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Based on observation, interview, and record review, the GB did not ensure the quality and safety of the contracted services provided in the hospital as evidenced by:

1. The quality of the contracted services provided to the hospital was not monitored and reviewed by the GB. Cross Reference A083.

2. The contracted pharmaceutical and engineering services did not ensure the safety of services provided to the hospital as evidenced by medication refrigerator temperatures not monitored and maintained. Cross References A084 and A491.

3. The contracted pharmaceutical services did not ensure medication adverse events were reviewed, analyzed, and used as the basis for quality improvement and did not ensure that pharmaceuticals were being supplied safely and effectively. Cross References A084 and A500.

4. The contracted food and nutrition services failed to ensure a full time person was granted authority for oversight and responsibility/daily management of the dietetic service resulting in lack of oversight of the contracted food service operations. Cross Reference A620.

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

Based on interview and document review, the GB failed to ensure the CEO was responsible for managing the hospital to:

1. Ensure pharmaceutical services were provided in a safe manner to meet the needs of the patients. Cross Reference A490.

2. Ensure patients had the rights to consent to their admission and transfer. Cross References to A131 and A133.

3. Ensure the QAPI program had monitored and maintained oversight of a newly implemented automated temperature monitoring system for medication refrigerators; reported medication errors to the hospital's P&T Committee in accordance with the hospital's P&P; tracked the safety of radiologic shielding equipment used in the hospital; analyzed data for the medical record services other than the total number of delinquent records following discharge; and included the tracking and trending of clinical nutrition systems and patient satisfaction of the food and nutrition services at the facility. Cross References A273 and A283.

4. Ensure all personnel engaged in providing radiologic services were protected and radiation equipment were monitored. Cross References A537 and A538.

5. Ensure the infection control practices were developed and implemented. Cross Reference A748.

Findings:

During an interview on 1/31/13 at 1455 hours, with the CEO, CMO, and COO, they acknowledged the findings and concerns regarding patient care safety, unsafe handling and storage of medications and vaccines within proper temperature range, contracted services and evaluations, medical staff credentialing and reappointment, expired medications and biologicals, medication administration, development of comprehensive care plans, infection control practices, and dietary services.

Based on interview and document review, the GB for the hospital failed to ensure contracted services for pharmacy, engineering, dietary, and medical records services were provided in a safe and effective manner and in compliance with the Medicare Conditions of participation and according to acceptable standards of practice.

Findings:

1. The quality and safety of pharmaceutical services supplied was not ensured when the pharmacy service did not:
a. Ensure provision of drugs and biologicals in accordance to the standards of practice and the hospital's P&P for safe handling and storage of medications and vaccines within proper temperature range. Cross Reference A491.

b. Provide sufficient sterile water in the MH cart for mixing the Dantrolene (muscle relaxant used for the treatment of MH) powdered vials to meet the needs of the patients in an MH emergency. Cross Reference A500, #1.

c. Provide pharmacy services that reviewed all medication orders for unnecessary duplication of pain management therapy. Cross Reference A500, #2.

d. Clarify the nasal spray medication order for Patient 17 to ensure the patient received correct medication dosages. Cross Reference A500, #3.

e. Report medication errors and adverse drug reactions to the hospitals P&T Committee in accordance with the hospital's P&P. Cross Reference A500, #4 and #5.

f. Provide documented evidence the Consultant Pharmacist reviewed and reported ADRs to the P&T Committee. Cross Reference A500, #5.

g. Separate expired CSs away from the non-expired CSs making them potentially available for patient use. Cross Reference A505.

2. The safety and quality of engineering services was not ensured because the engineering service personnel did not monitor and maintain refrigerator temperatures to preserve medications and vaccines at the required temperatures. Cross reference A726.

3. The contracted service providing medical record services to the hospital did not provide oversight of the medical record until the time of the patient's discharge. The QA data analyzed by the medical records department at discharge showed the total delinquency rate only. There was no breakdown of the data to show specific areas needing improvement. Cross Reference A273, #5.


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4. On 1/28/13 at 0845 hours, in an interview with the Supervisor of Food and Nutrition Service Operation (contracted service), she explained the contractor was responsible for the provision of food service and clinical nutrition services at the hospital.

Review of the "Master Purchased Services Agreement, Article VIII, HOI (Hoag Orthopedic Institute) Patient dietary Services and Non-Patient Food Services" indicated, under "Performance Standards," "(Contracted service) shall provide the Food Services substantially in accordance with established and recognized professional standards applicable to dietary services and with reasonable care in accordance with all Applicable Laws, rules, and regulations that apply or relate to the performance of the Food Services. (Contracted service) shall maintain overall responsibility for providing or arranging for the coordination, management, and review of the Patient Dietary Services to meet regulatory standards and licensing for in-patient care."

There was no indication in the contract between the hospital and the contracted food service as to how monitoring of the contracted food service provider would be conducted to ensure compliance with all federal and state rules and regulations. There was no indication of what reports would be reviewed and if site visits of the contracted food service operation would be conducted, and who would be responsible for those actions.

On 1/29/13 at 1102 hours, a review of the hospital QA data showed no trended data for monitoring of clinical nutrition activities specifically within the hospital. Clinical quality assurance data was integrated with data belonging to the hospital providing the contracted service (with a different provider number) and could not be differentiated. In a concurrent interview with the Director and Manager of Food and Nutrition Service Operation (contracted service) they also confirmed there was no patient satisfaction data collected, trended, and analyzed for food service operations specifically at the hospital.

On 1/29/13 at 1435 hours, in an interview with the CNO, she confirmed the above findings. The CNO stated there was no information reported through the hospital's PI Committee addressing clinical nutrition activities and patient satisfaction with food service specifically at the hospital. The CNO stated there was an "Annual Clinical Contract Evaluation" completed on 8/10/12, related to the food service contractor.

Concurrent review of the evaluation revealed it was generic in nature and did not delineate focal areas specific to the contractor as a food service provider.

Based on interview and record review, the GB for the hospital did not review the evaluations of the contracted services to ensure the quality of those services, creating the risk of substandard services being provided in the hospital.

Findings:

The hospital's P&P titled Clinical Contracts, Tracking and Evaluation, effective 11/1/10, read in part, "The (hospital name) Board of Managers is responsible for ensuring that services performed under the contract meet (hospital name)'s criteria for selection, which includes, but is not limited to, the ability of the individual or entity to provide services: a. In accordance with the organization's requirement, b. In a safe and efficient manner, c. In compliance with the Centers for Medicare and Medicaid Hospital Conditions of Participation ..." and "A summary of the management review of every contract will be presented to the Board of Managers, who will determine when opportunities for improvement on the contract are identified, the individual or entity will be monitored for correction and sustainability of the improvement activity.., and "Administration will collect the evaluation forms and summarize the contract recommendations for the Board of Managers" and "The Board of Managers will review the contract evaluation summary and make a decision on contract renewal, modification or termination."

1. During a review of medication refrigerator temperature data on 1/30/13, three medication refrigerators were found consistently out of the correct temperature range. Cross Reference A491.

During a review of the Annual Clinical Contract Evaluation for Engineering Services dated 7/12/12, the review contained comments indicating concerns with the quality of the service provided, including concerns about lack of communication, timeliness issues and delays in resolving problems, dissatisfaction with some testing procedures, and possible staffing or leadership issues.

The summary of contract evaluations was reviewed, and it did not contain information about the deficiencies in the engineering services.

2. Review of the "Master Purchased Services Agreement, Article VIII, HOI (Hoag Orthopedic Institute) Patient dietary Services and Non-Patient Food Services," indicated, under "Performance Standards," "(Contracted service) shall provide the Food Services substantially in accordance with established and recognized professional standards applicable to dietary services and with reasonable care in accordance with all Applicable Laws, rules, and regulations that apply or relate to the performance of the Food Services. (Contracted service) shall maintain overall responsibility for providing or arranging for the coordination, management, and review of the Patient Dietary Services to meet regulatory standards and licensing for in-patient care."

There was no indication in the contract between the hospital and the contracted food service as to how monitoring of the contracted food service provider would be conducted to ensure compliance with all federal and state rules and regulations. There was no indication of what reports would be reviewed and if site visits of the contracted food service operation would be conducted, and who would be responsible for those actions.

On 1/29/13 at 1102 hours, a review of the hospital QA data, showed no trended data for monitoring of clinical nutrition activities specifically within the hospital. Clinical quality assurance data was integrated with data belonging to the hospital providing the contracted service (with a different provider number) and could not be differentiated. In a concurrent interview with the Director and Manager of Food and Nutrition Service Operation (contracted service) they also confirmed there was no patient satisfaction data collected, trended, and analyzed for food service operations specifically at the hospital.

On 1/29/13 at 1435 hours, in an interview with the CNO, she stated there was an "Annual Clinical Contract Evaluation" completed on 8/10/12, related to the food service contractor.

Concurrent review of the evaluation revealed it was generic in nature and did not delineate focal areas specific to the contractor as a food service provider.

3. The contract evaluation for the linen service was reviewed and included issues with the contracted service provider such as no scrubs available at the beginning of the day.

During an interview on 1/31/13 at 1455 hours, with the CEO, CMO, and COO, they stated the Board was not reviewing the contract evaluations or contract evaluation summaries. The COO stated issues with the Engineering contracted service identified on the contract evaluation, such as concerns about communication, staffing and leadership, were not brought to the attention of the Board of Managers for the hospital.

Based on record review and interview, the hospital failed to ensure the consent for admission signed by two of 33 sampled patients (Patients 5 and 31) corresponding to the hospital from which the patients received services. This could result in confusion for the patients as to which hospital was providing services.

Findings:

1. On 1/30/13, Patient 5's medical record was reviewed. Patient 5 was admitted to the hospital for a surgical service on 7/10/12. The patient was a minor patient and the patient's parent signed the admission documentation.

Two sets of Condition of Admission forms were signed and filed in the patient's medical record. The first Condition of Admission read "The above patient is admitted to Hoag Orthopedic Institute (Hospital) for inpatient and/or outpatient treatment subject to the following terms and conditions:"

The second Condition of Admission form signed showed "The above-named patient is admitted to (Hospital B) for inpatient, outpatient and/or emergency treatment subject to the following terms and conditions:" Both documents were signed on 7/10/12 at 0950 hours. The record reviewed showed the patient stayed in Hoag Orthopedic Institute for the whole hospitalization.

2. On 1/30/13, Patient 31's medical record was reviewed. Patient 31 was admitted to the hospital for a surgical service on 3/9/12. The patient was a minor patient and the patient's parent signed the admission documentation.

Two sets of a Condition of Admission form were signed and filed in the patient's medical record. The first Condition of Admission read "The above patient is admitted to Hoag Orthopedic Institute (Hospital) for inpatient and/or outpatient treatment subject to the following terms and conditions:"

The second Condition of Admission form signed showed "The above-named patient is admitted to (Hospital B) for inpatient, outpatient and/or emergency treatment subject to the following terms and conditions:" Both documents were signed on 2/22/12 at 1325 hours.

Patient 31's record showed the patient was admitted to Hoag Orthopedic Institute for a surgical procedure on 3/7/12. On 3/9/12 at 0700 hours, the patient was discharged from Hoag Orthopedic Institute due to a medical emergency and admitted to Hospital B's ICU for further treatment.

On 1/31/13 at 0910 hours, during an interview, the hospital's Business Services Supervisor stated each patient who was admitted to the hospital for surgical services was instructed to sign a Condition of Admissions form for each of the two hospitals, Hoag Orthopedic Institute and Hospital B. The Supervisor stated the patient signed an Hoag Orthopedic Institute consent to allow the patient to receive services. The consent for Hospital B admission was to allow that hospital to provide ancillary services such as lab, radiation imaging, and blood bank services. The Supervisor stated there was no hospital P&P for the process; however, each of the admission office staff was trained to obtain the two consents. The Supervisor stated the signing of the two Condition of Admission consents was "very convenient."

Based on interview and record review, the hospital failed to ensure a signature was obtained to provide consent to the conditions of admission and for transfer to another facility for one of 33 sampled patients (Patient 15), creating the risk for the patient's wishes to not be followed.

Findings:

The hospital's P&P titled Inter-facility Transfer of Patients, effective 11/1/10, read in part, "Patient and/or person legally responsible for patient must sign a 'Transfer Acknowledgement and Consent' form."

The medical record for Patient 15 was reviewed on 1/29/13. Patient 15 was transferred to the hospital from another hospital's emergency department for a surgical procedure. However, after the surgery, the decision was made to transfer the patient to a third hospital to receive a higher level of care.

Patient 15 had a history of dementia. The record contained copies of legal documents naming a specific family member as the healthcare surrogate decision-maker. The space on the Conditions of Admission form and the Inter-facility Transfer form for signature of patient/parent/conservator/guardian did not contain the signature or consenting information from the patient's representative. Instead, the statement "pt (patient) unable to sign, confused" was recorded on the Condition of Admission document, which was signed by the nurse. The Inter-facility Transfer form had a space for the patient's signature, but the space was left blank.

In an interview with the Supervisor of Health Information Management on 1/29/13 at 0930 hours, she concurred there was no consent documented on the Condition of Admission or transfer forms.

Based on observation, interview, and record review, the hospital's QAPI program failed to:

1. Monitor and maintain oversight of a newly implemented automated temperature monitoring system for medication refrigerators.

2. Report medication errors to the hospital's P&T Committee in accordance with the hospital's P&P.

3. Provide documented evidence the Consultant Pharmacist reviewed and reported ADRs to the P&T Committee.

4. Track the safety of radiologic shielding equipment used in the hospital.

5. Analyze data for the medical record services other than the total number of delinquent records following discharge.

The above failures created the risk of substandard healthcare for patients using the hospital.

Findings:

The hospital's P&P titled Performance Improvement Plan dated 11/1/11, read in part, "The Performance Improvement Committee is responsible for overseeing the implementation of the Performance Improvement Plan organization-wide." and "All Hospital Departments and Share/Purchased/Leased Services collaborate in continuous performance improvement activities. This includes collaboration with other departments, services or disciplines in an organization-wide approach to process design, measurement, analysis and improvement."

1. During a review of the Annual Clinical Contract Evaluation for Engineering Services dated 7/12/12, the review contained comments indicating concerns with the quality of the service provided, including concerns about lack of communication, risks to patient safety, timeliness issues and delays in resolving problems, dissatisfaction with some testing procedures, and possible staffing or leadership issues. However, the document did not contain intentions to modify or terminate the contract to obtain improved services.

During a review of hospital documents, three medication refrigerators had persistently out of range temperatures.

In an interview with the Administrator of Facilities on 1/31/13 at 0925 hours, he stated the automated temperature monitoring system was implemented 12/1/12. The system was designed to monitor the refrigerator temperatures, to alert engineering staff when they were out of range, and subsequently to alert clinical staff. The Administrator stated the system did not work for the three refrigerators. The Administrator stated parallel temperature monitoring was conducted for two weeks after 12/1/12; however, the alarm system was only tested for only 25% of the refrigerators. The Administrator stated temperature data was archived after the two weeks, but no one had been assigned to monitor the system or review the data.

The Manager of Engineering stated he was concerned the system was not alarming as intended, but that he did not review the individual refrigerator logs to see if they were maintaining the correct temperature.

On 2/1/13 at 0900 hours, the Administrator of Facilities presented a copy of an email sent on 12/20/12, to the Manager of Engineering, the Head of Pharmacy, and two other people, regarding a third floor refrigerator alarm.

In a concurrent interview, the Administrator of Facilities stated at least some of the second level alarms were transmitted.

During an interview with the Head of Pharmacy on 2/1/13 at 0900 hours, she stated she occasionally received messages that refrigerator temperatures were out of range. The Head of Pharmacy stated she believed pharmacy management would be telephoned by engineering if there was a problem with the refrigerator temperatures.

During another interview, on 2/1/13 at 1005 hours, the Head of Pharmacy stated she received some alarm notices, but thought engineering was handling them.

2. Review of the hospital's P&P titled Medication Errors, Review and Trending showed "The pharmacy consultant in conjunction with Risk Management, compiles information relating to medication errors. This information is reviewed by the Pharmacy and Therapeutics Committee, Safety Management Council, and other departments as necessary...The pharmacy consultant reports to the Pharmacy and Therapeutics Committee on a semi-annual basis regarding the number of significant medication errors and identifiable trends."

During an interview on 1/31/13 at 1030 hours, the Head of Pharmacy and the Manager of Patient Safety & Compliance indicated medication error data and analysis were reported to the PIC and not to the P&T Committee.

During a concurrent interview, the Head of Pharmacy did not indicate she was aware of the hospital's P&P indicating she needed to present the medication error reports to the P&T Committee.

3. Review of the hospital's P&P titled Pharmacy Consulting Services - Scope of Practice showed "The Pharmacy consulting services provide the basic pharmacy services...Review Adverse Drug Reactions and identifying appropriate actions."

During an interview on 1/31/13 at 1030 hours, the Head of Pharmacy and the Manager of Patient Safety & Compliance indicated the ADRs were reviewed in the PIC meetings of which the Head of Pharmacy was a member. The Head of Pharmacy stated the review of the ADRs related to Narcan use (a medication used to reverse the adverse effects of opiate pain medication) was just undertaken. The Head of Pharmacy stated she reviewed the use of Narcan from the present going back to June, 2012.

When asked about the outcome of the review, the Head of Pharmacy was unable to provide documented evidence to show the review of Narcan use and that cases were discussed in the PIC and the P&T Committee meetings.

In addition, when asked about the use of Narcan by Patient 30 during a code (emergency resuscitation), the Head of Pharmacy did not indicate the use of the medication was reviewed.

Review of the P&T meeting minutes did not indicate ADRs were discussed during the meeting.

4. The hospital's P&P titled Safety Rules, effective 11/1/10, read in part, "All lead aprons, mini lead aprons, gloves and gonad shields will be inspected annually." and "Any of the devices found to be defective will be either replaced or repaired."

The logs for radiation safety lead aprons were reviewed on 1/29/13. The log showed on 1/10/12, holes were found in aprons identified as Phil, A-13 and A-14. However, the typed copy of the log that included the 2013 evaluation recorded "no holes" for both A-13 and A-14. The hole in the Phil apron was still present. The pink shield and gray apron handwritten on one log were not included in the 2013 aprons reviewed.

The hospital supplied a copy of a purchase order dated October, 2012, showing new aprons were ordered, including one with stitched label for Phil; however, it was unclear if the aprons were received as the 2013 record continued to show a hole in the "Phil" apron.

During a teleconference call with the Radiation Safety Officer on 1/29/13 at 1135 hours, he stated he was responsible for the safety of the lead aprons used in the hospital; however, a different physician actually reviewed the apron check logs. The Radiation Safety Officer was unable to state if the defective aprons were discarded.

During an interview with the Director of Perioperative Services on 1/31/13 at 1435 hours, she was asked to review the radiation safety apron logs. The Director stated the screening and tracking documentation was inadequate. The Director confirmed the aprons noted to have a hole in 2012, also appeared on the 2013 list without a defect recorded. The Director stated no new aprons had replaced the aprons found to be defective in 2012. In addition, the Director was unable to supply additional information regarding the status of the aprons that were handwritten on the 2012 list, but did not appear on the 2013 list.


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5a. During a review of the medical records for Patients 14 and 15, the records appeared to include documentation of clinical activities at Hospital B, filed by error in the hospital's medical record system. Cross Reference A438.

During an interview with the Supervisor Health Information Management on 1/31/13 at 1405 hours, she stated less than 2-3 percent of the medical records contained dictations meant for Hospital B. The Supervisor stated if the patient requested medical records from admission to Hospital B, the medical records dictated on this hospital's dictation system would not be included. She stated the physicians were not selecting the correct code when dictating.

During an interview with the Manager of Patient Safety on 1/30/13 at 0930 hours, she stated since no pattern of documentation in the wrong hospital's medical record had been noted, the issue had not been discussed by the quality department.

b. On 1/30/13 at 1000 hours, the Supervisor of Health Information Management was interviewed to discuss the QAPI program for the Medical Records Department. The Supervisor stated the Medical Records Department was responsible to ensure a patient's medical record was complete according the hospital's requirements. The Supervisor stated this process began after the patient's discharge from the hospital. Physicians were required to complete the medical record within 14 days following the patient's discharge or the physician was notified their record was delinquent. The Supervisor was asked to provide documentation to show the department's quality measures as reported to the hospital's QAPI committee.

On 1/31/13, the Supervisor of Health Information Management provided a Medical Record Delinquency Statistics Report for 2012. The document showed the average monthly discharge rate was 422 patients with an average monthly delinquency rate of 23%.

During an interview on 1/31/13 at 1400 hours, the Supervisor stated the medical record delinquency rate referred to an incomplete record at 30 days after the patient's discharge. The average monthly delinquency rate included many different issues such as unsigned physician's orders, missing or unsigned H&Ps, unsigned operative and consultation reports, and unsigned or missing Discharge Summaries. However when asked, the Supervisor stated the audit did not breakdown the data to show the specific delinquency rates for each of the areas analyzed by the Department. The Supervisor stated the Department had not used specific delinquency data in order to show areas for improvement.

Based on staff interview and document review, the hospital failed to have an ongoing QAPI program that included tracking and trending of clinical nutrition systems and patient satisfaction of the food and nutrition services at the facility.

Findings:

On 1/29/13 at 1102 hours, review of the hospital's quality assurance data showed no trended data for monitoring of clinical nutrition activities specifically within the hospital. Clinical quality assurance data was integrated with data belonging to the hospital providing the contract service (with a different provider number) and could not be differentiated. In a concurrent interview with the Director and Manager of Food and Nutrition Service Operation, they also confirmed there was no patient satisfaction data collected, trended, and analyzed for food service operations specifically at the hospital.

On 1/29/13, at 1435 hours, in an interview with the CNO, she confirmed the above findings and stated there was no information reported through the hospital's PI Committee addressing clinical nutrition activities and patient satisfaction with food service specifically at the facility.

Based on interview and record review, the hospital failed to ensure medications related adverse events for three of the three patients reviewed (Patients 31, 32, and 33) were subject to review and analysis, creating the risk of substandard healthcare outcomes for patients using the hospital.

Findings:

The hospital's P&P titled Performance Improvement Plan dated 11/1/11, read in part, "The Performance Improvement Committee is responsible for overseeing the implementation of the Performance Improvement Plan organization-wide." and "All Hospital Departments and Share/Purchased/Leased Services collaborate in continuous performance improvement activities. This includes collaboration with other departments, services or disciplines in an organization-wide approach to process design, measurement, analysis and improvement."

The hospital's P&P titled Pharmacy and Therapeutics Committee, Membership, effective 11/1/10, read in part, "The Committee shall advise on the choice of drugs available; review all drug usage evaluation studies, review all adverse drug reactions ... "

The hospital's P&P titled Pharmacy Consulting Services- Scope of Practice dated 12/15/11, indicated under Key Functions: "Monitoring of medication administration incidents." and "Reviewing Adverse Drug Reactions and identifying appropriate actions."

The hospital's P&P titled Sentinel, Clinical & Adverse Review Process & Reporting, effective 11/1/10, read in part, "An adverse Event is defined as an undesirable and usually unanticipated event."

1. During a review of the "code blue" log (list of patients who required resuscitation), showed Patient 32 was listed in the year of 2012.

Review of the medical record for Patient 32 showed documentation in the Discharge Summary dated 3/28/12, the patients was elderly. The physician documented the patient had "Decreased level of consciousness, likely secondary to narcotics and benzodiazepines." "Low-dose Seroquel at ....the patient received this dose, but was also given Norco (a pain medication containing narcotics) as well as PRN (as needed) Xanax (anti-anxiety, sedative drug) all at the same time and was subsequently noted to be unresponsive and bradycardic (very low heart rate) with a heart rate in the 30's (normal heart rate is 60-80)."

According to the Rapid Response Team's documentation dated 3/27/12 at 2320 hours, under Assessment, "Respirations Shallow, unresponsive to painful stimuli." Narcan (a medication used to reverse the effects of narcotics) was given to the patient by the Rapid Response Team. The patient was then transferred to Hospital B for treatment at a higher level of care.

During a review of the Physician's Progress Note for Patient 32 dated 3/27/12 at 2358 hours, "Pt was noted to be bradycardic to the 30's and subsequently unresponsive. She had received her night doses of medications approx. one hour prior ...she was unresponsive to deep sternal rub, and had fixed pinpoint pupils. She was given two doses of..Narcan, after which she started moving all four extremities ...Pt will be transferred to CCU of another hospital."

During an interview with the Manager of Patient Safety & Compliance on 1/28/13 at 1425 hours, the QA process was reviewed. The Manager stated she and a member of the Sentinel Event Committee (MD F) reviewed all medical records which had potential for patient harm. These patient records were gleaned from Midas (the event reporting system), risk management, grievances, and coded complications of care. All patients transferred to a higher level of care were also reviewed. All medical incidents which needed to be reviewed further were referred to the Sentinel Events Committee and evaluated for quality of patient care. The Manager further clarified graphed data regarding transferred patients and the reasons for transfer was compiled by mining transfer data in the medical record by performance improvement personnel, and was presented to the PI Committee. However, individual cases were not presented for review by the committee.

During a second interview with the Manager of Patient Safety & Compliance on 1/31/13 at 1200 hours, the Manager confirmed the medication incident for Patient 32 was not considered an adverse event and was therefore not referred for further review. The Manager stated there was some confusion regarding the definition of "adverse events" due to the way the hospital's policy was written. The Manager considered adverse events meant "the 28 adverse events" listed in the policy. The Manager stated she did not consider patient transfers to a higher level of care to be adverse events, but as events that had the potential to be an adverse event.

During an interview with the Risk Manager on 2/1/13 at 1000 hours, she stated the "code blue" reports were not referred to the Pharmacy Department for review, but adverse outcomes related to medications may have been identified by the pharmacist through other means.

2. During a review of the "code blue" log showed Patient 31 was listed in the year 2012.

Review of the medical record for Patient 31 showed a Pain Management Physician's Consultation report dated 3/7/2012, the patient was elderly. The physician documented under plan: "Continue Dilaudid (pain medication) PCA (patient controlled anesthesia)." "Once the patient is ...off the PCA, tolerating oral intake, we'll try Nucynta (pain medication) ... as needed." Further review of the medical record indicated during surgery and thereafter, Patient 31 received the following for pain: a nerve block, general anesthesia, Dilaudid, Nuyentin, a Voltaren patch, Methadone, and Demerol.

Review of the Goal/Outcome Evaluation form for Patient 31 dated 3/9/12 at 0703 hours, showed the Rapid Response team was called to the patient's room. Documentation showed "Rapid response called, pt (patient) opens her eyes to verbal stimuli, does not follow commands. Narcan given." The Narcan was given to reverse the effects of the pain medications and the patient was transferred to Hospital B for a higher level of care.

During an interview on 2/1/13 at 0835 hours, with MD D and MD E, they were asked to review Patient 31's medical record and the medications she received. When told the medical staff did not follow the Pain Management Physician's recommendation dated 3/7/12, MD D stated "I can't comment on the pain team's management of this case." When asked if he felt this medical record should have been reviewed due to the ADR, MD D stated, "Yes." MD D also stated the anesthesiologists or the hospitalists should have reviewed the case. MD D and MD E were informed there was no documented evidence to show the medication incident involving Patient 31 was sent for further review. MD E stated "if it was not reviewed, it should have been reviewed."

During an interview with the Head of Pharmacy on 2/1/13 at 1020 hours, she reviewed the medical record of Patient 31 and the medications received. The Head of Pharmacy stated she would present this case to the P&T Committee for review. The Head of Pharmacy stated Pharmacy was behind in presenting cases to the P&T Committee and had not yet presented this case from March 2012.

3. Patient 33 was admitted to the hospital on 7/10/12, for a knee surgery. According to the discharge summary dated 7/10/12, "Postoperatively, however, the patient was quite sleepy in the Recovery Room and was difficult to awaken up on the floor. Her breathing became slowed and her pulse ox diminished significantly. It was felt she was oversedated, but she should be observed and she was given Narcan and transferred to (other hospital name) Intensive Care Unit for one-on one care and observation."

During an interview with the Head of Pharmacy on 2/1/13 at 1005 hours, she stated medication related adverse events were identified through the event reporting system and through reports from the automated dispensing machines. The Head of Pharmacy stated medical records associated with such events were reviewed through part of December, 2012. However, when asked about two code blue cases from March, 2012, (Patients 31 and 32), the Head of Pharmacy stated she had not reviewed that month.

The Head of Pharmacy showed Patient 33's case from July, 2012, was reviewed and discussion was planned at the P&T Committee meeting. However, the Head of Pharmacy stated adverse events were not discussed at the P&T Committee meeting in December, 2012. The Head of Pharmacy stated no cases from 2012, had been discussed at the P&T Committee yet. The Head of Pharmacy stated the department was behind in reviewing adverse events cases.

In an interview with the CNO on 1/29/13 at 1015 hours, the CNO stated she believed the Sentinel Clinical Event Committee reviewed all transfers to a higher level of care. When asked how the cases were brought to the attention of the committee, the CNO stated staff was to fill out a report in the events reporting system; however, she was not sure if they did so every time.

In a second interview with the CNO on 1/31/13 at 0840 hours, she stated there was no study to monitor if adverse events reports were made when expected.

The Manager of Clinical Outcomes and the Manager of Patient Safety & Compliance were interviewed on 1/29/13 at 1455 hours. When asked to state the PIPs the hospital was conducting, staff named several projects. However, when asked about the analyzing, tracking, and trending of adverse patient events, such as Code Blues and drug administration incidents, the Manager of Clinical Outcomes and the Manager of Patient Safety & Compliance were unable to name PIPs based on such events.

Based on interview and record review, the hospital failed to ensure three of the seven physicians reviewed for credentialing were proctored at the time hospital privileges were granted (MDs A, B, and C). This failure increased the risk of poor quality medical care for all hospital patients.

Findings:

The Medical Staff Bylaws dated 4/12, page 6, read in part, "With the exception of Community Staff Members, each staff member in his or her initial appointment shall undergo a period of observation by designated monitors as described in these Bylaws ..." and "Appropriate records shall be maintained."

During a review of the credential files for MDs A, B, and C, no documented evidence was located to show the physicians were proctored for the privileges they were granted.

During a concurrent interview with Medical Staff Services on 1/30/13 at 1330 hours, she confirmed the absence of documented evidence to show proctoring of the three physicians.

Based on interview and document review, the hospital failed to ensure the Medical Staff Department Chair indicated whether clinical privileges were recommended for one NP. In addition, the medical staff did not ensure criteria was developed for reappointment of medical staff members. These failures created the risk of medical staff members being reappointed who were not qualified.

Findings:

1. The credential file of NP 1 was reviewed on 1/30/13 at 1000 hours, with Medical Staff Services. The file contained a form, Medical Staff Services Checklist for Activating New Physician dated 1/24/12. The top of the form contained a section for department review with three possible choices: recommend clinical privileges; recommend clinical privileges with special conditions; and other. None of the choices was selected for NP 1.

Medical Staff Services stated the section had been left blank in error.

2. The Medical Staff Bylaws dated 4/12, read on page 13, "The medical staff shall develop a policy and procedure, subject to the administration's approval, that sets forth the process for sending and processing reapplication forms."

Medical Staff Services was interviewed on 1/31/13 at 1355 hours. When asked about the criteria for reappointment to the medical staff, Medical Staff Services stated she was unable to supply a policy with the criteria. She stated the re-appointment criteria for both the medical staff and allied health practitioners needed to be more clearly defined.

Based on interview and record review, the hospital failed to ensure required elements were completed on the H&P examination by the PA for one of 33 sampled patients (Patient 16). In addition, the H&P was not reviewed and signed by the supervising surgeon. This created the risk of a substandard healthcare outcome for that patient.

Findings:

Review of the Medical Staff Rules and Regulations dated 6/12, showed "The contents of the history and physical shall be pertinent and current. Inpatient records require a comprehensive history and physical which includes: chief complaint, present and past illness, present medications/allergies, relevant past social and family histories, systemic review, examination, conclusions/impressions, and plan of care for the patient." and "When performed by a nurse practitioner or physician assistant, the history and physical must be signed by the admitting practitioner within 24 hours or prior to any invasive procedure."

A handwritten H&P examination for Patient 16 dated 6/27/12 at 0630 hours, completed by the PA, was reviewed. The pre-printed document contained spaces for the documentation of a medical history, medications, social history, and family history; however, those spaces were left blank. The review of systems section showed the box was checked indicating no pertinent history for nine of nine systems including respiratory, cardiovascular, gastrointestinal, and genitourinary systems. The form was signed by the PA, but not by the surgeon.

Review of Patient 16's medical record showed documentation on the consultation and medication reconciliation forms indicating the patient took numerous medications at home and had several medical conditions, such as obstructive sleep apnea and a history of a small bowel obstruction. The review of systems form filled out by the patient contained "yes" answers to 13 questions about symptoms the patient had experienced in the past including shortness of breath, swelling in the legs and feet, dizziness, frequent urination, abdominal pain, and diarrhea.

In an interview with the Supervisor of Health Information Management on 1/29/13 at 0955 hours, the Supervisor confirmed some sections of the document were left blank.

Based on interview and document review, the hospital failed to ensure criteria for reappraisal of NPs and PAs was developed, creating the risk of substandard healthcare by those practitioners.

Findings:

The Medical Staff Rules and Regulations dated 6/12, read in part, "The appropriate clinical department shall evaluate the qualifications and extent of authority assigned to each Allied Health Professional. The evaluation shall be based upon the individual training, experience, and demonstrated competency of each individual taking into consideration the permissible scope of service rendered by the particular Allied Health Professional."

The required elements were not completed on the H&P examination by the PA for one of 33 sampled patients (Patient 16). In addition, the H&P was not reviewed and signed by the supervising surgeon. This created the risk of a substandard healthcare outcome for that patient. Cross Reference A358.

In an interview with Med Staff 1 on 1/31/13 at 1355 hours, she stated criteria had been developed for RN First Assistant's; however, there were no reappraisal criteria developed for NPs or PAs.

Based on observation, interview, and record review, the hospital failed to ensure the weight of one of three patients reviewed (Patient 1) was accurately measured on admission.

Findings:

The hospital's P&P titled "Intake Assessment: Vital Signs, Intake and Output, Weight" dated of 12/15/11, showed: "Nursing personnel are responsible for accurate and timely collection and entry of data points, including heart rate, respirations, blood pressure, weight, intake and output (I&O). All patients will be weighed on admission and entered in the medical record (EMR)."

On 1/28/13 at 1345 hours, review of the medical record for Patient 1 indicated the patient was admitted on 1/25/13, for a surgery. A "stated" weight of 175 pounds was documented in the medical record. There were no other weights documented in the medical record.

On 1/28/13 at 1410 hours, in an interview with RN D, she stated patients were weighed on admission. Thereafter, the patients were weighed by a doctor's order should follow-up weights be deemed necessary. RN D confirmed the patient's "stated" weight was his pre-operative weight and there was no subsequent weight.

When asked to obtain the Patient 1's weight, RN B entered the patient's room and attempted to obtain the patient's weight from the bed scale. RN B reported a weight of 162 pounds (a thirteen pound difference from the stated weight); however, the RN stated she was not sure if the bed scale had been "zeroed out" prior to Patient 1 occupying the bed and that the weight was accurate. RN B stated she would have to remove the patient from the bed in order to "zero out" the scale.

Based on observation, interview, and record review, the hospital failed to ensure a care plan was developed/individualized for three of six patients' care plans reviewed (Patients 4, 6, and 7). A lack of comprehensive care plan development may result in interventions not initiated which can further compromise the patient's medical status.

Findings:

The hospital's P&P titled Assessment/Progress Notes and Plan of Care dated 12/15/11, showed the purpose of the plan of care was to identify patient/family needs, identify problems, progress on the pathway and plan nursing care interventions. The policy showed care is planned per physician order, designated clinical pathways, and identified patient problems based on individual assessment and interdisciplinary communication. Problems are prioritized every shift and progress toward goal is documented.

1. Patient 7 was interviewed on 1/28/13 at 0945 hours. The patient stated she fell and broke her hip and was brought into the hospital two days ago on 1/26/13, for surgery. The patient stated she was unable to move and reposition herself in bed due to the surgery and pain issues.

The medical record for Patient 7 was reviewed with RN A and the CNO on 1/28/13 at 0955 hours. The patient was admitted to the hospital on 1/26/13, for a surgical repair of fractured hip. The patient was assessed as at risk for skin breakdown/pressure ulcer due to her age, physical condition, surgery and inability to move herself in the bed. The patient received pain medication as needed.

Review of the care plan for Patient 7 did not show a care plan was initiated to address either the patient's risk of skin breakdown or pain management. This was confirmed by RN A.

2. Patient 6 was interviewed on 1/29/13 at 0920 hours. The patient was observed wearing a soft neck collar and was sitting upright in the bed. The patient stated the collar was for support as he had a neck surgery the day before.

The medical record for Patient 7 was reviewed with RN B and the CNO on 1/29/13 at 0930 hours. The patient was admitted to the hospital on 1/28/12, for a surgical fusion of the cervical spine (a procedure to treat nerve root or spinal cord compression by decompressing the spinal cord and nerve roots in order to stabilize the corresponding cervical (neck) vertebrae). The patient was receiving IV pain medication as needed.

When asked to state nursing interventions for a patient after a cervical fusion surgery, RN B stated the patients may wear a cervical neck collar for support, staff would log roll or turn the patient in bed keeping the body in perfect alignment, elevate the head of the bed to decrease swelling, and assess the patient's swallowing ability with each meal.

Review of the care plan for Patient 7 with RN B did not show a care plan to address the patient's surgery was developed with interventions planned for post-operative care.

3. The medical record for Patient 4 was reviewed with RN B and the CNO on 1/29/13 at 1000 hours. The patient was admitted to the hospital on 1/28/12, for a total right hip replacement surgery.

Review of the medical record for Patient 4 showed a care plan for a total hip replacement surgery had been initiated; however, no interventions had been selected and planned for the patient.

When asked, the CNO stated it was the expectation for nursing staff to develop a care plan for each patient based on their assessed care needs.

Based on interview, the hospital failed to ensure the medical record service was organized with processes in place to maintain complete oversight of the electronic and paper medical record during a patient's stay in the hospital. This resulted in the potential for physician's dictated reports and telephone orders not to be reviewed as correct and electronically signed in a timely manner to promote safe patient care.

Findings:

On 1/30/13 at 1000 hours, the Supervisor of Health Information Management was interviewed. The Supervisor stated the Medical Records Department was responsible to ensure the patient's medical record was complete following discharge from the hospital.

The Supervisor was asked about the procedure for the authentication of physician's telephone or verbal orders. The Supervisor explained the physician remotely, or while at the hospital, entered a patient's order directly into the EMR. However, if the nurse received a telephone order from the physician, the order was entered in the patient's EMR by the nurse or clerical staff. The presence of a telephone or verbal order needing a signature was sent to the physician as an alert that a signature was needed.

When asked if there was any follow-up by the Medical Records staff to ensure telephone orders were signed within 48 hours, the Supervisor stated no. When asked if there was any follow-up by the Medical Records staff to ensure dictated reports, such as consultations and operative reports were reviewed and signed by the physician as correct in a timely manner, the Supervisor stated no. The Supervisor stated the Medical Records Department did not monitor for incomplete orders or unsigned reports until after the patient's discharge.

Based on interview and record review, the hospital failed to ensure the accuracy of the medical records for four of 33 sampled patients (Patients 5, 14, 15, and 16) as evidenced by:

1. For Patients 14 and 15, clinical activities dictated in the patients' medical records appeared to have been carried out at another hospital.

2. For Patient 16, a physician's dictated Consultation Report was placed under the listing for H&P examinations in the EMR; There was a discrepancy between the nursing documentation assessment and the anesthesia post anesthesia documentation; In addition, the reason for a transfer to another hospital was not noted on the transfer document.

3. There was no documentation on the medical record to show a test dose was given to Patient 5 prior to the full dose of the antibiotics as requested by the surgeon.

These failures created the risk of substandard healthcare for those patients.

Findings:

1a. During a review of the medical record for Patient 14 on 1/30/13, the physician's Operative Report indicated the patient had a knee surgery on 7/30/12. The patient required drainage of the knee on 8/13/12. The Operative Reports for both procedures were dictated in the hospital's dictation system, had the hospital's name at the top of the document, and were a part of the patient's medical record.

During interviews with the Manager of Clinical Outcomes on 1/30/13 at 1020 hours, she stated Patient 14 did not appear in the patient readmission data for the second procedure on 8/13/12.

During an interview with the Manager of Clinical Outcomes and the Risk Manager on 1/30/13, at 1400 hours, they stated Patient 14 was admitted to another hospital for the second surgery. The dictation of the 8/13/12 Operative Report was made in the wrong hospital system's dictation system and introduced into the medical record in error.

b. During a review of the medical record of Patient 15 on 1/29/13 at 0930 hours, the record showed the patient was transferred from the emergency department of another hospital for a hip surgery. The decision was made to obtain a cardiology consultation and later the patient was again transferred to a different hospital. The record contained a cardiology consultation on the hospital's letterhead; however, the consultation was dictated at 1500 hours, after the patient was transferred at 1030 hours. The consultation contained comments indicating the patient was seen after transfer: "The patient was transferred to the (subsequent hospital name) for further evaluation and preoperative clearance prior to his hip surgery."

In a discharge note, the hospitalist indicated the patient would be seen in the other hospital by the cardiologist after the transfer.

The patient was not seen in the hospital by the cardiologist, but in the subsequent hospital indicating the dictation occurred in the incorrect hospital's dictation system.

In a concurrent interview with the Supervisor of Health Information Management and the Risk Manager, they stated the location of the patient during the cardiology consultation, whether in their hospital or a subsequent hospital, was not clear.

During an interview with the Supervisor of Health Information Management on 1/31/13 at 1405 hours, she stated less than 2-3 percent of the records contained dictations meant for another facility. The Supervisor stated if the patient requested medical records from the admission to the other hospitals, the medical records which had been dictated on this hospital's dictation system would not be included. The Supervisor stated the physicians had not selected the correct code when dictating.

2a. During a review of the EMR of Patient 16 on 1/29/13, the content list for the record showed a H&P examination. However, when the document was selected for review, the document was instead a Consultation Report dated 6/27/12, by a urologist.

In an interview with the Supervisor Health Information Management on 1/29/13 at 0955 hours, she stated the consultation document was filed as a H&P examination in error.

b. The post-anesthesia care notes from a 6/27/12 surgery showed the PACU nurse recorded the patient's condition at 1249 hours, as respiratory effort "0," meaning apnea or mechanical ventilation; and consciousness as "0," meaning unresponsive. At 1310 hours, the nursing notes indicated consciousness as "1," meaning arousable. At 1400 hours, the nursing notes indicated the patient was a level "2," meaning fully awake.

The post-anesthesia note by the anesthesiologist was reviewed. Documentation indicated the patient was awake and alert at 1254 hours.

During an interview with MD D on 1/29/13 at 1110 hours, he concurred there was a discrepancy between the mental status described by the nurse and described by the anesthesiologist.

c. The Transfer Acknowledgement and Consent form was pre-printed and contained sections to document the reason for transfer and the risks and benefits of transfer. However, the form was blank except for the signature of the physician.

During an interview with MD D on 1/29/13 at 1110 hours, he reviewed the transfer form. MD D confirmed the reason for transfer should have been filled in for Patient 16.


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3. Patient 5's medical record was reviewed on 1/29/13, with MD E. Patient 5 came to the hospital on 7/10/12, for a surgical procedure. The Pre-operative Surgery Orders from the surgeon for prophylactic antibiotics showed the patient was to receive Cefazolin (antibiotic) one gm IV prior to the incision time with oversight by an anesthesiologist. An additional note ordered "test dose by anesthesiologist."

The Anesthesia Preop/intraop Record showed an area for documentation of Allergies/Reactions that the patient had an allergy to Amoxicillin (antibiotic). The allergic reactions included "other, short of breath." The documentation showed the patient was twice given one gram of Cefazolin during the procedure. However, there was no documented evidence to show a test dose was given as ordered.

On 1/29/13 at 1215 hours, during interview, MD E reviewed Patient 5's record. MD E stated he was the anesthesiologist who provided care for the patient. MD E confirmed a test dose would have been given to the patient before the full dose of the antibiotics was administered. However, MD E reviewed the record and could not locate information to show a test dose was administered to the patient.

Based on observation, interview, and record review, the hospital failed to provide pharmaceutical services that meet the needs of the patients as evidenced by the hospital's failures to:
1. Ensure provision of drugs and biologicals in accordance to the standards of practice and the hospital's P&P for safe handling and storage of medications and vaccines within proper temperature range. Cross Reference A491.

2. Provide sufficient sterile water in the MH cart for mixing the Dantrolene powdered vials to meet the needs of the patients in an MH emergency. Cross Reference A500, #1.

3. Clarify the nasal spray medication order to ensure the patient received correct medication dosages.

4. Provide pharmacy services that reviewed all medication orders for unnecessary duplication of pain management therapy. Cross Reference A500, #2.

5. Report medication errors and adverse drug reactions to the hospitals P&T Committee in accordance with the hospital's P&P. Cross Reference A500, #4.

6. Provide documented evidence the Consultant Pharmacist reviewed and reported to the P&T Committee ADRs. Cross Reference A500, #5.

7. Separate expired CSs away from the non-expired CSs making them potentially available for patient use. Cross Reference A505.

The cumulative effect of the systemic problems resulted in the hospital's failure to ensure the provision of pharmaceutical services in a safe environment that met the needs of the patients.

Based on observation, interview, and document review, the hospital failed to administer drugs and biologicals in accordance with the hospital's P&P consistent with the standards of practice for safe provision of medications that meet the needs of the patient. The failed practices resulted in administration of potentially sub-potent drugs and biologicals. Patients were placed in potentially serious harm by disregarding manufacturers and CDC's recommendations and the hospital's P&P for safe handling and storage of medications and vaccines within proper temperature range.

In addition, the hospital failed to respond timely to address the potential risk of vaccinations that had the potential to not provide protection from flu and pneumococcal infections and to implement immediate preventive actions to minimize the impact on the rest of the patients.

Due to the hospital's failure to use best practices for safe and effective administration of drugs and biologicals and avoid medication misadventures, the survey team called an immediate jeopardy on 1/31/13 at 1130 hours with the hospital's management staff.

After receiving an acceptable immediate plan of action that included:

1. All existing influenza and pneumonia vaccines were removed from use and discarded.
2. The medications Thrombin, Bacitracin and Diltiazem were removed from the Satellite Pharmacy Night Locker Inner Core Refrigerator and discarded.
3. Any of the above three medications dispensed from the Satellite Pharmacy Night Locker Inner Core Refrigerator were removed from use and discarded.
4. All patients who received influenza and pneumonia vaccine during the dates of 12/1/12-1/30/13, were sent notification letters by certified mail.
5. Calibrated digital thermometers and glycol were placed in all medication refrigerators.
6. Manual Medication Refrigerator Logs were placed on all medication refrigerators.
7. Manual checks on the nursing medication refrigerators will be done by the Charge Nurse or Relief Charge Nurse. Manual checks on the Pharmacy refrigerators will be done by Pharmacy techs. Refrigerators with vaccines will be checked twice a day. Inservices for staff on the hospital's P&P were provided beginning on 1/31/13 and completed on 2/1/13.
8. Medication Refrigerator Temperature Logs will be audited and initialed daily for completeness by the Department Manager.

Follow-up observations and interviews with staff were conducted to confirm the implementation of the hospital's plan of action. The IJ was abated on 2/1/13 at 1515 hours, prior to the exit of the survey team from the hospital.

Findings:

Review of the hospital's P&P titled Refrigerator and Freezer Temperature Monitoring indicated the following:

"Many patient related refrigerators...requiring temperature monitoring throughout the facilities have a remote temperature monitoring (RTM) system installed... This RTM system is maintained and managed by Engineering. The RTM sensor continuously monitors the temperature and if out of acceptable range for pre-determined time range...it will alarm and communicate to dispatch. Dispatch will create a ticket for engineering response. Engineering will respond to troubleshoot and assess. If engineering is not able to fix the unit within an acceptable time frame the department will also be notified and an action plan would be initiated to address items in the refrigerator.

For refrigerators and freezers that do not have remote temperature monitoring, or when the system goes offline, manual daily record will be required. If temperature remains out of acceptable range, staff are to communicate to dispatch using the 54000 service line...

Out of Range Action Plan (medications with temperature range between 36 and 46 degrees F): Move, or if more than four hours out of range and not shelf stable, discard."

According to the 2011 published guideline by the CDC titled Vaccine Storage & Handling Guide December, the following was recommended for Influenza Vaccines TIV: Afluria, Fluarix, FluLaval, Fluvirin, Fluzone, Fluzone High- Dose, Fluzone Intradermal and Pneumococcal Vaccines PCV13: Prevnar 13 PPSV23: Pneumovax 23:

"Vaccine exposed to temperatures outside the recommended range- either too warm or too cold- requires immediate corrective action! Vaccine providers should have a current emergency vaccine retrieval and storage plan.

According to the 2012 published guidelines by the CDC titled Vaccine Storage and Handling Toolkit that addressed the importance of monitoring the refrigerator temperature to preserve the potency of the vaccines:

Vaccine Potency :
Excessive heat or cold exposure can damage vaccines, resulting in reduced potency. Once potency is lost, it cannot be restored. Each time vaccines are exposed to excessive heat or cold, reduced potency increases. Eventually, if the vaccine cold chain is not properly maintained, all potency will be lost, and the vaccines become useless.

While exposure to both warm and cold temperatures can affect the potency of refrigerated vaccines, a single exposure to freezing temperatures will destroy some refrigerated vaccines. HepB and DTaP/DT/Tdap/Td vaccines are especially sensitive to freezing temperatures. That is why it is important to regularly monitor the temperature of your vaccines and take immediate corrective action when a storage unit temperature reading is outside the recommended range (temperature excursion).

Burden of Vaccine Cold Chain Failure
Out-of-range temperatures (temperature excursions) can be caused by inadequate temperature monitoring, unreliable equipment, and inappropriate use of small dormitory-style refrigerator/freezer units. Temperature excursions require immediate corrective action. Reduced vaccine potency due to inappropriate storage conditions can be costly. Patients who receive vaccine with reduced potency caused by inappropriate storage conditions may not be fully protected against vaccine-preventable diseases.

In the General Recommendations on Immunization, the Advisory Committee on Immunization Practices (ACIP) recommends "vaccine exposed to inappropriate temperatures that is inadvertently administered generally should be repeated."

Providers should contact their state/local health department immunization program, vaccine manufacturer(s), or both for guidance. Recalling patients to repeat vaccine doses should be considered.

Reading and Documenting Temperatures:
CDC recommends the routine vaccine storage and handling plan include reading and documenting storage unit temperatures a minimum of twice each workday as well as the minimum/maximum temperatures daily (preferably in the morning). This best practice recommendation can prevent inadvertent loss of vaccine and the potential need for revaccination by assuring that temperature excursions are identified quickly so that immediate corrective action can be taken.

This best practice recommendation applies to all vaccine storage units, regardless of whether or not there is a temperature alarm, a digital data logger thermometer, or a chart recorder thermometer. These readings will provide a better indication of any problems with the storage unit's function...

Stored temperature monitoring data should be downloaded and reviewed at least weekly by providers, both to ensure the timely review of the data and the appropriate response to issues.

Temperature Alarms:

These systems are not fool proof. Large vaccine losses and the need to revaccinate have occurred despite using alarmed, continuous monitoring systems. Issues around untrained personnel who do not know how to read the monitor, unexpected events, poor monitoring and response procedures, equipment failure, and improper maintenance have all been implicated in these vaccine storage events.

CDC continues to recommend that at a minimum vaccine storage unit temperatures be read manually and documented twice daily, including minimum/maximum temperatures daily (preferably in the morning), regardless of whether there is a temperature alarm or where the readout occurs. This provides assurance that the equipment is working correctly and if an alarm system should fail or a response process is not correctly followed, the issue will be identified quickly. Immediate corrective action can then be taken that may save vaccines.

The Manufacturers of pneumococcal vaccine, Pneumovax, and flu vaccine, Fluzone, recommend the vaccines be stored between 2 and 8 degrees Celsius (C) or between 36 and 46 degrees Fahrenheit (F).

LexiComp, a leading provider of drug and clinical reference, in addition to the manufacturers' recommended storage temperature range also indicated that vaccines' potency is destroyed by freezing and recommends that vaccines not be used if frozen.

During a tour of the hospital's two nursing stations starting on 1/28/13 at 1000 hours, medication refrigerators were observed connected to the Pyxis MedStation (automated medication dispensing cabinet: ADC).

During a concurrent interview, the CNO stated the hospital's medication refrigerators were monitored centrally via an electronic temperature monitoring system overseen by the Engineering Department.

During an interview on 1/29/13 at 1400 hours, the Manager of Engineering stated there were six medication refrigerators throughout the hospital monitored by Engineering. If a temperature stayed out of range for 45 minutes, the dispatch would get an alert notification. The dispatch then notified the engineering personnel on the Irvine Campus who would respond, inspect, and resolve the problem. The Manager stated there was, in addition to the alert sent to the dispatch, an outlook user group that included himself, the pharmacist and others that would get the notification of the temperature out of range. The Manager stated the central temperature monitoring of the medication refrigerators was implemented on 12/1/12.

Review of the temperature log for the medication refrigerator labeled, 353, indicated the temperature was out of range for more than a month.

During a concurrent interview, the Manager of Engineering was unable to confirm an email was sent to the dispatch, engineering, and to the outlook email user group. The Manager was unable to confirm the Engineering Department promptly addressed and corrected the issue.

There was no documented evidence provided at this time to show the Engineering Department ensured the Head of Pharmacy was notified of inappropriate medication refrigerator temperatures. The Manager of Engineering stated he failed to communicate the temperature issue to the Head of Pharmacy and the clinical floor managers.

During an interview on 1/29/13 at 1330, Engineering Staff was asked for the last dispatch log that was communicated to engineering that was not successfully resolved. The Manager of Engineering was unable to produce any documented evidence indicating the Engineering Department for the hospital responded and addressed the issues of the medication refrigerator temperature out of range for days and any documented reasons the Engineering Department was unable to resolve for the issue during this time period.

During an interview with Manager of Engineering on 1/30/13 at 1400 hours, he stated there were times when he tried to fix the communication issue and brought up the possibility of a major software revision that might have caused the system failure of notifying the dispatch of the temperature alerts. The Manager of Engineering stated for approximately three weeks there was a problem with communication failure that resulted in email alerts not being sent to the outlook user group that included the pharmacist. The Manager of Engineering stated this was known to him for about three weeks, but he failed to communicate to his concerns to the Head of Pharmacy and the Clinical Managers.

During an interview on 1/31/13 at 1630, the Head of Pharmacy stated she did not receive any alerts from the engineering and did not indicate knowledge of the out of range refrigerators and that communication between the consultant pharmacist and engineering took place to address the out of range temperatures.

On 1/29/13, review of the temperature log from the central electronic monitoring of all medication refrigerators for the hospital with the Manager of Engineering revealed the following:

* In the medication refrigerator located in the third floor Satellite Pharmacy Night Locker labeled, 353: From 12/5/12 to 1/12/13, the temperature was logged consistently higher than the upper limit of 46 degrees F, with the highest temperature reading of 54.7 degrees F.

* The third floor nursing unit medication refrigerator labeled 352 showed the following:
From 12/1 to 12/6/12, the temperature was logged consistently lower than the lower limit of 36 degrees F, with the lowest temperature reading of 28.1 degrees F (below freezing).
From 12/22 at 0300 hours to 12/23/12 at 0000 hours, the temperature was logged between 30.9 and 31.9 degrees F (below freezing).
From 1/4/13 at 1030 hours to 1/7/13 at 0300 hours, the temperature was logged between 31 and 32 degrees F (below freezing).
From 1/9/13 to 1/13/13, the temperature was out of range, below the lower limit of the proper temperature range of 36 to 46 degrees F.
From 1/14/13 to 1/17/13, the temperature stayed mostly below the lower limit of the proper temperature range.

* The second floor nursing unit medication refrigerator labeled 346 showed the following:
From 12/30/12 to 1/7/13, the temperature stayed mostly below the lower limit of the proper temperature range.
From 1/7 at 1030 hours to 1/8/13 at 0430 hours, the temperature stayed mostly in the 60 and 61 degrees F range.

Review of the hospital provided document that displayed name, strength, size, and quantity of medication content of the reviewed medication refrigerators indicated the following medications including the vaccines stored in the medication refrigerators currently were removed from patient use:

* In Medication Refrigerator located in the third floor Satellite Pharmacy Night Locker labeled 353:
27 vials of Bacitracin (injectable antibiotic) 500000 units;
11 vials of cisatracurium (nerve blocking agent) 10 mg/ 5 ml;
60 vials of Diltiazem (drug used to stabilize heart beat) 25 mg/5 ml;
41 vials of Diltiazem 125 mg/25 ml;
100 ampules of neomycin for irrigation (antibiotic); and
16 vials of Thrombin (blood clotting factor).

* In third floor nursing unit medication refrigerator labeled 352:
8 vials of Influenza Vaccine; and
13 syringes of Pneumo Vaccine.

* In second floor nursing unit medication refrigerator labeled 346:
8 vials of Diltiazem 50 mg/10 ml;
6 vials of Diltiazem 25 mg/5 ml;
7 syringes of Pneumo Vaccine; and
37 vials of Influenza Vaccine.

* In the OR Medication Refrigerator:
52 vials of Bacitracin 50000 units;
15 vials of Diltiazem 25 mg/5 ml;
114 vials of Neosporin (antibiotic) GU Irrigant 1 ml; and
23 vials of Thrombin 5000 units.

During an interview on 1/31/13 at 1430 hours, Head of Pharmacy acknowledged the potency of the vaccines stored in the medication refrigerators could not be assured. The Head of Pharmacy stated all vaccines currently stocked in the medication refrigerators that were exposed to inappropriate temperature were all removed from the patient care units.

On 2/1/13 at 0900 hours, the Administrator of Facilities presented a copy of an email sent on 12/20/12, to the Manager of Engineering, the Head of Pharmacy, and two other people regarding a third floor refrigerator alarm.

In a concurrent interview, the Administrator of Facilities stated at least some of the second level alarms were transmitted.

During an interview with the Head of Pharmacy on 2/1/13 at 0900 hours, she stated she occasionally received messages that refrigerator temperatures were out of range. The Head of Pharmacy stated she believed pharmacy management was to be telephoned by engineering if there was a problem with the refrigerator temperatures.

During a second interview on 2/1/13 at 1005 hours, the Head of Pharmacy stated she received some alarm notices, but thought engineering was handling them.

Based on interview, observation, and document review, the hospital failed to ensure drugs and biologicals were controlled and distributed in accordance with the applicable standards of practice, consistent with State law in a manner to promote patient safety by failing to:

1. Provide sufficient sterile water in the MH cart for the mixing of Dantrolene powdered vials to meet the needs of the patients in an MH emergency.

2. Provide pharmacy services that reviewed all medication orders for unnecessary duplication of pain management therapy for three of three patients reviewed (Patients 17, 28, and 29).

3. Clarify the nasal spray medication order for Patient 17 to ensure the patient received correct medication dosages.

4. Report medication errors and ADRs to the hospital's P&T Committee in accordance with the hospital's P&P.

5. Provide documented evidence the Consultant Pharmacist reviewed and reported ADRs to the P&T Committee.

Findings:

1. Review of the hospital's P&P titled Emergency Supply of Medications showed "Each drug tray shall contain a cover sheet clearly visible from the outside. This cover sheet will convey the following information...A list of the contents, their quantities, and the expiration dates."

During a tour of the hospital's Surgery Department on 1/28/13 at 1130 hours, inspection of the hospital's MH cart revealed there were 30 vials of Dantrolene which required 60 ml of sterile water to mix the powder in each vial of Dantrolene. However, only ten vials of 100 ml sterile water were observed, which would not be enough to mix all 36 vials of Dantrolene, all of which might be potentially required immediately.

In addition, review of the content list did not show the quantity of each medication stocked in the MH cart.

During an interview on 1/28/13 at 1400 hours, Head of Pharmacy confirmed the above findings.

2. Review of the hospital's P&P titled Pharmacy Consulting Services - Scope of Service indicated the following "The Pharmacy consulting services provide the basic pharmacy services to (the hospital)...Review and assess medication orders entered into the computer system by physicians or their representatives...Key Functions...Physician order review and processing...Pharmacist review of all medication orders."

a. Review of Patient 17's EMR on 1/29/13, revealed the patient's medication profile contained following duplicate PRN (as needed) narcotic pain medications:

Hydromorphone 0.25 to 0.75 mg IV every 15 minutes PRN for pain.
Hydromorphone 0.5 to 1 mg IV every 1 hour PRN for pain.

b. Review of Patient 28's EMR on 1/30/13, revealed the patient's medication profile contained following duplicate PRN narcotic pain medications:

Hydromorphone 0.25 to 0.75 mg IV every 15 minutes PRN for pain.
Hydromorphone 0.5 to 1 mg IV every 1 hour PRN for pain.

Hydrocodone/acetaminophen 10 mg/325 mg 1 to 2 tablets by mouth every 4 hours PRN for pain.
Oxycodone IR (Immediate Release) 5 to 10 mg tablet by mouth every 4 hours PRN for pain.

c. Review of Patient 29's EMR on 1/30/13, revealed the patient's medication profile contained following duplicate PRN narcotic pain medications:

Hydromorphone 0.25 to 0.75 mg IV every 15 minutes PRN for pain.
Hydromorphone 0.5 to 1 mg IV every 1 hour PRN for pain.

During an interview on 1/30/13 at 1030 hours, Nursing Educator A was unable to provide an explanation for having the duplicate injectable hydromorphone orders and duplicate oral pain medications. The Educator acknowledged the nurses could potentially administer both oral medications at the same time and likewise for the injectable hydromorphone orders.

During an interview on 1/30/13 at 1130 hours, MD D explained the reason for the duplication of PRN narcotic pain medication orders. MD D stated the predetermined physician's order set authorized by the anesthesiologist for release by nursing staff was not properly reviewed by the anesthesiologist. The hydromorphone IV injectable order was available in addition to the hydromorphone order included in the order set for release/activation by nursing staff at appropriate times.

During a concurrent interview, the CNO explained another physician was responsible for ordering both hydrocodone/acetaminophen 10 mg/325 mg tablets and oxycodone IR tablets. The CNO indicated that currently the duplication of therapy was not being prevented by the hospital's Health Information System's Electronic Health Record.

During an interview on 1/31/13 at 1630 hours, the Head of Pharmacy acknowledged the duplicate PRN pain medication orders were verified by the pharmacists; however, they should have been clarified with the physician to eliminate possible duplication of therapy.

3. During a medication pass observation with RN E on 1/29/13 at 0900 hours, the RN gave fluticasone (for allergic rhinitis) nasal spray to Patient 17, who proceeded to administer herself with two sprays in one nostril and another two sprays to the other nostril, for a total of four sprays.

Review of Patient 17's EMR showed a physician's order authorized on 1/2/13, for fluticasone nasal spray 0.05% two sprays to nostrils one time a day.

According to LexiComp, a leading pharmacy and clinical reference, dosing for adult is as follows:

"Flonase? (fluticasone propionate): Initial: 2 sprays (50 mcg/spray) per nostril once daily (200 mcg/day); alternatively, the same total daily dosage may be divided and given as 1 spray per nostril twice daily (200 mcg/day). After the first few days, dosage may be reduced to 1 spray per nostril once daily for maintenance therapy (100 mcg/day)."

During an interview on 1/29/13 at 1500 hours, the Head of Pharmacy acknowledged the order was not clear enough to determine whether the patient should have been administered two sprays per day or four sprays per day. The Head of Pharmacy stated the order should have been clarified.

4. Review of the hospital's P&P titled Medication Errors, Review and Trending showed "The pharmacy consultant in conjunction with Risk Management, compiles information relating to medication errors. This information is reviewed by the Pharmacy and Therapeutics Committee, Safety Management Council, and other departments as necessary...The pharmacy consultant reports to the Pharmacy and Therapeutics Committee on a semi-annual basis regarding the number of significant medication errors and identifiable trends."

During an interview on 1/31/13 at 1030 hours, the Head of Pharmacy and the Manager of Patient Safety & Compliance indicated medication error data and analysis were reported to the PIC and not to the P&T Committee.

During a concurrent interview, the Head of Pharmacy did not indicate she was aware of the hospital's P&P indicating she needed to present the medication error reports to the P&T Committee.

5. Review of the hospital's P&P titled Pharmacy Consulting Services - Scope of Practice showed "The Pharmacy consulting services provide the basic pharmacy services...Review Adverse Drug Reactions and identifying appropriate actions."

During an interview on 1/31/13 at 1030 hours, the Head of Pharmacy and the Manager of Patient Safety & Compliance indicated the ADR's were reviewed in the PIC meetings, of which the Head of Pharmacy was a member. The Head of Pharmacy stated the review of the ADRs related to Narcan use was just undertaken. The Head of Pharmacy stated she reviewed the use of Narcan from the present going back to June of 2012.

When asked about the outcome of the review, the Head of Pharmacy was unable to provide documented evidence to show the review of Narcan use and that case(s) were discussed in the PIC and the P&T Committee meetings.

In addition, when asked about the use of Narcan by Patient 30 during a code, the Head of Pharmacy did not indicate the use of the medication was reviewed.

Review of the P&T meeting minutes did not indicate ADRs were discussed during the meeting.

Based on observation, interview, and document review, the hospital failed to separate expired CSs away from the non-expired CSs making them potentially available for patient use.

Findings:

Review of the hospital's P&P titled Controlled Drug Procedure showed "Obsolete or outdated controlled substances handling:

a. Obsolete or outdated controlled substances shall be collected by the pharmacy for disposal.
b. When a controlled substance has become obsolete or outdated, it shall be removed from the inventory and the transaction recorded as a journal entry.
c. The drug will then be placed in the outdate box designated for Scheduled II or others."

During a tour of the hospital's third floor on 1/28/13 at 1530 hours, expired CSs were observed stored together with the following usable CSs for patient use in the Pyxis C-II Safe located in the Satellite Pharmacy's Night Locker Inner Core:
Forty 50-ml injectable PCA (Patient Controlled Analgesia) syringes containing fentanyl (narcotic pain medication) 10 mg/ml.

During a concurrent interview, the Head of Pharmacy acknowledged the fentanyl syringes were stored on the same shelf as the expired CSs inside the Pyxis C-II Safe. The Head of Pharmacy stated she was not aware they should not have been stored in the same area.

Based on interview and record review, the hospital failed to ensure their P&P was implemented for all personnel engaged in providing radiologic services to wear radiation safety monitoring badges, creating the risk of excessive radiation exposure.

Findings:

The hospital's P&P titled Safety Rules, effective 11/1/10, read in part, "Scope: This policy applies to (hospital name) and to all staff, medical staff and contractors." and "Personnel dealing directly with radiation will be furnished a personnel monitoring device." and "The Radiation Safety Officer shall determine whether or not a person will be monitored."

During a review of the radiation safety badge logs and the operative room logs dated 12/12, and 1/13, showed MD G provided services at the hospital which would routinely entail use of fluoroscopy; however, MD G did not appear on the radiation safety badge log.

During a teleconference with the Radiation Safety Officer on 1/29/13 at 1135 hours, the Safety Officer stated he believed the policy regarding radiation safety badges applied only to employees of the hospital and not to the medical staff. The Radiation Safety Officer stated the radiation safety badges were to be worn by all hospital employees exposed to radiation. The Radiation Safety Officer stated he was not sure all staff were wearing their badges, although there was an expectation they would wear the badges. The Radiation Safety Officer stated the physician was in a supervisory capacity. There was an expectation they would wear the radiation safety badge and require others do so as well.

Based on interview and record review, the hospital failed to ensure lead aprons used for radiation shielding were monitored and removed from service when defective per the hospital's P&P, creating the risk of excessive radiation exposure.

Findings:

The hospital's P&P titled Safety Rules, effective 11/1/10, read in part, "All lead aprons, mini lead aprons, gloves and gonad shields will be inspected annually." and "Any of the devices found to be defective will be either replaced or repaired."

The logs for radiation safety lead aprons were reviewed on 1/29/13. The log showed on 1/10/12, holes were found in aprons identified as Phil, A-13 and A-14. However, the typed copy of the log that included the 2013 evaluation recorded "no holes" for both A-13 and A-14. The hole in the Phil apron was still present. The pink shield and gray apron that were handwritten on one log were not included in the 2013 aprons reviewed.

The hospital supplied a copy of a purchase order dated October, 2012, showing new aprons were ordered, including one with stitched label for Phil; however, it was unclear if the aprons were received as the 2013 record continued to show a hole in the "Phil" apron.

During a teleconference with the Radiation Safety Officer on 1/29/13 at 1135 hours, he stated he was responsible for the safety of the lead aprons used in the hospital; however, a different physician actually reviewed the apron check logs. The Radiation Safety Officer was unable to state if the defective aprons were discarded.

During an interview with the Director of Perioperative Services on 1/31/13 at 1435 hours, she was asked to review the radiation safety apron logs. The Director stated the screening and tracking documentation was inadequate. The Director confirmed the aprons noted to have a hole in 2012, also appeared on the list on 2013 without a defect recorded. The Director stated no new aprons had replaced the aprons found to be defective in 2012. In addition, the Director was unable to supply additional information regarding the status of the aprons that were handwritten on the 2012 list, but did not appear on the 2013 list.

Based on observation, staff interview, and document review, the hospital failed to ensure a full-time individual was granted authority for oversight and responsibility/daily management of the dietetic services resulting in:

1. Lack of oversight of the contracted food service operations.

2. Inadequate food supplies consistent with the provisions of the stand-by menu and the absence of a plan for the service of the stand-by menu to patients prescribed puree and renal diets.

3. Absence of annual employee competencies related to the operation of the stand-by kitchen. The stand-by kitchen was not routinely used and annual competency checks would ensure that employees continued to be aware of the purpose of the kitchen and operationalizing the procedures related to mobilization of the kitchen.

4. Absence of quality assurance monitoring of patient satisfaction with dietary services and of clinical services provided at the hospital.

5. Failure to ensure appropriate temperature monitoring of the freezer component of the refrigerator unit located in the nourishment room on the 3rd floor.

Findings:

1a. On 1/28/12, at 0905 hours, in an interview with the Manager of Food and Nutrition Service Operation (contracted food service) and the Director of Food and Nutrition Services Operation (contracted food service), they confirmed there was no full-time individual assigned to provide oversight and daily management of food service operations at the hospital. The Director of Food and Nutrition Services stated the responsibility was shared among herself, the Manager of Food and Nutrition Service Operation, and the Supervisor of Food and Nutrition Service Operation (all contracted food service staff).

Review of the Food and Nutrition Services Department organization chart did not show the chart was specific to the hospital and oversight of food and nutrition services at the hospital was not clearly delineated. The Director and the Manager of Food and Nutrition Service Operation also had oversight of food service operations at two other hospital campuses (different provider number) while the Supervisor was designated as providing oversight of another hospital campus and not this hospital. Neither the Manager nor the Supervisor of Food and Nutrition Service Operation had direct reporting lines to hospital administration.

On 1/29/13 at 1155 hours, during a review of the personnel file of the Supervisor of Food and Nutrition Services, the "Staff Achievement Evaluation" dated as completed on 4/20/12, identified the Supervisor as an employee of another hospital campus and not the hospital. The "Expectations" delineated did not encompass specific requirements for oversight of dietary services within the hospital. Under "Evidence of Performance," the Supervisor was noted to have assured timely completion of the annual "Standby Kitchen Integrity" checklist, but no other reference was made to oversight of specific activities related to dietary (food service and clinical) activities within the hospital.

b. On 1/29/13, at 0902 hours, during an inspection of the contracted food service provider's kitchen, in Walk-In Refrigerator #3, the following food items were noted to be stored on a shelf designated for daily food circulation: six ready to eat containers of barbecue chicken salad dated with a use-by date of 1/25/13; four ready to eat containers of barbecue chicken salad dated with a use-by date of 1/26/13; and one ready to eat container of shrimp Louie salad dated with a use-by date of 1/25/13. The Supervisor of Food and Nutrition Operation, present at the time of the observation, stated the containers should be placed in the "discard" container.

In the reach-in refrigerator located near the cook's area, a two-pound container of liquid whole eggs was noted opened and was not dated as to when it had been opened. The container was imprinted with a manufacturer use-by date of 3/22/13. Another two-pound container of liquid egg whites, was also opened and not dated as to when it had been opened. The container was imprinted with a manufacturer use-by date of 2/21/13.

In a concurrent interview with the Executive Sous Chef (of the contracted food service provider), he stated the two egg products listed above would be kept until the manufacturer use-by dates.

Further inspection of the egg containers showed the container of liquid whole eggs was imprinted with a manufacturer recommendation as follows: "Use within 3 days of opening." The container of liquid egg whites was imprinted with a manufacturer recommendation as follows: "Use within 7 days of opening."

Review of the hospital's "Food Storage Shelf Life - Expiration Pull Date System Methods" indicated the following: "Prioritize pull dates using the following: First = Expiration (Code) Date on Container, Second = Manufacturer Recommendations ..."

2. On 1/28/13 at 0905 and 1115 hours, during a tour of the hospital's stand-by kitchen (a kitchen designed to be mobilized should the hospital's contract with the outside foodservice vendor be impacted and the hospital placed in a position to have to provide food for patients onsite), the dry storage area was noted to contain approximately 76 packets of peanut butter and a case of assorted cereal containing 14 Total Raisin Bran, 16 Cinnamon Toast Crunch, 16 Honey Nut Cheerios and 8 Cheerios for a total of 54 boxes of assorted cereal.

Review of the hospital's stand-by menu showed Cheerios were designated to be served to all patients (one each) (licensed bed capacity of 70 beds) and peanut butter was to be served to all patients (two each). This meant the hospital should have maintained 70 servings of Cheerios and 140 packets of peanut butter on hand for service of one day's menu. This was confirmed in a concurrent interview with the Supervisor of Food and Nutrition Service Operation.

In addition, a two and one-half gallon box of Minute Maid Lemonade was observed in the dry storage room. The Supervisor of Food and Nutrition Service Operation explained the lemonade was in a concentrated form. The box was designed to be placed in a juice dispenser to be properly diluted for service to patients. However, there was no juice dispenser located in the stand-by kitchen. There were no directions found on the box of lemonade to show how to manually dilute the product to the concentration to be served to patients. The Minute Maid Lemonade was to be served to all patients during the lunch and dinner meals.

Review of the hospital's "Stand-By Kitchen Integrity Checklist Annual Report - Annual Year 2012," indicated "Patient Food Service:...Patient Standby menu inventory present and rotated - Oct (October 2012): Inventory rotated and updated."

Further review of the stand-by kitchen menu showed no provisions for service of alternate food to patients prescribed puree and renal diets. The nutritional analysis of the menu showed it averaged 3000 mg of sodium and 99 gm of protein which would be excessive to patients prescribed renal diets (typically receiving 2000 mg of sodium and 60 gm of protein). In addition, items such as dry cereal and peanut butter were items to be "avoided" according to the hospital's diet manual recommendations for a puree diet. The Manager and Supervisor of Food and Nutrition Service Operation acknowledged the absence of directions to staff for the provision of appropriate food items on the hospital's stand-by kitchen menu to patients prescribed puree and renal diets.

3. On 1/29/13 at 1155 hours, during a review of employee personnel files, documentation showed dietary employees received an orientation to the operation of the stand-by kitchen in October, 2010. Since that time there was no further annual review of employee competencies related to the operation of the stand-by kitchen. This was confirmed in an interview with the Supervisor of Food and Nutrition Service Operation and the Manager of Food and Nutrition Service Operation.

4. On 1/29/13 at 1102 hours, a review of the hospital's QA data showed no trended data for monitoring of clinical nutrition activities specifically within the hospital. Clinical quality assurance data was integrated with data belonging to the hospital who provided the contracted service and could not be differentiated. In a concurrent interview with the Director and Manager of Food and Nutrition Service Operation, they also confirmed there was no patient satisfaction data collected, trended, and analyzed for the food service operations specifically at the this hospital.

On 1/29/13, at 1435 hours, in an interview with the CNO, she confirmed the above findings. The CNO stated there was no information reported through the hospital's PI Committee addressing clinical nutrition activities and patient satisfaction with food service specifically at this hospital.

5. On 1/29/13 at 1507 hours, during an inspection of the nourishment area located on the third floor, no thermometer was noted in the freezer compartment of the refrigerator/freezer unit designated for patient nourishments. In addition, there was no temperature monitoring log noted.

In a concurrent interview with the Manager of Food and Nutrition Service Operation and the Supervisor of Food and Nutrition Service Operation, present at the time of the observation, they acknowledged the absence of a thermometer and temperature log. The staff stated the freezer was supposed to be monitored remotely via a "sensor" by the Engineering Department. They were unaware for how long the "sensor" was unavailable.

Based on staff interview and document review, the hospital failed to ensure:

1. Stand-by kitchen menus were comprehensively analyzed for the nutritional components to meet the current national standards including the RDA and the DRI of the Food and Nutrition Board of the National Research Council for all diets served at the hospital.

2. One of three patients reviewed received a nutritional assessment in a timely manner in accordance with the hospital's P&P (Patient 2).

Findings:

1. On 1/29/13 at 0935 hours, review of the hospital's stand-by kitchen menu analysis indicated the menu was not comprehensively analyzed for the nutritional components to meet the current national standards including the RDA and the DRI of the Food and Nutrition Board of the National Research Council for all diets served at the hospital.

The nutrition analysis included an evaluation of only ten nutrients that did not include fiber, vitamins (other than Vitamin K) and other minerals. In addition, there were no provisions for service of alternate food to patients prescribed puree and renal diets nor an analysis for the nutritional content of the menus to be served on puree and renal diets.

The menu analysis did not include a comparison to a reference population consistent with the population typically served at the hospital to ensure adequacy of the nutrients provided.

In a concurrent interview with the Manager of Food and Nutrition Service Operation, she acknowledged the aforementioned and stated the nutritional analysis process was still a "work in progress."

2. On 1/28/13 at 1420 hours, the medical record for Patient 2 was reviewed. Patient 2 was admitted to the hospital on 1/24/13, with diagnoses that included cellulitis (bacterial skin infection) of the left hip. Further review of the medical record revealed there was no nutrition assessment completed for the patient four days after admission.

In a concurrent interview with the Manager of Food and Nutrition Service Operation, she stated cellulitis was considered an infection which would place the patient at "High Risk," according to the hospital's "MNT (medical nutrition therapy) Prioritization of Care." Therefore, the Manager stated the patient should have been assessed by the RD within 24 hours of identification of the nutritional risk. The Manager of Food and Nutrition Service Operation further stated the patient was "flagged" to be seen on 1/25/13; however, she was not sure why the nutrition assessment was not completed.

Based on observation, interview, and record review, the hospital failed to ensure the system for the electronic monitoring of refrigerators for the storage of food and pharmaceuticals was operating properly and in accordance with nationally accepted guidelines for food and manufacturer's recommendations for pharmaceuticals. Three refrigerators used for the storage of medications and vaccines were found out of range temperatures for extended periods of times resulting in the administration of potentially sub-potent drugs and biologicals. Disregarding of the manufacturers and CDC's recommendations and the hospital's P&P for safe handling and storage of medications, vaccines, and food within proper temperature ranges placed patients in potentially serious harm.

Findings:

1. During a tour of the hospital's two nursing stations starting on 1/28/13 at 1000 hours, medication refrigerators were observed connected to the Pyxis MedStation (automated medication dispensing cabinet: ADC).

During a concurrent interview, the CNO stated the hospital's refrigerators were monitored centrally via an electronic temperature monitoring system overseen by the Engineering Department.

During an interview on 1/29/13 at 1400 hours, the Manager of Engineering stated there were six medication refrigerators throughout the hospital monitored by Engineering. If a temperature stayed out of range for 45 minutes, the dispatch would get an alert notification. The dispatch then notified the engineering personnel on the Irvine Campus who would respond, inspect, and resolve the problem. The Manager stated there was, in addition to the alert sent to the dispatch, an outlook user group that included himself, the pharmacist, and others would get the notification of the temperature out of range. The Manager stated the central temperature monitoring of the medication refrigerators was implemented on 12/1/12.

On 1/29/13, review of the temperature log from the central electronic monitoring of all medication refrigerators for the hospital with the Manager of Engineering revealed the following:

* In the medication refrigerator located in the third floor Satellite Pharmacy Night Locker labeled, 353: From 12/5/12 to 1/12/13, the temperature was logged consistently higher than the upper limit of 46 degrees F, with the highest temperature reading of 54.7 degrees F.

* The third floor nursing unit medication refrigerator labeled 352 showed the following:
From 12/1 to 12/6/12, the temperature was logged consistently lower than the lower limit of 36 degrees F, with the lowest temperature reading of 28.1 degrees F (below freezing).
From 12/22 at 0300 hours to 12/23/12 at 0000 hours, the temperature was logged between 30.9 and 31.9 degrees F (below freezing).
From 1/4/13 at 1030 hours to 1/7/13 at 0300 hours, the temperature was logged between 31 and 32 degrees F (below freezing).
From 1/9/13 to 1/13/13, the temperature was out of range, below the lower limit of the proper temperature range of 36 to 46 degrees F.
From 1/14/13 to 1/17/13, the temperature stayed mostly below the lower limit of the proper temperature range.

* The second floor nursing unit medication refrigerator labeled 346 showed the following:
From 12/30/12 to 1/7/13, the temperature stayed mostly below the lower limit of the proper temperature range.
From 1/7 at 1030 hours to 1/8/13 at 0430 hours, the temperature stayed mostly in the 60 and 61 degrees F range.

* These refrigerators contained influenza and pneumonia vaccines, Thrombin, Bacitracin, Diltiazem, Neomycin, and cisatracurium medications.

When asked, the Manager of Engineering was unable to confirm an email was sent to the dispatch, engineering, and to the outlook email user group. The Manager was unable to confirm the Engineering Department promptly addressed and corrected the issue.

There was no documented evidence provided at this time to show the Engineering Department ensured the Head of Pharmacy was notified of inappropriate medication refrigerator temperatures. The Manager of Engineering stated he failed to communicate the temperature issue to the Head of Pharmacy and the clinical floor managers.

During an interview on 1/29/13 at 1330 hours, the Manager of Engineering was unable to produce documented evidence to indicate the Engineering Department for the hospital responded and addressed the issues of the medication refrigerator temperature out of range for days. No documented evidence was provided to show reasons the Engineering Department was unable to resolve for the issue during this time period.

During an interview with Manager of Engineering on 1/30/13 at 1400 hours, he stated there were times when he tried to fix the communication issue and brought up the possibility of a major software revision that might have caused the system failure of notifying the dispatch of the temperature alerts. The Manager of Engineering stated for approximately three weeks there was a problem with communication failure that resulted in email alerts not being sent to the outlook user group that included the pharmacist. The Manager of Engineering stated this was known to him for about three weeks, but he failed to communicate his concerns to the Head of Pharmacy and the Clinical Managers.

During an interview on 1/31/13 at 1630 hours, the Head of Pharmacy stated she did not receive any alerts from the Engineering Department. The Head of Pharmacy did not indicate knowledge of the out of range refrigerators or that communication between the consultant pharmacist and engineering took place to address the out of range temperatures.

However, on 2/1/13 at 0900 hours, the Administrator of Facilities presented a copy of an email sent on 12/20/12, to the Manager of Engineering, the Head of Pharmacy, and two other people regarding a third floor refrigerator alarm.

In a concurrent interview, the Administrator of Facilities stated at least some of the second level alarms were transmitted.

During an interview with the Head of Pharmacy on 2/1/13 at 0900 hours, she stated she occasionally received messages that refrigerator temperatures were out of range. The Head of Pharmacy stated she believed pharmacy management was to be telephoned by Engineering if there was a problem with the refrigerator temperatures.

During a second interview on 2/1/13 at 1005 hours, the Head of Pharmacy stated she received some alarm notices, but thought engineering was handling them.

2. On 1/29/13 at 1507 hours, during an inspection of the nourishment area located on the third floor, no thermometer was noted in the freezer compartment of the refrigerator/freezer unit designated for patient nourishments. In addition, there was no temperature monitoring log noted.

In a concurrent interview with the Manager of Food and Nutrition Service Operation and the Supervisor of Food and Nutrition Service Operation, present at the time of the observation, they acknowledged the absence of a thermometer and temperature log. The staff stated the freezer was supposed to be monitored remotely via a "sensor" by the engineering department. They were unaware for how long the "sensor" was unavailable.

Based on observation, interview, and record review the hospital failed to:

1. Develop and monitor the temperature of the SPD area.

2. Ensure the enzymatic solution to clean instruments prior to sterilization was mixed per the manufacturer's guidelines.

3. Ensure the disinfectant contact time was followed per the manufacturer's recommendations.

4. Ensure the intubation scopes were properly cleaned, processed, and disinfected.

5. Ensure staff wore a mask during an ongoing surgical procedure.

6. Implement the hospital's surgical attire P&P to ensure personal cloth hats were laundered daily and covered by a disposable hat while in semi-restricted and restricted areas in the surgical area.

7. Ensure the correct use of the disinfectant to clean the blood sugar testing machine.

8. Ensure hospital surfaces were intact, cleaned, and disinfected.

9. Check an emergency box of intubation equipment monthly to ensure there were no outdated supplies available for patient use.

These failures had the potential to result in an unsafe environment for patient care.

Findings:

1. According to the CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities 2008, in the central processing area(s), the sterile storage area should be a limited access area with controlled temperature and relative humidity. The guidelines showed the temperature may be as high as 75 degrees F and the humidity 30-60% in all work areas except sterile storage where the relative humidity should not exceed 70%.

On 1/28/13 at 1400 hours, the SPD area was toured with the Director of Perioperative Services. The Manager of SPD stated the Engineering Department was responsible for monitoring the temperature and relative humidity in the SPD. The Director stated the Engineering Department was to notify the SPD for any abnormality.

On 1/29/13 at 0915 hours, during an interview, the Director Engineering stated the department was not aware of the recommendation to monitor the temperature and humidity in the sterile storage area. The Director stated a P&P was not developed to monitor parameters for that area.

On 1/29/13 at 1350 hours, the hospital's Infection Control Committee was interviewed. Members of the Committee stated they were not aware of the requirement to monitor temperature and humidity in the SPD.

2. According to the CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities 2008, cleaning is the removal of foreign material (e.g., soil, and organic material) from objects, and is normally accomplished using water with detergents or enzymatic products. Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Also, if soiled materials dry or bake onto the instruments, the removal process becomes more difficult and the disinfection or sterilization process less effective or ineffective. Surgical instruments should be presoaked or rinsed to prevent drying of blood and to soften or remove blood from the instruments.

The guidelines also showed items must be cleaned using water with detergents or enzymatic cleaners. Enzyme solutions should be used in accordance with manufacturer's instructions which include proper dilution of the enzymatic detergent and contact with equipment for the amount of time specified on the label as detergent enzymes can result in asthma or other allergic effects in users.

On 1/28/13 at 1347 hours, the instrumentation cleaning processes was observed. The Instrument Technician stated the SPD staff used spray bottles of enzymatic solution to clean the powered instrument handles. The solution was then wiped off with a clean cloth. The Technician stated the Lead Instrument Technician mixed and prepared the spray solution for the technicians to use.

In a concurrent interview with the Lead Instrument Technician he stated he added one and a half ounces of enzymatic agent to 750 ml of water. The Lead Technician stated he prepared three bottles each time five to seven times a day.

Review of the manufacturer's instruction showed to use a half ounce of enzymatic agent mixed with one gallon (3785 ml) water.

3. On 1/29/13 at 1100 hours, the Anesthesia Department was toured. During interview, the anesthesia lead technician stated she used disinfectant wipes to clean all the dirty equipment used for the patients. When asked, the lead technician was not sure of the contact time required for the disinfectant, she stated she believed it should be 30 seconds to one minute.

Review of the container label showed the manufacturer's instruction for the contact time was three minutes.

4. The hospital's P&P titled Anesthesia Machine and Equipment Maintenance and Cleaning dated 1/13, showed the Fiberoptic Intubation Scope (flexible scope used to guide in difficult airway intubations, a tube inserted into the airway) will be decontaminated, cleaned, and processed via high level disinfection in the Olympus OER PRO (an automatic disinfecting machine for scopes) by an anesthesia technician after each patient use.

On 1/29/13 at 1100 hours, during an interview, the Anesthesia Lead Technician stated the department's records showed two patients used Fiberoptic Intubation Scopes on 1/16/13. The Lead Technician stated the hospital did not have equipment to process dirty Fiberoptic Intubation Scopes. The Anesthesia Technician transported the scopes to the GI lab sterile processing unit at Hospital B for decontamination and cleaning. The Lead Technician stated staff from each hospital could process the used scopes. The Technician stated there was no specific assignment to show which hospital's staff was responsible for the process.

During a the tour of the GI lab at Hospital B, the scope processing record for Fiberoptic Intubation Scopes from Hoag Orthopedic Institute was reviewed. There was no documented evidence to show the Fiberoptic Intubation Scopes were processed following use on 1/16/13.

On 1/29/13 at 1350 hours, during an interview with the Infection Control Committee, the Director of Infection Prevention stated she was aware the Fiberoptic Intubation Scopes were disinfected at another hospital. However, when asked, the Director stated there was no mechanism in place to monitor the quality of the scope disinfection process provided by the other hospital services.

5. The hospital's P&P titled Dress Code, Intra Operative dated 12/15/11, showed all persons entering restricted areas of the surgical suite when there are open sterile items or staff in sterile attire present are to wear a mask.

On 1/28/13 at 0832 hours, the OR was toured with the Director of Perioperative Services. A staff member was observed in surgical attire without a mask during an ongoing surgical procedure. The Director identified the person as the attending surgeon for that procedure.

6. AORN 2012, Recommended Practices for Surgical Attire, Recommendation IV, showed all personnel should cover head and facial hair including sideburns and the nape of the neck when in the semi-restricted and restricted areas. Reusable personal head coverings should be laundered in a health care-accredited laundry facility after each daily use.

On 1/28/13 at 0930 hours, OR staff were observed wearing reusable cloth hats in the ORs and sterile central core area.

On 1/31/13 at 0920 hours, during an interview, the Director of Perioperative Services stated seven OR staff wore their own cloth surgical hats. The Director stated inservices were provided for those staff that chose to wear personal cloth head covers. The staff was directed to cover their personal cloth hats with disposable hats when working in restricted and semi-restricted areas. The Director stated she was unable to confirm staff laundered their cloth hats daily.


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7. The manufacturer's guidance for disinfecting the Accu-chek Inform system (a machine used to test a patient's blood sugar) obtained from the manufacturer's website on 1/31/13, read in part, "Before using a disinfectant solution on the Accu-check Inform system, refer to the product labeling for required contact time for disinfecting to ensure the active ingredients are acceptable for use."

The hospital's P&P titled Blood Glucose, Determination of Using the Accu-Chek Inform Blood Glucose Monitor, effective 3/2/10, read in part "Cleaning of the Accu-chek Inform system is performed after each patient use." and "Wipe the surface of the Accu-chek Inform system with a soft cloth slightly dampened (not wet) with 70% isopropyl alcohol, full strength (may use alcohol pledget)."

The Accu-Chek Inform Initial Competency and annual competency educational documents were reviewed. The documents showed the machine was to be cleaned with an alcohol pledget.

During an interview with RN D on 1/28/13 at 0845 hours, the RN stated the glucometer machine was taken to a patient's bedside. RN D stated the machine was wiped with a Sani-Wipe cloth after use and the disinfectant was allowed to air dry. RN D was not aware of the need for a particular wet contact time.

RN D demonstrated the cleaning of the glucometer. The chemical disinfectant appeared to dry in 30 seconds. The label on the disinfectant showed a wet contact time of 2 minutes was required to be effective.

During an interview with the Director of Infection Prevention on 1/29/13 at 1100 hours, she stated staff were to disinfect point of care testing devices (such as a glucometer) using Super Sani Plus Wipes after each use with a two minute wet contact time. The Director stated there was an online module regarding use of the wipes.

8 a. According to AORN, Recommended Practices for Environmental Cleaning in the Perioperative Setting, Recommendation I: The patient should be provided a clean, safe environment. It states in part, "Health care-associated infections have been linked to external sources, which can include environmental surfaces. The risk of infection from pathogenic organisms on environmental surfaces is due not only to their presence, but to their ability to survive on and be transferred to many surfaces." Also per AORN, "Dust is known to contain human skin and hair, fabric fibers, pollens, mold, fungi, insect parts, glove powder, and paper."

According to the CDC, for hospitals, the floors and walls should be constructed of materials capable of withstanding chemical agents used for cleaning or disinfecting. Ceilings and wall surfaces should be constructed of non-shedding materials.

During an observation on 1/28/13, at 0915 hours, in three patient rooms, the horizontal surface of the patient's bedside table was not intact and the black paint was peeling indicating the top surface of the bedside table could not be effectively disinfected between patients.

b. A heavy layer of dust was observed on the horizontal surface of the base of a rolling vital signs monitor located in the hallway of the nursing unit.

During a concurrent interview with RN C, she confirmed the observations regarding the damaged bedside tables and dust on the vital sign monitor.

During an interview on 1/29/13 at 1400 hours, the Director of Infection Prevention, the Medical Director of Infection Prevention, and the Infection Preventionist explained their Environment of Care Rounds. The staff stated the rounds included a regularly scheduled tour of all patient care areas. When questioned regarding the peeling paint on the horizontal surfaces in patient rooms and dust on the vital sign monitor, they confirmed these findings needed to be corrected.


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9. During a tour of the third floor nursing unit with Clinical Educator A on 1/28/13 at 1115 hours, a orange tackle box was observed in the clean utility room. The box was labeled "Intubation Box" and was secured with a plastic twist off lock. The label showed the earliest expiration date on supplies in the box was 11/12.

During an interview with the Manager of Respiratory Therapy on 1/28/13 at 1130 hours, he stated the intubation box contained an extra supply of airways preferred by the physicians who responded to emergencies on the unit. When opened, the inventory list of the contents showed the earliest expiration date of 11/12 was for a LMA #5 (laryngeal mask airway); however, on page two of the contents, the only LMA #5 showed a expiration date of 11/13. The Manager stated the intubation box was checked by staff in Supply Chain Management. The last check documented was 8/3/11.

During an interview with the Manager of Supply Chain Management on 1/28/13 at 1200 hours, the Manager stated there was no P&P specifically for checking the intubation box; however, the hospital's P&P required their department to conduct monthly quality assurance checks of emergency crash carts to ensure there were no outdated supplies available for patient use.