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Based on observation, staff and patient interviews, medical record and document reviews, the hospital governing body failed to effectively oversee hospital operations, ensure that the Conditions of Participation for Quality Assurance and Performance Improvement, Pharmaceutical Services, and Surgical Services were met and to 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 ensure an effective system for monitoring and evaluating the services performed under a contract in order to verify the services were safe and effective (Refer to A 0084).

B. 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 0940).

C. The hospital failed to ensure that pharmaceutical services met the needs of all patients (Refer to A 0490).

D. The hospital failed to ensure that an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program was developed, implemented and maintained for high risk patient care activities throughout the hospital (Refer to A 0263).

These failures (described in detail in Conditions of Participation A 0263, A 0490, and A 0940) resulted in a potential for increased infections, medication errors, and adverse events 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:

Review on 10/3/11 of the Medical Staff Bylaws, last approved 6/30/11, documented under section 6.9 for Hospital Board Oversight Responsibilities, "The Medical Staff acknowledges that the Board must act to protect the quality of medical care provided and to ensure the competency of the Medical Staff and the responsible governance of the Hospital in the event that the Medical Staff fails in any of its duties and responsibilities."

In an interview with the former Chief of Staff and a current member of the Governing Board (MD 9) on 10/6/11 at 1 p.m., MD 9 indicated that the ultimate responsibility for hospital operations and practices was held by the governing board. MD 9 acknowledged that governance structures had not effectively succeeded to ensure that sound medical practices based on nationally recognized and evidence based standards were consistently implemented throughout the hospital (e.g., sedation care standards, infection control and medication storage standards, pre and post-surgical patient assessments, and surgical site verification procedures).

Review on 10/3/11 of the Governing Board Bylaws, approved 3/23/06, documented a number of corporate responsibilities of board members. Other provisions of the bylaws delegated responsibilities to a corporate chief executive officer and to the medical staff, who were expected to provide written reports to keep the Board informed. The Board "May delegate the management of this Corporation to any person or persons, or committee however composed, provided the activities and affairs of this Corporation shall be managed and all corporate powers shall be exercised under the ultimate direction of the [governing board]." The delegated parties were responsible to organize administrative functions and policies to show they were accountable for their delegated responsibilities. Specific patient care oversight by the Board was documented on page 6 which directed the Board to institute procedures to establish and monitor an effective medical and hospital care performance improvement program. Section 9.1 on page 31 read, "The Board shall establish, maintain, support and exercise oversight of an ongoing quality assessment/performance improvement and risk program that includes specific and effective review, evaluation and monitoring mechanisms to assess, preserve and improve the overall quality and efficiency of patient care in the hospital." However, no language in the bylaws, nor other leadership documents presented, directly held the Board legally responsible for the conduct of the hospital as an institution, to ensure hospital patients received high quality care, and to furnish and maintain facilities for the proper care and safety of all patients, physicians, and employees.

Based on staff interview and document review, the governing body failed to ensure that contracted services were performed in a safe and effective manner when an effective quality oversight system to objectively measure and evaluate the performance of contracted vendors on a periodic basis was not documented in a plan or policy to hold the governing body responsible to ensure that vendor services were continuously safe and effective. This failure contributed, in part, to a breakdown in the servicing of hospital equipment (past non-compliance) with potential for subsequent non-compliance of contracted vendors to meet the terms of their patient care service agreements, and threatened the safety of all patients.

Findings:

In an interview with Administrator (ADM) 1 on 10/6/11 at 12:30 p.m., ADM 1 indicated the following:

A problem with the reliability of medication storage refrigerators throughout the hospital was recently identified. The service contract for the vendor responsible for the medication refrigerator temperature monitoring had not been extended, and the hospital had not implemented a reliable surveillance system to replace the vendor's monitoring, until recently. An 18 month gap in verifications of safe medication storage required disposal of large quantities of medications, and evaluation of patients who were potentially given ineffective medications during that period. Through the investigation of the multiple levels of surveillance for medication storage, the hospital learned that a contracted engineer had not produced complete reports of other hospital equipment that the engineer was obligated to periodically test and service, in accordance with the service contract. As a result, equipment may not have been functioning safely if it missed its periodic testing. Although the department managers were responsible to oversee and verify the services provided by contracted vendors, and submit evaluations periodically to hospital committees (which reported ultimately to the governing board), the processes for these evaluations and reporting were not defined in any written policy, quality plan, or governance documents to ensure a line of accountability based on objective measures of performance.

Review of the quality assurance plan and governance bylaws and policies failed to identify a written commitment to evaluate the services performed by contracted vendors, and periodically report the outcomes to the governing board, in order to ensure the services were safe, effective, and in accordance with the terms of the contract. No reports to show analyses of the contracted services (based on objective performance measures and presented to the governing board) were presented.

Based on observation, interviews, and medical record/facility document review, the facility failed to ensure that an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program was developed, implemented, and maintained for patient care activities throughout the facility as evidenced by:

1. Medication Administration - Pharmaceutical Services had no process to effectively monitor or report adverse drug reactions (ADRs) related to the failure of the Medication Safety Committee to continue monthly and/or quarterly meetings for review of medication errors which would allow the QAPI committee to identify and implement an action plan and the inability to retrieve and analyze data from a computer data collection software thereby relying on staff self-reporting of ADRs and the lack of department manager follow up on potential "triggers" (medications ordered that may result in ADRs). (Refer to A 0267 and A 0508)

2. Surgical Services - the process for determining the competency of registered nurse (RN) intravenous (IV - administration of fluids through a small tube inserted into a vein) medication and sedation administration was not supported by documentation of demonstrated safe medication administration. (Refer to A 0267 and A 0945(4))

3. Infection Control - there was no process to analyze the impact to patient safety related to the air quality and terminal cleaning of the endoscopy surgical procedure room. (Refer to A 0275 and A 0951(4)(h))

4. Quality Assurance - the quality assurance program had no process to effectively analyze the data collected for medications given late, which in turn prevented an action plan for performance improvement in patient care areas. (Refer to A 0285 and A 0945(4))

These failures put patients at risk for adverse medication reactions, infection, and poor patient safety. The cumulative effect of these systemic problems resulted in the inability of the facility to comply with the statutorily-mandated Condition of Participation for Quality Assurance and Performance Improvement.

Based on interview and record review, the facility had no process (1) to ensure that pharmacy effectively measured, analyzed, and tracked medication administration errors for performance improvement and patient safety which continued to allow the potential for serious medication errors and/or ADRs and (2) for determining the competency of registered nurse (RN) intravenous (IV-small tube placed into patients vein) medication and sedation administration which could increase the risk for potential medication errors and compromise patient safety.

Findings:

1. On 10/10/11 at 9:55 am, a review of the facility policy Medication Error Prevention and Reporting - Hospitalwide, dated 7/10, indicated under III. Philosophy: "B. Since medication errors may result in serious, adverse consequences for patients, the facility has targeted Medication administration as an area for on-going performance improvement on an organization-wide basis."

During an interview on 10/10/11 at approximately 11:45 a.m., the pharmacy director (DP) stated medication error data was reported and analyzed quarterly at the Medication Safety Committee meeting (a sub-committee of the Pharmacy and Therapeutics Committee) that DP indicated was established January 2011.

Review of the monthly Medication Safety Committee minutes for January through August 2011, revealed that on 1/28/11 the committee discussed a summary review of 132 medication errors dating 1/10 through 6/10. The DP indicated that no monthly Medication Safety Committee meetings had been held since August 2011 and that no documentation of quarterly review of medication errors by the Medication Safety Committee was available since January 2011. When asked to specify the committee where the medication errors were being reported for interdisciplinary review and input DP stated, "Medication errors are not going anywhere right now."

Review of the facility policy Medication Error Prevention and Reporting - Hospitalwide, dated 7/10, indicated under IV. Policy, item A: "7. Medication errors shall be tracked and trended with summaries reported and reviewed by Department Managers and the Medical Staff through appropriate channels." Under item XIV. Program Implementation, the policy indicated: "A. Performance measurement data is collected, trended and analyzed to determine if opportunities exist to prevent and reduce medication errors....C. Opportunities to reduce medication errors that reflect system issues are addressed through the organization's performance improvement process."

During an interview on 10/10/11 at 12:30 p.m., the pharmacy director acknowledged that a review and analysis of hospital-wide medication errors had not been addressed by the Medication Safety Committee since 1/28/11.

During an interview on 10/10/11 at 12:10 pm, a registered pharmacist (RPh 2) indicated that the staff pharmacists do not individually follow up on potential adverse drug reactions (ADR) "triggers" (such as reversal agents for narcotics,sedatives, blood sugar lowering medications, and blood thinners), but referred them to her for follow up, analysis, and notification to physicians of an ADR. RPh 2 indicated "trigger drug" reports had not been analyzed for September 2011, and acknowledged physicians may not have been notified that an ADR had occurred resulting in the need for these reversal agents. RPh 2 also indicated that a computer computer software for ADR triggers was not in use because the data was hard to review and analyze. RPh 2 acknowledged that ADRs were under-reported at the hospital.

The failure of the pharmacy to collect effective data and have the Medication Safety Committee analyze the results prohibited the information from being forwarded to the QAPI committee for the formulation of a performance improvement plan and implementation of an action plan to reduce medication errors and ADRs. This lack of action allowed the potential for serious medication errors and/or ADRs to continue.

2. The facility had no process to determine registered nurse intravenous medication and sedation competencies to assure patient safety and prevent medication errors and/or over/under sedation of patients during surgical procedures.

During an interview on 10/5/11 at 10 am, a nurse manager for the mobile bowel and lung surgery team (CN 1) indicated that RNs were routinely assigned to perform sedation care for patients that had procedures in or with their unit. CN 1 also acknowledged that surgeons routinely ordered, and RNs implemented, rapid administration of sedation/analgesia medications without adjusting dosages for the age and condition of the patient, as directed in the hospital sedation training module and national sedation care guidelines.

Review on 10/10/11 of the competency files for CN 1, RN 3, and RN 4 with ADM 1 indicated that competencies for the use of surgical instruments to grasp, bite, clamp and dilate were checked off at orientation/hire, but not on a periodic basis after that time. These competencies were dated 2003 for CN 1, 2008 for RN 3, and 2005 for RN 4. Moderate Sedation competencies were documented by a 12 item checklist completed at a skills fair biannually, but the checklist did not verify the method of determining competence (e.g. formal training, knowledge test, demonstration of skills, chart review), which was signed by a RN from the team, whose competency was signed off by a RN she herself had evaluated. Sedation competencies for RN 4 were dated 9/22/08 (three years ago). Medication Administration and IV Therapy competencies were documented in an annual performance evaluation tool for CN 1 dated 8/4/11, for RN 3 dated 2/28/11, and for RN 4 dated 3/9/11, all current and marked as competent. The requirements for medication tasks included "Prepares and administers medications according to manufacturer's guidelines, policy/procedure and with consideration of the age-specific needs of the patient." The files contained no summary of patient outcomes for each RN. No privileging for surgical tasks or sedation care was documented. (refer to A 0945(4))

The position statement titled "Conscious Sedation" from the California Board of Registered Nursing (BRN) retrieved from www.rn.ca.gov on 10/12/11, indicated the facility "should have in place a process for evaluating and documenting the RNs demonstration of the knowledge, skills, and abilities for the management of clients receiving agents to render conscious sedation. Evaluation and documentation of competency should occur on a periodic basis."

The lack of a process to evaluate and document RN competencies for IV sedation/medication administration had the potential to compromise patient safety.

The quality assessment performance improvement (QAPI) program data collected by the infection control coordinator (ICC) for Clostidium Difficile (C-diff- a contagious bowel infection causing severe diarrhea) to monitor the effectiveness, safety of services, and quality of care did not include the environmental and cleaning impact for spread of the bacteria to prevent contamination of other patients using the bowel and lung surgical unit.

Findings:

During a tour of the endoscopy (bowel and lung) surgical unit on 10/6/11 at 7:10 am, a portable air conditioning unit (approximately 5 feet tall and 3-4 feet wide) was observed installed in the unit. Also noted in the room was a fan mounted near the ceiling which the endoscopy charge nurse (CN 1) stated, in a concurrent interview, was to circulate air in the orperating room (OR) during the procedure if it became to warm.

During an interview on 10/10/11 at 9:30 am, the facilities manager (MGR 2) acknowledged that the recirculation of air through the portable unit may have altered the previous ventilation balance (recirculated air through a central system filtering particulate matter allowing bacterial reduction with specific humidity and temperatures of air to reenter the room), particularly when the doors were propped open and fans were circulating, which may permit contaminated air from neighboring patient rooms to enter the OR and distribute to the surgical equipment and supplies. MGR 2 indicated that measurements of air balance and pressures were not conducted to verify proper OR conditions and minimize the circulation of dust and other contaminants when the portable unit was installed. MGR 2 acknowledged that the current physical plant design of the bowel and lung surgery unit did not permit the regulation and control of temperature, humidity, and air exchanges within subsections of the contiguous restricted (the patient occupied operating room) and semi-restricted areas (clean versus dirty areas and storage areas) in accordance with nationally recognized infection control standards. (cross reference to A 0951(h))

During an interview on 10/5/11 at 3 pm, the infection control coordinator (ICC) indicated he had routine monitoring and daily reports with lab report access to collect the data and track C-diff positive infections in the hospital. The ICC stated the cleaning practices for C-diff was essential to reducing the spread during and after a patients hospital stay, but that he did not track specific data for the bowel and lung surgical unit.

During an interview on 10/6/11 at 11:30 am, the ICC indicated that monitoring of infection control practices related to ventilation and environmental cleaning in the bowel and lung surgery unit were not captured by the infection control and safety surveillance activities currently in place.

Based interview and document review, the facility failed to develop and implement a process to identify the reasons medications were being given late on data collected for an action plan to be implemented to improve medication administration performance on individual patient units.

Findings:

On 10/6/11 at 10 am, a document review was conducted with the director of quality management (DQM). A compliance report from the "Med Safety Committee," dated 8/2011, documented (page 1 of 6) the percentage of medications that were administered to patients late (31 minutes after the scheduled time or later) from 2/2011 through 8/11. The data included was separated into the percentages for each patient care area as well as the total percentage of late medications hospitalwide.

The individual monthly percentages were added together and the seven month average percentages obtained for the separate patient care units. The hospitalwide average percentage rate for the seven month period, 2/11 through 8/11 was 12.26%. Five patient care units had individual average percentages above the hospitalwide percentage: 2Central = 15.86%, 2West = 14.54%, 3Main = 12.57%, 3West = 13.91%, and 4Main = 13.28%.

DQM stated there was a problem in the data collection system for late administration of medications. DQM stated there was no way the present system could break down the reasons the medications were listed as late. The collection system could only give a total of the medications given after the 30 minute time span allowed after the scheduled time.

When asked what the facility was doing to get accurate actual reasons for the medications being given late, the DQM stated the facility and quality assurance and performance improvement (QAPI) committee had no process to distinguish why the medications were late to try and improve in any one specific area. The DQM stated at this point the facility "did not know what areas to improve and what to leave alone."

Based on observation, interview, clinical record and facility document review, the facility failed to develop and implement a diabetic plan of care for one of 30 sampled patients (Patient 28). This failure had the potential for loss of blood sugar control and metabolic complications for Patient 28.

Findings:

Clinical record review on 10/5/11 at 10:40 a.m. revealed Patient 28 was a 78 year-old admitted to the facility on 10/2/11 with multiple diagnoses including non-insulin dependent diabetes mellitus and diabetic neuropathy (damage to nerves from high blood sugar levels related to diabetes).

Review of Patient 28's History and Physical (dated 10/2/11) and Admission Medication Reconciliation Form indicated medications prior to admission included Metformin 500 mg daily (a blood sugar lowering medication indicated for diabetes).

Review of Patient 28's admission Physician Orders revealed an order to hold the Metformin; and to assess fingerstick blood sugars before each meal three times daily and at bedtime.

Patient 28's admission laboratory assessments indicated an estimated mean blood glucose of 191.2 (normal value 70 - 130 mg/dL, or milligrams per deciliter) and elevated HbA1c of 8.4% (normal value 4 to 6%). HbA1c, or glycosylated hemoglobin, is a laboratory blood test that provides an index of a person's average blood glucose concentration over the preceding six to twelve week period (Source: WebMD.com)

Review of Patient 28's 10/2/11 through current (10/5/11) electronic Medication Administration Records (MARs) and laboratory assessments revealed no evidence of fingerstick blood sugar assessment documentation; review of Patient 28's Diabetic/Insulin Record flow sheet, which had a handwritten entry of "FSBS QAC + HS [fingerstick blood sugars before meals and at bedtime]," indicated no blood sugars were documented by licensed nursing staff.

During a concurrent interview, a risk management staff member (RM 1) verified Patient 28's clinical record findings.

Patient 28's nursing care plans revealed a plan of care entitled "Gastrointestinal/Nutrition." The document included three columns related to Patient Problems (indicating unchecked boxes related to the potential for low or high blood sugars); Expected Outcomes (indicating an unchecked box related to achievement of normal blood glucose levels); and Interventions. (indicating an unchecked box related to monitoring of blood glucose levels). The first column of the document indicated boxes for date/initial (by licensed nursing staff) when the problem was identified or resolved. No dates, initials or other nursing documentation were noted on the "Gastrointestinal/Nutrition" plan of care.

During an interview on 10/5/11 at 11:35 a.m., RM 1 verified that Patient 28's plan of care related to her blood sugars contained no licensed nursing staff entries or checked boxes.

Review of the facility policy "Patient Care Plan - Hospitalwide," dated 6/08, indicated under III. Policy, item A: "A written or individualized standard Patient Care Plan shall be provided for each patient with the exception of short stay patients (less than 24 hours)." Under IV. Procedure, the policy stipulated: "A. Problem Statement/Nursing Diagnosis: 1. Each patient' s individual problems/needs are identified from the assessment data and patient care standards and are entered on the Patient Care Plan by the admitting RN."

During an interview on 10/5/11 at 3:30 p.m. RN 5 confirmed Patient 28's "Gastrointestinal/Nutrition" plan of care should have been initiated by licensed nursing staff on admission (10/2/11), but was unable to explain why the document had no licensed nursing staff entries 2 ? days after Patient 28 was admitted. The failure of nursing staff to initiate the nutritional plan of care had the potential to leave out vital information for dietary staff to prepare the correct diet for the patient, identify potential allergies to specific foods which may cause harm to the patient, and omit information for the dieticien and/or physician that would provide the adequate nutritional needs for Patient 28.

Based on interview and record review the facility failed to ensure a contracted license nurse was supervised to prevent late medications and the omission of three medications for one of 30 sampled patients (patient 4). This failure had the potential to reduce the effectiveness of medications given to Patient 4 by giving routinely scheduled medications including antibiotics past the effective timing range and thus omitting three doses of antibiotics.

Findings:

During a record review on 10/3/11, Patient 4's medication administration records (MAR's) were reviewed. Documentation of medications given indicated that on 10/2/11, within a 12 hour period, seven medications were administered late (outside the 30 minute before or after scheduled time limit per facility policy) and three antibiotic medications were omitted (Flagyl, Vancomycin, and Nystatin-topical).

During a an interview on 10/3/11 at 3:45 pm, the risk management manager (MGR 3) stated the nurse that had administered the medications to Patient 4 was a contracted non-employee (licensed travelling nurse) assigned to the unit since her completion of orientation.

During an interview on 10/5/11 at 4 pm, the director of education and staff development (DE 1) stated all new traveling nurses contracted by the facility are given a two day offsite orientation for required paperwork, facility rules & regulations, required tests/exams, computer orientation, and information that is specific to the facility. DE 1 stated the new nurses also get a one day orientation on the floor in which they are assigned to work with a preceptor that orients them to the floor and signs off a check list of the nurse's skills. DE 1 stated there was no further direct supervision of the travelling nurses. DE 1 stated that the facility expected that if the traveler nurse felt they needed more time or were having problems they would need to let their manager know.

A review of RN 10's employee file was reviewed on 10/5/11. An undated document titled "Evaluation of Traveler Unit Orientation" was completed by RN 10 for her orientation on 2W (2 West) and verified by DE 1. Question number 3 asked the traveler "Were the preceptor and orientee scheduled together consistently?" to which RN 10 documented her response as "No." Question number 5 asked the traveler "Was an experienced nurse assigned to work with the orientee in the absence of the preceptor?" to which RN 10 documented her response as "No." Number 9 asked the traveler to respond to the statement "The orientation has enabled me to meet the identified goals and objectives." to which RN 10 documented her response as "No."

RN 10 had indicated her one day of floor orientation was not acceptable because her preceptor was not with her throughout the day. The full day of preceptorship would be important for the traveler to understand the expectations of working on the unit and be able to have questions answered promptly within a situation. The preceptor would have pointed out problems and/or potential mistakes to the traveler prior to working directly with patients by themselves thereby lessening the potenial for injury/harm to the patients.

Based on staff interview, medical record and document review, the hospital failed to ensure safe administration and monitoring of medications, administration of an IV, and completion of fasting blood sugar testing in accordance with physician orders, hospital policy, and/or acceptable standards of practice (e.g. manufacturers' Specifications, state regulations, organizational standards) for 8 of 10 sampled patient records reviewed (Patients 4, 15, 16, 17, 18, 19, 25, and 28), as evidenced by:

1. Patients were administered intravenous (IV, inserted through a tube into a patient's vein) medications that included Versed (sedative) and Fentanyl (narcotic) during surgical procedures without dose adjustments for age and underlying risk conditions or documented justification by a physician for use of drugs in doses outside of parameters (acceptable limits) and/or without evaluation of each patient's response to drugs administered in accordance with manufacturer recommendations, hospital policies, and acceptable standards of practice (Patients 4, 15, 16, and 17).

2. Medications were not administered in the optimal time intervals as ordered (Patient 18 received an antibiotic 1 hour late, Patient 19 received an antibiotic 2 to 4 hours late), or were not administered at all (Patient 15 did not receive a bowel prep treatment as ordered prior to surgery), in accordance with hospital policy, standards of practice, and state regulations.

3. High risk medications were administered with no physician orders documented or read back as verbal orders (Patients 15 and 17) as required by hospital policy and standards of practice.

4. Obtain a physician's order prior to administering an intravenous solution for one of 30 sampled patients (Patient 25), with the potential for excessive fluid intake.

5. Implement a physician's order for routine fingerstick blood sugar (FSBS) assessments in a diabetic patient (Patient 28) who had been receiving a blood sugar lowering medication (metformin) prior to admission, with the potential for loss of blood sugar control and metabolic complications.

These failures put patients at risk for untoward reactions to medications, or compromised response to ordered treatments, injury and harm.

Findings:

1. High risk medications were administered by rapid IV push without dosage adjustments.

Surgical record review with nursing management during the survey from 10/3/11 to 10/10/11 showed that hospital patients received high risk sedation/analgesia medications (Versed/Fentanyl), administered without adequate monitoring, in doses outside of recommended parameters, and by methods (rapid IV push) not in accordance with hospital policy and accepted standards of practice as follows:

a. Patient 4, age 91 with a history of dementia, a heart rhythm disorder requiring drug treatment to keep the blood from clotting, and recent hospitalization for a bowel infection (C diff colitis), was admitted to the hospital on 9/21/11 and had bowel surgery for bleeding from the lower bowel (rectum) on 9/29/11. Moderate sedation care was planned for the surgery. (Moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, also known as moderate sedation/analgesia, IV sedation, or conscious sedation.) One minute before surgery started, a sedation drug (Versed, 2 milligrams [mg]) and a narcotic drug (Fentanyl, 50 micrograms [mcg]) were administered rapidly within one minute into Patient 4's vein (IV). Within 9 minutes, Patient 4's blood pressure dropped by 40% and remained low for 15 minutes, while rescue fluids were administered. Other than pain, sedation level, and a machine printout of vital sign measurements for heart rate, blood pressure, breathing rate, and blood oxygen level, no nursing assessments of skin color, airway features, depth of breathing, or regularity/alterations of heart rhythm, particularly during the period of persistent low blood pressure, were documented. Oxygen administration was documented only once, at the time of sedation/analgesia drug administration, and not documented as continued or adjusted during surgery, during the period of low blood pressure and rescue, or during the recovery period.

b. Patient 4 had a subsequent upper bowel surgery under RN-administered moderate sedation on 10/2/11 for problems with eating and anemia from suspected bleeding. Weight loss of 13 pounds and a drop in the red blood cell count (from 12.0 to 9.0 hemoglobin) was documented for the interval between surgeries. Sedation with 2 mg of Versed and 50 mcg of Fentanyl was again administered rapidly within 1 minute as surgery was started, despite the problem that had occurred on 9/29/11 with the same drugs and same doses. In fact, an additional 2 mg of Versed was administered 5 minutes later, with no documented justification for pain, restlessness, or discomfort that would warrant additional sedation treatment. Pain levels were documented as zero, while sedation levels were "frequently drowsy" throughout the procedure. A machine printout of breathing rate showed periods of very rapid breathing. However, no supplemental oxygen, skin color, airway features or depth of breathing were documented throughout the procedure.

c. Patient 15, age 78 with co-existing conditions of high blood pressure, gout, medication-treated sleep disorder, and seizure disorder, had bowel surgery under RN-administered moderate sedation on 2/25/11 for rectal bleeding after a recent bowel biopsy. At the start of surgery, 3 mg of Versed and 50 mcg of Fentanyl were administered rapidly within 1 minute. Pain level was zero and sedation level was drowsy at the time of the drug administration. Additional 1 mg Versed and 25 mcg of Fentanyl were administered one minute later. Supplemental oxygen administration was not documented. A machine printout of breathing rate showed a breathing rate of 5 breaths per minute (normal rate is 12 breaths per minute) at the time of the first drug administration, and no rates were documented thereafter. During surgery, a bleeding site was identified which required injection of a high risk medication to reduce blood flow to the site. No nursing assessments of skin color, airway features, directly measured breathing rate or depth of breathing (particularly during the period when the machine did not record measurements), or regularity/alterations of heart rhythm were documented.

d. Patient 16, age 75 with co-existing conditions of high blood pressure, previous open heart surgery, and a breathing disorder during sleep (sleep apnea), had bowel surgery under RN-administered moderate sedation on 2/24/11 for rectal bleeding and low blood pressure that required rescue treatments in the emergency room on 2/23/11. Five minutes before surgery started, 2 mg of Versed and 25 mcg of Fentanyl were administered rapidly within 1 minute. Three minutes later, additional 1 mg of Versed was administered when the pain level was zero and Patient 16 was drowsy. Seven minutes later, 1 mg Versed and 25 mcg Fentanyl were administered when the pain level was 2 out of 10 (highest) and sedation level was unchanged as drowsy. A machine printout showed high breathing rates through portions of the surgery. No supplemental oxygen administration was documented throughout the sedation and surgery treatments, or during the recovery period. No nursing assessments of skin color, airway features, directly measured breathing rate or depth of breathing, or regularity/alterations of heart rhythm during the sedation and surgery treatments were documented.

e. Patient 17, age 61 with co-existing conditions of high blood pressure, diabetes, severe lung disease, past open heart surgery, obesity, and recent hospitalization for pneumonia and a blood clot in the leg, had heart surgery under RN-administered moderate sedation in the heart studies laboratory on 9/12/11 for a new-onset and currently evolving heart attack that could require life-saving interventions. Tests showed moderate kidney failure prior to surgery. No nursing or airway physical assessments by the sedation RN were documented. No blood pressure was documented from arrival in the surgical unit at 12:33 p.m. to 12:54 p.m., during which time injections of a high risk skin anesthetic medication, dye contrast medications for x-ray imaging, and 2 mg of Versed into the vein were administered. Machine-recorded entries of vital sign measurements, pain level, and sedation level were documented, but pain and sedation levels were repeatedly carried over and did not reflect actual observations by the monitoring RN. A narcotic medication for chest pain was administered at 1:18 p.m., with no evidence the treatment was effective. Continued monitoring of medication effects was not documented for 30 minutes between 1:24 p.m. and 1:55 p.m. as Patient 17 was transported to a post-surgical location. No nursing assessments of skin color, directly-measured breathing rate or depth of breathing, or regularity/alterations of heart rhythm during the sedation and surgery treatments were documented.

Review on 10/12/11 of the 2011 Association for Peri-Operative Registered Nurses (AORN) Guidance Statement: Safe Medication Practices in Perioperative Settings Across the Life Span directed RNs to continually assess, monitor, and document each patient's response to medications administered.

Review on 10/12/11 of the 2011 AORN Guidance Statement: Preoperative Patient Care in the Ambulatory Surgery Setting, directed at settings where invasive procedures such as heart studies, bowel and lung surgeries were performed, documented that a perioperative RN should conduct a preoperative nursing assessment on admission to the surgical unit on the day of surgery. The assessment should include baseline physical assessment and a nursing plan of care based on risks for compromised breathing, infection, and other risk areas related to surgery and anesthesia (including moderate sedation care).

Review on 10/12/11 of the 2011 AORN Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia documented under item III documented the elements of a pre-sedation nursing assessment, to determine a patient's suitability for RN-administered moderate sedation. Recommendations directed the perioperative registered nurse to perform an assessment of the patient's airway before administering moderate sedation/analgesia, to consult with an anesthesia provider if the patient presented with a history of severe sleep apnea, to use continuous positive airway pressure (CPAP) machines for selected sleep apnea patients, and to position high-risk patients in a manner to facilitate an open airway. Recommendation II also recommended consultation with an anesthesia professional for patients with a known history of heart or breathing instability (such as Patient 17), previous difficulties with sedation, airway-related issues, and one or more significant co-existing health conditions (Patients 4, 15, 16, and 17). Recommendation VI documented that Monitoring of vital sign measurements, level of consciousness, comfort level, adequacy of breathing, and other indicators should be performed before starting the procedure, after administration of sedative or analgesic medications, and periodically, at least every five minutes during the procedure. Recommendation V(c) documented, "Each IV agent should be administered separately in incremental doses and titrated to desired effect." Recommendation XI documented that policies and procedures for managing patients receiving moderate sedation/analgesia should include "risk assessment and criteria for consultation (e.g., anesthesia)," and "moderate sedation/analgesia medication administration and dosage guidelines."

Review on 10/10/11 of the hospital's training module for moderate sedation, last reviewed 1/11, documented "relative contraindications to moderate sedation" that caused increased risk for complications (conditions that were present in Patients 4, 15, 16, and 17) as: concurrent heart attack, moderate kidney failure, and severe lung disease. Instead of consulting with an anesthesia provider, the training directed RNs to confer with the ordering physician. There was no specific guidance for managing patients with obesity, large tongues, thick necks, or sleep apnea who would benefit by specialized airway support and/or care by an anesthesia professional. In a section titled Elderly Patients, a warning that such patients may "become toxic on standard dosing or have prolonged or exaggerated drug effects" with direction to "reduce dose and prolong dosing intervals" was noted. However, specific dose limits or formulas for determining the dosing reductions were not provided. Under Narcotic Specific Precautions was documented "rapid IV administration increases the incidence of adverse reactions." A section titled Pre-Procedure Assessment Protocol directed the RN documented assessment to include a "review" of health conditions including sleep apnea, lung sounds, abnormal airway structure, physical assessments, vital sign measurements, and other items, but did not direct the RN to perform such assessments directly and document the results. References for the training module ranged from 1991 to 2002.

Review on 10/10/11 of a hospital-wide policy titled IV Sedation - Adult Patient, last approved 8/08, documented as Patient Criteria the same items described as relative contraindications in the sedation training module described above, without specifying when to consult with an anesthesia professional. Under Procedure item VI(D), "Place patient on supplemental oxygen" was documented; yet Policy item III(F) read "Patients are to receive supplemental oxygen during IV sedation except [bowel and lung surgery] patients whose initial oxygen saturations are above 94%," without justifying why bowel and lung surgery patients' risks would be different from other patients. Tables of sedation/analgesia medications that listed dosing and methods of administration were attached to the policy. One table documented administration of Versed to be titrated every 3 to 5 minutes, and Fentanyl every 5-10 minutes. Another table gave maximum total dosages for Versed and Fentanyl, and documented "In older or debilitated patients, dosages need to be reduced," without providing specific dose limits or reduction formulas for age and combinations of drugs. The organizational references for this policy were dated 1993 for the Association of peri-Operative Registered Nurses (AORN) reference, and 1996 for the American Society of Anesthesiologists (ASA) reference (outdated).

Review on 10/10/11 of a policy titled IV Medications, last approved 5/24/11, directed the RN to review the manufacturer literature when preparing ordered medications. In an attachment under Guidelines for IV Push Medication, the minimum rate of administration for Fentanyl was listed as "3-5 minutes, rapid administration may cause chest wall rigidity." In a separate attachment under Guidelines: Comments/Monitoring Considerations for Versed documented "Administer over at least 2 minutes and wait at least an additional 2 minutes to fully evaluate effect. High Risk Med; BBW (black box warning). May cause severe respiratory depression, respiratory arrest or apnea." However, the policy under item III(F) noted that the Monitoring Considerations section "contains recommendations and are not required, unless designated otherwise."

Review on 10/12/11 of the manufacturer's insert (Roche) for Versed (midazolam HCL) injection carried a boxed warning: "Intravenous Versed has been associated with respiratory depression and respiratory arrest (cessation of breathing), especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy (brain injury) has resulted. Intravenous Versed should be used only in hospital or ambulatory care settings, including physicians and dental offices that provide for continuous monitoring of [heart and breathing] functions."

The boxed warning further indicated, "The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult. Lower doses are necessary for older (over 60 years) or debilitated patients and patients receiving concomitant narcotic or other central nervous system (CNS) depressants. The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and allow an additional 2 or more minutes to fully evaluate the sedative effect."

According to a U.S. Food and Drug Administration Black Box Warning and Lexi-Comp, an online drug reference retrieved at , combining Versed with narcotics or other central nervous system depressants (Fentanyl) "poses particular risk for respiratory depression, apnea (stop breathing) or respiratory arrest. Versed doses should be reduced by 30-50%. "

It was further indicated, "Conscious sedation: Elderly I.V.: Initial 0.5 mg slow, give no more than 1.5 mg in a 2 minute period; if additional titration is needed, give no more than 1 mg over 2 minutes, waiting another 2 or more minutes to evaluate sedative effect; a total dose of >3.5 mg is rarely necessary."

The Lexi-Comp reference website, , provided information about intravenous fentanyl. Specific caution for geriatric patients was given, "Elderly have been found to be twice as sensitive as younger patients to the effects of fentanyl." Starting dose was 25 micrograms given slowly, with the same warning to reduce dosage by 25-33% when combined with other central nervous system depressants (such as Versed).

The drug manufacturer's insert (Hospira) for Fentanyl Citrate Injections categorized the drug as a narcotic analgesic. "The onset of action of fentanyl is almost immediate when the drug is given intravenously; however, the maximal analgesic and respiratory depressant effect may not be noted for several minutes. The usual duration of action of the analgesic effect is 30 to 60 minutes after a single intravenous dose of up to 100 mcg ... The peak respiratory depressant effect of a single intravenous dose of fentanyl citrate is noted 5 to 15 minutes following injection." Under Precautions section it was noted, "The initial dose of fentanyl citrate should be appropriately reduced in elderly and debilitated patients. The effect of the initial dose should be considered in determining incremental doses." It was noted, "Cardiovascular Effects: Fentanyl may produce bradycardia (slowed heart rate), which may be treated with Atropine. Fentanyl should be used with caution in patients with cardiac bradyarrhythmias (slow heart rate rhythms)." The Adverse Reactions section noted that "As with other narcotic analgesics, the most common serious adverse reactions reported to occur with fentanyl are respiratory depression, apnea, rigidity, and bradycardia; if these remain untreated, respiratory arrest, circulatory depression or cardiac arrest could occur."

In an interview on 10/5/11 at 10 a.m. with CN 1, a nurse manager for the perioperative location where bowel and lung surgeries were routinely performed, CN 1 acknowledged that surgeons routinely ordered, and RNs implemented, rapid administration of sedation/analgesia medications without adjusting dosages for age and condition of the patient, as directed in the hospital sedation training module and national sedation care guidelines.

Review on 10/5/11 at 2:30 p.m. of the medical records for Patients 4, 15, 16 and 17 (all patients over the age of 60 with multiple serious co-existing conditions and risks for adverse reactions during IV sedation and surgery, and patients who had IV sedation care supervised by physicians with IV sedation privileges) with Administrator (ADM) 1, who supervised the perioperative nurse managers and directors, ADM 1 acknowledged that Patients 4, 15, 16 and 17 were not administered IV sedation medications as recommended by the product labeling and U.S. Food and Drug safety administration (FDA), or by the medication policies and IV sedation training modules currently used by the hospital. [Drugs were administered rapidly without adjustments in dosing for age and condition, oxygen was not consistently administered, RNs were not assigned to continuously monitor each patient, RNs did not document physical assessment prior to sedation.]

2. Medications were not administered as ordered.

Review of medical records on 10/4/11 at 4 p.m. with the Director of Quality Management (DQM) and on 10/5/11 at 3 p.m. with the Director of Pharmacy Services (DP), confirmed the following:

a. Patient 15 was admitted to the hospital on 2/24/11 for rectal bleeding related to a surgical procedure ten days earlier. Pre-operative medications to prepare Patient 15 for further surgery included orders for a laxative drink to be given right away when Patient 15 was in the emergency room on 2/24/11 at 10 p.m., and again at 6 a.m. the next morning on 2/25/11 prior to surgery. The 6 a.m. order was not transferred to a medication administration record along with other medications, and was not documented as administered. Prior to surgery, the surgeon documented "Prep was just yellow," indicating the stool was not clear as expected with a successful bowel prep. Surgery did proceed, with the potential to have poor visualization of a lesion or bleeding site in the bowel and increased risk for surgical site infection from excessive bacterial presence at the site.

b. Patient 18 had open heart surgery to replace a heart valve on 8/2/11. An order was documented on 8/2/11 at 2 p.m. for a post-operative antibiotic to be given every 12 hours for 48 hours, starting at 6 p.m. on 8/2/11. The medication administration record documented the antibiotic start was administered at 6:59 p.m., one hour late. Steady-state blood levels of antibiotics rely on precise dosing intervals for the antibiotic to be optimally effective.

c. Patient 19 was admitted to the hospital on 7/22/11 for a gallstone problem that required surgical repair. An order for an antibiotic was issued in the emergency room on 7/22/11 at 7:12 p.m. and administered at 8:20 p.m. Admitting orders documented to administer the same antibiotic every 6 hours, starting with the 8:20 dose. The next administration of the antibiotic was documented on 7/23/11 at 6:55 a.m., ten hours after the previous dose, and 2 hours after the time scheduled by the pharmacy to be administered (5 a.m.) as noted on the medication administration record. Optimal pre-operative antibiotic benefit was not achieved by this 4 hour delay in administration.

Review on 10/10/11 of a hospital-wide policy titled Medication Administration - Non-IntelliDOT and IntelliDot System, last approved 10/10, documented, "Medication may be given only upon the specific written order of the physician ... All orders must specify the name of the drug, the amount to be given, the frequency to be given..."

Review on 10/12/11 of the 2011 AORN Guidance Statement: Preoperative Patient Care in the Ambulatory Surgery Setting, intended for care performed in settings where invasive procedures were performed, documented that a pre-operative nursing assessment should verify that prescribed surgical preparations were administered prior to surgery.

Review on 10/12/11 of the California Code of Regulations Title 22, a state standard for general acute care hospitals, under Division 5, Chapter 1, section 70263(g)(2) documented, "Medications and treatments shall be administered as ordered."

2d. Patient 4, age 91, was admitted to the hospital on 9/2/11, for treatment of a bowel infection ( C diff colitis) and had a history of dementia and a heart rhythm disorder. During record review on 10/4/11 at 8 am, Patient 4's medication administration record (MAR) for 10/3/11 (7 am) through 10/4/11 (7 am), read that Patient 4 had 20 routine medications ordered by her physician during that 24 hour period.

The documentation on the MAR, by licensed nurses RN 10 and RN 11, indicated that during this same 24 hour period, seven medications were given late (outside the 30 minutes before or after the scheduled medication administration time) and five medications were not given. The risk management manager (MGR 3) verified the late/omitted medications for Patient 4 and stated it was the facility policy and procedure (P&P) to administer medications, that are scheduled at routine times and/or intervals, within 30 minutes before to 30 minutes after the scheduled time/dose.

The following medications were administered late or not given, on 10/3/11 (7 am) to 10/4/11 (7 am), to Patient 4:
Metronidazole (Flagyl, antibiotic, ordered 9/22/11) 500 milligrams (mg) PO (by mouth) 3 times a day - 9 am dose not given, 1 pm dose delayed - then given 3 hours (hr) and 25 minutes (min) late that resulted in the 5 pm dose not being given.
Vancomycin (antibiotic, ordered 9/22/11) 250 mg PO 4 times a day - 9 am dose given 48 min late, 1 pm dose given 3 hr and 26 min late that resulted in the 5 pm dose not being given, and the 9 pm dose 28 min late. Consistent blood levels of antibiotics rely on precise timing of doses for the antibiotic to be most effective.
Nystatin (anti-fungal, ordered 9/23/11) 1 application topically every 6 hr and as needed for incontinence - 12 pm dose documented as delayed/not given at 12:43 pm, 6 pm dose not given. Consistency in the application of timed topical antifungals and as needed after the patient is cleaned from incontinence (unable to control urine and/or bowel movements) is important to keep the anti-fungal medication at its' most effective level.
Rifaximin (anti-diarrheal, ordered 9/29/11) 550 mg PO 2 times a day - 9 am dose given 29 min late, 9 pm dose given 13 min late. Outside facility P&P time span.
Albumin (protein found in the tissue and fluids of plants and animals, ordered 10/1/11) 25% 100 milliliters (ml) IV (intravenous-administered through a small catheter/tube placed into the patients vein) every 8 hrs. 12 pm dose given 13 min late. It is important to keep consistent protein levels within the body to avoid further and possibly life threatening complications by administering the fluid protein replacement at precise/ordered time spans.

A facility P&P titled "Medication Administration - Non-IntelliDOT and IntelliDOT System - Hospitalwide" (version 1, III (O)(3)) and last updated 10/10, read "Medications must be administered within 30 minutes prior to, or 30 minutes after the designated schedule time."

During an interview on 10/4/11 at 11:30 am, a licensed nurse (RN 12) stated that during the day shift of 10/3/11 she could see that RN 10 was "rushed" and asked her if she could help RN 10 with anything. RN 12 stated RN 10 politely refused RN 12's assistance and indicated she was "just a little behind" on her meds.

When asked to for this surveyor to interview RN 10, the charge nurse (CN 2) stated that RN 10 was not working 10/4/11 but was scheduled to work the day shift the next day (10/5/11). During an interview on 10/5/11 at 7:15 am, a case manager (CM 1) stated that RN 10 had been terminated from her traveling contract with the facility on 10/4/11. MGR 3 stated RN 10 had not been terminated because of the medication errors on 10/3/11 but that was just another addition in a culmination of problems related to RN 10.

3. Medication orders were not documented by an authorized prescriber.

Review on 10/6/11 at 2:30 p.m. of medical records with ADM 1 confirmed the following:

a. Patient 15 had lower bowel surgery under RN-administered moderate sedation on 2/25/11. Medications administered during surgery included IV fluids, sedation and pain medications. The medications were verbally ordered but not noted as such. No physician-signed orders for these same medications were documented. [Patients 4 and 16 also had bowel surgeries under RN-administered moderate sedation with administration of IV fluids, oxygen, sedation and pain medications via verbal directives, which were not documented as verbal orders with a "read-back" step to minimize risk for errors.]

b. Patient 17 had heart surgery under RN-administered moderate sedation on 9/12/11. Medications administered by staff during the surgery included contrast dye for x-ray imaging, oxygen, IV fluids, sedation and pain medications, which were documented in an electronic software program. No physician-signed orders for these same medications were documented. Some medications were issued verbally, but not documented as such with read-back.

Review on 10/3/11 of the 5/11 Medical Staff Rules and Regulations, under Section B-3 documented, "Orders shall be in writing. Verbal orders shall be written and signed by a registered nurse [or authorized person]."

Review on 10/10/11 of a hospital-wide policy titled Medication Administration - Non-IntelliDOT and IntelliDOT System, last approved 10/10, documented under item III(A)(1), "Medication may be given only upon the specific written order of the physician ... All orders must specify the name of the drug, the amount to be given, the frequency to be given, the route of administration and reason if PRN (as needed basis). If any of these elements are missing, the order must be clarified with the prescriber before administering." Item III(A)(2) read, "Each verbal/telephone order should be read back to the provider to assure accuracy."

Review on 10/10/11 of a hospital-wide policy titled Medication Prescribing & Ordering, last approved 10/09, documented under item II, "Individuals who prescribe/order medications are authorized legally and granted clinical privileges to do so, either by written or oral order." Item II(A) documented that a verbal order was to be countersigned by the physician within 24 hours.

Review on 10/12/11 of the 2011 AORN Guidance Statement: Safe Medication Practices in Perioperative Settings Across the Life Span directed RNs to perform a "read-back" of each verbal order.










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4. No Physician's order to run an IV fluid continuously to keep a vein open.

During an observation of medication administration on 10/4/11 at 9:30 a.m. RN 7 was observed to insert an intravenous (IV) tubing into a 100 mL minibag of Penicillin G four million units (an intravenous antibiotic) and hang the minibag on the upper hook of the bedside IV pole; flush Patient 25's central intravenous line with 10 mL of normal saline (0.9% sodium chloride); then piggyback the antibiotic solution tubing into the primary IV tubing. RN 7 then set Patient 25's intravenous pump to infuse the antibiotic solution over one hour. Hanging on lower hook of the IV pole (and attached to the primary IV tubing) was a partially infused 500 mL bag of intravenous normal saline (labeled with a small adhesive bar code label indicating Patient 25's name, physician, medical record number, age, date of birth and date of admission). RN 7 stated the bag of normal saline was being infused at 20 mL/hr as a "TKO" (to keep the vein open) so that Patient 25 would not be awakened when her intravenous antibiotic was infused every four hours; RN 7 further stated that the "TKO" normal saline solution had not been ordered by Patient 25's physician.

At 10:15 a.m., a reconciliation of observations made during the medication pass with Patient 25's current Physician Orders revealed an order (dated 9/27/11) for Penicillin G four million units IV every 4 hours. Patient 25 had an additional Physician Order (written 9/26/11) to discontinue IV hydration fluids which had been ordered on 9/24/11 (normal saline).

During an interview on 10/4/11 at 10:25 a.m. RN 8 verified Patient 25's clinical record findings. A concurrent repeat observation at Patient 25's bedside revealed the partially infused 500 mL bag of normal saline; RN 8 confirmed that approximately 200 mL of solution remained in the bag. RN 8 further confirmed Patient 25 did not have a current physician's order for normal saline as a "TKO," and therefore it should not be infusing.

Review of the facility policy Medication Administration - Non-IntelliDOT and IntelliDOT System - Hospitalwide (dated 10/10), indicated under III. Policy: "A. General Policies: 1. Medication may given only upon the specific written order of the physician ...."

5. Failure to implement a physician's order for fingerstick blood sugar testing 4 times a day.

Clinical record review on 10/5/11 at 10:40 a.m.

Based on observation, interview, record and facility document review, the facility failed to ensure that pharmaceutical services met the needs of the patients as policies and procedures to provide safe and effective use of drugs were not implemented as evidenced by the following:

1. A diabetic plan of care was developed and implemented in accordance with facility policy (Refer to A-0396).
2. Medications were administered in accordance with the order of the practitioner and facility policy (Refer to A-0404).
3. Medication storage areas were inspected monthly by a pharmacist in accordance with facility policy (Refer to A-0492).
4. Medications were controlled, distributed and administered to provide patient safety (Refer to A-0500)
5. The sterile compounding area was maintained in accordance with facility policy (Refer to A-0501)
6. The facility developed and implemented effective reporting systems for the identification of medications and adverse drug reactions (Refer to A-0508).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview, record review and facility document review the facility failed to ensure three of seven inpatient nursing station medication storage areas were inspected by a pharmacist monthly in accordance with facility policy, with the potential for unsafe or unsecure medication storage.

Findings:

On 10/10/11 at 9:55 a.m. copies of the monthly pharmacist drug storage inspection documents were requested from the pharmacy director (DP).

Review of the provided documents filed in the "Pharmacist Inspections" binder revealed the following findings for three of the seven patient care units reviewed:

1 West: Monthly pharmacist drug storage inspection dated September 2011; next filed inspection document dated May 2010;
CVICU: Monthly pharmacist drug storage inspection dated October 2011; next filed inspection document dated April 2010;
ICU: Monthly pharmacist drug storage inspection dated October 2011; next filed inspection document dated April 2010.

During an interview on 10/10/11 at approximately 11:45 a.m., the DP confirmed missing the data for monthly pharmacist drug storage inspections for 15 months (1 West); 17 months (CVICU); and 17 months (ICU). DP indicated there has been staffing turnover of pharmacists and assignments have been re-organized; and acknowledged the monthly inspections are not being consistently completed throughout the hospital as a result.

Review of the facility policy, Drug Storage Inspections - Pharmacy, dated 5/10, indicated under IV. Procedure: "A. Inspections will be conducted at least every 30 days by a pharmacist .... B.4. Complete the Drug Storage Inspections Checklist (Attachment 1). List any details of any item that is out of compliance a. The pharmacist will be responsible for the identification and removal of outdated, deteriorated, and unauthorized drugs from stock."

Based on observation, interview, clinical record and facility document review, the facility failed to implement their policy for safe and effective medication use for three of 30 sampled patients (Patients 24, 29 and 30) when:

1. Fentanyl transdermal patches (skin patches applied to the skin containing fentanyl, a potent narcotic pain medication) were dispensed for two (Patients 29 and 30) who were non-opioid tolerant according to manufacturer specifications and facility guidelines, with the potential for respiratory depression and death.

2. Patient 24's oral metoclopramide (a medication that enhances gastric motility) was not scheduled before meals in accordance with manufacturer specifications and facility guidelines, with the potential for lack of effectiveness.

Findings:

1a. During an interview on 10/5/11 at 4:30 p.m. DP and RPh 1 discussed revisions to their pharmacy guidelines, based on patient safety and previously identified non-compliances during a Medication Error Reduction Plan licensing survey conducted by the Department in August 2011. The guidance revisions focused on determining opioid tolerance prior to the dispensing of fentanyl transdermal patches. DP and RPh 1 indicated that details of the guidelines were revised and communicated during an all-staff pharmacy meeting on 9/8/11 when the pharmacists were directed to objectively document (in the patients' electronic pharmacy profiles) the prior 7 days' opiate usage to demonstrate opioid tolerance prior to dispensing fentanyl patches; if the narcotic use was deemed insufficient according to the guidelines, the pharmacists were directed to contact the prescriber. DP and RPh 1 indicated an attempt to implement a physician-driven "Fentanyl Patch Order" protocol was rejected at the Pharmacy and Therapeutics Committee meeting on 9/27/11.

According to the manufacturer package insert, the fentanyl (also known as Duragesic) patch is a very potent narcotic (opioid) pain medication applied to the skin. Fentanyl patches are indicated only for treating persistent, moderate to severe pain in patients who are opioid tolerant (patients who take regular doses of around-the-clock narcotic pain medication). Opioid naive patients (who do not take regular, daily around the clock narcotic pain medication) have increased risk for side effects including respiratory depression (decreased breathing rate) and death.

Additionally, the Food and Drug Administration (FDA) required fentanyl patch manufacturers to place the following warning on the labeling: "Fentanyl should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl 25 mcg/hr. Patients who are considered opioid tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. Because serious or life-threatening hypoventilation could occur, fentanyl patch is contraindicated in patients who are not opioid-tolerant."

Review of the revised facility guidelines for fentanyl patch administration (available in the pharmacy's electronic alert system when orders are profiled by a pharmacist), provided by RPh 1, revealed:
"Indications: Fentanyl patches are indicated for the management of persistent, moderate to severechronic (sic) pain that requires continuous opioid administration for an extended period of time AND cannot be managed by other means.
Contraindications to use due to risk of serious or life-threatening respiratory depression:
1. Patients who are not opioid tolerant
2. Management of postoperative pain
3. Management of mild pain or intermittent pain
4. Management of acute pain or if opioid analgesia is only needed for a short period of time.
Patients must be opioid tolerant. Patients must have been taking:
A. Morphine PO, at least 45 mg/day, for at least 7 days.
B. Oxycodone PO, at least 30 mg/day, for at least 7 days.
C. Hydromorphine PO, at least 8 mg/day, for at least 7 days.
D. An equianalgesic dose of another opioid, for at least 7 days."

Closed record review on 10/5/11 at 4:45 p.m. revealed Patient 29 was a 79 year-old admitted to the facility on 9/20/11 (through the emergency department) with diagnoses including pneumonia, lung cancer and osteoarthritis. Patient 29 resided at a skilled nursing facility prior to admission.

Review of Patient 29's history and physical (dated 9/21/11) revealed her pre-admission opiate-containing pain medication was Vicodin 5/500 every four hours as needed for pain; the document did not specify frequency of usage. Vicodin 5/500 contains 5 mg of hydrocodone (an opiate indicated for moderate pain) and 500 mg of acetaminophen (a mild pain reliever).

Review of Patient 29's Admission Medication Reconciliation form indicated, under "Active Home Meds " (taken prior to admission) her only opiate-containing medication pain medication was Vicodin 5/500 every 6 hours as needed.

Patient 29's admission Physician Orders included an order for Vicodin 5/500 every four hours as needed for pain.

During a concurrent interview, RPh 1 verified Patient 29's clinical record findings.

According to GlobalRph.com, oral hydrocodone 5 mg (a component of Vicodin 5/500) is approximately equivalent in opiate potency to oral morphine 5 mg. Source:

Review of Patient 29's emergency department (ED) Medication Reconciliation form, dated 9/20/11, indicated two Vicodin 5/500 tablets were administered in the ED.

Review of Patient 29's electronic MARs (for the 7-day period 9/20/11 through 9/26/11) revealed the following Vicodin usage:
9/20/11: No Vicodin administered after admission (total 10mg hydrocodone in ED, approximately equivalent to 10 mg oral morphine);
9/21/11: One Vicodin 5/500 tablet administered (total 5 mg hydrocodone, approximately equivalent to 5 mg oral morphine);
9/22/11: Two Vicodin 5/500 tablets administered (total 10 mg hydrocodone, approximately equivalent to 10 mg oral morphine);
9/23/11: Two Vicodin 5/550 tablets administered (total 10 mg hydrocodone, approximately equivalent to 10 mg oral morphine);
9/24/11: Three Vicodin 5/500 tablets administered (total 15 mg hydrocodone, approximately equivalent to 15 mg oral morphine);
9/25/11: Two Vicodin 5/500 tablets administered (total 10 mg hydrocodone, approximately equivalent to 10 mg oral morphine);
9/26/11: No Vicodin administered.

Further review of Patient 29's Physician Orders revealed on 9/27/11 (at 8:15 a.m.) for Duragesic 25 mcg (micrograms) patch "now and every 72 hours;" review of Patient 29's 9/27/11 electronic MAR indicated the 25 mcg patch was applied by licensed nursing staff at 9:35 a.m.

Review of the dispensing pharmacist's electronic profile clinical documentation (dated 9/27/11) revealed documentation, "ASSESSED PATIENT IS OPIOID TOLERANT ....CLINICAL EXPLANATION: PT [patient] IT (sic) NEW PT BEING PUT ON HOSPICE PT WAS RECEIVEING (sic) VICODIN PREVIOUSLY."

Further clinical record review revealed that on 9/27/11 at 3:25 p.m. RPh 2 wrote a physician verbal order to decrease Patient 29's fentanyl patch to 12 mcg every 3 days; review of Patient 29's 9/27/11 electronic MAR indicated the 12 mcg patch was applied at 6 p.m. (approximately 8.5 hours after the initial 25 mcg patch).

During an interview on 10/6/11 at 8:30 a.m. RPh 2 verified receipt of the verbal order from Patient 29's physician on 9/27/11 to decrease Patient 29's fentanyl patch from 25 mcg to 12 mcg every 3 days after being informed of the 25 mcg physician order by the staff pharmacist who authorized dispensing of the first dose the same morning. RPh 2 stated that she spoke with Patient 29's physician, who indicated the patient was taking "max doses" of Vicodin before admission at the skilled nursing facility; RPh 2 acknowledged that she reviewed Patient 29's hospital usage of Vicodin 5/500 during the time period 9/20/11 through 9/26/11, but not at the pre-admission MARs from the skilled nursing facility; RPh 2 stated the 12 mcg fentanyl dose was "appropriate." RPh 2 acknowledged that Patient 29 was not opioid tolerant according to facility (45 mg per day oral morphine equivalent) or manufacturer guidelines for 7 days prior to initiation of the fentanyl patch on 9/27/11, and was unable to provide manufacturer information supporting the use of a 12 mcg patch in a non-opioid tolerant patient.

During an interview on 10/6/11 at 9:30 a.m. RPh 1 confirmed that on the morning of 9/27/11 a staff pharmacist had authorized the dispensing of a fentanyl 25 mcg patch for Patient 29 and had documented opioid tolerance had been achieved in the pharmacy's electronic profile system.

1b. Closed record review on 10/6/11 at 9:55 a.m. revealed Patient 30 was a 79 year-old admitted 9/6/11 with multiple diagnoses including a history of bladder carcinoma, alcoholic cirrhosis of the liver and frequent falls.

Review of Patient 30's history and physical (dated 9/7/11) indicated she was receiving no opiate pain medications prior to admission.

Review of Patient 30's admission orders revealed Physician's Orders for Dilaudid 1 mg orally every 4 hours as needed for moderate pain (or Dilaudid 0.5 mg IV every 4 hours as needed if not tolerated or cannot take by mouth); and Dilaudid 2 mg orally every 4 hours as needed for severe pain (or Dilaudid 1 mg IV every 4 hours as needed if not tolerated or cannot take by mouth). Dilaudid is the brand name for hydromorphone.

Review of Patients 30's MARs (for the 7 day period 9/6/11 through 9/12/11) revealed the following oral and IV Dilaudid usage:
9/6/11: No Dilaudid administered;
9/7/11: Total 2 mg oral Dilaudid administered;
9/8/11: Total 6 mg oral and 1 mg IV Dilaudid administered;
9/9/11: Total 6 mg oral Dilaudid administered;
9/10/11: Total 6 mg oral Dilaudid administered;
9/11/11: Total 6 mg oral Dilaudid administered;
9/12/11: 2 mg oral Dilaudid administered at 8:18 a.m.

Further review of Patient 30's Physician Orders revealed an order for Duragesic patch 25 mcg every 3 days on 9/12/11 at 9:30 a.m. Review of Patient 30's 9/12/11 electronic MAR indicated the first patch was applied by licensed nursing staff at 9:50 a.m.

Review of the dispensing pharmacist's electronic profile clinical documentation (dated 9/12/11) revealed documentation, "ASSESSED PT IS OPIOID TOLERANT ....CLINICAL EXPLANATION: PT ASSESSED FOR DURAGESIC PATCH - PT HAS BEEN RECEIVING DILAUDID 6 - 8 MG/DAY FOR PAST 6 DAYS (FROM 9/6 TO 9/12); PT IS GOING TO HOSPICE CARE; STARTING DOSE OK; CANCER PATIENT."

During an interview on 10/6/11 at 10:40 a.m. RPh 1 verified Patient 30's clinical record findings and acknowledged Patient 30 was not opioid tolerant according to facility (8 mg per day of oral Dilaudid) or manufacturer guidelines for 7 days prior to initiation of the Duragesic patch on 9/12/11. RPh1 was unable to provide manufacturer information supporting the use of Duragesic patches in cancer patients who are non-opioid tolerant.

During a concurrent interview, DP indicated the staff pharmacists who dispensed Duragesic patches to Patients 29 and 30 were not working that day and therefore unavailable for an interview.

2. During an observation of medication administration on 10/4/11 at 9:10 a.m. RN 9 was observed to prepare and administer a dose of oral metoclopramide 5 mg to Patient 24 (along with his other scheduled morning medications). Patient 24 indicated that he had consumed part of his breakfast; a covered meal tray was observed on a table adjacent to the left side of his bed.

At 10:03 a.m., a reconciliation of observations made during the medication pass with Patient 24's current Physician Orders revealed an admission order (dated 10/3/11) for metoclopramide (also known as Reglan) 5 mg four times daily.

Review of Patient 24's electronic Medication Administration Record (MAR) indicated the morning dose of metoclopramide was scheduled at 9 a.m.

According to Lexi-Comp ONLINE, a nationally recognized medication reference resource, metoclopramide should be administered on an empty stomach 30 minutes before meals.

Review of the facility policy Medication Administration - Non-IntelliDOT and IntelliDOT System - Hospitalwide (dated 10/10), indicated under III. Policy: "N. Medication Administration Schedule: 11. It is recommended that some medications be administered before or after meals. Recommended administration times for these medications are designated on the computer generated M.A.R. 12. Standard times for Administering Drugs: a. a.c. [before meals] 7:30 - 11:30-5:30."

During an interview on 10/4/11 at 12:40 p.m. RPh 4, who indicated she had profiled Patient 24's admission orders into the computer on 10/3/11, stated she should have scheduled the metoclopramide MAR administration times before meals and at bedtime in accordance with manufacturer specifications and facility guidelines.

Based on interview, record review and facility document review the facility failed to ensure cleaning of the sterile compounding area was documented in accordance with facility policy and procedure for three of 15 months (for the period June 2010 through September 2011).


Findings:

During a tour of the pharmacy on 10/3/11 at 11:15 a.m. (accompanied by the pharmacy director (DP)), the cleaning records for the sterile compounding area (for compounding patient intravenous solutions) were requested. The failure of the facility to document the cleaning of the sterile compounding area indicated the area may not have been cleaned according to policy procedure which increased the risk of contamination to the IV solutions and thus increase the risk of potential harm to patients that received the compounded IV solutions.

The records provided by DP were filed in a binder labeled "I.V. Room Compliance." The documents (entitled "Pharmacy Cleaning Log for Compounding Area") detailed daily dates for cleaning and sanitizing of laminar airflow hoods (cabinets with highly filtered air used for compounding sterile intravenous medications); weekly cleaning of the "clean room" (enclosed room containing laminar airflow hoods) and monthly cleaning of the "ante room" (room adjacent to the clean room where supplies are stored and staff wash hands and don protective wear prior to entering the clean room). Staff signatures and dates were noted on the documents. The documents filed in the "I.V. Room Compliance" binder were dated from June 2010 to September 2011. A more detailed review of the log sheets revealed no cleaning records for July, August and December 2010.

During a concurrent interview, DP confirmed cleaning log sheets for July, August and December 2010 were not available.

Review of the facility policy, Sterile Operating Procedures for Sterile Compounding - Pharmacy, dated 1/10, indicated under IV. Procedure, item A: "Environmental Controls: 1. The cleaning, sanitizing and organizing of the direct and contiguous compounding areas (DCCA) is the responsibility of trained pharmacists and pharmacy technicians....5. Completion of all scheduled cleaning and sanitizing procedures will be documented."

Based on interview and facility document review the facility failed to report all adverse drug reaction (ADR) and medication error data to the hospital-wide quality assurance system in accordance with their policy, with the potential for delay in corrective actions and quality of care review.

Findings:

1a. On 10/10/11 at 9:55 a.m. copies of the monthly pharmacist drug storage inspection documents were requested; the pharmacy director (DP) indicated pharmacists completed monthly observations of medication administration as a component of the inspection.

Review of the facility policy, Drug Storage Inspections - Pharmacy, dated 5/10, indicated under IV. Procedure: "A. Inspections will be conducted at least every 30 days by a pharmacist.... B. Inspect the nursing unit for compliance with [facility name] policies regarding ....6. Medication administration: Observe the medication administration process by watching a nurse perform a medication pass ....b. Ensure safety measures are taken by the nurse, including....v. Verifies right drug, right dose, right time....ix. Administers right drug via right route and at right time (+/- 30 minutes of scheduled time)."

Review of the provided documents filed in the "Pharmacist Inspections" binder revealed "Observed Medication Pass" documents (with no patient name) completed by staff pharmacists on 1/20/11 and 8/22/11 that had handwritten check marks under "not met" for item #10: "Administers right drug via right route and at right time (+/- 30 minutes of scheduled time). Stays with patient until med taken."

Review of the facility policy Medication Error Prevention and Reporting - Hospitalwide, dated 7/10, indicated under I. Definition: "A. Medication Errors include inappropriate prescribing, patient noncompliance, dispensing errors and medication administration errors." Under III. Philosophy, the policy indicated: "B. Since medication errors may result in serious, adverse consequences for patients, the [facility name] has targeted Medication Administration as an area for on-going performance improvement on an organization-wide basis." IV. Policy indicated: "The On-Line Occurrence Report (Medication Incident Report form during computer downtime) shall be used hospital wide to report actual errors or incidents that have the potential to cause a significant error that are caught before the error reaches the patient. 1. Medication errors that reach the patient shall be reported immediately to the prescribing physician or his/her designee." Under VII. Types of Medication Errors, the policy defined: "....B. Wrong drug...F. Wrong rate/route....H. Wrong time (Administration of medication outside a predefined time interval from its 30 minutes before or after scheduled administration time)."

During an interview on 10/10/11 at approximately 11:45 a.m. DP confirmed that failure to give the right drug via right route and at right time (in accordance with facility policy) would constitute a medication error. DP acknowledged that the possible medication errors observed by staff pharmacists on 1/20/11 and 8/22/11 were not fully defined; and because the name of the patient was not documented it would be difficult to verify if the possible medication errors were reported to the patients' physicians or through the hospitalwide medication error reporting system and quality assurance program.

1b. During an interview on 10/10/11 at approximately 11:45 a.m. DP stated medication error data was reported and analyzed quarterly at the Medication Safety Committee meeting (a sub-committee of the Pharmacy and Therapeutics Committee) that DP indicated was established January 2011.

Review of the Medication Safety Committee minutes for January, February, March, April, May, June, July and August 2011 revealed that on 1/28/11 the committee discussed a summary review of 132 medication errors dating 1/10 through 6/10; DP indicated no Medication Safety Committee meetings had been held since August 2011. When asked to provide documentation of quarterly review of medication errors by the Medication Safety Committee since January 2011, DP was unable to provide documentation that quarterly review of medication errors had occurred. When asked to specify the committee where the medication errors were being reported for interdisciplinary review and input DP stated, "Medication errors are not going anywhere right now."

Review of the facility policy Medication Error Prevention and Reporting - Hospitalwide, dated 7/10, indicated under IV. Policy, item A: "7. Medication errors shall be tracked and trended with summaries reported and reviewed by Department Managers and the Medical Staff through appropriate channels a. Significant medication errors....shall be reviewed by the Pharmacy and Therapeutics Committee quarterly. Under XIII. Medication Error Prevention and Reduction Program Elements, item N indicated: "Committees that participate in the organizational oversight of medication use safety include, but are not limited to....4. Pharmacy & Therapeutics Sub-Committee (P & T)." Under item XIV. Program Implementation, the policy indicated: "A. Performance measurement data is collected, trended and analyzed to determine if opportunities exist to prevent and reduce medication errors....C. Opportunities to reduce medication errors that reflect system issues are addressed through the organization's performance improvement process."

During an interview on 10/10/11 at 12:30 p.m. DP acknowledged that a review and analysis of hospitalwide medication errors had not been addressed by the Medication Safety Committee since 1/28/11.

2. During a discussion of adverse drug reaction (ADR) reporting on 10/10/11 at 12:10 p.m. RPh 2 indicated that the Pharmacy and Therapeutics Committee had been reviewing serious ADRs, but that the Medication Safety Committee would be reviewing the data in the future.

RPh 2 indicated staff pharmacists do not individually follow up on potential ADR "triggers" (such as reversal agents for narcotics, sedatives, blood sugar lowering medications and blood thinners), but referred them to her for follow-up and analysis; RPh 2 further indicated "trigger drug" reports had not been analyzed for September 2011, and acknowledged physicians may not have been notified that an ADR had occurred resulting in the need for these reversal agents.

Review of the facility policy, Adverse Drug Reaction Program - Hospitalwide, dated 6/09, indicated under III. Procedure...."B. Pharmacy Screening: Pharmacists shall evaluate physician drug orders for antidotes, antihistamines, steroids, discontinued drugs, abrupt dosage reduction or doses held, lab and drug level orders and will try to correlate this information to screen for potential adverse drug reactions. All uses of Digibind [antidote for toxic blood levels of digoxin, a cardiac medication], flumazenil [a reversal agent for benzodiazepine-type sedatives] and naloxone [a reversal agent for opiate medications] will be reviewed to screen for potential adverse drug reactions. 2. Vigilanz will screen for trigger drugs, certain specified lab values or combinations of drug and lab values (warfarin and INRs [international normalized ratios, laboratory tests used to monitor blood clotting] greater than 3.5). The Vigilanz report will be reviewed by the pharmacist for reporting and Tracking Adverse Drug Reactions on a periodic basis and a summary analysis will be presented to the P & T [Pharmacy and Therapeutics] Committee."

During a continued interview, RPh 2 explained that Vigilanz was a data mining software used to screen for ADRs; RPh 2 stated she was "not using the software, as the data is hard to extrapolate." Rph 2 acknowledged that ADRs were under-reported at the hospital.

Based on observation, interview, and record review, the facility failed to ensure Infection Control collaborated with Environmental Services to provide consistent and thorough terminal cleaning of isolation rooms for patients on isolation for C-Difficile (C-diff- bowel infection). The failure of this collaboration resulted in the omission of bleach to be included in the policy and procedure for terminal cleaning of the isolation rooms that had contained patients with C-diff. This had the potential for environmental staff members not familiar with the terminal cleaning procedure for C-diff to use a product that would not be effective against the C-diff bacteria and infect the next patient entering those rooms.

Findings:

During an observation on 10/6/11 at 7:10 am, free-hanging, vertical, slatted blinds were observed across the length of the windows in the endoscopy room. The windows were near the top of the ceiling of the endoscopy room approximately 10 to 12 feet from floor level.

During an interview on 10/6/11 at 7:45 am, the housekeeping services manager (MGR 1) stated that the high windows in the endoscopy room were not cleaned after each case involving a patient with C-diff and that the vertical, slatted blinds were never included in the terminal cleaning for a room where a patient had been diagnosed with C-diff.

During an interview on 10/6/11 at 9:35 am, an environmental specialist (ES 1) stated she was familiar with the terminal cleaning process for the endoscopy room after a patient with C-diff had left the room. ES 1 stated to clean the room bleach was used instead of the usual hospital approved disinfectant. ES 1 stated she wiped down "everything" and then stated the blinds over the windows are individual slats and that these were not cleaned or wiped down in the terminal cleaning of the room.

During an observation with MGR 1 on 10/6/11 at 9:40 am, while in the cardiovascular intensive care unit (CVICU) it was observed that the rooms with windows facing an open courtyard had window blinds that were also vertical with individual slats. MGR 1 stated that these rooms with the vertical blinds would not be cleaned with the bleach during the terminal cleaning after a patient with C-diff had been discharged or moved to another room. MGR 1 stated that any room in the hospital with a window to the outside had the vertical blinds as "curtains" and that they were never removed unless damaged.

An Infection Control policy titled "Guidelines for Cleaning Isolation Patient Rooms on Discharge", last dated 1/09, there was no instruction or documentation in the policy & procedure (P&P) that bleach was used for the terminal cleaning of isolation rooms where C-diff had been identified. The guidance in the P&P for contact isolation, specifically for resistant bacteria and (C-diff), staff were to complete terminal cleaning "a hospital approved germicide and with the removal of cubicle curtains." MGR 1 verified that bleach was not included in the P&P for terminal cleaning of C-diff contaminated areas (i.e. patient, treatment, exam, and or surgical rooms) and if a staff member followed the policy and procedure they would have used the germicide rather than the bleach that was required..

During an interview on 10/6/11 at 10 am, MGR 1 stated the infection control coordinator (ICC) spoke with him "just about every day" but ICC had not mentioned a problem with the terminal cleaning. MGR 1 stated he got the P&P for terminal cleaning from the ICC.

During an interview on 10/5/11 at 3 pm, the ICC stated that C-diff cases were tracked by him in the facility and that the monitoring of trends for overall was a large area for his quality assurance performance improvement projects. The ICC stated the precautions for preventing the spread of C-diff included the terminal cleaning of all treatment rooms at the end of the day unless it involved an isolation case which would involve cleaning all surfaces with an approved solution then mopping after the case. The ICC verified the P&P for terminal cleaning had not been updated since 2009.

The Mayo Clinic patient information website () for C-diff read that the C-diff bacteria "produce hardy spores that can persist in a room for weeks or months" The recommendation to prevent the spread of C-diff in any setting was that "all surfaces should be carefully disinfected with a product that contains chlorine bleach." C-diff spores can survive routine cleaning products that do not contain bleach.

C-diff spores that have been spread to the vertical blinds by staff, patient, or visitor contact would in effect recontaminate the room after terminal cleaning unless these were also included in the total "surface" cleaning with bleach.

Based on observation, staff interviews, medical record and document reviews, the hospital failed to provide surgical services that were well organized and in accordance with nationally recognized standards of practice in order ensure safe and high quality surgical care to all patients as evidenced by:

A. The hospital failed to ensure that the organization of surgical services was appropriate to the scope of services offered as evidenced by inconsistent perioperative practices (e.g. surgical attire and traffic patterns, cleaning and disinfecting practices, ventilation monitoring, medication administration and post-operative nursing care) among various locations where surgical procedures were performed with fragmented oversight to provide clear direction of care in accordance with acceptable standards of practice. (Refer to A 0941)

B. The hospital failed to ensure that unlicensed surgical technologists (Techs) who functioned in the scrub nurse role for surgical procedures (1) performed within the scope of practice for unlicensed personnel, and (2) were supervised by a registered nurse who was not assigned to other dedicated duties, in accordance with acceptable standards of practice, in all surgical locations of the hospital. (Refer to A 0943)

C. The hospital failed to arrange for qualified registered nurses (RNs) to perform circulating duties in the operating room for all operating room locations in accordance with state regulations and acceptable standards of practice. (Refer to A 0944)

D. The hospital assigned surgical tasks and duties to physicians, allied health practitioners (AHPs, non-physicians with advanced medical practice skills), registered nurses (RNs) and surgical technologists (Techs) without verifying the qualifications and current competencies of those individuals, and for some, without delineating the authority to perform the duties through a formal privileging process, in accordance with acceptable standards of practice, hospital policies, and medical staff policies/bylaws. (Refer to A 0945)

E. 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)

F. The hospital failed to ensure that a complete and accurate updated examination and assessment of the patient, performed by the operating surgeon, to reflect the current condition of the patient was documented prior to surgery in accordance with hospital policies and acceptable standards of practice. (Refer to A 0952)

G. The hospital failed to ensure that the verification of informed consent for surgery was signed by an authorized party in accordance with hospital policy. (Refer to A 0955)

H. The hospital failed to ensure that each operating room was equipped with (1) an effective emergency call system, and (2) a tracheotomy kit that was immediately available, to ensure preparedness and timely emergency response for all surgical patients. (Refer to A 0956)

I. The hospital failed to ensure adequate immediate post-operative care was provided in accordance with physician orders, hospital policy, and acceptable standards of care. (Refer to A 0957)

J. The hospital failed to ensure the operating room register was complete and accurate to identify each patient's age, sex, and operating room number or location for each surgery performed in all surgical locations. (Refer to A 0958)

K. The hospital failed to ensure that an operative report describing techniques and findings in accordance with medical staff rules and regulations was documented immediately after surgery, and dictated in detail, by the operating surgeon. (Refer to A 0959)

These failures put patients at risk for adverse surgical outcomes or infections.

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.



27519

Based on observation, staff interview and document review, the hospital failed to ensure that the organization of surgical services was appropriate to the scope of services offered as evidenced by inconsistent perioperative practices (e.g. surgical attire and traffic patterns, cleaning and disinfecting practices, ventilation monitoring, medication administration and post-operative nursing care) among various locations where surgical procedures were performed with fragmented oversight to provide clear direction of care in accordance with acceptable standards of practice. This failure put patients at risk for medical errors or adverse surgical outcomes from poorly understood surgical care direction.

Findings:

1. Surgical attire and traffic patterns were varied among surgical locations.

During a brief tour of the bowel and lung surgery unit on 10/3/11 at 2 p.m., a physician dressed in street clothes, a paper cover gown, gloves and mask was observed to be talking on a portable telephone within the operating room during a surgical procedure for random Patient 31. The physician's shirt collar, lower pant legs and shoes were exposed. The physician wore no hair or shoe coverings. No signage or floor markings denoted limited access to the operative suite.

In an interview on 10/5/11 at 10 a.m. with CN 1, a nurse who managed the unit, CN 1 indicated that the physicians who routinely performed surgeries in the unit wore street clothing, with a paper cover gown, gloves and a mask during the surgery, but hospital-laundered clean surgical clothing, hair and shoe coverings were not required for any staff who performed decontamination, equipment processing, stocking, or operating room support in the surgical unit. CN 1 indicated that the unit nurses and technicians provided mobile services to distant units of the hospital as well as an outside surgery center. CN 1 indicated that The nurses and technicians often changed into clothing from the offsite surgery center, and wore those clothes back and forth to the hospital for the mobile services. CN 1 stated that hospital-issued clean surgical clothing was available to physicians and unit staff, but not required. Visitors to the surgical unit were not required to wear special garb when no procedures were in progress. Access to the operating room and storage/processing locations for staff was through the decontamination room. CN 1 indicated that the hospital policy was to wear full surgical attire in this surgical unit, the practice was otherwise and did not comply with policy.

Observations of care on 10/5/11 in the central operating room suite indicated that persons entering work rooms and operating rooms beyond the patient pre-operative/recovery room area wore clean hospital-issued scrub clothing, hats, dedicated shoes or shoe coverings, and masks in more protected locations. Surgeons wearing street clothes were not observed to enter operating rooms. Signs were posted on entry doors to limit access to authorized persons and a red line on the floor identified separation of traffic to restricted and semirestricted locations.

In an interview on 10/6/11 at 11:30 a.m. with the Infection Control Coordinator (ICC), the ICC stated that infection control policies and practices were based on the organizational standards or AORN and the Centers for Disease Control and Prevention (CDC). The ICC stated that the perioperative infection control practices were expected to be followed throughout the hospital where surgical activities were provided, including the standards for surgical attire. The ICC agreed that clean properly-laundered clothing or complete coveralls, hair coverings, and shoe coverings were standard for staff who worked in the restricted and semi-restricted surgical areas (where instrument processing, decontamination, supply storage, and surgery were performed). The ICC had no measurements of compliance for infection control practices by staff who worked in the bowel and lung surgery unit.

2. Cleaning and disinfection practices were varied.

In an interview on 10/5/11 at 10 a.m. with Tech 1, a technician who routinely assisted in surgical procedures, stocked supplies, and maintained the bowel and lung surgery unit throughout the day, Tech 1 indicated that between-case cleaning was limited to spraying a disinfectant on the outside surfaces of two carts used during surgery and wiping with a gauze pad after 30 seconds (the manufacturer recommended keeping wet for 10 minutes to be effective). Tech 1 indicated that staff did not include other surfaces close to the surgical field or touched during and after the surgery, such as machine dials and switches, specimen cart, desk, and computer in the between-case cleaning. Tech 1 indicated that three carts containing surgical equipment and supplies from the unit were routinely utilized to perform bedside procedures in distant parts of the hospital. The unit had no documented process or practice to periodically clean and disinfect the mobile carts, or other storage sites for equipment and sterile supplies. Tech 1 indicated that he was not aware of special cleaning and disinfecting policies designed for the distant locations where the mobile team performed surgeries, to prepare those spaces prior to surgery, or to clean up after the surgeries were performed.

In an observation of care between cases in a central operating room on 10/5/11 at 11 a.m., staff were observed to wipe off surfaces of instrument tables, kick buckets, operating tables, anesthesia cart, and cords or equipment that was to be reused on surgical patients with a disinfectant registered by the U.S. Environmental Protection Agency in the correct manner for the disinfectant to be effective. No surfaces in the operating room were omitted to be cleaned.

In an interview and review of policies on 10/6/11 at 10 a.m. with Manager (MGR) 1, who served as the contracted housekeeping manager, MGR 1 indicated that the bowel and lung surgery unit was cleaned at the end of the day by the staff who maintained the neighboring patient rooms of that wing of the hospital. However, the central operating room suite was cleaned at the end of the day by a dedicated staff experienced in surgical environmental services. Staff was expected to thoroughly clean in both locations. However, the policies did not specify to clean the portable air conditioner and air filter units, large exposed air ducts, or window blinds in the bowel and lung surgery unit as part of the end of day cleaning. Policies did not specify to clean contaminated surfaces in patient rooms after bedside procedures were performed.

3. Ventilation monitoring practices were varied.

On 10/5/11, during inspections of the surgical locations, logs of ventilation measurements (temperature, humidity, air exchange rates) were reviewed, but no logs for the bowel and lung surgery unit were presented. Administrative staff reported on 10/6/11 at 3 p.m. that logs of ventilation measurements were not maintained for the bowel and lung surgery unit.

In an interview on 10/6/11 at 11:30 a.m. with the Infection Control Coordinator (ICC), the ICC stated that monitoring of ventilation measurements in the bowel and lung surgery unit or distant procedure locations of the hospital were not captured as part of the infection control surveillance activities to minimize cross contamination and surgical site infections, as recommended by the Association for peri-Operative Registered Nurses and the Center for Disease Control and Prevention.

4. Medication administration practices did not comply with standards.

Review on 10/10/11 at 12:10 p.m. of medical records with Administrator (ADM) 1, who supervised the perioperative managers and directors, of patients who had surgeries under Registered Nurse (RN)-administered moderate sedation (moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, also known as moderate sedation/analgesia, IV sedation, or conscious sedation) indicated that high risk medications were given rapidly without adjustments for age, patient condition, or interval for each medication to exert its effect and be assessed for adverse reaction.

In an interview on 10/5/11 at 10 a.m. with CN 1, a nurse manager for the perioperative location where bowel and lung surgeries were routinely performed, CN 1 acknowledged that surgeons routinely ordered, and RNs implemented, rapid administration of sedation/analgesia medications without adjusting dosages for age and condition of the patient, as directed in the hospital sedation training module and medication policy, the product safety labeling, and national sedation care guidelines.

5. Post-operative nurse monitoring practices varied.

Review on 10/10/11 at 12:10 p.m. of medical records with Administrator (ADM) 1, who supervised the perioperative managers and directors, indicated that nursing staff did not document assessments of each patient's condition in accordance with AORN standards during surgery and in the critical first hour or two following surgery as ordered by a physician for two patients cared for in the heart studies laboratory and intensive care unit (Patients 17 and 18). Medical records for patients monitored after surgery in the post-anesthesia care unit did have standard assessments documented.

In an interview on 10/6/11 at 2:30 p.m. with ADM 1, ADM 1 acknowledged that several attempts to reorganize surgical services had been started, but not completed. For example, a perioperative nursing director was hired a year ago to improve the management of perioperative services. The new employee started meeting with staff, analyzing services, and revising policies, but had not implemented many planned changes. Over the past year, the Director of Anesthesia Services worked on revising moderate sedation policies, but the proposed alterations (which did not entirely conform to sedation standards) were still undergoing approvals and were not yet implemented. ADM 1 acknowledged that infection control surveillance activities were not capturing the surgical practices throughout the hospital.

Based on staff interview, medical record and document review, the hospital failed to ensure that unlicensed surgical technologists (Techs) who functioned in the scrub nurse role for surgical procedures (1) performed within the scope of practice for unlicensed personnel, and (2) were supervised by a registered nurse who was not assigned to other dedicated duties, in accordance with acceptable standards of practice, in all surgical locations of the hospital for 4 of 8 surgical records reviewed (Patients 4, 15, 16, and 17). These failures had the potential harm to patients for staff members to perform certain aspects of a surgical procedure when they are not adequately trained or specifically licensed to do so and the supervising registered nurse was assigned other duties during the procedure taking their attention away from the procedural accuracy of the technologists.

Findings:

1. In an interview on 10/5/11 beginning at 10 a.m. with Surgical Technologist (Tech) 1, a technician assigned to a mobile team that provided services for bowel and lung surgeries throughout the hospital, Tech 1 indicated the following:

Staffing for the team ' s surgeries routinely included one unlicensed Tech, one licensed registered nurse (RN), and one licensed physician-surgeon. The RN was responsible to provide moderate sedation care (the administration of drugs to render a minimally depressed level of consciousness that allows a surgical patient to retain the ability to independently and continuously maintain a patent airway and respond appropriately to verbal commands and physical stimulation, also known as moderate sedation/analgesia, conscious sedation and intravenous sedation), to perform circulating duties, and to supervise the Tech. The Tech ' s duties included transporting patients, stocking and setting up the surgical equipment, cleaning and processing the equipment after use, handing supplies to the surgeon, organizing the tissue specimens for evaluation by a laboratory, and cleaning some surfaces between cases (all duties commonly performed by a scrub tech). The physician also directed the Tech to assist in the surgical procedure by manually operating the remote slider mechanisms of various surgical instruments used to grasp, bite into, dilate, and clamp tissue (mechanisms to penetrate, sever, or otherwise manipulate/alter tissue is considered surgical practice as defined by the American College of Surgeons, ST-11, revised 4/07). In some instances, the physician directed the Tech to press firmly into anatomical regions of a patient ' s abdomen in order for the physician to guide a scope instrument through the bowel passage.

Tech 1 indicated that he never attended a formal surgical technologist training program and possessed no certifications to perform the described tasks. Tech 1 learned the described skills on the job from other Techs and the physician, though that training was not documented.

Review on 10/10/11 at 12:10 p.m. of the competency records for three surgical technologists who worked with the mobile bowel and lung surgery team (Tech 1, Tech 2, and Tech 3) with Administrator 1 indicated no evidence of current health practitioner licensure, formal training, surgical technologist certifications, or current competence for the physician-directed patient care tasks described by Tech 1 above. Competencies dated 2008 for Tech 1 and Tech 2 did document approval (Uses Equipment Appropriately and Safely) for various surgical instruments that grasp, clamp, dilate, and inject medications, as well as the preparation of medications, without clarifying the role of the Tech as technical only, and limiting the role from direct patient care, which would require licensure.

Review on 10/5/11 of the job description for O.R. (operating room) Technician, last revised 9/08 and presented as the current job description for Tech 1, 2, and 3, noted that a valid state nursing license, Interim Permit, or O.R. Tech certification was required. An O.R. Technician was defined as a person who assisted the operating room team under the direct supervision of the surgeon and the circulating RN. Skills included demonstrating the safe use of equipment, such as lifts, beds, tables, and patient care devices. Use of surgical instruments and directly participating in surgical procedures was not specifically listed.

In an interview on 10/10/11 at 11 a.m. with the director of the heart studies laboratory (DCL), who identified himself as an licensed x-ray Tech, DCL indicated that one RN (to provide moderate sedation care, circulate, and supervise Techs) and two Techs (one to function as a scrub tech and one to function as a monitor of technical data measurements) were routinely assigned for heart studies surgeries. One task routinely performed by the scrub tech was to apply firm pressure to a major blood vessel entry site after a sheath was removed at the end of the surgical procedure, as directed by a department protocol, to prevent major blood loss. Although requested, the protocol was not presented prior to completion of the survey.

Review on 10/10/11 of a policy titled Surgery - Scrub Nurse Responsibilities in CVOR (heart operating room), last approved 7/11, documented a number of technical duties, none of which included direct patient care or the application of direct pressure to a major blood vessel to prevent blood loss as a duty. Although requested, the blood vessel compression protocol (a hospital-approved procedure for a specially trained staff member to perform a medical treatment or task) was not presented, prior to completion of the survey.

Review on 10/10/11 of a policy titled Endoscopy - Structure Standards, last approved 12/08, item IV.C.1.d documented that RNs were responsible to provide patient care in accordance with the state practice act. Item VI.C.1.e documented that the Tech was responsible for technical assistance to the surgeon, to help the RN as needed and "participating, as appropriate with patient care." However, Item VIII.B Staffing requirements directed for only a minimum of 2 staff (one must be RN), and noted that all RNs and Techs give technical assistance AND direct patient care, without directing the staff to have appropriate training, licensure, certifications, and competence to give direct patient care.

2. Review on 10/10/11 of a job description for Perioperative RN, last revised 8/08 and presented as the current job description for RNs working in the mobile bowel and lung surgery team and heart studies laboratory team, documented under Critical Thinking Skills item 14 that the perioperative RN demonstrated knowledge of job descriptions and appropriately delegated to OR techs based on their current clinical competence.

Review on 10/6/11 at 2:30 p.m. of the medical records for Patients 4, 15, 16, and 17 with Administrator (ADM) 1, who supervised the perioperative nurse managers and directors, confirmed that a RN specifically assigned to supervise Tech staff, and not also assigned to perform dedicated care such as moderate sedation or scrub duties, was not documented as present for surgeries performed on 9/29/11 and 10/2/11 for Patient 4, on 2/25/11 for Patient 15, on 2/24/11 for Patient 16, and on 9/12/11 for Patient 17.

Review on 10/12/11 of on-line position statements published by the state licensing board for registered nurses (BRN) retrieved from , which serves as a standard of practice for licensed nursing professionals, and the state medical practice and nurse practice acts documented in the state Business and Professions code (B&P, state laws) retrieved from , indicated the following guidance:

The RN As Supervisor - RNs have an obligation to assure that subordinates are clinically competent to perform the functions delegated to them.

Scrub Nursing Functions by Non-RNs - Any individual not licensed to practice professional nursing who performs scrub nursing functions may do so only as an assigned technical function under the direct supervision of a perioperative registered nurse.

Functions Performed by Unlicensed Personnel (B&P 2725.3) - A licensed hospital shall not assign unlicensed personnel to perform nursing functions in lieu of a registered nurse and may not allow unlicensed personnel to perform functions under the direct clinical supervision of a registered nurse that require a substantial amount of scientific knowledge and technical skills.

Conscious Sedation - RNs managing the care of patients receiving conscious sedation must perform in a manner consistent with the standard of practice, and shall not leave the patient unattended or engage in tasks that would compromise continuous monitoring of the patient by the RN (such as supervising Techs and circulating duties).

Medical Practice defined (B&P 2051) - Authorized the holder of a physician's and surgeon's certificate (medical license) to sever or penetrate the tissues of human beings, with additional limited authority for practitioner categories (e.g. physician assistant, podiatrist, dentist) that did not include unlicensed technicians.

In an interview with ADM 1 on 10/6/11 at 2:30 p.m., ADM 1 indicated the perioperative practices were expected to conform with the practice standards and recommendations of the Association of peri-Operative Registered Nurses (AORN) throughout the hospital.

Review of the 2011 AORN Guidance Statement on Perioperative Staffing documented as minimum intraoperative requirements: One RN per patient per operating room in the role of the circulating nurse. One scrub person per patient per room (RN, licensed practical nurse, or surgical technologist); in some circumstances a scrub person may not be required. One dedicated RN to manage moderate sedation different from the dedicated RN circulator.

Review of the 2011 AORN Position Statement on One Perioperative Registered Nurse Circulator Dedicated to Every Patient Undergoing a Surgical Or Other Invasive Procedure echoed the minimum requirement for one perioperative registered nurse circulator to be dedicated to each patient undergoing a surgical/invasive procedure, physically present during the patient's entire intraoperative experience, to permit access to the unique clinical knowledge, judgment, and critical-thinking skills possessed by the perioperative RN.

Review of the 2011 Association of peri-Operative Registered Nurses (AORN) Position Statement on Allied Health Care Providers and Support Personnel in the Perioperative Practice Setting preamble documented that a perioperative registered nurse was responsible for the supervision of delegated nursing tasks to allied health providers and support personnel, including sterile processing technicians, endoscopy technicians, and surgical technologists.

Based on staff interview, medical record and document review, the hospital failed to arrange for qualified registered nurses (RNs) to perform circulating duties in the operating room for all operating room locations in accordance with state regulations and acceptable standards of practice. This failure posed a risk to patient safety by not affording immediate availability of nursing interventions for emergencies and other patient needs.

Findings:

In an interview and record review on 10/3/11 at 1:30 p.m. with the Director of Quality Management (DQM) of Patient 4's surgical records for bowel surgeries performed on 9/29/11 and 10/2/11, DQM indicated that the staff signatures for each surgery reflected the presence of one RN to administer and monitor moderate sedation (the administration of drugs to render a minimally depressed level of consciousness that allows a surgical patient to retain the ability to independently and continuously maintain a patent airway and respond appropriately to verbal commands and physical stimulation, also known as moderate sedation/analgesia, conscious sedation and intravenous sedation), one technician, and one physician throughout each surgery. DQM indicated that an additional RN was not routinely staffed or present for surgeries performed in the endoscopy surgical unit (where bowel and lung surgeries were routinely performed). Instead, the sedation RN also functioned in the role of circulator RN.

Review on 10/3/11 of the medical records for other patients who had surgeries outside of the main operating room suites (Patient 15 had bowel surgery on 2/25/11, Patient 16 had bowel surgery on 2/24/11 for rectal bleeding and required rescue interventions for low blood pressure during surgery, and Patient 17 had urgent heart surgery for an acute heart attack on 8/12/11), with DQM indicated that one RN was listed in the role of circulator, the same RN who performed the moderate sedation care for each patient, and no other circulating RN was documented.

In an interview on 10/5/11 at 10 a.m. with Charge Nurse (CN) 1, a nurse manager for the Endoscopy surgical unit, CN 1 stated that only one RN was routinely assigned to bowel and lung surgery cases that were serviced by the Endoscopy team. CN 1 indicated that the single RN performed in the role of sedation RN and circulating RN. Intraoperative duties included administration of sedation medications and continuous monitoring of the surgical patient's response to surgery and the medications, as well as labeling specimen containers, supervising the surgical technician, applying pressure to the patient's abdomen to assist the surgeon if requested, and using a telephone to call for supplies that were not readily available, or to call for help for emergency rescue if the patient experienced a life-threatening event. CN 1 stated that no additional RN was assigned to be immediately available to the Endoscopy team on a routine basis.

In an interview on 10/10/11 at 11 a.m. with Nurse Manager (NM) 2, who supervised the heart procedure laboratory where some heart surgeries were performed, NM 2 stated that staffing for the heart surgery laboratory required only one RN to perform both sedation and circulating duties. Although a second RN was sometimes assigned to perform technical duties as a scrub (assistant to the surgeon in the sterile field) or to monitor technical equipment and record measurements, the second RN did not function as a circulator. Circulating duties were similar to those described by CN 1.

Review on 10/10/11 of a policy titled Endoscopy-Structure Standards, last approved 12/08, documented under item V.A that a minimum of two staff (one RN, one technician) were available for 24 hour services (for bowel and lung surgeries). Item VI.C.3 required implementation of the hospital's policy for moderate sedation.

The position statement titled Conscious Sedation from the California Board of Registered Nursing (BRN), last revised 7/97, retrieved at www.rn.ca.gov on 10/11/11, in part indicated: "... National guidelines for administering conscious sedation should be consulted in establishing agency (facility) policies and procedures ... RNs managing the care of patients receiving conscious sedation shall not leave the patient unattended or engage in tasks that would compromise continuous monitoring of the patient by the registered nurse. Registered nurse functions as described in this policy may not be assigned to unlicensed assistive personnel ... "

Review on 10/10/10 of the Moderate Sedation training module required for all perioperative locations where RNs performed moderate sedation care documented, "The RN responsible for administering Moderate Sedation and monitoring the patient will not be engaged in procedural activities significant enough to distract her/him from the task of patient monitoring." Neither the training module nor the moderate sedation policies presented during the survey required the sedation RN to provide continuous (uninterrupted) patient monitoring. As a result, circulating duties were assigned to sedation RNs. No policies were presented that specified that a circulating RN was to be dedicated to circulating duties and not simultaneously acting in other surgical team member roles (such as sedation or scrub).

Review on 10/10/11 of a policy titled Surgery-Perioperative Unit Structure Standards, last approved 12/08, documented under item IV.A.5, "the perioperative RN may meet the needs of the Perioperative Department in the role of circulator or scrub person as mandated by the Nursing Practice Act (state laws regulated by the RN licensing authority) and the Standards of Perioperative Nursing." The references cited for the policy included the Association for peri-Operative Registered Nurses (AORN) Recommended Standards and Guidelines, and no other nationally recognized organization was listed.

In an interview on 10/6/11 at 2:30 p.m. with Administrator (ADM) 1 who supervised the perioperative managers and directors throughout the hospital, ADM 1 indicated that the hospital-wide perioperative policies were expected to conform with the standards and practices recommended by the Association for peri-Operative Registered Nurses (AORN). ADM 1 acknowledged that circulating RNs, separate and distinct from sedation RNs, were not routinely staffed for procedures performed outside of the central operating room suites.

Review of the 2011 AORN Guidance Statement on Perioperative Staffing documented as minimum intraoperative requirements: One RN per patient per operating room in the role of the circulating nurse. One scrub person per patient per room (RN, licensed practical nurse, or surgical technologist); in some circumstances a scrub person may not be required. One dedicated RN to manage moderate sedation different from the dedicated RN circulator.

Review of the 2011 AORN Position Statement on One Perioperative Registered Nurse Circulator Dedicated to Every Patient Undergoing a Surgical Or Other Invasive Procedure echoed the minimum requirement for one perioperative registered nurse circulator to be dedicated to each patient undergoing a surgical/invasive procedure, physically present during the patient's entire intraoperative experience, to permit access to the unique clinical knowledge, judgment, and critical-thinking skills possessed by the perioperative RN.

Review of the California Code of Regulations Title 22, a state standard for general acute care hospitals, under Division 5, Chapter 1, section 70217(a)(2) documented, "The surgical service operating room shall have at least one registered nurse assigned to the duties of the circulating nurse and a minimum of one additional person serving as scrub assistant for each patient-occupied operating room. "

Review of the 2011 Association of peri-Operative Registered Nurses (AORN) Position Statement on Allied Health Care Providers and Support Personnel in the Perioperative Practice Setting preamble documented that a perioperative registered nurse was responsible for the supervision of delegated nursing tasks to allied health providers and support personnel, including sterile processing technicians, endoscopy technicians, and surgical technologists.

Review of a position statement from the California Board of Registered Nurses (BRN) effective January 2011 documented,"The Board of Registered Nursing interprets any individual not licensed to practice professional nursing who performs scrub nursing functions may do so only as an assigned technical function under the direct supervision of a perioperative registered nurse." Therefore, when non-RN staff were performing nursing functions, continuous supervision by a RN (other than the sedation RN) must be arranged. Typically, that role was filled by a circulating RN.

Based on staff interview and document review, the hospital assigned surgical tasks and duties to physicians, allied health practitioners (AHPs, non-physicians with advanced medical practice skills), registered nurses (RNs) and surgical technologists (Techs) without verifying the qualifications and current competencies of those individuals, and for some, without delineating the authority to perform the duties through a formal privileging process, in accordance with acceptable standards of practice, hospital policies, and medical staff policies/bylaws, as evidenced by:

1. The hospital leadership approved moderate sedation (the administration of drugs to render a minimally depressed level of consciousness that allows a surgical patient to retain the ability to independently and continuously maintain a patent airway and respond appropriately to verbal commands and physical stimulation, also known as moderate sedation/analgesia, conscious sedation and intravenous [IV] sedation) and/or endotracheal intubation (placement of a tube through the mouth or nose into the lungs to provide breathing support) clinical privileges for 4 of 4 physician files reviewed (MD 1, MD 2, MD 3, and MD 4) without documented evidence of current knowledge and demonstrated proficiency in performing moderate sedation or intubation skills in accordance with medical staff policy and organizational standards of care.

2. The hospital leadership approved surgical assist clinical privileges for 3 of 4 AHP files reviewed (Registered Nurse First Assist [RNFA] 6, Physician Assistant [PA] 7, and PA 8) with documented qualifications or delegated authority in accordance with state scope of practice and organizational standards of practice.

3. The hospital leadership permitted surgical assist tasks to be performed by unlicensed staff and licensed nurses during bowel, lung, and heart surgery procedures without assigning clinical privileges or evaluating qualifications, current competency, and/or authority to practice medicine, in accordance with medical staff policy, state and organizational standards of practice and scope of practice state laws for 3 of 3 surgical technologists reviewed (Tech 1, Tech 2, and Tech 3).

4. The hospital leadership assigned moderate sedation care to RNs without ensuring that current competence was demonstrated in accordance with state and organizational standards for 3 of 3 RNs reviewed (CN 1, RN 3, and RN 4).

These failures put patients at risk to have surgery performed by unqualified persons.

Findings:

1. The hospital did not verify current knowledge and demonstrated competency for moderate and endotracheal intubation privileges of physicians.

Review on 10/3/11 of the 5/11 Medical Staff Credentialing Manual under item 2.2-2 documented that clinical privileges shall be evaluated on the basis of the practitioner ' s education, training, and experience. The basis for ongoing privilege determinations shall be made in connection with observed clinical performance demonstrated ability and judgment, proctoring, the results of peer review, and the documented results of patient care audit/quality activities.

In a review on 10/4/11 at 11 a.m. of medical staff files with the medical staff coordinator, the following was identified:

a. MD 1, a gastroenterology (stomach and bowel) specialist, was appointed to the medical staff in 1985. Ten charts to evaluate MD 1 ' s performance for IV sedation care were reviewed in 1993, after which MD 1 was continuously granted IV sedation privileges up to the current appointment cycle. No evidence of formal education and training for IV sedation was documented. No evidence of current knowledge or IV sedation skills (airway assessment, management and rescue), and no evidence of direct observations (proctoring) of IV sedation performance were documented. No current chart review outcomes for IV sedation care, by physicians qualified to perform the same skills, were documented.

b. MD 2, a heart and chest surgeon, was appointed to the medical staff in 2003. Clinical privileges for IV sedation and endotracheal intubation were continuously approved up until the current appointment cycle. No evidence of formal education and training for IV sedation was documented. No evidence of current knowledge, no evidence of current skills for IV sedation (airway assessment, management and rescue) or endotracheal intubation (e.g. advanced cardiac life support certification, ACLS), and no evidence of direct observations (proctoring) of IV sedation or endotracheal intubation performance were documented. No current chart review outcomes for IV sedation care or endotracheal intubation, by physicians qualified to perform the same skills, were documented.

c. MD 3, a general surgeon, was appointed to the medical staff in 1998 and granted continuous privileges for IV sedation and endotracheal intubation up until the current appointment cycle. Although MD 3 passed an IV sedation knowledge test in 1998, there was no documented evidence of formal education and training for IV sedation. No evidence of current knowledge, no evidence of current skills for IV sedation (airway assessment, management and rescue) or endotracheal intubation (e.g. ACLS), and no evidence of direct observations (proctoring) of IV sedation or endotracheal intubation performance were documented. No current chart review outcomes for IV sedation care or endotracheal intubation, by physicians qualified to perform the same skills, were documented.

d. MD 4, an internist who routinely performed surgical procedures, was appointed to the medical staff in 2005 and granted continuous privileges for IV sedation up until the current appointment cycle. No evidence of formal education and training for IV sedation was documented. No evidence of current knowledge, no evidence of current skills for IV sedation (airway assessment, management and rescue, ACLS certification expired 3/10/11), and no evidence of direct observations (proctoring) of IV sedation performance were documented. No current chart review outcomes for IV sedation care, by physicians qualified to perform the same skills, were documented.

The medical staff coordinator indicated that the qualifications for IV sedation privileges (for non-anesthesiologists) included either passing a knowledge test at the time of initial request (but not at subsequent renewals of the privileges), or possession of a valid ACLS certification, or having retrospective chart reviews of ten sedation care patients for physicians on staff prior to 2001. No qualifications for endotracheal intubation were required by policy.

Review of a policy titled Credentialing Requirements for IV Sedation Privileges, last reviewed 12/08, confirmed the IV sedation qualifications as described by the medical staff coordinator. The policy added, "Privileges will be continued at the time of reappointment based on continued compliance with IV sedation standards as determined through on-going peer review studies." The policy did not identify the source of IV sedation standards (e.g. nationally recognized organization). The policy did not require documented evidence of formal education and training, proctoring, current knowledge, ongoing demonstrations of airway assessment, monitoring, and rescue skills, ACLS, or other methods to meet acceptable standards of practice.

In an interview on 10/6/11 at 1 p.m. with the former Chief of Staff and current member of the medical staff leadership committee (MD 9), MD 9 indicated that the medical staff had struggled for years with developing criteria for determining moderate sedation qualifications and competence. MD 9 expected IV sedation care to comply with the recommendations of the American Society of Anesthesiologists (ASA).

Review on 10/5/11 at 2:30 p.m. of the medical records for Patients 4, 15, 16 and 17 (all patients over the age of 60 with multiple serious co-existing conditions and risks for adverse reactions during IV sedation and surgery, and patients who had IV sedation care supervised by MD 1 or other physicians with IV sedation privileges) with Administrator (ADM) 1, who supervised the perioperative nurse managers and directors, ADM 1 acknowledged that Patients 4, 15, 16 and 17 were not administered IV sedation medications as recommended by the product labeling and U.S. Food and Drug safety administration (FDA), or by the medication policies and IV sedation training modules currently used by the hospital. [Drugs were administered rapidly without adjustments in dosing for age and condition, oxygen was not consistently administered, RNs were not assigned to continuously monitor each patient.]

Review on 10/12/11 of the ASA Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, issued on 10/18/06, documented that professionals who administer, or supervise the administration of, moderate sedation, as well as the "supervised sedation professionals," should have specialized and formal education, training, and current demonstrated competency for the knowledge and skills related to respiratory physiology, cardiac rhythms, medication pharmacology, airway management, and rescue from unintended oversedation or complications. The ASA recommended privileging all practitioners given this patient care authority with ongoing performance improvement oversight by the facility governing body.

Review on 10/12/11 of American College of Surgeons standard ST-46 titled "Statement on patient safety principles for office-based surgery utilizing moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia" documented under Core Principle #10, "Physicians administering or supervising moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia should have appropriate education and training."

2. AHPs were not qualified or authorized to perform surgical assist duties.

In a review on 10/4/11 at 11 a.m. of medical staff files with the medical staff coordinator, the following was identified:

a. RNFA 6 was appointed to the medical staff on 2/25/10 and granted surgical assist privileges. Although RNFA 6 completed an accredited RNFA training program, part of which was provided by the hospital in the past year, there was no documented evidence of perioperative nursing certification (CNOR) in the file. No standardized procedures for surgical assist tasks that exceeded the training of a registered nurse were documented. No evidence of patient outcomes for surgical care provided by RNFA 6 was documented.

b. PA 7 was appointed to the medical staff on 7/28/11 and granted history and physical assessment, surgical assist, and minor skin incision repair privileges. No evidence of a Delegation of Services Agreement, authorizing PA 7 to perform defined surgical tasks and signed by PA 7's supervising physician, was documented.

c. PA 8 was reinstated to the medical staff on 5/31/10 and granted history and physical assessment, surgical assist and minor skin incision repair privileges. A Delegation of Services Agreement signed by supervising physicians on 3/10/10 did not clearly specify authority to perform or assist in surgical tasks (e.g. by naming specific therapeutic procedures).

Review on 10/12/11 of the 2011 Association for peri-Operative Registered Nurses (AORN) Position Statement on RN First Assistants, documented, "Registered nurses practicing in surgery are functioning in an expanded perioperative nursing role." Minimum qualifications to practice as an RNFA included current and ongoing certification in perioperative nursing (CNOR). Privileging should incorporate peer or faculty review of performance.

3. Surgical assist tasks were performed by unqualified staff.

In an interview on 10/5/11 beginning at 10 a.m. with Surgical Technologist (Tech) 1, a technician assigned to a mobile team that provided services for bowel and lung surgeries throughout the hospital, Tech 1 indicated the following:

Staffing for the team's surgeries routinely included one unlicensed Tech, one licensed registered nurse (RN), and one licensed physician-surgeon. In addition to scrub nurse duties, the Tech also assisted in the surgical procedure by manually operating the remote slider mechanisms of various surgical instruments used to grasp, bite into, dilate, and clamp tissue (mechanisms to penetrate, sever, or otherwise manipulate/alter tissue is considered surgical practice as defined by the American College of Surgeons, ST-11, revised 4/07). In some instances, the physician directed the Tech to press firmly into anatomical regions of a patient's abdomen in order for the physician to guide a scope instrument through the bowel passage.

Tech 1 indicated that he never attended a formal surgical technologist training program and possessed no certifications to perform the described tasks. Tech 1 learned the described skills on the job from other Techs and the physician, though that training was not documented.

Review on 10/12/11 of the product literature for one of the surgical instruments routinely operated by the mobile team Techs indicated that the potential adverse effects of using the instrument to bite into bowel tissue included bleeding, infection, and poking a hole through the bowel wall. [Risks of pressing firmly on a patient ' s abdomen include pain or injury to underlying organs. Risks of injecting medications include allergic or adverse reactions, bleeding, and infection.]

Review on 10/10/11 at 12:10 p.m. of the competency records for three surgical technologists who worked with the mobile bowel and lung surgery team (Tech 1, Tech 2, and Tech 3) with Administrator 1 indicated no evidence of current health practitioner licensure, formal training, surgical technologist certifications, or current competence for the physician-directed patient care tasks described by Tech 1 above. Competencies dated 2008 for Tech 1 and Tech 2, only, did document approval (Uses Equipment Appropriately and Safely) for various surgical instruments that grasp, clamp, dilate, and inject medications, as well as the preparation of medications, without clarifying the role of the Tech as technical only, and limiting the role from direct patient care, which would require licensure.

Review on 10/5/11 of the job description for O.R. (operating room) Technician, last revised 9/08 and presented as the current job description for Tech 1, 2, and 3, noted that a valid state nursing license, Interim Permit, or O.R. Tech certification was required. An O.R. Technician was defined as a person who assisted the operating room team under the direct supervision of the surgeon and the circulating RN. Skills included demonstrating the safe use of equipment, such as lifts, beds, tables, and patient care devices. Use of surgical instruments and directly participating in surgical procedures was not specifically listed.

In an interview on 10/10/11 at 11 a.m. with the director of the heart studies laboratory (DCL), who identified himself as an licensed x-ray Tech, DCL indicated that one RN (to provide moderate sedation care, circulate, and supervise Techs) and two Techs (one to function as a scrub tech and one to function as a monitor of technical data measurements) were routinely assigned for heart studies surgeries. One task routinely performed by the scrub tech was to apply firm pressure to a major blood vessel entry site after a sheath was removed at the end of a surgical procedure, as directed by a department protocol, to prevent major blood loss. Although requested, the protocol was not presented prior to completion of the survey.

Review on 10/10/11 of a policy titled Surgery - Scrub Nurse Responsibilities in CVOR (heart operating room), last approved 7/11, documented a number of technical duties, none of which included direct patient care or the application of direct pressure to a major blood vessel to prevent blood loss as a duty. No other policy was presented that directed a Tech to apply firm pressure to a large blood vessel to prevent major blood loss during surgery.

Review on 10/10/11 of a policy titled Endoscopy - Structure Standards, last approved 12/08, Item VI.C.1.e documented that the Tech was responsible for technical assistance to the surgeon, to help the RN as needed and "participating, as appropriate with patient care." However, Item VIII.B Staffing requirements noted that all RNs and Techs give technical assistance AND direct patient care, without directing the staff to have appropriate training, licensure, certifications, and competence to give direct patient care.

In a review of medical staff files and privileging rosters on 10/4/11 at 11 a.m. with the medical staff coordinator (MSC), the MSC indicated that no surgical technologists or RNs were granted privileges for surgical assist tasks, unless they were also licensed in an AHP category.

Review on 10/3/11 of the 5/11 Medical Staff Credentialing Manual under item 2.1 documented that a practitioner shall be entitled to exercise only those clinical privileges or specified services specifically granted by the governing board.

The Center for Medicare and Medicaid Services, in the current State Operations Manual Appendix A, under CFR 482.51 defined "surgery" in accordance with the American College of Surgeons at www.facs.org/fellow_info/statements/st-11.html. "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 also is the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue ... can be cut, burned, vaporized, frozen, sutured, probed, ..."

Review on 10/12/11 of the American College of Surgeons Statements on Principles for G. Surgical Assistants, retrieved from , documented that it may be necessary to utilize nonphysicians as first assistants. Assistants with additional surgical training should meet national standards and be credentialed by the appropriate local authority.

In conclusion, the hospital permitted unlicensed and unqualified staff to perform surgical tasks without subjecting them to the privileging process. The hospital permitted surgical technologists to perform various aspects of the surgical procedure involving alteration of tissue (clamping and penetrating) for which they had no evidence of competence and no legal authority.

4. Current demonstrated competence for sedation and surgical assisting RNs not documented.

In an interview on 10/5/11 at 10 a.m. with CN 1, a nurse manager for the mobile bowel and lung surgery team, CN 1 indicated that RNs were routinely assigned to perform sedation care, circulate, and supervise Techs during surgical procedures. In addition, the team RNs were qualified to perform all the Tech duties (described above by Tech 1) and could fill in if a Tech was not available.

Review on 10/10/11 of the competency files for CN 1, RN 3, and RN 4 with ADM 1 indicated that competencies for the use of surgical instruments to grasp, bite, clamp and dilate were checked off at orientation/hire, but not on a periodic basis after that time. These competencies were dated 2003 for CN 1, 2008 for RN 3, and 2005 for RN 4. Moderate Sedation competencies were documented by a 12 item checklist completed at a skills fair biannually but the checklist did not verify the method of determining competence (e.g. formal training, knowledge test, demonstration of skills, chart review), which was signed by a RN from the team, whose competency was signed off by a RN she herself had evaluated. Sedation competencies for RN 4 were dated 9/22/08 (three years ago). Medication Administration and IV Therapy competencies were documented in an annual performance evaluation tool for CN 1 dated 8/4/11, for RN 3 dated 2/28/11, and for RN 4 dated 3/9/11, all current and marked as competent. The requirements for medication tasks included "Prepares and administers medications according to manufacturer's guidelines, policy/procedure ad with consideration of the age-specific needs of the patient." The files contained no summary of patient outcomes for each RN. No privileging for surgical tasks or sedation care was documented.

Review on 10/5/11 at 2:30 p.m. of the medical records for Patients 4, 15, 16 and 17 (all patients over the age of 60 with multiple serious co-existing conditions and risks for adverse reactions during IV sedation and surgery, and patients who had IV sedation care supervised by MD 1 or other physicians with IV sedation privileges) with Administrator (ADM) 1, who supervised the perioperative nurse managers and directors, ADM 1 acknowledged that Patients 4, 15, 16 and 17 were not administered IV sedation medications as recommended by the manufacturer product labeling and U.S. Food and Drug safety administration (FDA), or by the medication policies and IV sedation training modules currently used by the hospital. [Drugs were administered rapidly without adjustments in dosing for age and condition, oxygen was not consistently administered, RNs were not assigned to continuously monitor each patient, RNs did not document physical assessment prior to sedation.]

In an interview on 10/5/11 at 10 a.m. with CN 1, CN 1 acknowledged that surgeons routinely ordered, and RNs implemented, rapid administration of sedation/analgesia medications without adjusting dosages for age and condition of the patient, as directed in the hospital sedation training module and national sedation care guidelines.

The documented RN competencies did not address the substandard practices of the sedation practitioner staff, and therefore did not accurately assess competence and performance.

Review on 10/12/11 of the ASA Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, issued on 10/18/06, documented that professionals who administer, or supervise the administration of, moderate sedation, as well as the "supervised sedation professionals," should have specialized and formal education, training, and current demonstrated competency for the knowledge and skills related to respiratory physiology, cardiac rhythms, medication pharmacology, airway management, and rescue from unintended oversedation or complications. The ASA recommended privileging all practitioners given this patient care authority with ongoing performance improvement oversight by the facility 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. Traffic patterns to locations where surgical procedures were performed (i.e. bowel and lung surgery unit) were not restricted to prevent entry of unauthorized persons and minimize cross contamination from potentially infectious sources in accordance with acceptable standards of practice.

2. Surgical attire and personal protective equipment practices did not conform to hospital policy and acceptable standards of practice to minimize cross-contamination in all locations (e.g. bowel and lung surgery unit, x-ray unit, nursing units for bedside surgery) where surgical procedures were performed.

3. Cleaning and disinfecting practices between surgical cases did not conform to acceptable standards of practice in all locations (e.g. bowel and lung surgery unit, x-ray unit, nursing units for bedside surgery) where surgical procedures were performed.

4. Surgical environments, equipment, and ventilation were not maintained to minimize mixing of contaminated air and cross contamination in critical processing and storage locations (bowel and lung surgery unit) in accordance with acceptable standards of practice.

5. Surgical personnel failed to periodically decontaminate and reprocess unused endoscope equipment in accordance with nationally recognized standards of practice.

These failures put patients at increased risk to develop surgical and other infections or adverse outcomes from a surgical experience.

Findings:

1. Traffic patterns in surgical areas were unrestricted.

During a tour of the hospital on 10/3/11 at 2 p.m. with the Director of Quality Management (DQM), a location known as the unit where bowel and lung surgeries were routinely performed was observed to be part of a building corridor that was shared with patient rooms, positioned directly across the hall from 3 rooms caring for young children. Two of the children (random Patients 32 and 34) had signs on their doors noting isolation precautions for resistant infections, and the doors were partly ajar to the hallway. Nursing staff and visitors entered and exited Patient 32's room multiple times. One of two closed doors to the surgical unit had a sign that read "OR #1." No signage or floor markings clearly denoted the rooms as having restricted access. An unlocked door opened to what resembled an office workroom with a desk, books, and a computer. The small room also had a counter with two sinks, and was considered the decontamination room for surgical equipment. A door exiting that room led directly to the operating room. The exit door was propped open. A physician dressed in street clothes, a paper cover gown and mask appeared on the operating room side of the exit door talking on a portable telephone. A surgical procedure for random Patient 31 was in progress in the operating room.

During an inspection on 10/5/11 at 10 a.m. of the bowel and lung surgery unit with CN 1, a nurse who managed the unit, the main door to the operating room labeled OR #1 was propped open with direct access to the building corridor. During the inspection, a hospital worker entered OR #1 to empty an uncovered waste basket. Hospital staff, patients, and visitors passed down the corridor in front of the open door to OR #1 continuously throughout the visit. OR #1 connected openly to a closet-sized space where instruments were disinfected, to the space where sterile supplies were stored, and to the office-decontamination room which directly connected to the same hallway corridor, though that unlocked door to the hallway was closed. A recently-used scope instrument was lying on a counter next to one of the sinks in the decontamination-office room. The door connecting that room to the operating room and instrument processing room was open. CN 1 indicated that a technician was in the middle of cleaning the scope. CN 1 indicated that special clothing or protective garments were not required to enter the surgical rooms when surgeries were not in progress, i.e., the areas were unrestricted.

Review of policies on 10/10/11 indicated the following:

a. A policy titled Endoscopy - Structure Standards, last approved 12/08, described the expectations for care in the bowel and lung surgery unit. The unit location served patients from nursing units, from the emergency room, and from the outpatient department. Under item VII for traffic safety were directions for patients to enter and exit the unit through the door labeled OR #1 directly from the corridor, for staff and physicians to enter through the office door which was to remain unlocked, and for supplies to be delivered to yet another door. The policy did not define the operating room as a restricted zone, or the decontamination, processing, and storage areas as semi-restricted.

b. In contrast, a policy titled Surgery - Perioperative Unit Structure Standards, last approved, 12/08, documented, "no one is permitted in the [operating room] without proper attire. Red lines are marked on the floor to prevent unnecessary traffic into the OR area."

c. A policy titled Sterile Processing-Decontamination: Receiving and Handling, last approved "July," documented under Purpose, "To establish a protocol for decontamination of instruments and equipment used in Surgery and in other parts of the hospital." Item IV documented, "Traffic control shall be strictly regulated. Limit unnecessary traffic through the decontamination area - doors must remain closed at all times."

Review on 10/12/11 of the 2011 Association of peri-Operative Registered Nurses (AORN) Perioperative Recommended Practices for Traffic Patterns in the Perioperative Practice Setting disclosed on page 95, under Purpose, that clearly defined and enforced traffic control practices protect personnel, patients, supplies, and equipment from potential sources of cross-contamination; safeguard the privacy of patients; and provide security. Recommendation I, item 1, documented that the surgical suite should be divided into areas designated by the physical activities performed in each as denoted by clearly marked signs to control movement into and out of the perioperative zones. The designated areas were defined as: Unrestricted area included a central control point to monitor the entrance of patients, personnel, and materials that did not require limitations for dress; Semi-restricted areas included support storage and work sites for processing instruments with access limited to authorized personnel wearing clean surgical clothing and coverings for hair; and Restricted areas included operating rooms, procedure rooms, and the clean core area with access limited to authorized personnel in surgical attire. Movement of personnel from unrestricted areas to either semi-restricted or restricted areas should be through a transition zone, where one can enter the area in street clothing and exit into the semi or restricted areas in surgical attire.

Under Recommendation III, item 2, "Doors to the operating or procedure rooms should be closed except during movement of patients, personnel, supplies and equipment." The air pressure within each operating room should be greater than in the semi-restricted areas to limit turbulent air flow that produced cross-contamination, and to maintain the critical balance of air pressure for each location. Recommendation IV directed the movement of clean and sterile supplies and equipment to be separated from contaminated supplies, equipment, and waste by space, time, or traffic patterns.

2. Surgical attire and personal protective equipment practices did not minimize cross-contamination.

During a brief tour of the bowel and lung surgery unit on 10/3/11 at 2 p.m. with DQM, a physician dressed in street clothes, a paper cover gown, gloves and mask was observed to be talking on a portable telephone within the operating room during a surgical procedure for random Patient 31. The physician's shirt collar, lower pant legs and shoes were exposed. The physician wore no hair or shoe coverings.

In an interview on 10/5/11 at 10 a.m. with CN 1, a nurse who managed the unit, CN 1 indicated that the physicians who performed surgeries in the unit routinely wore street clothing, with a paper cover gown, gloves and a mask during the surgery, but hospital-laundered clean surgical clothing, hair and shoe coverings were not required for any staff who performed decontamination, equipment processing, stocking, or operating room support in the surgical unit. CN 1 indicated that the unit nurses and technicians provided mobile services to distant units of the hospital as well as an outside surgery center. CN 1 indicated that the nurses and technicians often changed into clothing from the offsite surgery center, and wore those clothes back and forth to the hospital for the mobile services. CN 1 stated that hospital-issued clean surgical clothing was available to physicians and unit staff, but not required. CN 1 indicated that the hospital policy was to wear full surgical attire in this surgical unit, but the practice was otherwise.

During the interview with CN 1 on 10/5/11 at 10 a.m., a hospital worker entered OR #1 to empty an uncovered waste basket filled with materials from the previous surgery. The worker did not don protective clothing to enter the operating room, and proceeded to enter patient rooms along the corridor adjacent to the surgical unit after exiting from OR #1. CN 1 indicated that special clothing or protective garments were not required to enter the surgical rooms when surgeries were not in progress, i.e., the areas were unrestricted.

In an interview on 10/6/11 at 11:30 a.m. with the Infection Control Coordinator (ICC), the ICC stated that infection control policies and practices were based on the organizational standards of AORN and the Centers for Disease Control and Prevention (CDC). The ICC stated that the perioperative infection control practices were expected to be followed throughout the hospital where surgical activities were provided, including the standards for surgical attire and personal protective equipment. The ICC agreed that clean properly-laundered clothing or complete coveralls, hair coverings, and shoe coverings were standard for staff who worked in the restricted and semi-restricted surgical areas (where instrument processing, decontamination, supply storage, and surgery were performed). The ICC had no measurements of compliance for infection control practices by staff who worked in the bowel and lung surgery unit.

Review of policies on 10/10/11 indicated the following:

a. A policy titled Endoscopy - Code of Safe Practice, last approved 3/16/11 and intended for care provided in the bowel and lung surgery unit, documented under item VI(B) that staff were expected to prevent the spread of infectious or contagious diseases in accordance with infection control policies.

b. A policy titled Endoscopy - Structure Standards, last approved 12/08 and intended for care provided in the bowel and lung surgery unit, documented that staff were to "wear clothing as required by the Dress Code."

c. A policy titled Surgery - Surgical Attire, last approved 1/10, documented, "Scrub clothes worn in the surgical environment are provided by the hospital. Employees working in the semi-restricted and restricted areas of surgery, PACU (post-anesthesia care unit), CVOR (heart surgery recovery unit), [off-campus surgery center], Cath Lab (where heart studies were performed) and Labor and Delivery OR (operating rooms) must wear scrub attire." The policy did not specify the dress code for the bowel and lung surgery unit. The policy also stated that scrub clothes were to be laundered by the hospital approved laundry and not worn home, disposable cover garments (if used) were to cover clothing entirely, and a disposable cap must cover all hair.

d. The only policies presented that defined a Dress Code were documented in policies that directed housekeeping staff who cleaned various surgical units at the end of each day, including the bowel and lung surgery unit. These policies [Environmental Specialist Assigned to PM Surgery #3 (terminal), last reviewed 10/09 , Terminal Cleaning of Operating Rooms and Cath Lab Suites - Hospitalwide, last approved 9/09, and Surgery - Terminal Cleaning of the Invasive Procedure Room in CVOR (where heart surgeries were performed)] defined the dress code as: a scrub top, scrub pant, booties, head covering, mask and gloves.

Review on 10/12/11 of the 2011 AORN Recommended Practices for Traffic Patterns in the Perioperative Practice Setting documented under Recommendation I that signs should clearly indicate the appropriate environmental controls and surgical attire required.

Review on 10/12/11 of the 2011 AORN Recommended Practices for Surgical Attire, directed for care in invasive procedure locations, indicated in Recommendation II that, "Clean surgical attire, including shoes, head covering, masks, jackets, and identification badges should be worn in the semirestricted and restricted areas of the surgical or invasive procedure setting. Clean attire minimizes the introduction of microorganisms and lint from health care personnel to clean items and the environment." Under Recommendation III, direction was given that, "All individuals who enter the semi-restricted and restricted areas should wear freshly laundered surgical attire that is laundered at a healthcare-accredited laundry facility, or disposable surgical attire provided by the facility and intended for use within the perioperative setting."

Review on 10/12/11 of the 2011 Association of peri-Operative Registered Nurses (AORN) Perioperative Recommended Practices for Traffic Patterns in the Perioperative Practice Setting documented on page 96, under Recommendation 1, that "Persons entering the semirestricted or restricted areas of the surgical suite for a brief time for a specific purpose (e.g., biomedical engineers) should cover all head and facial hair and may don either freshly laundered surgical attire or a single use coverall suit (e.g., jumpsuit) designed to totally cover outside apparel."

3. Cleaning and disinfecting practices were not effective to minimize cross-contamination.

In an interview and inspection on 10/5/11 at 10 a.m. with CN 1, a nurse who managed the unit where bowel and lung surgeries were routinely performed, and Tech 1, who routinely maintained the equipment and space for the unit, Tech 1 stated that following a surgical procedure after the patient departed from the operating room, he wiped down the top and sides of a cart where surgical equipment was positioned during the surgery (scope cart) with a disinfectant solution (A 456 II Disinfectant Cleaner). CN 1 indicated that she also wiped off the surface of a medication cart where intraoperative medications were routinely prepared, prior to setting up for the next surgery. Other surfaces observed in the room, such as an emergency supply cart, specimen cart, suction canisters, heart monitoring machine, knobs to turn on lights and oxygen gas, tubing, desk, computer keyboard, other electronic equipment, a large portable air conditioner with exposed air duct winding up one wall and across a ceiling, a smaller portable air filter, a portable circulating fan, and waste disposal receptacles, were not routinely wiped off between cases even though they were frequently touched or exposed to aerosols generated during surgery. Tech 1 showed the bottle of cleaning solution. The label did not identify the organisms killed or instructions for use. Tech 1 stated that he sprayed the solution on a surface, waited about 30 seconds, and wiped with a clean gauze swatch. Neither CN 1 nor Tech 1 could recall formal training, competencies, or policies related to the procedures for cleaning between surgical cases.

Review on 10/6/11 of the manufacturer's instructions for use of A 456 II Disinfectant Cleaner directed for treated surfaces to remain wet for 10 minutes, to be effective.

In an interview on 10/6/11 at 10 a.m. with Manager (MGR) 1, who served as the contracted housekeeping manager, MGR 1 indicated that the end of day (terminal) cleaning procedures were defined in the contracted staff job descriptions. MGR 1 stated that surgery staff should have been trained to use disinfecting solutions properly. MGR 1 presented policies that described the job duties for staff who cleaned each surgical location in the hospital. The policies did not specify cleaning of the portable ventilation equipment or large exposed air ducts traversing up the wall and across the ceiling in the unit operating room. The policies did not specify how electronic equipment would be disinfected. The policies did not include disinfecting window coverings (blinds) daily in surgical locations (operating room, patient room). The policies did not specify to use a disinfectant registered by the U.S. Environmental Protection Agency (EPA).

In an interview on 10/5/11 at 10 a.m. with Tech 1, a technician who routinely stocked and maintained the bowel and lung surgery unit throughout the day, Tech 1 indicated that surgical equipment and supplies from the unit were routinely utilized to perform bedside procedures in distant parts of the hospital. Tech 1 indicated that he was not aware of special cleaning and disinfecting policies designed for the distant locations where the mobile team performed surgeries, to prepare those spaces prior to surgery, or to clean up after the surgeries were performed.

Review on 10/12/11 of the 2011 AORN Recommended Practices for Prevention of Transmissible Infections in the Perioperative Practice Setting documented under Recommendation IX that the environment should be kept in a clean and sanitary condition by cleaning and decontamination all equipment and environmental surfaces between procedures.

Review on 10/12/11 of the 2011 AORN Recommended Practices for Environmental Cleaning in the Perioperative Setting documented under Recommendation II, "A safe, clean environment should be reestablished after each surgical procedure. Routine cleaning and disinfecting reduces the amount of dust, organic debris, and microbial load in the environment...Operating rooms should be cleaned after each surgical or invasive procedure with a lint-free or microfiber cloth moistened with a detergent/disinfectant and water. Non porous surfaces such as ...blood pressure cuffs and other patient equipment should be cleaned and disinfected with an Environmental Protection Agency (EPA) registered hospital disinfectant between patient use. All receptacles (e.g., bins, kick buckets, pails), work surfaces, and tables should be cleaned and disinfected. Manufacturer's cleaning recommendations should be consulted before cleaning computer key boards, monitor screens ...and other electronic devices." Spray bottles containing disinfectant that produce aerosols should not be used. Recommendation IV read, "Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily." Recommendation IV(a)(3) noted that the following areas were included as requiring cleaning and disinfecting: all horizontal surfaces, hallways and floors, substerile areas, scrub/utility areas and sterile storage areas. Under Recommendation V, direction was given, "All areas and equipment in the surgical practice setting should be cleansed according to an established schedule." Recommendation X(a) indicated that P&Ps for environmental cleaning and disinfecting should include frequency of cleaning and disinfecting and chemicals approved for use.

4. Equipment and environments were not maintained to minimize cross-contamination.

During an inspection of the bowel and lung surgery unit on 10/5/11 at 10 a.m., the following conditions that posed risks for cross-contamination were identified and confirmed by unit staff:

a. The operating room (OR) space was observed to be continuous (without separation) with the space used to store equipment and sterile supplies.

Review on 10/12/11 of the 2011 AORN Recommended Practices for Traffic Patterns in the Perioperative Practice Setting documented that an operating room or procedure room was classified as a restricted area to limit the introduction of contaminants into the space where surgical wounds would be exposed. Storage areas for clean and sterile supplies and work areas for storage and processing of instruments were semirestricted to limit traffic and contaminants to a lesser extent.

b. The OR connected to a room the size of a closet that housed chemicals and a processing machine used to disinfect surgical equipment. The room had an accordion door that was open and not designed to effectively seal the air circulation between rooms.

Review on 10/12/11 of the AORN Recommended Practices for Cleaning and Processing Flexible Endoscopes (type of bowel surgery equipment) and Endoscope Accessories documented under Recommendation VI that adequate ventilation was required to protect personnel from the high-level disinfecting fumes generated from chemicals used to process endoscope equipment. See also Ventilation standards under item (h) below.

c. The OR also connected to a small combined office and decontamination room, located within 3 feet of the equipment processing accordion door, where surgical equipment was cleaned after surgery. Two sinks were positioned at opposite ends of the counter where contaminated equipment was cleaned. A recently used scope was coiled on the counter next to one sink. A fan was circulating air over that sink. The other sink was used for staff to wash hands before and after surgery. The door between the decontamination room and the OR was propped open.

In an interview with CN 1 during the 10/5/11 inspection, CN 1 indicated that staff washed their hands before and after surgery using one of the sinks in the decontamination room. CN 1 indicated that cleaning and disinfecting of the hand washing sink before and after decontamination activities or surgeries (when the decontamination door was open) were not routinely performed.

Review on 10/12/11 of the 2011 AORN Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories documented under Recommendation XI documented that endoscope decontamination should be in an area physically separated from where patient care activities are performed. Sinks were required to manually clean or remove visible materials from the endoscopes, and had washing facilities (another sink) was required to decontaminate hands after removal of protective garments.

Review on 10/12/11 of the 2011 AORN Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment documented under Recommendation VII that instruments should not be decontaminated in scrub or hand sinks, due to risk for cross contamination (direct or by aerosol generation) of the sink and faucet used for clean activities (e.g. hand washing, surgical hand antisepsis). The decontamination area should be physically separate from clean areas and include a door. The door should be kept closed, except when moving personnel and equipment to exhaust contaminant-containing aerosols out of the building.

d. A fan mounted high near the ceiling was circulating air over the OR as well. A large portable air conditioner unit was positioned within the OR with a large air duct extending out of it, up the wall, across the ceiling, and into the space above the ceiling. A smaller portable air filter was stationed across the room from the air conditioner. The OR door was propped open.

Review on 10/12/11 of the 2011 AORN Perioperative Standards and Recommended Practices, under Recommended Practices for a Safe Environment of Care, Recommendation V advised that free-standing fans should not be used in the OR or sterile processing areas where dust and contaminants would be further circulated, and doors to the OR should be kept closed.

e. An uncovered supply cart containing uncovered packaged sterile instruments that traveled to distant parts of the hospital (x-ray department) and used for liver surgeries was stationed in an area that directly communicated with the OR (no door separation) only a few feet from the open decontamination room. Also in that space was a tall uncovered storage cart holding other sterile instruments, and a pole on which with a drying scope was hung.

In an interview with Tech 1 during the 10/5/11 inspection, Tech 1 indicated that the liver surgery supplies cart, a nursing medication cart, and a scope cart that held the equipment needed for the mobile team ' s procedures were routinely brought in and out of the unit for patients who required surgery in the x-ray department, in the emergency room, in the intensive care unit, or at the bedside in other nursing units. Tech 1 indicated that the carts were cleaned when staff had time, but no formal routine cleaning schedule or log was maintained to show the frequency of cleaning. The maintenance of these storage items was not part of the terminal cleaning procedures performed by housekeeping staff.

Review on 10/12/11 of the 2011 AORN Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories documented under Recommendation XI that endoscopes should be decontaminated in an area physically separated from locations where clean items were handled. It further stated that closed storage facilities help to prevent contamination of stored supplies.

Review on 10/12/11 of the 2011 AORN Recommended Practices for Selection and Use of Packaging Systems for Sterilization documented under Recommendation XII that sterile items should be transported in covered or enclosed carts to protect items from exposure to environmental contaminants.

f. Also in the storage section of the OR were two cabinets with closed doors and automated ventilation used to store surgical scope equipment. In one cabinet, 9 scopes were hanging on fixtures approximately 7-8 feet high. One scope had slipped from its fixture and the tip of the scope was touching a paper drape on the floor of the cabinet. A plastic basket holding equipment accessories was stationed on the floor of the cabinet. Other scopes were touching the basket and sides of the cabinet. Gray dust material was wiped from a ledge inside the cabinet.

In an interview with Tech 1 during the 10/5/11 inspection, Tech 1 indicated that there was no policy or log maintained to show the frequency of cleaning the scope storage cabinets, but staff cleaned them when they had time. The maintenance of the storage cabinets was not part of the terminal cleaning procedures performed by housekeeping staff.

Review on 10/12/11 of the 2011 AORN Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories documented under Recommendation IX that endoscopes should be stored in a closed cabinet that allowed air to circulate around the scopes. The scopes should hang without touching the bottom of the cabinet or other surfaces. Storage cabinets should be cleaned and disinfected with an EPA-registered disinfectant when visibly soiled and on a weekly or monthly schedule to decrease dust and soil build up.

g. An uncovered and unlabeled plastic wastebasket holding paper and plastic wrappers discarded from the previous surgery was on the floor under the wall oxygen source.

Review on 10/12/11 of the 2011 AORN Recommended Practices for Environmental Cleaning in the Perioperative Setting documented under Recommendation III that disposable items contaminated with blood or tissue required specialized handling. Contaminated disposable items may include gowns, gloves, sponges, procedural drapes, suction tubing, liners, canisters, and opened or used supplies. Disposable items that were not contaminated were considered noninfectious and should be placed in a separate receptacle designated for noninfectious waste.

h. No gauges to measure temperature and humidity were identified in the surgical rooms.

In an interview on 10/10/11 at 9:30 a.m. with the hospital facilities manager (MGR 2), MGR 2 indicated that a portable air conditioner (approximately 5 feet tall and 3-4 feet wide) was temporarily installed into the operating room space of the bowel and lung surgery unit while a permanent roof-top ventilation unit was constructed. MGR 2 acknowledged that the recirculation of air through the portable unit may have altered the previous ventilation balance, particularly when the doors were propped open and fans were circulating, which may permit contaminated air from neighboring patient rooms to enter the OR and distribute to the surgical equipment and supplies. MGR 2 indicated that measurements of air balance and pressures were not conducted to verify proper OR conditions and minimize the circulation of dust and other contaminants when the portable unit was installed. MGR 2 acknowledged that the current physical plant design of the bowel and lung surgery unit did not permit the regulation and control of temperature, humidity, and air exchanges within subsections of the contiguous restricted and semi-restricted areas in accordance with nationally recognized infection control standards.

During the survey, a request for temperature, humidity, and air exchange monitoring was made. Administrative staff reported on 10/6/11 at 3 p.m. that logs of ventilation measurements were not maintained for the bowel and lung surgery unit.

Review on 10/12/11 of the 2011 AORN Perioperative Standards and Recommended Practices, under Recommended Practices for a Safe Environment of Care, Recommendation V documented the guidelines for maintaining heating and air ventilation systems to avoid potential infection and safety hazards. Daily monitoring of temperature, humidity and air exchanges in specific surgical care areas were detailed to ensure the levels were maintained in a safe range.

The recommended temperature within the operating room suite and work areas in sterile processing was 68 to 73 degrees Fahrenheit (F), the decontamination area was 60 to 65 degrees F, and the recovery area was 70 to 75 degrees F.

AORN recommended that relative humidity should be maintained between 30 and 60 percent in the instrument processing areas and should be maintained below 70 percent in sterile storage areas. High humidity increases the risk for microbial growth where sterile supplies are stored or procedures are performed. Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust.

AORN recommended, "The air exchange rate in the perioperative area should be carefully controlled. The number of air exchanges per hour is based upon the need to remove microbiological or chemical contaminants from the environment." Air exchanges per hour recommendations were: minimum 15 (20-25 preferred) for the OR, 10 for the decontamination area, and 4 for the clean/sterile storage area.

AORN recommended doors to the operating room should remain closed except when patients, personnel, and supplies were being actively moved in and out. The pressure gradient in the OR should be positive to outer corridors at all times. Negative air flow for the decontamination location, and positive air flow for the clean/sterile storage area were recommended. Free-standing fans should not be used in the OR nor in sterile processing areas.

In an interview on 10/6/11 at 11:30 a.m. with the infection control coordinator (ICC), the ICC indicated that monitoring of infection control practices related to ventilation and environmental cleaning in the bowel and lung surgery unit and other places where surgery was routinely performed (e.g. x-ray department, emergency room, bedside) were not captured by the infection control and safety surveillance activities currently in place. The ICC indicated that maintenance of the bowel and surgery unit environment, equipment and supplies was not specified in policies, but the expectation was to maintain the unit in accordance with AORN or other infection control standards in order to reduce the risk of microbial (germs) growth in sterile supplies, to reduce contaminants in the air from reaching disinfected equipment and surfaces, and to reduce the risk of patients developing surgical site infections.

5. Surgical personnel fail

Based on staff interview, medical record and document review, the hospital failed to ensure that a complete and accurate updated examination and assessment of the patient, performed by the operating surgeon, to reflect the current condition of the patient was documented prior to surgery in accordance with hospital policies and acceptable standards of practice for 5 of 8 surgical patient records reviewed (Patients 4, 15, 16, 17 and 20). This failure resulted in the potential to not recognize the need for additional intraoperative support or consultation, in order to arrange for a safe surgery and anesthesia plan and to minimize the risk for adverse outcomes for all surgical patients.

Findings:

Review on 10/4/11 at 4 p.m. of medical records with the Director of Quality Management (DQM) confirmed the following findings:

Patient 4, age 91 who had bowel surgeries performed on 9/29/11 and 10/2/11, was admitted to the hospital on 9/21/11 for weakness, low blood pressure, and concerns for recurrence of a recent bowel infection (C diff colitis). On 9/28/11 a consultation by a bowel specialist (MD 1) documented that Patient 4 passed two stools, each with "a large amount of bright red blood and clots" on that day. Tests were ordered and on 9/30/11 a bowel surgical procedure to evaluate the source of the continued lower bowel bleeding was performed by MD 1 in the Endoscopy unit. A form titled Interval History & Physical, signed by MD 1 on 9/29/11 at 7:57 p.m., documented, "I have examined the patient and the patient's condition is unchanged," referring to the 9/28/11 consultation which noted examination findings for head shape, mouth color and wetness, neck stiffness, a heart rhythm disorder, and lung sounds, among other body findings. A box was checked to note "Pre-sedation assessment completed," but the specific features of airway assessment (e.g. mouth opening, neck shape and motion, heart sounds and rhythm, lung sounds) were not documented. A box was checked to designate "ASA Class 2." (ASA Class is a surgical risk classification system originally developed by the American Society of Anesthesiologists [ASA]. ASA Class 2 means a patient with mild systemic disease.) The form indicated that planned moderate sedation anesthesia services were intended. [Moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, also known as moderate sedation/analgesia, IV (intravenous, medications injected directly into a vein) sedation, or conscious sedation.] Nursing entries did not document features of airway examination either. During the surgery, Patient 4's blood pressure dropped by 40% four minutes after administration of sedation/analgesia medications, and persisted low for 15 minutes, requiring rescue with IV fluid treatments.

Patient 4 had a second bowel surgery on 10/2/11 after losing 11 pounds and developing severe anemia since the 9/29/11 surgery. The Interval History & Physical form similarly documented that MD 1 examined Patient 4 and the condition was unchanged. The box for pre-sedation assessment was not checked and no features of an airway assessment were documented. ASA Class 2 was again checked, despite the fragile condition of Patient 4 at that time.

In an interview on 10/5/11 at 10 a.m. with CN 1, a registered nurse (RN) who managed the mobile endoscopy unit team to provide bowel and lung surgeries throughout the hospital, CN 1 indicated that the team RNs who performed moderate sedation care did not routinely perform a complete nursing assessment with airway examination on their patients prior to sedation and surgery. CN 1, who observed the practices of most of the surgeons on the team over many years, indicated that the surgeons routinely spoke to each patient prior to surgery, but also did not directly examine or perform and document an examination of the airway features that are known to pose a risk for sedation complications (such as obesity, short neck, large tongue, incomplete opening of the mouth, limited neck motion, lung congestion, heart rhythm disorders). CN 1 was familiar with the airway features, but indicated the RNs were not formally taught to assess the features in the hospital's training for sedation care. RNs also were not formally taught about the significant complications that correlate with ASA Class levels. CN 1 stated that the mobile endoscopy unit did not accept ASA Class 4 patients, but often served very sick patients with active bleeding from the emergency room or intensive care unit who required life-saving surgeries. [ASA Class 4 means a patient with a condition that poses a constant threat to life, requires life-saving treatments].

In an interview on 10/10/11 at 11 a.m. NM 2, a registered nurse who managed the nursing care for the heart studies laboratory where heart surgeries were performed, NM 2 indicated that no hospital policy limited the acuity (severity or stability of patient conditions) for RN-administered sedation care in the heart studies laboratory. RNs provided moderate sedation care routinely for patients with life-threatening and severe conditions, including ASA Class 4 patients. NM 2 indicated that sedation RNs did not document complete physical assessment or airway assessment features for their patients prior to sedation.

In an interview on 10/5/11 at 12:30 p.m. with DQM, DQM indicated that physicians (either anesthesiologists or surgeons) were expected to document the ASA Class level for each surgical patient prior to surgery. However, there was no quality process to evaluate the accuracy of the ASA designations, which were not questioned by nursing staff.

In an interview on 10/6/11 at 1 p.m. with the former Chief of Staff (MD 9), who currently served on the medical staff leadership committee and governing board, MD 9 indicated that he expected IV sedation care to comply with the standards and recommendations of the American Society of Anesthesiologists (ASA) and Association for peri-Operative Registered Nurses (AORN). MD 9 indicated that it was standard practice for each doctor who performed surgery to assess each patient with a physical examination on the day of surgery to determine whether it was safe to proceed with surgery. MD 9 indicated that for physician-supervised moderate sedation patients, an airway assessment by the surgeon prior to surgery was also standard (to include evaluation of head, neck, mouth, heart, lungs, and high risk factors such as obesity, breathing disorders, or severe disease complications). Physicians were expected to consult with anesthesia professionals for high risk patients. MD 9 agreed that patients who required urgent surgery for active bleeding problems and currently evolving heart attacks did not have medically stable conditions and would not be considered ASA Class 2, mild systemic disease.

Review of additional surgical patient records with Administrator (ADM) 1, who supervised the perioperative managers and directors, on 10/6/11 and 10/10/11 confirmed the following:

Patient 15, age 78 with co-existing conditions of high blood pressure, gout, sleep disorder, and seizure disorder, had bowel surgery under RN-administered moderate sedation on 2/25/11 for bleeding after a recent bowel biopsy. ASA Class 2 was noted. No features of an airway assessment prior to surgery and sedation were documented. Actively bleeding tissue was identified during surgery, requiring surgical repair and medication injection to control the bleeding.

Patient 16, age 75 with co-existing conditions of high blood pressure, heart disease requiring major surgery a few years ago, and a breathing disorder during sleep, had bowel surgery under RN-administered moderate sedation on 2/24/11 for bleeding after a recent bowel biopsy and low blood pressure that required rescue in the emergency room. The Interval History & Physical form signed by the surgeon prior to surgery documented ASA Class 3. The box for pre-sedation assessment was not checked and no features of an airway assessment prior to surgery and sedation were documented.

Patient 17, age 61 with co-existing conditions of high blood pressure, diabetes, severe lung disease, past surgery for serious heart disease, recent hospitalization for pneumonia and blood clot in the leg, and obesity, had surgery in the heart studies laboratory for an new-onset evolving heart attack that could require life-saving interventions on 9/12/11. Tests prior to surgery showed moderate kidney failure. ASA Class 2 was designated on a form titled Invasive Procedures Physician Documentation. Boxes were checked to designate a plan for moderate sedation care and pre-sedation assessment, but features of an airway assessment prior to surgery and sedation were not documented. A box for Monitored anesthesia care by an anesthesiologist was included on the form and not checked. Patient 17 was found to have diseases of a heart valve and heart blood vessels that required additional surgeries on 9/21/11 and 9/22/11.

Patient 20, age 22, had pelvic surgery on 8/12/11. A history and physical assessment (H&P) dictated and signed by the surgeon was dated 8/9/11. A form titled Interval History & Physical noted no change in the patient's condition from the 8/9/11 H&P, but was signed by the surgeon after surgery on 8/12/11 at 11:33 a.m. (The Anesthesia Record documented anesthesia start time was 10:36 a.m., end time was 11:33 a.m., and surgery times were not documented.)

Review of the California Code of Regulations Title 22, a state standard for general acute care hospitals, under Chapter 1, section 70223(d)(1) documented that prior to commencing surgery the person responsible for administering anesthesia, or the surgeon if a general anesthetic is not to be administered, shall verify ... and ascertain that a record of an interval medical history and physical examination performed and recorded within the previous 24 hours appeared in the patient's medical record.

Review on 10/12/11 of the 2004 American Society for Anesthesiologists (ASA) statement "Distinguishing Monitored Anesthesia Care (MAC) from Moderate Sedation/Analgesia" indicated that high risk patients benefit by the presence of an anesthesia professional regardless of the target levels of sedation/analgesia or types of medications used during surgical procedures. Given that the surgeon is concentrating on the technical operative tasks, and a registered nurse is dedicated to monitoring the patient's airway and response to surgery and medications, an anesthesia professional possesses superior training and skills to manage a high risk patient: "An essential component of MAC is the anesthesia assessment and management of a patient's actual or anticipated physiological derangements or medical problems that may occur during a diagnostic or therapeutic procedure ... In some patients who may require only minimal sedation, MAC is often indicated because even small doses of these medications could precipitate adverse physiologic responses that would necessitate acute clinical interventions and resuscitation (life-saving rescue)." The ASA statement emphasized that "in situations where the procedure is more invasive or when the patient is especially fragile, optimizing sedation level is necessary to achieve ideal procedural conditions."

Review on 10/10/11 of the hospital's moderate sedation training module, last reviewed 1/11, documented as relative contraindications for moderate sedation: Concurrent heart attack, moderate kidney failure, severe lung disease, and obvious anatomical airway abnormalities. These relative contraindications were also stated in a section for Patient Criteria in the hospitalwide policy titled IV Sedation - Adult Patient, last reviewed 8/08. Neither the training module nor the IV Sedation policy limited the conditions under which RN-administered sedation care was approved, or for which anesthesiologist consultation was appropriate (such as unstable ASA Class 3, ASA Class 4, or patients high risk for difficult airway rescue or surgical complications that require skilled assessment and response). Neither document defined the elements of an airway assessment or required a physician to document current examination findings prior to surgery and sedation. Neither document required the sedation RN to perform their own physical assessment (to include airway) prior to performing sedation care. The training document did not provide guidance for the RN or surgeon to recognize the need for consultation with an anesthesia professional.

Review on 10/12/11 of a chapter from the online Merck Manual for Professionals (a nationally recognized reference for medical practice) titled Preoperative Evaluation retrieved at documented that a preoperative evaluation was intended to minimize surgical risk by identifying correctable abnormalities and by determining whether additional monitoring was needed or whether a procedure should be delayed so to better control an underlying disorder. The preoperative physical examination should include not only the areas affected by the surgical procedure but also the cardiopulmonary system and a search for any signs of ongoing infection (e.g. lungs, skin). Surgical risk factors were identified to include age greater than 70 years, heart attack within 6 months, poorly controlled heart failure, other heart diseases, co-existing infections, poor gas exchange in the lungs, low blood potassium level, and low blood protein level.

Review on 10/12/11 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 (included moderate sedation). This evaluation must include airway assessment, anesthesia risk assessment and anesthesia drug and allergy history.

Review on 10/12/11 of the 2011 AORN guidance statement related to preoperative care in the ambulatory surgery setting (directed to procedural surgeries including bowel and lung scope surgeries) directed on pages 600-601 that a medical history and physical examination should be conducted and documented before a surgical or invasive procedure, reviewed immediately before surgery, and any changes to the patient's condition then documented. AORN also recommended that a pre-anesthesia evaluation and assessment be conducted and documented for patients receiving any type or level of anesthesia (including moderate sedation) to determine whether the patient was an appropriate candidate for the proposed type of anesthesia services, particularly for patients with significant co-existing conditions.

Review on 10/12/11 of the 2011 Association for peri-Operative Registered Nurses (AORN) Standards and Recommended Practices indicated under item II of the Recommended Practices for Managing the Patient with Moderate Sedation/Analgesia (page 328) that certain patients may not be candidates for moderate sedation/analgesia administered by perioperative registered nurses. Such patients may require care provided by an anesthesia provider qualified to administer monitored anesthesia care and to rescue the patient from a deeper level of sedation, or qualified to convert to general anesthesia if needed. Item IIa documented that the perioperative registered nurse (RN) should assess the patient to determine the appropriateness of registered nurse-administered sedation/analgesia based on selection criteria defined by the health care organization. The ASA Physical Status (PS) Classification (same as ASA Class described above) may be used as a means of determining patient appropriateness for registered nurse-administered sedation/analgesia. ASA PS1, PS2, and medically stable PS3 patients were normally considered appropriate for RN-administered moderate sedation/analgesia. Item IIb documented, "Consultation with an anesthesia provider should be obtained if a patient presents with any one of the following: known history of respiratory or hemodynamic (lung or heart) instability; previous difficulties with anesthesia or sedation; severe sleep apnea (breathing disorder during sleep) or other airway related issues; one or more significant co-morbidities; inability to communicate or cooperate; multiple medications with potential for drug interaction with sedative analgesics; ASA physical classification of an unstable PS3, and ASA PS4 or above."

Review on 10/12/11 of standard ST-25 from the American College of Surgeons (ACS) titled "ACS Statement on Principles Underlying Perioperative Responsibility," retrieved from , under item 4 documented 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.

2. During record review on 10/4/11 at 2 pm with MGR 3, admission documentation indicated Patient 4 was 91 years old and admitted to the facility on 9/22/11 with a history of dementia and C diff colitis (bowel infection).

Patient 4 was scheduled for an Esophagogastroduodenoscopy (EGD-surgical procedure to insert a tube with a visual scope on the end into the mouth and advance to look for problems in the esophagus (throat to stomach), stomach, and into small bowel) on 10/2/11, that was signed by two licensed nurse witnesses after calling Patient 4's POA 1 ( power of attorney) for permission to perform the procedure. Review of three previous consent forms ( 2 for central line insertions and 1 for a colonoscope- visualization of the colon via rectum by a scope) indicated that Patient 4 had been able to sign her own consent forms.

During a telephone interview on 10/5/11 at 7:15 am, Patient 4's POA stated the morning of 10/2/11 he received a telephone call from RN 13 to give permission for Patient 4's physician to perform a surgical procedure. POA 1 stated RN 13 told him she was on a speaker phone with another "nurse" present to act as a witness to his consent. POA 1 stated RN 13 explained the risks and benefits to him and that he gave his consent for the procedure to be done for Patient 4. When asked if the physician called him to also explain the risks and benefits of the procedure, POA 1 stated he received no other calls concerning Patient 4's procedure.

During an interview on 10/5/11 at 7:30 am, when asked why Patient 4 did not sign her own consent form for the EGD, RN 13 stated that Patient 4 had a history of dementia and that morning she was more confused. RN 13 stated she did not feel Patient 4 would be able to understand the procedure or consent information so she called her POA who had the legal authority to give consent. RN 13 stated she explained the risks and benefits to the POA while on a speaker phone with another licensed nurse present to witness the verbal consent and both nurses signed the consent form that verified the POA had given his permission for the surgery.

A document in Patient 4's medical records titled "Interval History & Physical" read that Patient 4's surgeon (MD 1), for the EGD on 10/22/11, had documented that the risks and benefits of the EGD had been explained to the patient and was signed by MD 1 on 10/2/11 at 10:42 am. Their was no documentation that indicated when MD 1 had explained the risks and benefits of the procedure to Patient 4 or what her cognitive status was. The Interval History & Physical form was also signed by MD 1 with the post-operative condition status on 10/2/11 at 10:43 am which indicated the Interval history & physical update was completed after the procedure was finished.

A facility policy and procedure (P&P) titled "Consents - Hospitalwide", last approved 7/08, read (III-G) the physician is responsible for obtaining the informed consent including discussing and documenting risks, benefits, and alternatives..." Under section IV(A)(4)(b) for how a telephone consent should be obtained the P&P read the "Attending Physician must inform patient's legal representative of the nature of the treatment, its risks and benefits, alternatives..." and IV(A)(4)(b)(i) "Witnessed by a resposible Hospital employee..."








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Based on staff interview, policy and medical record review, the hospital failed to ensure (1) that the verification of informed consent for surgery was signed by an authorized party for 1 of 8 surgical records reviewed (Patient 19) and (2) that the physician informed the responsible party of the risks, benefits, and alternatives for an invasive procedure for one of 30 sampled patients (Patient 4) in accordance with hospital policy. This failure posed a threat that surgery could proceed against a patient's wishes or without full understanding of the surgical proceeding.

Findings:

1. Review on 10/6/11 at 3 p.m. with the Director of Quality Management (DQM) of the medical record for Patient 19 indicated that Patient 19 underwent gallbladder surgery on 9/22/11. The signature line for a surgical procedure consent verification form dated 9/22/11, however, was blank. DQM confirmed that the medical record contained no documented verification that Patient 19 consented to the surgery.

Review on 10/10/11 of a policy titled Consents - Hospitalwide, last approved 7/08, documented under item III.G, "An Informed Consent Form shall be signed by the patient before initiation of a surgical, diagnostic or therapeutic procedure which involves known risk of bodily harm." Item III.H read, "The staff member obtaining the signature on the consent form is responsible for verifying the correct procedure and location (e.g. left vs right) with the patient by physical assessment and with the physician's written order." Item IV.C documented that the purpose of informed consent was to indicate that the patient was aware that he had the right to consent to or refuse a procedure.

Based on observation, staff interview, and document review, the hospital failed to ensure that each operating room was equipped with (1) an effective emergency call system and (2) a tracheotomy kit (surgical tools used to provide direct access to the large lower airway when the airway above was obstructed) that was immediately available, to ensure preparedness and timely emergency response for all surgical patients.

Findings:

1. During a tour of the Endoscopy surgical unit (a location where bowel and lung surgeries were routinely performed) on 10/5/11 at 10 a.m. and interview with CN 1 (a nurse manager for the unit), CN 1 stated that the room was not equipped with an emergency button to call for help for a patient emergency. Instead, a nurse who was monitoring the patient's airway and vital functions, or a technician who was assisting the physician with the surgery, would need to interrupt their duties to telephone for help, which would take longer than the time needed to push a designated button. No additional staff was routinely present and available to arrange for help.

2. During inspection of the emergency supplies for the Endoscopy surgical unit on 10/6/11 at 2:51 p.m. and interview with CN 1, CN 1 confirmed that no tracheotomy kit was immediately available to the Endoscopy surgical unit.

Review on 10/10/11 of policies presented that addressed the contents of emergency supplies and equipment to be stocked and immediately available to the Endoscopy surgical unit failed to include a tracheotomy kit.

Based on staff interview, medical record and document review, the hospital failed to ensure adequate immediate post-operative care was provided in accordance with physician orders, hospital policy, and acceptable standards of care for 2 of 8 patient records reviewed (Patients 17 and 18). This failure in post-surgical monitoring put patients at risk for potential injury and adverse events from non-recognition of the need for timely critical care interventions.

Findings:

In a review of medical records with Administrator (ADM) 1, who supervised the perioperative managers and directors, on 10/10/11 at 12:10 p.m., the following was confirmed:

a. Patient 17, age 61 with co-existing conditions of high blood pressure, diabetes, severe lung disease, past surgery for serious heart disease, recent hospitalization for pneumonia and blood clot in the leg, and obesity, had surgery in the heart studies laboratory for a new-onset and currently evolving heart attack that could require life-saving interventions on 9/12/11. Moderate sedation care was performed. (Moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, also known as moderate sedation/analgesia, IV [intravenous, insertion of drugs directly into a patient ' s vein] sedation, or conscious sedation.) Tests prior to surgery showed moderate kidney failure. The surgery was performed between 12:44 p.m. and 1:03 p.m. Medications were administered during and after surgery. The final entries for nursing assessment or vital sign measurements in the heart studies laboratory were recorded at 1:23 p.m. when the blood pressure was elevated and the pain level was unchanged from the pain level prior to administration of a narcotic pain medication at 1:18 p.m.

Patient 17 departed from the operating room at 1:24 p.m., and was transported to the intensive care unit (ICU) for the remainder of the post-operative and transition care to take place there. No further documentation of Patient 17's condition occurred until 1:55 p.m. when the ICU care documentation was initiated. During that 30 minutes, Patient 17's medical risks included bleeding from the surgical site and adverse effects to the medications administered. In the ICU, limited nursing assessments which included vital sign measurements, skin condition, pain, and fall risk, were documented at 1:55 p.m., but assessments did not include physical assessment of heart rhythm, depth of breathing, wound site for bleeding, level of consciousness, mobility or Aldrete Score (a scoring system to evaluate a patient ' s recovery from surgery and anesthesia). The next entries for vital sign measurements were documented at 2:30 p.m., 2:45 p.m., and at 15 minute intervals thereafter. Intermittent entries related to chest pain and nausea were noted, but level of consciousness, circulation, heart and lung exam were not documented until 7:30 p.m. (6 hours after departing from the operating room). Post-operative Aldrete scores were not documented.

The physician orders for Patient 17's post-operative care upon transfer from the operating room to the ICU on 9/12/11 documented, "Assess and document vital signs including distal pulse (to determine blood circulation force to arms and legs) and arterial access site (surgical wound) every 15 minutes x 4, every 30 minutes x 4, every hour x 4, then per unit routine." The ICU entries did not show that all these elements were documented as directed, during a critical period of recovery from the surgery.

b. Patient 17 had a subsequent major chest surgery performed on 9/22/11 under general anesthesia. The Anesthesia Record documented that the surgery ended at 2 p.m. Post-operative recovery care was to take place in the ICU. An ICU entry documented "received report" at 2 p.m. No further entries were documented until 2:45 p.m. when descriptions of wound sites and each artificial tube and line inserted into Patient 17's body were described. However, complete vital sign measurements and nursing assessments of Patient 17's circulation, level of consciousness, heart and ventilation status, and mobility/strength were not documented until 3 p.m., a full hour after completion of surgery with no monitoring documented. Those same nursing assessments were not continued at 15-30 minute intervals thereafter. Post-operative Aldrete scores were not documented.

c. Patient 18, age 74 with co-existing conditions of diabetes, high blood pressure, and previous heart surgery, had open heart surgery for replacement of an artificial heart valve under general anesthesia on 8/2/11. The Anesthesia Record indicated Patient 18 departed at 1:45 p.m. for the ICU where recovery would occur. Vital sign measurements in the ICU were documented at 1:46 p.m. However, assessments of circulation, level of consciousness, breathing depth, mobility, arm/leg strength, pain, or wound sites were not documented until 3 p.m. Post-operative Aldrete scores were not documented.

In an interview on 10/10/11 at 11 a.m. with NM 2, a nurse manager for the heart studies laboratory, NM 2 indicated that the average time to transport a patient from the heart studies laboratory or neighboring operating rooms to the ICU normally took only a few minutes. Surgical patients were attached to vital sign monitoring machines during transport and were accompanied by an RN (registered nurse) who was responsible for continuously assessing and monitoring the patient until handed off to an ICU nurse. NM 2 acknowledged that the transporting RN was capable of documenting assessments if the transport interval exceeded the expected post-operative monitoring documentation intervals.

In an interview on 10/6/11 at 2:30 p.m. with ADM 1, ADM 1 indicated that post-operative monitoring was expected to include a nursing assessment on arrival to the monitoring unit, vital sign measurements and reassessments every 15 minutes x 4, then every 30 minutes x 2, then as the patient's condition and physician orders dictated, no matter in which location the recovery care was provided, including the ICU.

Review on 10/10/11 of policies, presented as what was available to guide staff for the monitoring of patients after surgery, indicated inconsistencies in the directions to nursing staff for monitoring criteria and frequency, depending on the type of surgery performed or the location of the post-operative monitoring. Examples included:

1. A policy titled Perioperative Post Anesthesia Care of the Surgical Patient, last approved 4/10, provided guidance for surgical patients cared for in the post-anesthesia care unit (PACU). The policy listed under Guidelines a requirement to measure vital signs every 15 minutes for one hour or until stable, then every 30 minutes for one hour, then every hour until discharge. An Aldrete score of 9 or 10 was required for discharge from the PACU. Breathing rate was to be directly measured and recorded at 15 minute intervals. Skin color was to be assessed on admission, temperatures were to be measured, and circulation of arms and legs were to be checked and documented for patients who had surgery of the arms or legs. Pain, stomach discomfort, wounds, dressings, drains, and voiding required attention and surveillance, but documentation was non-specific.

2. A policy titled Practice Standards - Perioperative RN/ORT - Nursing, last approved 9/08, documented as a job responsibility for RNs who cared for surgical patients: A thorough post-operative assessment for the patient arriving in PACU should be completed within 15 minutes of arrival in the department. The assessment included temperature, heart rate, breathing rate, blood pressure measurement, blood oxygen level, Aldrete score, skin color, lung sounds and breathing effort, heart rhythm, blood circulation force, level of consciousness, pain, strength/movement of arms and legs, and wound sites.

3. A policy titled Criteria for Discharge, last approved 2011, directed the care for ambulatory surgery patients to be able to leave the hospital after recovery from surgery and anesthesia. For those patients, Aldrete Score above 8, with return of vital sign measurements to within 20% of the pre-surgery levels and stable for 30 minutes, was required for patients who received general anesthesia. The same criteria applied for patients who had moderate sedation except for an observation stay of 15 minutes. The policy did not require the same elements to be assessed as described in the Perioperative Post Anesthesia Care of the Surgical Patient, did not specify the intervals for reassessments, and did not specify what elements were to be documented.

4. A hospital-wide policy titled IV Sedation - Adult Patient, last approved 8/08, directed monitoring criteria for surgical patients in all locations who received moderate sedation (i.e. patients who did not receive general anesthesia). The policy directed post-operative monitoring to be performed every 5-15 minutes for breathing depth and rate, movement of arms and legs, heart rate, blood pressure measurement, blood oxygen level, and skin color until parameters were met, plus Aldrete scoring until the score was 7 or above, to permit transfer from a procedure area to a the sending unit location. Upon return to the sending unit, heart rate, blood pressure measurement, breathing rate, and level of consciousness were to be monitored every 15 minutes x 2, every 30 minutes x 2 hours, and then per orders or routine care (similar to Patient 17's physician orders).

5. A policy titled Post-Operative Care - Hospitalwide, last approved 5/08, directed care for patients who completed post-anesthesia recovery in the PACU and returned to a hospital nursing unit. A nursing assessment on arrival was to include skin color, level of consciousness, breathing rate and depth, stomach examination, wounds, drains, tubes, voiding, comfort, pain, and other features. Assessments were to be documented "on charting forms."

In an interview on 10/6/11 at 2:30 p.m. with ADM 1, ADM 1 indicated that no policy specific for post-surgical nursing care in the ICU was documented. Surgical patients who recovered from surgery in the ICU instead of the PACU were expected to have the same type of monitoring as patients in the PACU, unless modified by physician orders. ADM 1 indicated that each nursing unit entered information into electronic medical records differently, and no longer used the paper forms in place when the policies were developed and implemented. ADM 1 indicated that vital sign measurements fed data directly into the electronic medical record systems. ADM 1 indicated that nurses no longer directly measured blood pressure, heart rate, breathing rate, and no longer documented the measurements as part of their direct patient assessments. [As a result, nurses may not be verifying the machine data with periodic direct measurements.] ADM 1 added that in the ICU other machine driven data was also entered into the electronic medical record (such as ventilator settings and heart pressure measurements). ADM 1 indicated that if nurses were busy delivering care, they would not be making entries in the medical record on a frequent basis or at the time the care was provided. As a result, the record may not accurately show the condition of the patient beyond the data, i.e. not based on the nursing findings, in real time. ADM 1 acknowledged that opportunities to recognize significant deviance from a routine surgical recovery may be missed or delayed if data was not supplemented and verified through the nursing assessment practices. ADM 1 indicated that a comparable system was in place for documenting vital sign measurements during surgery and recovery by printing out the memory record of the machine used during moderate sedation surgeries, without documenting nurse verified measurements or assessments of skin color, heart rhythm and breathing depth.

Review on 10/12/11 of the 2011 AORN Recommended Practices for Documentation of Perioperative Nursing Care advised, "The patient's record should reflect the perioperative patient's plan of care, including assessment, diagnosis, outcome identification, planning, implementation, and evaluation ... The patient's record should reflect a continuous evaluation of perioperative nursing care and the patient's response to applied nursing interventions."

Review on 10/12/11 of the American Society of Anesthesiologists committee standard titled "Standards for Postanesthesia Care," last amended 10/21/09, indicated that all patients who have received general anesthesia, regional anesthesia or monitored anesthesia care (MAC) shall receive appropriate postanesthesia management (as addressed in the statement). Standard IV specified that a patient's condition shall be evaluated continually in the PACU. Particular attention should be given to monitoring oxygenation, ventilation, circulation, level of consciousness and temperature. Use of an appropriate PACU scoring system is encouraged for each patient on admission, at appropriate intervals prior to discharge and at the time of discharge.

Review on 10/12/11 of the 2011 AORN Standards and Recommended Practices, under Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia, documented for item VII(a) that the same monitoring parameters (safe boundaries of specified patient characteristics) used during the procedure (e.g. vital sign measurements every 5 minutes for sedation/analgesia) should be used during the recovery phase. Postoperative care and monitoring should be consistent for all patients, should include wounds, dressings, drains, pain, heart rate and rhythm, level of consciousness, blood pressure, heart monitoring, oxygen level, and breathing assessment by direct observation and/or listening to the lungs. Item VIII(b) (discharge readiness) directed that patients who received sedation/analgesia should remain awake for at least 20 minutes without stimulation before they were considered ready for discharge. Use of a sedation scale in combination with a modified wakefulness test may ensure a more objective discharge criterion, compared to using the caregiver's judgment alone. Item VIII(d)(1) documented that written discharge criteria should include an evaluation of the patient for nausea, vomiting, pain, chills, shivering, the surgical site condition, bleeding, emotional status, fluid and urinary status, cognitive abilities, peripheral circulation, and temperature before being discharged to home. The criteria should include a numeric scoring system to evaluate the patient's condition.

Based on staff interview, policy, surgical log and medical record reviews, the hospital failed to ensure the operating room register was complete and accurate to identify each patient's age, sex, and operating room number or location for each surgery performed in all surgical locations. These failures had the potential to place the information/reports obtained from procedures in the wrong patient's medical records (i.e. patients with the same names), to place other patients at risk if contaminants were found at a later time than the procedure and the room was not cleaned properly and patients already in the room would be unable to be tracked for infection. The lack of information also had the potential to make data collected for infection control and surgical services incorrect and thus performance improvement action plans.

Findings:

In an interview and record review on 10/3/11 at 1:30 p.m. with the Director of Quality Management (DQM) of Patient 4's surgical records for bowel surgeries performed on 9/29/11 and 10/2/11, DQM indicated that the location of where the surgeries were performed was documented on the Pre-procedure Checklists as occurring in the Endoscopy surgical unit for both.

In an interview and surgical log (titled Endoscopy Register) review with Charge Nurse 1 (CN 1), a nurse manager for the Endoscopy unit where bowel and lung surgeries were routinely performed, on 10/5/11 at 10 a.m., CN 1 indicated that the Endoscopy team performed surgeries in one room of the Endoscopy unit as well as at distant locations, such as the x-ray unit, intensive care unit, main operating room suites, outpatient surgery unit, and at the bedside of patients throughout the hospital. Patient room numbers were entered on the Endoscopy Register for each surgical patient, but for patients who had surgeries not performed in their room, the location was not documented. CN 1 acknowledged that from the surgical log documentation, one could not determine where the mobile team performed the surgical procedures.

Review on 10/6/11 at 3 p.m. of the surgical log for the Endoscopy surgical unit for the period from 10/1/11 to 10/6/11 documented only the inpatient room number assigned to Patient 4 at the time of each surgery, and not that the surgeries on 9/29/11 and 10/2/11 took place in the Endoscopy surgical unit location. Locations for other patients could not be determined as only the patient rooms or origins (emergency room) were noted. Age and sex of each patient entered on the log was not documented.

Review on 10/6/11 of the California Code of Regulations Title 22 (a state standard for surgical care in acute care hospitals), Division 5, Chapter 1, Article 3, section 70223(f)(1) and (2) documented that a register (log) of operations shall be maintained to include age, sex, and operating room number (location) for each surgical procedure performed.

Review on 10/6/11 of a policy titled Endoscopy - Record Keeping/Data Management, last approved 2/7/11, listed the specific data sources to be entered on the Patient Log Book for the Endoscopy unit. The items did not include age, sex, or location where the procedure was performed.

Based on staff interview, medical record and document review, the hospital failed to ensure that an operative report describing techniques and findings in accordance with medical staff rules and regulations was documented immediately after surgery, and dictated in detail, by the operating surgeon for 1 of 8 surgical patient records reviewed (Patient 17). This failure had the potenial for the delay of patient care if further treatment/surgery were needed with specific information of what had been done not already in the patient's medical records.

Findings:

In an interview and review on 10/10/11 at 11 a.m. of the medical record for Patient 17 with the nurse manager (NM 2) for the heart studies laboratory and Administrator 1, the following documentation was confirmed:

Patient 17 presented to the hospital with an evolving heart attack and had a type of surgical heart study performed urgently on 9/12/11 in the heart studies laboratory operating room. The surgery ended at 1:04 p.m. (surgeon scrubbed out) and the patient was transferred out of the operating room at 1:34 p.m. On a form titled Invasive Procedures Physician Documentation, the surgeon had written "see progress notes" under the section titled Immediate Post-Procedure Note, signed on 9/12/11 at 1:20 p.m. The portions to document the pre and post-surgical diagnoses, findings, blood loss, tissue comments, and complications were not completed. The progress notes documented a short consultation entry on 9/12/11 at 12:15 p.m. (prior to surgery) that described the planned procedure with signatures that matched the operating surgeon. No progress notes written by the operating surgeon described the operative techniques and findings, or other details of surgery similar to what the Invasive Procedures form contained. No dictated operative report by the operating surgeon was produced either.

Review on 10/3/11 of the 5/11 Medical Staff Rules and Regulations, presented as current, documented under section C-4, "Operative reports shall include a detailed account of the findings, the technical procedures performed, the specimens removed, the postoperative diagnosis, and the name of the primary surgeon and any assistants. Operative reports shall be written or dictated as soon as patient care permits but no later than 24 hours following surgery. In addition, to ensure continuity of care, a brief note shall be handwritten in the patient ' s medical record following any procedure."

Based on interview and record review, the facility had no process (1) to ensure that pharmacy effectively measured, analyzed, and tracked medication administration errors for performance improvement and patient safety which continued to allow the potential for serious medication errors and/or ADRs and (2) for determining the competency of registered nurse (RN) intravenous (IV-small tube placed into patients vein) medication and sedation administration which could increase the risk for potential medication errors and compromise patient safety.

Findings:

1. On 10/10/11 at 9:55 am, a review of the facility policy Medication Error Prevention and Reporting - Hospitalwide, dated 7/10, indicated under III. Philosophy: "B. Since medication errors may result in serious, adverse consequences for patients, the facility has targeted Medication administration as an area for on-going performance improvement on an organization-wide basis."

During an interview on 10/10/11 at approximately 11:45 a.m., the pharmacy director (DP) stated medication error data was reported and analyzed quarterly at the Medication Safety Committee meeting (a sub-committee of the Pharmacy and Therapeutics Committee) that DP indicated was established January 2011.

Review of the monthly Medication Safety Committee minutes for January through August 2011, revealed that on 1/28/11 the committee discussed a summary review of 132 medication errors dating 1/10 through 6/10. The DP indicated that no monthly Medication Safety Committee meetings had been held since August 2011 and that no documentation of quarterly review of medication errors by the Medication Safety Committee was available since January 2011. When asked to specify the committee where the medication errors were being reported for interdisciplinary review and input DP stated, "Medication errors are not going anywhere right now."

Review of the facility policy Medication Error Prevention and Reporting - Hospitalwide, dated 7/10, indicated under IV. Policy, item A: "7. Medication errors shall be tracked and trended with summaries reported and reviewed by Department Managers and the Medical Staff through appropriate channels." Under item XIV. Program Implementation, the policy indicated: "A. Performance measurement data is collected, trended and analyzed to determine if opportunities exist to prevent and reduce medication errors....C. Opportunities to reduce medication errors that reflect system issues are addressed through the organization's performance improvement process."

During an interview on 10/10/11 at 12:30 p.m., the pharmacy director acknowledged that a review and analysis of hospital-wide medication errors had not been addressed by the Medication Safety Committee since 1/28/11.

During an interview on 10/10/11 at 12:10 pm, a registered pharmacist (RPh 2) indicated that the staff pharmacists do not individually follow up on potential adverse drug reactions (ADR) "triggers" (such as reversal agents for narcotics,sedatives, blood sugar lowering medications, and blood thinners), but referred them to her for follow up, analysis, and notification to physicians of an ADR. RPh 2 indicated "trigger drug" reports had not been analyzed for September 2011, and acknowledged physicians may not have been notified that an ADR had occurred resulting in the need for these reversal agents. RPh 2 also indicated that a computer computer software for ADR triggers was not in use because the data was hard to review and analyze. RPh 2 acknowledged that ADRs were under-reported at the hospital.

The failure of the pharmacy to collect effective data and have the Medication Safety Committee analyze the results prohibited the information from being forwarded to the QAPI committee for the formulation of a performance improvement plan and implementation of an action plan to reduce medication errors and ADRs. This lack of action allowed the potential for serious medication errors and/or ADRs to continue.

2. The facility had no process to determine registered nurse intravenous medication and sedation competencies to assure patient safety and prevent medication errors and/or over/under sedation of patients during surgical procedures.

During an interview on 10/5/11 at 10 am, a nurse manager for the mobile bowel and lung surgery team (CN 1) indicated that RNs were routinely assigned to perform sedation care for patients that had procedures in or with their unit. CN 1 also acknowledged that surgeons routinely ordered, and RNs implemented, rapid administration of sedation/analgesia medications without adjusting dosages for the age and condition of the patient, as directed in the hospital sedation training module and national sedation care guidelines.

Review on 10/10/11 of the competency files for CN 1, RN 3, and RN 4 with ADM 1 indicated that competencies for the use of surgical instruments to grasp, bite, clamp and dilate were checked off at orientation/hire, but not on a periodic basis after that time. These competencies were dated 2003 for CN 1, 2008 for RN 3, and 2005 for RN 4. Moderate Sedation competencies were documented by a 12 item checklist completed at a skills fair biannually, but the checklist did not verify the method of determining competence (e.g. formal training, knowledge test, demonstration of skills, chart review), which was signed by a RN from the team, whose competency was signed off by a RN she herself had evaluated. Sedation competencies for RN 4 were dated 9/22/08 (three years ago). Medication Administration and IV Therapy competencies were documented in an annual performance evaluation tool for CN 1 dated 8/4/11, for RN 3 dated 2/28/11, and for RN 4 dated 3/9/11, all current and marked as competent. The requirements for medication tasks included "Prepares and administers medications according to manufacturer's guidelines, policy/procedure and with consideration of the age-specific needs of the patient." The files contained no summary of patient outcomes for each RN. No privileging for surgical tasks or sedation care was documented. (refer to A 0945(4))

The position statement titled "Conscious Sedation" from the California Board of Registered Nursing (BRN) retrieved from www.rn.ca.gov on 10/12/11, indicated the facility "should have in place a process for evaluating and documenting the RNs demonstration of the knowledge, skills, and abilities for the management of clients receiving agents to render conscious sedation. Evaluation and documentation of competency should occur on a periodic basis."

The lack of a process to evaluate and document RN competencies for IV sedation/medication administration had the potential to compromise patient safety.

Based on interview and record review, the facility had no process (1) to ensure that pharmacy effectively measured, analyzed, and tracked medication administration errors for performance improvement and patient safety which continued to allow the potential for serious medication errors and/or ADRs and (2) for determining the competency of registered nurse (RN) intravenous (IV-small tube placed into patients vein) medication and sedation administration which could increase the risk for potential medication errors and compromise patient safety.

Findings:

1. On 10/10/11 at 9:55 am, a review of the facility policy Medication Error Prevention and Reporting - Hospitalwide, dated 7/10, indicated under III. Philosophy: "B. Since medication errors may result in serious, adverse consequences for patients, the facility has targeted Medication administration as an area for on-going performance improvement on an organization-wide basis."

During an interview on 10/10/11 at approximately 11:45 a.m., the pharmacy director (DP) stated medication error data was reported and analyzed quarterly at the Medication Safety Committee meeting (a sub-committee of the Pharmacy and Therapeutics Committee) that DP indicated was established January 2011.

Review of the monthly Medication Safety Committee minutes for January through August 2011, revealed that on 1/28/11 the committee discussed a summary review of 132 medication errors dating 1/10 through 6/10. The DP indicated that no monthly Medication Safety Committee meetings had been held since August 2011 and that no documentation of quarterly review of medication errors by the Medication Safety Committee was available since January 2011. When asked to specify the committee where the medication errors were being reported for interdisciplinary review and input DP stated, "Medication errors are not going anywhere right now."

Review of the facility policy Medication Error Prevention and Reporting - Hospitalwide, dated 7/10, indicated under IV. Policy, item A: "7. Medication errors shall be tracked and trended with summaries reported and reviewed by Department Managers and the Medical Staff through appropriate channels." Under item XIV. Program Implementation, the policy indicated: "A. Performance measurement data is collected, trended and analyzed to determine if opportunities exist to prevent and reduce medication errors....C. Opportunities to reduce medication errors that reflect system issues are addressed through the organization's performance improvement process."

During an interview on 10/10/11 at 12:30 p.m., the pharmacy director acknowledged that a review and analysis of hospital-wide medication errors had not been addressed by the Medication Safety Committee since 1/28/11.

During an interview on 10/10/11 at 12:10 pm, a registered pharmacist (RPh 2) indicated that the staff pharmacists do not individually follow up on potential adverse drug reactions (ADR) "triggers" (such as reversal agents for narcotics,sedatives, blood sugar lowering medications, and blood thinners), but referred them to her for follow up, analysis, and notification to physicians of an ADR. RPh 2 indicated "trigger drug" reports had not been analyzed for September 2011, and acknowledged physicians may not have been notified that an ADR had occurred resulting in the need for these reversal agents. RPh 2 also indicated that a computer computer software for ADR triggers was not in use because the data was hard to review and analyze. RPh 2 acknowledged that ADRs were under-reported at the hospital.

The failure of the pharmacy to collect effective data and have the Medication Safety Committee analyze the results prohibited the information from being forwarded to the QAPI committee for the formulation of a performance improvement plan and implementation of an action plan to reduce medication errors and ADRs. This lack of action allowed the potential for serious medication errors and/or ADRs to continue.

2. The facility had no process to determine registered nurse intravenous medication and sedation competencies to assure patient safety and prevent medication errors and/or over/under sedation of patients during surgical procedures.

During an interview on 10/5/11 at 10 am, a nurse manager for the mobile bowel and lung surgery team (CN 1) indicated that RNs were routinely assigned to perform sedation care for patients that had procedures in or with their unit. CN 1 also acknowledged that surgeons routinely ordered, and RNs implemented, rapid administration of sedation/analgesia medications without adjusting dosages for the age and condition of the patient, as directed in the hospital sedation training module and national sedation care guidelines.

Review on 10/10/11 of the competency files for CN 1, RN 3, and RN 4 with ADM 1 indicated that competencies for the use of surgical instruments to grasp, bite, clamp and dilate were checked off at orientation/hire, but not on a periodic basis after that time. These competencies were dated 2003 for CN 1, 2008 for RN 3, and 2005 for RN 4. Moderate Sedation competencies were documented by a 12 item checklist completed at a skills fair biannually, but the checklist did not verify the method of determining competence (e.g. formal training, knowledge test, demonstration of skills, chart review), which was signed by a RN from the team, whose competency was signed off by a RN she herself had evaluated. Sedation competencies for RN 4 were dated 9/22/08 (three years ago). Medication Administration and IV Therapy competencies were documented in an annual performance evaluation tool for CN 1 dated 8/4/11, for RN 3 dated 2/28/11, and for RN 4 dated 3/9/11, all current and marked as competent. The requirements for medication tasks included "Prepares and administers medications according to manufacturer's guidelines, policy/procedure and with consideration of the age-specific needs of the patient." The files contained no summary of patient outcomes for each RN. No privileging for surgical tasks or sedation care was documented. (refer to A 0945(4))

The position statement titled "Conscious Sedation" from the California Board of Registered Nursing (BRN) retrieved from www.rn.ca.gov on 10/12/11, indicated the facility "should have in place a process for evaluating and documenting the RNs demonstration of the knowledge, skills, and abilities for the management of clients receiving agents to render conscious sedation. Evaluation and documentation of competency should occur on a periodic basis."

The lack of a process to evaluate and document RN competencies for IV sedation/medication administration had the potential to compromise patient safety.

The quality assessment performance improvement (QAPI) program data collected by the infection control coordinator (ICC) for Clostidium Difficile (C-diff- a contagious bowel infection causing severe diarrhea) to monitor the effectiveness, safety of services, and quality of care did not include the environmental and cleaning impact for spread of the bacteria to prevent contamination of other patients using the bowel and lung surgical unit.

Findings:

During a tour of the endoscopy (bowel and lung) surgical unit on 10/6/11 at 7:10 am, a portable air conditioning unit (approximately 5 feet tall and 3-4 feet wide) was observed installed in the unit. Also noted in the room was a fan mounted near the ceiling which the endoscopy charge nurse (CN 1) stated, in a concurrent interview, was to circulate air in the orperating room (OR) during the procedure if it became to warm.

During an interview on 10/10/11 at 9:30 am, the facilities manager (MGR 2) acknowledged that the recirculation of air through the portable unit may have altered the previous ventilation balance (recirculated air through a central system filtering particulate matter allowing bacterial reduction with specific humidity and temperatures of air to reenter the room), particularly when the doors were propped open and fans were circulating, which may permit contaminated air from neighboring patient rooms to enter the OR and distribute to the surgical equipment and supplies. MGR 2 indicated that measurements of air balance and pressures were not conducted to verify proper OR conditions and minimize the circulation of dust and other contaminants when the portable unit was installed. MGR 2 acknowledged that the current physical plant design of the bowel and lung surgery unit did not permit the regulation and control of temperature, humidity, and air exchanges within subsections of the contiguous restricted (the patient occupied operating room) and semi-restricted areas (clean versus dirty areas and storage areas) in accordance with nationally recognized infection control standards. (cross reference to A 0951(h))

During an interview on 10/5/11 at 3 pm, the infection control coordinator (ICC) indicated he had routine monitoring and daily reports with lab report access to collect the data and track C-diff positive infections in the hospital. The ICC stated the cleaning practices for C-diff was essential to reducing the spread during and after a patients hospital stay, but that he did not track specific data for the bowel and lung surgical unit.

During an interview on 10/6/11 at 11:30 am, the ICC indicated that monitoring of infection control practices related to ventilation and environmental cleaning in the bowel and lung surgery unit were not captured by the infection control and safety surveillance activities currently in place.

Based interview and document review, the facility failed to develop and implement a process to identify the reasons medications were being given late on data collected for an action plan to be implemented to improve medication administration performance on individual patient units.

Findings:

On 10/6/11 at 10 am, a document review was conducted with the director of quality management (DQM). A compliance report from the "Med Safety Committee," dated 8/2011, documented (page 1 of 6) the percentage of medications that were administered to patients late (31 minutes after the scheduled time or later) from 2/2011 through 8/11. The data included was separated into the percentages for each patient care area as well as the total percentage of late medications hospitalwide.

The individual monthly percentages were added together and the seven month average percentages obtained for the separate patient care units. The hospitalwide average percentage rate for the seven month period, 2/11 through 8/11 was 12.26%. Five patient care units had individual average percentages above the hospitalwide percentage: 2Central = 15.86%, 2West = 14.54%, 3Main = 12.57%, 3West = 13.91%, and 4Main = 13.28%.

DQM stated there was a problem in the data collection system for late administration of medications. DQM stated there was no way the present system could break down the reasons the medications were listed as late. The collection system could only give a total of the medications given after the 30 minute time span allowed after the scheduled time.

When asked what the facility was doing to get accurate actual reasons for the medications being given late, the DQM stated the facility and quality assurance and performance improvement (QAPI) committee had no process to distinguish why the medications were late to try and improve in any one specific area. The DQM stated at this point the facility "did not know what areas to improve and what to leave alone."

Based on staff interview, medical record and document review, the hospital failed to ensure safe administration and monitoring of medications, administration of an IV, and completion of fasting blood sugar testing in accordance with physician orders, hospital policy, and/or acceptable standards of practice (e.g. manufacturers' Specifications, state regulations, organizational standards) for 8 of 10 sampled patient records reviewed (Patients 4, 15, 16, 17, 18, 19, 25, and 28), as evidenced by:

1. Patients were administered intravenous (IV, inserted through a tube into a patient's vein) medications that included Versed (sedative) and Fentanyl (narcotic) during surgical procedures without dose adjustments for age and underlying risk conditions or documented justification by a physician for use of drugs in doses outside of parameters (acceptable limits) and/or without evaluation of each patient's response to drugs administered in accordance with manufacturer recommendations, hospital policies, and acceptable standards of practice (Patients 4, 15, 16, and 17).

2. Medications were not administered in the optimal time intervals as ordered (Patient 18 received an antibiotic 1 hour late, Patient 19 received an antibiotic 2 to 4 hours late), or were not administered at all (Patient 15 did not receive a bowel prep treatment as ordered prior to surgery), in accordance with hospital policy, standards of practice, and state regulations.

3. High risk medications were administered with no physician orders documented or read back as verbal orders (Patients 15 and 17) as required by hospital policy and standards of practice.

4. Obtain a physician's order prior to administering an intravenous solution for one of 30 sampled patients (Patient 25), with the potential for excessive fluid intake.

5. Implement a physician's order for routine fingerstick blood sugar (FSBS) assessments in a diabetic patient (Patient 28) who had been receiving a blood sugar lowering medication (metformin) prior to admission, with the potential for loss of blood sugar control and metabolic complications.

These failures put patients at risk for untoward reactions to medications, or compromised response to ordered treatments, injury and harm.

Findings:

1. High risk medications were administered by rapid IV push without dosage adjustments.

Surgical record review with nursing management during the survey from 10/3/11 to 10/10/11 showed that hospital patients received high risk sedation/analgesia medications (Versed/Fentanyl), administered without adequate monitoring, in doses outside of recommended parameters, and by methods (rapid IV push) not in accordance with hospital policy and accepted standards of practice as follows:

a. Patient 4, age 91 with a history of dementia, a heart rhythm disorder requiring drug treatment to keep the blood from clotting, and recent hospitalization for a bowel infection (C diff colitis), was admitted to the hospital on 9/21/11 and had bowel surgery for bleeding from the lower bowel (rectum) on 9/29/11. Moderate sedation care was planned for the surgery. (Moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, also known as moderate sedation/analgesia, IV sedation, or conscious sedation.) One minute before surgery started, a sedation drug (Versed, 2 milligrams [mg]) and a narcotic drug (Fentanyl, 50 micrograms [mcg]) were administered rapidly within one minute into Patient 4's vein (IV). Within 9 minutes, Patient 4's blood pressure dropped by 40% and remained low for 15 minutes, while rescue fluids were administered. Other than pain, sedation level, and a machine printout of vital sign measurements for heart rate, blood pressure, breathing rate, and blood oxygen level, no nursing assessments of skin color, airway features, depth of breathing, or regularity/alterations of heart rhythm, particularly during the period of persistent low blood pressure, were documented. Oxygen administration was documented only once, at the time of sedation/analgesia drug administration, and not documented as continued or adjusted during surgery, during the period of low blood pressure and rescue, or during the recovery period.

b. Patient 4 had a subsequent upper bowel surgery under RN-administered moderate sedation on 10/2/11 for problems with eating and anemia from suspected bleeding. Weight loss of 13 pounds and a drop in the red blood cell count (from 12.0 to 9.0 hemoglobin) was documented for the interval between surgeries. Sedation with 2 mg of Versed and 50 mcg of Fentanyl was again administered rapidly within 1 minute as surgery was started, despite the problem that had occurred on 9/29/11 with the same drugs and same doses. In fact, an additional 2 mg of Versed was administered 5 minutes later, with no documented justification for pain, restlessness, or discomfort that would warrant additional sedation treatment. Pain levels were documented as zero, while sedation levels were "frequently drowsy" throughout the procedure. A machine printout of breathing rate showed periods of very rapid breathing. However, no supplemental oxygen, skin color, airway features or depth of breathing were documented throughout the procedure.

c. Patient 15, age 78 with co-existing conditions of high blood pressure, gout, medication-treated sleep disorder, and seizure disorder, had bowel surgery under RN-administered moderate sedation on 2/25/11 for rectal bleeding after a recent bowel biopsy. At the start of surgery, 3 mg of Versed and 50 mcg of Fentanyl were administered rapidly within 1 minute. Pain level was zero and sedation level was drowsy at the time of the drug administration. Additional 1 mg Versed and 25 mcg of Fentanyl were administered one minute later. Supplemental oxygen administration was not documented. A machine printout of breathing rate showed a breathing rate of 5 breaths per minute (normal rate is 12 breaths per minute) at the time of the first drug administration, and no rates were documented thereafter. During surgery, a bleeding site was identified which required injection of a high risk medication to reduce blood flow to the site. No nursing assessments of skin color, airway features, directly measured breathing rate or depth of breathing (particularly during the period when the machine did not record measurements), or regularity/alterations of heart rhythm were documented.

d. Patient 16, age 75 with co-existing conditions of high blood pressure, previous open heart surgery, and a breathing disorder during sleep (sleep apnea), had bowel surgery under RN-administered moderate sedation on 2/24/11 for rectal bleeding and low blood pressure that required rescue treatments in the emergency room on 2/23/11. Five minutes before surgery started, 2 mg of Versed and 25 mcg of Fentanyl were administered rapidly within 1 minute. Three minutes later, additional 1 mg of Versed was administered when the pain level was zero and Patient 16 was drowsy. Seven minutes later, 1 mg Versed and 25 mcg Fentanyl were administered when the pain level was 2 out of 10 (highest) and sedation level was unchanged as drowsy. A machine printout showed high breathing rates through portions of the surgery. No supplemental oxygen administration was documented throughout the sedation and surgery treatments, or during the recovery period. No nursing assessments of skin color, airway features, directly measured breathing rate or depth of breathing, or regularity/alterations of heart rhythm during the sedation and surgery treatments were documented.

e. Patient 17, age 61 with co-existing conditions of high blood pressure, diabetes, severe lung disease, past open heart surgery, obesity, and recent hospitalization for pneumonia and a blood clot in the leg, had heart surgery under RN-administered moderate sedation in the heart studies laboratory on 9/12/11 for a new-onset and currently evolving heart attack that could require life-saving interventions. Tests showed moderate kidney failure prior to surgery. No nursing or airway physical assessments by the sedation RN were documen

Based on observation, interview, clinical record and facility document review, the facility failed to implement their policy for safe and effective medication use for three of 30 sampled patients (Patients 24, 29 and 30) when:

1. Fentanyl transdermal patches (skin patches applied to the skin containing fentanyl, a potent narcotic pain medication) were dispensed for two (Patients 29 and 30) who were non-opioid tolerant according to manufacturer specifications and facility guidelines, with the potential for respiratory depression and death.

2. Patient 24's oral metoclopramide (a medication that enhances gastric motility) was not scheduled before meals in accordance with manufacturer specifications and facility guidelines, with the potential for lack of effectiveness.

Findings:

1a. During an interview on 10/5/11 at 4:30 p.m. DP and RPh 1 discussed revisions to their pharmacy guidelines, based on patient safety and previously identified non-compliances during a Medication Error Reduction Plan licensing survey conducted by the Department in August 2011. The guidance revisions focused on determining opioid tolerance prior to the dispensing of fentanyl transdermal patches. DP and RPh 1 indicated that details of the guidelines were revised and communicated during an all-staff pharmacy meeting on 9/8/11 when the pharmacists were directed to objectively document (in the patients' electronic pharmacy profiles) the prior 7 days' opiate usage to demonstrate opioid tolerance prior to dispensing fentanyl patches; if the narcotic use was deemed insufficient according to the guidelines, the pharmacists were directed to contact the prescriber. DP and RPh 1 indicated an attempt to implement a physician-driven "Fentanyl Patch Order" protocol was rejected at the Pharmacy and Therapeutics Committee meeting on 9/27/11.

According to the manufacturer package insert, the fentanyl (also known as Duragesic) patch is a very potent narcotic (opioid) pain medication applied to the skin. Fentanyl patches are indicated only for treating persistent, moderate to severe pain in patients who are opioid tolerant (patients who take regular doses of around-the-clock narcotic pain medication). Opioid naive patients (who do not take regular, daily around the clock narcotic pain medication) have increased risk for side effects including respiratory depression (decreased breathing rate) and death.

Additionally, the Food and Drug Administration (FDA) required fentanyl patch manufacturers to place the following warning on the labeling: "Fentanyl should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl 25 mcg/hr. Patients who are considered opioid tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. Because serious or life-threatening hypoventilation could occur, fentanyl patch is contraindicated in patients who are not opioid-tolerant."

Review of the revised facility guidelines for fentanyl patch administration (available in the pharmacy's electronic alert system when orders are profiled by a pharmacist), provided by RPh 1, revealed:
"Indications: Fentanyl patches are indicated for the management of persistent, moderate to severechronic (sic) pain that requires continuous opioid administration for an extended period of time AND cannot be managed by other means.
Contraindications to use due to risk of serious or life-threatening respiratory depression:
1. Patients who are not opioid tolerant
2. Management of postoperative pain
3. Management of mild pain or intermittent pain
4. Management of acute pain or if opioid analgesia is only needed for a short period of time.
Patients must be opioid tolerant. Patients must have been taking:
A. Morphine PO, at least 45 mg/day, for at least 7 days.
B. Oxycodone PO, at least 30 mg/day, for at least 7 days.
C. Hydromorphine PO, at least 8 mg/day, for at least 7 days.
D. An equianalgesic dose of another opioid, for at least 7 days."

Closed record review on 10/5/11 at 4:45 p.m. revealed Patient 29 was a 79 year-old admitted to the facility on 9/20/11 (through the emergency department) with diagnoses including pneumonia, lung cancer and osteoarthritis. Patient 29 resided at a skilled nursing facility prior to admission.

Review of Patient 29's history and physical (dated 9/21/11) revealed her pre-admission opiate-containing pain medication was Vicodin 5/500 every four hours as needed for pain; the document did not specify frequency of usage. Vicodin 5/500 contains 5 mg of hydrocodone (an opiate indicated for moderate pain) and 500 mg of acetaminophen (a mild pain reliever).

Review of Patient 29's Admission Medication Reconciliation form indicated, under "Active Home Meds " (taken prior to admission) her only opiate-containing medication pain medication was Vicodin 5/500 every 6 hours as needed.

Patient 29's admission Physician Orders included an order for Vicodin 5/500 every four hours as needed for pain.

During a concurrent interview, RPh 1 verified Patient 29's clinical record findings.

According to GlobalRph.com, oral hydrocodone 5 mg (a component of Vicodin 5/500) is approximately equivalent in opiate potency to oral morphine 5 mg. Source:

Review of Patient 29's emergency department (ED) Medication Reconciliation form, dated 9/20/11, indicated two Vicodin 5/500 tablets were administered in the ED.

Review of Patient 29's electronic MARs (for the 7-day period 9/20/11 through 9/26/11) revealed the following Vicodin usage:
9/20/11: No Vicodin administered after admission (total 10mg hydrocodone in ED, approximately equivalent to 10 mg oral morphine);
9/21/11: One Vicodin 5/500 tablet administered (total 5 mg hydrocodone, approximately equivalent to 5 mg oral morphine);
9/22/11: Two Vicodin 5/500 tablets administered (total 10 mg hydrocodone, approximately equivalent to 10 mg oral morphine);
9/23/11: Two Vicodin 5/550 tablets administered (total 10 mg hydrocodone, approximately equivalent to 10 mg oral morphine);
9/24/11: Three Vicodin 5/500 tablets administered (total 15 mg hydrocodone, approximately equivalent to 15 mg oral morphine);
9/25/11: Two Vicodin 5/500 tablets administered (total 10 mg hydrocodone, approximately equivalent to 10 mg oral morphine);
9/26/11: No Vicodin administered.

Further review of Patient 29's Physician Orders revealed on 9/27/11 (at 8:15 a.m.) for Duragesic 25 mcg (micrograms) patch "now and every 72 hours;" review of Patient 29's 9/27/11 electronic MAR indicated the 25 mcg patch was applied by licensed nursing staff at 9:35 a.m.

Review of the dispensing pharmacist's electronic profile clinical documentation (dated 9/27/11) revealed documentation, "ASSESSED PATIENT IS OPIOID TOLERANT ....CLINICAL EXPLANATION: PT [patient] IT (sic) NEW PT BEING PUT ON HOSPICE PT WAS RECEIVEING (sic) VICODIN PREVIOUSLY."

Further clinical record review revealed that on 9/27/11 at 3:25 p.m. RPh 2 wrote a physician verbal order to decrease Patient 29's fentanyl patch to 12 mcg every 3 days; review of Patient 29's 9/27/11 electronic MAR indicated the 12 mcg patch was applied at 6 p.m. (approximately 8.5 hours after the initial 25 mcg patch).

During an interview on 10/6/11 at 8:30 a.m. RPh 2 verified receipt of the verbal order from Patient 29's physician on 9/27/11 to decrease Patient 29's fentanyl patch from 25 mcg to 12 mcg every 3 days after being informed of the 25 mcg physician order by the staff pharmacist who authorized dispensing of the first dose the same morning. RPh 2 stated that she spoke with Patient 29's physician, who indicated the patient was taking "max doses" of Vicodin before admission at the skilled nursing facility; RPh 2 acknowledged that she reviewed Patient 29's hospital usage of Vicodin 5/500 during the time period 9/20/11 through 9/26/11, but not at the pre-admission MARs from the skilled nursing facility; RPh 2 stated the 12 mcg fe

Based on observation, staff interviews, medical record and document reviews, the hospital failed to provide surgical services that were well organized and in accordance with nationally recognized standards of practice in order ensure safe and high quality surgical care to all patients as evidenced by:

A. The hospital failed to ensure that the organization of surgical services was appropriate to the scope of services offered as evidenced by inconsistent perioperative practices (e.g. surgical attire and traffic patterns, cleaning and disinfecting practices, ventilation monitoring, medication administration and post-operative nursing care) among various locations where surgical procedures were performed with fragmented oversight to provide clear direction of care in accordance with acceptable standards of practice. (Refer to A 0941)

B. The hospital failed to ensure that unlicensed surgical technologists (Techs) who functioned in the scrub nurse role for surgical procedures (1) performed within the scope of practice for unlicensed personnel, and (2) were supervised by a registered nurse who was not assigned to other dedicated duties, in accordance with acceptable standards of practice, in all surgical locations of the hospital. (Refer to A 0943)

C. The hospital failed to arrange for qualified registered nurses (RNs) to perform circulating duties in the operating room for all operating room locations in accordance with state regulations and acceptable standards of practice. (Refer to A 0944)

D. The hospital assigned surgical tasks and duties to physicians, allied health practitioners (AHPs, non-physicians with advanced medical practice skills), registered nurses (RNs) and surgical technologists (Techs) without verifying the qualifications and current competencies of those individuals, and for some, without delineating the authority to perform the duties through a formal privileging process, in accordance with acceptable standards of practice, hospital policies, and medical staff policies/bylaws. (Refer to A 0945)

E. 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)

F. The hospital failed to ensure that a complete and accurate updated examination and assessment of the patient, performed by the operating surgeon, to reflect the current condition of the patient was documented prior to surgery in accordance with hospital policies and acceptable standards of practice. (Refer to A 0952)

G. The hospital failed to ensure that the verification of informed consent for surgery was signed by an authorized party in accordance with hospital policy. (Refer to A 0955)

H. The hospital failed to ensure that each operating room was equipped with (1) an effective emergency call system, and (2) a tracheotomy kit that was immediately available, to ensure preparedness and timely emergency response for all surgical patients. (Refer to A 0956)

I. The hospital failed to ensure adequate immediate post-operative care was provided in accordance with physician orders, hospital policy, and acceptable standards of care. (Refer to A 0957)

J. The hospital failed to ensure the operating room register was complete and accurate to identify each patient's age, sex, and operating room number or location for each surgery performed in all surgical locations. (Refer to A 0958)

K. The hospital failed to ensure that an operative report describing techniques and findings in accordance with medical staff rules and regulations was documented immediately after surgery, and dictated in detail, by the operating surgeon. (Refer to A 0959)

These failures put patients at risk for adverse surgical outcomes or infections.

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.



27519

Based on observation, staff interview and document review, the hospital failed to ensure that the organization of surgical services was appropriate to the scope of services offered as evidenced by inconsistent perioperative practices (e.g. surgical attire and traffic patterns, cleaning and disinfecting practices, ventilation monitoring, medication administration and post-operative nursing care) among various locations where surgical procedures were performed with fragmented oversight to provide clear direction of care in accordance with acceptable standards of practice. This failure put patients at risk for medical errors or adverse surgical outcomes from poorly understood surgical care direction.

Findings:

1. Surgical attire and traffic patterns were varied among surgical locations.

During a brief tour of the bowel and lung surgery unit on 10/3/11 at 2 p.m., a physician dressed in street clothes, a paper cover gown, gloves and mask was observed to be talking on a portable telephone within the operating room during a surgical procedure for random Patient 31. The physician's shirt collar, lower pant legs and shoes were exposed. The physician wore no hair or shoe coverings. No signage or floor markings denoted limited access to the operative suite.

In an interview on 10/5/11 at 10 a.m. with CN 1, a nurse who managed the unit, CN 1 indicated that the physicians who routinely performed surgeries in the unit wore street clothing, with a paper cover gown, gloves and a mask during the surgery, but hospital-laundered clean surgical clothing, hair and shoe coverings were not required for any staff who performed decontamination, equipment processing, stocking, or operating room support in the surgical unit. CN 1 indicated that the unit nurses and technicians provided mobile services to distant units of the hospital as well as an outside surgery center. CN 1 indicated that The nurses and technicians often changed into clothing from the offsite surgery center, and wore those clothes back and forth to the hospital for the mobile services. CN 1 stated that hospital-issued clean surgical clothing was available to physicians and unit staff, but not required. Visitors to the surgical unit were not required to wear special garb when no procedures were in progress. Access to the operating room and storage/processing locations for staff was through the decontamination room. CN 1 indicated that the hospital policy was to wear full surgical attire in this surgical unit, the practice was otherwise and did not comply with policy.

Observations of care on 10/5/11 in the central operating room suite indicated that persons entering work rooms and operating rooms beyond the patient pre-operative/recovery room area wore clean hospital-issued scrub clothing, hats, dedicated shoes or shoe coverings, and masks in more protected locations. Surgeons wearing street clothes were not observed to enter operating rooms. Signs were posted on entry doors to limit access to authorized persons and a red line on the floor identified separation of traffic to restricted and semirestricted locations.

In an interview on 10/6/11 at 11:30 a.m. with the Infection Control Coordinator (ICC), the ICC stated that infection control policies and practices were based on the organizational standards or AORN and the Centers for Disease Control and Prevention (CDC). The ICC stated that the perioperative infection control practices were expected to be followed throughout the hospital where surgical activities were provided, including the standards for surgical attire. The ICC agreed that clean properly-laundered clothing or complete coveralls, hair coverings, and shoe coverings were standard for staff who worked in the restricted and semi-restricted surgical areas (where instrument processing, decontamination, supply storage, and surgery were performed). The ICC had no measurements of compliance for infection control practices by staff who worked in the bowel and lung surgery unit.

2. Cleaning and disinfection practices were varied.

In an interview on 10/5/11 at 10 a.m. with Tech 1, a technician who routinely assisted in surgical procedures, stocked supplies, and maintained the bowel and lung surgery unit throughout the day, Tech 1 indicated that between-case cleaning was limited to spraying a disinfectant on the outside surfaces of two carts used during surgery and wiping with a gauze pad after 30 seconds (the manufacturer recommended keeping wet for 10 minutes to be effective). Tech 1 indicated that staff did not include other surfaces close to the surgical field or touched during and after the surgery, such as machine dials and switches, specimen cart, desk, and computer in the between-case cleaning. Tech 1 indicated that three carts containing surgical equipment and supplies from the unit were routinely utilized to perform bedside procedures in distant parts of the hospital. The unit had no documented process or practice to periodically clean and disinfect the mobile carts, or other storage sites for equipment and sterile supplies. Tech 1 indicated that he was not aware of special cleaning and disinfecting policies designed for the distant locations where the mobile team performed surgeries, to prepare those spaces prior to surgery, or to clean up after the surgeries were performed.

In an observation of care between cases in a central operating room on 10/5/11 at 11 a.m., staff were observed to wipe off surfaces of instrument tables, kick buckets, operating tables, anesthesia cart, and cords or equipment that was to be reused on surgical patients with a disinfectant registered by the U.S. Environmental Protection Agency in the correct manner for the disinfectant to be effective. No surfaces in the operating room were omitted to be cleaned.

In an interview and review of policies on 10/6/11 at 10 a.m. with Manager (MGR) 1, who served as the contracted housekeeping manager, MGR 1 indicated that the bowel and lung surgery unit was cleaned at the end of the day by the staff who maintained the neighboring patient rooms of that wing of the hospital. However, the central operating room suite was cleaned at the end of the day by a dedicated staff experienced in surgical environmental services. Staff was expected to thoroughly clean in both locations. However, the policies did not specify to clean the portable air conditioner and air filter units, large exposed air ducts, or window blinds in the bowel and lung surgery unit as part of the end of day cleaning. Policies did not specify to clean contaminated surfaces in patient rooms after bedside procedures were performed.

3. Ventilation monitoring practices were varied.

On 10/5/11, during inspections of the surgical locations, logs of ventilation measurements (temperature, humidity, air exchange rates) were reviewed, but no logs for the bowel and lung surgery unit were presented. Administrative staff reported on 10/6/11 at 3 p.m. that logs of ventilation measurements were not maintained for the bowel and lung surgery unit.

In an interview on 10/6/11 at 11:30 a.m. with the Infection Control Coordinator (ICC), the ICC stated that monitoring of ventilation measurements in the bowel and lung surgery unit or distant procedure locations of the hospital were not captured as part of the infection control surveillance activities to minimize cross contamination and surgical site infections, as recommended by the Association for peri-Operative Registered Nurses and the Center for Disease Control and Prevention.

4. Medication administration practices did not comply with standards.

Review on 10/10/11 at 12:10 p.m. of medical records with Administrator (ADM) 1, who supervised the perioperative managers and directors, of patients who had surgeries under Registered Nurse (RN)-administered moderate sedation (moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, also known as moderate sedation/analgesia, IV sedation, or conscious sedation) indicated that high risk medications were given rapidly without adjustments for age, patient condition, or interval for e

Based on staff interview, medical record and document review, the hospital failed to ensure that unlicensed surgical technologists (Techs) who functioned in the scrub nurse role for surgical procedures (1) performed within the scope of practice for unlicensed personnel, and (2) were supervised by a registered nurse who was not assigned to other dedicated duties, in accordance with acceptable standards of practice, in all surgical locations of the hospital for 4 of 8 surgical records reviewed (Patients 4, 15, 16, and 17). These failures had the potential harm to patients for staff members to perform certain aspects of a surgical procedure when they are not adequately trained or specifically licensed to do so and the supervising registered nurse was assigned other duties during the procedure taking their attention away from the procedural accuracy of the technologists.

Findings:

1. In an interview on 10/5/11 beginning at 10 a.m. with Surgical Technologist (Tech) 1, a technician assigned to a mobile team that provided services for bowel and lung surgeries throughout the hospital, Tech 1 indicated the following:

Staffing for the team ' s surgeries routinely included one unlicensed Tech, one licensed registered nurse (RN), and one licensed physician-surgeon. The RN was responsible to provide moderate sedation care (the administration of drugs to render a minimally depressed level of consciousness that allows a surgical patient to retain the ability to independently and continuously maintain a patent airway and respond appropriately to verbal commands and physical stimulation, also known as moderate sedation/analgesia, conscious sedation and intravenous sedation), to perform circulating duties, and to supervise the Tech. The Tech ' s duties included transporting patients, stocking and setting up the surgical equipment, cleaning and processing the equipment after use, handing supplies to the surgeon, organizing the tissue specimens for evaluation by a laboratory, and cleaning some surfaces between cases (all duties commonly performed by a scrub tech). The physician also directed the Tech to assist in the surgical procedure by manually operating the remote slider mechanisms of various surgical instruments used to grasp, bite into, dilate, and clamp tissue (mechanisms to penetrate, sever, or otherwise manipulate/alter tissue is considered surgical practice as defined by the American College of Surgeons, ST-11, revised 4/07). In some instances, the physician directed the Tech to press firmly into anatomical regions of a patient ' s abdomen in order for the physician to guide a scope instrument through the bowel passage.

Tech 1 indicated that he never attended a formal surgical technologist training program and possessed no certifications to perform the described tasks. Tech 1 learned the described skills on the job from other Techs and the physician, though that training was not documented.

Review on 10/10/11 at 12:10 p.m. of the competency records for three surgical technologists who worked with the mobile bowel and lung surgery team (Tech 1, Tech 2, and Tech 3) with Administrator 1 indicated no evidence of current health practitioner licensure, formal training, surgical technologist certifications, or current competence for the physician-directed patient care tasks described by Tech 1 above. Competencies dated 2008 for Tech 1 and Tech 2 did document approval (Uses Equipment Appropriately and Safely) for various surgical instruments that grasp, clamp, dilate, and inject medications, as well as the preparation of medications, without clarifying the role of the Tech as technical only, and limiting the role from direct patient care, which would require licensure.

Review on 10/5/11 of the job description for O.R. (operating room) Technician, last revised 9/08 and presented as the current job description for Tech 1, 2, and 3, noted that a valid state nursing license, Interim Permit, or O.R. Tech certification was required. An O.R. Technician was defined as a person who assisted the operating room team under the direct supervision of the surgeon and the circulating RN. Skills included demonstrating the safe use of equipment, such as lifts, beds, tables, and patient care devices. Use of surgical instruments and directly participating in surgical procedures was not specifically listed.

In an interview on 10/10/11 at 11 a.m. with the director of the heart studies laboratory (DCL), who identified himself as an licensed x-ray Tech, DCL indicated that one RN (to provide moderate sedation care, circulate, and supervise Techs) and two Techs (one to function as a scrub tech and one to function as a monitor of technical data measurements) were routinely assigned for heart studies surgeries. One task routinely performed by the scrub tech was to apply firm pressure to a major blood vessel entry site after a sheath was removed at the end of the surgical procedure, as directed by a department protocol, to prevent major blood loss. Although requested, the protocol was not presented prior to completion of the survey.

Review on 10/10/11 of a policy titled Surgery - Scrub Nurse Responsibilities in CVOR (heart operating room), last approved 7/11, documented a number of technical duties, none of which included direct patient care or the application of direct pressure to a major blood vessel to prevent blood loss as a duty. Although requested, the blood vessel compression protocol (a hospital-approved procedure for a specially trained staff member to perform a medical treatment or task) was not presented, prior to completion of the survey.

Review on 10/10/11 of a policy titled Endoscopy - Structure Standards, last approved 12/08, item IV.C.1.d documented that RNs were responsible to provide patient care in accordance with the state practice act. Item VI.C.1.e documented that the Tech was responsible for technical assistance to the surgeon, to help the RN as needed and "participating, as appropriate with patient care." However, Item VIII.B Staffing requirements directed for only a minimum of 2 staff (one must be RN), and noted that all RNs and Techs give technical assistance AND direct patient care, without directing the staff to have appropriate training, licensure, certifications, and competence to give direct patient care.

2. Review on 10/10/11 of a job description for Perioperative RN, last revised 8/08 and presented as the current job description for RNs working in the mobile bowel and lung surgery team and heart studies laboratory team, documented under Critical Thinking Skills item 14 that the perioperative RN demonstrated knowledge of job descriptions and appropriately delegated to OR techs based on their current clinical competence.

Review on 10/6/11 at 2:30 p.m. of the medical records for Patients 4, 15, 16, and 17 with Administrator (ADM) 1, who supervised the perioperative nurse managers and directors, confirmed that a RN specifically assigned to supervise Tech staff, and not also assigned to perform dedicated care such as moderate sedation or scrub duties, was not documented as present for surgeries performed on 9/29/11 and 10/2/11 for Patient 4, on 2/25/11 for Patient 15, on 2/24/11 for Patient 16, and on 9/12/11 for Patient 17.

Review on 10/12/11 of on-line position statements published by the state licensing board for registered nurses (BRN) retrieved from , which serves as a standard of practice for licensed nursing professionals, and the state medical practice and nurse practice acts documented in the state Business and Professions code (B&P, state laws) retrieved from , indicated the following guidance:

The RN As Supervisor - RNs have an obligation to assure that subordinates are clinically competent to perform the functions delegated to them.

Scrub Nursing Functions by Non-RNs - Any individual not licensed to practice professional nursing who performs scrub nursing functions may do so only as an assigned technical function under the direct supervision of a perioperative registered nurse.

Functions Performed by Unlicensed Personnel (B&P 2725.3) - A licensed ho

Based on staff interview, medical record and document review, the hospital failed to arrange for qualified registered nurses (RNs) to perform circulating duties in the operating room for all operating room locations in accordance with state regulations and acceptable standards of practice. This failure posed a risk to patient safety by not affording immediate availability of nursing interventions for emergencies and other patient needs.

Findings:

In an interview and record review on 10/3/11 at 1:30 p.m. with the Director of Quality Management (DQM) of Patient 4's surgical records for bowel surgeries performed on 9/29/11 and 10/2/11, DQM indicated that the staff signatures for each surgery reflected the presence of one RN to administer and monitor moderate sedation (the administration of drugs to render a minimally depressed level of consciousness that allows a surgical patient to retain the ability to independently and continuously maintain a patent airway and respond appropriately to verbal commands and physical stimulation, also known as moderate sedation/analgesia, conscious sedation and intravenous sedation), one technician, and one physician throughout each surgery. DQM indicated that an additional RN was not routinely staffed or present for surgeries performed in the endoscopy surgical unit (where bowel and lung surgeries were routinely performed). Instead, the sedation RN also functioned in the role of circulator RN.

Review on 10/3/11 of the medical records for other patients who had surgeries outside of the main operating room suites (Patient 15 had bowel surgery on 2/25/11, Patient 16 had bowel surgery on 2/24/11 for rectal bleeding and required rescue interventions for low blood pressure during surgery, and Patient 17 had urgent heart surgery for an acute heart attack on 8/12/11), with DQM indicated that one RN was listed in the role of circulator, the same RN who performed the moderate sedation care for each patient, and no other circulating RN was documented.

In an interview on 10/5/11 at 10 a.m. with Charge Nurse (CN) 1, a nurse manager for the Endoscopy surgical unit, CN 1 stated that only one RN was routinely assigned to bowel and lung surgery cases that were serviced by the Endoscopy team. CN 1 indicated that the single RN performed in the role of sedation RN and circulating RN. Intraoperative duties included administration of sedation medications and continuous monitoring of the surgical patient's response to surgery and the medications, as well as labeling specimen containers, supervising the surgical technician, applying pressure to the patient's abdomen to assist the surgeon if requested, and using a telephone to call for supplies that were not readily available, or to call for help for emergency rescue if the patient experienced a life-threatening event. CN 1 stated that no additional RN was assigned to be immediately available to the Endoscopy team on a routine basis.

In an interview on 10/10/11 at 11 a.m. with Nurse Manager (NM) 2, who supervised the heart procedure laboratory where some heart surgeries were performed, NM 2 stated that staffing for the heart surgery laboratory required only one RN to perform both sedation and circulating duties. Although a second RN was sometimes assigned to perform technical duties as a scrub (assistant to the surgeon in the sterile field) or to monitor technical equipment and record measurements, the second RN did not function as a circulator. Circulating duties were similar to those described by CN 1.

Review on 10/10/11 of a policy titled Endoscopy-Structure Standards, last approved 12/08, documented under item V.A that a minimum of two staff (one RN, one technician) were available for 24 hour services (for bowel and lung surgeries). Item VI.C.3 required implementation of the hospital's policy for moderate sedation.

The position statement titled Conscious Sedation from the California Board of Registered Nursing (BRN), last revised 7/97, retrieved at www.rn.ca.gov on 10/11/11, in part indicated: "... National guidelines for administering conscious sedation should be consulted in establishing agency (facility) policies and procedures ... RNs managing the care of patients receiving conscious sedation shall not leave the patient unattended or engage in tasks that would compromise continuous monitoring of the patient by the registered nurse. Registered nurse functions as described in this policy may not be assigned to unlicensed assistive personnel ... "

Review on 10/10/10 of the Moderate Sedation training module required for all perioperative locations where RNs performed moderate sedation care documented, "The RN responsible for administering Moderate Sedation and monitoring the patient will not be engaged in procedural activities significant enough to distract her/him from the task of patient monitoring." Neither the training module nor the moderate sedation policies presented during the survey required the sedation RN to provide continuous (uninterrupted) patient monitoring. As a result, circulating duties were assigned to sedation RNs. No policies were presented that specified that a circulating RN was to be dedicated to circulating duties and not simultaneously acting in other surgical team member roles (such as sedation or scrub).

Review on 10/10/11 of a policy titled Surgery-Perioperative Unit Structure Standards, last approved 12/08, documented under item IV.A.5, "the perioperative RN may meet the needs of the Perioperative Department in the role of circulator or scrub person as mandated by the Nursing Practice Act (state laws regulated by the RN licensing authority) and the Standards of Perioperative Nursing." The references cited for the policy included the Association for peri-Operative Registered Nurses (AORN) Recommended Standards and Guidelines, and no other nationally recognized organization was listed.

In an interview on 10/6/11 at 2:30 p.m. with Administrator (ADM) 1 who supervised the perioperative managers and directors throughout the hospital, ADM 1 indicated that the hospital-wide perioperative policies were expected to conform with the standards and practices recommended by the Association for peri-Operative Registered Nurses (AORN). ADM 1 acknowledged that circulating RNs, separate and distinct from sedation RNs, were not routinely staffed for procedures performed outside of the central operating room suites.

Review of the 2011 AORN Guidance Statement on Perioperative Staffing documented as minimum intraoperative requirements: One RN per patient per operating room in the role of the circulating nurse. One scrub person per patient per room (RN, licensed practical nurse, or surgical technologist); in some circumstances a scrub person may not be required. One dedicated RN to manage moderate sedation different from the dedicated RN circulator.

Review of the 2011 AORN Position Statement on One Perioperative Registered Nurse Circulator Dedicated to Every Patient Undergoing a Surgical Or Other Invasive Procedure echoed the minimum requirement for one perioperative registered nurse circulator to be dedicated to each patient undergoing a surgical/invasive procedure, physically present during the patient's entire intraoperative experience, to permit access to the unique clinical knowledge, judgment, and critical-thinking skills possessed by the perioperative RN.

Review of the California Code of Regulations Title 22, a state standard for general acute care hospitals, under Division 5, Chapter 1, section 70217(a)(2) documented, "The surgical service operating room shall have at least one registered nurse assigned to the duties of the circulating nurse and a minimum of one additional person serving as scrub assistant for each patient-occupied operating room. "

Review of the 2011 Association of peri-Operative Registered Nurses (AORN) Position Statement on Allied Health Care Providers and Support Personnel in the Perioperative Practice Setting preamble documented that a perioperative registered nurse was responsible for the supervision of delegated nursing tasks to allied health providers and support personnel, including sterile processing technicians, endosco

Based on staff interview and document review, the hospital assigned surgical tasks and duties to physicians, allied health practitioners (AHPs, non-physicians with advanced medical practice skills), registered nurses (RNs) and surgical technologists (Techs) without verifying the qualifications and current competencies of those individuals, and for some, without delineating the authority to perform the duties through a formal privileging process, in accordance with acceptable standards of practice, hospital policies, and medical staff policies/bylaws, as evidenced by:

1. The hospital leadership approved moderate sedation (the administration of drugs to render a minimally depressed level of consciousness that allows a surgical patient to retain the ability to independently and continuously maintain a patent airway and respond appropriately to verbal commands and physical stimulation, also known as moderate sedation/analgesia, conscious sedation and intravenous [IV] sedation) and/or endotracheal intubation (placement of a tube through the mouth or nose into the lungs to provide breathing support) clinical privileges for 4 of 4 physician files reviewed (MD 1, MD 2, MD 3, and MD 4) without documented evidence of current knowledge and demonstrated proficiency in performing moderate sedation or intubation skills in accordance with medical staff policy and organizational standards of care.

2. The hospital leadership approved surgical assist clinical privileges for 3 of 4 AHP files reviewed (Registered Nurse First Assist [RNFA] 6, Physician Assistant [PA] 7, and PA 8) with documented qualifications or delegated authority in accordance with state scope of practice and organizational standards of practice.

3. The hospital leadership permitted surgical assist tasks to be performed by unlicensed staff and licensed nurses during bowel, lung, and heart surgery procedures without assigning clinical privileges or evaluating qualifications, current competency, and/or authority to practice medicine, in accordance with medical staff policy, state and organizational standards of practice and scope of practice state laws for 3 of 3 surgical technologists reviewed (Tech 1, Tech 2, and Tech 3).

4. The hospital leadership assigned moderate sedation care to RNs without ensuring that current competence was demonstrated in accordance with state and organizational standards for 3 of 3 RNs reviewed (CN 1, RN 3, and RN 4).

These failures put patients at risk to have surgery performed by unqualified persons.

Findings:

1. The hospital did not verify current knowledge and demonstrated competency for moderate and endotracheal intubation privileges of physicians.

Review on 10/3/11 of the 5/11 Medical Staff Credentialing Manual under item 2.2-2 documented that clinical privileges shall be evaluated on the basis of the practitioner ' s education, training, and experience. The basis for ongoing privilege determinations shall be made in connection with observed clinical performance demonstrated ability and judgment, proctoring, the results of peer review, and the documented results of patient care audit/quality activities.

In a review on 10/4/11 at 11 a.m. of medical staff files with the medical staff coordinator, the following was identified:

a. MD 1, a gastroenterology (stomach and bowel) specialist, was appointed to the medical staff in 1985. Ten charts to evaluate MD 1 ' s performance for IV sedation care were reviewed in 1993, after which MD 1 was continuously granted IV sedation privileges up to the current appointment cycle. No evidence of formal education and training for IV sedation was documented. No evidence of current knowledge or IV sedation skills (airway assessment, management and rescue), and no evidence of direct observations (proctoring) of IV sedation performance were documented. No current chart review outcomes for IV sedation care, by physicians qualified to perform the same skills, were documented.

b. MD 2, a heart and chest surgeon, was appointed to the medical staff in 2003. Clinical privileges for IV sedation and endotracheal intubation were continuously approved up until the current appointment cycle. No evidence of formal education and training for IV sedation was documented. No evidence of current knowledge, no evidence of current skills for IV sedation (airway assessment, management and rescue) or endotracheal intubation (e.g. advanced cardiac life support certification, ACLS), and no evidence of direct observations (proctoring) of IV sedation or endotracheal intubation performance were documented. No current chart review outcomes for IV sedation care or endotracheal intubation, by physicians qualified to perform the same skills, were documented.

c. MD 3, a general surgeon, was appointed to the medical staff in 1998 and granted continuous privileges for IV sedation and endotracheal intubation up until the current appointment cycle. Although MD 3 passed an IV sedation knowledge test in 1998, there was no documented evidence of formal education and training for IV sedation. No evidence of current knowledge, no evidence of current skills for IV sedation (airway assessment, management and rescue) or endotracheal intubation (e.g. ACLS), and no evidence of direct observations (proctoring) of IV sedation or endotracheal intubation performance were documented. No current chart review outcomes for IV sedation care or endotracheal intubation, by physicians qualified to perform the same skills, were documented.

d. MD 4, an internist who routinely performed surgical procedures, was appointed to the medical staff in 2005 and granted continuous privileges for IV sedation up until the current appointment cycle. No evidence of formal education and training for IV sedation was documented. No evidence of current knowledge, no evidence of current skills for IV sedation (airway assessment, management and rescue, ACLS certification expired 3/10/11), and no evidence of direct observations (proctoring) of IV sedation performance were documented. No current chart review outcomes for IV sedation care, by physicians qualified to perform the same skills, were documented.

The medical staff coordinator indicated that the qualifications for IV sedation privileges (for non-anesthesiologists) included either passing a knowledge test at the time of initial request (but not at subsequent renewals of the privileges), or possession of a valid ACLS certification, or having retrospective chart reviews of ten sedation care patients for physicians on staff prior to 2001. No qualifications for endotracheal intubation were required by policy.

Review of a policy titled Credentialing Requirements for IV Sedation Privileges, last reviewed 12/08, confirmed the IV sedation qualifications as described by the medical staff coordinator. The policy added, "Privileges will be continued at the time of reappointment based on continued compliance with IV sedation standards as determined through on-going peer review studies." The policy did not identify the source of IV sedation standards (e.g. nationally recognized organization). The policy did not require documented evidence of formal education and training, proctoring, current knowledge, ongoing demonstrations of airway assessment, monitoring, and rescue skills, ACLS, or other methods to meet acceptable standards of practice.

In an interview on 10/6/11 at 1 p.m. with the former Chief of Staff and current member of the medical staff leadership committee (MD 9), MD 9 indicated that the medical staff had struggled for years with developing criteria for determining moderate sedation qualifications and competence. MD 9 expected IV sedation care to comply with the recommendations of the American Society of Anesthesiologists (ASA).

Review on 10/5/11 at 2:30 p.m. of the medical records for Patients 4, 15, 16 and 17 (all patients over the age of 60 with multiple serious co-existing conditions and risks for adverse reactions during IV sedation and surgery, and patients who had IV sedation care supervised by MD 1 or other physicians with IV sedation privileges) with Administrator (ADM) 1, who supervised the perioperative nurse managers and dire

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. Traffic patterns to locations where surgical procedures were performed (i.e. bowel and lung surgery unit) were not restricted to prevent entry of unauthorized persons and minimize cross contamination from potentially infectious sources in accordance with acceptable standards of practice.

2. Surgical attire and personal protective equipment practices did not conform to hospital policy and acceptable standards of practice to minimize cross-contamination in all locations (e.g. bowel and lung surgery unit, x-ray unit, nursing units for bedside surgery) where surgical procedures were performed.

3. Cleaning and disinfecting practices between surgical cases did not conform to acceptable standards of practice in all locations (e.g. bowel and lung surgery unit, x-ray unit, nursing units for bedside surgery) where surgical procedures were performed.

4. Surgical environments, equipment, and ventilation were not maintained to minimize mixing of contaminated air and cross contamination in critical processing and storage locations (bowel and lung surgery unit) in accordance with acceptable standards of practice.

5. Surgical personnel failed to periodically decontaminate and reprocess unused endoscope equipment in accordance with nationally recognized standards of practice.

These failures put patients at increased risk to develop surgical and other infections or adverse outcomes from a surgical experience.

Findings:

1. Traffic patterns in surgical areas were unrestricted.

During a tour of the hospital on 10/3/11 at 2 p.m. with the Director of Quality Management (DQM), a location known as the unit where bowel and lung surgeries were routinely performed was observed to be part of a building corridor that was shared with patient rooms, positioned directly across the hall from 3 rooms caring for young children. Two of the children (random Patients 32 and 34) had signs on their doors noting isolation precautions for resistant infections, and the doors were partly ajar to the hallway. Nursing staff and visitors entered and exited Patient 32's room multiple times. One of two closed doors to the surgical unit had a sign that read "OR #1." No signage or floor markings clearly denoted the rooms as having restricted access. An unlocked door opened to what resembled an office workroom with a desk, books, and a computer. The small room also had a counter with two sinks, and was considered the decontamination room for surgical equipment. A door exiting that room led directly to the operating room. The exit door was propped open. A physician dressed in street clothes, a paper cover gown and mask appeared on the operating room side of the exit door talking on a portable telephone. A surgical procedure for random Patient 31 was in progress in the operating room.

During an inspection on 10/5/11 at 10 a.m. of the bowel and lung surgery unit with CN 1, a nurse who managed the unit, the main door to the operating room labeled OR #1 was propped open with direct access to the building corridor. During the inspection, a hospital worker entered OR #1 to empty an uncovered waste basket. Hospital staff, patients, and visitors passed down the corridor in front of the open door to OR #1 continuously throughout the visit. OR #1 connected openly to a closet-sized space where instruments were disinfected, to the space where sterile supplies were stored, and to the office-decontamination room which directly connected to the same hallway corridor, though that unlocked door to the hallway was closed. A recently-used scope instrument was lying on a counter next to one of the sinks in the decontamination-office room. The door connecting that room to the operating room and instrument processing room was open. CN 1 indicated that a technician was in the middle of cleaning the scope. CN 1 indicated that special clothing or protective garments were not required to enter the surgical rooms when surgeries were not in progress, i.e., the areas were unrestricted.

Review of policies on 10/10/11 indicated the following:

a. A policy titled Endoscopy - Structure Standards, last approved 12/08, described the expectations for care in the bowel and lung surgery unit. The unit location served patients from nursing units, from the emergency room, and from the outpatient department. Under item VII for traffic safety were directions for patients to enter and exit the unit through the door labeled OR #1 directly from the corridor, for staff and physicians to enter through the office door which was to remain unlocked, and for supplies to be delivered to yet another door. The policy did not define the operating room as a restricted zone, or the decontamination, processing, and storage areas as semi-restricted.

b. In contrast, a policy titled Surgery - Perioperative Unit Structure Standards, last approved, 12/08, documented, "no one is permitted in the [operating room] without proper attire. Red lines are marked on the floor to prevent unnecessary traffic into the OR area."

c. A policy titled Sterile Processing-Decontamination: Receiving and Handling, last approved "July," documented under Purpose, "To establish a protocol for decontamination of instruments and equipment used in Surgery and in other parts of the hospital." Item IV documented, "Traffic control shall be strictly regulated. Limit unnecessary traffic through the decontamination area - doors must remain closed at all times."

Review on 10/12/11 of the 2011 Association of peri-Operative Registered Nurses (AORN) Perioperative Recommended Practices for Traffic Patterns in the Perioperative Practice Setting disclosed on page 95, under Purpose, that clearly defined and enforced traffic control practices protect personnel, patients, supplies, and equipment from potential sources of cross-contamination; safeguard the privacy of patients; and provide security. Recommendation I, item 1, documented that the surgical suite should be divided into areas designated by the physical activities performed in each as denoted by clearly marked signs to control movement into and out of the perioperative zones. The designated areas were defined as: Unrestricted area included a central control point to monitor the entrance of patients, personnel, and materials that did not require limitations for dress; Semi-restricted areas included support storage and work sites for processing instruments with access limited to authorized personnel wearing clean surgical clothing and coverings for hair; and Restricted areas included operating rooms, procedure rooms, and the clean core area with access limited to authorized personnel in surgical attire. Movement of personnel from unrestricted areas to either semi-restricted or restricted areas should be through a transition zone, where one can enter the area in street clothing and exit into the semi or restricted areas in surgical attire.

Under Recommendation III, item 2, "Doors to the operating or procedure rooms should be closed except during movement of patients, personnel, supplies and equipment." The air pressure within each operating room should be greater than in the semi-restricted areas to limit turbulent air flow that produced cross-contamination, and to maintain the critical balance of air pressure for each location. Recommendation IV directed the movement of clean and sterile supplies and equipment to be separated from contaminated supplies, equipment, and waste by space, time, or traffic patterns.

2. Surgical attire and personal protective equipment practices did not minimize cross-contamination.

During a brief tour of the bowel and lung surgery unit on 10/3/11 at 2 p.m. with DQM, a physician dressed in street clothes, a paper cover gown, gloves and mask was observed to be talking on a portable telephone within the operating room during a surgical pr

Based on staff interview, medical record and document review, the hospital failed to ensure that a complete and accurate updated examination and assessment of the patient, performed by the operating surgeon, to reflect the current condition of the patient was documented prior to surgery in accordance with hospital policies and acceptable standards of practice for 5 of 8 surgical patient records reviewed (Patients 4, 15, 16, 17 and 20). This failure resulted in the potential to not recognize the need for additional intraoperative support or consultation, in order to arrange for a safe surgery and anesthesia plan and to minimize the risk for adverse outcomes for all surgical patients.

Findings:

Review on 10/4/11 at 4 p.m. of medical records with the Director of Quality Management (DQM) confirmed the following findings:

Patient 4, age 91 who had bowel surgeries performed on 9/29/11 and 10/2/11, was admitted to the hospital on 9/21/11 for weakness, low blood pressure, and concerns for recurrence of a recent bowel infection (C diff colitis). On 9/28/11 a consultation by a bowel specialist (MD 1) documented that Patient 4 passed two stools, each with "a large amount of bright red blood and clots" on that day. Tests were ordered and on 9/30/11 a bowel surgical procedure to evaluate the source of the continued lower bowel bleeding was performed by MD 1 in the Endoscopy unit. A form titled Interval History & Physical, signed by MD 1 on 9/29/11 at 7:57 p.m., documented, "I have examined the patient and the patient's condition is unchanged," referring to the 9/28/11 consultation which noted examination findings for head shape, mouth color and wetness, neck stiffness, a heart rhythm disorder, and lung sounds, among other body findings. A box was checked to note "Pre-sedation assessment completed," but the specific features of airway assessment (e.g. mouth opening, neck shape and motion, heart sounds and rhythm, lung sounds) were not documented. A box was checked to designate "ASA Class 2." (ASA Class is a surgical risk classification system originally developed by the American Society of Anesthesiologists [ASA]. ASA Class 2 means a patient with mild systemic disease.) The form indicated that planned moderate sedation anesthesia services were intended. [Moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, also known as moderate sedation/analgesia, IV (intravenous, medications injected directly into a vein) sedation, or conscious sedation.] Nursing entries did not document features of airway examination either. During the surgery, Patient 4's blood pressure dropped by 40% four minutes after administration of sedation/analgesia medications, and persisted low for 15 minutes, requiring rescue with IV fluid treatments.

Patient 4 had a second bowel surgery on 10/2/11 after losing 11 pounds and developing severe anemia since the 9/29/11 surgery. The Interval History & Physical form similarly documented that MD 1 examined Patient 4 and the condition was unchanged. The box for pre-sedation assessment was not checked and no features of an airway assessment were documented. ASA Class 2 was again checked, despite the fragile condition of Patient 4 at that time.

In an interview on 10/5/11 at 10 a.m. with CN 1, a registered nurse (RN) who managed the mobile endoscopy unit team to provide bowel and lung surgeries throughout the hospital, CN 1 indicated that the team RNs who performed moderate sedation care did not routinely perform a complete nursing assessment with airway examination on their patients prior to sedation and surgery. CN 1, who observed the practices of most of the surgeons on the team over many years, indicated that the surgeons routinely spoke to each patient prior to surgery, but also did not directly examine or perform and document an examination of the airway features that are known to pose a risk for sedation complications (such as obesity, short neck, large tongue, incomplete opening of the mouth, limited neck motion, lung congestion, heart rhythm disorders). CN 1 was familiar with the airway features, but indicated the RNs were not formally taught to assess the features in the hospital's training for sedation care. RNs also were not formally taught about the significant complications that correlate with ASA Class levels. CN 1 stated that the mobile endoscopy unit did not accept ASA Class 4 patients, but often served very sick patients with active bleeding from the emergency room or intensive care unit who required life-saving surgeries. [ASA Class 4 means a patient with a condition that poses a constant threat to life, requires life-saving treatments].

In an interview on 10/10/11 at 11 a.m. NM 2, a registered nurse who managed the nursing care for the heart studies laboratory where heart surgeries were performed, NM 2 indicated that no hospital policy limited the acuity (severity or stability of patient conditions) for RN-administered sedation care in the heart studies laboratory. RNs provided moderate sedation care routinely for patients with life-threatening and severe conditions, including ASA Class 4 patients. NM 2 indicated that sedation RNs did not document complete physical assessment or airway assessment features for their patients prior to sedation.

In an interview on 10/5/11 at 12:30 p.m. with DQM, DQM indicated that physicians (either anesthesiologists or surgeons) were expected to document the ASA Class level for each surgical patient prior to surgery. However, there was no quality process to evaluate the accuracy of the ASA designations, which were not questioned by nursing staff.

In an interview on 10/6/11 at 1 p.m. with the former Chief of Staff (MD 9), who currently served on the medical staff leadership committee and governing board, MD 9 indicated that he expected IV sedation care to comply with the standards and recommendations of the American Society of Anesthesiologists (ASA) and Association for peri-Operative Registered Nurses (AORN). MD 9 indicated that it was standard practice for each doctor who performed surgery to assess each patient with a physical examination on the day of surgery to determine whether it was safe to proceed with surgery. MD 9 indicated that for physician-supervised moderate sedation patients, an airway assessment by the surgeon prior to surgery was also standard (to include evaluation of head, neck, mouth, heart, lungs, and high risk factors such as obesity, breathing disorders, or severe disease complications). Physicians were expected to consult with anesthesia professionals for high risk patients. MD 9 agreed that patients who required urgent surgery for active bleeding problems and currently evolving heart attacks did not have medically stable conditions and would not be considered ASA Class 2, mild systemic disease.

Review of additional surgical patient records with Administrator (ADM) 1, who supervised the perioperative managers and directors, on 10/6/11 and 10/10/11 confirmed the following:

Patient 15, age 78 with co-existing conditions of high blood pressure, gout, sleep disorder, and seizure disorder, had bowel surgery under RN-administered moderate sedation on 2/25/11 for bleeding after a recent bowel biopsy. ASA Class 2 was noted. No features of an airway assessment prior to surgery and sedation were documented. Actively bleeding tissue was identified during surgery, requiring surgical repair and medication injection to control the bleeding.

Patient 16, age 75 with co-existing conditions of high blood pressure, heart disease requiring major surgery a few years ago, and a breathing disorder during sleep, had bowel surgery under RN-administered moderate sedation on 2/24/11 for bleeding after a recent bowel biopsy and low blood pressure that required rescue in the emergency room. The Interval History & Physical form signed by the surgeon prior to surgery documented ASA Class 3. The box for pre-sedation assessment was not checked and no features of an airway assessment prior to surgery and sedation were documented.

Patient 17, age 61 with co-existing conditions of high blood pres

2. During record review on 10/4/11 at 2 pm with MGR 3, admission documentation indicated Patient 4 was 91 years old and admitted to the facility on 9/22/11 with a history of dementia and C diff colitis (bowel infection).

Patient 4 was scheduled for an Esophagogastroduodenoscopy (EGD-surgical procedure to insert a tube with a visual scope on the end into the mouth and advance to look for problems in the esophagus (throat to stomach), stomach, and into small bowel) on 10/2/11, that was signed by two licensed nurse witnesses after calling Patient 4's POA 1 ( power of attorney) for permission to perform the procedure. Review of three previous consent forms ( 2 for central line insertions and 1 for a colonoscope- visualization of the colon via rectum by a scope) indicated that Patient 4 had been able to sign her own consent forms.

During a telephone interview on 10/5/11 at 7:15 am, Patient 4's POA stated the morning of 10/2/11 he received a telephone call from RN 13 to give permission for Patient 4's physician to perform a surgical procedure. POA 1 stated RN 13 told him she was on a speaker phone with another "nurse" present to act as a witness to his consent. POA 1 stated RN 13 explained the risks and benefits to him and that he gave his consent for the procedure to be done for Patient 4. When asked if the physician called him to also explain the risks and benefits of the procedure, POA 1 stated he received no other calls concerning Patient 4's procedure.

During an interview on 10/5/11 at 7:30 am, when asked why Patient 4 did not sign her own consent form for the EGD, RN 13 stated that Patient 4 had a history of dementia and that morning she was more confused. RN 13 stated she did not feel Patient 4 would be able to understand the procedure or consent information so she called her POA who had the legal authority to give consent. RN 13 stated she explained the risks and benefits to the POA while on a speaker phone with another licensed nurse present to witness the verbal consent and both nurses signed the consent form that verified the POA had given his permission for the surgery.

A document in Patient 4's medical records titled "Interval History & Physical" read that Patient 4's surgeon (MD 1), for the EGD on 10/22/11, had documented that the risks and benefits of the EGD had been explained to the patient and was signed by MD 1 on 10/2/11 at 10:42 am. Their was no documentation that indicated when MD 1 had explained the risks and benefits of the procedure to Patient 4 or what her cognitive status was. The Interval History & Physical form was also signed by MD 1 with the post-operative condition status on 10/2/11 at 10:43 am which indicated the Interval history & physical update was completed after the procedure was finished.

A facility policy and procedure (P&P) titled "Consents - Hospitalwide", last approved 7/08, read (III-G) the physician is responsible for obtaining the informed consent including discussing and documenting risks, benefits, and alternatives..." Under section IV(A)(4)(b) for how a telephone consent should be obtained the P&P read the "Attending Physician must inform patient's legal representative of the nature of the treatment, its risks and benefits, alternatives..." and IV(A)(4)(b)(i) "Witnessed by a resposible Hospital employee..."








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Based on staff interview, policy and medical record review, the hospital failed to ensure (1) that the verification of informed consent for surgery was signed by an authorized party for 1 of 8 surgical records reviewed (Patient 19) and (2) that the physician informed the responsible party of the risks, benefits, and alternatives for an invasive procedure for one of 30 sampled patients (Patient 4) in accordance with hospital policy. This failure posed a threat that surgery could proceed against a patient's wishes or without full understanding of the surgical proceeding.

Findings:

1. Review on 10/6/11 at 3 p.m. with the Director of Quality Management (DQM) of the medical record for Patient 19 indicated that Patient 19 underwent gallbladder surgery on 9/22/11. The signature line for a surgical procedure consent verification form dated 9/22/11, however, was blank. DQM confirmed that the medical record contained no documented verification that Patient 19 consented to the surgery.

Review on 10/10/11 of a policy titled Consents - Hospitalwide, last approved 7/08, documented under item III.G, "An Informed Consent Form shall be signed by the patient before initiation of a surgical, diagnostic or therapeutic procedure which involves known risk of bodily harm." Item III.H read, "The staff member obtaining the signature on the consent form is responsible for verifying the correct procedure and location (e.g. left vs right) with the patient by physical assessment and with the physician's written order." Item IV.C documented that the purpose of informed consent was to indicate that the patient was aware that he had the right to consent to or refuse a procedure.

Based on staff interview, medical record and document review, the hospital failed to ensure adequate immediate post-operative care was provided in accordance with physician orders, hospital policy, and acceptable standards of care for 2 of 8 patient records reviewed (Patients 17 and 18). This failure in post-surgical monitoring put patients at risk for potential injury and adverse events from non-recognition of the need for timely critical care interventions.

Findings:

In a review of medical records with Administrator (ADM) 1, who supervised the perioperative managers and directors, on 10/10/11 at 12:10 p.m., the following was confirmed:

a. Patient 17, age 61 with co-existing conditions of high blood pressure, diabetes, severe lung disease, past surgery for serious heart disease, recent hospitalization for pneumonia and blood clot in the leg, and obesity, had surgery in the heart studies laboratory for a new-onset and currently evolving heart attack that could require life-saving interventions on 9/12/11. Moderate sedation care was performed. (Moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, also known as moderate sedation/analgesia, IV [intravenous, insertion of drugs directly into a patient ' s vein] sedation, or conscious sedation.) Tests prior to surgery showed moderate kidney failure. The surgery was performed between 12:44 p.m. and 1:03 p.m. Medications were administered during and after surgery. The final entries for nursing assessment or vital sign measurements in the heart studies laboratory were recorded at 1:23 p.m. when the blood pressure was elevated and the pain level was unchanged from the pain level prior to administration of a narcotic pain medication at 1:18 p.m.

Patient 17 departed from the operating room at 1:24 p.m., and was transported to the intensive care unit (ICU) for the remainder of the post-operative and transition care to take place there. No further documentation of Patient 17's condition occurred until 1:55 p.m. when the ICU care documentation was initiated. During that 30 minutes, Patient 17's medical risks included bleeding from the surgical site and adverse effects to the medications administered. In the ICU, limited nursing assessments which included vital sign measurements, skin condition, pain, and fall risk, were documented at 1:55 p.m., but assessments did not include physical assessment of heart rhythm, depth of breathing, wound site for bleeding, level of consciousness, mobility or Aldrete Score (a scoring system to evaluate a patient ' s recovery from surgery and anesthesia). The next entries for vital sign measurements were documented at 2:30 p.m., 2:45 p.m., and at 15 minute intervals thereafter. Intermittent entries related to chest pain and nausea were noted, but level of consciousness, circulation, heart and lung exam were not documented until 7:30 p.m. (6 hours after departing from the operating room). Post-operative Aldrete scores were not documented.

The physician orders for Patient 17's post-operative care upon transfer from the operating room to the ICU on 9/12/11 documented, "Assess and document vital signs including distal pulse (to determine blood circulation force to arms and legs) and arterial access site (surgical wound) every 15 minutes x 4, every 30 minutes x 4, every hour x 4, then per unit routine." The ICU entries did not show that all these elements were documented as directed, during a critical period of recovery from the surgery.

b. Patient 17 had a subsequent major chest surgery performed on 9/22/11 under general anesthesia. The Anesthesia Record documented that the surgery ended at 2 p.m. Post-operative recovery care was to take place in the ICU. An ICU entry documented "received report" at 2 p.m. No further entries were documented until 2:45 p.m. when descriptions of wound sites and each artificial tube and line inserted into Patient 17's body were described. However, complete vital sign measurements and nursing assessments of Patient 17's circulation, level of consciousness, heart and ventilation status, and mobility/strength were not documented until 3 p.m., a full hour after completion of surgery with no monitoring documented. Those same nursing assessments were not continued at 15-30 minute intervals thereafter. Post-operative Aldrete scores were not documented.

c. Patient 18, age 74 with co-existing conditions of diabetes, high blood pressure, and previous heart surgery, had open heart surgery for replacement of an artificial heart valve under general anesthesia on 8/2/11. The Anesthesia Record indicated Patient 18 departed at 1:45 p.m. for the ICU where recovery would occur. Vital sign measurements in the ICU were documented at 1:46 p.m. However, assessments of circulation, level of consciousness, breathing depth, mobility, arm/leg strength, pain, or wound sites were not documented until 3 p.m. Post-operative Aldrete scores were not documented.

In an interview on 10/10/11 at 11 a.m. with NM 2, a nurse manager for the heart studies laboratory, NM 2 indicated that the average time to transport a patient from the heart studies laboratory or neighboring operating rooms to the ICU normally took only a few minutes. Surgical patients were attached to vital sign monitoring machines during transport and were accompanied by an RN (registered nurse) who was responsible for continuously assessing and monitoring the patient until handed off to an ICU nurse. NM 2 acknowledged that the transporting RN was capable of documenting assessments if the transport interval exceeded the expected post-operative monitoring documentation intervals.

In an interview on 10/6/11 at 2:30 p.m. with ADM 1, ADM 1 indicated that post-operative monitoring was expected to include a nursing assessment on arrival to the monitoring unit, vital sign measurements and reassessments every 15 minutes x 4, then every 30 minutes x 2, then as the patient's condition and physician orders dictated, no matter in which location the recovery care was provided, including the ICU.

Review on 10/10/11 of policies, presented as what was available to guide staff for the monitoring of patients after surgery, indicated inconsistencies in the directions to nursing staff for monitoring criteria and frequency, depending on the type of surgery performed or the location of the post-operative monitoring. Examples included:

1. A policy titled Perioperative Post Anesthesia Care of the Surgical Patient, last approved 4/10, provided guidance for surgical patients cared for in the post-anesthesia care unit (PACU). The policy listed under Guidelines a requirement to measure vital signs every 15 minutes for one hour or until stable, then every 30 minutes for one hour, then every hour until discharge. An Aldrete score of 9 or 10 was required for discharge from the PACU. Breathing rate was to be directly measured and recorded at 15 minute intervals. Skin color was to be assessed on admission, temperatures were to be measured, and circulation of arms and legs were to be checked and documented for patients who had surgery of the arms or legs. Pain, stomach discomfort, wounds, dressings, drains, and voiding required attention and surveillance, but documentation was non-specific.

2. A policy titled Practice Standards - Perioperative RN/ORT - Nursing, last approved 9/08, documented as a job responsibility for RNs who cared for surgical patients: A thorough post-operative assessment for the patient arriving in PACU should be completed within 15 minutes of arrival in the department. The assessment included temperature, heart rate, breathing rate, blood pressure measurement, blood oxygen level, Aldrete score, skin color, lung sounds and breathing effort, heart rhythm, blood circulation force, level of consciousness, pain, strength/movement of arms and legs, and wound sites.

3. A policy titled Criteria for Discharge, last approved 2011, directed the care for ambulatory surgery patients to be able to leave the hospital after recovery from surgery and anesthesia. For those patients, Aldrete Score above 8, with return of vital sign