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Based on interview and record review, the hospital failed to inform the results of the grievance in writing to one of 49 sampled patients' (44) complaint within 30 days as indicated in the hospital's "Complaint/Conflict Resolution" policy and procedure which had caused Patient 44's complaint not being responded to promptly. This violation had the potential to affect all patients who filed grievances to the hospital.

Findings:

On 3/1/12, at 11:15 AM, during an interview, the Patient Representative (PR) explained the hospital's grievance policy and procedure. She stated when she received a written complaint, she would initiate the investigation and the hospital had 30 days to respond to the complainant in writing. A copy of the complaint log and the hospital grievance policy were requested at this time.

On 3/1/12, the complaint log provided by the PR was reviewed. Patient 44 had filed a written complaint on communication issues to the hospital on 1/9/12. A letter was sent to the patient to acknowledge the receipt of the complaint. However, the log indicated the status of the complaint as of today was still pending. At this time, the policy and procedure on "Complaint/Conflict Resolution" effective "February 2012" was reviewed. Under "Level of Resolution," it read, "b. Manager/Supervisor/Director will: ...g. Complaint at this level involves an investigation, resolution and written response within 30 days."

On 3/1/12, at 2:45 PM, the PR and the Quality Manager (QM) were both interviewed regarding the written letter on Patient 44's complaint. The PR stated the complaint had not been resolved yet and a letter was not written to the patient to inform her of the status of investigation. The QM explained it was the administration's responsibility to write the letter, not the PR. However, the incomplete complaint had not been followed up on to determine why it had not been completed.

Based on observation, interview, and record review, the hospital failed to obtain a current physician order for restraints for one of 49 sampled patients (17) which had the potential to result in inappropriate restraint usage and denial of patient rights.

Findings:

During an observation on 2/27/12 at 4:10 PM, Patient 17 was in bed with soft restraints applied to both of his wrists.

The clinical record for Patient 17 was reviewed on 2/27/12. The last physician order for the use of restraints was written 2/25/12 at 11:12 PM and expired on 2/26/12 at 11:12 PM.

During an interview with Charge Nurse 1 on 2/27/12 at 4:10 PM, she reviewed the clinical record and was unable to find documentation of a current physician order for the use of restraints.

The hospital policy and procedure titled "Restraints: Management of Non Violent, Non Self-Destructive Behavior" dated 5/11, indicated "f. A new order is required for each episode of restraint. The order for each episode may not exceed 24 hours".

Based on administrative document review and staff interview, the hospital failed to ensure the medical staff enforced their policies and procedures regarding the frequency of the Medical Record Committee meeting, which had the potential to cause medical records related issues not being dealt with timely.

Findings:

The Medical Staff Organization and Function Manual, approved July 2008, was reviewed on 2/28/12. The MS (Medical Staff Coordinator) Staff A stated that this manual is supplemental to the Medical Staff Bylaws, Rules and Regulations. The Medical Record Committee section stated the meetings shall be held at least six times per year. A review of the minutes for the entire year of 2011 revealed only three meetings were held (March, October, and November). This finding was confirmed by Health Information Services Staff B and Administrative Staff O on the afternoon of 3/1/12.

Based on observation, interview, and record review, the hospital failed to implement physician orders for one of 49 sampled patients (23) which had the potential to result in unintentional weight loss and inaccurate assessment of nutritional needs. Consistently weighing one of 49 sampled patients (2), who was receiving TPN (total parental nutrition, a way of supplying all the nutritional needs of the body by bypassing the digestive system and dripping nutrient solution directly into a vein). This had the potential to cause Patient 2 to go unmonitored for excess fluids.

Findings:

1. The clinical record for Patient 23 was reviewed on 3/1/12. The physician orders, dated 2/21/12 at 11:17 AM indicated an order for nursing staff to weigh Patient 23 daily as he was receiving total parenteral nutrition (specialized nutrition given in the veins). There was no documented weight on 2/24/12, 2/25/12, or 2/29/12.

During an interview with Registered Nurse (RN) 1 on 3/1/12 at 2:30 PM, she stated Patient 23 refused treatment at times. She reviewed the clinical record and was unable to find documented weights or refusal of being weighed for 2/24/12, 2/25/12, or 2/29/12.



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2. During an observation on 2/29/12, at 10:55 AM, on the east medical-surgical unit, Patient 2 was seen resting in bed. She had an intravenous line inserted in her chest and connected to an intravenous solution, TPN. At this time, Patient 2 stated she had a major abdominal surgery last August but was never recovered from the illness. She had lost 80 pounds due to consistent nausea and vomiting.

On 2/29/12, at 11:30 AM, Patient 2's electronic medical record was reviewed with a RN 6. The record showed Patient 2 was weighed on the date of admission, 2/23/12. TPN was prescribed and initiated on 2/24/12. RN 6 was unable to find any documentation to indicate Patient 2 was weighed again since admission. At 3:50 PM, the Clinical Supervisor (CS) 1 tried to locate Patient 2's weight in the electronic record and confirmed the patient had not been weighed for the past five days.

On 3/1/12, at 3:35 PM, both the Clinical Director ICU (CD) 1 and CS 1 were interviewed regarding the frequency of weighing patients on TPN. She explained before the implementation of electronic medical records, TPN protocol was in hard copy and weighing the patient daily was part of the nursing orders. With the implementation of the electronic medical records, the nursing orders were no longer a part of TPN orders. Nursing staff now had to rely on physicians' orders to weigh patients to enable them to monitor a patient's fluids status. When asked what would be the standard of practice in the hospital for a patient on TPN to be weighed, CD 1 stated, "Per TPN protocol, twice a week on medical-surgical (units)."

Based on observation, interview, and record review, the hospital failed to develop and update the nursing care plan for three out of 49 sampled patients (12, 13, and 22).

1. For Patient 12 and 22, the hospital failed to develop a nursing care plan for pain management which had the potential to result in ineffective pain control.

2. For Patient 13, the hospital failed to initiate a plan of care after surgery which had the potential for the patient to develop possible complications such as infection at the incision site and skin breakdown.

Findings:

The clinical record for Patient 22 was reviewed on 2/28/12. The admission nursing assessment, dated 2/23/12 at 1:47 AM, indicated Patient 22 was nonverbal and the presence of pain was determined using the hospital's nonverbal pain scale and facial grimacing. The physician orders, dated 2/22/12 at 11:45 PM, indicated Patient 22 was receiving Fentanyl Citrate (a potent pain medication given through the veins) 50 micrograms per hour. The physician orders, dated 2/25/12, changed the pain medication to Percocet one tablet for pain rated 1-4 on a scale of 10, two tablets for pain rated 5-10, and morphine 2 milligrams every two hours for breakthrough pain. A review of the current nursing care plans for Patient 22 did not include a care plan for pain management.

During an interview with Clinical Director (CD) 1 on 2/28/12 at 4 PM, she reviewed the clinical record and was unable to find documentation of a pain management nursing care plan.

The hospital policy and procedure titled "Pain Management", dated 1/12, indicated "An individualized plan of care will include interventions to treat pain as necessary."



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2. The clinical record for Patient 12 was reviewed on 2/28/12 at 3:30 PM. The operative reports dated 2/19/12 and 2/25/12 indicated Patient 12 had extensive abdominal surgeries on those dates. The physician's orders dated 2/27/12 indicated Patient 12 was receiving Fentanyl 50 micrograms per hour intravenously (through his blood vessels). When the nursing care plans for Patient 12 was reviewed, a care plan for pain was not found.

During an interview with Registered Nurse 2 on 2/28/12 at 4:05 PM, she verified a nursing care plan was not developed for Patient 12. She stated, "I thought I made one."

3. The clinical record for Patient 13 was reviewed on 3/1/12 at 12 PM. The history and physical dated 2/24/12 indicated Patient 13 would be having an operation and after the operation he would be kept on a breathing machine and heavily sedated. The physician immediate post-operative note indicated Patient 13's operation was completed on 2/29/12 at 5:48 PM. The physician's medication orders indicated Patient 13 was receiving a lorazepam (an antianxiety, sedative-hypnotic medication) drip, morphine (a potent pain medication given through the veins) drip, cisatracurium (a medication that prevents muscle movement) drip, and an antibiotic medication. The nursing care plans for Patient 13 did not include the risk of infection for the surgical incisions, or the risk of skin break down for the muscle blocking and sedative medications he was receiving.

During an interview with the Clinical Director (CD) 1 of the intensive care unit on 3/1/12 at 12:15 PM, she verified Patient 13 should have care plans for the risk of infection and skin break down. She stated regardless of the patients location, the care plans should be initiated within eight hours.

The hospital policy and procedure titled "Interdisciplinary Plan of Care" dated 5/08, read "The plan of care will address: New, potential or existing problems. The Registered Nurse will create and print the initial Plan of Care within eight (8) hours of admission."

Based on interview and record review, the hospital failed to perform the complete verification process prior to a blood transfusion for two of 49 (16 and 17) sampled patients which had the potential to result in the wrong blood given to the wrong patient resulting in shock and/or death. The hospital also failed to ensure training in fluid and electrolytes as part of training for intravenous ( IV: medications and fluids given into the vein) therapy for nursing staff performing this duty which had the potential to result in lack of complete knowledge for intravenous therapy.

Findings:

1. The clinical record for Patient 16 was reviewed on 2/27/12. The transfusion record, dated 2/24/12 at 5:30 AM, indicated Patient 16 received one unit of packed red blood cells leukocyte-reduced (blood with reduced white cell content). The form indicated only one nurse verified the blood product identification tag with the component label, the patient's wristband, and the physician's orders.

During an interview with Charge Nurse (CN) 1, on 2/27/12 at 3:45 PM, she reviewed the clinical record and was unable to find documentation that two staff verified the unit of blood prior to administration.

2. The clinical record for Patient 17 was reviewed on 2/27/12. The transfusion record, dated 2/8/12 at 7:30 PM, indicated Patient 17 received one unit of packed red blood cells leukocyte-reduced. The form indicated only one nurse verified the blood product identification tag with the component label, the patient's wristband, and the physician's orders.

During an interview with CN 1, on 2/27/12 at 4:10 PM, she reviewed the clinical record and was unable to find documentation that two staff verified the unit of blood prior to administration.

The hospital policy and procedure titled "Blood and Blood Product Transfusions: Routine and Emergency" dated 2/12, indicated "Blood and/or blood products must be verified by two registered nurses, a registered nurse and an IV certified licensed vocational nurse, or a registered nurse and a physician, nurse practitioner or physician's assistant. There must always be at least one registered nurse."

3. The hospital nursing orientation and competency evaluation processes were reviewed on 2/29/12. The Basic Skills Inventory for Intravenous Therapy, no date, included venipuncture (inserting a catheter into a vein) techniques with supervised practice, intravenous pump usage, and blood/blood product administration. There was no training on fluid and electrolyte balance listed.

During an interview with Nurse Educator 1 on 2/29/12 at 10:45 AM, she stated fluid and electrolyte training is covered in basic nursing training and not included in the hospital intravenous therapy competencies.

Based on record and administrative document review, and staff interview, the hospital failed to ensure that all records contained an updated history and physical report prior to surgery in two of seven records. This had the potential to cause patient medical needs to go un-noted and un-met.

Findings:

The Medical Staff Rules and Regulations, last approved January 2009, were reviewed on 2/28/12. Section B.2. states that a complete history and physical examination (H&P) will be recorded within 24 hours of admission or outpatient surgical procedure; and if the patient has had a complete admission H&P within 30 days of the operating room procedure, an updated H&P will be documented which will include any historical events, which have occurred since the last document, updated medications, and a recent physical examination.

Record 27 was reviewed on 2/29/12. The patient had an outpatient cardiac catheterization done on 1/12/12. The H&P was done on 12/29/11. The Pre Anesthesia/Procedure-Patient Evaluation form (used to document the interval/updated H&P) lacked completion of all the required sections.

Record 30 was reviewed on 3/1/12. The patient had an outpatient procedure performed under general anesthesia on 2/23/12. There was no complete H&P found in the record, even though the update note made reference to the H&P of 2/2/12. The update note was handwritten by the physician, however the date and time were not documented below the signature on the line provided.

The above findings were confirmed concurrently by Health Information Services Staff D.

Based on medical record and administrative document review and staff interview, the hospital failed to ensure that all records documented a discharge summary in two of seven records. This failure had the potential to result in records lacking vital information for continuity of care for patients after discharge.

Findings:

The Medical Staff Rules and Regulations, last approved January 2009, were reviewed on 2/28/12. Section B.9.b. states: "A discharge clinical summary shall be dictated on all medical records of hospitalized patients and written for normal obstetrical deliveries and normal newborn infants... The discharge summary shall include: admission and discharge dates; admission diagnosis; reason for hospitalization; hospital course to include pertinent lab, x-ray and other results; procedures/results/complications, discharge instructions; diet; follow-up;activity; medications; and condition on discharge..."

Record 28 was reviewed on 2/29/12. The normal newborn infant was born in the hospital and discharged after two days. There was no discharge summary report or a final physician progress note with the above-listed required elements.

Record 30 was reviewed on 3/1/12. The patient had a surgical procedure performed under general anesthesia, to remove a cancerous heel lesion, on an outpatient basis. There was no physician progress note at all.

The above findings were confirmed concurrently by Health Information Services Staff D.

Based on administrative document and medical record review and staff interview, the hospital failed to ensure that records were completed within fourteen (14) days following discharge, as required by Medical Staff Rules and Regulations. This failure had the potential to result in records lacking vital information for continuity of care for patients both during their hospital stay and after discharge.

Findings:

The Medical Staff Rules and Regulations, last approved January 2009, were reviewed on 2/28/12. Section B.9.c. states: "The patient's medical shall be complete at the time of discharge, including progress notes, final diagnosis, and clinical summary... Records may remain in the incomplete category for no longer than fourteen (14) days following date of discharge. Records, if not completed during the 14-day period, become delinquent records."

On 2/28/12, Health Information Services (HIS) Staff B provided and discussed a report of a current count of delinquent medical records. The report listed the total number of delinquent records as 1614; total unsigned/un-cosigned reports as 1164, total unsigned orders as 292, and total un-dictated reports as 158.

Three additional, more detailed reports (printed 2/28/12) were reviewed with HIS Staff B on 3/1/12. These reports revealed that one physician (MD-A) had nine discharge summaries that were still un-dictated more than 100 days following the date of the patients' discharge; one operative report still un-dictated from 10/20/11; and 17 unsigned orders more than 250 days delinquent. These findings were confirmed by HIS Staff B on 3/1/12.

Based on observation, interviews, review of the hospital's policies and procedures, patient clinical records, the hospital failed:

1. To document and monitor their temperatures for solution stored in warmers. (A491)

2. To ensure the safe use of droperidol (medication used for nausea and vomiting) according to the hospital protocol and the FDA (Food and Drug Administration) boxed warning. (A500)

3. To provide pharmaceutical services that would ensure patient safety by providing pharmacy oversight of all medications removed from the Pyxis (Automated Dispensing Cabinets). (A500)

4. To ensure medication was administered in accordance to physician order and dosage orders did not require interpretation by nursing staff. (A500)

5. To ensure adequate amount of sterile water for injection was available to reconstitute dantrolene (a muscle relaxer) during medical emergency. (A500)

6. To provide security of stored medications located in one area of the hospital. (A502)

The cumulative effects of these systematic problems resulted in the hospital's inability to ensure the provisions of quality of health care in a safe environment.

Based on observation, interview and record review, the hospital failed to monitor and store irrigation fluid (fluid used for wound irrigation) at the appropriate temperatures as specified by the manufacture recommendation and hospital policy. Temperatures registering outside the manufacturer's recommended range and duration could result in the loss of integrity of the solutions and potentially harm patients by not providing the expected therapeutic effect.

Findings:

During an inspection of the operating room (OR) with Director of Pharmacy (DOP) on 2/29/12 at 2:32 PM, a warmer was found in the center core area. Numerous pour bottles of 0.9% normal saline irrigation fluid were found inside.

Review of the February 2012 temperature log for this warmer revealed temperature monitoring was not consistently carried out by staff and was missing on the following dates: 2/4/12, 2/5/12 and 2/17/12.

During the interview with the DOP at 2:38 p.m., she acknowledged the temperatures for the OR warmer should have been monitored on those days to ensure acceptable storage conditions were met.

Further review of the temperature log revealed the temperature of the warmer was in the range between 128 and 129 F over the past month which was far exceeded the hospital policy of maintaining warmer temperature for not exceeding 104 F for a period of no longer than 30 days.

According to the hospital policy and procedure entitled, "Temperature Control - Solutions and Linens" dated 4/2008, on page 2 under Temperature recommendations it read, "3. Plastic irrigation pour bottles: b. Not exceeding 40 C (104 F) for period of no longer than 30 days. A daily log will be maintained on all solution warming cabinets. (Hospital Name) nursing and ancillary staff will be instructed in the handling and storage of warmed solutions during department orientation."

Based on observation, interview, policy and procedure, and clinical record review, the hospital failed:

1. To ensure the safe use of droperidol (medication used for nausea and vomiting) according to the hospital protocol and the FDA (Food and Drug Administration) boxed warning (an alert that appears on the package insert warning of significant risk of serious or life threatening adverse effects).

2. To ensure the safe and effective use of medications in the Emergency Department (ED) to protect patients from potential undue adverse medication consequences as evidenced by the lack of pharmacy monitoring and oversight.

3. To ensure medication was administered in accordance to physician order and dosage orders that did not require interpretation by the nurse.

4. To ensure medication was available in the event of a medical emergency in the operating room.

These failures had the potential for adverse outcomes for the hospital's patient population.

Findings:

1. On 2/27/12, Pharmacist (Pharm) 1 provided a list of patients who had received droperidol over the previous 30 days. The clinical records for eight patients were randomly selected for review.

The review of Patient 45, Patient 46, and Patient 47 clinical records with Pharm 1 and the Director of Pharmacy (DOP) showed all three patients were admitted to the ED on 2/3/12, 2/19/12, and 2/17/12 respectively and they were ordered droperidol by their ED physician to be administered during their stay in the ED. There was not documented evidence of any ECG testing (a diagnostic tool that measures and records the electrical activity of the heart ) prior to administration of droperidol. On 2/11/12, Patient 48 was ordered ECG while in the ED prior to administration of droperidol, but his ECG result was contraindicated with the use of this medication according to the manufacture guideline.

On 3/1/12 at 9:38 AM, during the interview with Pharm 1, he acknowledged he did not find any documented evidence that a 12-lead ECG (A 12-lead EKG is one in which 12 different electrical signals of the heart are recorded at approximately the same time) was ordered for the three of the eight patients who had received droperidol while during their visit to the ED.

Based on the monitoring procedures prior to administration of the droperidol, four out of eight patients were prescribed and administered droperidol not in accordance with the hospital protocol and with the FDA boxed warning.

The boxed warning for droperidol which was required by the FDA to be published with each container of the drug provided the following information: "Cases of QT prolongation and/or torsade de pointes (heart rhythm disturbances) have been reported in patients receiving Inapsine (droperidol brand name) at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal." The boxed warning also cautions that, "Based on these reports, all patients should undergo a 12-lead ECG (electrocardiogram) prior to administration of Inapsine to determine if a prolonged QT interval (that is, QT greater than 440 milliseconds for males or 450 milliseconds for females) is present." Also, "Inapsine is contraindicated in patients with known or suspected QT prolongation...".

On 3/1/12 at 10:23 AM, during the interview with Registered Nurse (RN) 6, she stated cardiac monitoring performed in the ED was usually a 3-lead ECG as opposed to the 12-lead ECG which was recommended by the manufacture to monitor patients given droperidol. The 12-lead ECG would have to be ordered according to RN 6 and to be indicated as such by the ordering physicians if it was to be used to identify QT prolongation. At 10:35 AM, RN 7 was interviewed about the use of droperidol in the ED and its required monitoring parameters; she was not able to provide information on specific boxed warning contraindication as related to the use of droperidol.

In the interview with the Emergency Department Manager (EDM) at 10:55 AM, she acknowledged there was some knowledge deficit regarding the specific monitoring requirement on the use of droperidol in the ED with some of her nursing staff.

2. On 2/29/12 at 10:11 AM, during an interview with Pharm 2 who stated pharmacists do not review medication orders in the ED unless the patient was admitted to the hospital. There was no medication review or oversight if the patient was admitted to the ED and treated with medications and then sent home. In addition, Pharm 2 stated pharmacists do not perform a concurrent or retrospective review of drugs removed by nurses from the ED's ADC (automated drug cabinet) for administration to patients. This is contrary to in-patients of the hospital, where medication orders were reviewed by pharmacists.

ASHP (American Society of Health-System Pharmacists) Guidelines: "Minimum Standard for Pharmacies in Hospitals," approved September 22, 1995, outlines the minimum requirements for pharmaceutical services in hospitals. The guideline under Medication Orders states, "All prescribers' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed."

ASHP Guidelines on the Safe Use of Automated Medication Storage and Distribution Devices," approved April 22, 1998 states:

"All medication distribution systems, both automated and nonautomated, have features that give nurses and other care-givers access to some medications before order review and approval by a pharmacist, especially in patient emergencies. Clearly stated organizational policies should be developed that limit access to medications before orders have been reviewed and approved by a pharmacist. Access to medications should be limited to the following cases:

1. The order has been reviewed and approved by a pharmacist.
2. The drug product has been approved by a multidisciplinary committee of physicians, pharmacists, and nurses who agree that it has minimal risk for misadventures.
3. There is a clinically urgent need for the medication that outweighs the potential risk.
4. Medication retrieval and administration are supervised by an identifiable, responsible physician (in the emergency department, catheterization laboratory, etc.).

Provision should be made for the retrospective review and reconciliation by a pharmacist of orders that were initiated without a pharmacist's review and approval."

Also, the Institute for Safe Medication Practices' (ISMP) recently issued "Guidance on the Interdisciplinary Safe Use of Automated Dispensing Cabinets" revalidates the "ASHP Guidelines" by listing twelve "Core Processes" that should be present for the use of Automated Dispensing Cabinets (ADCs). Two of the "Core Processes" state:

Core Process # 3 Use Pharmacy-Profiled ADCs
Rationale: The use of a "profiled "ADC ensures that the pharmacist will validate the new medication order, including first doses, in the pharmacy computer system prior to the medication being dispensed or accessed by the nurse or other healthcare professional.

Core Process # 9 Establish criteria for ADC System Overrides
Rationale: Use of ADC overrides should be situationally dependent, and not based merely on a medication or list of medications. While there may be a list of drugs with the potential to be obtained emergently, there may be many other situations when there is sufficient time for the pharmacist to review the medication prior to retrieving the dose. Criteria for systems overrides should be established that allow emergency access in circumstances in which waiting for a pharmacist to review the order before accessing the medication could adversely impact the patient's condition.

The Guidelines include implementing strategies that reduce the risk of error when an override is used, including:

· Requiring an independent double-check with another licensed healthcare provider when removing organization-identified high-alert medications on override.
· Requiring documentation of override rationale.
· Developing a staff competency assessment related to the safe use of overrides.
· Routinely reviewing override reports to identify and address barriers to the pharmacist's review of the drug order prior to administration.

The hospital did not have written policies and procedures that established and followed the guidelines of both ASHP and ISMP per the DOP.

3. Review of the clinical record for patients who were given Propofol (medication for sedation) while in the Intensive Care Unit (ICU) with Clinical Director (CD) 1 and the DOP revealed that Patient 49 was ordered Propofol for sedation and to be administered with the starting dose of 5 microgram (mcg)/kilogram per minute intravenously and to be titrated to a sedation goal of 3 (A drug-induced depression of consciousness during which the
patient cannot easily be roused) and with a maximum dose of 60 mcg/kg/min. Further review of the Propofol order flow sheet with CD 1 showed that the Propofol order was initiated at 15 mcg/kg/min on 2/27/12 at 11 AM instead of the ordered starting dose of 5 mcg/kg/min.

In the interview with CD 1 on 2/29/12 at 11:48 AM, she acknowledged the Propofol starting dose for Patient 49 should be at 5 mcg/kg/min as it was written by her physician. She also agreed the Propofol sedation protocol did not provide specific instruction on how to titrate such order.

California Code of Regulations (CCR), Title 22, section 70263(c) requires the Pharmaceutical and Therapeutic Committee to develop and implement policies and procedures for the safe use of medications and CCR, Title 22, 70263(q), states, "The order shall include the name of the drug, the dosage and the frequency of administration, the route of administration, if other than oral, and the date, time and signature of the prescriber."

Dosage range orders do not promote safe medication use. They do not ensure that the physician's orders are complete and provide a clear direction to the clinical staff on how to execute those orders. A dosage range order is based on subjective interpretation by the individual administering the medication.

4. At 2:52 PM on 2/29/12, the malignant hyperthermia (hereditary condition in which certain anesthetics cause high body temperatures and muscle rigidity) emergency cart in the Operating Room was inspected with the DOP. The cart contained two 1000 ml (milliliter) bags of sterile water for injection. The Malignant Hyperthermia Association of the United States (MHAUS) recommends using 60 ml of sterile water for injection for each vial. Therefore, 2160 ml of sterile water was required to dissolve the contents of the 36 vials of dantrolene (muscle relaxant) in the cart. Therefore, the cart did not contain sufficient sterile water for injection to dissolve the dantrolene.

In the interview with the DOP at 2:58 PM, she acknowledged an additional 160 ml of sterile water for injection would need to be added to their Malignant Hyperthermia cart.

Based on observation, interview, and record review, the hospital failed to ensure stored medications were located in a secure and safe place. Medications were found unsecured in the Operating Room (OR) of the hospital which had the potential for unauthorized persons to remove and/or tamper with the medications.

Findings:

On 2/29/12 at 2:10 PM, during an inspection of the OR department, the anesthesia cart in OR Suite 4 was found unlocked and with over 30 different medications unsecured and without the supervision of a healthcare professional. Medications found were indicated for muscle relaxation, heart problems, high blood pressure, and for emergency care. Unauthorized individuals could walk into the room and have access to all these medications. During an interview with the Anesthesiologist when he returned to OR Suite 4 during this observation, he stated he had gone to the restroom and forgot to lock the cart.

The hospital policy and procedure titled "Medication Storage and Security" dated 3/2011, read "All medications will be secured in locked areas at all times and accessed only by authorized personnel."

Based on observation, interview, and review of job responsibilities, the hospital's Director of Food and Nutrition (DFN) failed to perform the essential functions and responsibilities as listed in his job description when the following unsanitary conditions were identified in the dietary department:
1. Approximate one inch of standing water under the fryer,
2. Several outdated food stored in the cold storage areas,
3. Staff did not perform accurate procedure in checking food temperatures.

These failures had the potential to cause food-borne illnesses to patients, staff, and visitors.

Findings:

1. During an initial tour of the dietary department with the DFN (Director of Food and Nutrition) and the Executive Chef (EC) on 2/27/12, at 1:20 PM, water one inch high was observed under the fryer. The DFN stated the water came from two leaking valves connected to the kettles and he had submitted a work order in January this year to the hospital maintenance to fix the clogged drains under the fryer. A copy of the work order was requested at that time.

At 3:30 PM, on 2/27/12, a concurrent interview and review of the work order was conducted with the DFN. The work order read "valves leaking-mop sink/both steam kettles." When asked if he had followed up on this work order since January, he did not provide an answer.

2. During the initial tour of the cold storage areas on 2/27/12, at 1: 25 PM, the following food items were found outdated:

In a refrigerator, labeled Ref-123, a tray of cooked chicken breasts was observed. The chicken had the expiration date of 2/21/12 written on the cover.

In a cooler, labeled Cooler 001, there were several expired food items in separate containers observed: A) Three containers were in the cooler with the expiration date of 2/25/12 written on the cover. They contained cooked rice noodle, marinara sauce, and cooked green onions. B) An opened, plastic container containing Parmesan and Romano cheese was also seen in the cooler with an expiration date 2/25/12 written on the outside. C) Two half-gallon cartons of cultured low fat buttermilk with the expiration date 2/21/12.

In Cooler 002, a tub of sport peppers, with the expiration date of December 2010, was observed still stored in the cooler.

3. During an initial tour with the EC on 2/27/12, at 2:20 PM, it was observed the kitchen had two warmers (Warmer 1 and 2) to hold cooked food items until serving. On request, the EC checked the temperatures of these food items. The EC placed his digital thermometer outside one of the metal containers in Warmer 1 until the reading was above 170 degrees Fahrenheit. He repeated the same procedure to another metal container in Warmer 2.

On 3/1/2, at 9:25 AM, during an interview, the DFN and the Clinical Nutrition Manager stated the proper procedure of checking the food temperature was to insert the thermometer in the center of the metal container to obtain the true reading. It would not be accurate to test the temperature by placing the thermometer outside the container.

The personnel file of the DFN was reviewed on 3/1/12. His "Job Description" required him to perform a variety of duties including personnel management and regulatory compliance.

Based on observation, interview, and medical record reviews, the hospital failed to provide an environment to avoid sources and transmission of
infections and communicable disease as evidenced by the hospital's failure to have effective systems in place to ensure:

A. Surgical instruments were sterilized in accordance with nationally accepted infection control standards when hinged instruments were
not sterilized in the open position (Refer to 0749, item 1).

B. Shared equipment potentially exposed to bloodborne pathogens (Hepatitis B, C, and the virus that causes immunodeficiency), was safely
and effectively cleaned and disinfected between each patient use (Refer to 0749, item 2. i., 2. ii., 2. iii, and 2 iv).

C. A functional and sanitary environment for the provision of surgical services so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area cross reference ( 0749, item 3 i, 3 ii, 3 iii).

D. Staff were screened for vaccine preventable diseases in accordance with nationally accepted infection control standards (Refer to 0749, item 4).

E. Staff were trained and competent to effectively disinfect the perioperative environment (Refer to 0749, item 5).

F. Surgical procedures were performed in a positive pressure environment (Refer to 0749, item 6).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services and care in a safe and effective manner in accordance with the statutorily-mandated Condition for Coverage for Infection Control Services.

Based on observation, staff interview, and document review, the infection control officer
failed to develop effective systems for identifying, reporting, investigating,and controlling infections and communicable diseases of patients and personnel in accordance with hospital policy and nationally recognized infection control guidelines as evidenced by these findings:

1. The hospital did not sterilize hinged surgical instruments in the open position. Failure of the hospital to sterilize hinged instruments in accordance with nationally accepted infection control guidelines placed surgical patients at risk for exposure to serious life-threatening infectious agents.

2. The hospital did not ensure that shared equipment potentially exposed to blood-borne
pathogens (Hepatitis B, C, and the virus that causes immunodeficiency), were cleaned and
disinfected between each patient in accordance with nationally accepted infection control
standards and manufacturer's recommendations when:

i. Glucometer's (a machine that measures patient blood sugar levels) were not effectively cleaned and disinfected between patient use.
ii. A high level disinfectant was not used in accordance with manufacturer's recommendations. Failure to use the product according to the manufacturer's instructions and State regulations placed hospital employees and the environment at risk for exposure to potential toxic effects of the disinfectant.
iii. Soiled bedside commodes and bedside buckets were stored available for patient use.
iv. Vaginal probes were disinfected in the same areas as hazardous waste was stored and surgical instruments were decontaminated. These practices placed the vaginal probes at increased risk for cross contamination from hazardous and potentially infectious waste and and thus placed hospital patients with vaginal probe procedures at increased risk for contact with hazardous and infectious materials that could cause serious infections.

3. The hospital failed to provide a functional and sanitary environment for the provision of surgical services so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area when:

i. The hospital failed to have an effective system in place to ensure appropriate identification of restricted areas and traffic patterns in the GI procedure (Gastrointestinal procedures performed on the digestive system) areas.
ii. The hospital staff persons were not wearing appropriate surgical attire in the GI procedure
area in accordance with standards of practice.
iii. The monitoring of air temperature and humidity was not performed in accordance with standards of practice in the perioperative (period extending from the time of hospitalization for surgery to the time of discharge) areas including the GI endoscopy (visual examination by means of an scope) procedure room.

4. The hospital did not develop and implement policies and procedures to ensure that staff were screened for vaccine preventable diseases.

5. The hospital did not have staff trained and competent to effectively disinfect the
perioperative environment.

6. The hospital did not maintain a positive pressure environment (rooms designed to maintain a flow of air out of the room, thus protecting the patient from possible contaminants and pathogens) in the cardiac catheter (a catheter used to diagnose and treat heart conditions) surgical procedure room.

7. The hospital failed to ensure proper labeling of a container contained a disinfectant (an agent that destroys or inhibits the activity of microorganisms, such as bacteria or fungi, that cause diseases. Most disinfectants are also, by nature, potentially harmful to humans used by the housekeeping department. Failure to label the container could cause mis-handling of the disinfectant and therefore, lead to bodily injury.
Findings:

1. During the initial tour of the sterile processing and supply storage areas on 2/28/12 at 8:35 AM multiple pairs of scissors were in the closed position in sealed peel pouches (Peel pouches are flexible packaging materials that combine a paper or synthetic barrier material and a transparent plastic film. Peel pouches are used primarily when visibility of the instrument is critical for its effective use). Eight of 11 vascular clamps were observed with blades in the closed position in peel pouches. Ten of 12 pairs of scissors were observed with blades in the closed position inside peel pouches, and four of four pairs of clamps were observed in the closed position inside peel pouches.

In an interview with Registered Nurse (RN) 5 on 2/28/12 at 8:40 AM, RN 5 was shown the scissors with blades closed in the peel pouches and asked if it was the hospital's usual practice of sterilizing the scissors (with the blades closed). RN 5 was unable to identify the problem of sterilizing the scissors with blades closed. RN 5 stated the hospital never used anything to keep hinged items open. RN 5 indicated the hospital followed AORN (Association of periOperative Registered Nurses) standards for sterilization of instruments. In a subsequent interview at 12:40 PM, RN 5 stated "There were oodles of hinged sterile instruments sterilized with the blades in the closed position." When questioned, RN 5 clarified the number of instruments represented by the term oodles meant in the hundreds.

Review of the hospital's policy titled "Steris Sterilization, dated 6/11 and presented as current, stipulated "Position clean instruments or equipment in processing tray to ensure that all surfaces will be exposed to sterilant."

The 2012 Perioperative Standards and Recommended Practices published by AORN was reviewed. Direction was given that, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces and instruments with hinges should be opened..."

2..i. During an interview with RN 6 on 2/29/12 at 2:15 PM, she indicated she cleaned the outside of the shared patient glucometer between patient use with Cavicide (a disinfectant). RN 6 indicated she cleaned the part of the glucometer where the strip with blood was inserted into the machine when it appeared soiled with water and alcohol.

During an interview with RN 7 on 2/29/12 at 1:55 PM, she indicated she cleaned the outside of the shared patient glucometer (a machine that patient use with Cavicide (a disinfectant). RN 7 indicated she cleaned the lens (part of the glucometer where the strip with blood was
inserted into the machine) each night with a bleach wipe.

During an interview with RN 7 on 2/29/12 at 2 PM, she indicated she cleaned the outside of the shared patient glucometer (a machine that measures patient blood sugar levels) was
cleaned nightly and when obviously soiled with a bleach wipe. RN 7 indicated indicated she
cleaned the part of the glucometer where the strip with blood was inserted into the machine each time.

The hospital's policy titled "Cleaning Schedule for Patient Care Equipment" dated 3/11 and
presented as current did not require glucometer's shared between patients to be cleaned after each patient use. The policy stipulated glucometer's should be cleaned when visibly soiled.

An article published in volume 38, number 3,(April 2010), of the American Journal of
Infection Control, by the Association for Professionals in Infection Control and Epidemiology, provided the following guidance:"Assign a glucometer to each patient if possible. Clean and disinfect glucometers if they must be shared between multiple patients. Thoroughly clean all visible soil or organic material (e.g., blood) from the glucometer before disinfection. Disinfect the exterior surfaces of the glucometer after each use following the manufacturer's directions. Use an E.P.A. (Environmental Protection Agency) registered disinfectant effective against HBV, HCV, and HIV (blood-borne pathogens) or a 1:10 bleach solution (1 part bleach to 9 parts water)."

The hospital failed to develop a policy and procedure to ensure the glucometer was
cleaned after each patient use to reduce the risk of cross contamination and transmission of
blood-borne pathogens (HBV, HCV, and HIV).

2. ii. On 2/28/12 at 1:55 PM EEGT (Electroencephalogram Technician) was observed soaking patient electroencephalogram (EEG), a test that measures and records the electrical activity of the brain by using sensors attached to a head cap, head caps in a basin in a sink located in the nerve conduction room with Metricide 28, a high level cleaning and disinfectant solution. The room had no external exhaust or windows. Two individuals, that EEGT identified as physicians, were sitting at computer a few feet away from were the EEG head caps were soaking in the Metricide solution. The EEGT was not wearing any equipment (PPE), such as a water resistant gown, gloves, and face mask.

During an interview with EEGT on 2/28/12 at 2 PM, she explained she had used the Metricide solution to clean the patient EEG caps (a cap placed on a patient's head to record the electrical activity of their brain) for the last 25 years. The EEGT acknowledged she had never worn any PPE (personal protective equipment) when using the Metricide to clean the caps. The EEGT indicated she was not aware the Metricide solution should be neutralized (chemically deactivated) before it was disposed of down the sink drain.

During an interview with the Infection Control Nurse (ICN) 1 she indicated she was not aware EEGT was using Metricide to disinfect the EEG caps. ICN 1 acknowledged EEGT should have only used this product in a well ventilated area wearing appropriate PPE, and the Metricide solution should have been neutralized before disposing of it down the sink. Metricide instructions indicated individuals should only use the product in a ventilated area and wear appropriate barrier protection such as latex gloves, gowns, masks or eye coverings.

Review of the The California Department of Toxic Substances Control (Cal/EPA) revealed used glutaraldehyde (Metricide) is classified as hazardous waste. Review of California Senate Bill - No. 2035, passed in 2000, stipulated medical facilities are allowed to treat and dispose of used glutaraldehyde without a permit, providing that: a) The sole active chemical of the neutralizing solution is glycine; and b) The waste is generated by a medical facility during the disinfection of medical devices; and c) The waste is treated at the site where it was generated.

2. iii. On 2/29/12 at 2:30 PM six (6) bedside patient commodes were observed stored behind the door in the dirty utility room a few feet from a hopper (a large toilet without a lid/or cover used to clean dirty items) in the hospital emergency room. One of the commode buckets had numerous brown smears on the bucket surfaces. A sign was posted on the wall of the dirty utility room stated "Please place clean commodes behind the door."

During an interview with RN 9 2/29/12 at 2:30 PM, she stated "That's not clean" pointing to the commode with brown smears on its surfaces. RN 9 indicated clean commodes had been stored in the dirty utility room for at least three years. RN 9 acknowledged it was confusing as to what equipment was soiled and what was clean. RN 9 also acknowledged that storing soiled equipment in close proximity with clean equipment could result in soiling of the clean equipment. Additionally, RN 9 acknowledged storing clean equipment in close location to the hopper, which was used to clean soiled equipment, including removal of human waste off the equipment, could result in soiling of the cleaned equipment.

During an interview with Charge Nurse (CN) 2 on 2/29/12 at 2:40 PM she acknowledged clean equipment should not be stored in the dirty utility room with soiled equipment.

The June 2003 Recommendations of Center for Disease Control (CDC) and the Healthcare Infection Control Practices Advisory Committee (HICPAC) for Environmental Infection Control in Health-Care Facilities were reviewed and provided the following information, "The most common point-of-use fixtures for water in patient-care areas are sinks, faucets, aerators, showers, and toilets. The potential for these fixtures to serve as a reservoir for pathogenic microorganisms has long been recognized. Wet surfaces and the production of aerosols facilitate the multiplication and dispersion of microbes."

2. iv. A tour of the labor and delivery area was conducted with ICN 1 on 2/28/12 at 2:05 PM. The soiled utility room had a sink containing soiled surgical instruments approximately two feet away from the station where vaginal probes were being disinfected in a closed system. The room was designated as a biohazardous waste disposal area by a sign on the door and it contained biohazardous waste in containers, including a container marked as containing placental waste. The sink where instruments were cleaned was
approximately two feet from the location where vaginal probes were being disinfected.

In a concurrent interview ICN 1 acknowledged the sink was used to decontaminate surgical
instruments used by labor and delivery that were likely soiled with blood and or body secretions. ICN 1 acknowledged when the probes were placed and removed from the closed disinfection system they would be in close proximity to the decontamination sink and the biohazardous waste containers until their removal to another location for permanent storage.

In a review of the 2012 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 result in
cross-contamination."

3. i. On 2/28/12 at 1 PM the endoscopy procedure area (referred to as the GI area) was
observed. The GI area, contained two GI surgical procedure rooms and a room for endoscopy cleaning, decontamination and disinfection. The GI area was entered through a door with a sign that indicated authorized personnel only; however there were no signs that indicated the permitted movement of staff and patients and requirements for entry into areas within the GI area.

An interview was conducted with ICN 1 on 2/29/12 at 11:15 AM. When asked about the
traffic patterns in the GI area, the ICN 1 indicated the GI area was not considered an OR (operating room) or perioperative area by the hospital; and therefore, it was not maintained as such and traffic patterns within the GI area had not been established.

During an interview with RN 3 and 4 on 2/28/12 at 1 PM, they indicated the types of procedures performed in the GI area included colonoscopy (the visualization of the colon [portion of the large intestine] with a long, flexible instrument 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), and biopsy (the removal of a small piece of living tissue from an organ or other part of the body for microscopic
examination), peg insertion (the placement of a tube in the abdomen through which nutrition can be given). On 2/29/12 at 12 PM, a review of the definition of surgery developed by the American College of Surgeons dated 4/2007 was conducted with the DSS and ICN's 1 and 2. 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." In a concurrent interview, the DSS acknowledged the procedures in the GI area would be considered surgeries under this definition.

Review of the The Perioperative Standards and Recommended Practices published by the AORN, 2012 edition indicated "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 and surgical attire required. The semi-restricted 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, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and patients. The restricted area includes operating rooms, procedure rooms, and the clean core area."

3. ii. From 2/28/12 through 2/29/12 RN 3 and RN 4 were observed moving throughout the GI area in scrubs but with no hair covering. During this time period the ICN 1 and 2 were observed moving throughout the GI area in their street clothes without hair coverings.

During an interview with RN 3 and 4 on 2/28/12 at 1 PM, they indicated they laundered their scrubs at home and acknowledged they did not cover their hair. RN's 3 and 4 indicated they wore gloves, water resistant gowns, and face masks but did not cover their hair when assisting with the GI procedures.

An interview was conducted with ICN 1 on 2/29/12 at 11:15 AM. When asked about the
requirement for wearing surgical attire in the GI area, the ICN 1 indicated the GI area was not considered an OR or perioperative area by the hospital; and therefore, staff and physicians were not required to wear surgical attire in the GI area or in the GI procedure rooms.

On 2/26/12 at 10 AM, in an interview with the DSS (Director of Surgical Services) and ICN's 1 and 2, a review of the definition of surgery developed by the American College of Surgeons dated 4/2007 was conducted. After reviewing this definition along with the types of procedures performed in the GI area, the DSS acknowledged the procedures performed in the GI area procedures were surgeries.

Review of the 2012 AORN Perioperative Standards and Recommended Practices, under
Recommended Practices for Surgical Attire, Recommendation II documented, "Clean surgical attire, including shoes, head covering, and all individuals who enter the semi-restricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite." Item II.c. documented, "Persons entering the semi-restricted or restricted areas of the surgical suite for a brief time for a specific purpose should cover all head and facial hair and should don either freshly laundered surgical attire; single-use attire, or a single-use jump suit designed to completely cover outside apparel." Recommendation III documented, "All individuals who enter the semi-restricted or restricted areas should wear freshly laundered 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." Recommendation VI documented, "All individuals entering the restricted areas should wear a mask when open sterile supplies and equipment are present."

The hospital policy titled "Operating Room Infection Control and Surgical Attire Guidelines" dated 8/2010 indicated the above recommendations were to be followed for the hospital's operating rooms.

3. iii. An interview was conducted with ICN 1 on 2/29/12 at 11:15 AM in the GI area. When asked about monitoring the GI areas for temperature and humidity, ICN 1 indicated the GI area was not considered an OR or perioperative area by the hospital; and, therefore, environmental monitoring of temperature, humidity, and room air exchange rates were not performed.

During an interview with RN 5 on 2/28/12 at 8:40 AM in the perioperative surgery suite, he stated temperatures in the perioperative areas were monitored daily and maintained between 64-70 degrees Fahrenheit. RN 5 indicated the Centers for Disease Control and Prevention (CDC) and the AORN sets the hospital's standards, including temperature standards, in the perioperative areas.

The 2012 edition of Perioperative Standards and Recommended Practices, published by the
AORN, made the following recommendations related to Safe Environment of Care: "Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system. Temperature should be maintained between 68º F to 73º F (20º C to 23º C) within the operating room suite and general work areas in sterile processing. Self-regulating, area-specific chiller units may be required because operating rooms are filled with personnel and heat-emitting equipment; therefore, achieving the low end of this range can be difficult. The decontamination area temperature should be maintained between 60º F to 65º F (16º C to 18º C). A temperature > of 70º F to 75º F (21º C to 24º C) should be maintained in recovery areas.

The air-exchange rate in the perioperative areas should be carefully controlled. The number of air changes per hour is based upon the need to remove microbiological or chemical contaminants from the environment. 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.

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.

Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed. Free-standing humidifiers should not be used because they can harbor microorganisms in fluid reservoirs and aerosolize these microorganisms into the clean environment. Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system.

4. Review of two of three medical staff files (Physicians 1, 2, and 3) was conducted on 2/29/12 at 3:30 PM and two of the three medical files (Physicians 2 and 3) did not contain documentation of screening for varicella, measles, mumps, rubella, or hepatitis B. During a concurrent interview with the Quality Manager (QM) she indicated the hospital was only required by the hospital's medical by-laws to obtain a current tuberculosis test (one-step) upon hire. The QM acknowledged all physicians were likely to have intimate contact with patients and also potential exposure to blood. The QM acknowledged the potential risk to hospital patients and physicians related to not screening physicians for the CDC recommended vaccine preventable diseases. She stated, "We will talk to medical staff and see if we can beef this up."

A review of RN 10's medical file was conducted on 2/29/12 at 3 PM. RN 10's date of hire was 2/27/12. The documentation indicated RN 10 had not completed the portion of the vaccination history form related to status of varicella immunity. During a concurrent interview with Employee Health Registered Nurse (E-Health RN), she stated, "We should have called the employee and obtained this information. She is still in orientation. We will check before she hits the floor."

A review of Laboratory Scientist (Lab) 1's medical file indicated she had a date of hire of 12/19/11. Documentation revealed she had signed acceptance for hepatitis B vaccine series if she was found not to have immunity. Documentation revealed Lab 1 was tested and found to be non-immune to hepatitis B and a notification letter was sent to her on 1/3/12. No response to the letter was documented and no further evidence of follow-up was found in the documentation.

In a concurrent interview with E-Health RN, she acknowledged no follow-up actions were documented and stated, "It is our procedure to send a second letter."

In an interview with E-Health RN, she stated, "We follow the Centers for Disease Control and Prevention (CDC) guidelines for screening our employee staff for vaccine preventable diseases."

The CDC Morbidity and Mortality Report (MMWR Volume 46, Number RR-18, December 26, 1997) documented on page 24: "Persons who work within medical facilities should be immune to measles and rubella. Immunity to mumps is highly desirable for all Healthcare Workers. Because any HCW (i.e., medical or nonmedical, paid or volunteer, full time or part time, student or non-student, with or without patient-care responsibilities) who is susceptible can, if exposed, contract and transmit measles or rubella, all medical institutions (e.g., inpatient and outpatient, public and private) should ensure that those who work within their facilities are immune to measles and rubella. Likewise, HCWs have a responsibility to avoid causing harm to patients by preventing transmission of these diseases." On page 25, the MMWR documented: "All HCWs should ensure that they are immune to varicella."

The CDC Guidelines for Preventing the Transmission of Mycobacterium tuberculosis (in a Health-Care Setting, 2005, page 10, "the classification of medium risk should be applied to settings in which the risk assessment has determined that health care workers (HCW) will or will possibly be exposed to persons with TB disease or to clinical specimens that might contain M. tuberculosis." The recommendations for medium risk included, "All HCWs should receive baseline TB screening (checked to identify presence of the disease) upon hire, using two-step TST (skin test) or a single BAMT (alternate test) to test for infection," and "After baseline testing for infection, HCWs should receive TB screening annually."

The Occupational Safety and Health Administration (OSHA) requires hepatitis B vaccine be offered to HCWs who have a reasonable expectation of being exposed to blood on the job.

Review of the 7/30/09 Association for Professionals in Infection Control and Epidemiology (APIC) Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Healthcare indicated that healthcare workers whose activities involved contact with blood or body fluids be offered hepatitis B vaccination.

5. On 2/28/12 at 9:30 AM Housekeeper (HK) 1 was observed cleaning OR 2. HK 1 was using a cloth to wipe multiple surfaces. He cleaned three metal tables and the surgical bed with one cloth. The tables began to dry 2.5 minutes after they were wiped and were completely dry in 4 minutes.

On 2/28/12 at 9 :35 AM HK 2 was observed mopping the floor of OR 2 she used one mop to clean the entire floor. The last part of the floor cleaned with the mop appeared dry.

During an interview with HK 1 he indicated he usually used two and sometimes three cloths to clean an entire operating room. HK 1 stated the the cleaner/disinfectant on the cloths was called Vindicator. When asked how long surfaces must remain wet with the disinfectant to kill microorganisms, HK 1 stated as soon as it dries it is effective to kill the organisms. HK 1 stated he received training for his job, but did not receive much training on how to clean, i.e. when to change cleaning cloths, how many cleaning cloths to use.

A review of the product information for the disinfectant Vindicator, indicated it was a EPA
Reg No 1839-167-1658 product with a a required contact time (time required for the surface to remain wet with the disinfectant solution to kill microorganism) of 10 minutes. The product instructions stipulated "Remove heavy soil deposits from surface then thoroughly wet
surface..."

6. During an interview on 2/28/12 at 3 PM with the Radiology Manager (RADM) in the cardiac catheter procedure area, she indicated the following types of surgical procedures performed in this area included but were not limited to: Angiograms (an x-ray of one or more blood vessels and used in diagnosing pathological conditions), cardiac catheterizations, renal and biliary stent placements (a tube designed to be inserted into a vessel or passageway to keep it open), and biopsies and were considered surgical procedures. The RADM indicated the room where these procedures were performed in the cardiac cath area was a negative pressure room (pressure less than that of the atmosphere).

An interview with Clinical Director (CD) 1 and concurrent review of the hospital's documentation of the cardiac catheter procedure room pressure on 2/28/12 at 3:05 PM was conducted. The documentation indicated the cardiac catheter procedure room was a negative pressure room. CD 1 acknowledged surgical procedures were performed in this room. CD 1 acknowledged the surgical procedure room in the cardiac catheter area was a negative pressure area and should be positive pressure (pressure greater than that of the atmosphere)to be consistent with the Association of the Operating Room Nurses (AORN) standards.

Review of the hospital's policy and procedure titled "Department of Radiology Scope of
Services" dated 12/2000 and presented as current, stipulated radiology procedures (angiography/intervention room) will follow the AORN Standards.

The 2012 edition of Perioperative Standards and Recommended Practices, published by the
AORN, made the following recommendations related to Safe Environment of Care: "Air-flow patterns are architecturally designed and engineered to minimize contamination of the
sterile field. Disruptions in the air-flow patterns within the operating room can redirect
contaminants onto the sterile field, increasing the risk of surgical site infection. The pressure
gradient in the operating room should be positive to outer corridors at all times."

The hospital's failure to ensure surgical procedures were performed in a positive pressure
environment in the cardiac cath procedure room placed patients undergoing surgery in this area at risk for increased surgical site infection.



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7. On 2/29/12, at 11:05 AM, in the hallway of the east medical-surgical unit with quality management staff, a housekeeping cart parked outside a patient's room was inspected. A plastic container with liquid solution and rags in it were seen on top of the housekeeping cart. The plastic container was not labeled.

Immediately, the patient services associate (PSA, housekeeper) was asked about the content in the plastic container. The PSA stated the solution in the container was "Vindicator 6." It was a disinfectant the hospital used to clean surfaces in patient care areas, such as a counter or floor. The PSA demonstrated how she refilled the plastic container with Vindicator 6 every morning. At this time, the PSA was asked if the plastic container should be labeled properly to inform others the content of the container. The PSA stated the original plastic container was missing a lid and she grabbed another unlabeled container to replace it. She stated she should have labeled the container.

On 2/29/12, at 4:10 PM, the housekeeping supervisor (HS) was informed of the finding. He stated the plastic container held chemicals (disinfectant) in it should be properly labeled. The HS stated he had some containers already labeled by the manufacturer specifically for "Vindicator 6" available for use. T

Based on interview and record review, the hospital failed to provide evidence of training, and in-services for nuclear medicine personnel which had the potential for adverse outcomes for the hospital's patients requiring the nuclear medicine service.

Findings:

During a concurrent interview with the Human Resource Director (HRD) and review of staff files on 2/29/12 at 2:20 PM, the employee and training files for Nuclear Medicine Technologist (NMT) 1 and NMT 2 were reviewed. Both files did not contain documentation of nuclear medicine training or yearly in-services for NMT 1 and NMT 2. These findings were verified by the HRD.

The hospital's policy and procedure titled "Orientation of New Employee" dated 3/17/05, read "It is the policy of (hospital) to provide in service and proper instructions to the nuclear medicine technologist..... Instruction, or in-service, will be given: Before assuming duties with or in the vicinity of radioactive materials, during annual refresher training.... In-service given must be documented, recorded, and filed in worker's file"