12:25 p.m., GIT 1 acknowledged he did not follow the manufacturer's instruction to read result at 90 seconds.

In review of a hospital document titled "Disinfection of Endoscope Instruments" there was stipulation: "High Level Disinfection...Use test strips following manufacturer's instructions..."


In further observation of the endoscope processing procedure in the GI Lab on 1/26/12 at 12:30 p.m., GIT 1's gloved-hands touched multiple areas such as the exterior portion of the automated endoscope reprocessor (AER), the reference books...etc. prior to removing the processed endoscope from the AER.

During an interview with ICP 1 on 1/26/12 at 12:50 p.m., the ICP 1 stated GI T 1 should not have touched multiple surfaces prior to handling the processed endoscope due to the potential for cross-contamination.

1c) Environmental Cleaning Practices:
i. At the entrance of the Operating Room (OR) 26 on 1/23/12 at 4 p.m., two boxes of stretch vinyl gloves, two boxes of flex vinyl gloves, and two boxes of nitrile gloves were ready for use on the top shelf of the housekeeping cart. The OR assistant (OR-H2) and two staff members were observed wearing the vinyl gloves when performing environmental cleaning. OR-H2 stated the staff could choose vinyl or nitrile gloves as the PPE (personal protective equipment) when performing environmental cleaning.

During an interview with ICP 1 on 1/23/12 at 4:25 p.m., ICP 1 confirmed that the employees had an option in using vinyl or nitrile gloves as the PPE during environmental cleaning.

During an observation and a concurrent interview in the Surgical Intensive Care Unit (SICU) on 1/24/12 at 10:25 a.m., a box of vinyl gloves was observed on the housekeeping cart. The Environmental Services staff (EVS-H) was observed wearing a pair of vinyl-like gloves during the environmental cleaning process, and ICP 1 confirmed the EVS-H was using the vinyl gloves during the environmental cleaning process.

In review of the 2011 Perioperative Standards and Recommended Practices, published by AORN, page 238, under Recommendation I.b.4., direction was given that, "Vinyl gloves should not be used in environmental cleaning and disinfection. Vinyl glove barrier protection failure rates can be very high."

ii. During an interview with OR Assistant (OR-H1) in the Janitor's closet on 1/23/12 at 4:10 p.m., when asked how to decide the pre-mixed disinfectant (HB Quat Disinfectant Cleaner Concentrate) was mixed in correct concentration as recommended by the manufacturer, OR-H1 stated she did not know.

The manufacturer's printed label attached to the HB Quat Disinfectant Cleaner Concentrate container was reviewed. The aforesaid label indicated "add 0.35 ounces per gallon of water to disinfect..."

During an interview with the supervisor of the OR Assistant/Housekeeping (OR-HS) on 1/23/12 at 4:18 p.m., OR-HS stated he would visual check the color of the disinfectant solution, but he could not determine if the pre-mixed disinfectant was in correct concentration or not. OR-HS also confirmed that there was no regular service to ensure the pre-mixed disinfectant was effective.

During an interview with the ICP 1 on 1/24/12 at 10:15, the ICP 1 stated the Environmental Services supervisor monitored the automated system regularly to ensure the pre-mixed disinfectant was in correct concentration, but there was no documentation to show the monitoring had been done and she could not determine if the concentration of the pre-mixed disinfectant was the same as recommended by the manufacturer.

On 1/25/12 at 11 a.m., the 2003 Guidelines for Environmental Infection Control in Health-Care Facilities, published by CDC and HICPAC, was reviewed. On page 133, under E.I.A., direction was given that, "Select EPA-registered disinfectants, if available, and use them in accordance with the manufacturer's instructions." Under E.I.C., direction was given that, "Follow manufacturers' instructions for cleaning and maintaining noncritical medical equipment.

iii. "During an interview with the OR-H1 in the operating suite on 1/23/12 at 4:12 p.m., when asked to describe decontamination procedures for a gross blood spill, OR-H1 stated she would use a blanket to clean the blood spill and mop the area with Quat (a disinfectant), and she would send the blood soaked blanket to the laundry with the used mop head in a regular soiled linen blue bag.

During an interview with ICP 1 on 1/23/12 at 4:20 p.m., ICP 1 stated the bloody blanket should be sent to regular laundry. At 4:50 p.m., ICP 1 further stated the hospital provided the orange absorbent material for cleaning blood and OR-H1 should not have addressed using the blanket for cleaning blood. OR-H1 did not address using bleach for decontamination of blood.

Review of the hospital policy titled "Isolation, All Categories: Availability of Infection Control Devices Waste and Waste Containers" dated 9/21/10 on 1/24/12 at 10 a.m., indicated "Blood spills: a. Blot blood spills with disposable material and discard in a red plastic bag. b. Clean blood spills with hospital disinfectant..."

On 1/25/12 at 11 a.m., the 2003 Guidelines for Environmental Infection Control in Health-Care Facilities, published by CDC and HICPAC, was reviewed. On page 77, under 3. Cleaning Strategies for Spills of Blood and Body Substances, direction was given that, "For spills containing large amounts of blood or other body substances, workers should first remove visible organic matter with absorbent material (e.g., disposable paper towels discarded into leak-proof, properly labeled containment) and then clean and decontaminate the area. If the surface is nonporous and a generic form of a sodium hypochlorite solution is used (e.g., household bleach)..."

iv. In Procedure Room 2 in the GI Laboratory on 1/26/12 at 10:45 a.m., the Registered Nurse (RN 9) performed environmental cleaning between the procedures. RN 9 wiped the countertop surfaces, the monitor for the EKG (electrocardiogram) machine and the cord, the pulse oximeter (equipment to check the amount of oxygen in the blood), the glove dispenser, the biohazard container...with one disinfectant wipe. The disinfectant wipe was dropped on floor and RN 9 picked up the used disinfectant wipe from the floor and started wiping multiple surfaces on the supply cart...and the door handle.

During an interview with ICP 1 on 1/26/12 at 10:55 a.m., ICP 1 stated RN 9 should have used more disinfectant wipes to clean the surfaces in order to allow all surfaces adequately wet to achieve the disinfection purposes. ICP 1 also stated RN 9 should not have re-used the disinfectant wipe which had been dropped on the floor due to the increased risk of cross-contamination.

1d) Handwashing:
i. During an interview with the Central Processing Manager (MPC) in the clean core of Pod 40 on 1/23/12 at 2:15 p.m., the CPM stated the hospital used the AORN (Association of periOperative Registered Nurses) and the AAMI (Association for the Advancement of Medical Instrumentation) guidelines as references for the OR infection control practices.

During an observation and a concurrent interview with Sterile Processing staff (SP 2) in the decontamination room of the Central Processing Department on 1/23/12 at 5 p.m., there was no hand-washing sink available. SP 2 confirmed there was no hand-washing sink in the decontamination room. SP 2 stated she went to the restroom, which was not near to the instrument decontamination areas, for handwashing.

During an observation in the decontamination room of the GI Lab on 1/26/12 at 11:45 a.m., there was no hand-washing sink available.


On 1/26/12 at 1 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 433, under Recommendation VII.b., direction was given that, "The decontamination area...should contain, but not be limited to, the following equipment...sinks to manually clean instruments, hand-washing facilities..."

On 1/26/12 at 1:15 p.m., a review of the 2011 Association for the Advancement of Medical Instrumentation document, which was provided by the hospital, indicated "Hand hygiene facilities (sinks) and waterless alcohol-based hand rubs should be conveniently located and designed to allow good hand hygiene-practices. They should be located in or near all areas in which instruments and other devices are decontaminated and prepared for sterilization...Hands should be washed when visibly soiled, after gloves are removed for any reason..."

During an observation of the endoscope decontamination process in the GI lab on 1/26/12 from 11:45 a.m. to 12:45 p.m., the GI Technician (GIT 1) removed gloves and put on gloves four times without performing hand hygiene.

During an observation of the handling of the soiled endoscope (an instrument used to visually examine an internal body canal or organ) in Procedure Room 2 of the GI laboratory on 1/26/12 at 1 p.m., GIT 1 did not perform hand hygiene between changing gloves.

In a review of the hospital policy titled " Handwashing (Hand Hygiene), dated 5/23/11, there was stipulation " Wash hands when visibly dirty or contaminated with proteinaceous (containing protein) material or with blood or other body fluids ...If hands are not visibly soiled, use an alcohol based hand rub for routinely decontaminating hands in the following situations ...After removing gloves ... "

A review of the 2011 Perioperative Standards and Recommended Practices, published by AORN, page 75, stipulated under Recommendation II.a., "A hand wash should be performed...before putting gloves on and after removing gloves..."

2. During an observation and a concurrent interview in the Surgical Intensive Care Unit (SICU) on 1/24/12 at 10:25 a.m., an Environmental Services Staff member (EVS-H) was unable to locate the information for the disinfectant used on the unit in the Material Safety Data Sheet (MSDS) binder in the MSDS binder. EVS-H stated she did not know where to get the information.

During an observation and a concurrent interview in the SICU on 1/24/12 at 11:45 a.m., when asked to find the MSDS information of the disinfectant that was used on the unit, a licensed nurse (RN 6) was not able to locate the MSDS information of the specified disinfectant in the MSDS binder.

During an interview with AS 2 on 1/24/12 at 12:05 p.m., AS 2 acknowledged that the MSDS information of the specified disinfectant was not available MSDS binder, the staff should call the supervisor for assistance. The supervisor would then call the AOD for further assistance (Administrative Staff on Duty) if the MSDS could not be located.

In review of the hospital policy titled "Hazardous Materials and Chemical Waste Handling", dated 10/15/10. there was stipulatio

Based on observations, staff interview and document review the hospital failed to provide surgical services in accordance with acceptable standards of practice for all patients, and ensure that outpatient surgical services were consistent in quality with inpatient care in accordance with the complexity of services offered when:

A. The hospital did not ensure that the organization of surgical services was appropriate to the scope of the services offered. The hospital failed to provide defined in writing and approved by the medical staff the scope of surgical services provided by the hospital in all inpatient and outpatient locations of the hospital (refer to A 0941).

B. The hospital failed to ensure that medical staff privileges to perform pre-surgical history and physical examinations (H&Ps), and updates to H&Ps, were formally issued to anesthesia providers who routinely performed H&P tasks as part of a surgical patient's care (refer to A 0945) .

C. The hospital failed to ensure that surgical services consistently met the unique needs of each patient by developing and/or implementing surgical care policies and procedures designed to assure the achievement and maintenance of high standards of medical practice and patient care (refer to A 0951).

D. The hospital failed to ensure that an accurate and complete history and physical examination (H&P, an assessment of the patient's health) and/or update to each surgical patient's complete H&P, performed by a qualified individual, was documented prior to the surgical procedure (refer to A 0952).

E. The hospital failed to ensure that a properly executed informed consent form for each operation was documented in the chart prior to surgery in accordance with hospital policy (refer to A 0955).

F. The hospital failed to ensure that an operative report that described the techniques and findings was documented immediately following surgery and signed by the surgeon in accordance with hospital policy (refer to A 0959).

G. The hospital failed to develop an effective system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel in accordance with acceptable standards of practice for all surgical services and locations (refer to A 0749).

These failures put patients at risk for injuries, infections, and poor surgical outcomes.

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Surgical Services.

Based on observations, staff interview and document review the hospital did not ensure that the organization of surgical services was appropriate to the scope of the services offered. The hospital failed to provide defined in writing and approved by the medical staff the scope of surgical services provided by the hospital in all inpatient and outpatient locations of the hospital.

Findings:

During the entrance conference on 1/23/12 starting at 10:45 a.m. the hospital administrative staff was asked to provide an organizational chart and the scope of surgical services defined in writing of all surgical services provided in all locations of the hospital. The administrative staff presented Medical Staff Organizational Chart of all Department by category of services, including Anesthesiology and Pain Medicine (MD 4) and Surgery (MD 11), along with other departments such as Department of Internal Medicine, Pediatrics, Radiology, etc. All listed Departments showed reporting to Medical Staff Executive Committee (MEC, MD 10), who directly reported to Chief Medical Officer (CMO). No organizational chart was provided showing how Surgery Services were organized. An organizational chart for Perioperative Services was provided, which only contained selected surgery services, such as the Main/Pavilion Operating Rooms (OR), Same Day Surgery Center and Central Processing, all reporting to the Director of Perioperative Services (MD 12). There was no scope of surgical services defined in writing for all surgical services provided in all locations of the hospital, including those provided outside of the operating rooms in each department.

In an interview with the Director of Perioperative Services (MD 12) on 1/23/12 at 11 a.m. the Director stated that he was only responsible for the main ORs as listed on the Perioperative Services organizational chart. The Director provided no oversight of invasive surgical procedures performed throughout the hospital at various inpatient and outpatient locations/departments. Each department was responsible for the care they provided and each department reported directly to the MEC committee. To his knowledge, there was no comprehensive description of surgical services that included all surgical invasive procedures provided at each location and/or department with an oversight by the Surgery Services. Invasive surgical procedures performed outside operating rooms were not considered surgeries by the hospital, therefore the Surgery Services oversight was not provided.

On 1/23/12 at 12 p.m., upon request, the hospital administrative staff provided a one page list of services where invasive (surgical) procedures were scheduled to be performed under sedation outside of the operating rooms listed as part of the Perioperative Services. The list indicated the following sites: ENT (ears, nose, throat), GI Lab (gastrointestinal), Pain Clinic, Pulmonary Lab (lung), Radiation Oncology (cancer), Same Day Surgery, University Birthing Suites, Vascular Access, Vascular Center (Cath Lab) and Interventional Radiology. Any invasive procedures that may have been performed in each Department of the hospital were not listed or monitored by surgical services.

The administrative staff also provided governing body advisory group (Governance Advisory Council) minutes showing in part that Invasive Procedures Review Committee (IPRC) presented annual reports to the Council. The reports included a Performance Improvement Annual Report from the IPRC. In the Executive Summary it was stated that "The goal of the IPRC is to provide oversight of minor surgical and other invasive procedures performed outside of the OR environment throughout the health system to ensure a single standard of care is provided regardless of the clinical division or location in which the procedure is provided."


22710

Review of the governing body advisory group monthly minutes between January 2010 and December 2011 confirmed no documented efforts to develop and implement hospital-wide surgical practices reflecting nationally recognized standards of practice for infection control, prevention of surgical errors and complications, safe maintenance of the surgical environments, assessment of surgical patients, or other surgical safety practices to minimize negative outcomes. Instead, various departments submitted individual summary reports of their performance, generally meeting benchmark goals for most departments. Unsafe practices were not described in the summary reports. No evidence of governing body discussion or direction for surgical services was presented.

In an interview on 1/26/12 at 4 p.m. with members of the medical staff and hospital leadership (including the former department chairmen for surgery and anesthesia, chief of staff, chief medical officer, chief financial officer), the leadership indicated that each specialty department functioned independently without a centralized division to oversee surgical services hospital-wide. Therefore, policies and practices among various outpatient surgical departments and some inpatient services differed according to what each service chose, and were not reviewed by a designated department head who took responsibility for the safety and effectiveness of these surgical services hospital-wide. As each service reported the results of their activities to both a quality committee and the medical executive committee, the primary person with surgical knowledge and expertise, and who served on both committees and was expected to be knowledgeable about each service's practices and performance, was the Chief Medical Officer (CMO). But the CMO was not formally designated to oversee all surgical care and services, or to verify that surgical practices in all locations conformed with basic and current nationally recognized standards of practice for surgical care. The CMO indicated that oversight of surgical services was a team effort with many people performing pieces of oversight. The CMO acknowledged that surgical care practices in various locations were not consistent, as they were governed by the individual departments. The hospital leadership presented no evidence to show efforts to review basic surgical practices across the spectrum of services, to identify which processes required standardization or which modifications would still meet the patient safety goals for nationally recognized organizational standards.

Review of the July 2011 Medical Staff Rules and Regulations under item XIII-F documented that the principal goal of the Invasive Procedure Review Committee was to improve patient care by evaluating surgical and other invasive procedures performed throughout the hospital. The hospital presented no documented evidence that the Invasive Procedure Review Committee had evaluated patient safety processes for surgical and invasive procedures in all locations where they were performed.

Based on staff interview and document review, the hospital failed to ensure that medical staff privileges to perform pre-surgical history and physical examinations (H&Ps), and updates to H&Ps, were formally issued to anesthesia providers who routinely performed H&P tasks as part of a surgical patient's care for 59 of 59 active staff anesthesia providers listed on the medical staff roster (MDs 4, 5, 12, 13, 27-81). This failure posed a risk to surgical patients that patient care could be performed by unqualified or unskilled medical staff.

Findings:

In an interview on 1/23/12 at 5:30 p.m., the Chief Medical Officer (CMO) stated that anesthesiology staff members routinely performed and documented pre-surgical history and physical examinations (H&Ps), and/or updates to H&Ps prior to surgery as part of the surgical care of each patient. In addition, anesthesiology staff members routinely supervised the care by resident physicians in training, who were also performing H&Ps/updates. The CMO indicated that this practice was authorized in the medical staff rules and regulations.

On 1/25/12 at 4:15 p.m., the medical staff files for two anesthesiology active staff members (MDs 4 and 5) were reviewed with a credentialing staff member (CS 1) who maintained the files, and a hospital regulatory compliance officer (CO 1). The privileging lists for MDs 4 and 5 did not document the authority to perform pre-surgical history and physical examinations (H&Ps), or updates to H&Ps. CO 1 indicated that anesthesiology staff members routinely performed H&P updates for surgical patients (if not documented by the admitting surgeon). Unlike surgeons, anesthesiology staff members did not routinely admit patients to the hospital which would require performing an H&P, and did not have admitting privileges. CO 1 indicated that the medical staff leadership had not specifically approved as an assigned privilege the authority to perform H&Ps to any anesthesiology staff. CO 1 stated that none of the anesthesiology staff members had documented approved privileges for H&Ps/H&P updates.

Review of the medical staff membership roster indicated there were 59 active anesthesiology staff members who were lacking approved privileges to perform pre-surgical H&Ps (MDs 4, 5, 12, 13, 27-81).

Review of the July 2011 Medical Staff Bylaws documented under Article VII, Section 2-B (items 6 and 7) that each department chairperson was responsible to (a) develop departmental privileging criteria, (b) supervise and evaluate the clinical work performed by members of their department, and (c) ensure that department members practiced within the privileging limits granted to them by the Governing Body.

Based on observation, staff interview, medical record and document review, the hospital failed to ensure that surgical services consistently met the unique needs of each patient by developing and/or implementing surgical care policies and procedures designed to assure the achievement and maintenance of high standards of medical practice and patient care when:

1. Surgical site verification practices did not comply with hospital policy and/or nationally recognized verification standards for all locations where surgical procedures were performed (e.g. emergency department, interventional radiology, distant outpatient locations), identified in 5 of 12 surgical patient records reviewed (Patients 12, 13, 15, 48, and 50), and resulted in a wrong-site surgery for 1 patient (Patient 50).

2. Surgical services' policies and procedures were not written, implemented and/or enforced in accordance with acceptable standards of medical practice and surgical patient care. Cleaning, disinfection, decontamination of surgical instruments and ventilation monitoring did not conform to nationally recognized standards. Barriers to minimize cross contamination that included restricting access of personnel (traffic), protective garments (surgical attire) and practices to protect and maintain a sterile field were not practiced in all locations where surgical procedures were performed, resulting in increased risk for environmental stresses or contamination of the surgical site.

Findings:

Review of the July 2011 Medical Staff Bylaws indicated under Article VII, Section 2-B(15) that the Governing Body authorized the Department Chairpersons to be responsible to participate in the development and implementation of policies and procedures that guided and supported the provision of care, treatment and services.

1. Surgical Site Verification

Review on 1/24/12 at 5 p.m. of the medical record of Patient 50 with MD 10, who served as the Chief of Staff for the medical staff, indicated that Patient 50 was admitted to the hospital on 7/14/11 for shortness of breath and fluid accumulation in the space surrounding the right lung. An invasive surgical procedure to drain the lung fluid (thoracentesis) was performed by two resident physicians in training (MDs 17 and 18) on the wrong lung side, posing an unnecessary risk for bleeding, infection, and/or further compromise of the patient's breathing. MD 10 indicated that had the resident physicians followed a standard surgical site verification process, the error and unnecessary risk for harm may have been prevented. The consequence of this error required additional x-ray studies and monitoring for the complications of the unnecessary surgery.

MD 10 further stated that all physicians were expected to conduct a process to verify the correct patient, correct procedure, and correct surgical site. However, in the emergency room and on units where procedures were performed at the bedside, the hospital's surgical site verification policy did not require the presence of more than one provider to participate in the verification process (e.g. MD plus registered nurse). MD 10 stated that many invasive procedures were performed in these locations by a single provider who was expected to, at a minimum, verify with the patient that the patient had consented to the procedure, the indication for the procedure, and the existing documented information (e.g. x-rays, scans, laboratory data, patient's complaint and examination findings) as part of the verification process. MD 10 confirmed that the documented record did not show that any other personnel (e.g. RN) participated in the surgical pause or Time Out portion of the site verification for Patient 50, and that the consent did not specify on which side of the chest the procedure would be performed.

In an interview with a hospital regulatory compliance officer (CO 1) on 1/26/12 at 12:30 p.m., CO 1 stated that the emergency department, outpatient departments, and locations other than the main operating room, pre-op holding/post-anesthesia care unit, radiology procedure areas, same day surgery center, children's surgery center, electrophysiology laboratories (electric activity of the heart), and birthing suites were not required to document a pre-procedure checklist as part of the site verification process when performing surgical procedures in those locations. CO 1 confirmed that there was no documented evidence of a pre-procedure checklist for the lung surgery performed on Patient 50 (described above) on 7/11/11, for a stomach surgery performed in the diagnostic radiology location on Patient 48 on 1/25/12, for a lung surgery performed on Patient 15 on 1/26/12, for a pain injection procedure performed on Patient 13 on 1/24/12, and for a spine procedure performed on Patient 12 on 1/24/12.

In an interview on 1/26/12 at 1:30 p.m. with MD 19, who served as the current director for the training program responsible for training MDs 17 and 18, MD 19 indicated that the department on which MDs 17 and 18 served reviewed and discussed the mis-steps of the events of July 14, 2011 for Patient 50. It was determined that MD 18 was supervising MD 17, but neither performed a thumping on the chest to locate fluid, a standard and necessary step in technique for this procedure. In addition, MDs 17 and 18 mis-interpreted the images of a device also used to locate fluid (ultrasound) and believed the fluid was located on the left chest. MD 19 indicated that MDs 17 and 18 had reviewed patient information including previous x-rays which clearly showed the fluid to be on the right side, but still erred as they chose to perform the procedure on the left side. The reviewers determined that MDs 17 and 18 did not perform the "time out" or verbal verification in the procedure room in accordance with policy. MD 19 indicated that patient's medical information and display of images within the procedure room or at the bedside was not required or routinely performed for chest drainage procedures, although the emergency department did have such capability with mobile digital imaging displays. MD 19 indicated that his department did not discuss the lack of designating the correct side on the patient's consent form, or the failure by MDs 17 and 18 to document a verification checklist.

Review on 1/26/11 at 1:30 p.m. of policy IV-19 titled Universal Protocol, last revised 1/20/10, documented that invasive procedures involving the puncture or incision of the skin, insertion of an instrument, or insertion of foreign matter into the body required use of the Universal Protocol to prevent errors of wrong patient, wrong body part, wrong side of the body or at the wrong level of the correctly identified anatomic site. The Universal Protocol was required for all procedures performed in all locations. The policy described the steps required to fulfill the Universal Protocol, which included a verbal verification (time-out) to be performed in the procedure/exam room by the personnel performing and assisting in the procedure, prior to the start of the procedure. Documentation of the verbal verifications (of identity, consent, type of procedure, location, allergies, type of special equipment, etc.) were to be documented on a standard pre-procedure checklist in the presence of the patient. Portions of the policy described tasks required of various surgical team members (registered nurses, assistants, anesthesia providers) depending on the location where the procedure was performed. Section G item 2 specified the role of the "Circulating/Procedure nurse" to initiate the time out process with the team as part of the Time Out process. Section H items 5(d) and 6(f) referenced how the performance of Time Out would be documented, concluding that the Time Out process applied to all hospital locations. The policy did not clarify when, or for which procedures, registered nurses would not be required to participate in the Time Out process. The policy did not specify that images should be displayed at the bedside, only that they be available.

Review of the 2008 World Health Organization (WHO) Guidelines for Safe Surgery, First Edition, emphasized the effectiveness of consistent verification practices to prevent wrong-site or wrong-patient errors. The organization recommended that all surgical team members independently perform verifications by checking the patient's records and radiographs (x-rays). The use of checklists was recommended. Immediately prior to starting the surgery (incision), a time out or surgical pause with all team members participating and appropriate diagnostic images (x-rays) available to confirm the patient, the procedure, the site of operation, and correct positioning should be documented. Among the various verification steps, WHO highly recommended that the surgical team collectively verify the correct patient, site and procedure during a time out or pause prior to incision in this manner: The surgeon should state out loud the patient's name, the operation to be performed, and the side and site of surgery. The nurse and anesthesia professional should confirm that the information is correct. Also highly recommended was that the team should confirm that the necessary imaging is available and displayed in the location where the procedure was performed. "Imaging is critical to ensure proper planning and conduct of many operations" and procedures. It should be confirmed that "essential imaging is in the room and prominently displayed for use" during the procedure.

Review of the National Quality Forum Safe Practices for Better Healthcare - 2009 Update documented under Safe Practice #26 that the use of the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery should be implemented for all invasive procedures.

Review of the American College of Surgeons Statement on ensuring correct patient, correct site, and correct procedure surgery [ST-41, approved 10/11/02], documented that all relevant records and imaging studies be in the operating room at the time when verification steps are taken.


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2. The Association of perioperative Registered Nurses (AORN) is a nationally recognized organization that makes recommendations for practices intended as guidelines adaptable to various practice settings including traditional operating rooms, ambulatory surgery centers, physicians' offices, cardiac catheterization suites, endoscopy suites, radiology departments, and all other areas where operative and other invasive procedures may be performed.

The Association of perioperative Registered Nurses (AORN) 2011 Edition recommended the following in the Recommended Practices for Traffic Patterns in the Perioperative Practice Setting, Recommendation I: "Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environment controls and surgical attire required." Traffic pattern areas were defined in item 1 as: (1) "unrestricted," a central control point established to monitor the entrance of patients, personnel, and materials; (2) "semirestricted," the peripheral support areas of the surgical suite with storage for clean and sterile supplies, work areas for storage and processing of instruments, scrub sinks, and corridors leading to the restricted areas of the surgical suite; surgical attire and hair coverings required; (3) "restricted," includes operating rooms, procedure rooms, and the clean core area; surgical attire and hair coverings required, masks required when sterile supplies open. Item 2 documented, "Movement of personnel from unrestricted areas to either semirestricted or restricted areas should be through a transition zone. A transition zone exists where one can enter the area in street clothing and exit into the semirestricted or restricted zone in surgical attire..."

The Association of perioperative Registered Nurses (AORN) 2011 Edition recommended in the section "Recommended Practices for Surgical Attire," Recommendation II, that "Clean surgical attire, including shoes, head covering, mask, jackets, and identification badges should be worn in the semirestricted and restricted areas of the surgical or invasive procedure setting...Recommendation III. All individuals who enter the semirestricted and restricted areas should wear freshly laundered surgical attire that is laundered at a health care-accredited laundry facility or disposable surgical attire provided by the facility and intended for use within the perioperative setting. Surgical attire helps contain bacterial shedding and promotes environmental cleanliness. An individual sheds millions of skin squames daily. Five percent to 10% of skin squames (shedding skin) carry bacteria..."

a. On 1/26/12 starting at 12 p.m. a tour of the Invasive Cardiovascular Laboratory (ICL) was conducted with the ICL and Vascular Access Departments Nurse Manager (NM 14) and other staff. No traffic restrictions were observed when entering the core corridor leading to the invasive procedures suites. No attire restrictions were imposed when entering the surgical suite when the suite was not in use (no active case).

NM 14 confirmed that the ICL main corridor was unrestricted as far as traffic and surgical attire were concerned. NM 14 stated that the ICL contained four surgical procedures suites in which surgical attire was required during procedures. Staff was allowed to enter into the corridor leading directly to the surgical procedure suites and to the procedure rooms wearing street clothes or home laundered scrubs. Surgical suites were not re-cleaned prior to surgical procedures after personnel in street clothing entered surgical suites. The ICL operated 24 hours a day, seven days a week, for emergency services.

Review of the policies and procedures (P&P) showed that standards of practice for traffic patterns in the surgical suites (P&P titled "Traffic Patterns in the Surgical Suite" revised 2/15/11) were applicable only to selected areas (Pavilion Operating Room, Same Day Surgery Center and Children's Surgery Center) and were not applicable to the ICL. The policy titled "Invasive Cardiovascular Services Structure Standards Heart & Vascular Center" (rev 1/22/12) indicated that complex invasive diagnostic and interventional cardiac, peripheral vascular procedures and electrophysiology procedures were performed in the ICL suites. The policy indicated in the "Infection Control " section that standard precautions were to be followed. It indicated that scrubs will be worn by clinical staff participating in direct patient care but it was optional for non-clinical personnel. There were no restricted or semi-restricted areas addressed in the P&P for the ICL.

Review of the facility P&P titled "Dress Code and Personal Appearance" (effective 1/3/12) showed that it was applicable to settings including Patient Care Services and Perioperative Services. The policy did not address traffic patterns, restricted areas or surgical attire. The P&P indicated, "...Only the following departments are authorized to wear hospital issued scrubs: a. Perioperative Services; b. Anesthesia; c. University Birthing Center; d. Cardiovascular Invasive Services; e. Radiology Staff Assigned to Interventional Procedures in Radiology ...". The policy assigned various scrubs colors to different staff roles (e.g. Registered Nurses (except Emergency Room) midnight blue ...etc.). However, the P&P did not speak to laundering of the scrubs and/or when/how scrubs should be worn, changed and laundered.

b. On 1/26/12 starting at 9:15 a.m., a tour of the Pulmonary Services Laboratory (PSL) was conducted with the Manager of the unit (NM 11). NM 11 stated that the PSL provided inpatient and outpatient services and performed diagnostic and therapeutic procedures, including invasive surgical procedures, which were performed in the Bronchoscopy Suite.

Review of the procedure schedule for 1/26/12 showed that Patient 15 was being prepared for thoracentesis procedure (an invasive surgical procedure during which a sterile catheter is inserted deep into the chest cavity to drain fluids surrounding lungs). Prior to the surgical procedure at 9:30 a.m., the fellow physician (MD 23) was observed explaining to the patient risks of the procedure, including bleeding and a collapsed lung (pneumothorax) for which treatment would include a chest tube insertion into the patient's lung through the chest wall to expand the lung.

On 1/26/12 starting at 9:32 a.m. Patient 15 was observed having thoracentesis procedure performed by two physicians (MD 23 assisted by the attending physician, MD 24). The insertion site was disinfected and sterile drapes applied prior to the procedure. A sterile catheter, supplies and sterile gloves were used during the procedure. The attending physician was wearing street clothing and the fellow hospital scrubs, both covered with a non-sterile disposable gown. Neither physician was observed wearing sterile gown and head coverings to ensure maintenance of sterile field and to protect the surgical site from microorganisms (from the environment and the staff's skin, clothes, and hair).

In an interview on 1/26/12 at 10:30 a.m., the Assistant Manager (NM 12) stated that all procedures performed in the PSL were considered clean and not sterile, even though sterile supplies were used, therefore the facility-wide Dress Code policy and Standard precautions applied. No traffic restrictions for the procedure room, any surgical attire or sterile field maintenance including sterile gown, head covering and mask were required. The Manager stated that PLS functioned according to the "Pulmonary Services Laboratory Unit Structure Standards" policy and not the operating rooms policies.

Review of the P&P titled "Pulmonary Services Laboratory Unit Structure Standards" (rev 7/5/11) indicated that the unit provided diagnostic and therapeutic procedures that included invasive surgical procedures such as bronchoplasty (surgical repair of a defect in the bronchus), pleural biopsy (a procedure to remove a sample of the tissue lining the lungs and the inside of the chest wall), thoracentesis (an invasive surgical procedure during which a sterile catheter is inserted deep into the chest cavity to drain fluids surrounding lungs), percutaneous tracheostomy (an operative procedure that creates a surgical airway in the cervical trachea), etc. The P&P referred to "Pulmonary Lab policy and Procedure Manual, Infection Control.II-1" for infection control policies.

Review of "Pulmonary Lab Policy and Procedure Manual, Infection Control.II-1" (rev 3/17/10) showed the policy did not direct that aseptic and/or sterile techniques and practices were to be followed during invasive surgical procedures to protect the surgical site/wound from microorganisms. There were no requirements to create surgical environment such as maintaining restricted access to the surgical/procedure suite, wearing surgical attire and to maintain a sterile field during surgical procedures, to protect the surgical sites and minimize microorganisms and infections.

During observations of care in the PLS on 1/26/12 starting at 9:15 a.m., in the surgical procedure suite (Bronchoscopy Suite), bronchoscopes were observed stored in a wall cabinet. There was a sink in the procedure room with a large basin containing Cidex OPA Solution (a potent disinfectant used for high level disinfection of scopes). A plastic-like divider separated the sink from the countertop to the left, which was labeled as a clean area. There was a plastic curtain separating the procedure bed from a desk and office supplies in the room. There was no physical barrier between the scope reprocessing area (sink and the disinfectant basin) and the space/bed used during surgical procedures.

NM 13 stated on 1/26/12 at 10:30 a.m. that the sink in the procedure room and the Cidex OPA Solution in the basin next to it were used after bronchoscopy procedures to clean and disinfect bronchoscopes by the nursing staff (using manual cold disinfection process). The procedure room was also used to store sterile and clean equipment and supplies. NM 13 stated that the procedure room was not treated as a surgical suite therefore only standard infection control policies applied (such as hand washing, using personal protective equipment, etc.). NM 13 acknowledged that sterile supplies were stored in the room. No terminal cleaning, room temperature, humidity or air exchanges were performed/monitored for the procedure room.

Review of the 2011 AORN Perioperative standards and recommended practices indicated under Recommendation XI of the "Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories " that "Flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled and patient care activities are performed. Physical separation of decontamination areas from areas where clean items are handled minimizes the risk of cross-contamination. Cross-contamination can result when soiled items are placed in close proximity to clean items or placed on surfaces upon which clean items are later placed. Aerosols created during cleaning can also cause cross-contamination."

The Perioperative Standards and Recommended Practices published by the Association of Perioperative Registered Nurses (AORN) 2011 edition, Recommendation IV, indicated, "Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily." Terminal cleaning was defined as cleaning that is performed at the completion of surgical practice settings' daily surgery schedule. Terminal cleaning is performed in surgical procedure rooms and scrub/utility areas. Recommendation V indicated that all areas and equipment in the surgical practice setting should be cleaned according to an established schedule. It was recommended (Section V. a. 1.) that "Areas and equipment that should be cleaned on a weekly or monthly basis should include, among others, walls and ceilings.

The Perioperative Standards and Recommended Practices published by the Association of Perioperative Registered Nurses (AORN) 2011 edition, Recommendation V of the "Recommended Practices for a Safe Environment of Care " indicated, "Potential hazards associated with HVAC (heating, ventilation, and air conditioning) systems in the practice setting should be identified, and safe practices should be established ...Air in the perioperative environment contains microbial-laden dust, lint, skin squames, and respiratory droplets. The number of microorganisms in the air in an operating room is directly proportional to the number of personnel moving in and around the room. Outbreaks of surgical-site infections have been traced to airborne contamination from colonized health care workers. Heating, ventilation and air conditioning systems dilute and remove contaminants from the air and control airflow patterns. Key components of an effective HVAC system are proper air quality, air volume changes, and air flow direction. In an operating room or procedural area, proper functioning of these components minimizes the contamination of the sterile field and risk of infection to the patient. A properly functioning HVAC system carries microbial-laden skin squames, dust, and lint away from the sterile field, and removes these contaminants through the exhaust ducts at the periphery." Section V.b. indicated, "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas."

c. On 1/24/12 starting at 12 p.m. observation of care in the Pain Clinic was conducted. The Pain Clinic had three procedure rooms in which various diagnostic and therapeutic procedures and injections were performed, including spinal injections (contrast and/or steroid medication deep injections) under local anesthetic or intravenous sedation and using X-ray imaging (fluoroscopy).

On 1/24/12 starting at 2 p.m. Patient 11 was observed having spinal diagnostic injection into neck spine with fluoroscopy use performed by a fellow physician supervised by the attending physician, MD 33. Prior to entering the procedure room, the registered nurse assisting with the surgery stated that surgical attire/scrubs were not required in the procedure room, only protective lead aprons/shields, hat and masks. The pain procedures were not considered by the hospital as surgeries therefore traffic patterns restrictions and surgical attire were not required for pain procedures.

On 1/24/12 at 3 p.m. the Manager of Pain Clinic (NM 15) was asked for policies and procedures addressing environmental and infection control practices in the pain clinic including attire required in the procedure room during a pain procedure. NM 15 was not able to locate a policy that would address the practices in the procedure room as observed or any other policy that would speak to traffic pattern, surgical attire or maintenance of sterile field during the pain procedures.

In an interview with MD 33 on after the procedure, MD 33 confirmed that the standard of practice for surgical attire during pain procedures included wearing a mask and sterile gloves and maintenance of sterile field, but also stated that the pain procedures were not considered surgical procedures by the hospital surgery services, therefore surgical attire, traffic restrictions, etc. were not practiced in the pain clinic.

Review of the hospital-wide policies related to surgical services and infection control standards and multiple interviews conducted during the survey (1/23/12 to 1/26/12) with the Medical Director of Perioperative Services (MD 12) and other hospital administrative and surgical staff showed that no appropriate protocols were developed hospital-wide for surgical procedures that were performed outside of main surgery suites, to ensure aseptic and sterile surveillance and practices were followed and maintained.

Based on observation, staff interview, medical record and document review, the hospital failed to ensure that an accurate and complete history and physical examination (H&P, an assessment of the patient's health) and/or update to each surgical patient's complete H&P, performed by a qualified individual, was documented prior to the surgical procedure for 6 of 12 sampled surgical patients (Patients 31, 48, 80, 81, 82, and 83), in accordance with hospital policy, medical staff rules and regulations, and acceptable standards of practice. This failure put surgical patients at risk for an unsafe surgical experience.

Findings:

Review on 1/23/12 at 5:30 p.m. of the medical record for Patient 31 with MD 5, who performed anesthesia services for Patient 31, indicated that Patient 31 had planned spine surgery on 1/23/12. Following surgery, Patient 31 displayed an abnormal heart rhythm and was admitted to a special monitoring care unit of the hospital (which was unplanned). The Anesthesia Operative Report noted anesthesia start time of 7:16 a.m. and anesthesia end time of 11:36 a.m. (with surgery occurring between). Patient 31 had a complete H&P documented by the spine surgeon on 1/11/12, which specifically noted absence of pulses (blood circulation) in both lower legs. Patient 31 also had co-existing heart problems for which a consultation with a heart specialist was documented on 12/29/11, and which provided an opinion that his heart condition did not prohibit him from proceeding with surgery and anesthesia. No update to the surgeon's H&P by the surgeon was documented on the day of surgery (admission). Instead, MD 5 stated that he and a resident physician in training (MD 23) performed the H&P update and documented that task together with a pre-anesthesia assessment in a note titled "Anesthesiology Pre Operative Screening Update." This particular shared note was started by MD 23 sometime prior to surgery, but MD 5 could not determine what was written prior to surgery, as both MD 23 and MD 5 signed the entries after surgery on 1/23/12 at 1:57 p.m. The Anesthesiology Pre Operative Screening Update documented, "The Anesthesia H&P was reviewed ... the patient has been examined, and there are no changes in the patient's condition since the H&P was completed." MD 5 could not determine what was meant by "Anesthesia H&P," since the only physician assessments he could find in this electronic record were the surgeon's report from 1/11/12 and the cardiologist's reports from December of 2011. MD 5 stated that usually a screening H&P was prepared through a pre-operative clinic and that was what was meant by "Anesthesia H&P."

In an interview with the Chief Medical Office (CMO) on 1/24/12 at 10 a.m., the CMO presented a report he had located from the electronic system dated 1/11/12 and titled Nursing/Ancillary Staff Pre-Anesthesia Screening, prepared and signed by a registered nurse. The CMO indicated that this document was considered the "Anesthesia H&P" which was referenced by MD 5 and MD 23 in their Anesthesiology Pre Operative Screening Update. The CMO indicated that approximately 1/3 to 1/2 of all elective pre-surgical patients were referred to a screening clinic where one physician, or one of 6 nurses, performed pre-surgical and/or pre-anesthesia assessments days to weeks prior to the scheduled surgery. The 6 nurses, however, did not possess the education and training comparable to physicians or advanced practice providers (mid-level practitioners), and thus were not qualified to assess the fitness for surgery or anesthesia for any patient.

[Note that the Centers for Medicare and Medicaid Services regulations written in the Code of Federal Regulations at CFR 482.52(b)(1) required that a pre-anesthesia assessment may only be performed by someone qualified to administer anesthesia, i.e. a qualified anesthesiologist, doctor of medicine or osteopathy, dentist, oral surgeon, podiatrist, certified registered nurse anesthetist, or anesthesiologist assistant under supervision. CFR 482.55(c)(5) defined the persons qualified to perform an H&P as those individuals legally authorized to practice within the state, and within their scope of practice. In California, those individuals included physicians and mid-level practitioners but not registered nurses.]


On 1/24/12 between 11 a.m. and 12:30 p.m., Patient 48 was observed to undergo a type of planned outpatient stomach surgery in the diagnostic radiology (imaging) department. The surgery was performed by MD 22. Moderate sedation (the administration of drugs to dull a patient's awareness and pain during a surgical procedure, a type of anesthesia service also known as conscious sedation) was administered and monitored by a registered nurse. No other staff (e.g. circulating nurse, scrub assistant, anesthesia physician) participated in the surgical procedure. MD 22 was not observed to perform a history and physical examination or airway assessment of Patient 48 prior to the procedure.

Review on 1/25/12 at 3 p.m. of the medical record for Patient 48 with a Patient Care Services Director (PCSD 4) indicated that Patient 48 had surgical placement of a tube through the skin of the abdomen into the underlying stomach to provide nutrition on 1/25/12 at 12:04 p.m. because Patient 48 could not swallow well. The surgery was performed in the imaging department by MD 22. No assessments by MD 22 prior to surgery were documented. An office visit dated 1/17/12 by a different treating physician noted high-risk health conditions, including compromise to Patient 48's nutrition and fluid balance, a severely low blood count (anemia), and kidney failure. The office examination documented diffuse swelling of the mouth and upper airway passage due to head and neck cancer and radiation treatments. The visit note did not document essential elements of an H&P (e.g. allergies, physical exam findings of the major organ systems, medications, and other serious health conditions that affect one's risk for surgery), and would be incomplete as an H&P.

On 1/25/12 at 6 p.m., the hospital presented documents related to Patient 48's surgery on 1/25/12. A document titled "Brief History & Physical for Outpatient Procedures with Sedation" was signed as a Pre Sedation Edit by a nurse practitioner (who did not participate in the surgical procedure) on 1/24/12 at 9:08 a.m. (the day before surgery, 27 hours prior to surgery). Prior to the signature on 1/24/12 at 9:08 a.m., the note read, "I have reviewed and assessed the patient immediately prior to procedure and the patient remains a candidate for conscious sedation. I have reviewed and concur with the nursing assessment completed prior to procedure." The document was signed again by the same nurse practitioner (NP) on 1/25/12 at 10:48 a.m. (prior to surgery). The only examination findings noted on the document were of heart and lung sounds, and some aspects of the abdomen. Although only a very mild surgical risk and mild degree of difficulty to rescue the airway were selected by the NP for this high risk patient, the NP did not document the condition of Patient 48's neck mobility, mouth and upper airway (which were previously described as abnormal). Specific examination of the skin where the surgery would be performed was also not described. Allergies, medications, vital sign measurements, mental condition, and general health history were items not included in the NP report, thereby rendering this H&P as incomplete. No documentation was presented to show that the surgeon (MD 22), who was responsible to decide whether the patient was fit for surgery and moderate sedation, had examined and assessed the patient to determine whether it was safe to proceed with the planned surgical care.

Review of a chapter from the 2006 online Merck Manual Professional titled Preoperative Evaluation: Care of the Surgical Patient, retrieved from , listed elements of a "relevant preoperative history" to include current symptoms of active heart/lung disorder or infection, risk factors for bleeding, blood clots, and infection, serious chronic diseases, complications of previous surgery or anesthesia, allergies, and current medications. Physical examination should include not only areas affected by the surgical procedure but also the heart and lung systems and a search for any signs of ongoing infection. The mental condition of the patient should be assessed.


Review of the surgical records for Patient 80 (wrist surgery on 1/24/12), Patient 81 (eye surgery on 1/24/12), Patient 82 (eye surgery on 1/24/12), and Patient 83 (eye surgery on 1/24/12) showed similar documentation of the anesthesiologist referring to an "Anesthesia H&P" that was performed by a registered nurse, as the findings to which the anesthesiologist was comparing in the pre-surgical assessment (H&P update) to determine that these patients were fit and ready for surgery and anesthesia. In each case, the anesthesiologist did not document an independent review of the medical evidence described in the registered nurse notes.

In an interview on 1/24/12 at 10 a.m. with MD 12, an anesthesiologist who served as the Director of Perioperative Services, MD 12 indicated that anesthesiologists, rather than the operating surgeons, routinely provided the documentation of H&P updates for pre-surgical patients, although they were not specifically privileged to do so. MD 12 indicated that the documented assessments of anesthesiologists did not routinely include specific descriptions of a patient's incision site or surgical condition, lower body examination findings (like leg pulses), or other aspects of a patient's condition that would affect their ability to tolerate the planned surgery independent of the ability to tolerate anesthesia. MD 12 indicated that anesthesiologists did review information in the patient's medical record as part of their pre-anesthesia assessment prior to surgery, and referred to reliance on the information contained in the Nursing/Ancillary Staff Pre-Anesthesia Screening prepared by an unqualified practitioner as the reference for the "Anesthesia H&P" update.

In an interview on 1/26/12 at 4 p.m. with the former Chairman of the Department of Surgery (MD 11) and the CMO, MD 11 agreed that the operating surgeon was responsible for his patient's surgical care, and the decision to proceed (or not) with a planned procedure. MD 11 acknowledged that signs of infection or unstable health conditions shortly before surgery is started adversely affect the successful outcome of the surgery. MD 11 stated that he expected that the operating surgeon should be knowledgeable about his patient's health conditions and to examine the incision site as part of an assessment prior to surgery, in case it was determined that it was not safe to proceed and before the patient received unnecessary pre-operative treatments. However, the CMO stated the hospital had no rule, policy, or requirement for the operating surgeon to examine, assess, and document an assessment (e.g. H&P update), prior to surgery, to show the surgeon took responsibility to determine that it was safe to proceed, based on that assessment. The CMO agreed a surgeon should not delegate surgeon responsibilities to other members of the health care team (non-surgeons).

In an interview on 1/26/12 at 4 p.m. with multiple members of the medial staff leadership, including the current and former Department Chairs for Anesthesiology (MDs 4 and 13) and MD 11, MD 13 indicated that hospital practices in surgery and anesthesiology should be based on nationally recognized standards to provide high quality care, particularly in a training institution such as theirs.

Review on 1/24/12 at 10 a.m. of hospital policy 2306 titled "Legal Medical Record Content/Core Elements," last revised 7/29/11, documented under VI-J-2 that for both inpatient and outpatient surgical procedures, an updated examination of the patient, including any changes in the patient's condition, must be recorded before the procedure.

Review on 1/24/12 at 10 a.m. of the July 2011 medical staff rules and regulations under section I-I addressed the requirements for H&Ps and H&P updates. For inpatient admissions, "a complete history and physical examination will be completed by the attending physician or other qualified licensed individual" within 30 days prior to admission or surgery. If the patient was admitted for surgery, the H&P and/or update must be performed and recorded within 24 hours of the surgery. "The update consists of a reassessment of the patient's current condition and may be documented as an interval note." The rules did not permit H&Ps or H&P updates to be performed by registered nurses. When H&Ps were done by outside physicians, a hospital physician was required to confirm the findings and sign the document.

Review of standard ST-25 from the American College of Surgeons (ACS) titled "ACS Statement on Principles Underlying Perioperative Responsibility," retrieved from , under item 4 that the surgeon was responsible for the proper preoperative preparation of the patient. Minimizing the risk of operation, while providing maximal opportunity for a satisfactory outcome, required full appreciation by the surgeon of the patient's condition. Item 5 noted that the surgeon was responsible for the safe and competent performance of the operation. Part of this responsibility included planning for the operation with the anesthesiologist in order to ensure anesthesia that was best for the patient.

In an interview on 1/24/12 at 10 a.m. with MD 12, MD 12 indicated that the anesthesia department followed the standards for anesthesia and moderate sedation care recommended by the American Society for Anesthesiology (ASA), more than any other medical organization. MD 12 acknowledged that the registered nurses who were performing pre-anesthesia screening assessments were not qualified anesthesia providers and not qualified to perform pre-anesthesia assessments. Anesthesia providers were expected to perform and document their own assessments, and not rely on the findings of unqualified practitioners.

In an interview on 1/26/12 at 4 p.m. with MD 4, who served as the Chairman for the Department of Anesthesiology, MD 4 agreed that in the case of Patient 48, the operating surgeon (MD 22) was responsible to supervise a trained registered nurse in the administration and monitoring of moderate sedation during the stomach tube surgery. Therefore, the operating surgeon would be expected to perform and document his own pre-sedation and airway assessments, rather than delegating that responsibility to another licensed practitioner (NP) who was not participating in the surgery.

According to the ASA Statement on Granting Privileges for Administration of moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, approved 10/25/05 and last amended 10/19/11, a nonanesthesiologist sedation practitioner is a licensed physician, dentist, or podiatrist not trained in anesthesiology but specifically trained to personally administer or supervise the administration of moderate sedation (by a trained licensed registered nurse, advanced practice nurse, or physician assistant). The ASA Statement did not recognize a NP as qualified to supervise other sedation professionals who require supervision.

Review on 5/20/11 of the National Integrated Accreditation for Healthcare Organization (NIAHO) standards for assessments prior to anesthesia services indicated that a pre-anesthesia or pre-sedation evaluation must be performed and documented, by an individual qualified and privileged to administer anesthesia/sedation, not more than 48 hours prior to surgery or procedure requiring anesthesia services. This evaluation must include airway assessment, anesthesia risk assessment and anesthesia drug and allergy history.

Based on staff interview and document review, the hospital failed to ensure that a properly executed informed consent form for each operation was documented in the chart prior to surgery in accordance with hospital policy for 1 of 12 surgical patients reviewed (Patient 50). This failure contributed to the performance of unnecessary surgery on the wrong body site.

Findings:

Review on 1/24/12 at 5 p.m. of the medical record of Patient 50 with MD 10, who served as the Chief of Staff for the medical staff, indicated that Patient 50 was admitted to the hospital on 7/14/11 for shortness of breath and fluid accumulation in the space surrounding the right lung. An invasive surgical procedure to drain the lung fluid (thoracentesis) was performed by two resident physicians in training (MDs 17 and 18) on the wrong side of the chest, posing an unnecessary risk for bleeding, infection, and/or further compromise of the patient's breathing. MD 10 indicated that had the resident physicians followed a standard surgical site verification process, the error and unnecessary risk for harm may have been prevented. The consequence of this error required additional x-ray studies and monitoring for the complications of the an unnecessary surgery.

MD 10 further stated that all physicians were expected to conduct a process to verify the correct patient, correct procedure, and correct surgical site. MD 10 stated that the team performing the procedure was expected to review the consent form with the patient to verify the type of procedure and location. MD 10 agreed that Patient 50's consent form listed the name of the procedure but not on which side of the chest it would be performed. MD 10 stated that nursing staff was not present just before the surgery was performed to verify everyone's understanding of what side of the chest Patient 50 had consented to have surgery on.

Review of the medical record for Patient 50 on 1/26/12 at 1:30 p.m. with MD 19, who served as the acting program director for a resident physician in training department, confirmed that Patient 50 had chest surgery performed on the wrong side by two residents physicians on 7/14/11. The care was reviewed by his department, and the department identified that the residents had not followed all requirements of standard surgical site verification. However, the department had not discussed the failure to accurately document on the consent form the correct side of the chest for this surgery. MD 19 acknowledged that had the consent form listed the correct side, any surgery team member who looked at the consent just prior to performing surgery could have intervened to have the surgeon reassess. Thus a critical step (consent verification) in the verification process was also missed.

Review on 1/26/11 at 1:30 p.m. of policy IV-19 titled Universal Protocol, last revised 1/20/10, documented that invasive procedures involving the puncture or incision of the skin, insertion of an instrument, or insertion of foreign matter into the body required use of the Universal Protocol to prevent errors of wrong patient, wrong body part, wrong side of the body or at the wrong level of the correctly identified anatomic site. The Universal Protocol was required for all procedures performed in all locations. The policy described the steps required to fulfill the Universal Protocol, which included verification (and documentation) of the consent with the patient (when possible) immediately prior to starting surgery.

Review of policy 2306 titled "Legal Medical Record Content/Core Elements," revised 7/29/11, under section VI-E-2(b) required that informed consent be documented on a consent form. The information written on the form "must be in clear, simple easily understood terms."

Based on staff interview and document review, the hospital failed to ensure that an operative report that described the techniques and findings was documented immediately following surgery and signed by the surgeon in accordance with hospital policy for 2 of 12 surgical patient records reviewed (Patients 48 and 50). This failure posed a risk for mis-communication and errors in the continuity of care for surgical patients.

Findings:

Review of the medical record for Patient 50 on 1/26/12 at 1:30 p.m. with MD 19, who served as the acting program director for a resident physician in training department, confirmed that Patient 50 had a chest surgery procedure performed by two residents physicians on 7/14/11, but no operative report written by the person(s) who performed the procedure was documented.

Review of the medical record for Patient 48 on 1/25/12 at 3 p.m. with a Patient Care Services Director (PCSD 4) confirmed the presence of a document titled "Attending Brief Operative Note" for a stomach surgery performed on 1/25/12 at 12:04 p.m. However, the note did not document the post-operative diagnosis, type of anesthesia, description of the procedure and surgical technique, findings, specimens, or estimated blood loss.

Review of policy 2306 titled "Legal Medical Record Content/Core Elements," revised 7/29/11, under section VI-P-1 that an operative report was required for all patients undergoing operative or other invasive procedures and/or anesthesia. The report shall be dictated or entered into the electronic medical record immediately after the procedure (upon completion). The report must include:

a. Pre- and post-operative diagnosis
b. Name of the procedure
c. Name of surgeon and assistants
d. Type of anesthesia administered
e. Description of the procedure, surgical technique
f. Findings
g. Specimens removed
h. Estimated blood loss
i. Complications and patient outcome

Based on staff interview, medical record and document review, the hospital failed to ensure that a pre-anesthesia evaluation was completed and documented by a qualified individual within 48 hours prior to surgery in accordance with hospital policy and acceptable standards of practice for 1 of 12 surgical patients reviewed (Patient 31). This failure posed a risk for staff to be unprepared from lack of documented information about a surgical patient's condition prior to surgery.

Findings:

Concurrent review on 1/23/12 at 5:30 p.m. of the medical record for Patient 31 with MD 5, who supervised the anesthesia care for Patient 31, indicated that Patient 31 had high risk health conditions and had spine surgery earlier that day (1/23/12 between 7:15 a.m. and 11:30 a.m.). MD 5 stated that a pre-anesthesia assessment was documented by a resident physician in training (MD 25) and cosigned by MD 5. The pre-anesthesia assessment was documented partly on an electronic medical record (EMR) form titled "Anesthesiology Pre Operative Screening Update" and partly on a paper record titled "Operative Report." MD 5 acknowledged that the elements of a standard pre-anesthesia assessment included review of existing reports and consultations by other providers, direct inquiry with the patient to identify medical and surgical risk factors and health conditions that affect the risk for the planned procedure, a physical examination with focus on the anatomy and features of the patient's upper and lower airways to guide the preparation and management of the anesthesia care, review of existing laboratory, imaging, and objective test results (such as electrocardiogram test of the heart), and assignment of a risk category and airway classification (called Mallampati score). MD 5 agreed that the pre-anesthesia assessment guided the treatment plan for the anesthesia care and should be performed by the person responsible for that care (qualified anesthesia professional). MD 5 stated that although MD 25 performed an assessment, MD 5 also independently performed his own assessment prior to the start of the anesthesia and surgery care. However, the EMR form that was signed by both MD 25 and MD 5 was not signed by either physician until several hours after surgery was completed. Unsigned EMR records were unavailable to staff until signed. MD 5 stated that the pre-anesthesia assessment was not documented prior to the delivery of anesthesia services (induction of an anesthetic state).

Furthermore, the paper portion of the pre-anesthesia assessment was not specifically signed with a date and time of the entries. Neither of the portions of the pre-anesthesia assessment documents detailed Patient 31's health conditions, or described the findings of existing abnormal test results related to Patient 31's heart. The vital sign measurements of the EMR form did not match the measurements recorded on the paper form. The EMR form documented laboratory test results obtained after surgery (not part of a pre-anesthesia assessment). Because the patient's history of allergies and diagnoses were noted on the paper form, but examination findings were noted on the EMR, the assessment itself was fragmented and not readily available to all staff participating in Patient 31's care for continuity.

In an interview on 1/26/12 at 4 p.m., MD 4, who served as the Department Chairman for Anesthesiology, confirmed that the hospital-wide anesthesia practices were based on the recommendations of the American Society for Anesthesiologists (ASA). MD 4 agreed that pre-anesthesia assessments were expected to be documented prior to the delivery of anesthesia care for all patients.

Review of policy 2306 titled "Legal Medical Record Content/Core Elements," revised 7/29/11, documented under item VI-C-2 that pre-anesthesia assessments should be performed and documented prior to any inpatient or outpatient surgery or procedure requiring anesthesia services. Item VI-J-1 documented that a pre-anesthesia assessment must be documented immediately before administering moderate sedation or anesthesia.

Review of the American Society for Anesthesiology (ASA) statement titled "Basic Standards for Preanesthesia Care," last affirmed 10/20/10, documented that the anesthesiologist was responsible to document in the patient's chart that a determination of the patient's medical status and the plan for anesthesia care were developed prior to the delivery of anesthesia care.

Based on observations, staff interview and document review the hospital failed to ensure that the organization of outpatient services was organized and appropriate and equipment, staff and facilities were adequate to meet the needs of patients in accordance with acceptable standards of practice.

A. The hospital failed to ensure infection control practices where invasive procedures were performed were in accordance with nationally established standards for surgical attire, traffic patterns, equipment cleaning, and environmental cleaning. (Refer to A 1077)


B. The hospital failed to have an effective system to monitor and maintain the relative humidity, temperature and air exchanges in the outpatient perioperative areas in accordance with nationally recognized infection control guidelines (perioperative areas include operating rooms, endoscopy rooms ( the rooms for procedures in which an instrument is passed into the body for the purpose of visual examining the interior of a body canal or hollow organ), decontamination room, sterile processing areas, sterile storage and recovery room area. (Refer to A 1077)

C. The hospital failed to ensure separation of clean and soiled supplies and location in accordance with nationally accepted infection control guidelines (refer to A 1077)

D. The hospital failed to ensure appropriate staff oversight of the outpatient surgical services departments and coordination with inpatient surgical services (Refer to A 1079)


The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Outpatient Services.

Based on observations, staff interviews, and document review, the hospital failed to provide and maintain a safe and sanitary environment for patients and employees in the outpatient clinic areas in accordance with hospital policy and nationally accepted guidelines as evidenced by:

1. The hospital failed to have an effective system to monitor and maintain the relative humidity, temperature and air exchanges in the outpatient perioperative areas in accordance with nationally recognized infection control guidelines (perioperative areas include operating rooms, endoscopy rooms (the rooms for procedures in which an instrument is passed into the body for the purpose of visual examining the interior of a body canal or hollow organ), decontamination room, sterile processing areas, sterile storage and recovery room area.

2. The hospital failed to ensure separation of clean and soiled supplies and location in accordance with nationally accepted infection control guidelines.

3. The hospital failed to ensure gas was stored safely.

4. The hospital failed to have an effective system to ensure compliance with use of surgical attire /personal protective equipment (PPE) in the perioperative and endoscopy areas in accordance with hospital policy and nationally accepted infection control guidelines.

5. The hospital failed to have an effective system to ensure traffic patterns were conformed to in accordance with nationally accepted infection control guidelines.

6. The hospital failed to have an effective system to ensure endoscopes were a) cleaned b) disinfected and c) stored in accordance with hospital policy and nationally accepted infection control guidelines

7. The hospital failed to have an effective system to ensure endoscopes blood spill were cleaned up according in accordance with hospital policy and nationally accepted infection control guidelines

8. The hospital failed to ensure glucometers (medical device used to measure blood sugar in patients) were cleaned according to policy.

1. During an interview Staff 80 on 1/25/12 at 12:00 p.m. , she stated " In GI- 2 we are not monitoring the rooms for temperature and humidity daily. They are doing an overall building surveillance (not room or area specific) of temperatures, and I am not sure about humidity monitoring. There is no monitoring of air exchange rates. "

On 1/25/12 at 12 00 p.m., the following e-mail statement was provided, addressed from Staff 82, in response to a request for GI-2 ' S policy on environmental monitoring: " The environmental monitoring policy requested is not relevant to procedure rooms that are not licensed as operating rooms. There is environmental monitoring that occurs, including temperature; however, the standards are not the same as the monitoring done for the operating rooms. "

During an interview with AMPO (Assist Manager of Plant Operations) 1/26/12 at approximately 2:30 p.m., he confirmed that daily monitoring of the outpatient GI-2 area room, including the procedure rooms were not performed. AMPO indicated that the reason they were not monitored was because the area was not considered a surgical suite. AMPO also indicated that the building the outpatient GI area was housed in did not have capacity for humidity adjustment.

Review of the Same Day Surgery Center daily temperature and humidity logs were reviewed on 1/24/12 at 6 p.m. The log legend indicated normal temperature values equaled 60 to 70F and normal humidity values equaled 20 to 60. The log legend indicated the code A was used to indicate temperature adjusted, code B for PO and M notified (plant operations and maintenance notified), and code C+ for door left open/closed. The logs documented the humidity in the operating rooms was consistently below 30 during the month of 12/11. There was no evidence on the log that Plan operations was notified on adjustments to environment controls were made. An example where humidity levels were out of range is listed below:

12/1/11 in OR1 the humidity was 25; in OR2 it was 25; in OR3 it was 25; OR4 it was 24.
12/2/11 in OR1 the humidity was 22; in OR2 it was 24; in OR 3 it was 24; OR4 it was 23.
12/5/11 in OR1 the humidity was 25; in OR2 it was 25; in OR 3 it was 25; OR4 it was 22.
12/6/11 in OR1 the humidity was 26; in OR2 it was 25; in OR 3 it was 24; OR4 it was 22.
12/7/11 in OR1 the humidity was 26; in OR2 it was 24; in OR 3 it was 24; OR4 it was 23.
12/22/11inOR1 the humidity was 21; in OR2 it was 20; in OR 3 it was 20; OR4 it was 20.

During an interview with AMPO on 6/26/12 at approximately 2:20 p.m., he acknowledged the humidity levels were below 30 throughout the month of December 2011 and no adjustments were made. AMPO stated there were no enforceable regulations that required the hospital to maintain the humidity in the out-patient operating rooms at a minimum of 30. AMPO stated he was aware of the national guidelines, such as AORN, but that these were standards and not enforceable requirements.

In a review of the 2011 Perioperative Standards and Recommended Practices, published by the Association of periOperative Registered Nurses (AORN), direction was provided
" Relative humidity should be maintained between 30 and 60% within the perioperative suite, including operating rooms ...Low humidity increases the risk for electrostatic charges which pose a fire risk in an oxygen rich environment or when flammable agents are in use and increase the potential for dust. "

2. On 1/24/12 at 10:23 a.m. the ENT (ears, nose throat) surgical procedure room was observed to contain a large card board box, papers, binders, and books stacked at the back of the room against a wall and not contained in a cabinet.

On 1/24/12 at 10:23 a.m., during an interview with ICP 10 (infection control preventionist) in the ENT surgical procedure room, he commented that office supplies were being stored in the surgical procedure room. ICP 10 stated that there was no way to disinfect these items and another place should be found to store them. The ICP 10 added that cardboard should never be stored in an operating room because it could contain cockroaches.

On 1/26/12 at 8:47 a.m., in the soiled utility room of the sixth floor of the ENT outpatient clinic, Staff 85 was observed cleaning a soiled endoscope at a sink that did not have a splash guard. When facing the sink, the counter to the left had a sign over it labeled "clean". Sitting on this counter approximately one foot away from the sink was an endoscope lying uncovered on a towel.

During an interview with the Staff 85 on 1/26/12 at 8:47 a.m. in the soiled utility room of the sixth floor of the ENT outpatient clinic, Staff 85 stated the endoscope on the towel on the clean counter had been processed using a high level disinfected. When asked how often the towel, where processed scopes were placed, was changed, staff 85 stated the towel was changed daily or for saturation. Staff 85 stated scopes on the towel were available for use. When questioned about why the scope was being left on the towel on the counter, Staff 85 stated it was more convenient for the physicians to obtain the scopes from the counter.

In an interview with ICP 10 on 1/26/12, she acknowledged the clean scope placed on the towel, or any subsequent clean scope on the towel could be contaminated by aerosols from the sink, where staff were cleaning the scope.

In a review of the 2011 Perioperative Standards and Recommended Practices, published by the Association of periOperative Registered Nurses (AORN), under Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, Recommendation VII indicates, "Instruments should be decontaminated in an area separate from locations where clean activities are performed...Physical separation from areas where clean items are handled minimizes the risk of contamination. Cross-contamination can occur when soiled items are placed in close proximity to clean items or placed on surfaces upon which clean items are later placed. Aerosols created during cleaning can also cross-contamination."

3. On 1/24/12 at 9:40 a.m. free standing container of labeled nitrogen was observed in the ENT surgical procedure room.

On 1/24/12 in a concurrent interview with Staff 84, she stated, "It (referring to the gas canister) should be in a holder. It is a volatile gas. "

4. An initial tour of the GI-2 outpatient clinic area was conducted on 1/25/10 at 8:30 a.m. The GI-2 clinic area was comprised of two procedure rooms, a decontamination/ high level disinfection processing room, hallways, and a recovery area. Staff 80 was observed wearing street clothes throughout the GI -2 clinic area, including the two surgical procedure rooms, and the room where the endoscopes were cleaned and disinfected.

During an interview with Staff 80 on 1/25/12 at 9:20 a.m., she indicated there was no requirement to wear surgical attire, i.e. facility laundered scrubs, head covering or masks, in the GI area. She stated "The types of procedures performed in the GI-2 area were not sterile". In a subsequent interview on 1/25/12 at 10:10 a.m., Staff 80 indicated the procedures done in the outpatient GI clinic were not considered surgeries and therefore staff persons were not required to wear surgical attire as practiced in a perioperative/operative area.

On 1/265/12 at 10 a.m., in an interview with Staff 81, a review of the definition of surgery developed by the American College of Surgeons dated 4/2007 was conducted. The definition of surgery indicated "Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or diseases processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles......All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel" and "biopsy was a procedure performed for the purpose of structurally altering the human body by the incision or destruction of tissues." Staff 81 acknowledged biopsy ( a procedure which structurally alter tissues) was always a potential occurrence with endoscopic procedures and he added perforation of the bowel was also always a possible occurrence when performing colonoscopy.

In a review of the hospital's Policy and Procedure titled "Dress Code - Standards for Operating Room Wearing Apparel", dated 1/7/12, there was stipulation "All persons entering the semi-restricted and restricted areas of the surgical suites are required to wear clean surgical scrubs...Semi-restricted area: Includes peripheral support areas of the surgical suite, storage, scrub sinks, hallway...Restricted area: Includes OR rooms, clean cores, substerile rooms...All personal clothing should be completely covered by the surgical attire."

In a review of the 2011 Perioperative Standards and Recommended Practices, published by the Association of periOperative Registered Nurses (AORN), Page 57, Recommendation Practices for Surgical Attire, direction was given that, "These recommended practices are intended as guidelines adaptable to various practice settings. These practice settings include traditional ORs, ambulatory surgery centers, physicians' offices, cardiac catheterization laboratories, endoscopy suites, radiology departments, and all other areas where surgery and other invasive procedures may be performed." Under Recommendation II, direction was given that, "Clean surgical attire, including shoes, head covering, masks, jackets...should be worn in the semirestricted and restricted areas of the surgical or invasive procedure setting." On page 95, under Recommendation I.1., direction was given that, "The semirestricted area includes the peripheral support areas of the surgical suite...Personnel are required to wear surgical attire and cover all head and facial hair. The restricted area includes ORs, procedure rooms, and the clean core area. Surgical attire and hair coverings are required..."

5. During the initial tour of the G-2 outpatient clinic area it was observed there were no signs denoting the clinic area limiting authorized personnel or denoting areas within the clinics requiring surgical attire.

During an interview with Staff 80 on 1/25/12 at 9:20 a.m., she indicated there was no defined restricted or semi-restricted areas in the GI-2 outpatient clinic area, because it was not considered a surgical area.

On 1/265/12 at 10 a.m., in an interview with Staff 81, a review of the definition of surgery developed by the American College of Surgeons dated 4/2007 was conducted. The definition of surgery indicated "Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or diseases processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles......All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel" that biopsy was a procedure performed for the purpose of structurally altering the human body by the incision or destruction of tissues." Staff 81 acknowledged biopsy (a procedure that structurally alters tissue) was always a potential occurrence with endoscopic procedures and he added perforation of the bowel was also always a possible occurrence when performing colonoscopy.

In a review of the 2011 Perioperative Standards and Recommended Practices, published by the Association of periOperative Registered Nurses (AORN), Page 95, Recommendation Practices for Traffic Patterns in the Perioperative Practice Setting, direction was given that Traffic Patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls ...The unrestricted area includes a control point to monitor the entrance of patients, personnel, and materials. ..The semirestricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments. Traffic is limited to authorized personnel. The restricted area includes ORs, procedure rooms, and the clean core area ... Movement of personnel from unrestricted areas to either semirestricted or restricted areas should be through a transition zone. A transition zone exists where one can enter the area in street clothing and exit into the semi-restricted or restricted zone in surgical attire.

6. a. On 1/26/12 at 8:30 a.m., endoscopes were observed being stored in an unlocked cabinet in the soiled utility room on the sixth floor of the outpatient ENT building. The door to the soiled utility room had a biohazardous material sign on the door.

1/26/12 at 7:00 a.m., the manufacturer's printed label attached to the Asepti-Zyme (endoscope cleaning solution) container was reviewed. The label indicated "Add one ounce per gallon (one gallon equals 3785 milliliters) of water..."

An interview was conducted with Staff 85 on 1/26/12 at 8:40 a.m. in the dirty utility room on the sixth floor of the outpatient ENT building. When Staff 85 was asked how to mix the endoscope cleaning solution (Asepti-Zyme) in correct concentration as recommended by the manufacturer, Staff 85 stated she eyeballed it. Staff 85 demonstrated how she measured the solution she used to clean the endoscopes. Staff 85 stated she used one pump of the cleaning solution (Asepti-Zyme) . Staff 85 then proceeded to measured out a pump and it was ? of an ounce. Staff 1 then filled the pan of water with an approximate amount she usually used. Staff 85 then proceeded to measure the water; it measured 1250 milliliters (ml). In a concurrent interview, Staff 85 acknowledged she had not mixed the Aspeti-Zyme according to the manufacturer's instructions.

On 1/25/12 at 4 p.m., the 2003 Guidelines for Environmental Infection Control in Health-Care Facilities, published by CDC (Centers for Disease Control and Prevention) and HICPAC (The Healthcare Infection Control Practices Advisory Committee, a federal advisory committee on infection control) ,was reviewed. On page 133, under E.I.A., direction was given that, "Select EPA-registered disinfectants, if available, and use them in accordance with the manufacturer's instructions."

6.b. On 1/26/12 at 8:43 on the sixth floor of the outpatient ENT building in the dirty utility room a scope was observed with the distal end (the end that goes inside the patient) submerged in a vertical tube mounted on the wall that was filled with a clear solution. In a concurrent interview Staff 85 indicated the scope was being submerged in full-strength Cidex (a solution used for high level disinfection). The proximal end was not submerged in the Cidex solution. When questioned about this Staff 85 stated "The part of the scope which goes in the patient is in Cidex for 12 minutes. The remainder of the scope is processed to be clean."

On 1/26/12 at 9:50 a.m., when asked why channeled scopes were being processed differently than the smaller viewing scopes, i.e. the viewing scopes were not being completely submerged in the Cidex solution for high level disinfections, ICP 10 indicated she needed the manufacturer's instructions for reprocessing viewing scopes to respond. A response and or manufacturer information was not provided.

On 1/26/12 at 1:00 p.m. a telephone interview was conducted with a technical support representative for Olympus endoscopes [brand of scope currently used at facility]. The representatives indicated all Olympus endoscopes were designed for and should be fully immersed for high level disinfection. The representative indicated that if a portion of the scope was not high level disinfected it could potentially be a source for contamination of infectious agents that could be spread to the other areas of the scope.

Review of the hospital's policy titled "Scope cleaning and Processing" , dated revised 1/24/12 and presented as current, indicated "Always follow manufacturer's recommendations for scope care and processing. These will include scope processor, and disinfectant manufacturers."

Review of the manufacturer's Cidex OPA solution ( the solution used to high level disinfect the endoscopes in the G-2 lab) instructions indicated "ensure all instruments are completely immersed in Cidex OPA solution."

6.c. On 1/26/12 at 8: 47 a.m., 7 endoscopes were observed stored in an unlocked cabinet in the dirty utility room on the sixth floor of the outpatient ENT clinic. Some of the endoscopes were in contact with the endoscope located adjacent to them in the closet.

During an interview with ICP 1 on 1/26/12 at 9:50 a.m., ICP 1 acknowledged the disinfected endoscopes should not be stored in a dirty utility room according to hospital policy.

On 1/26/12 at 8 .a.m., the hospital's policy and procedure titled "Scope Cleaning and Processing", dated 1/24/12 was reviewed. The policy indicated "Once the cleaning cycle is complete...and dry using forced air...remove from processor and carry to clean utility room..."

On 1/26/12 at 1 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 420, under Recommendation IX., direction was given that, "Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes microbial contamination." Under Recommendation IX.a., Flexible endoscopes should be stored in a closed cabinet with...sufficient space for storage of multiple endoscopes without touching..."

7. An interview was conducted with Staff 86 on 1/25/12 at 11:25 a.m. in operating room 4 of the Same Day Surgery Center. In response to a question of how she would clean up a large blood spill, Staff 86 stated she would wipe up the blood with the soiled patient blanket and then mop with the H25Quad (a disinfectant). Staff 86 stated she would dispose of the bloody linens in the blue bag used to dispose of regular waste. A few minutes later Staff 86 returned and said "I meant to say I would dispose of the bloody linens in the red plastic bags for hazardous waste ."

Review of the hospital's policy and procedure titled "Isolation, All Categories: Availability of Infection Control Devices Waste and Waste Containers" dated 9/21/10 on 1/24/12 at 10 a.m., indicated "Blood spills: a. Blot blood spills with disposable material and discard in a red plastic bag."

On 1/25/12 at 5 p.m., the 2003 Guidelines for Environmental Infection Control in Health-Care Facilities, published by CDC and HICPAC, was reviewed. On page 77, under 3. Cleaning Strategies for Spills of Blood and Body Substances, direction was given that, "For spills containing large amounts of blood or other body substances, workers should first remove visible organic matter with absorbent material (e.g., disposable paper towels discarded into leak-proof, properly labeled containment)."

8 During an interview with staff 87 on 1/23/12 at 1:15 p.m. in the Same Day Surgery Clinic (SDSC), she stated the glucometer shared between patients should be cleaned once a day with alcohol.

During an interview with staff 89 on 1/23/12 at 1:20 p.m., in the SDSC, she stated the glucometer shared between patients should be cleaned once a day with alcohol.

During an interview with staff 90 on 1/23/12 at 1:25 p.m., in the SDSC, she stated the glucometer shared between patients should be cleaned after each patient once a day with alcohol.

During an interview with Staff 91 on 1/25/11, in the GI-2 outpatient surgery clinic, she stated the glucometer should be cleaned after each patient use. Staff 91 stated she cleaned the glucometer by wiping it down with a tissue that had been sprayed with 70% alcohol.

During an interview with ICP 1 on 1/26/12 at 10 a.m. in the outpatient ENT clinic, when asked what was the facility's policy for cleaning shared glucometers she stated "The policy states clean the glucometer after each patient use. Use a Super Sani-Wipe. Let dry for two minutes. Super Sani-Wipes kill Hepatitis B and HIV" (blood borne agents that can cause serious infections).

Based on staff interview and hospital record review, the hospital failed to ensure appropriate oversight of the outpatient surgical services departments and coordination with inpatient surgical services.

Findings:


In an interview with the Director of Perioperative Services (MD 12) on 1/23/12 at 11 a.m. MD 12 stated he was only responsible for the main ORs as listed on the Perioperative Services organizational chart. MD 12 provided no oversight of invasive surgical procedures performed throughout the hospital at various inpatient and outpatient locations/departments. Each department was responsible for the care they provided and each department reported directly to the MEC (Medical Executive Committee). To his knowledge, there was no comprehensive description of surgical services that included all surgical invasive procedures provided at each location and/or department with an oversight by the Surgery Services. Invasive surgical procedures performed outside operating rooms were not considered surgeries by the hospital, therefore the Surgery Services oversight was not provided.

On 1/23/12 at 12 p.m., upon request, the hospital administrative staff provided a one page list of services where invasive (surgical) procedures were scheduled to be performed under sedation outside of the operating rooms listed as part of the Perioperative Services. The list indicated the following sites: ENT (ears, nose, throat), GI Lab (gastrointestinal), Pain Clinic, Pulmonary Lab (lung), Radiation Oncology (cancer), Same Day Surgery, University Birthing Suites, Vascular Access, Vascular Center (Cath Lab) and Interventional Radiology. Any invasive procedures that may have been performed in each Department of the hospital were not listed or monitored by surgical services.

The administrative staff also provided governing body advisory group (Governance Advisory Council) minutes showing in part that Invasive Procedures Review Committee (IPRC) presented annual reports to the Council. The reports included a Performance Improvement Annual Report from the IPRC. In the Executive Summary it was stated that "The goal of the IPRC is to provide oversight of minor surgical and other invasive procedures performed outside of the OR environment throughout the health system to ensure a single standard of care is provided regardless of the clinical division or location in which the procedure is provided."

Review of the governing body advisory group monthly minutes between January 2010 and December 2011 confirmed no documented efforts to develop and implement hospital-wide surgical practices reflecting nationally recognized standards of practice for infection control, prevention of surgical errors and complications, safe maintenance of the surgical environments, assessment of surgical patients, or other surgical safety practices to minimize negative outcomes. Instead, various departments submitted individual summary reports of their performance, generally meeting benchmark goals for most departments. Unsafe practices were not described in the summary reports. No evidence of governing body discussion or direction for surgical services was presented.

In an interview on 1/26/12 at 4 p.m. with members of the medical staff and hospital leadership (including the former department chairmen for surgery and anesthesia, chief of staff, chief medical officer, chief financial officer), the leadership indicated that each specialty department functioned independently without a centralized division to oversee surgical services hospital-wide. Therefore, policies and practices among various outpatient surgical departments and some inpatient services differed according to what each service chose, and were not reviewed by a designated department head who took responsibility for the safety and effectiveness of these surgical services hospital-wide. As each service reported the results of their activities to both a quality committee and the medical executive committee, the primary person with surgical knowledge and expertise, and who served on both committees and was expected to be knowledgeable about each service's practices and performance, was the Chief Medical Officer (CMO). But the CMO was not formally designated to oversee all surgical care and services, or to verify that surgical practices in all locations conformed with basic and current nationally recognized standards of practice for surgical care. The CMO indicated that oversight of surgical services was a team effort with many people performing pieces of oversight. The CMO acknowledged that surgical care practices in various locations were not consistent, as they were governed by the individual departments. The hospital leadership presented no evidence to show efforts to review basic surgical practices across the spectrum of services, to identify which processes required standardization or which modifications would still meet the patient safety goals for nationally recognized organizational standards.

Review of the July 2011 Medical Staff Rules and Regulations under item XIII-F documented that the principal goal of the Invasive Procedure Review Committee was to improve patient care by evaluating surgical and other invasive procedures performed throughout the hospital. The hospital presented no documented evidence that the Invasive Procedure Review Committee had evaluated patient safety processes for surgical and invasive procedures in all locations where they were performed.

Based on observation, interview and record review, the hospital failed to provide emergency medical services that were well organized and in accordance with acceptable standards of practice in order to ensure safe and high quality emergency care to all patients.

1. The hospital failed to establish policies, procedures and standards for emergency medical services, including the management of patients presenting with a psychiatric complaint, were established, evaluated and or updated on an ongoing basis. (Refer to A-1104)

2. The physicians failed to complete a Transfer Summary prior to the transfer of patients to an in-patient psychiatric facility which included a) the receiving facility had accepted the patient, b) the risks and benefits of the transfer had been explained to the patient, (c) the patient had consented to or refused the transfer and d) all medical records related to the patient's condition had been sent with the patient at the time of transfer. (Refer to A-1104)

3. The hospital failed to ensure adequate medical and nursing personnel provided the necessary care and services, including ongoing assessments, interventions and monitoring, to meet the needs of patients who presented to the ED. (Refer to A-1112)

4. The hospital failed to provide evidence of current competency for triage nurses, functioning under standardized procedures, who initiated the Medical Screening Exam (MSE) for patients presenting to the ED. (Refer to A-1112)

The cumulative effect of these systemic problems resulted in the hospital's inability to comply with the statutorily-mandated condition for emergency services.























28991

Based on staff interview and hospital record review, the hospital failed to ensure appropriate oversight of the outpatient surgical services departments and coordination with inpatient surgical services.

Findings:


In an interview with the Director of Perioperative Services (MD 12) on 1/23/12 at 11 a.m. MD 12 stated he was only responsible for the main ORs as listed on the Perioperative Services organizational chart. MD 12 provided no oversight of invasive surgical procedures performed throughout the hospital at various inpatient and outpatient locations/departments. Each department was responsible for the care they provided and each department reported directly to the MEC (Medical Executive Committee). To his knowledge, there was no comprehensive description of surgical services that included all surgical invasive procedures provided at each location and/or department with an oversight by the Surgery Services. Invasive surgical procedures performed outside operating rooms were not considered surgeries by the hospital, therefore the Surgery Services oversight was not provided.

On 1/23/12 at 12 p.m., upon request, the hospital administrative staff provided a one page list of services where invasive (surgical) procedures were scheduled to be performed under sedation outside of the operating rooms listed as part of the Perioperative Services. The list indicated the following sites: ENT (ears, nose, throat), GI Lab (gastrointestinal), Pain Clinic, Pulmonary Lab (lung), Radiation Oncology (cancer), Same Day Surgery, University Birthing Suites, Vascular Access, Vascular Center (Cath Lab) and Interventional Radiology. Any invasive procedures that may have been performed in each Department of the hospital were not listed or monitored by surgical services.

The administrative staff also provided governing body advisory group (Governance Advisory Council) minutes showing in part that Invasive Procedures Review Committee (IPRC) presented annual reports to the Council. The reports included a Performance Improvement Annual Report from the IPRC. In the Executive Summary it was stated that "The goal of the IPRC is to provide oversight of minor surgical and other invasive procedures performed outside of the OR environment throughout the health system to ensure a single standard of care is provided regardless of the clinical division or location in which the procedure is provided."

Review of the governing body advisory group monthly minutes between January 2010 and December 2011 confirmed no documented efforts to develop and implement hospital-wide surgical practices reflecting nationally recognized standards of practice for infection control, prevention of surgical errors and complications, safe maintenance of the surgical environments, assessment of surgical patients, or other surgical safety practices to minimize negative outcomes. Instead, various departments submitted individual summary reports of their performance, generally meeting benchmark goals for most departments. Unsafe practices were not described in the summary reports. No evidence of governing body discussion or direction for surgical services was presented.

In an interview on 1/26/12 at 4 p.m. with members of the medical staff and hospital leadership (including the former department chairmen for surgery and anesthesia, chief of staff, chief medical officer, chief financial officer), the leadership indicated that each specialty department functioned independently without a centralized division to oversee surgical services hospital-wide. Therefore, policies and practices among various outpatient surgical departments and some inpatient services differed according to what each service chose, and were not reviewed by a designated department head who took responsibility for the safety and effectiveness of these surgical services hospital-wide. As each service reported the results of their activities to both a quality committee and the medical executive committee, the primary person with surgical knowledge and expertise, and who served on both committees and was expected to be knowledgeable about each service's practices and performance, was the Chief Medical Officer (CMO). But the CMO was not formally designated to oversee all surgical care and services, or to verify that surgical practices in all locations conformed with basic and current nationally recognized standards of practice for surgical care. The CMO indicated that oversight of surgical services was a team effort with many people performing pieces of oversight. The CMO acknowledged that surgical care practices in various locations were not consistent, as they were governed by the individual departments. The hospital leadership presented no evidence to show efforts to review basic surgical practices across the spectrum of services, to identify which processes required standardization or which modifications would still meet the patient safety goals for nationally recognized organizational standards.

Review of the July 2011 Medical Staff Rules and Regulations under item XIII-F documented that the principal goal of the Invasive Procedure Review Committee was to improve patient care by evaluating surgical and other invasive procedures performed throughout the hospital. The hospital presented no documented evidence that the Invasive Procedure Review Committee had evaluated patient safety processes for surgical and invasive procedures in all locations where they were performed.

Based on observation, interview and record review, the hospital failed to ensure policies and procedures that clearly and appropriately defined the management of patients who presented for emergency services were established and followed when there was no evidence of policies and procedures to define:

1. Patient reception and triage flow.
2. Patient physical assessment and re-assessment guidelines to determine a) what conditions would constitute the five levels of acuity, b) how frequently to reassess a condition and c) what clinical and psychological parameters would be used.
3. Components of a Medical Screening Exam (MSE) to include the time seen by the physician, history and physical, impression/diagnosis and final disposition by the physician.
4. Management of patients presenting with a psychiatric condition or complaint, including a) a risk assessment for self harm or harm to others and b) management of a patient on an Involuntary Hold (5150).
5. Transfer policies to include appropriate processes for patients transferred to an in-patient psychiatric facility.

Findings:

1. In an Initial Tour of the Emergency Department (ED) on 1/23/12 at 11:20 a.m. with the Chief of Staff/Vice Chair of the ED (COS) and the ED Nurse Manager (NM 9), a staff station was observed just inside the entrance to the waiting area with two security officers and a volunteer present sitting at the desk. NM 9 stated patients arriving through the ED lobby entrance were asked by staff at the desk to wait in line for a triage nurse. NM 9 stated there was no patient pre-screening or sign in at this desk as there were no staff present, including registration, qualified to screen patients or record the time of arrival. NM 9 acknowledged there was no way to track how long patients waited for triage, however if there were more than three patients standing in line the triage nurse was to call the charge nurse for extra help.

In an observation of the waiting area on 1/23/12 at 2:50 p.m. with NM 9, there were eight patients standing in line to be triaged. One triage nurse was present and the other three triage rooms were dark and unoccupied. NM 9 called the Charge Nurse to request an additional triage nurse.

In an observation of the waiting area on 1/25/12 at 11 a.m., approximately fifteen people (patients and visitors) were waiting in a line outside the triage room. The triage nurse stated she was relieving someone for a break and had not called for help.

In an interview with RN 11 on 1/25/12 at 11:15 a.m., she stated she would periodically make observations of the patients waiting in line to see if anyone appeared distressed and needed to be seen first. RN 11 stated she would try to go out and ask patients their chief complaint in order to determine the order in which they should be seen.

The Nurse Manager in a concurrent interview stated there were no established written policies or procedures to define processes for:

a) Patient reception and initial screening, including the time of arrival to the ED.
b) Patient flow in the waiting area in order to prioritize patients who present with a chief complaint indicative of a higher acuity.
c) Re-assessments of patients in the waiting area according to acuity and address what the minimum components of a re-assessment should be.

2. On 1/24/12 at 11:30 a.m., a review of the Emergency Department's (ED) five level triage system was conducted in a team interview with the COS, NM 9, an ED Assistant Nurse Manager (ANM 1), the ED Performance Improvement Nurse (PIN/ED) and the ED Nurse Educator (ED/NE) (the team). The team described the five level triage system in the ED and stated it was "loosely" structured on the recommendations of a joint task force in a document published in February of 2005. The team revealed, more specifically, their five level triage system had been modeled after the Canadian Emergency Department Triage and Acuity Scale (CTAS) Implementation Guidelines and presented these documents for review.

The document titled Five-Level Triage: A Report from the American College of Emergency Physicians (ACEP) and the Emergency Nurses Association, dated February of 2005, was an analysis of the literature regarding ED triage with recommendations regarding the use of five level systems in the United States.

The document titled Revisions to the Canadian Emergency Department Triage and Acuity Scale (CTAS) Implementation Guidelines, dated November 2004, stipulated the 5-level triage scale was to be used for classifying the acuity of the patient according to the presenting complaint. The CTAS further noted the initial triage level would determine the frequency of re-assessments and recommended re-assessments every: a) 15 minutes for a Category 1 (crisis, resuscitative), b) 30 minutes for a Category 2 (emergent) and c) one hour for a Category 3 (urgent), the categories defined as higher levels of acuity.

The team presented the hospital Standardized Procedure Policy ID: XII-70, Page 2, Triage Categories, where there was stipulation:
"After the initial MSE has been completed, the nurse will assign a triage category to the patient from Category 1 (crisis) to Category V (non-emergent). "The categories were defined as:

a) Category 1: "Red" Conditions that are threats to life or limb or vision (or imminent risk of deterioration) requiring aggressive, immediate interventions. (Crisis or Resuscitative)

b) Category II: "Orange" Conditions that present a potential life or limb-threatening emergency or patients who present with other acute illnesses or injuries and significant risk factors that could lead to a life or limb. (Emergent)

c) Category III: "Yellow" Conditions where life and limb is not an immediate threat to well-being, but has the potential to develop into a serious problem requiring emergency intervention if treatment is not expedient. The patient's condition is stable, but treatment should be provided as soon as possible. (Urgent)

d) Category IV: "Green" Conditions that are at low risk for deterioration while the patient is waiting. Significant complications from the illness or injury will not likely result if treatment is delayed.

e) Category V: "Blue" A patient for which the MSE has excluded an emergent medical condition. (Non-Emergent)

The team referred to a document ttitled ED Structure Standards for direction on further Patient Management, Patient Screening. In review of this document, dated 9/2009, there was stipulation: "The frequency of vital signs and reassessments of patients who are required to wait prior to being placed in a treatment area is determined by their acuity level. Patients of the higher acuity levels, Red, Orange and Yellow will be rechecked every two hours whenever possible. Patients of the lower acuity levels, Green and Blue, will be rechecked every four hours whenever possible". The document further directed "Patient reassessments may be deferred if patient acuity or census in the unit is excessively high or staffing issues prevent it". The team acknowledged that re-assessments should be performed at time intervals in accordance with their level of acuity. The team also acknowledged it was not acceptable to defer re-assessments due to staffing or acuity in the ED.

Continuing the interview, the team acknowledged there were no ED policies and procedures available for nursing and medical staff to clearly define:

a) Complaints or conditions that would place patients effectively and consistently in the various categories for Category 1 (crisis, resuscitative), Category 2 (emergent), Category 3 (urgent), Category 4 or Category V (non-emergent). The team stated the triage nurse, based on training and experience, would "use their judgement" to determine the degree of acuity according to the chief complaint.
b) Time frames, by acuity, for re-assessments of patients waiting to be seen by the physician after the initial MSE by the nurse.
c) Assessment parameters for various emergent medical and psychiatric conditions.

The team further revealed there were no policies and procedures for the management of patients who present with suicidal or assaultive complaints, including a) a risk assessment for self harm and/or harm to others and b) management of a patient on a 51-50 Involuntary Hold.

3. In review of a hospital Policy ID: 1101 titled Emergency Medical Treatment and Active Labor Act (EMTALA), revised 12/28/11, Page 3, B. Transfer Procedures, there was stipulation for the requirements for an appropriate transfer of a patient for treatment of an emergency medical condition. As described in the definitions section of this policy, an emergency medical condition would include psychiatric disturbances. The facility was required to provide documentation that: a) the receiving facility had accepted the patient, b) the risks and benefits of the transfer had been explained to the patient, c) the patient had consented to or refused the transfer and d) all medical records related to the patient's condition had been copied and sent with the patient at the time of transfer.

In review of the medical records of four of four psychiatric patients (41, 42, 46, 47), on a 5150 Involuntary Hold, transferred to an in-patient psychiatric facility, there was no evidence of a transfer summary to include a) the receiving facility had accepted the patient, b) the risks and benefits of the transfer had been explained to the patient, (c) the patient had consented to or refused the transfer and d) all medical records related to the patient's condition had been copied and sent with the patient at the time of transfer.

In an interview with the COS on 1/24/12 at 12 p.m., he stated a Transfer Summary was not done by the physician on patients who were transferred by qualified medical personnel to an in-patient psychiatric facility as the medical staff considered these patients to be discharged, not transferred. The COS acknowledged there was no evidence present in the medical record to denote a) the receiving facility had accepted the patient, b) the risks and benefits of the transfer had been explained to the patient, (c) the patient had consented to or refused the transfer and d) all medical records related to the patient's condition had been copied and sent with the patient at the time of transfer.

27966

Based on observation, staff and patient interviews, medical record and document reviews, the hospital failed to ensure that:

1. Adequate medical and nursing personnel provided the necessary care and services to meet the needs of seven of 12 sampled patients who presented to the Emergency Department (ED) with a) psychiatric complaints or behaviors, including suicidal ideations (41, 42, 45, 46, 47, 49) and b) an emergent medical condition (44) when;

a) Of the six of six sampled patients who presented with complaints of suicidal or assaultive behaviors, three were triaged as a Level 2 (Emergent) (41, 42, 45), one was triaged as a Level 3 (Urgent) (49) and two as a Level 4 (Non-Urgent) (45, 46) with no suicide or assaultive risk assessment being done.

b) One of six sampled medical patients (44), triaged as a Level 1 (Crisis or Resuscitative), "requiring immediate and aggressive attention and interventions," was placed on a hallway bed without close observation or monitoring.

c) One of six sampled psychiatric patients was not seen by the physician during the ED stay (45); one of six sampled psychiatric patients, triaged as a Level 4 (Non-Emergent), did not see a physician for eleven hours, twenty five minutes after triage (47).

d) Six of six sampled psychiatric patients had no evidence of ongoing assessments and monitoring to ensure appropriate interventions were being taken to stabilize the patient and provide for their safety.

2. Thirteen of 80 nurses, working in ED triage areas under standardized procedures, were qualified to initiate a Medical Screening Exam (MSE), when there was no evidence that current competencies had been assessed according to established criteria.

Findings:

1. In a review of the medical records of six of six sampled patients (41, 42, 45, 46, 47, 49) who presented to the ED with psychiatric complaints, including suicidal ideations between 11/28/11 and 1/23/12 the following was noted.

a. On 1/23/12 between 12:30 and 2 p.m. Patient 49 was observed to be seated on the edge of a bed in a hallway of the ED, fully dressed and accompanied by a visitor who was reclining on Patient 49's hallway bed. A Charge Nurse (CN 1) approached the visitor, mistaking that person for Patient 49. Six additional hall beds with assigned patients were lined up along the corridors of the emergency room in the area where Patient 49 was observed. The hall beds were spaced about 3-4 feet apart. No privacy curtains surrounded each hall bed. Patients, visitors and staff were observed to pass through the halls where the hall patients were openly viewed. No staff was observed to closely supervise and attend to Patient 49, who was here for a suicidal complaint. No call buttons or means of signaling staff for help was observed to be available to Patient 49 or other hall patients. The hall bed was positioned within 50 feet of an unlocked door that exited to the outside of the building.

In an interview with Patient 49 and the visitor at 12:30 p.m., they stated they arrived to the hospital 1.5 hours earlier (around 11 a.m.). Patient 49 stated he was waiting patiently and if he needed help, he would yell loudly and hope that someone would come.

In an interview on 1/23/12 at 1 p.m. with the ED Nurse Manager (NM 9), she indicated that several patients, including those triaged as Category 1 (life-threatening requiring immediate, aggressive care and interventions) were currently located in the waiting room or in hall beds. These patients had not yet seen a physician and were not continuously assessed by nursing staff. CN 1 indicated that Patient 49, although suicidal, was triaged as Category 3 (Urgent), had not yet seen a physician, and was waiting in the hall bed to be seen by a social worker since 11:40 a.m. CN 1 indicated that one internal triage nurse was responsible to tend to all the hall patients, seven at that time, among many other duties (such as fielding telephone calls from ambulances in the field, triaging ambulance admissions and providing emergency department staff communications from outside providers).

Review on 1/24/12 at 3:15 p.m. of the medical record for Patient 49 with the Chief of Staff (COS), who also served as an associate clinical director for the Emergency Department, confirmed that the initial nursing triage assessment for Patient 49 (first contact with a medical provider) was documented at 11:32 a.m. on 1/23/12. The note documented that Patient 49 was depressed about a recent serious medical diagnosis but was not yet treated with medication or enrolled in a mental health treatment program. "Friend states pt (patient) wanting to harm himself counselor told him to come to er." Measurements of heart rate, breathing rate, blood pressure and blood oxygen level were recorded, but no other assessment details (e.g. physical condition, suicide risk assessment including history of suicide attempts, possession of dangerous weapons) were documented. Patient 49 was placed in the hall bed described above, with no staff assigned to closely assess and monitor his identified condition (suicidal). A request for evaluation by a social worker was documented at 11:40 a.m., at the time he was placed in the hall bed. A social worker evaluation was documented at 2:19 p.m. (following the period of observation by the SA). The social worker determined that Patient 49 was high-risk (had escalating suicidal thoughts and a plan to kill himself, prior depression and substance abuse problems). The social worker determined that Patient 49 was a danger to self and placed him on a 5150 Involuntary Hold (5150) so he could not leave the hospital to harm himself.

Further medical record review of Patient 49 indicated that vital sign measurements were recorded 4 hours after admission, but no nursing physical or mental assessments were documented until 1/24/12 at 6:30 a.m., 18 hours after admission to the ED. Documentation of a physician assessment was begun at 4:31 p.m. (5 hours after admission), indicating a plan to transfer Patient 49 to a psychiatric facility once a medical clearance evaluation was completed and a facility could accept him. The physician assessment was signed as complete on 1/23/12 at 11:45 p.m. At 11:58 p.m., a physician order for a psychiatric evaluation was documented. More complete nursing assessments were documented between 5 a.m. and 10:30 a.m. on 1/24/12 (head to toe), with no further mental health assessments documented by nursing staff. A psychiatric assessment by a medical student and co-signed by an attending physician was documented on 1/24/12 at 11:42 a.m. The psychiatric consultation recommended the involuntary hold be ceased and the patient discharged home "to self." An antidepressant medication was also recommended, and then prescribed by an emergency department physician, who did not document an independent assessment, a discharge impression or a discharge disposition summary for Patient 49 prior to discharge from the ED on 1/24/12 at 1:58 p.m.

In an interview on 1/24/12 at 3:15 p.m. with the COS, the COS indicated that suicidal risk assessments were not routinely performed by triage nursing staff or others upon the identification of a suicidal problem or other psychiatric emergency medical condition. Social workers generally took the responsibility to determine suicidal and homicidal risk, if requested by ED staff. Response times for social worker evaluations varied, depending upon their other workload and duties. The COS acknowledged that mental health patients often had co-existing serious health conditions and a social worker was not qualified to evaluate organic health conditions. There was no requirement for a physician to evaluate a patient with a potential psychiatric emergency medical condition emergently, as expected for other emergent health conditions like chest pain, head injury, etc., despite the fact that psychiatric conditions can have an organic cause. There was no consistency in assigning a triage priority for evaluation and treatment of suicidal patients as "emergent."

The COS further acknowledged that Patient 49 had a psychiatric emergency medical condition upon arrival to the hospital, but that the hospital had no other care capability to offer, aside from the social worker evaluation and transfer to a psychiatric hospital. The hospital did not routinely provide protections to prevent high-risk patients from leaving the hospital. The COS indicated that the only protections the hospital could provide for a patient who was a danger to self or others, and at risk to flee, would be "restraints". The COS indicated that alternative protections, such as frequent nursing contact and assessments to calm patients and identify early signs of agitation or escalating behaviors, assigning trained staff (e.g. sitters, security officers) to continuously watch a high-risk patient, and/or priority placement of high-risk patients in ED beds where close nursing oversight was arranged were not routinely offered and were not included in ED policies to care for high-risk patients with psychiatric emergency medical conditions. The COS acknowledged that physicians (and not social workers) were responsible to direct the care of all patients in the ED, but physicians did not routinely recognize the need to assess promptly and order stabilizing treatments for patients with mental health conditions, other than ordering restraints.

b. Patient 45, a 39 year old homeless male recently released from prison, was triaged as a Category 4 (Non-emergent) in the ED on 12/22/11 at 1:43 a.m. A triage note documented at 1:45 a.m., stated Patient 45 was "stressed at this time" and "feels like hurting somebody". Patient 45 was seen by a Licensed Clinical Social Worker (LSCW) at 3:42 a.m. The LSCW documented Patient 45 denied having active suicidal or homicidal ideations at that time. The LCSW noted Patient 45 exhibited anxiety as evidenced by "pacing, rapid speech, frequent hand gestures and repetitive statements" but "does not meet criteria for 5150 detainment." . Patient 45 was discharged at 6:23 a.m. During Patient 49's approximately four hour stay ED stay, there was no evidence of any nursing assessment to determine the level of risk of self harm or harm to others. From the time Patient 45 was triaged at 1:45 a.m. until he was discharged at 6:23 a.m. there were no documented assessments of behaviors (i.e. affect, mood, speech, communication, concentration, comprehension, insight, judgement, thought process, anxiety) or ongoing monitoring or interventions taken (i.e. personal belongings removed, patient was directly observed, quiet environment). There was no evidence Patient 45 had been seen by a physician during the stay in the ED.

c. Patient 42, a 50 year old, arrived by ambulance to the ED on 12/25/11 at 2:20 p.m. with a chief complaint of feeling suicidal for two days and was triaged as a Category 2 (Emergent). At 2:22 p.m., the triage nurse noted Patient 42 was "feeling irritated with mood swings" and was "currently taking zoloft [an antidepressant] and Seroquel[(an antipsychotic]." At 2:42 p.m., the triage nurse documented Patient 42 "was thinking of slicing his wrists with a razor blade". At 4:20 p.m., Patient 42 was seen by a LCSW who documented Patient 42 was placed on a 5150 involuntary hold as a danger to himself. At 9:35 p.m., the nurse documented Patient 42 stated he was now hearing voices that are telling him to hurt himself. Patient 42 felt he was unable to control the impulse to cut his wrist and commit suicide to stop the voices. The LSCW documented Patient 42 had been to the ED a few weeks prior but "left before eval could be completed. Patient 45 was transferred to an in-patient psychiatric facility on 12/26/12 at 10:04 a.m. During Patient 42's approximately 20 hour ED stay, there was no evidence of any nursing assessment to determine the level of risk of self harm or harm to others. There was no evidence of any interventions taken to ensure Patient 42's safety from self harm with the exception of restraints noted to have been used from 12/25/11 at 9 p.m. until 12/26/11 at 6 a.m. There was no documentation on why restraints had been placed.

d. Patient 46, a 32 year old, was triaged in the ED on 12/5/11 at 3:10 a.m. with a chief complaint of depression and suicidal ideation and assigned a Category 4 (Non-Emergent). At 3:22 a.m. the triage nurse documented Patient 46 "is having thoughts of harming herself or others". At 3:47 a.m., the ED physician documented Patient 46's depression and suicidal ideations had been worsening significantly over the last few months. Patient 46 had had prior suicidal attempts and complained of auditory hallucinations, delusions and paranoia. At 4:07 a.m., the nurse documented "pt beginning to escalate behavior" but did not describe the behaviors or interventions taken to calm patient. At 5:15 a.m., Patient 46 was seen by a LCSW and "placed on a 5150 for danger to self and gravely disabled. From 4:07 a.m. until 12:07 p.m. there were no nursing notes to reflect observation of behaviors or interventions taken for Patient 46's safety. At 12:07 p.m. the nurse documented "pt upset about having belt in place". Patient was noted to have a posey belt (a restraint) placed at 6:28 a.m. There was no reference in nursing documentation to the reason for the placement of a restraint. Patient 46 was transferred to an in-patient psychiatric facility at 9:52 p.m. During Patient 46's approximately 19 hour ED stay, there was no evidence of any nursing assessment to determine the level of risk of self harm or harm to others. There was no evidence of ongoing monitoring or interventions taken to ensure Patient 46 was free of self harm even when behaviors were escalating. Patient 46 was placed in restraints without documentation of prior interventions or rationale for restraints.

e. Patient 41, a 23 year old, was triaged in the ED on 1/23/12 at 9:52 a.m. with a chief complaint of suicidal and homicidal ideations and was assigned a Category 2 (Emergent). At 11:06 a.m. the physician documented Patient 41 was actively suicidal, wanting to walk in front of a bus. At 4:59 p.m. the LCSW placed Patient 41 on a 5150 as a danger to herself. On 1/24/12 at 1:14 p.m. Patient 41 was transferred to an in-patient psychiatric facility. During Patient 41's approximately 27 hour ED stay, there was no evidence of any nursing assessment to determine the level of risk of self harm or harm to others. There was no evidence of any ongoing monitoring, assessment of behaviors or interventions taken to ensure Patient 41 was free from self harm during the 28 hour ED stay.


f. Patient 47, a 46 year old homeless female, was triaged in the ED on 11/28/11 at 7:12 p.m. with a chief complaint of "assaultive and suicidal behavior" and assigned a Category 2 (Emergent). Patient 47 had an active plan to cut herself with drywall blades she had collected. There was no documentation of ongoing monitoring or interventions taken to ensure Patient 47's safety. Patient 47 was not seen by a physician until 11/29/11 at 6:37 a.m. Patient 47 was transferred to an in-patient psychiatric facility on 11/29/12 at 2:50 p.m. During Patient 47's approximately 20 hour ED stay, there was no evidence of any nursing assessment to determine the level of risk of self harm or harm to others. There was no evidence of any ongoing monitoring, assessment of behaviors or interventions taken to ensure Patient 47 was free from self harm during the ED stay.

2. In review of one of six sampled patients who presented to the ED with an emergency medical condition between 12/31/11 and 1/23/12, the following was noted:

a. Patient 44 was observed standing in line for triage on 1/23/12 at 11:20 a.m. Patient 44, with a chief complaint of left leg pain and a prior history of a clot in the left leg who stated she stopped taking her coumadin (a medication used to stop blood clots from forming in the blood vessels) two days ago, was triaged at 12:05 p.m. and assigned a Category 1 (life threatening, requiring immediate attention, intervention). At 12:19 p.m., Patient 44 was placed in a hallway bed in the ED. Six other patients were in this area and assigned to the internal triage nurse whose responsibilities included the observation of hallway patients as well as triaging patients who arrived by ambulance and taking ambulance and other provider calls.

In an interview with Patient 44 on 1/23/12 at 1:55 p.m., she stated she had severe pain in her back and the back of the knee. Patient 44 stated she had been seen by a physician in the office that morning and was told she might have internal bleeding. Patient 44 stated she was also told her blood pressure was low. She was instructed by her physician to come to the ED. Patient 44 stated she chose to come to this facility (a considerable distance away from the physician's office) as they had previously treated her for a "hole in my heart". Patient 44 stated the doctor said an ambulance could be called but she preferred to drive with a friend. Patient 44 stated her left leg had started to feel numb while she was standing in line, but it was feeling better now that it was elevated. Patient 44 was transferred to an ED patient room at 1:34 p.m. and seen by a physician at 1:39 p.m (one and a half hours after being triaged as a Level 1). The physician, in a history and physical performed in the ED, not timed, diagnosed Patient 44 with bilateral deep vein thromboses (clots in the blood vessels), administered four units of packed cells and Patient 44 was transferred to the Intensive Care Unit.

3. In an Initial Tour of the ED on 1/23/12 at 11:20 a.m., NM 9 stated approximately 80 nurses had been trained to perform the MSE and functioned under standardized procedures. These procedures were approved by the Medical Staff, for:

1. Policy ID: XII-67 Standardized Procedure on Ordering Orthopaedic Films on Isolated Traumatic Extremity Injuries (Revised: 9/09)
2. Policy ID: XII-72 Standardized Procedure for Nursing Criteria and Orders for Acute Respiratory Distress Protocol (Revised: 9/09)
3. Policy ID: XII-70 Medical Screening Exam and Triage-Adult and Pediatric (Revised: 7/10)
4. Policy ID: XII-62 Initiating Administration of Acetaminophen/Ibuprofen During Triage of Pediatric Patients in the Emergency Department (Revised 7/10)
5. Policy ID: XII-71 Emergency Department Nursing Intervention for Patients Suspected of Community Acquired Pneumonia (New: 7/11)
6. Policy ID: 48 Obtaining Blood Specimens to Expedite Treatment in Patients With Systemic Inflammatory Response System (SIRS) and Signs and Symptoms of Infection (New: 7/11)

In a concurrent interview with the COS, Chief of Staff, he stated ED nurses trained to perform the MSE were able to order interventions using the standardized procedures listed above. Some examples include: lab tests, x-rays, medications and electrocardiograms (a test to measure the electrical activity of the heart), in order to expedite the diagnosis and treatment of patients presenting to the ED.

Additional components of the MSE were defined in Policy ID: XII-70 Medical Screening Exam and Triage-Adult and Pediatric, revised 7/10 and included an assessment of the chief complaint, vital signs including pain level, mental status compared to baseline, skin assessment, the ability to walk, a focused physical exam and the description of the patient's general appearance. A pertinent medical and surgical history was to be obtained as well as a list of medications taken by the patient and any allergies.

Policy ID: XII-70, a standardized procedure titled Medical Screening Exam and
Triage-Adult and Pediatric, revised 7/12/10, Page 3-4, defined the education and training requirements for nurses assigned to Internal Triage (ambulance entrance) and External Triage (lobby entrance) areas. The requirement for annual certification included a successful review, by an ANII (Assistant Nurse Manager or designee), of a minimum of ten triages performed by the nurse. The policy further stipulated "Biannual Certification of the triage-related Standardized Procedures XII-62, XII-67, XII-70 and XII-71" which included only four of the six established standardized procedures.

A review of the personnel records of 13 nurses, who had been employed in the ED from two to six years, and assigned to Internal or External Triage revealed:

1. Thirteen of 13 nurses had no evidence of any annual review of triages performed.
2. Six of thirteen nurses had no evidence of any review of the standardized procedures prior to November of 2011.

In an interview with the ED Nurse Educator (ED/NE) on 1/26/12 at 11 a.m., she acknowledged the annual competency review of triages performed by nurses assigned to triage areas had not been completed. The ED/NE acknowledged there was no evidence all triage nurses had reviewed the standardized procedures and successfully completed the post test prior to 2011. The ED/NE acknowledged the Structure Standards needed to be updated to include the additional two standardized procedures XII-48 and XII-72.

Based on interview and record review, the hospital failed to follow department policy in the delivery of respiratory therapy services for two of 80 sampled patients (20, 60).

Findings:

In a review of mechanically-ventilated (on a ventilator) Patient 20's medical record, peak airway pressures (PAWP) and high peak inspiratory pressure (PIP) the machine alarm settings were noted to be documented as follows:

Time/Date/PAWP/High PIP Alarm Setting
3:13 a.m.,1/23/12 - 21 centimeters (cm) water (H2O) - 40 cm H2O
5:34 a.m., 1/23/12 - 16 cm H2O - 40 cm H2O
8:30 a.m., 1/23/12 - 12 cm H2O - 40 cm H2O
12:25 p.m., 1/23/12 - 12 cm H2O - 40 cm H2O
4:05 p.m., 1/23/12 - 15 cm H2O - 40 cm H2O
11:50 a.m., 1/24/12 - 7.6 cm H2O - 30 cm H2O
12:20 p.m., 1/24/12 - 8 cm H2O - 30 cm H2O.

In a review of mechanically-ventilated Patient 60's medical record, PAWPs and high peak PIP alarm settings were documented as follows:

Time/Date/PAWP/High PIP Alarm Setting
2:15 a.m., 1/22/12 - 16 cm H2O - 40 cm H2O
5:15 a.m., 1/23/12 - 24 cm H2O - 40 cm H2O
8:45 a.m., 1/23/12 - 10 cm H2O - 40 cm H2O
12:39 p.m., 1/23/12 - 9 cm H2O - 40 cm H2O
4:45 p.m., 1/23/12 - 21 cm H2O - 40 cm H2O.

Review of the hospital's 2011 "Ventilator Management" policy revealed, "Ventilator alarms will be set following these guidelines: High pressure limit should be set 10 cm. H2O above peak pressure."

During a 2:30 p.m., 1/23/12 interview, the Manager, Respiratory Care Department (RM) reviewed recent PAWPs and PIPs for Patients 20 and 60. Of the high PIP alarm settings for Patient 20 at 5:34 a.m. and 8:30 a.m., 1/23/12 and Patient 60 at 5:15 a.m. and 8:45 a.m., 1/23/12 she stated, "It [the high PIP alarm] should have been set lower, maybe 30, but policy permits different alarm settings with appropriate documentation." However, she was unable to find medical record documentation of rationale for the elevated alarm settings.

Based on observation, interview and record review, the hospital failed to consistently document provided respiratory services in the medical record for three of 80 Patients (61, 62 and 63).

Findings:

Review of Patient 61's medical record reflected a 3:41 p.m., 1/22/12 physician order for "PAP [positive airway pressure treatments] two times daily. Start 1/22/12, 1538 [3:38 p.m.]." On 1/24/12, a single treatment at 12:01 p.m. was documented.

In an interview on 1/2/12 at 12:31 p.m., Respiratory Services Manager (RM) stated, "There is no note from the night therapist as to why it [the second PAP treatment on 1/24/12] wasn't done."

Review of Patient 62's medical record reflected a 9:49 p.m., 1/21/12 physician order for PAP treatments. in an interview with RM on 1/26/12 at 12:31 p.m., the ordered frequency of the treatments was twice daily. On 1/24/12, a single treatment at 10:30 a.m. was documented.

During the 12:31 p.m., 1/26/12 RM interview, she stated, "It [documentation of treatment] needs to be in the EMR [electronic medical record]. It should have been charted."

Review of Patient 63's medical record reflected a 1:32 p.m., 1/24/12 physician order for PAP treatments three times daily. On 1/24/12, treatments at 7:59 a.m. and 2:19 p.m. were documented. On 1/25/12, one treatment attempt was made at 10:01 a.m. and "patient sleeping" was documented at 11:01 p.m. when a second treatment was attempted.

During the 12:31 p.m., 1/26/12 interview with the RM, she stated, "Nights didn't do it [the third ordered treatment] on the 24th and nobody charted why it was missed. A 4 p.m. treatment [given] on the 25th was not noted in the EMR [electronic medical record]."

In an 11:15 a.m., 1/24/12 interview with the RM, she stated, "If a patient isn't available for a treatment or refuses a treatment, we should write that."

Review of Respiratory Care Department policy "Guidelines for Standard Administration Times for Respiratory Medications and Therapeutic Procedures," revised 10/11, indicated, "All respiratory medications to be given by Respiratory Care will be documented in the MAR [Medication Administration Record] immediately post treatment or the RCP [Respiratory Care Practitioner] will notify the bedside nurse ...In this case, documentation will be done ...no later than 3 hours post treatment."

Based on interview, record review and facility document review, the hospital failed to consistently measure, analyze and track episodes of hypoglycemia (low blood sugar) related to insulin (medication to lower bloods sugar) administration in accordance with their policy.

Findings:

According to Institute of Safe Medication Practices (ISMP), a nationally recognized organization that promotes the safe use of medication in healthcare facilities, insulin is considered a high-risk, high alert medication due to the heightened potential for significant patient harm. ISMP recommends healthcare facilities utilize special safeguards to reduce the risk of insulin adverse effects.

Lexi-Comp ONLINE, a nationally recognized drug information source, indicated that the most common adverse effect of insulin is hypoglycemia (low blood sugar). Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death.

According to the American Diabetes Association, normal fasting (before meals) blood sugar ranged from 70 - 130 mg/dL (milligrams per deciliter, unit of measure).

A list of patients who received reversal agents for hypoglycemia (low blood sugar) for the time period 1/16/12 through 1/23/12 was requested from and provided by Pharmacist 1 (Pharm 1).

During an interview on 1/23/12 at 2:10 p.m. Pharm 1 indicated the pharmacy generated a report daily for intensive care patients who have experienced a blood glucose less than 50 mg/dL and who have received a reversal drug such as 50% dextrose (sugar solution)injection. Pharm 1 further indicated the report had not yet been rolled out to the entire hospital.

A review of one current and one closed Electronic Medical Record (EMR) revealed the following issues in both of those records:

a. Clinical EMR review revealed Patient 36 was a 72 year-old trauma (motor vehicle collision) patient admitted to the facility on 12/16/11 with spinal injury and multiple fractures; medical history included Diabetes Mellitus II (non-insulin dependent). Patient 36 was receiving liquid nutrition enterally (through a feeding tube).

Review of Patient 36's Physician Orders included the following insulin orders: Lantus insulin (long-acting) 30 units subcutaneous (injected underneath the skin) daily at bedtime (ordered 1/8/12); regular (short-acting) insulin 4 units subcutaneous every 6 hours (ordered 1/9/12); and regular insulin sliding scale (amount to be administered subcutaneous based on assessed blood sugar results every six hours).

Further EMR review indicated Patient 36 underwent a surgical procedure on 1/18/12; enteral feedings were held after midnight on the same day.

Patient 36's EMR Medication Administration Record (MAR) revealed that on 1/18/12 at 6:15 a.m. 25 grams of dextrose was administered I.V. (infusion of liquid substances directly into a vein) by a licensed nurse for an assessed blood sugar of 53 mg/dL.

During an interview on 1/25/12 at approximately 2 p.m. a Nurse Manager (NM 2) verified Patient 36's clinical EMR findings.

During an interview on 1/25/12 at approximately 5:20 p.m. Pharm 7 confirmed that an online incident report had not been filed by licensed nursing staff or a pharmacist related to Patient 36's episode of hypoglycemia on 1/18/12.

Further review of Patient 36's EMR revealed an additional surgical procedure was performed on 1/20/12; enteral feedings were held on 1/19/12.

Patient 36's EMR MAR revealed that on 1/20/12 at 5:45 a.m. 25 grams of dextrose was administered I.V. by a licensed nurse for an assessed blood sugar of 44 mg/dL.

During an interview on 1/25/12 at approximately 2 p.m. Nurse Manager (NM) 2 verified Patient 36's clinical EMR findings. During a concurrent interview Pharm 3 acknowledged Patient 36's insulin regimen should have been evaluated due to his nutritional feedings being held to possibly avert the episodes of hypoglycemia.

Review of two pharmacists' EMR clinical notations revealed that on 1/18/12 at 3:06 p.m. a clinical pharmacist documented: "BS [blood sugar] of 53 this AM; TRM [trauma service] aware, will follow trend, if hypoglycemic will d/w [discuss with] team decreasing Lantus. On 1/20/12 at 2:42 p.m. Pharm 4 documented: "BG [blood glucose] this am 44 ....paged twice to inquire if can decr [decrease] lantus even if by just a few units. No call back ....pls f/u [follow up am stick [fingerstick blood sugar] tmrw [tomorrow]."

During an interview on 1/26/12 at 12:20 p.m. Pharm 4 confirmed the aforementioned documentation in Patient 36's EMR. Pharm 4 indicated being very busy with a high patient load and did not follow up; Pharm 4 further indicated she did not generate an online incident report related to Patient 36's two episodes of hypoglycemia.

During an interview on 1/26/12 at 12:20 p.m., Pharm 3 confirmed that an online incident report had not been filed by licensed nursing staff or a pharmacist related to Patient 36's episode of hypoglycemia on 1/20/12.

b. Closed EMR review revealed Patient 37 was a 65 year-old admitted to the facility on 1/16/12 with diagnoses including Diabetes Mellitus type II (non-insulin dependent) and squamous cell carcinoma (a type of skin cancer) of the head and neck. Patient 37 was receiving liquid nutrition through a gastrostomy tube (GT) (tube surgically placed in the stomach for the administration of liquid nutrition and medications).

Patient 37's Physician Orders included an order for regular insulin sliding scale and fingerstick blood sugar assessments every six hours (at 6 a.m., 12 noon, 6 p.m. and midnight).

Review of Patient 37's Internal Medicine Admission History and Physical EMR indicated a history of resection of the jaw and floor of the mouth; a flap of skin from Patient 37's fibula (back area of lower leg) had been grafted to the jaw area June 2011 and was poorly healing; ENT (ear, nose and throat physician) had planned for surgery on 1/23/12 to reconstruct the area.

Review of Patient 37's Glycemic Control EMR indicated on 1/21/12 she received GT feedings and on 1/22/12 the feedings were stopped in advance of the surgery [NPO status].

Review of Patient 37's EMR MAR indicated no sliding scale insulin had been administered from 1/16/12 through 1/21/12 due to stable fingerstick blood sugars. Patient 37's 1/22/12 EMR MAR revealed that at 12:27 a.m., a licensed nurse administered 2 units of regular insulin for an assessed fingerstick blood sugar of 193 mg/dL. The record further indicated that on 1/22/12 at 6:11 a.m. 25 grams of dextrose was given I.V. by licensed nursing staff for an assessed low blood sugar of 33 mg/dL; another 25 gram dose of dextrose was given I.V. at 11:55 a.m. for an assessed low blood sugar of 54 mg/dL.

During an interview on 1/26/12 at approximately 9:30 a.m. Pharm 8 indicated that patients with physician's order sets including dextrose I.V. for reversal of hypoglycemia may not be readily identified by pharmacists as an adverse drug reaction.

During an interview on 1/26/12 at approximately 12:15 p.m. NM 2 verified Patient 37's clinical EMR findings. During a concurrent interview, Pharm 3 confirmed that an online incident report had not been filed by licensed nursing staff or a pharmacist related to Patient 37's two episodes of hypoglycemia requiring I.V. dextrose administration on 1/22/12.

Review of the hospital policy 1633 Medication Related Event Management Program (revised 2/14/11) indicated under III. Definitions and Descriptions, item F: "ADVERSE DRUG REACTION (ADR): Any undesired response associated with the use of a medication that requires medical intervention or a significant alteration in therapy." The policy further indicated under IV. Medication Event Related Reporting, item B. Adverse Drug Reaction Reporting, number 1: "When a pharmacist or nurse becomes aware of an adverse reaction, he/she should immediately assure the responsible medical service is aware, initiate appropriate therapy adjustments with responsible physician and complete an online incident report."

During an interview on 1/26/12 at 12:20 p.m. Pharm 3 indicated that patients with standing orders (order sets) for dextros

Based on interview, record review and facility document review, the hospital failed to consistently measure, analyze and track episodes of hypoglycemia (low blood sugar) related to insulin (medication to lower bloods sugar) administration in accordance with their policy.

Findings:

According to Institute of Safe Medication Practices (ISMP), a nationally recognized organization that promotes the safe use of medication in healthcare facilities, insulin is considered a high-risk, high alert medication due to the heightened potential for significant patient harm. ISMP recommends healthcare facilities utilize special safeguards to reduce the risk of insulin adverse effects.

Lexi-Comp ONLINE, a nationally recognized drug information source, indicated that the most common adverse effect of insulin is hypoglycemia (low blood sugar). Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death.

According to the American Diabetes Association, normal fasting (before meals) blood sugar ranged from 70 - 130 mg/dL (milligrams per deciliter, unit of measure).

A list of patients who received reversal agents for hypoglycemia (low blood sugar) for the time period 1/16/12 through 1/23/12 was requested from and provided by Pharmacist 1 (Pharm 1).

During an interview on 1/23/12 at 2:10 p.m. Pharm 1 indicated the pharmacy generated a report daily for intensive care patients who have experienced a blood glucose less than 50 mg/dL and who have received a reversal drug such as 50% dextrose (sugar solution)injection. Pharm 1 further indicated the report had not yet been rolled out to the entire hospital.

A review of one current and one closed Electronic Medical Record (EMR) revealed the following issues in both of those records:

a. Clinical EMR review revealed Patient 36 was a 72 year-old trauma (motor vehicle collision) patient admitted to the facility on 12/16/11 with spinal injury and multiple fractures; medical history included Diabetes Mellitus II (non-insulin dependent). Patient 36 was receiving liquid nutrition enterally (through a feeding tube).

Review of Patient 36's Physician Orders included the following insulin orders: Lantus insulin (long-acting) 30 units subcutaneous (injected underneath the skin) daily at bedtime (ordered 1/8/12); regular (short-acting) insulin 4 units subcutaneous every 6 hours (ordered 1/9/12); and regular insulin sliding scale (amount to be administered subcutaneous based on assessed blood sugar results every six hours).

Further EMR review indicated Patient 36 underwent a surgical procedure on 1/18/12; enteral feedings were held after midnight on the same day.

Patient 36's EMR Medication Administration Record (MAR) revealed that on 1/18/12 at 6:15 a.m. 25 grams of dextrose was administered I.V. (infusion of liquid substances directly into a vein) by a licensed nurse for an assessed blood sugar of 53 mg/dL.

During an interview on 1/25/12 at approximately 2 p.m. a Nurse Manager (NM 2) verified Patient 36's clinical EMR findings.

During an interview on 1/25/12 at approximately 5:20 p.m. Pharm 7 confirmed that an online incident report had not been filed by licensed nursing staff or a pharmacist related to Patient 36's episode of hypoglycemia on 1/18/12.

Further review of Patient 36's EMR revealed an additional surgical procedure was performed on 1/20/12; enteral feedings were held on 1/19/12.

Patient 36's EMR MAR revealed that on 1/20/12 at 5:45 a.m. 25 grams of dextrose was administered I.V. by a licensed nurse for an assessed blood sugar of 44 mg/dL.

During an interview on 1/25/12 at approximately 2 p.m. Nurse Manager (NM) 2 verified Patient 36's clinical EMR findings. During a concurrent interview Pharm 3 acknowledged Patient 36's insulin regimen should have been evaluated due to his nutritional feedings being held to possibly avert the episodes of hypoglycemia.

Review of two pharmacists' EMR clinical notations revealed that on 1/18/12 at 3:06 p.m. a clinical pharmacist documented: "BS [blood sugar] of 53 this AM; TRM [trauma service] aware, will follow trend, if hypoglycemic will d/w [discuss with] team decreasing Lantus. On 1/20/12 at 2:42 p.m. Pharm 4 documented: "BG [blood glucose] this am 44 ....paged twice to inquire if can decr [decrease] lantus even if by just a few units. No call back ....pls f/u [follow up am stick [fingerstick blood sugar] tmrw [tomorrow]."

During an interview on 1/26/12 at 12:20 p.m. Pharm 4 confirmed the aforementioned documentation in Patient 36's EMR. Pharm 4 indicated being very busy with a high patient load and did not follow up; Pharm 4 further indicated she did not generate an online incident report related to Patient 36's two episodes of hypoglycemia.

During an interview on 1/26/12 at 12:20 p.m., Pharm 3 confirmed that an online incident report had not been filed by licensed nursing staff or a pharmacist related to Patient 36's episode of hypoglycemia on 1/20/12.

b. Closed EMR review revealed Patient 37 was a 65 year-old admitted to the facility on 1/16/12 with diagnoses including Diabetes Mellitus type II (non-insulin dependent) and squamous cell carcinoma (a type of skin cancer) of the head and neck. Patient 37 was receiving liquid nutrition through a gastrostomy tube (GT) (tube surgically placed in the stomach for the administration of liquid nutrition and medications).

Patient 37's Physician Orders included an order for regular insulin sliding scale and fingerstick blood sugar assessments every six hours (at 6 a.m., 12 noon, 6 p.m. and midnight).

Review of Patient 37's Internal Medicine Admission History and Physical EMR indicated a history of resection of the jaw and floor of the mouth; a flap of skin from Patient 37's fibula (back area of lower leg) had been grafted to the jaw area June 2011 and was poorly healing; ENT (ear, nose and throat physician) had planned for surgery on 1/23/12 to reconstruct the area.

Review of Patient 37's Glycemic Control EMR indicated on 1/21/12 she received GT feedings and on 1/22/12 the feedings were stopped in advance of the surgery [NPO status].

Review of Patient 37's EMR MAR indicated no sliding scale insulin had been administered from 1/16/12 through 1/21/12 due to stable fingerstick blood sugars. Patient 37's 1/22/12 EMR MAR revealed that at 12:27 a.m., a licensed nurse administered 2 units of regular insulin for an assessed fingerstick blood sugar of 193 mg/dL. The record further indicated that on 1/22/12 at 6:11 a.m. 25 grams of dextrose was given I.V. by licensed nursing staff for an assessed low blood sugar of 33 mg/dL; another 25 gram dose of dextrose was given I.V. at 11:55 a.m. for an assessed low blood sugar of 54 mg/dL.

During an interview on 1/26/12 at approximately 9:30 a.m. Pharm 8 indicated that patients with physician's order sets including dextrose I.V. for reversal of hypoglycemia may not be readily identified by pharmacists as an adverse drug reaction.

During an interview on 1/26/12 at approximately 12:15 p.m. NM 2 verified Patient 37's clinical EMR findings. During a concurrent interview, Pharm 3 confirmed that an online incident report had not been filed by licensed nursing staff or a pharmacist related to Patient 37's two episodes of hypoglycemia requiring I.V. dextrose administration on 1/22/12.

Review of the hospital policy 1633 Medication Related Event Management Program (revised 2/14/11) indicated under III. Definitions and Descriptions, item F: "ADVERSE DRUG REACTION (ADR): Any undesired response associated with the use of a medication that requires medical intervention or a significant alteration in therapy." The policy further indicated under IV. Medication Event Related Reporting, item B. Adverse Drug Reaction Reporting, number 1: "When a pharmacist or nurse becomes aware of an adverse reaction, he/she should immediately assure the responsible medical service is aware, initiate appropriate therapy adjustments with responsible physician and complete an online incident report."

During an interview on 1/26/12 at 12:20 p.m. Pharm 3 indicated that patients with standing orders (order sets) for dextros

Based on medical record review, dietary staff interview and dietary document review the hospital failed to ensure a comprehensive performance improvement program for medical nutrition therapy as evidenced by lack of effective interventions to ensure the clinical performance monitoring indicator for medical nutrition therapy was improved and/or sustained after the identification of the problem. Failure to ensure comprehensive medical nutrition therapy may further compromise patient medical status and may result in increased length of hospitalization.

Findings:

During medical record review from 1/24-1/26/12 between the hours of 9 a.m. and 3 p.m. it was noted that multiple patients did not receive timely nutrition assessment and/or medical nutrition therapy (Cross Reference A630). In an interview on 1/26/12 beginning at 2:30 p.m., with RD 3 and 5 they were asked to describe the system for ensuring adequate coverage for clinical nutrition care. They stated that in 2009 the hospital identified that there was a decline in patients' medical nutrition therapy. At that time the hospital developed a plan to hire a relief dietitian, eliminate dietitian "back up" of screening patients at admission, rather relying on nursing staff to assess initial nutritional risk, create a brief follow up note and cross train dietitians to multiple areas of expertise. They also stated that while these interventions were put in place the department continued to struggle with adequate Registered Dietician (RD) staffing. She stated that while the hiring of a relief dietitian seemed to make the most impact this position was often required to provide long-term relief for RDs who were on extended leaves of absence and vacations rather than the intended purpose of the relief RD to cover regular days off. They additionally stated that the hospitals' clinical dietitians were routinely called upon to provide relief coverage for the outpatient children's clinic. They also stated that within the next several months she was anticipating additional vacancies due to retirements. The surveyors also asked what the expectation was for RDs in terms of patient load. They stated that depending on the acuity of patients a reasonable load would be an average of 8 patients/day. They also stated that currently it was not uncommon for the RD load to be greater than that and may be 10-14 patients/day depending on patient acuity.

Review of clinical nutrition schedules from 7/11-12/11 revealed that for any given month there were 2-4 RDs who were not working for 5 or greater consecutive days and consistently there were 2 or more RD's who were unavailable on the same work week.

In an interview on 1/26/12 at 3 p.m., with DDS (Dietary Service Manager) 1, who had overall responsibility for the department, was asked by the surveyors how he ensured adequate RD coverage. He stated that several years ago it was identified that patients were not receiving timely medical nutrition therapy. He also stated that he felt the addition of a relief dietitian solved the issue. He also stated that he felt the current staffing was adequate, that the department was reaching its goals and confirmed that the expected production of the RDs was to see approximately 8 patients/shift.

Review of performance improvement activity summary report 06/14/11 and submitted by DSM 1 on 1/30/12 revealed that for Fiscal Year (FY) 2009 through 2010 the department reached the benchmark of 90% compliance for January 2009 through April 2010; however the remaining 8 months the benchmark did not reach the desired goal, rather ranged from 79-89% compliance. Review of year to date statistics beginning July, 2011 through December, 2011 revealed that when utilizing the percentage of patients receiving intervention by the RD, the compliance ranged from 71-81%, with an acceptable benchmark of 90%. It was noted that the hospital also had a Registered Dietitian internship program. While utilization of internship hours increased compliance to 75-85% it did still not meet the hospital developed benchmark of 90%. While the use of student interns may benefit the staffing levels for hospital departments, students participating in the internship program were not registered by the Commission on Dietetic Registration (CDR) and would not possess the depth and breadth of expertise of a Registered Dietitian. Cumulative review of statistics provided by the nutrition department revealed that despite the development of a multi-faceted action plan the final outcome did not improve the percentage of patients seen from FY 2009 through 2010 that required medical nutrition therapy.

Based on medical record review, dietary staff interview and dietary document review the hospital failed to ensure a comprehensive performance improvement program for medical nutrition therapy as evidenced by lack of effective interventions to ensure the clinical performance monitoring indicator for medical nutrition therapy was improved and/or sustained after the identification of the problem. Failure to ensure comprehensive medical nutrition therapy may further compromise patient medical status and may result in increased length of hospitalization.

Findings:

During medical record review from 1/24-1/26/12 between the hours of 9 a.m. and 3 p.m. it was noted that multiple patients did not receive timely nutrition assessment and/or medical nutrition therapy (Cross Reference A630). In an interview on 1/26/12 beginning at 2:30 p.m., with RD 3 and 5 they were asked to describe the system for ensuring adequate coverage for clinical nutrition care. They stated that in 2009 the hospital identified that there was a decline in patients' medical nutrition therapy. At that time the hospital developed a plan to hire a relief dietitian, eliminate dietitian "back up" of screening patients at admission, rather relying on nursing staff to assess initial nutritional risk, create a brief follow up note and cross train dietitians to multiple areas of expertise. They also stated that while these interventions were put in place the department continued to struggle with adequate Registered Dietician (RD) staffing. She stated that while the hiring of a relief dietitian seemed to make the most impact this position was often required to provide long-term relief for RDs who were on extended leaves of absence and vacations rather than the intended purpose of the relief RD to cover regular days off. They additionally stated that the hospitals' clinical dietitians were routinely called upon to provide relief coverage for the outpatient children's clinic. They also stated that within the next several months she was anticipating additional vacancies due to retirements. The surveyors also asked what the expectation was for RDs in terms of patient load. They stated that depending on the acuity of patients a reasonable load would be an average of 8 patients/day. They also stated that currently it was not uncommon for the RD load to be greater than that and may be 10-14 patients/day depending on patient acuity.

Review of clinical nutrition schedules from 7/11-12/11 revealed that for any given month there were 2-4 RDs who were not working for 5 or greater consecutive days and consistently there were 2 or more RD's who were unavailable on the same work week.

In an interview on 1/26/12 at 3 p.m., with DDS (Dietary Service Manager) 1, who had overall responsibility for the department, was asked by the surveyors how he ensured adequate RD coverage. He stated that several years ago it was identified that patients were not receiving timely medical nutrition therapy. He also stated that he felt the addition of a relief dietitian solved the issue. He also stated that he felt the current staffing was adequate, that the department was reaching its goals and confirmed that the expected production of the RDs was to see approximately 8 patients/shift.

Review of performance improvement activity summary report 06/14/11 and submitted by DSM 1 on 1/30/12 revealed that for Fiscal Year (FY) 2009 through 2010 the department reached the benchmark of 90% compliance for January 2009 through April 2010; however the remaining 8 months the benchmark did not reach the desired goal, rather ranged from 79-89% compliance. Review of year to date statistics beginning July, 2011 through December, 2011 revealed that when utilizing the percentage of patients receiving intervention by the RD, the compliance ranged from 71-81%, with an acceptable benchmark of 90%. It was noted that the hospital also had a Registered Dietitian internship program. While utilization of internship hours increased compliance to 75-85% it did still not meet the hospital developed benchmark of 90%. While the use of student interns may benefit the staffing levels for hospital departments, students participating in the internship program were not registered by the Commission on Dietetic Registration (CDR) and would not possess the depth and breadth of expertise of a Registered Dietitian. Cumulative review of statistics provided by the nutrition department revealed that despite the development of a multi-faceted action plan the final outcome did not improve the percentage of patients seen from FY 2009 through 2010 that required medical nutrition therapy.

Based on observations, interviews, clinical records and documents review, the hospital failed to follow physician's orders for Patients 7 and 20 when:

1. Patient 7 received 350 mcg (micrograms) of Fentanyl (pain medication) when 200 mcg was ordered;
2. Patient 20 a) received propofol (medication frequently used to provide relaxation and loss of awareness in ventilator patients) at a starting rate of 10 mcg/kg/min (micrograms per kilogram per minute) when 5 mcg/kg/min was ordered; and b) Richmond Agitation-Sedation Scores (RASS, a tool for evaluating patient sedation on a scale of +4 to -5) in conjunction with propofol administration were not documented.

Findings:

1. On 1/23/12 at 1:45 p.m., a tour of the Tower 2, [burn unit], was conducted with Nurse Manager (NM 7). At 1:48 p.m., an interview was conducted with Registered Nurse (RN 7). RN 7 was providing care for Patient 7 and when questioned whether she charted the medications administered to Patient 7, RN 7 indicated she had not. RN 7 stated the medications administered were written on the glass door in Patient 7's room. Noted on the glass door was Fentanyl with a total dose of 250 mcg. RN 7 stated she gave an additional dose of Fentanyl of 50 mcg at 12:30 p.m., making the total dose 300 mcg.

On 1/24/12 at 3 p.m., the clinical records for Patient 7 were reviewed. Review of Patient 7's physician's orders contained the following dated 1/23/12 at 3:07 p.m.: "Fentanyl (Sublimaze) 25-200 mcg PREMED (pre-medication before procedure) Route: IV (intravenous -into the vein)" Another order dated 1/23/12 at 9:13 a.m. indicated the following: "Fentanyl 50 mcg/ml (microgram per milliliters) injection. Start: 1/23/12 0913 (9:13 a.m.) Standing Count: 1 Occurrences."

Review of Patient 7's January 2012 Medication Administration Record (MAR) indicated the Fentanyl was administered on 1/23/12 at 10 a.m. "200 mcg" total procedure dose. The next time this medication was documented as administered was at 9:30 p.m. The MAR did not contain documentation of the 50 mcg dose.

On 1/24/12 at 4:36 p.m., during an interview with Pharm 2, a request for the Pyxis system(medication delivery system) printout for Patient 7 was requested. This printout would show how much of Fentanyl was removed for Patient 7. The printout for Patient 7 indicated 4 vials of Fentanyl 100 mcg/ml was removed by RN 7 from the Pyxis (total of 400 mcg) on 1/23/12 at 9:13 a.m. (The printout indicated 50 mcg of Fentanyl was wasted.)

On 1/25/12 at 11:10 a.m., a follow-up interview was conducted with RN 7. RN 7 stated she removed 4 vials of the Fentanyl (totaling 400 mcg) and administered 350 mcg to Patient 7. RN 7 stated she gave the wrong dose of medication based on the physician orders for Patient 7.

According to the hospital policy "Medication Administration" revised 1/12/12 "All medications require a physician's order. The physician's order must include: 4. Dose (amount) of medication."


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2. In a review of Patient 20's medical record, propofol was noted as ordered to be started 1/23/12 at "5 mcg. per kg. per minute. Titrate [change the dose] to RASS -1 to +1."

Documentation indicated propofol was started in the Emergency Department (ED) at 5:47 a.m., 1/23/12 at 10 mcg./kg./min. (micrograms per kilogram per minute) The first RASS score was not noted until 9 a.m., 1/23/12, after the patient had been admitted to the Medical Intensive Care Unit.

In a 4:45 p.m., 1/24/12 interview with NM 9, she stated she "would have expected to see documentation from the nurse [starting the propofol] as to why it was started at 10 mcg." In addition, she "could not find [ED] RASS scores either. Nurses are trained to do these and they should have been done." At 1:35 p.m., 1/25/12, AM (assistant manager) 1 stated she too was unable to provide additional information regarding the absence of RASS scores or why propofol was started at a level higher than the physician ordered.

Review of the hospital "Medication Administration" policy, revised 1/12/12, reflected, "Administer medications according to the Five Rights: right patient, right medication, right dose, right time and right route....If PRN [as needed] medication administered, record...the patient's behavioral and physiological response within 60 minutes after administration...."

Based on observations, interviews and record reviews, the hospital failed to ensure that medications were administered in accordance with the physicians' orders, the manufacturer's specification, and the hospital policy and procedures as for seven of 80 sampled patients (28, 29, 30, 31, 32, 39, 66).

Findings:

1. During an observation of medication administration on 1/24/12, at 9:48 a.m., a Registered Nurse (RN 4) was observed to flush Patient 28's peripheral (placed in the arm vein) I.V. line with approximately 5 mL(milliliters, unit of measure) normal saline with a prefilled syringe; RN 4 then administered 2 mL of ondansetron (medication for nausea) (2 mg/mL, or a total of 4 mg in the prepared syringe) into the I.V. line over approximately 20 seconds, then flush with an additional 5 mL of normal saline.

Review of Patient 28's Electronic Medical Record (EMR) current Physician Orders on 1/24/12 revealed an order (dated 1/23/12) for ondansetron 4 mg every 12 hours if needed for nausea/vomiting. Review of the EMR MAR revealed the following instructions for administration: "IV push (undiluted) over 2 - 5 minutes."

Review of the hospital policy XIII-33, Administration of Adult and Pediatric IV Medications, revised 12/8/11, indicated under II. Procedure, item G, "Adult Inpatient and Outpatient Areas: Administration of IV Push Medications," 3. Procedure: "e. Attach prepared syringe and administer medication as ordered, not exceeding maximum dosage and rate specified in Attachments 1 and 2."

Review of the policy attachment (provided by Pharmacist (Pharm) 3), entitled "Guidelines for Intravenous Drug Administration for Adult Patients EXCEPT in Emergency Situations," updated 1/24/12, indicated ondansetron should be administered "Slow IV push 2 - 8 mg over 2 - 5 minutes."

During an interview on 1/24/12 at 9:50 a.m. RN 4 acknowledged administering Patient 28's I.V. push ondansetron over less than two to five minutes during the morning observation of medication administration; RN 4 further acknowledged potential risks of administering the medication too rapidly.

During an interview on 1/24/12 at 10:10 a.m. the Nurse Manager (NM 3) confirmed the expectation that licensed nursing staff administer I.V. push ondansetron in accordance with facility guidelines.

2. During an observation of medication administration on 1/24/12, at 12: 33 p.m., a Registered Nurse (RN 5) was observed to flush Patient 29's peripheral I.V. line with approximately 5 mL normal saline with a prefilled syringe; RN 5 then administered 8 mL of furosemide (diuretic) (10 mg/mL, or a total of 80 mg in the syringe prepared by RN 5) into the I.V. line over approximately 30 seconds, then flush with an additional 5 mL of normal saline.

Review of Patient 29's EMR current Physician Orders revealed an order (dated 1/24/12) for a one time dose of furosemide 80 mg I.V. Review of the EMR MAR revealed the following instructions for administration: "IV push (undiluted) over 1 - 3 minutes."

Review of the facility policy XIII-33, Administration of Adult and Pediatric IV Medications, revised 12/8/11, indicated under II. Procedure, item G, "Adult Inpatient and Outpatient Areas: Administration of IV Push Medications," 3. Procedure: "e. Attach prepared syringe and administer medication as ordered, not exceeding maximum dosage and rate specified in Attachments 1 and 2."

Review of the policy attachment (provided by Pharm 3), entitled "Guidelines for Intravenous Drug Administration for Adult Patients EXCEPT in Emergency Situations," updated 1/24/12, indicated furosemide should be administered "Slow IV push Max dose 80 mg over 1 - 3 minutes."

During an interview on 1/24/12 at approximately 12:40 p.m. RN 5 stated furosemide 80 mg I.V. should be administered over three minutes, and indicated belief that Patient 29's dosage had been administered according to facility guidelines. RN 5 acknowledged not checking her watch during the administration of Patient 29's I.V. furosemide to verify the actual administration rate.

During an interview on 1/24/12 at 4:15 p.m. NM 3 confirmed the expectation that licensed nursing staff administer I.V. push furosemide in accordance with facility guidelines.

3. During an observation of medication administration on 1/25/12, at approximately 8:58 a.m., a Registered Nurse (RN 6) was observed to withdraw Patient 39's solid tablet dosage from the Automatic Dispensing Cabinet (ADC) ; RN 6 then crushed each medication in the packaging. Several of Patient 39's medications included: isosorbide dinitrate 15 mg (indicated for heart disease); olanzapine 5 mg rapidly dissolving tablet (indicated for psychosis); carvedilol 25 mg (indicated for heart failure); famotidine 20 mg (indicated for gastric hyperacidity); hydralazine 30 mg (indicated for high blood pressure); and simvastatin 40 mg (indicated for high cholesterol). RN 6 then carried the medications to Patient 39's room, opened the packaging and mixed all of the medications together in a plastic dosing cup with approximately 30 mL of sterile water for irrigation. RN 6 then flushed Patient 39's NG (nasogastric, a flexible tube placed into the nose then stomach for the administration of liquid nutrition and medications) tube with approximately 20 mL of water in a plastic enteral syringe; administered the slurry of the six combined medications in water via the same syringe; then flushed the NG tube with approximately 50 mL of sterile water after the medications were administered.

Review of Patient 39's EMR current Physician Orders included orders for isosorbide dinitrate 15 mg NG three times daily; olanzapine 5mg rapidly dissolving tablet NG every morning; carvedilol 25 mg NG twice daily; famotidine 20 mg NG every morning; hydralazine 30 mg NG three times daily; and simvastatin 40 mg NG every morning.

Review of the facility policy VIII-11 Enteral Tube Feeding Management, revised 8/12/11, indicated under item D. Monitoring Feeding, 4. Tube Patency a: " ....If it is absolutely necessary to give medication through the feeding tube, use liquid medications when possible. Each medication should be given separately ....Consult the pharmacy for medication and formula administration compatibilities and flush between each medication. "

During an interview on 1/25/12 at 10:45 a.m. NM 4 confirmed medications given through a feeding tube, including an NG, should be administered separately.

During an interview on 1/25/12 at approximately 1:20 p.m. RN 6 acknowledged she should have administered Patient 39's morning meds separately through the NG tube. RN 6 indicated consideration of the potential for fluid overload with multiple medications and the need to flush the NG tube with water between each one. RN 6 further indicated Patient 39 did not have a Physician's Order to restrict the administration of fluids.


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4. During a medication pass observation on Nursing Unit 11 on 1/24/12 at 9:10 a.m. in the presence of a Nurse Manager (NM) 4, RN 16 was observed giving 5 milliliters (ml) of Nystatin (anitfungal medication) suspension to Patient 30, who was alert, oriented, and spoke English. Patient 30 had an order to "swish and swallow" with 5 ml of Nystatin four times a day to prevent mouth infection. At the time of observation, RN 16 gave to medication to the patient but did not emphasize the medication needed to be swished in the mouth for as long as possible before swallowing. As a result, the patient took the medication and immediately swallowed it, without swishing the medication in the mouth.

To date, Lexi-Comp, a nationally recognized drug information resource, indicates that Nystatin "should be swished about the mouth and retained in the mouth for as long as possible (several minutes) before swallowing."

During the same medication pass observation, RN 16 used a large syringe to flush the PEG tube with water before and after the administration of a medication. The syringe was not labeled nor dated. RN 1 was unable to tell the last time the syringe was changed and how often it should be changed.

On 1/25/12 at 9:15 a.m., Tower 11 Nurse Manager (NM 6) said the syringe used for enteral feeding and drug admin

Based on staff interview, medical record and document review, the hospital failed to ensure that all medical records were accessible to care providers and accurately written to show the chronology of care delivery, in accordance with hospital policy, medical staff rules and regulations, and standards of practice. This failure occurred when shared and pended notes did not clearly identify the times and authors of all medical record entries for 3 of 3 sampled patients (Patients 31, 44 and 49). This failure posed a risk for errors from mis-information among care providers who rely on the clarity and accuracy of entries to reflect each patient's condition and the rationale for the care decisions, which are critical features for safe and continuous care.

Findings:

1. Concurrent review on 1/23/12 at 5:30 p.m. of the medical record for Patient 31 with MD 5, who supervised the provision of anesthesia care to Patient 31 for spine surgery earlier that day, indicated that a pre-surgical assessment was documented by a resident physician in training (MD 25). The surgery and anesthesia care were performed on 1/23/12 between 7:15 a.m. and 11:30 a.m. The pre-surgical assessment was signed by the resident physician on 1/23/12 at 1:57 p.m. (7 hours after the care was initiated rather than prior to the care), and signed by the supervising physician (MD 5) also on 1/23/12 at 1:57 p.m. MD 5 stated that MD 25 started the assessment note the day before surgery, but whatever was started was placed in a "pending" and "shared" status and not officially part of the legal medical record until it was signed. While in a shared status, multiple providers were able to add information to the initial note. MD 5 indicated that because the note was not signed until many hours after the pre-surgical assessment should have been performed, several portions of the note were added and downloaded into it (e.g. vital sign measurements and laboratory results obtained after surgery) and were not chronologically part of the pre-surgical assessment. Thus the pre-surgical note was not accurate and did not reflect the chronology of care provided. Neither front-line clinical provider staff nor health information technology staff were able to show when the pre-surgical note was started, when the patient examination (integral to the performance of the assessment) was performed, or when additional entries were made while the note remained in the shared or pended state (as care was being delivered), prior to entering the final signatures at 1:57 p.m.

Review of recommendations from the American Health Information Management Association (AHIMA) titled "Update: Maintaining a Legally Sound Health Record - Paper and Electronic," [source: AHIMA e-HIM Work Group on Maintaining the Legal HER, Journal of AHIMA 76, no. 10, November-December 2005] documented, "Authentication shows authorship and assigns responsibility for an act, event, condition, opinion, or diagnosis ... Each organization should establish a definition of a legally authenticated entry and establish rules to promptly authenticate every entry in the health record by the author responsible for ordering, providing, or evaluating the service furnished." AHIMA further directed that medical record entries should be made as soon as possible after an event or observation was made. An entry shall never be made in advance. The record must reflect the continuous chronology of the patient's healthcare. The chronology must be readily apparent in any given view. Every entry must include a complete date and time, accessible by the reviewer.

2. Concurrent review on 1/24/12 at 3:15 p.m. of the medical record for Patient 49 with RN 21, who specialized in health information technology for quality review purposes, indicated that Patient 49 was treated in the Emergency Department (ED) on 1/23/12 starting at 11:28 a.m. An ED physician assessment note was started by a supervising physician (MD 30) on 1/23/12 at 4:31 p.m. as a shared document. The electronic revision history for each identified "version" of the assessment note showed entries at 5:38 p.m. as an edit by MD 30, at 7:07 p.m. as an edit by a resident physician (MD 16), and 11:45 p.m. as signature by MD 30. RN 21 could not demonstrate the actual entries made at each encounter on the retrieved versions for each entry time. Only by putting each version side by side could it be determined that MD 16 changed a single phrase from "Utox ***" to "Utox negative" as the entry to his edit at 7:07 p.m. Information (laboratory test results) was added to the final version but that version was described as a signature, not as an addendum or edit plus signature. All early versions included MD 30's signature, even though it was not entered until 11:45 p.m. RN 21 could not produce the original entries from when the note was started.

In an interview on 1/26/12 at 3:20 p.m. with the Director of Health Information Management (HIM-2), HIM-2 stated that the shared assessment notes did not readily identify the authors for edits and added information by date and time of entry in the final legal version of the electronic medical record. The final version would be the document provided when requested by a patient or outside entity. To determine the content of entries provided by the authors listed in the revision history required digging into the "back side" of the system, which would not be produced (multiple versions) for a record request. HIM-2 claimed that the edit entries were identified by the appearance of bolded type. However, the 3 versions provided by RN 21 for Patient 49 showed bolded type for identical entries on each of the 3 versions (for statements under the physical examination portion of the assessment). The edit alteration made by MD 16 related to "Utox" did not appear in bolded type.

Review of the medical record for Patient 44 with HIM-1 on 1/26/12 at 3:20 p.m. showed bolded type entries (without identified date, time, author) on identical sections of each of 4 versions of a shared ED note for care provided to Patient 44 on 1/23/12 between 2:22 p.m. and 4:13 p.m.

3. Additional review on 1/24/12 at 5 p.m. of the medical record for Patient 49 with the Chief of Staff (COS), who served as a clinical director for the ED, indicated that the ED physician assessment note for Patient 49 documented the treatment plan was to transfer Patient 49 to an outside hospital. However, Patient 49 was not transferred to a hospital, but was discharged home (according to the nursing notes) on 1/24/12 at 1:57 p.m. No further edits, addendums, or separate notes by the ED physicians were made to reconcile the change in the treatment plan, finalized by MD 30 on 1/23/12 at 11:45 p.m. A separate note by a consulting specialist documented a recommendation to discharge home and not transfer. But the consultant was not listed as the ED attending physician and did not directly issue the treatment orders and instructions for Patient 49. No additional notes by ED physicians were documented to reconcile a change in the treatment plan (to show they were aware of the consultant's recommendation and to show they agreed with the consultant or not). Thus, the continuity and clear direction of care for Patient 49, by the physicians responsible for his care, was not documented.

Review of recommendations from the American Health Information Management Association (AHIMA) titled "Update: Maintaining a Legally Sound Health Record - Paper and Electronic," [source: AHIMA e-HIM Work Group on Maintaining the Legal HER, Journal of AHIMA 76, no. 10, November-December 2005] documented specific procedures to make changes or clarifications (corrections and amendments) to the electronic medical record. Previous information should not be deleted or written over. When information was not written in a timely manner, subsequent entries should be identified as late entries, with date, time and author identified. An addendum was considered a type of late entry that was used to provide additional information in conjunction with a previous entry. The addendum should be identified with date, time, author, reason for writing the addendum, and entered as soon a

Based on observation, staff interviews, and document review, the hospital failed to ensure:
1. The nutritional needs of the patients were met in accordance with recognized dietary practices when menus were not analyzed to ensure they met Recommended Dietary Allowances or the Dietary Reference Intake (DRI) of the Food and Nutrition Board or the National Research Council for Fiber, Calcium, Iron, Vitamin D, Vitamin E, Biotin and Foliate;
2. The Renal diet did not meet the diet manual description.; and
3. Two of 80 sampled patients (22 and 77) and random patients (Patient 80 and 81) were not assessed in a timely manner according to hospital policy. This put patients at risk of menus not providing required nutrients and compromising medical care.

Findings:

Foodservice

1. Registered Dietitian 1 (RD 1) and RD 2 were asked for the nutrient analysis of the menus. Review of the regular menu indicated the daily average of dietary fiber was 12.9 grams (g) per day; calcium was 795 milligrams (mg); and 8.79 mg of iron. Further review of the regular menu indicated there were minimal levels of Vitamin D; one day indicated only 0.7 micrograms (mcg); 3.55 mg of Vitamin E; 185 mcg of Foliate; and no values for Biotin. Review of the low fat and low cholesterol menu indicated there was 17.3 g of fiber per day.

Review of the Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes for Elements, indicated for Calcium that males and females between 19 through 50 years of age to receive 1,000 mg; females between the age of 51 though 70 to receive 1,200 mg; and females and males greater than 70 years of age is 1,200 mg. The DRIs for Calcium are dated 1997. The hospital menu was inadequate in Calcium depending on the age and gender by 205 through 405 mg. It indicated for Iron that for females between 19 through 50 years of age to receive 18 mg. The DRIs for Iron are dated 2001. The hospital menu is inadequate for Iron by 9.21 mg.

Review of the Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes for Vitamins, indicated for Vitamin D that females and males between 19 and 70 years of age is 15 mcg; and females and males greater than 70 years of age is 20 mcg. The DRIs for Vitamin D are dated 2011. The hospital menu is inadequate in Vitamin D depending on age and gender by 14.3 through 19.3 mcg. It indicated for Vitamin E that males and females between 19 through greater than 70 years of age are to receive 15 mg. The DRIs for Vitamin E are dated 2000. The hospital menu is inadequate for Vitamin E by 11.45 mg. It indicated for Foliate for males and females between 19 through greater than 70 years of age are to receive 400 mcg. The DRIs for Folate are dated 1998. The hospital menu is inadequate by 215 mcg. It indicated for Biotin for males and females between 19 through greater than 70 years of age are to receive 30 mcg. The DRIs for Biotin are dated 1998. The hospital menu is completely inadequate for Biotin.

Review of the DRI for Macronutrients, dated 2002/2005, indicated total fiber for males 19 through 50 years of age is 38 g; and 50 through greater than 70 years of age is 30 g; females nine through 18 years of age is 26 g; 19 through 50 years of age is 25 g; 50 through greater than 70 years of age is 21 g. The hospital menu is inadequate in Fiber depending on the age and gender by 8.1 through 25.1 g.

On 1/26/12 at 1:35 p.m. an interview was conducted with RD 1 and RD 2 regarding the analysis of the menus. RD 1 stated when they analyzed the menus they looked at the macronutrients which were carbohydrate, protein, and fat to make sure they were meeting the appropriate amounts. RD 2 stated depending on the diet they would look at micronutrients, like the renal diet for potassium, sodium, phosphorus. RD 1 stated when they did the menu they also made sure there was a daily serving of Vitamin C and two to three servings of calcium. RD 1 stated for the pediatric and OB (pregnant or lactating patients) menu they had three servings of calcium to meet the recommended intakes. When asked, RD 1 stated they analyzed their menus using a computerized nutrition software program. RD 1 stated that depending on the product they may not have all the nutritional information input into the program. RD 1 stated sometimes they use a nutrition label not the information from the USDA (United States Department of Agriculture) database which would make the analysis not completely accurate. RD 1 stated they could probably go back and re-analyze the menus and pull more items from the USDA database to get a more accurate analysis. RD 1 and RD 2 acknowledged that their non-select menu should meet the DRIs.

The menu analysis could not ensure the quantifiable amounts of these nutrients were provided for the diets.

2. Review of the diet manual indicated the renal diet provided approximately 80 grams (g) of protein, two g of potassium, two g of sodium and less than 1200 milligrams of phosphorus per day.

Review of the renal menu indicated on Fridays's the patients would receive 111.8 g of protein and on Saturday the patients would receive 87 g. The daily average showed the renal diet provided 86.3 g of protein.

On 1/26/12 at 1:35 p.m. an interview was conducted with RD 1 and RD 2 regarding the analysis of the renal menu. RD 1 stated when they analyzed the menus they looked at the macronutrients which were carbohydrate, protein, and fat to make sure they were meeting the appropriate amounts. RD 2 stated depending on the diet they would look at micronutrients, like the renal diet for potassium, sodium, phosphorus. RD 1 and RD 2 were not aware that the protein levels were that high on those days and acknowledged those levels were not in accordance with their diet manual.

Clinical Nutrition

3. Review of the clinical record for Patient 22 was initiated on 1/25/12. Patient 22 was admitted on 1/14/12 with diagnoses of cellulitis and sepsis (severe illness in which the bloodstream is overwhelmed by bacteria). Patient 22 had a medical history which included hepatitis C (an infectious disease affecting primarily the liver, caused by the hepatitis C virus), liver disease, and right lower extremity ulcerations (sores). Review of the physician's orders dated 1/14/12 indicated a regular diet. Review of the physician's orders dated 1/17/12, indicated an order for a multivitamin, folic acid and thiamine. Review of the physician's orders dated 1/24/12 indicated an order for Ensure Clinical Strength (oral nutrition supplement with extra calories and protein).

Review of the wound care consult note dated 1/18/12, indicated Patient 22 had 2 right lower extremity leg wounds. The anterior leg wound was measured as 7.5 by 5.5 centimeters (cm); and the posterior leg wound was measured as 7 by 4.5 cm. The plan included to maximize nutrition and hydration.

Review of the nutrition flow sheet dated 1/14/12 at 8:38 a.m. through 1/25/12 at 1:00 p.m. indicated Patient 22 had no documented intakes for percent meal intake for 7 of those meals. It also indicated Patient 22 ate 50 % or less of her meal 15 times out of the 28 documented meal intakes. Approximately 53% of the time, Patient 22 ate fair to poor. It indicated that Patient 22 ate 25% or less of her meal 12 out of the 28 documented meal intakes. Approximately 43% of the time, Patient 22 ate poor.

Further review of Patient 22, indicated there was no nutritional assessment or note in the record.

On 1/25/12 at 2:09 p.m. an interview was conducted with RD 4. RD 4 stated the patient had a nasty wound and they should have seen the patient by day nine of admission since nothing else would have brought them in to see her any sooner. RD 4 stated they would use clinical judgment to determine if this patient was at nutritional risk. When asked, RD 4 stated he did not know why the patient was receiving a nutrition supplement.

Review of the policy titled " Nutrition Screening/Level of Care " dated 9/11 revealed that All patients not identified "at nutrition risk" at time of admission will be re-evaluated by the Dietitian, within 7-9

Based on observations, staff interviews, and document review, the hospital failed to maintain the relative humidity, temperature, and air exchange in the perioperative areas such as operating rooms (ORs), sterile storage, sterile processing area, decontamination room and the GI Lab (Gastrointestinal Laboratory - a department offers a variety of services for patients with digestive concerns) in accordance with nationally recognized infection control guidelines (The Association of perioperative Registered Nurses -AORN).

These failures had the potential for putting the patients at risk due to a) posing a fire hazard in an oxygen-enriched environment; or b) conducing bacterial growth which would compromise the integrity of wrapped sterile items and cause infection; or c) interrupting airflow patterns within the operative settings which could cause contamination of the sterile field, increasing the risk of surgical site infection.

Findings:

During observations in the ORs on 1/23/12 from 2:15 p.m. to 2:30 p.m., the temperatures displayed on the thermostats in the OR 36, 46, and 48 were 73.7 degrees Fahrenheit (F), 73.5 degrees F, and 73.7 degrees F respectively.

During an interview on 1/23/12 at 2:25 p.m. with the Administrative Nurse of Surgeries (RN 2), RN 2 stated the normal range of the OR temperature was 68 degrees F to 72 degrees F; the normal range of the OR humidity level was 20% (percent) to 60 %. RN 2 also stated the Plant Operations and Maintenance (POM) staff were responsible for the OR temperature and humidity monitoring and they would notify the OR staff if the temperature and humidity were out of normal range.

During an interview with RN 1 on 1/23/12 at 2:35 p.m., RN 1 stated the OR staff did not monitor the OR temperature and humidity; the OR staff would not notice the difference if only a few degrees above or below the normal range. RN 1 also stated the POM staff would call the OR staff if the temperature and humidity alarm went off.

During an interview with the Manager of Central Processing (MCP) in the clean core of Pod 40 on 1/23/12 at 2:15 p.m., the MCP stated the temperature and humidity of the perioperative areas were monitored and controlled by the POM department. The MCP stated that the hospital used the AORN (Association of periOperative Registered Nurses) and the AAMI (Association for the Advancement of Medical Instrumentation) guidelines as references for the OR infection control practices.

During an interview with the Assistant OR Manager (RN 1) in the OR suite on 1/23/12 at 4:55 p.m., RN 1 stated the hospital used the AORN guidelines as references for the OR infection control practices and acknowledged that the current published (2011 edition) AORN guidelines indicated the relative humidity within the perioperative suite should be maintained between 30% and 60%.

On 1/26/12 the 2011 Perioperative Standards and Recommended Practices, published by the AORN, were reviewed. On page 218, under Recommendation V.b., direction was given that, "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area...endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas." On page 219, under Recommendation V.c., direction was given that, "Temperature should be monitored and recorded daily..." Under recommendation V.c.1., direction was given that, "Temperature should be maintained between 68 degrees F (Fahrenheit) to 73 degrees F within the operating room suite and...in sterile processing." Under Recommendation V.c.2., direction was given that, "The decontamination area temperature should be maintained between 60 degrees F to 65 degrees F." Under Recommendation V.d., direction was given that, "The air-exchange rate in the perioperative area should be carefully controlled." Under Recommendation V.d.1. The minimum rate of total air exchanges per hour should be maintained at a constant level as follows...Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges...Postanesthesia care unit: Six air exchanges per hour...Sterile storage area: four air exchanges per hour. Under Recommendation V.e. Air-flow patterns within the perioperative setting should be controlled and uninterrupted."

On 1/26/12 at 2:45 p.m., the hospital's temperature and humidity log of 23 ORs (OR 21, 23, 24, 25, 26, 27, 28, 31, 32, 33, 34, 35, 36, 37, 38, 41, 42, 43, 44, 45, 46, 47, and 48) for 1/25/12 was reviewed with the Assistant Manager of the Plant Operations and Maintenance;(AMPO). The aforesaid document indicated the temperatures were out of the range of 68 degrees F and 73 degrees F in OR 21, 23, 25, 32, 33, 44, 45, 46, and 48; the humidity level of OR 48 was 28.2 % (percent) which was below 30%. The AMPO stated the AORN standard was only the goal and the staff should follow the parameters set by the hospital. The AMPO further stated the hospital's OR humidity standard was 20% to 60% and the hospital's OR temperature standard was 65 degrees F to 76 degrees F, which were different from the AORN standard.

Observations and staff interviews showed that the hospital also failed to maintain the relative humidity, temperature, and air exchange in the sterile storage, sterile processing area, decontamination room and the GI Lab, as evidenced by:

During an observation and a concurrent interview in the sterile storage of the Central Processing department on 1/24/12 at 3:30 p.m., there was no device displaying the temperature and humidity. The MCP confirmed that there was no device for monitoring temperature and humidity in the sterile storage and the sterile processing area; the POM staff were responsible for the temperature, humidity, and air exchanges monitoring.

During an observation and a concurrent interview in the decontamination room of the Central Processing department on 1/23/12 at 5 p.m., there was no device displaying the temperature and humidity. The MCP confirmed that there was no device for monitoring temperature and humidity in the decontamination room and the POM staff was responsible for the temperature, humidity, and air exchanges monitoring.

During an observation and a concurrent interview in the GI Lab on 1/25/12 at 11:25 a.m., there was no device displaying the temperature and humidity. The GI Lab manager (NM 13) confirmed that there was no device for monitoring temperature and humidity in the GI Lab and the POM staff was responsible for the temperature, humidity, and air exchanges monitoring.

During an interview with the APOM on 1/26/12 at 2:45 p.m., the APOM stated GI lab was not considered as a surgical area, so the temperature and humidity and air exchanges were not being monitored. The APOM confirmed there was no humidity control in the Central Processing department and the GI Lab. The APOM also stated the POM staff set the OR temperature range from 65 degrees F to 76 degrees F and the OR humidity range from 25% to 60%, which were different from the AORN standard; the alarms would not go off if the temperature and humidity were within the POM settings. The APOM also stated the OR staff had a choice to adjust the OR temperature between 68 degrees F and 73 degrees F. The APOM further indicated that the temperature setting for OR 48 was from 65 degrees F to 85 degrees F because it was the OR where surgical procedures for burn patients were performed. When asked if there was any document showing the air exchanges monitoring for the perioperative area, the APOM stated no annual report was available, but random checking had been done.

On 1/26/12 at 3:15 p.m., a review of the hospital's policy and procedure titled "Energy Management and Conservation" dated 7/25/10 indicated the parameters of the temperature in the ORs, Central Processing Areas, and Supply Storage Areas are 68 -72 degrees F, 70-76 degrees F, and 68-78 degrees F respectively; the parameters of the relative humidity in the ORs, Central Processing Areas, and Supply Storage Areas are 50%-60%, 30%-50%, and 30%-60% respectively. The aforesaid document also indicated an

Surveyor: Bender-Porter, Dagma


Surveyor: Craig, Deborah

Based on observations, interviews and record review, the hospital failed to develop an effective system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel when:

1. Surgical infection control standards in areas where invasive procedures were performed in in-patient and out-patient services were not in accordance with nationally accepted infection control standards for:
a) Surgical attire including personal protective equipment (PPE), traffic patterns
b) Cleaning of surgical equipment
c) Environmental cleaning
d) Handwashing
2) Staff were unable to access information on chemical hazards and precautions.
3) Biohazard waste was not secured.
4) Tuberculosis screening of employees was not in accordance with nationally recognized infection control guidelines.
5) There was no evidence of the physicians daily assessment of the need for a central line.
6) Food was not stored, prepared and served in safe, sanitary conditions.
7) Glucometers were not being cleaned according to infection control standards.

Findings:

1a) Surgical Attire/PPE:
i. During a tour in the Operating Rooms (ORs) with the Infection Control Practitioner (ICP 1) and the OR Assistant Manager (AM 2) on 1/23/12 from 1:50 p.m. through 4:30 p.m., ICP 1 was observed wearing turtle neck clothing under her scrub suit. Approximately 1 inch of the turtle neck clothing was not completely covered by the warm-up jacket. ICP 1 accompanied the surveyor walking through the perioperative areas, including the operating rooms, the hallway...and the clean cores.

During an interview with AM 2 in the hallway of the operating suite on 1/23/12 at 4:05 p.m., AM 2 stated it was acceptable for staff members to wear personal clothing not completely covered by surgical attire in the operating rooms.

ii. During an observation in the anesthesia board runner room (Room 3P648) on 1/23/12 at 2:02 p.m., Anesthesiologist (MD 27) was observed wearing white personal clothing under the scrub suit. About 2 inches of the white clothing was not covered by the scrub suit at the V-neck area.

During an interview with ICP 1 on 1/24/12 at 9 a.m., ICP 1 stated the anesthesia board runner room was a semi-restricted area and staff members were required to wear surgical attire appropriately.

iii. During an interview with the GI Laboratory Manager (NM 13) on 1/25/12 at 11:25 a.m., NM 13 stated staff were not required to wear surgical attire in the decontamination room if there was no instrument processing in the room, that was, wearing street clothes was allowed in the decontamination area in the GI Lab.

During an interview with a Registered Nurse (RN 8) in a tour of the GI Lab on 1/26/12 at 9:30 a.m., RN 8 stated staff were not required to wear surgical attire and a hair cover if there was no patient or procedure set up in the room (that was, the staff could wear street clothes in the procedure room). When asked the types of procedures were performed in the procedure room, RN 8 stated the procedures performed included colonoscopy (the visualization of the colon [portion of the large intestine] with a long, flexible instrument that consists of a tube and a light), EGD (Esophagogastroduodenoscopy or upper endoscopy - a procedure that enables the examiner to examine the swallowing tube, stomach, and the first portion of small bowel using a thin flexible tube that can be looked through on a monitor), liver biopsy (the removal of a small piece of living tissue from the liver for microscopic examination), and biopsy (the removal of a small piece of living tissue from an organ or other part of the body for microscopic examination). RN 8 stated biopsy was the removal of "a little bit of tissue" and she did not consider biopsy as a type of surgery.

On 1/26/12 at 10 a.m., in an interview with the Nurse Manager (NM 13) and RN 8, a review of the definition of surgery developed by the American College of Surgeons dated 4/2007 was conducted. The definition of surgery indicated "Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or diseases processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles......All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel" NM 13 and RN 8 acknowledged that biopsy was a procedure performed for the purpose of structurally altering the human body by the incision or destruction of tissues. NM 13 also confirmed there was no defined restricted or semi-restricted areas in the GI laboratory and the staff were not required to follow the surgical attire as practiced in the operating suite.


iv. During an observation in the decontamination room of the GI Laboratory on 1/26/12 at 11 a.m., the Gastrointestinal Procedure Technician (GI T 1) was observed handling the soiled endoscope and the high-level disinfectant without wearing a mask.

During an interview with the NM 13 on 1/26/12 at 12:50 p.m., the NM 13 stated the staff should have worn a mask during the decontamination process.

On 1/26/12 at 1:30 p.m., a review of the hospital's policy and procedure titled "Personal Protective Equipment (PPE)" dated 7/30/10 indicated "Decontamination area: To protect staff members against biological and chemicals hazards, the following...must be worn when working in the decontamination area...mask."

In a review of the hospital's Policy and Procedure titled "Dress Code - Standards for Operating Room Wearing Apparel", dated 1/7/12, there was stipulation "All persons entering the semi-restricted and restricted areas of the surgical suites are required to wear clean surgical scrubs...Semi-restricted area: Includes peripheral support areas of the surgical suite, storage, scrub sinks, hallway...Restricted area: Includes OR rooms, clean cores, substerile rooms...All personal clothing should be completely covered by the surgical attire. Clothing that cannot be covered by the surgical attire should not be worn."


In a review of the 2011 Perioperative Standards and Recommended Practices, published by the Association of periOperative Registered Nurses (AORN), Page 57, Recommendation Practices for Surgical Attire, direction was given that, "These recommended practices are intended as guidelines adaptable to various practice settings. These practice settings include traditional ORs, ambulatory surgery centers, physicians' offices, cardiac catheterization laboratories, endoscopy suites, radiology departments, and all other areas where surgery and other invasive procedures may be performed." Under Recommendation II, direction was given that, "Clean surgical attire, including shoes, head covering, masks, jackets, and...should be worn in the semi-restricted and restricted areas of the surgical or invasive procedure setting." On page 95, under Recommendation I.1., direction was given that, "...The sequestrated area includes the peripheral support areas of the surgical suite...Personnel are required to wear surgical attire and cover all head and facial hair. The restricted area includes ORs, procedure rooms, and the clean core area. Surgical attire and hair coverings are required..."

1b) Cleaning of Surgical Equipment:
i. Flash Sterilization:
During an interview with the Manager of Central Processing (MCP) in the clean core of Pod 40 in the Operating Suite on 1/23/12 at 2:15 p.m., the MCP stated the hospital used the AORN (Association of periOperative Registered Nurses) and the AAMI (Association for the Advancement of Medical Instrumentation) guidelines as references for the OR infection control practices. When asked the reasons for flash sterilization in the hospital, the MCP stated there were only 2 sets of dental instrument

Based on observations, staff interview and document review the hospital did not ensure that the organization of surgical services was appropriate to the scope of the services offered. The hospital failed to provide defined in writing and approved by the medical staff the scope of surgical services provided by the hospital in all inpatient and outpatient locations of the hospital.

Findings:

During the entrance conference on 1/23/12 starting at 10:45 a.m. the hospital administrative staff was asked to provide an organizational chart and the scope of surgical services defined in writing of all surgical services provided in all locations of the hospital. The administrative staff presented Medical Staff Organizational Chart of all Department by category of services, including Anesthesiology and Pain Medicine (MD 4) and Surgery (MD 11), along with other departments such as Department of Internal Medicine, Pediatrics, Radiology, etc. All listed Departments showed reporting to Medical Staff Executive Committee (MEC, MD 10), who directly reported to Chief Medical Officer (CMO). No organizational chart was provided showing how Surgery Services were organized. An organizational chart for Perioperative Services was provided, which only contained selected surgery services, such as the Main/Pavilion Operating Rooms (OR), Same Day Surgery Center and Central Processing, all reporting to the Director of Perioperative Services (MD 12). There was no scope of surgical services defined in writing for all surgical services provided in all locations of the hospital, including those provided outside of the operating rooms in each department.

In an interview with the Director of Perioperative Services (MD 12) on 1/23/12 at 11 a.m. the Director stated that he was only responsible for the main ORs as listed on the Perioperative Services organizational chart. The Director provided no oversight of invasive surgical procedures performed throughout the hospital at various inpatient and outpatient locations/departments. Each department was responsible for the care they provided and each department reported directly to the MEC committee. To his knowledge, there was no comprehensive description of surgical services that included all surgical invasive procedures provided at each location and/or department with an oversight by the Surgery Services. Invasive surgical procedures performed outside operating rooms were not considered surgeries by the hospital, therefore the Surgery Services oversight was not provided.

On 1/23/12 at 12 p.m., upon request, the hospital administrative staff provided a one page list of services where invasive (surgical) procedures were scheduled to be performed under sedation outside of the operating rooms listed as part of the Perioperative Services. The list indicated the following sites: ENT (ears, nose, throat), GI Lab (gastrointestinal), Pain Clinic, Pulmonary Lab (lung), Radiation Oncology (cancer), Same Day Surgery, University Birthing Suites, Vascular Access, Vascular Center (Cath Lab) and Interventional Radiology. Any invasive procedures that may have been performed in each Department of the hospital were not listed or monitored by surgical services.

The administrative staff also provided governing body advisory group (Governance Advisory Council) minutes showing in part that Invasive Procedures Review Committee (IPRC) presented annual reports to the Council. The reports included a Performance Improvement Annual Report from the IPRC. In the Executive Summary it was stated that "The goal of the IPRC is to provide oversight of minor surgical and other invasive procedures performed outside of the OR environment throughout the health system to ensure a single standard of care is provided regardless of the clinical division or location in which the procedure is provided."


22710

Review of the governing body advisory group monthly minutes between January 2010 and December 2011 confirmed no documented efforts to develop and implement hospital-wide surgical practices reflecting nationally recognized standards of practice for infection control, prevention of surgical errors and complications, safe maintenance of the surgical environments, assessment of surgical patients, or other surgical safety practices to minimize negative outcomes. Instead, various departments submitted individual summary reports of their performance, generally meeting benchmark goals for most departments. Unsafe practices were not described in the summary reports. No evidence of governing body discussion or direction for surgical services was presented.

In an interview on 1/26/12 at 4 p.m. with members of the medical staff and hospital leadership (including the former department chairmen for surgery and anesthesia, chief of staff, chief medical officer, chief financial officer), the leadership indicated that each specialty department functioned independently without a centralized division to oversee surgical services hospital-wide. Therefore, policies and practices among various outpatient surgical departments and some inpatient services differed according to what each service chose, and were not reviewed by a designated department head who took responsibility for the safety and effectiveness of these surgical services hospital-wide. As each service reported the results of their activities to both a quality committee and the medical executive committee, the primary person with surgical knowledge and expertise, and who served on both committees and was expected to be knowledgeable about each service's practices and performance, was the Chief Medical Officer (CMO). But the CMO was not formally designated to oversee all surgical care and services, or to verify that surgical practices in all locations conformed with basic and current nationally recognized standards of practice for surgical care. The CMO indicated that oversight of surgical services was a team effort with many people performing pieces of oversight. The CMO acknowledged that surgical care practices in various locations were not consistent, as they were governed by the individual departments. The hospital leadership presented no evidence to show efforts to review basic surgical practices across the spectrum of services, to identify which processes required standardization or which modifications would still meet the patient safety goals for nationally recognized organizational standards.

Review of the July 2011 Medical Staff Rules and Regulations under item XIII-F documented that the principal goal of the Invasive Procedure Review Committee was to improve patient care by evaluating surgical and other invasive procedures performed throughout the hospital. The hospital presented no documented evidence that the Invasive Procedure Review Committee had evaluated patient safety processes for surgical and invasive procedures in all locations where they were performed.

Based on observation, staff interview, medical record and document review, the hospital failed to ensure that surgical services consistently met the unique needs of each patient by developing and/or implementing surgical care policies and procedures designed to assure the achievement and maintenance of high standards of medical practice and patient care when:

1. Surgical site verification practices did not comply with hospital policy and/or nationally recognized verification standards for all locations where surgical procedures were performed (e.g. emergency department, interventional radiology, distant outpatient locations), identified in 5 of 12 surgical patient records reviewed (Patients 12, 13, 15, 48, and 50), and resulted in a wrong-site surgery for 1 patient (Patient 50).

2. Surgical services' policies and procedures were not written, implemented and/or enforced in accordance with acceptable standards of medical practice and surgical patient care. Cleaning, disinfection, decontamination of surgical instruments and ventilation monitoring did not conform to nationally recognized standards. Barriers to minimize cross contamination that included restricting access of personnel (traffic), protective garments (surgical attire) and practices to protect and maintain a sterile field were not practiced in all locations where surgical procedures were performed, resulting in increased risk for environmental stresses or contamination of the surgical site.

Findings:

Review of the July 2011 Medical Staff Bylaws indicated under Article VII, Section 2-B(15) that the Governing Body authorized the Department Chairpersons to be responsible to participate in the development and implementation of policies and procedures that guided and supported the provision of care, treatment and services.

1. Surgical Site Verification

Review on 1/24/12 at 5 p.m. of the medical record of Patient 50 with MD 10, who served as the Chief of Staff for the medical staff, indicated that Patient 50 was admitted to the hospital on 7/14/11 for shortness of breath and fluid accumulation in the space surrounding the right lung. An invasive surgical procedure to drain the lung fluid (thoracentesis) was performed by two resident physicians in training (MDs 17 and 18) on the wrong lung side, posing an unnecessary risk for bleeding, infection, and/or further compromise of the patient's breathing. MD 10 indicated that had the resident physicians followed a standard surgical site verification process, the error and unnecessary risk for harm may have been prevented. The consequence of this error required additional x-ray studies and monitoring for the complications of the unnecessary surgery.

MD 10 further stated that all physicians were expected to conduct a process to verify the correct patient, correct procedure, and correct surgical site. However, in the emergency room and on units where procedures were performed at the bedside, the hospital's surgical site verification policy did not require the presence of more than one provider to participate in the verification process (e.g. MD plus registered nurse). MD 10 stated that many invasive procedures were performed in these locations by a single provider who was expected to, at a minimum, verify with the patient that the patient had consented to the procedure, the indication for the procedure, and the existing documented information (e.g. x-rays, scans, laboratory data, patient's complaint and examination findings) as part of the verification process. MD 10 confirmed that the documented record did not show that any other personnel (e.g. RN) participated in the surgical pause or Time Out portion of the site verification for Patient 50, and that the consent did not specify on which side of the chest the procedure would be performed.

In an interview with a hospital regulatory compliance officer (CO 1) on 1/26/12 at 12:30 p.m., CO 1 stated that the emergency department, outpatient departments, and locations other than the main operating room, pre-op holding/post-anesthesia care unit, radiology procedure areas, same day surgery center, children's surgery center, electrophysiology laboratories (electric activity of the heart), and birthing suites were not required to document a pre-procedure checklist as part of the site verification process when performing surgical procedures in those locations. CO 1 confirmed that there was no documented evidence of a pre-procedure checklist for the lung surgery performed on Patient 50 (described above) on 7/11/11, for a stomach surgery performed in the diagnostic radiology location on Patient 48 on 1/25/12, for a lung surgery performed on Patient 15 on 1/26/12, for a pain injection procedure performed on Patient 13 on 1/24/12, and for a spine procedure performed on Patient 12 on 1/24/12.

In an interview on 1/26/12 at 1:30 p.m. with MD 19, who served as the current director for the training program responsible for training MDs 17 and 18, MD 19 indicated that the department on which MDs 17 and 18 served reviewed and discussed the mis-steps of the events of July 14, 2011 for Patient 50. It was determined that MD 18 was supervising MD 17, but neither performed a thumping on the chest to locate fluid, a standard and necessary step in technique for this procedure. In addition, MDs 17 and 18 mis-interpreted the images of a device also used to locate fluid (ultrasound) and believed the fluid was located on the left chest. MD 19 indicated that MDs 17 and 18 had reviewed patient information including previous x-rays which clearly showed the fluid to be on the right side, but still erred as they chose to perform the procedure on the left side. The reviewers determined that MDs 17 and 18 did not perform the "time out" or verbal verification in the procedure room in accordance with policy. MD 19 indicated that patient's medical information and display of images within the procedure room or at the bedside was not required or routinely performed for chest drainage procedures, although the emergency department did have such capability with mobile digital imaging displays. MD 19 indicated that his department did not discuss the lack of designating the correct side on the patient's consent form, or the failure by MDs 17 and 18 to document a verification checklist.

Review on 1/26/11 at 1:30 p.m. of policy IV-19 titled Universal Protocol, last revised 1/20/10, documented that invasive procedures involving the puncture or incision of the skin, insertion of an instrument, or insertion of foreign matter into the body required use of the Universal Protocol to prevent errors of wrong patient, wrong body part, wrong side of the body or at the wrong level of the correctly identified anatomic site. The Universal Protocol was required for all procedures performed in all locations. The policy described the steps required to fulfill the Universal Protocol, which included a verbal verification (time-out) to be performed in the procedure/exam room by the personnel performing and assisting in the procedure, prior to the start of the procedure. Documentation of the verbal verifications (of identity, consent, type of procedure, location, allergies, type of special equipment, etc.) were to be documented on a standard pre-procedure checklist in the presence of the patient. Portions of the policy described tasks required of various surgical team members (registered nurses, assistants, anesthesia providers) depending on the location where the procedure was performed. Section G item 2 specified the role of the "Circulating/Procedure nurse" to initiate the time out process with the team as part of the Time Out process. Section H items 5(d) and 6(f) referenced how the performance of Time Out would be documented, concluding that the Time Out process applied to all hospital locations. The policy did not clarify when, or for which procedures, registered nurses would not be required to participate in the Time Out process. The policy did not specify that images should be displayed at the bedside, only that they be available.

Review of the 2008 World Health Organization (WHO) Guidelines for Safe Surgery, First Edition, emphasized the effecti

Based on observation, staff interview, medical record and document review, the hospital failed to ensure that an accurate and complete history and physical examination (H&P, an assessment of the patient's health) and/or update to each surgical patient's complete H&P, performed by a qualified individual, was documented prior to the surgical procedure for 6 of 12 sampled surgical patients (Patients 31, 48, 80, 81, 82, and 83), in accordance with hospital policy, medical staff rules and regulations, and acceptable standards of practice. This failure put surgical patients at risk for an unsafe surgical experience.

Findings:

Review on 1/23/12 at 5:30 p.m. of the medical record for Patient 31 with MD 5, who performed anesthesia services for Patient 31, indicated that Patient 31 had planned spine surgery on 1/23/12. Following surgery, Patient 31 displayed an abnormal heart rhythm and was admitted to a special monitoring care unit of the hospital (which was unplanned). The Anesthesia Operative Report noted anesthesia start time of 7:16 a.m. and anesthesia end time of 11:36 a.m. (with surgery occurring between). Patient 31 had a complete H&P documented by the spine surgeon on 1/11/12, which specifically noted absence of pulses (blood circulation) in both lower legs. Patient 31 also had co-existing heart problems for which a consultation with a heart specialist was documented on 12/29/11, and which provided an opinion that his heart condition did not prohibit him from proceeding with surgery and anesthesia. No update to the surgeon's H&P by the surgeon was documented on the day of surgery (admission). Instead, MD 5 stated that he and a resident physician in training (MD 23) performed the H&P update and documented that task together with a pre-anesthesia assessment in a note titled "Anesthesiology Pre Operative Screening Update." This particular shared note was started by MD 23 sometime prior to surgery, but MD 5 could not determine what was written prior to surgery, as both MD 23 and MD 5 signed the entries after surgery on 1/23/12 at 1:57 p.m. The Anesthesiology Pre Operative Screening Update documented, "The Anesthesia H&P was reviewed ... the patient has been examined, and there are no changes in the patient's condition since the H&P was completed." MD 5 could not determine what was meant by "Anesthesia H&P," since the only physician assessments he could find in this electronic record were the surgeon's report from 1/11/12 and the cardiologist's reports from December of 2011. MD 5 stated that usually a screening H&P was prepared through a pre-operative clinic and that was what was meant by "Anesthesia H&P."

In an interview with the Chief Medical Office (CMO) on 1/24/12 at 10 a.m., the CMO presented a report he had located from the electronic system dated 1/11/12 and titled Nursing/Ancillary Staff Pre-Anesthesia Screening, prepared and signed by a registered nurse. The CMO indicated that this document was considered the "Anesthesia H&P" which was referenced by MD 5 and MD 23 in their Anesthesiology Pre Operative Screening Update. The CMO indicated that approximately 1/3 to 1/2 of all elective pre-surgical patients were referred to a screening clinic where one physician, or one of 6 nurses, performed pre-surgical and/or pre-anesthesia assessments days to weeks prior to the scheduled surgery. The 6 nurses, however, did not possess the education and training comparable to physicians or advanced practice providers (mid-level practitioners), and thus were not qualified to assess the fitness for surgery or anesthesia for any patient.

[Note that the Centers for Medicare and Medicaid Services regulations written in the Code of Federal Regulations at CFR 482.52(b)(1) required that a pre-anesthesia assessment may only be performed by someone qualified to administer anesthesia, i.e. a qualified anesthesiologist, doctor of medicine or osteopathy, dentist, oral surgeon, podiatrist, certified registered nurse anesthetist, or anesthesiologist assistant under supervision. CFR 482.55(c)(5) defined the persons qualified to perform an H&P as those individuals legally authorized to practice within the state, and within their scope of practice. In California, those individuals included physicians and mid-level practitioners but not registered nurses.]


On 1/24/12 between 11 a.m. and 12:30 p.m., Patient 48 was observed to undergo a type of planned outpatient stomach surgery in the diagnostic radiology (imaging) department. The surgery was performed by MD 22. Moderate sedation (the administration of drugs to dull a patient's awareness and pain during a surgical procedure, a type of anesthesia service also known as conscious sedation) was administered and monitored by a registered nurse. No other staff (e.g. circulating nurse, scrub assistant, anesthesia physician) participated in the surgical procedure. MD 22 was not observed to perform a history and physical examination or airway assessment of Patient 48 prior to the procedure.

Review on 1/25/12 at 3 p.m. of the medical record for Patient 48 with a Patient Care Services Director (PCSD 4) indicated that Patient 48 had surgical placement of a tube through the skin of the abdomen into the underlying stomach to provide nutrition on 1/25/12 at 12:04 p.m. because Patient 48 could not swallow well. The surgery was performed in the imaging department by MD 22. No assessments by MD 22 prior to surgery were documented. An office visit dated 1/17/12 by a different treating physician noted high-risk health conditions, including compromise to Patient 48's nutrition and fluid balance, a severely low blood count (anemia), and kidney failure. The office examination documented diffuse swelling of the mouth and upper airway passage due to head and neck cancer and radiation treatments. The visit note did not document essential elements of an H&P (e.g. allergies, physical exam findings of the major organ systems, medications, and other serious health conditions that affect one's risk for surgery), and would be incomplete as an H&P.

On 1/25/12 at 6 p.m., the hospital presented documents related to Patient 48's surgery on 1/25/12. A document titled "Brief History & Physical for Outpatient Procedures with Sedation" was signed as a Pre Sedation Edit by a nurse practitioner (who did not participate in the surgical procedure) on 1/24/12 at 9:08 a.m. (the day before surgery, 27 hours prior to surgery). Prior to the signature on 1/24/12 at 9:08 a.m., the note read, "I have reviewed and assessed the patient immediately prior to procedure and the patient remains a candidate for conscious sedation. I have reviewed and concur with the nursing assessment completed prior to procedure." The document was signed again by the same nurse practitioner (NP) on 1/25/12 at 10:48 a.m. (prior to surgery). The only examination findings noted on the document were of heart and lung sounds, and some aspects of the abdomen. Although only a very mild surgical risk and mild degree of difficulty to rescue the airway were selected by the NP for this high risk patient, the NP did not document the condition of Patient 48's neck mobility, mouth and upper airway (which were previously described as abnormal). Specific examination of the skin where the surgery would be performed was also not described. Allergies, medications, vital sign measurements, mental condition, and general health history were items not included in the NP report, thereby rendering this H&P as incomplete. No documentation was presented to show that the surgeon (MD 22), who was responsible to decide whether the patient was fit for surgery and moderate sedation, had examined and assessed the patient to determine whether it was safe to proceed with the planned surgical care.

Review of a chapter from the 2006 online Merck Manual Professional titled Preoperative Evaluation: Care of the Surgical Patient, retrieved from , listed elements of a "relevant preoperative history" to include current symptoms of active heart/lung disorder or infection, risk factors for bleeding, blood clots, and infection, serious chronic diseases, complicat

Based on observations, staff interviews, and document review, the hospital failed to provide and maintain a safe and sanitary environment for patients and employees in the outpatient clinic areas in accordance with hospital policy and nationally accepted guidelines as evidenced by:

1. The hospital failed to have an effective system to monitor and maintain the relative humidity, temperature and air exchanges in the outpatient perioperative areas in accordance with nationally recognized infection control guidelines (perioperative areas include operating rooms, endoscopy rooms (the rooms for procedures in which an instrument is passed into the body for the purpose of visual examining the interior of a body canal or hollow organ), decontamination room, sterile processing areas, sterile storage and recovery room area.

2. The hospital failed to ensure separation of clean and soiled supplies and location in accordance with nationally accepted infection control guidelines.

3. The hospital failed to ensure gas was stored safely.

4. The hospital failed to have an effective system to ensure compliance with use of surgical attire /personal protective equipment (PPE) in the perioperative and endoscopy areas in accordance with hospital policy and nationally accepted infection control guidelines.

5. The hospital failed to have an effective system to ensure traffic patterns were conformed to in accordance with nationally accepted infection control guidelines.

6. The hospital failed to have an effective system to ensure endoscopes were a) cleaned b) disinfected and c) stored in accordance with hospital policy and nationally accepted infection control guidelines

7. The hospital failed to have an effective system to ensure endoscopes blood spill were cleaned up according in accordance with hospital policy and nationally accepted infection control guidelines

8. The hospital failed to ensure glucometers (medical device used to measure blood sugar in patients) were cleaned according to policy.

1. During an interview Staff 80 on 1/25/12 at 12:00 p.m. , she stated " In GI- 2 we are not monitoring the rooms for temperature and humidity daily. They are doing an overall building surveillance (not room or area specific) of temperatures, and I am not sure about humidity monitoring. There is no monitoring of air exchange rates. "

On 1/25/12 at 12 00 p.m., the following e-mail statement was provided, addressed from Staff 82, in response to a request for GI-2 ' S policy on environmental monitoring: " The environmental monitoring policy requested is not relevant to procedure rooms that are not licensed as operating rooms. There is environmental monitoring that occurs, including temperature; however, the standards are not the same as the monitoring done for the operating rooms. "

During an interview with AMPO (Assist Manager of Plant Operations) 1/26/12 at approximately 2:30 p.m., he confirmed that daily monitoring of the outpatient GI-2 area room, including the procedure rooms were not performed. AMPO indicated that the reason they were not monitored was because the area was not considered a surgical suite. AMPO also indicated that the building the outpatient GI area was housed in did not have capacity for humidity adjustment.

Review of the Same Day Surgery Center daily temperature and humidity logs were reviewed on 1/24/12 at 6 p.m. The log legend indicated normal temperature values equaled 60 to 70F and normal humidity values equaled 20 to 60. The log legend indicated the code A was used to indicate temperature adjusted, code B for PO and M notified (plant operations and maintenance notified), and code C+ for door left open/closed. The logs documented the humidity in the operating rooms was consistently below 30 during the month of 12/11. There was no evidence on the log that Plan operations was notified on adjustments to environment controls were made. An example where humidity levels were out of range is listed below:

12/1/11 in OR1 the humidity was 25; in OR2 it was 25; in OR3 it was 25; OR4 it was 24.
12/2/11 in OR1 the humidity was 22; in OR2 it was 24; in OR 3 it was 24; OR4 it was 23.
12/5/11 in OR1 the humidity was 25; in OR2 it was 25; in OR 3 it was 25; OR4 it was 22.
12/6/11 in OR1 the humidity was 26; in OR2 it was 25; in OR 3 it was 24; OR4 it was 22.
12/7/11 in OR1 the humidity was 26; in OR2 it was 24; in OR 3 it was 24; OR4 it was 23.
12/22/11inOR1 the humidity was 21; in OR2 it was 20; in OR 3 it was 20; OR4 it was 20.

During an interview with AMPO on 6/26/12 at approximately 2:20 p.m., he acknowledged the humidity levels were below 30 throughout the month of December 2011 and no adjustments were made. AMPO stated there were no enforceable regulations that required the hospital to maintain the humidity in the out-patient operating rooms at a minimum of 30. AMPO stated he was aware of the national guidelines, such as AORN, but that these were standards and not enforceable requirements.

In a review of the 2011 Perioperative Standards and Recommended Practices, published by the Association of periOperative Registered Nurses (AORN), direction was provided
" Relative humidity should be maintained between 30 and 60% within the perioperative suite, including operating rooms ...Low humidity increases the risk for electrostatic charges which pose a fire risk in an oxygen rich environment or when flammable agents are in use and increase the potential for dust. "

2. On 1/24/12 at 10:23 a.m. the ENT (ears, nose throat) surgical procedure room was observed to contain a large card board box, papers, binders, and books stacked at the back of the room against a wall and not contained in a cabinet.

On 1/24/12 at 10:23 a.m., during an interview with ICP 10 (infection control preventionist) in the ENT surgical procedure room, he commented that office supplies were being stored in the surgical procedure room. ICP 10 stated that there was no way to disinfect these items and another place should be found to store them. The ICP 10 added that cardboard should never be stored in an operating room because it could contain cockroaches.

On 1/26/12 at 8:47 a.m., in the soiled utility room of the sixth floor of the ENT outpatient clinic, Staff 85 was observed cleaning a soiled endoscope at a sink that did not have a splash guard. When facing the sink, the counter to the left had a sign over it labeled "clean". Sitting on this counter approximately one foot away from the sink was an endoscope lying uncovered on a towel.

During an interview with the Staff 85 on 1/26/12 at 8:47 a.m. in the soiled utility room of the sixth floor of the ENT outpatient clinic, Staff 85 stated the endoscope on the towel on the clean counter had been processed using a high level disinfected. When asked how often the towel, where processed scopes were placed, was changed, staff 85 stated the towel was changed daily or for saturation. Staff 85 stated scopes on the towel were available for use. When questioned about why the scope was being left on the towel on the counter, Staff 85 stated it was more convenient for the physicians to obtain the scopes from the counter.

In an interview with ICP 10 on 1/26/12, she acknowledged the clean scope placed on the towel, or any subsequent clean scope on the towel could be contaminated by aerosols from the sink, where staff were cleaning the scope.

In a review of the 2011 Perioperative Standards and Recommended Practices, published by the Association of periOperative Registered Nurses (AORN), under Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, Recommendation VII indicates, "Instruments should be decontaminated in an area separate from locations where clean activities are performed...Physical separation from areas where clean items are handled minimizes the risk of contamination. Cross-contamination can occur when soiled items are placed in close proximity to clean items or placed on surfaces upon which clean items are later placed. Aerosols created during cleaning can also cross-contamination."

3. On 1/24/12 at 9:40 a.m. free standing container of labeled nit

Based on observation, interview and record review, the hospital failed to provide emergency medical services that were well organized and in accordance with acceptable standards of practice in order to ensure safe and high quality emergency care to all patients.

1. The hospital failed to establish policies, procedures and standards for emergency medical services, including the management of patients presenting with a psychiatric complaint, were established, evaluated and or updated on an ongoing basis. (Refer to A-1104)

2. The physicians failed to complete a Transfer Summary prior to the transfer of patients to an in-patient psychiatric facility which included a) the receiving facility had accepted the patient, b) the risks and benefits of the transfer had been explained to the patient, (c) the patient had consented to or refused the transfer and d) all medical records related to the patient's condition had been sent with the patient at the time of transfer. (Refer to A-1104)

3. The hospital failed to ensure adequate medical and nursing personnel provided the necessary care and services, including ongoing assessments, interventions and monitoring, to meet the needs of patients who presented to the ED. (Refer to A-1112)

4. The hospital failed to provide evidence of current competency for triage nurses, functioning under standardized procedures, who initiated the Medical Screening Exam (MSE) for patients presenting to the ED. (Refer to A-1112)

The cumulative effect of these systemic problems resulted in the hospital's inability to comply with the statutorily-mandated condition for emergency services.























28991

Based on staff interview and hospital record review, the hospital failed to ensure appropriate oversight of the outpatient surgical services departments and coordination with inpatient surgical services.

Findings:


In an interview with the Director of Perioperative Services (MD 12) on 1/23/12 at 11 a.m. MD 12 stated he was only responsible for the main ORs as listed on the Perioperative Services organizational chart. MD 12 provided no oversight of invasive surgical procedures performed throughout the hospital at various inpatient and outpatient locations/departments. Each department was responsible for the care they provided and each department reported directly to the MEC (Medical Executive Committee). To his knowledge, there was no comprehensive description of surgical services that included all surgical invasive procedures provided at each location and/or department with an oversight by the Surgery Services. Invasive surgical procedures performed outside operating rooms were not considered surgeries by the hospital, therefore the Surgery Services oversight was not provided.

On 1/23/12 at 12 p.m., upon request, the hospital administrative staff provided a one page list of services where invasive (surgical) procedures were scheduled to be performed under sedation outside of the operating rooms listed as part of the Perioperative Services. The list indicated the following sites: ENT (ears, nose, throat), GI Lab (gastrointestinal), Pain Clinic, Pulmonary Lab (lung), Radiation Oncology (cancer), Same Day Surgery, University Birthing Suites, Vascular Access, Vascular Center (Cath Lab) and Interventional Radiology. Any invasive procedures that may have been performed in each Department of the hospital were not listed or monitored by surgical services.

The administrative staff also provided governing body advisory group (Governance Advisory Council) minutes showing in part that Invasive Procedures Review Committee (IPRC) presented annual reports to the Council. The reports included a Performance Improvement Annual Report from the IPRC. In the Executive Summary it was stated that "The goal of the IPRC is to provide oversight of minor surgical and other invasive procedures performed outside of the OR environment throughout the health system to ensure a single standard of care is provided regardless of the clinical division or location in which the procedure is provided."

Review of the governing body advisory group monthly minutes between January 2010 and December 2011 confirmed no documented efforts to develop and implement hospital-wide surgical practices reflecting nationally recognized standards of practice for infection control, prevention of surgical errors and complications, safe maintenance of the surgical environments, assessment of surgical patients, or other surgical safety practices to minimize negative outcomes. Instead, various departments submitted individual summary reports of their performance, generally meeting benchmark goals for most departments. Unsafe practices were not described in the summary reports. No evidence of governing body discussion or direction for surgical services was presented.

In an interview on 1/26/12 at 4 p.m. with members of the medical staff and hospital leadership (including the former department chairmen for surgery and anesthesia, chief of staff, chief medical officer, chief financial officer), the leadership indicated that each specialty department functioned independently without a centralized division to oversee surgical services hospital-wide. Therefore, policies and practices among various outpatient surgical departments and some inpatient services differed according to what each service chose, and were not reviewed by a designated department head who took responsibility for the safety and effectiveness of these surgical services hospital-wide. As each service reported the results of their activities to both a quality committee and the medical executive committee, the primary person with surgical knowledge and expertise, and who served on both committees and was expected to be knowledgeable about each service's practices and performance, was the Chief Medical Officer (CMO). But the CMO was not formally designated to oversee all surgical care and services, or to verify that surgical practices in all locations conformed with basic and current nationally recognized standards of practice for surgical care. The CMO indicated that oversight of surgical services was a team effort with many people performing pieces of oversight. The CMO acknowledged that surgical care practices in various locations were not consistent, as they were governed by the individual departments. The hospital leadership presented no evidence to show efforts to review basic surgical practices across the spectrum of services, to identify which processes required standardization or which modifications would still meet the patient safety goals for nationally recognized organizational standards.

Review of the July 2011 Medical Staff Rules and Regulations under item XIII-F documented that the principal goal of the Invasive Procedure Review Committee was to improve patient care by evaluating surgical and other invasive procedures performed throughout the hospital. The hospital presented no documented evidence that the Invasive Procedure Review Committee had evaluated patient safety processes for surgical and invasive procedures in all locations where they were performed.

Based on observation, interview and record review, the hospital failed to ensure policies and procedures that clearly and appropriately defined the management of patients who presented for emergency services were established and followed when there was no evidence of policies and procedures to define:

1. Patient reception and triage flow.
2. Patient physical assessment and re-assessment guidelines to determine a) what conditions would constitute the five levels of acuity, b) how frequently to reassess a condition and c) what clinical and psychological parameters would be used.
3. Components of a Medical Screening Exam (MSE) to include the time seen by the physician, history and physical, impression/diagnosis and final disposition by the physician.
4. Management of patients presenting with a psychiatric condition or complaint, including a) a risk assessment for self harm or harm to others and b) management of a patient on an Involuntary Hold (5150).
5. Transfer policies to include appropriate processes for patients transferred to an in-patient psychiatric facility.

Findings:

1. In an Initial Tour of the Emergency Department (ED) on 1/23/12 at 11:20 a.m. with the Chief of Staff/Vice Chair of the ED (COS) and the ED Nurse Manager (NM 9), a staff station was observed just inside the entrance to the waiting area with two security officers and a volunteer present sitting at the desk. NM 9 stated patients arriving through the ED lobby entrance were asked by staff at the desk to wait in line for a triage nurse. NM 9 stated there was no patient pre-screening or sign in at this desk as there were no staff present, including registration, qualified to screen patients or record the time of arrival. NM 9 acknowledged there was no way to track how long patients waited for triage, however if there were more than three patients standing in line the triage nurse was to call the charge nurse for extra help.

In an observation of the waiting area on 1/23/12 at 2:50 p.m. with NM 9, there were eight patients standing in line to be triaged. One triage nurse was present and the other three triage rooms were dark and unoccupied. NM 9 called the Charge Nurse to request an additional triage nurse.

In an observation of the waiting area on 1/25/12 at 11 a.m., approximately fifteen people (patients and visitors) were waiting in a line outside the triage room. The triage nurse stated she was relieving someone for a break and had not called for help.

In an interview with RN 11 on 1/25/12 at 11:15 a.m., she stated she would periodically make observations of the patients waiting in line to see if anyone appeared distressed and needed to be seen first. RN 11 stated she would try to go out and ask patients their chief complaint in order to determine the order in which they should be seen.

The Nurse Manager in a concurrent interview stated there were no established written policies or procedures to define processes for:

a) Patient reception and initial screening, including the time of arrival to the ED.
b) Patient flow in the waiting area in order to prioritize patients who present with a chief complaint indicative of a higher acuity.
c) Re-assessments of patients in the waiting area according to acuity and address what the minimum components of a re-assessment should be.

2. On 1/24/12 at 11:30 a.m., a review of the Emergency Department's (ED) five level triage system was conducted in a team interview with the COS, NM 9, an ED Assistant Nurse Manager (ANM 1), the ED Performance Improvement Nurse (PIN/ED) and the ED Nurse Educator (ED/NE) (the team). The team described the five level triage system in the ED and stated it was "loosely" structured on the recommendations of a joint task force in a document published in February of 2005. The team revealed, more specifically, their five level triage system had been modeled after the Canadian Emergency Department Triage and Acuity Scale (CTAS) Implementation Guidelines and presented these documents for review.

The document titled Five-Level Triage: A Report from the American College of Emergency Physicians (ACEP) and the Emergency Nurses Association, dated February of 2005, was an analysis of the literature regarding ED triage with recommendations regarding the use of five level systems in the United States.

The document titled Revisions to the Canadian Emergency Department Triage and Acuity Scale (CTAS) Implementation Guidelines, dated November 2004, stipulated the 5-level triage scale was to be used for classifying the acuity of the patient according to the presenting complaint. The CTAS further noted the initial triage level would determine the frequency of re-assessments and recommended re-assessments every: a) 15 minutes for a Category 1 (crisis, resuscitative), b) 30 minutes for a Category 2 (emergent) and c) one hour for a Category 3 (urgent), the categories defined as higher levels of acuity.

The team presented the hospital Standardized Procedure Policy ID: XII-70, Page 2, Triage Categories, where there was stipulation:
"After the initial MSE has been completed, the nurse will assign a triage category to the patient from Category 1 (crisis) to Category V (non-emergent). "The categories were defined as:

a) Category 1: "Red" Conditions that are threats to life or limb or vision (or imminent risk of deterioration) requiring aggressive, immediate interventions. (Crisis or Resuscitative)

b) Category II: "Orange" Conditions that present a potential life or limb-threatening emergency or patients who present with other acute illnesses or injuries and significant risk factors that could lead to a life or limb. (Emergent)

c) Category III: "Yellow" Conditions where life and limb is not an immediate threat to well-being, but has the potential to develop into a serious problem requiring emergency intervention if treatment is not expedient. The patient's condition is stable, but treatment should be provided as soon as possible. (Urgent)

d) Category IV: "Green" Conditions that are at low risk for deterioration while the patient is waiting. Significant complications from the illness or injury will not likely result if treatment is delayed.

e) Category V: "Blue" A patient for which the MSE has excluded an emergent medical condition. (Non-Emergent)

The team referred to a document ttitled ED Structure Standards for direction on further Patient Management, Patient Screening. In review of this document, dated 9/2009, there was stipulation: "The frequency of vital signs and reassessments of patients who are required to wait prior to being placed in a treatment area is determined by their acuity level. Patients of the higher acuity levels, Red, Orange and Yellow will be rechecked every two hours whenever possible. Patients of the lower acuity levels, Green and Blue, will be rechecked every four hours whenever possible". The document further directed "Patient reassessments may be deferred if patient acuity or census in the unit is excessively high or staffing issues prevent it". The team acknowledged that re-assessments should be performed at time intervals in accordance with their level of acuity. The team also acknowledged it was not acceptable to defer re-assessments due to staffing or acuity in the ED.

Continuing the interview, the team acknowledged there were no ED policies and procedures available for nursing and medical staff to clearly define:

a) Complaints or conditions that would place patients effectively and consistently in the various categories for Category 1 (crisis, resuscitative), Category 2 (emergent), Category 3 (urgent), Category 4 or Category V (non-emergent). The team stated the triage nurse, based on training and experience, would "use their judgement" to determine the degree of acuity according to the chief complaint.
b) Time frames, by acuity, for re-assessments of patients waiting to be seen by the physician after the initial MSE by the nurse.
c) Assessment parameters for various emergent medical and psychiatric conditions.

The team further revealed there were no policies and procedures for the management of patients who present with suicidal or assaultive complaints, including

27966

Based on observation, staff and patient interviews, medical record and document reviews, the hospital failed to ensure that:

1. Adequate medical and nursing personnel provided the necessary care and services to meet the needs of seven of 12 sampled patients who presented to the Emergency Department (ED) with a) psychiatric complaints or behaviors, including suicidal ideations (41, 42, 45, 46, 47, 49) and b) an emergent medical condition (44) when;

a) Of the six of six sampled patients who presented with complaints of suicidal or assaultive behaviors, three were triaged as a Level 2 (Emergent) (41, 42, 45), one was triaged as a Level 3 (Urgent) (49) and two as a Level 4 (Non-Urgent) (45, 46) with no suicide or assaultive risk assessment being done.

b) One of six sampled medical patients (44), triaged as a Level 1 (Crisis or Resuscitative), "requiring immediate and aggressive attention and interventions," was placed on a hallway bed without close observation or monitoring.

c) One of six sampled psychiatric patients was not seen by the physician during the ED stay (45); one of six sampled psychiatric patients, triaged as a Level 4 (Non-Emergent), did not see a physician for eleven hours, twenty five minutes after triage (47).

d) Six of six sampled psychiatric patients had no evidence of ongoing assessments and monitoring to ensure appropriate interventions were being taken to stabilize the patient and provide for their safety.

2. Thirteen of 80 nurses, working in ED triage areas under standardized procedures, were qualified to initiate a Medical Screening Exam (MSE), when there was no evidence that current competencies had been assessed according to established criteria.

Findings:

1. In a review of the medical records of six of six sampled patients (41, 42, 45, 46, 47, 49) who presented to the ED with psychiatric complaints, including suicidal ideations between 11/28/11 and 1/23/12 the following was noted.

a. On 1/23/12 between 12:30 and 2 p.m. Patient 49 was observed to be seated on the edge of a bed in a hallway of the ED, fully dressed and accompanied by a visitor who was reclining on Patient 49's hallway bed. A Charge Nurse (CN 1) approached the visitor, mistaking that person for Patient 49. Six additional hall beds with assigned patients were lined up along the corridors of the emergency room in the area where Patient 49 was observed. The hall beds were spaced about 3-4 feet apart. No privacy curtains surrounded each hall bed. Patients, visitors and staff were observed to pass through the halls where the hall patients were openly viewed. No staff was observed to closely supervise and attend to Patient 49, who was here for a suicidal complaint. No call buttons or means of signaling staff for help was observed to be available to Patient 49 or other hall patients. The hall bed was positioned within 50 feet of an unlocked door that exited to the outside of the building.

In an interview with Patient 49 and the visitor at 12:30 p.m., they stated they arrived to the hospital 1.5 hours earlier (around 11 a.m.). Patient 49 stated he was waiting patiently and if he needed help, he would yell loudly and hope that someone would come.

In an interview on 1/23/12 at 1 p.m. with the ED Nurse Manager (NM 9), she indicated that several patients, including those triaged as Category 1 (life-threatening requiring immediate, aggressive care and interventions) were currently located in the waiting room or in hall beds. These patients had not yet seen a physician and were not continuously assessed by nursing staff. CN 1 indicated that Patient 49, although suicidal, was triaged as Category 3 (Urgent), had not yet seen a physician, and was waiting in the hall bed to be seen by a social worker since 11:40 a.m. CN 1 indicated that one internal triage nurse was responsible to tend to all the hall patients, seven at that time, among many other duties (such as fielding telephone calls from ambulances in the field, triaging ambulance admissions and providing emergency department staff communications from outside providers).

Review on 1/24/12 at 3:15 p.m. of the medical record for Patient 49 with the Chief of Staff (COS), who also served as an associate clinical director for the Emergency Department, confirmed that the initial nursing triage assessment for Patient 49 (first contact with a medical provider) was documented at 11:32 a.m. on 1/23/12. The note documented that Patient 49 was depressed about a recent serious medical diagnosis but was not yet treated with medication or enrolled in a mental health treatment program. "Friend states pt (patient) wanting to harm himself counselor told him to come to er." Measurements of heart rate, breathing rate, blood pressure and blood oxygen level were recorded, but no other assessment details (e.g. physical condition, suicide risk assessment including history of suicide attempts, possession of dangerous weapons) were documented. Patient 49 was placed in the hall bed described above, with no staff assigned to closely assess and monitor his identified condition (suicidal). A request for evaluation by a social worker was documented at 11:40 a.m., at the time he was placed in the hall bed. A social worker evaluation was documented at 2:19 p.m. (following the period of observation by the SA). The social worker determined that Patient 49 was high-risk (had escalating suicidal thoughts and a plan to kill himself, prior depression and substance abuse problems). The social worker determined that Patient 49 was a danger to self and placed him on a 5150 Involuntary Hold (5150) so he could not leave the hospital to harm himself.

Further medical record review of Patient 49 indicated that vital sign measurements were recorded 4 hours after admission, but no nursing physical or mental assessments were documented until 1/24/12 at 6:30 a.m., 18 hours after admission to the ED. Documentation of a physician assessment was begun at 4:31 p.m. (5 hours after admission), indicating a plan to transfer Patient 49 to a psychiatric facility once a medical clearance evaluation was completed and a facility could accept him. The physician assessment was signed as complete on 1/23/12 at 11:45 p.m. At 11:58 p.m., a physician order for a psychiatric evaluation was documented. More complete nursing assessments were documented between 5 a.m. and 10:30 a.m. on 1/24/12 (head to toe), with no further mental health assessments documented by nursing staff. A psychiatric assessment by a medical student and co-signed by an attending physician was documented on 1/24/12 at 11:42 a.m. The psychiatric consultation recommended the involuntary hold be ceased and the patient discharged home "to self." An antidepressant medication was also recommended, and then prescribed by an emergency department physician, who did not document an independent assessment, a discharge impression or a discharge disposition summary for Patient 49 prior to discharge from the ED on 1/24/12 at 1:58 p.m.

In an interview on 1/24/12 at 3:15 p.m. with the COS, the COS indicated that suicidal risk assessments were not routinely performed by triage nursing staff or others upon the identification of a suicidal problem or other psychiatric emergency medical condition. Social workers generally took the responsibility to determine suicidal and homicidal risk, if requested by ED staff. Response times for social worker evaluations varied, depending upon their other workload and duties. The COS acknowledged that mental health patients often had co-existing serious health conditions and a social worker was not qualified to evaluate organic health conditions. There was no requirement for a physician to evaluate a patient with a potential psychiatric emergency medical condition emergently, as expected for other emergent health conditions like chest pain, head injury, etc., despite the fact that psychiatric conditions can have an organic cause. There was no consistency in assigning a triage priority for evaluation and treatment of suicidal patients as "emergent."

The COS further acknowledged that Patient 49 had a psychiatric emergency medical condition upon arrival to the hospital