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Based on observation, interview, and record review, the facility's governing body, the legally responsible entity for the conduct of hospital operations, failed to provide oversight to the pharmaceutical, dietary, and infection control departments which resulted in the identification of systemic deficiencies in these areas. In addition, the governing body failed to ensure that the quality assessment and performance improvement program involved all hospital departments and services and reflected the complexity of the hospital's organization and services.

Findings:

The facility failed to meet the Condition of Participation of Governing Body (A00043) as identified under the the following tags:

1. The facility's governing body failed to assess and monitor the services provided by three of their contract providers which resulted in a lack of surveillance for maintenance of vending machines containing potentially hazardous foods, the potential for undetected dish machine problems and unsafe or ineffective pest control services in a hospital with a licensed bed capacity for 612 patients. (A-0083).

2. The facility's governing body failed to ensure that three contract services pertinent to dietetic services had been provided in a safe and effective manner and failed to evaluate the quality of these contract services. There was no evidence that these contract services were incorporated into and evaluated by the hospital wide quality assurance and performance improvement program (QAPI). (A-0084).

The facility failed to meet the Condition of Participation of Quality Assessment and Performance Improvement Program (A-0263) as identified under the following tags:

1 .The hospital failed to measure, analyze, and accurately track quality data in order to improve hospital performance. (A-0267).

2. The facility 's governing body failed to ensure that an ongoing program for quality improvement was defined, implemented and maintained when three contract services were not incorporated into the hospital wide QAPI (quality assurance and performance improvement) program and there was no system in place to evaluate the quality of services provided by these contract providers. (A-0310).

3. The facility failed to conduct an annual determination of the number of performance improvement projects. The deficient practice eliminated an opportunity for the facility's leadership to form a comprehensive overview of the facility's projects and to assess whether the scope of the projects was appropriate. (A-0317).

The facility failed to meet the Condition of Participation of Pharmaceutical Services (A-0490) as identified under the following tags:

1. The facility failed to ensure that drug distribution and storage was administered in accordance with accepted professional principles. Viaspan, a prescription organ storage solution was ordered by the hospital material services and delivered directly to the surgical department with no oversight by the pharmacy department. (A-0491).

2. The facility failed to provide pharmaceutical services to meet the needs of the patients when medications where not controlled and distributed in accordance with standards of practice, federal and state laws. (A-0500).

The facility failed to meet the Condition of Participation of Food and Dietetic Services (A-0618) as identified under the following tags:

1 .The facility failed to ensure that the director of dietetic services was responsible for the daily operations of the department. (A-0620).

2. The facility failed to provide comprehensive job-specific training to clinical nutrition and food service staffs. (A-0622).

3. The facility failed to ensure physician approval of diet orders prior to implementation. (A-0629).

4. The hospital failed to ensure that the nutritional needs of patients were in conformance with recognized dietary practices as identified in hospital manuals and references as well as being in accordance with the orders of the physicians responsible for the care of the patients. (A-0630).

The facility failed to meet the Condition of Participation of Infection Control (A-0747) as identified under the following tags:

1. The facility failed to implement its Hand Hygiene policy and failed to implement its Hepatitis B Vaccine policy. (A-0748).

2. The facility failed to ensure that there were infection control measures to prevent the development of foodborne illness and cross-contamination in the kitchens and ancillary foodservice operations, failed to have a thorough infection control surveillance system to monitor the conditions and practices of dietetic service staff as well as outsourced contractors and failed to identify breaches in infection control practices exposing patients to an unsafe environment that could be a source of infection and cross contamination. A-0749).

The cumulative effects of these systemic problems resulted in the failure of the hospital's governing body to ensure that its patients were provided with safe, effective and quality care.

Based on interview and record review, the facility's governing body failed to assess and monitor the services provided by three of their contract providers which resulted in a lack of surveillance for maintenance of vending machines containing potentially hazardous foods, the potential for undetected dishmachine problems and unsafe or ineffective pest control services in a hospital with a licensed bed capacity for 612 patients.

Findings:

On 3/18/10 between 9:50 a.m. and 10 a.m., review of three of three contracted services for the dietetic services department indicated departures regarding, term, co-signature and administrative authority. There was no term specified for the contracted vending service responsible for the maintenance and repletion of machines containing dry, refrigerated and frozen foods available for patients, staff and visitors. For the dishmachine maintenance service, there had been a failure to have a hospital administrative representative co-sign. Additionally, the contracts for vending, dishmachine and pest control services lacked a statement regarding the hospital's administrative authority for responsibility and surveillance.

At 10 a.m. during review of the quality assurance measures, Registered Dietitian 30 stated that there had not been a quality assurance system specific to these three services. Additionally, at 10:20 a.m. Dietary Management Staff 17 stated that no one from the hospital had incorporated these three services in any quality assurance program and that was of concern, most specifically to the vending service. Additionally, per reference to a document Dietary Management Staff 17 then presented, it had not been until 3/17/10 at 4:11 p.m. that Department Manager 29 was in receipt of the e-mail from the contracted service regarding their protocols for the fixed and settable temperatures for the units containing refrigerated beverages and frozen foods. By conclusion of the survey, no one from the dietetic services department could locate any reports from the contracted vending service for the past year and there was no documented evidence of incorporation of this service for any aspect of hospital surveillance pertinent to safety and sanitation.

Also, on 3/18/10 between 9:50 a.m. and 10 a.m. review of the dishmachine service document presented as the contracted duties revealed that it was undated, titled "Machine Warewashing Service Policy" and covered varied services: scheduled visits, checking detergent wash solution, checking and regulating temperature, checking steam and fill valves, doing mechanical adjustments as well as conducting other inspections including electrical in addition to provision of : reports; on-site training of hospital staff; reference charts and recommendations to management as well as fielding other special operations. However, there was nothing in the document to show hospital responsibilities and this was of concern as the dietetic service dishmachines were used to clean and sanitize wares from the kitchens and ancillary food service operations.

At 10:25 a.m. Dietary Management Staff 17 stated she had conferred with Department Manager 29 who had been "checking since yesterday" and there was no evidence "anywhere" of surveillance to ensure efficacy, safety and sanitation of the processes used by the three contracted services. Likewise, on 3/18/10 between 10:50 a.m. and 10:55 a.m.. review of the "Pest Elimination Agreement" did not show the hospital's administrative responsibilities and as of 11 a.m. Dietary Manager 17 and Registered Dietitian 30 stated that this service had not been part of the quality assurance program for the dietary department and that as far as they knew, "no hospital department" had included this service in their quality assurance program.

The facility's governing body failed to be responsible for the services provided by three of its contract providers, failed to ensure that services provided by three contract providers permitted the hospital to comply with all applicable conditions of participation and failed to incorporate these contract services into its QAPI (quality assurance and performance improvement) program.

Based on document review and staff interview the hospital failed to ensure that three contracted services pertinent to dietetic services had been provided in a safe, effective manner. By not having had such services evaluated by the hospital's quality assessment and performance improvement (QAPI) program there had been lack of surveillance for maintenance of vending machines containing potentially hazardous foods, potential for undetected dishmachine problems and unsafe or ineffective pest control services in a hospital with a licensed bed capacity for 612 patients.

Findings:

1. On 3/18/10 between 9:50 a.m. and 10 a.m. while in an administrative conference room review of three of three contracted services for the dietetic services department revealed departures regarding, term, co-signature and administrative authority. There was no term specified for the contracted vending service responsible for the maintenance and repletion of machines containing dry, refrigerated and frozen foods available for patients, staff and visitors. For the dishmachine maintenance service, there had been a failure to have a hospital administrative representative co-sign. Additionally, the contracts for vending, dishmachine and pest control services lacked a statement regarding the hospital's administrative authority for responsibility and surveillance.

At 10 a.m. during review of the quality assurance measures, Registered Dietitian 30 stated that there had not been a quality assurance system specific to these three services. Additionally, at 10:20 a.m. Dietary Management Staff 17 stated that no one from the hospital had incorporated these three services in any quality assurance program and that was of concern, most specifically to the vending service. Additionally, per reference to a document Dietary Management Staff 17 then presented, it had not been until 3/17/10 at 4:11 p.m. that Department Manager 29 was in receipt of the e-mail from the contracted service regarding their protocols for the fixed and settable temperatures for the units containing refrigerated beverages and frozen foods. By conclusion of the survey, no one from the dietetic services department could locate any reports from the contracted vending service for the past year and there was no documented evidence of incorporation of this service for any aspect of hospital surveillance pertinent to safety and sanitation.

Also, on 3/18/10 between 9:50 a.m. and 10 a.m. review of the dishmachine service document presented as the contracted duties revealed that it was undated, titled "Machine Warewashing Service Policy" and covered varied services: scheduled visits, checking detergent wash solution, checking and regulating temperature, checking steam and fill valves, doing mechanical adjustments as well as conducting other inspections including electrical in addition to provision of : reports; on-site training of hospital staff; reference charts and recommendations to management as well as fielding other special operations. However, there was nothing in the document to show hospital responsibilities and this was of concern as the dietetic service dishmachines were used to clean and sanitize wares from the kitchens and ancillary food service operations.

At 10:25 a.m. Dietary Management Staff 17 stated she had conferred with Department Manager 29 who had been "checking since yesterday" and that there was no evidence "anywhere" of surveillance to ensure efficacy, safety and sanitation of the processes used by the three contracted services. Likewise, on 3/18/10 between 10:50 a.m. and 10:55 a.m.. review of the "Pest Elimination Agreement" did not show the hospital's administrative responsibilities and as of 11 a.m. Dietary Management Staff 17 and Registered Dietitian 30 stated that this service had not been part of the quality assurance program for the dietary department and that as far as they knew, "no department" had included this service in their quality assurance program.

On 3/18/10 between 10:30 a.m. and 10:40 a.m. while in an administrative conference room, Registered Dietitian 30 stated that the failure to not have included these three contracted services in the quality assurance program had been "an oversight". Further, as of 10:50 a.m. Dietary Management Staff 17 stated that these items would need to be addressed "soon" so as to ensure safety to patients, staff and visitors. Further, at 11 a.m. Dietary Management Staff 17 stated, "This should be easy to fix".

Based on record review, the facility failed to include off-campus locations in its policy regarding medical emergencies. The definitions in the policy limited its application to hospital property within 250 yards of one of the main hospital campuses, and the attached quick reference guide detailing responses at various locations did not include two child development centers on the hospital license. The deficient practice had the potential to limit staff understanding of the appropriate response to emergency situations at hospital facilities located more than 250 yards from the main hospital campuses.

Findings:

Review of the facility policy "MEDICAL EMERGENCIES ON THE PACIFIC, DAVIES, AND CALIFORNIA CAMPUS AND IN OUTPATIENT CLINICS AND DEPARTMENTS NOT CONTIGUOUS WITH THE MAIN CAMPUS" indicated that hospital property was defined as "The entire main campus of the hospital (i.e., the physical area immediately adjacent to CPMC's main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings), including the parking lot, sidewalk and driveway, but excluding other areas or structures that are not part of the hospital such as physicians offices (or other entities that participate separately under Medicare)..." The policy described procedures for persons presenting with potential emergencies at the dedicated emergency departments and "For Departments or Locations on Hospital Property Other Than Dedicated Emergency Departments (See definition of 'Hospital Property')". No provisions were present in the policy's text regarding how emergencies at hospital locations more than 250 yards from the main campuses would be handled. Comparison of the attached "Hospital and Off-Site Locations Emergency Response Quick Reference Guide" to the hospital's license indicated that two child development centers located at 1625 Van Ness Avenue and at 1580 Valencia Street were licensed as part of California West Campus Hospital at 3700 California Street, but were not included on the quick reference guide.

Review of driving directions obtained from maps.yahoo.com indicated that the driving distance from 3700 California Street to 1625 Van Ness Avenue was 2.10 miles, and that the driving distance from 3700 California Street to 1580 Valencia Street was 4.55 miles.

Review of a revised copy of the facility's emergency policy presented during the survey indicated that the child development centers had been added to the quick reference guide but the definition limiting hospital property to locations within 250 yards of the main buildings had not.

Based on document and record review and staff interview, the hospital failed to ensure that hospital staff and practitioners providing care acknowledged patients' advance directives in 3 of 16 records.

Findings: The hospital's policy number 3.30, "Advance Health Care Directive," last revised 1/10 was reviewed on 3/17/10. Procedure Section II. C. states: "Patients may at any time during their stay appoint a surrogate decision-maker for that hospitalization.... The nurse will place a green sticker on the chart in the Physician Progress Notes naming the surrogate and notifying the physician that the patient has appointed a healthcare decision maker. The MD's signature on the green sticker indicates that a discussion with the patient regarding his/her wishes has taken place, and that the physician acknowledges the patient's choice of a surrogate...."

Records 12, 18, and 25 were reviewed 3/16-17/10. Each contained one of the above-mentioned green stickers; however the physicians had not signed the stickers as required by hospital policy. These omissions were confirmed by the Health Information Management staff on the afternoon of 3/18/10.

Based on observation, interview and record review, the facility failed to ensure the confidentiality of clinical records by placing nursing charts containing personal health information in racks outside patient rooms on nursing unit 4N, 4S, 5N, 5S, 6N and 6S. The nursing charts were in areas where the public and unauthorized personnel could potentially view the patient information without authorization.

Findings:

During a tour of nursing unit 4N and 4S on 3/15/10 at 11 a.m., there were binders outside of each patient room which contained the following information: patient's full name, medical record number, room number, sex, age, date of birth, date of admission, doctor's names, intake and output sheets, care plans, blood sugar results, vital signs, and nursing assessments. These binders were also observed on nursing unit 5N, 5S, 6N and 6S and were accessible to the public and non authorized personnel to view.

On 3/15/10 at 1:55 p.m., nursing unit 5N was toured with CN 1 (charge nurse). There were binders containing personal health information in racks outside the patient rooms. The unit had a primary nursing station where nursing staff were working. There was another work station towards the back of the unit but no nursing staff were working at this station. The patient rooms at the back of the unit were not visible from the primary nursing station.

CN 1 was interviewed regarding the binders outside the patients rooms. She stated that all units use these "bedside charts." She said this made it easier for the nursing staff as they did not have to return to the nursing station to chart in the patient's "main" medical record. When asked about maintaining the confidentiality of the bedside charts, she responded " The nurse's watch the charts" and "We've never had any issues." She acknowledged the potential for members of the public and unauthorized personnel to view the bedside charts.

A review of the facility's Patient Rights indicated the following:

While you are a patient at (name of facility), you have the right to:

8. Confidential treatment of all communications and records pertaining to your care and stay in the hospital. Written permission shall be obtained before medical records can be made available to anyone not directly concerned with your care.

Based on interview and record review, the facility failed to follow it's Restraint Management: Medical Restraints, Behavioral Restraints, & Seclusion policy when staff failed to report to the CMS (centers for medicare & medicaid services) regional office the death of three patients ( Patient 44, 45 & 46 ) who died while in restraints or within 24 hours of the removal of restraints. Patient 44 & 45 died within 24 hours of the removal of restraints and Patient 46 died while in restraints.

Findings:

On 3/19/10 at 9 a.m., a list of patients who died while in restraints or within 24 hours of the removal of restraints was reviewed with the CNO (chief nursing officer). The CNO stated that Patient 44 & 45 died within 24 hours of the removal of restraints and Patient 46 died while in restraints but the deaths were not reported to CMS because of a "misunderstanding." She stated when a patient dies, the registered nurse or nurse manager of the unit completes a Death Worksheet which includes notifying risk management if the patient died while in restraints or within one week of the discontinuation of restraints. Risk management reviews the record and is responsible for reporting the death to CMS. However, the CNO stated that risk management staff have only been reporting deaths that occur within one week of the discontinuation of restraints/seclusion and when it was reasonable to assume that the use of restraints/seclusion contributed directly or indirectly to the patient's death.

The Director of Risk Management who was present during the interview stated that Patient 44, 45 & 46's death was reported to risk management and reviewed, but was not reported to CMS because it was determined that the use of restraints did not contribute directly or indirectly to Patient 44, 45 & 46's death.

The facility's Restraint Management: Medical Restraints, Behavioral Restraints, & Seclusion policy was reviewed and indicated the following:

Death Reporting Requirements: (name of facility) reports any deaths associated with the use
of seclusion or restraint.

1. (name of facility) reports the following information to CMS:

Each death that occurs while a patient is in restraint or seclusion.
Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion.
Each death known to the hospital that occurs within 1 week after restraint or seclusion where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient's death. "Reasonable to assume" in this context includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation.

2. (name of facility) Risk Management Department reports each death referenced above to CMS. These possible restraint related deaths must be reported to CMS by telephone no later than the close of business the next business day following knowledge of the patient's death.

3. Staff must document in the patient's medical record the date and time the death was reported to CMS.

Based on observations, interviews, and document reviews, the hospital failed to maintain an effective quality assessment and performance improvement program as evidence by:

Findings:

1. The hospital failed to track accurate quality data to measure and to analyze pharmacists reviewing physician medication orders prior to nurses administering to patients for non-emergent medications when a one day audit revealed up to an estimated 537 physicians' orders where not reviewed by a pharmacist prior to nurse administration. (A 267)

2. The hospital failed to track identify and analyze missing and excessive medications in the Pyxis machines when the hospital failed to account for missing and extra medications that would indicate that a patient received too much (received extra doses), missed a dose, or were given the wrong medication when a one day audit revealed 112 extra doses and 107 missing doses were found in Pyxis machines throughout the hospital. (A 267)

3. The hospital failed to develop and implement a quality assessment and performance improvement program to assess the safe and appropriate use of drugs with boxed warning (black box warning). The hospital did not identify that fentanyl transdermal patches and clozapine were used not in accordance with the boxed warning issued by FDA to ensure patient safety. (A 267)

4. The hospital failed to develop a quality assurance system for the surveillance, identification and remediation of unsafe, unsanitary conditions and practices within the dietetic service department and for those foodservice operations supported by three contracted services who performed tasks within the kitchens and ancillary areas. (A 267)

5. The hospital failed to develop a quality assurance system for the surveillance, identification and remediation of unsafe staff practices in the California campus to ensure patients safety. (A 267)

6.The facility's governing body failed to ensure that an ongoing program for quality improvement was defined, implemented, and maintained when three contract services were not incorporated into the hospital wide QAPI (quality asssurance and performance improvement) program and there was no system in place to evaluate the quality of services provided by three contract providers. A-0310)

7. The facility failed to conduct an annual determination of the number of performance improvement projects. The deficient practice eliminated an opportunity for the facility's leadership to form a comprehensive overview of the facility's projects and to assess whether the scope of the projects was appropriate. (A-0317)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective quality assessment and performance improvement program in accordance with the statutorily-mandated Conditions of Participation for quality assessment and performance improvement.

Based on interview and document review, the hospital failed to measure, analyze, and accurately track quality data in order to improve hospital performance as evidenced by:

1. The hospital failed to track accurate quality data to measure and to analyze pharmacists reviewing physician medication orders prior to nurses administering to patients for non-emergent medications when a one day audit revealed up to an estimated 537 physicians' orders where not reviewed by a pharmacist prior to nurse administration.

2 The hospital failed to track, identify and analyze missing and excessive medications in the Pyxis machines when the hospital failed to account for missing and extra medications that would indicate that a patient received too much (received extra doses), missed a dose, or were given the wrong medication when a one day audit revealed 112 extra doses and 107 missing doses were found in Pyxis machines throughout the hospital.

3. The facility failed to develop and implement a quality assurance system for the surveillance and identification of inappropriate use of medications with boxed warning (black box warning). Fentanyl transdermal patches and clozapine were used not in accordance with the FDA issued boxed warning (black box warning) to ensure patient safety.

4. The hospital failed to develop a quality assurance system for the surveillance, identification and remediation of unsafe, unsanitary conditions and practices within the dietetic service department and for those foodservice operations supported by three contracted services who performed tasks within the kitchens and ancillary areas.

5. The hospital failed to develop a quality assurance system for the surveillance, identification and remediation of unsafe staff practices in the California campus to ensure patients safety.

Findings:

1. According to the hospital policy and procedures titled Medication Administration and Safe Practices indicated "All newly ordered medications require pharmacy verification prior to drug withdrawal from Pyxis. "

During an interview on 03/15/10 at 10:00 am Director of Pharmacy (DOP) 1 and DOP 2 both stated that the nurses had access to all the medication in the Pyxis machines at anytime, however they were told to wait 30 minutes so that the Pharmacists could review the orders prior to the Nurse administering the medication. They stated that the Pharmacists had 30 minutes to review and verify the orders before the Nurses would administer the medication.

A review of documents tracking quality data (QA) to measure pharmacists reviewing medications within 30 minutes dated 03/01/10 and 12/04/09 indicated 100% compliance for all shifts. This data indicated that 100% of the physicians' orders were reviewed by a pharmacist within 30 minutes.

A review of a hospital document of a one day audit initiated by the Department of Public Health dated 03/19/10 indicated 537 medication orders were not reviewed by Pharmacists within 30 minutes. There were up to 537 medication orders were nurses administered the medication prior to a pharmacist's review.

The interviewed Pharmacy Systems Manager on 03/19/10 at 11:26 am, stated that the reason why the QA data was inaccurate was because the low frequency and the small sample size of the audits. He said that they did not do enough audits for pharmacists verifying orders within 30 minutes. He also said that he did not review enough of the actual orders.

2. A review of a hospital document dated 03/19/10 indicated QA data that was initiated by the Department, the quantity of un-reconcilable medications categorized as missing and excessive doses of medications for a one day audit on 03/15/10. The audit indicated that there were 112 doses of medications in excess and 107 doses of missing medications.

The interviewed Pharmacy Systems Manager stated on 03/17/10 at 4:00 pm that he was not aware of the actual causes of the missing and excessive doses because it had not been investigated. He stated that it could have been refilled or entered in the Pyxis incorrectly. He also stated that the missing and excessive doses could have been medication errors. He said that the errors could have been administration of too much medication, not administering medications to patients, or giving the wrong medication to a patient. He acknowledged that when patients were given too much medication, not administered medication or given the wrong medication could cause significant harm patient or death.

A review of the titled document CPMC Non Narcotic Discrepancy Reports 2009 indicated QA data of missing and excessive doses found in the Pyxis machines throughout the hospital. For February 2009 there were 9 extra or missing doses. For July 2009 there were 9 extra or missing doses.

During an interview on 03/19/10 at 11:26 am, the Pharmacy Systems Manager stated the reason why the QA data was inaccurate was because of the low frequency of the audits. He said that they did not do enough audits for extra and missing doses.

3. Review of records of patients who were initially prescribed fetanyl patches between 3/17/10 to 3/19/10 revealed that 3 out of 3 patients (Patient 60, 61 and 63) were prescribed and administered the medication not in accordance with the FDA issued boxed warning.

During an interview at approximately 10:20 a.m. on 3/22/10, DOP 2 stated that the clinical pharmacists were assumed the responsibility of reviewing records of patients who were newly started on fentanyl patches one day after the administration of the patch (3 days after if patch was applied on Fridays). DOP 2 further stated that he had not received any reports from the clinical pharmacists about inappropriate use of fentanyl patches. When being asked what the hospital had done to ensure that the reviews were performed by the clinical pharmacists, DOP 2 answered that he could not tell if the reviews in fact happened and said, " there obviously is a gap that I need to follow up on. "

A review of the clozapine monitoring log sheet on 3/27/10 showed that only WBC (white blood cell count) was monitored by pharmacy staff for patients who were on clozapine since 2009. Patients ' s ANC (absolute neutrophil count) were not monitored to minimize the risk of agranulocytosis during therapy as indicated by the FDA issued boxed warning.

During an interview at approximately 11:10 a.m. on 3/17/10, Staff Pharmacist 81 stated that she did not confirm patients' registration in the program to receive clozapine therapy prior to dispensing the drug if the physicians indicated that the patients were on clozapine prior to admission. Staff Pharmacist 81 also stated that pharmacists only recorded and monitoedr WBC for patient on clozapine.

The hospital failed to have a quality assessment process to identify use of medications inconsistent with FDA issued boxed warning (black box warning).


05041


4. Between 3/15/10 and 3/17/10 inspections of the Pacific Campus and California Campus kitchens and ancillary foodservice operations (e.g. two vending sites, a kiosk, two cafeterias and a cafe) revealed unsafe procedures for storing, cooling, preparing, serving and distributing potentially hazardous (non-acidic, protein-containing) foods e.g. meats and there had been potentially cross-contaminating, unsafe usage of chemicals used to sanitize ice machines, surfaces and food-grade equipment. Also, there was the observed inattention to labeling and dating of foods such that foods had been retained past safe use-by dates and there was the potential for unsafe food preparation in the vicinity of areas without sufficient air gaps to prevent back-splashing as well as continued use of damaged equipment, e.g. cracked trays.

On 3/18/10 between 10:30 a.m. and 10:40 a.m. Registered Dietitian 30 stated that there had not been a quality assurance system specific to prevention of an unsafe, unsanitary foodservice and had considered monitoring activities within the job responsibilities of Dietary Management Staff 7 and her designees as well the responsibility of the Infection Control Committee. Upon learning of the pervasiveness of the findings and the need for remediation, Registered Dietitian 30 stated at 10:50 a.m. that while the on-going program had included review of specific clinical nutrition care issues and patient satisfaction survey data which had encompassed food quality, that "something new was possible" to evaluate the origin and type of remediation for
identified deficient foodservice conditions and practices.


16951

5. On 3/15/10, the following observations indicated there was no monitoring or quality system surveilance of staffs' activities and practices to identify issues that could jeopardize patients safety in the California campus.

a. During the initial tour on 3/15/10 at 11:20 am, a sign posted on the closet above the sink in the utility room on the second floor Labor and Delivery Unit, indicated that intruments be rinsed and placed in red plastic container. There was a hopper next to the sink closet. There was a box of gloves in the overhead closet, but there were no other personal protective equipment (PPE) available.

Using the hopper to rinse dirty equipments could produce splashing of contaminated water and tranfer of microorganisms to the staff who used the hopper if personal protective equipment was not worn.

The nurse supervisor who was present during the tour stated the sink was for rinsing used vaginal delivery instruments. When asked about the availability of PPE she stated the nurses bring the used instruments into the utility room still wearing the gown and gloves they wore to assist in the delivery. When asked why they don't remove their gloves, she stated the nurses put the instruments in a basin then add some water to prevent blood from drying on the instruments, and then bring the basin to the utility room.

On 3/15/10 at 11:30 am, RN 1 stated the used instruments were being rinsed in the hand washing sink inside the patients room before being brought to the utility room and placed in the red plastic container. In an interview at 11:40 am, RN 2 stated rinsing of used intruments is done in the sink in the patient's room.

Rinsing used vaginal delivery instruments using the hand washing sink could contaminate the sink with blood borne pathogens (disease causing microorganism carried by blood) that could potentially be passed on and cause infection to staff, patients, and/or visitors who would be using the sink.

In an interview on 3/18/10 at 3 pm, the Infection Control Preventionist (ICP)stated the infection control committee does hazard surveillance rounds and that every department manager made sure they have the right materials. The ICP also stated it's a "practice that got started and no one seem to catch, it's not a good practice. Hand washing sink is not to be used to clean equipment."

There was no explanation provided as to why the unsafe practice of rinsing used instruments in the sink had not been identified as an infection control/prevention problem during the manager's surveillance rounds.

b. On 3/15/10 at 11:50 am, it was observed that almost all of the equipment carts have a container of Sani-Cloth Plus. Upon closer inspection of the Sani-Cloth container it was noted that the container was marked with the date it was manufactured; however, it was not marked with an expiration date.

RN 3 who was present during the observation stated they were using Sani-Cloth to disinfect the equipment inbetween patient use. RN 3 stated she did not know if it had an expiration date.

The Infection Control Preventionist on 3/18/10 at 3:15 pm stated the infection control committee approved the use of Sani-Cloth; however, she was not aware of the expiration date or the shelf life of the product. When they called the manufacturer they were told the manufacturer is regulated by EPA (Environmental Protection Agency) and they do not have to list the expiration date at the bottom of the container; but was told that the product is good for two years.

The infection control committee did not ensure that the department responsible for dispensing the product had a system to monitor the use of Sani-Cloth to ensure it was not to be used beyond its shelf life.

c. On 3/15/10 at 1:50 pm on the fifth floor, a new container of cranberry juice was observed in the handwashing sink in the pantry (Room 5440). The nurse manager (RN 6) stated the container was frozen and was being thawed. It would be used to replace the empty container in the juice dispenser. RN 6 also stated she was not aware who placed the container of juice for thawing in the hand washing sink.

There was no barrier between the juice container and the handwashing sink. This could potentially contaminate the juice container with microorganisms from the handwashing sink and further contaminate the juice dispenser.

In an interview with the Manager of Dietary Services (Dietary Staff 1) on 3/18/10 at 10:30 am, stated the juice container should not be thawed in the handwashing sink. It should be thawed in the refrigerator if there is no sink available for thawing.

d. On 3/15/10 at 11:10 am, a housekeeping closet on the second floor was left unlocked. Inside the closet were four chemicals. Each chemical was in a gallon container with hoses attached to a dispenser control.

In a concurrent interview, Housekeeping Staff 1 (HS 1) was asked how she transfers chemicals from the gallon container to a secondary container (spray bottle container with capacity of approximately 500 ml) the housekeeper was using in the work area. HS 1 one showed the surveyor a spray bottle and explained that she would fill it up to a certain level, at the same time pointing to the bottle at approximately 1 1/2 inch level from the bottom. She added that she would add water up to the neck of the bottle.

In an interview with the Director of Environmental Services (DES) on 3/18/10 at 11 am, the DES was informed of the observation and stated he was flushtered because the surveyor was describing a process of dilution. He stated the chemicals when dispensed from the containers were already premixed to its desired concentration.

On 3/18/10 at 1:30 am, HS 2 unlocked the janitor's closet to show the surveyor and DES the chemicals inside. When asked how she transfer chemicals into a secondary container, HS 2 had difficulty explaning the process. The housekeeping manager gave her a spray bottle with some liquid inside. HS 2 stated the fluid in the container was water. HS 2 attempted to dispense the Sanimaster chemical into the container but the manager directed her to first empty the container. HS 2 proceeded to dispense the Sanimaster into the spray bottle container until the bottle was 1/4 full. HS 2 then added water to the chemical up to the neck of the container.

The DES who was present during observation stated HS 2 was not supposed to dilute the chemical since the chemical coming out of the dispenser was already premixed.

Review of the Material Data Sheet for Sanimaster on 3/18/10 indicated it was a sanitizer.

Chemicals that were premixed to its desired concentration when diluted will reduce the potency of the chemical and will no longer be effective.

Enviromental Services failed to ensure that proper preparation of chemicals was adhered to by the housekeeping staff in order to ensure effectiveness of the sanitizing agents to prevent infection or cross contamination.

In an interview on 3/18/10 at 3 pm, the Infection Control Preventionist (ICP)stated the infection control committee does hazard surveillance rounds and that every department manager made sure they have the right materials.

In an interview with the Infection Control Preventionist on 3/18/10 at 3 pm, when asked about the role of the Infection Control Committee in the facility's quality assessment, stated they only track and report certain areas like cesarean section infections; however, department managers conduct environmental hazard surveillance.

Based on interview and record review, the facility 's governing body failed to ensure that an ongoing program for quality improvement was defined, implemented and maintained when three contract services were not incorporated into the hospital wide QAPI (quality assurance and performance improvement) program and there was no system in place to evaluate the quality of services provided by these contract providers. This resulted in a lack of surveillance for maintenance of vending machines containing potentially hazardous foods, the potential for undetected dishmachine problems and unsafe or ineffective pest control services in a hospital with a licensed bed capacity for 612 patients.


Findings:

On 3/18/10 between 9:50 a.m. and 10 a.m. review of three of three contracted services for the dietetic services department indicated departures regarding, term, co-signature and administrative authority. There was no term specified for the contracted vending service responsible for the maintenance and repletion of machines containing dry, refrigerated and frozen foods available for patients, staff and visitors. For the dishmachine maintenance service, there had been a failure to have a hospital administrative representative co-sign. Additionally, the contracts for vending, dishmachine and pest control services lacked a statement regarding the hospital's administrative authority for responsibility and surveillance.

At 10 a.m. during review of the quality assurance measures, Registered Dietitian 30 stated that there had not been a quality assurance system specific to these three services. Additionally, at 10:20 a.m. Dietary Management Staff 17 stated that no one from the hospital had incorporated these three services in any quality assurance program and that was of concern, most specifically to the vending service. Additionally, per reference to a document Dietary Management Staff 17 then presented, it had not been until 3/17/10 at 4:11 p.m. that Department Manager 29 was in receipt of the e-mail from the contracted service regarding their protocols for the fixed and settable temperatures for the units containing refrigerated beverages and frozen foods. By conclusion of the survey, no one from the dietetic services department could locate any reports from the contracted vending service for the past year and there was no documented evidence of incorporation of this service for any aspect of hospital surveillance pertinent to safety and sanitation.

Also, on 3/18/10 between 9:50 a.m. and 10 a.m. review of the dishmachine service document presented as the contracted duties revealed that it was undated, titled "Machine Warewashing Service Policy" and covered varied services: scheduled visits, checking detergent wash solution, checking and regulating temperature, checking steam and fill valves, doing mechanical adjustments as well as conducting other inspections including electrical in addition to provision of : reports; on-site training of hospital staff; reference charts and recommendations to management as well as fielding other special operations. However, there was nothing in the document to show hospital responsibilities and this was of concern as the dietetic service dishmachines were used to clean and sanitize wares from the kitchens and ancillary food service operations.

At 10:25 a.m. Dietary Management Staff 17 stated she had conferred with Department Manager 29 who had been "checking since yesterday" and there was no evidence "anywhere" of surveillance to ensure efficacy, safety and sanitation of the processes used by the three contracted services. Likewise, on 3/18/10 between 10:50 a.m. and 10:55 a.m.. review of the "Pest Elimination Agreement" did not show the hospital's administrative responsibilities and as of 11 a.m. Dietary Manager 17 and Registered Dietitian 30 stated that this service had not been part of the quality assurance program for the dietary department and that as far as they knew, "no hospital department" had included this service in their quality assurance program.

On 3/18/10 between 10:30 a.m. and 10:40 a.m., Registered Dietitian 30 stated that the failure to include these three contracted services in the quality assurance program had been "an oversight". On 3/18/10 at 10:50 a.m., Dietary Management Staff 17 said that these items would need to be addressed "soon" to ensure safety of patients, staff and visitors and stated "This should be easy to fix".

The facility had no system in place to monitor the services provided by three of its contract providers and failed to incorporate these contract services into its QAPI (quality assurance and performance improvement) program.

Based on interview and record review, the facility failed to conduct an annual determination of the number of performance improvement projects. The deficient practice eliminated an opportunity for the facility's leadership to form a comprehensive overview of the facility's projects and to assess whether the scope of the projects was appropriate.

Findings:

In an interview on 3/19/10 at 10:05 a.m., Staff A stated "I don't know that we have an exact number" regarding the performance improvement projects. She stated that the facility had 200-300 projects "a couple of years ago", that a binder presented to the surveyor had details regarding six projects, and that the projects were often department-based. She stated that the facility did have an annual assessment of its performance improvement projects which indicated that there were 23 projects.

Review of the annual assessment indicated that it included "A partial list of quality and safety programs we participate in..." and a listing of 23 achievements. Review of the achievements indicated that the radiology department performance improvement projects were not included.

Review of the facility's performance improvement plan indicated that there was an appendix naming the "Organizational Strategic Priority Areas", but there was no enumeration of all the facility's performance improvement projects.

Based on interview and record review, the facility failed to consider the quantity and quality of specific work during reappointment for 1 of 8 sampled credentials files (Practitioner 4). The deficient practice limited use of a mechanism by which the facility could assess the current competence of its medical staff.

Findings:

Review of Practitioner 4's credentials file indicated that he was board certified in radiology in 1980, board certified in nuclear medicine in 1981, and was reappointed to the facility's active medical staff on 7/31/08. A peer review report indicated that none of Practitioner 4's interpretations had been reviewed by his peers; a note by the department chair indicated that Practitioner 4 was "not a part of the RadPeer process." An activity report indicated Practitioner 4 had been the admitting physician for one patient in the two years prior to reappointment. The facility's physician reappointment profile indicated Practitioner 4 had no "Quality Referral Contributions", no inpatient mortality, and no patient complaints. There was no information in the credentials file regarding the number of studies Practitioner 4 had interpreted or whether those interpretations were satisfactory.

In an interview on 3/19/10 at 1:07 p.m., Staff B stated that the radiology department chair wouldn't be familiar with Practitioner 4's clinical work. Staff C stated that physician participation as peer reviewers in the RadPeer system had increased since 2009 and that Practitioner 4 was now included, although with tiny numbers compared to the other physicians. He stated that he had considered the absence of complaints by other physicians to indicate that there were no problems, but that he would come up with a plan to have Practitioner 4's work evaluated.

Based on interview and record review, the facility failed to enforce provisions in its medical staff bylaws for 2 of 8 sampled credentials files (Practitioners 1 and 2). Practitioner 1 was reappointed to the medical staff even though he had exceeded the number of medical records suspension days which the bylaws stated would result in relinquishment of medical staff membership. Practitioner 2 was reappointed to the active category of the facility's medical staff even though there was no documentation that he had met the facility's minimum threshold for activity. The deficient practices circumvented institutional quality safeguards contained in the bylaws. The facility also failed to ensure that the Medical Records Committee had a quorum for six (6) of ten (10) meetings held in 2009.


Findings:

1. Review of the facility's medical staff bylaws indicated, "The circumstances set forth below shall result in an automatic probation, suspension or termination or relinquishment of privileges and/or Medical Staff membership. A meeting with the Executive Committee may be requested. Such meeting, if requested, shall be limited to the question of whether the grounds for action as set forth below, have occurred... vii. Medical Records Delinquency. Whenever a Staff member fails to complete the Hospital medical records of any patient for whom he/she is responsible, as required by the Rules and Regulations and Hospital Policies and Procedures governing completion of medical records and any laws or regulations, such Staff member's Medical Staff clinical privileges... shall be automatically suspended... and shall remain so suspended until all delinquent medical records are completed. Bona fide vacation or illness may constitute an acceptable excuse... Failure of the physician to complete his/her medical records resulting in a total of 90 days of suspension within a 12-month period shall constitute automatic and voluntary resignation and relinquishment of Medical Staff membership and privileges... Whenever a Staff member's... Staff Membership and clinical are suspended or modified pursuant to this Article..., SPECIAL NOTICE of such action shall be given to the Staff member, and written notice to the Executive Committee, the Department Chair, the Division Chief, if applicable, the Chief Executive Officer and the Board... Reinstatement of privileges and/or membership shall depend upon the circumstances giving rise to the automatic probation, suspension, termination or relinquishment of privileges and/or membership as described in this section."

Review of the facility's "MEDICAL RECORDS SUSPENSION POLICY & PROCEDURE" indicated that it was approved by the medical executive committee (MEC) on 1/9/02 and by the governing body on 1/24/02. It indicated that the procedure for implementing the bylaws provisions would consist of a report to the MEC and a letter to the physician after 30 suspension days; a report to the credentials committee, another letter to the physician, and an appearance by the physician before the credentials committee after 60 suspension days; and a report to the MEC and credentials committee plus a final notice to the physician with termination of membership and privileges after 90 suspension days.

Review of Practitioner 1's credentials file indicated that he was reappointed to the facility's medical staff on 2/28/10. The department chair's reappointment recommendation indicated that Practitioner 1 had accumulated 96 medical record suspension days.

Review of memos provided by the medical records department indicated that Practitioner 1 had accrued 22 days suspension on 4/24/09, 55 days suspension on 6/8/09, and 82 days suspension on 7/13/09. The memos indicated that Practitioner 1 had been copied on each, and each memo indicated that 90 days suspension would result in voluntary resignation and relinquishment of medical staff membership and privileges.

In an interview on 3/18/10 at 3:14 p.m., Staff D stated that her team had verbally reported to the medical staff office when Practitioner 1 exceeded 90 days suspension and that her department did not re-report once that threshold had been crossed.

In an interview on 3/19/10 at 1:07 p.m., Staff B stated that because of a glitch in medical records, the facility had not notified Practitioner 1 at the usual timepoints, he was only notified at 82 days suspension, and "We had a problem of not knowing at 60 days." He stated the facility was working to tighten up the notification, but that Practitioner 1 had 90 days suspension by the time he came to the credentials committee in August, that Practitioner 1 came when asked, was penitent, and that he (Staff B) hadn't heard of problems since. He stated that it wouldn't make sense to enforce the bylaws provision without the facility doing its part.

2. Review of the facility's medical staff bylaws indicated, "Active Staff members... are required to have ten (10) admissions, or inpatient referrals to other physicians or inpatient consultations or outpatient procedures per year. If a staff member does not have ten (10) admissions, or inpatient referrals to other physicians or consultations or outpatient procedures, they will be moved to another staff category. This provision can be waived by the Executive Committee for good cause for non-admitting and limited activity staff members who make a meaningful professional contribution towards the mission of the Hospital appropriate to the nature of their specialty."

Review of Practitioner 2's credentials file indicated that he was reappointed to the active category of the facility's medical staff on 2/28/10. An activity report in Practitioner 2's file indicated that for the two years prior to reappointment, Practitioner 2 had been the surgeon on four inpatients and had provided a consultation on one of the four patients. No notations regarding a waiver by the Executive Committee were present. Comparison of Practitioner 2's credentials file to Practitioner 4's credentials file indicated that Practitioner 4 had been required to complete a document explaining how he had fulfilled the active staff requirements while Practitioner 2 had not.

In an interview on 3/19/10 at 1:07 p.m., Staff B stated that the intent of the bylaws provision was to ensure a physical presence, and that if Practitioner 2 was a regular surgical assistant that he was contributing. Staff B stated that the facility relied on the department chair to indicate whether Practitioner 2 met the requirements and that the documentation in Practitioner 4's credentials file was not required. Staff B did not explain the apparent discrepancy between his statements indicating that the department chair could waive the activity requirement and the language in the bylaws which indicated that the Executive Committee could grant the waiver.


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2. The Medical Staff Bylaws, approved 10/22/09, were reviewed on 3/15/10. Section 5.a. defines a quorum as: "Fifty (50) percent of the Active Medical Staff members of a committee, but not less than three (3) members shall constitute a quorum at any meeting...."

The minutes of the 2009 Medical Records Committee meetings were reviewed on 3/15/10. There were nine (9) physicians on the membership roster. Ten (10) meetings were held and only four (4) meetings documented evidence that three (3) physician members were in attendance. On the morning of 3/17/10, Health Information Management staff confirmed that a quorum was not present during six (6) of the meetings.

Based on medical record review and nursing staff interview the hospital failed to ensure comprehensive care planning for 1 patient (Patient 5) who was being tube fed. Lack of comprehensive care planning development for tube fed patients may result in nursing staff delaying or failing to deliver all necessary care and services, resulting in further compromise of medical status.

Findings:

Patient 5 was admitted with diagnoses including diabetes and end stage renal disease with dialysis treatments. It was also noted that the patient was admitted with an enteral feeding in place. Medical record review was conducted on 3/17/10 beginning at 10:15 am. Admission physician order dated 3/15/10 noted a physicians' enteral tube feeding protocol "A" with Nepro (a nutritional supplement), "Dietitian to determine appropriate TF and goal rate."

A nursing admission assessment dated 3/15/10 and completed by the admitting nurse noted that the patient had a pre-existing enteral (a tube for delivering nutrition supplementation through a wall to the stomach).feeding tube.
Review of hospital copy titled "Daily Orders Summary" for 3/15/10 revealed that at 11:04 am, the RD entered a written order into the computer system as a written order entered for the physician. Review of the hospital document titled "Critical Care Flow Sheet" dated 3/15/10 revealed that nursing staff implemented the tube feeding order beginning at 1 pm, as a result of the order entered into the PCIS (Patient Care Information System).

Review of the medical record revealed that while Patient 5 had care plans for pressure ulcer prevention and for nutrition services, there was no developed care plan for tube feedings.

In an interview on 3/17/10 with Licensed Nurse (LN) 13 she stated that nursing staff utilized the "CPMC Tube Feeding Protocols (2009)" as the care plan. LN 13 also stated that during every shift nursing staff printed out a "patient care summary" which included elements such as basic diagnosis, nurse to nurse communications, nursing orders as well as medications in addition to several other non-nursing related elements. The surveyor asked LN 13 what happened to the document at the end of each shift, to which she responded that it was destroyed. She also stated that to her knowledge she had never seen a standardized care plan for tube feeding care within the hospital.

Review of hospital document on 3/17/10 titled "CMPC Tube Feeding Protocols (2009)" noted that the general guidelines such as the responsibility of the Dietitian, verification of tube placement and guidelines for residual; however there was no indication that these elements were routinely evaluated as part of the patients' routine care or part of the permanent medical record. There was also no mechanism that would allow nursing staff to comprehensively track interventions as care needs were identified.

Based on interviews and record review, the hospital failed to ensure that medications were administered in accordance with physicians' orders and acceptable standards of practice. Patient 59 was administered morphine 2mg intravenously inconsistent with physician's order and in the absence of documented pain. Patient 59 was administered heparin (a blood thinner) subcutaneously when there was a physician ' s order to not administer anticoagulants (blood thinners) while the patient had an epidural (an area of the spinal column) catheter in place. Patient 63 was administered ? of a fentanyl 25 mcg/hr transdermal patch inconsistent with the physician's order of fentanyl 12 mcg/hr transdermal patch. Using cut or damaged fentanyl patches may lead to the rapid release and absorption of the medication.

Finding:

1. A review of Patient 59 ' s clinical record at approximately 10:40 a.m. on 3/16/10 showed that Patient 59 was admitted to the hospital on 3/15/10. Patient 59 ' s medication administration record (MAR) on the Critical Care Flow Sheet showed that Patient 59 was administered morphine 2mg intravenously at approximately 5:00 p.m. on 3/15/10. Patient 59 ' s hourly pain score was documented as 0 (no pain) from 3:00 p.m. to 10:00p.m. on 3/15/10. Morphine sulfate (a narcotic pain relieving medication) 4mg intravenously every 2 hours as needed for pain was order by the physician at approximately 10:36 a.m. on 3/15/10. There was no record of any physician ' s order for morphine 2mg.

During an interview at approximately 11:25 a.m. on 3/16/10, RN 81 stated that she removed the morphine 2mg syringe from Pyxis (an automated drug dispensing cabinet) and administered to Patient 59 at approximately 5:00 p.m. on 3/15/10 because she recalled that Patient 59 was complaining of pain. RN 81 also stated that Patient 59 ' s epidural pain control medication was increased at 3:00 p.m. on that day and therefore she decided to only give morphine 2mg instead of the physician ordered dose of morphine 4mg. When being asked why she gave Patient 59 pain medication when the pain score recorded no pain between 3:00 p.m. to 10:00 p.m. on that day, RN 81 stated that she forgot to document Patient 59 ' s complaint of pain but was not able to give an explanation on the " 0 " pain score documented on the patient ' s flow sheet.

2. A review of Patient 59 ' s clinical record at approximately 10:40 a.m. on 3/16/10 showed that Patient 59 was admitted to the hospital on 3/15/10. Patient 59 was started on an epidural drip of fentanyl 30mcg/hr (micrograms per hour) at 10:00 a.m. on 3/15/10 for pain control. A nursing order written by the physician at the same time indicated that anticoagulants (blood thinning medications) should not be administered while Patient 59 ' s epidural catheter was in place and within 12 hours after the removal of the catheter. Heparin sodium (a blood thinning medication) 5000 units subcutaneously twice daily was ordered by Patient 59 ' s physician at approximately 1:12 p.m. on 3/15/10.

A review of Patient 59 ' s medication administration record (MAR) on the Critical Care Flow Sheet showed that Patient 59 was administered heparin sodium 5000 units subcutaneous on 3/15/10 and 3/16/10 while the epidural catheter was in place for the delivery of fentanyl for pain control. There was no documented communication between nursing staff and the physician to clarify the appropriateness of administering heparin while the patient still had the epidural catheter in place.

Heparin is a blood thinning agents indicated for the prevention of blood clot formation.
The use of heparin in patients with epidural puncture is associated with an increased risk of epidural or spinal hematoma. A spinal subdural or epidural hematoma is an accumulation of blood in the subdural or epidural space that can mechanically compress the spinal cord.

3. A review of Pyxis fentanyl dispensing report on 3/16/10 showed that one fentanyl 25mcg/hr transdermal patch was removed by RN 80 on 3/2/10 for Patient 63. There was a documented wastage witnessed by RN 83 indicated that only 12mcg of the patch was given and 13 mcg of the patch was wasted.

Fentanyl transdermal patch is a controlled delivery system that releases a very potent narcotic medicine, fentanyl, at a determined rate through the skin for pain relief. The patch is designed to deliver a consistent amount of fentanyl continuously while the patch is applied to skin. Cutting of the patch can cause damage to the controlled release delivery system of the patch and lead to rapid release and absorption of fentanyl though the skin which may result in fatal fentanyl overdose. Fentanyl patches are available in the following strength: 12mcg/hr, 25mcg/hr, 50mcg/hr, 75mcg/hr and 100mcg/hr.

A review of Patient 63 ' s clinical record showed that the patient was admitted to the hospital on 2/27/10 for compression fracture. Fentanyl 12 mcg/hr patch was ordered by the physician on 3/2/10.

During an interview at approximately 3:40 p.m. on 3/17/10, RN 80 stated that she did not handle fentanyl patches very often and she remembered that Patient 63' fentanyl patch was an unusual order because she believed that fentanyl patch was not commercially available as a 12 mcg/hr patch. RN 80 further stated that she removed a fentanyl 25 mcg/hr patch from Pyxis, cut it in half and applied the half patch to Patient 63 ' s skin on 3/2/10. RN 80 also stated that she could not remember if there was a hospital policy and procedure on the use of fentanyl patches.

Based on interview and record review the hospital failed to administer Allopurinol for a patient to prevent complication from chemotherapy within the hospital policy time frame of 30 minutes.

Finding:

According to the hospital policy and procedures titled Medication Administration and Safe Practices indicated "Administration...Now and routine orders are to be executed within 30 minutes from the time of order."

A review of the clinical record indicated Patient 73 was a 50 year old female with a past medical history of non-Hodgkin's lymphoma (cancer). She was placed on a course of chemotherapy and prior to chemotherapy was given Allopurinol to prevent complications that maybe caused from Tumor Lysis Syndrome (complication from breakdown of products from dying cancer cells).

In an interview on 03/15/10 at 2:45 p.m., Pharmacist 73, after reviewing the clinical record stated that the physician's order was written on 03/15/10 at 10:54 a.m. He also stated that the nurse had not administered the medication until 03/15/10 at 2:00 p.m. The order was not administered to the patient for over 3 hours.

During an interview on 03/16/10 at 3:00 p.m., Physician 70 stated that Patient 73 had a large tumor and Allopurinol was used to prevent the complications of Tumor Lysis Syndrome. He also stated that this patient had been started on Allopurinol on a three day course of Allopurinol prior to chemotherapy. After chemotherapy he had discontinued the Allopurinol but his attending physician suggested keeping the patient on Allopurinol because the patient was still at risk for complications from Tumor Lysis Syndrome (TLS). He also stated that he did not expect the medication to start beyond two hours. He said if the patient had complications due to TLS there could be potential harm for delaying the administration of the medication.

Based on medical record and document review and staff interview, the facility failed to ensure that records were accurately written by having an approved abbreviation list. This failure had the potential to result in misinterpretation of documentation within health records.

Findings:

On 3/15/10 at 10:30 a.m., interview with Staff D revealed that the hospital does not have a list of approved acceptable abbreviations. She referred to "'Policy and Procedure #1.07, Subject: National Patient Safety Goals-page 2, #2. Standardize a list of abbreviations, acronyms, symbols and dose designations that are not to be used throughout the organization."

On 3/15/10 beginning at 11:30 a.m., during tray line observation it was noted that Patient 4 had a physician ordered diet restricting phosphorus. It was also noted that the tray ticket that Patient 4 was given was a renal diet.

Medical record review was conducted on 3/16/10 beginning at 2:00 p.m. Review of undated hospital document titled "Nutrition Note" which was completed by the Diet Assistant revealed that the Assistant noted the current diet order as being a low phosphorus diet. The RD reviewed the note on 3/13/10 and noted the low phosphorus diet, per the MD; however there was no indication that the RD alerted diet office staff to provide guidance for the physician ordered diet. It was also noted that the abbreviation for a low phosphorus diet utilized by the RD was a downward arrow followed by a capitalized P. In a concurrent interview with RD 4, the surveyor asked if the abbreviation was a hospital approved abbreviation, to which she replied that since this was not on the abbreviation list that was not allowed, it could be used. In an interview on 3/15/10 at 12:30 p.m., with the Infection Control Preventionist, she was asked the meaning of the abbreviation to which she replied that it denoted a low potassium diet.

On 3/17/10 at 3.30 p.m., review of the "American Health Information Management Association, (AHIMA), Chicago, Illinois -Practice Brief, Journal of AHIMA 76, No. 10" " Maintaining a Legally Sound Health Record-Paper and Electronic"-Page 7 "-Use of Abbreviations-......Healthcare organizations should set a standard for acceptable abbreviations to be used in the health record and develop an organization-specific abbreviation list."

Based on medical record review, Registered Dietitian and physician staff interview and medical record review the hospital failed to ensure physician approval of diet orders prior to implementation as evidenced by 1) nursing initiation of tube feeding goal rates for 2 of 2 enteral feedings (Patients 5 and 65) without physician signature and 2) implementation of nutrition supplements for 1 patient prior to obtaining physician approval (Patient 6). Failure of the physician to order diets may result in further compromising the clinical status of patients.

Findings:

Pacific Campus

1. Patient 5 was admitted with diagnoses including diabetes and end stage renal disease with dialysis treatments. It was also noted that the patient was admitted with an enteral feeding (a feeding tube placed in the intestine) in place. Medical record review was conducted on 3/17/10 beginning at 10:15 am. A nursing nutrition screening assessment dated 3/15/10 triggered a nutrition consult. Admission physician order dated 3/15/10 noted an order for physicians' enteral tube feeding protocol "A" with Nepro (a nutritional supplement), "Dietitian to determine appropriate TF and goal rate."

A comprehensive nutrition assessment dated 3/15/10 and completed by the RD noted that documentation for the current diet order repeated the physicians' order for "goal rate per RD's recommendation protocol." The RD recommended a feeding goal rate at 30 cc's/hour "per TF [tube feeding] protocol."

Review of hospital copy titled "Daily Orders Summary" for 3/15/10 revealed that at 11:04 am, the RD entered an order into the computer system as a written order entered for the physician. There was no additional electronic physicians ' signature. Review of the hospital document titled "Critical Care Flow Sheet" dated 3/15/10 revealed that nursing staff implemented the tube feeding order beginning at 1 pm, as a result of the order entered into the PCIS (Patient Care Information System).

In an interview on 3/17/10 beginning at 10:30 am, with RD 4 she was asked to describe how Patient 5's order would be interpreted by the RD. She stated that she would complete a comprehensive assessment and determine the desired rate of feeding. She also stated that the hospital had developed a tube feeding protocol to allow RD's to implement the order. She further stated that she believed that since the physician wrote the order for the RD to determine the rate it would allow the RD to input the order with the expectation that nursing would implement the order without obtaining a physicians' order.

Similarly Patients 6 and 65 had nutrition supplementation orders intended to be evaluated by the RD and entered into the electronic medical record without by staff with no order writing privileges (Cross Reference 329).

In an interview on 3/18/10 at 11:45 a.m., Physician 5 and RD 12 the surveyor asked them to describe the intent of the implementation of the tube feeding protocol. Physician 5 stated that the protocol was initiated in an effort to assist physicians in determining enteral support for patients. He stated the intent was to initiate feeding at a slow rate as soon as the feeding was ordered and the RD would determine the rate of the formula. He also stated that it was his expectation that the RD contact him to obtain a verbal order prior to implementation of the feeding. In a follow up interview on 3/18/10 at 12:30 p.m., with Physician 5 the surveyor asked whether or not the hospital granted order writing privileges to ancillary health professionals, to which he replied "no."

In an interview on 3/18/10 at 3 p.m., with HIM 2 she was asked to describe the auditing system for entering of verbal orders. She stated the hospital electronic medical record had a "role based access" indicating that if a person was designated to allow to write orders they would be given that level of access to the electronic record. She also stated that the hospital had no process of verification or was auditing records to ensure only those whose role was to enter medical orders were able to do so.

Based on medical record review and staff interview, the facility failed to ensure that the State sterilization consent form was properly executed in 1 of 1 sterilization records and failed to follow its procedure for obtaining consent to surgery for one (Patient 34) of two sampled post-cesarian section patients.

Findings:

1. On the afternoon of 3/17/10, record 26 was reviewed. The patient had signed the State of California Consent Form PM 330 on 1/12/10. By law, the sterilization procedure is not to be done until at least thirty days after signing the form. The post-partum tubal ligation was done on 2/09/10 (a period of less than thirty days) and the Physician's Statement section of the form had not been completed to explain the reason for not waiting the full thirty days. The physician had signed this section, but did not enter the date or reason.

On the afternoon of 3/17/10, Health Information Management staff confirmed that the consent form was incomplete.


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2. Review of Patient 34's clinical record on 3/16/10 indicated the patient had a cesarian section on 3/12/10.

The form titled Consent to Surgery was signed by the patient on 3/12/10. The section in the consent form to filled out with the type of surgery to be performed was left blank. The section requiring entry of surgeons's name was also left blank.

Review of the facility's "Procedure For Obtaining Patient Consent" indicated that the first step in the consent process is for the physician to give an explanation of the nature of the procedure ... Second, the nurse obtains the patient's signature on the Consent To Surgery ... which verifies that the patient has been informed by the physician and authorizes the procedure.

The steps in obtaining patient consent indicated as step #2 "Verify the wording of the consent by checking the physician's order. Under "Key Points" for step #2 indicated that once the preoperative orders are written, the nurse may fill in the consent form as specified in the physician's order, which clearly sets forth all the information identifying the procedure or operation. "(Administrative P&P 1.72)".

Step #3, "Fill in the consent form as specified in the physician's order".

Patient 34's signed consent form did not indicate what type of surgery and the physician who will perform the surgery, the patient consented to.

On 3/16/10 at 11:20 am, RN 7 was not able to explain why the consent was incomplete.

Based on observation, medical record review and staff interview the hospital failed to ensure that nursing notes and other information necessary for the monitoring of conditions were accurate and complete. By not having accurate, complete admission information as well as accessible plans, round reports and accurate daily weights there was the inability to have correctly included this information in the determination of care needs (Patient 1). Further, there had been the lack of complete information with respect to weight and intake for two patients with well-established histories of weight changes and poor intake and as a consequence, they had not been monitored as closely as what had been intended. (Patients 2 and 3).

Findings:

1. Patient 1 was an adult male admitted on 3/9/10 who had multiple diagnoses and medical conditions including acute and chronic liver disease with encephalopathy (a brain dysfunction) with progressing renal failure who expired on 3/16/10. At 11 a.m. both Registered Dietitian 26 and Nursing Staff 33 stated that they were both aware, per "rounds" that Comfort Care measures had been recommended, inclusive of discontinuation of tube feeding within the week, but that they could not locate the documentation of the discussion during rounds. Also, Dietary Management Staff 17, Registered Dietitian 12 and Registered Dietitian 26 stated that they were surprised that could they could not locate an updated care plan which may have addressed the 3/13/10 discontinuation of tube feeding.

On 3/15/10 between 10:34 a.m. and 12:50 p.m. while in the ICU (Intensive Care Unit) review of Patient 1's medical record revealed that in the Nursing Baseline Assessment (form) there had been the failure to have completed the sections pertaining to Advanced Directive, the alternate section for Pain Assessment when there is an alteration or impairment in communication and the fields pertaining to education and learning. Although there was a note, "Unable to complete assessment pt. intubated/unarousable" at least one of the fields (i.e. the alternate section for Pain Assessment) was to have been completed by nursing staff as it addressed "breathing independent of vocalization", "negative vocalization", "facial expression", "body language" and "consolability"--all elements within the scope of nursing assessment. Further, per the physician consult of 3/10/10 Patient 1 had been transferred to the hospital from another separately licensed hospital and had a wife who was knowledgeable regarding his condition, medical history and psychosocial concerns. As written in the Nursing Baseline Assessment (form), it is unclear as to why some information had not been entered and if there had been an attempt to interview his wife, especially as contact information had been documented.

Additionally, during observations during re-measuring and re-weighing as well as medical record review there were other indications of errors, e.g. the failure to reconcile admission information pertaining to height and weight and the failure to have factored the weight of heel boots during daily weighing as the "Weight List" had not included them for subtraction and nursing staff had not made a documented attempt to determine the weight of them. The discrepancies for admission height and weight had been marked as the Nursing Baseline Assessment (form) had Patient 1 as a five feet eight inches and admission weight, 84.2 kg (185.24 lbs) whereas the Patient Care Summary had his height as five feet five inches and admission weight, 93.6 kg (205.92 lbs). At 12:50 p.m. Dietary Management Staff 17, Registered Dietitian 12 and Nursing Staff 33 stated that in addition to the aforementioned omissions that they would review these other concerns.

2. Patient 2 was a five foot tall adult female admitted on 3/9/10 with a diagnosis of metastasized cancer who had oral pain affecting her appetite. Patient 2 had incurred sudden weight loss and gain during her course of stay: 3/9/10--60 kg (132 lbs), 3/11/10--61.6 kg (135.52 lbs), 3/12/10--63.7 kg (140.14 lbs) and 3/16/10--62.1 kg (136.62 lbs) .

On 3/16/10 between 10:10 a.m. and 10:50 a.m. review of Patient 2's medical record while in the Pacific Campus Med Surg unit with Dietary Management Staff 17 and Registered Dietitian 34 revealed the failure of nursing staff to have not only recorded daily weights in accord with the 3/9/10 physician orders for 3/10/10 , 3/13/10, 3/14/10 and 3/15/10 but they had not noted, why the entries were missing. Also omitted were meal-percentage intakes for dinner on 3/12/10 and 3/15/10 and instances where the type of food rather than the amount (e.g. of juk, a Chinese rice porridge) within the context of the meal had been noted and there was confusing recording of percentage intake (e.g. the prescribed provision of a formula, Ensure for lunch on 3/15/10 ) when still prescribed the Full Liquid Diet. At 10:50 a.m. both Dietary Management Staff 17 and Registered Dietitian 34 acknowledged the respective oversights as well as the failure to not have had complete data available for use during course of stay as well as for planned imminent discharge.

3. Patient 3 was an adult female admitted 3/1/10 with GI (gastrointestinal) bleed, anemia, leukocytosis (elevated white blood cells), coagulopathy (a defect in blood clotting mechanisms), alcoholic hepatitis, cirrhosis, acute renal failure, malnutrition and a flank hematoma (a swelling or mass of blood). During the course of stay Patient 3 was in respiratory failure, intubated, extubated and re-intubated and had a fever (which would affect both caloric and fluid needs). Historically, per the admission nursing screen Patient 3 had lost more than ten pounds in the month prior to admission and had problems with nausea and vomiting. By 3/3/10 Registered Dietitian 26 had identified Patient 3 at high nutritional risk, having potential risk for refeeding syndrome and needing tube feeding with special attention for fluids, lipids and amino acids as well as nutrients (via TPN--total parenteral nutrition/IV fluids). Additionally, there were physician's orders for daily weight, effective 3/4/10.

As of 3/9/10 Patient 3 was tube fed Nepro, an enteral formula and administered medications via tube with 30 cc's of water before and after each medication administration such that it was unclear upon review of the flow sheet entries on 3/16/10 between 1:45 p.m. and 1:55 p.m. if the amount of water provided in formula and via all flushes was less than or exceeded calculated needs of water per day as there were varying responses from Registered Dietitian 26, Registered Dietitian 31, Nursing Staff 32 and Nursing Staff 33 as of 2 p.m. with respect to interpretation of totals on the daily flow sheets.
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On 3/16/10 between 2 p.m. and 2:40 p.m. while in the Pacific Campus CCU (Critical Care Unit) review of daily weight data between 3/1/10 when Patient 3 weighed 61.3 kg (134.86 lbs) and 3/16/10 when she weighed 60.2 kg (132.44 lbs) revealed marked weight gains e.g. an increase from the admission weight to 64.8 kg (142.56 lbs) on 3/2/10 and an increase from 55.9 kg on 3/7/10 (122.98 lbs) to 59.1 kg (130.02 lbs) on 3/8/10 and losses (e.g. a drop from 64.8 kg (142.56 lbs) on 3/2/10 to 57.7 kg (126.94 lbs) on 3/3/10 and a drop from 58.5 kg (128.7 lbs) on 3/5/10 to 52 kg (114.4 lbs) on 3/6/10.

Given the varied intake of total volumes per day and uncertainty as to the total Calories, protein and water provided between 3/9/10 and 3/15/10 per 24 hours, considering unaccounted for downtime as well as holds for extubation, unstable medical status, re-intubation, residuals and hypoactive bowel sounds --weight changes were not solely due to fluid intake and output, but varied caloric intakes as evidenced by the surveyor requested information from Registered Dietitian 26 available as of 10/16/10 at 3 p.m. e.g. 3/9/10--1728 Calories, 3/10/10--132 Calories, 3/11/10--0 Calories, 3/12/10--1404 Calories, 3/13/10--1701 Calories, 3/14/10--1089 Calories and 3/15/10--270 Calories and this was of concern given that on 3/3/10 (the date of the initial nutrition assessment) Caloric needs were assessed to be at least 1700 Calories. Additionally, the documentation generated by Registered Dietitian 26 upon request of the surveyor also showed that the lower limit of calculated protein needs as determined in the initial nutrition assessment was not met on five of these days and while intermittent reasons had been given, e.g. residual volume there had not been complete, correlative documentation within Patient 3's medical record..

Based on observation, interviews and document reviews, the hospital failed to meet the Conditon of Pharmaceutical Services when it failed to ensure the provision of pharmaceutical services and care that met the needs of the patients as evidenced by:

Findings:

1. The Pharmacy and Therapeutics Committee as delegated by the medical staff, failed to develop policies and procedures to ensure the safe use of medications and to minimize drug errors:

a. The hospital did not have a written policies and procedures to ensure the safe use of fentanyl transdermal patches. Patient 60 and 63 were prescribed and administered fentanyl transdermal patches not in accordance with FDA public health advisory and manufacturer ' s prescribing information to minimize the risk of dangerous side effects. (See A 404 and A500)

b. The hospital failed to develop and consistently implement policies and procedures on the safe use of IV (intravenous) potassium chloride including ordering, preparation and administration. Patient 62 was ordered potassium chloride IV (intravenous) infusion at a rate exceeded the hospital guidelines for safe administration. Patient 62 ' s potassium chloride for infusion was prepared by the pharmacy and distributed to the nursing units in a concentrated form not suitable for infusion. Nursing staff caring for Patient 62 did not know the proper way to dilute potassium chloride to ensure safe administration. (See A 500)

c. The hospital did not have policies and procedures to ensure the safe and effective distribution of high potassium content solution including cardioplegic solution and Viaspan organ storage solution to minimize the risk of errors from inadvertent administration if these products. (See A 491 and A 500)

2. The hospital failed to account for missing and extra medications that could indicate that a patient received too much, missed a dose, or were given the wrong medication when a one day audit revealed 112 extra doses and 107 missing doses were found in Pyxis machines throughout the hospital. (see A500)

3. The hospital pharmacists failed to review physician medication orders prior to nurses administering to patients for non-emergent medications when a one day audit revealed up to an estimated 537 physicians' orders where not reviewed by a pharmacist prior to nurse administration. (see A500)

4. The hospital policy does not adhere to professional standard of practice when the policy allowed nurses to administer medications prior to a pharmacist's review. (see A500)

5. The hospital failed to ensure the safe and effective use of automated dispensing cabinets. There was no system in place to ensure that medications were removed from Pyxis (an automated dispensing cabinet) after the medication orders were reviewed and approved by pharmacists. The hospital did not have a system to track medications removed from Pyxis without a physician ' s orders. (See A 500)

6. The hospital failed to maintain an established pharmacy and therapeutics committee when different levels of membership, as defined by voting rights, between physicians, pharmacists, nurses, and administrators were warranted within the committee. (see A500)

7. Pharmacists failed to review and verify physicians ' orders in accordance with hospital policy when a pharmacist did not review labs and/or allergies for three patients and that were on Caffeine Citrate, Vancomycin, and Depakote. (see A500)

8. The hospital failed to administer Allopurinol for a patient to prevent complications from chemotherapy within the hospital policy time frame of 30 minutes. (See A 500)

9. The hospital failed to ensure that emergency medication supply is readily available for the management of malignant hyperthermia, a potentially fatal condition if not managed timely. (See A 500)

10. The hospital failed to ensure the proper storage of drugs and biologicals to ensure product integrity. (See A 500)

11. The hospital failed to monitor patients on Clozaril (Clozapine) for agranulocytosis to ensure the appropriate use of the medication. (See A 500)

An immediate jeopardy situation was declared pertaining to the failure of the hospital to ensure the safe use of fentanyl patches at 1:30 p.m. on 3/18/10 in the presence of the hospital Senior Director and the Director of Pharmacy.

The immediate jeopardy was abated at 1:30 p.m. on 3/19/10 after an immediate corrective action plan was accepted by the Department.

The cumulative effects of these systemic problems resulted in the inability of the hospital to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.

Based on observation, interviews and document review, the hospital failed to ensure that drug distribution and storage was administered in accordance with accepted professional principles. Viaspan, a prescription organ storage solution was ordered by the hospital material services and delivered directly to the surgical department with no oversight by the pharmacy department.


Findings:

During an inspection of the medication storage refrigerator located in the sterile corridor of the surgical department at the Pacific Campus at approximately 4:05 p.m. on 3/16/10, 10 bags of Viaspan were observed being stored in the refrigerator with other chilled IV solution for the management of malignant hyperthermia, an emergency condition which can be fatal if not managed timely.

Viaspan is a prescription organ preservation solution used in transplant surgery or organ harvesting. It contains high concentration of potassium (125 mEq/liter) and is not for systemic administration by direct injection or intravenous infusion. Inadvertent systemic administration of Viaspan may lead to life-threatening side effects.

During an interview at the same time of the inspection, DOP 2 stated that he did not know what Viaspan was for and was unsure how it was distributed in the hospital.

During a group meeting at approximately 10:20 a.m. on 3/17/10, the hospital Senior Director stated that all Viaspan were removed from the OR refrigerator and were secured in the pharmacy as of 4:40 p.m. on 3/16/10. The Senior Director further stated that an investigation conducted on 3/16/10 revealed that Viaspan had been ordered by material services and were delivered directly to the surgical department with no oversight in the distribution of the product by the pharmacy department.

ISMP (Institute for Safe Medication Practices) issued a Medication Safety Alert on the distribution of Viaspan in July 2005 stating that due to the fact that the packaging of Viaspan resembled common IV solution, it was recommended that hospitals should review the processes for stocking, storing and handling of the product to avoid fatal error from misadministration.

The American Society for Health System Pharmacist (ASHP) published Guidelines on Minimum Standard for Pharmacy in Hospital stated that the hospital pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital. Policies and procedures governing these functions shall be developed by the pharmacy with input from other appropriate hospital staff and committees.

The hospital failed to ensure that the pharmacy provided oversight on the distribution of Viaspan, an organ storage solution not suitable for systemic administration to patients, to ensure patient safety. The storage of Viaspan with IV solution for emergency use posed a heightened risk of inadvertent administration of Viaspan should Viaspan be removed from the refrigerator by mistake in the emergency situation of a patient developing malignant hyperthermia requiring chilled IV solution to manage the condition.

Based on observation, interviews, and document review, the hospital failed to delivery pharmaceutical services to meet the needs of the patients when medications where not controlled and distributed in accordance with standards of practice, federal and state laws as evidenced by:

1. Failure to develop policies and procedures to ensure the safe use of fentanyl transdermal patches. Patient 60 and 63 were prescribed and administered fentanyl transdermal patches not in accordance with FDA public health advisory and manuafacturer ' s prescribing information.

2. Failure to develop and implement policies and procedures to ensure the safe use of IV (intravenous) potassium chloride including prescribing, preparation and administration. Patient 62 was ordered potassium chloride IV (intravenous) infusion at a rate exceeded the hospital guidelines. Patient 62 ' s potassium chloride for infusion was not prepared by the pharmacy in a ready for administration form to minimize administration error. Nursing staff caring for Patient 62 did not know the proper way to dilute the concentrated potassium chloride prior to administration.

3. Failure to develop policies and procedures on the distribution and storage of high potassium concentration solution including cardioplegic solution and Viaspan, an organ storage solution, to minimize the risk of errors.

4. The hospital failed to account for missing and extra medications in the automated dispensing cabinet that could indicate that a patient received too much, missed a dose, or were given the wrong medication when a one day audit revealed 112 extra doses and 107 missing doses were found in Pyxis machines throughout the hospital.

5. The hospital failed to have a system in place to ensure that pharmacists reviewed physician medication orders prior to nurses administering to patients for non-emergent medications when a one day audit revealed up to an estimated 537 physicians' orders where not reviewed by a pharmacist prior to nurse administration.

6. The hospital policy does not adhere to professional standard of practice when the policy allowed nurses to administer medications prior to pharmacist's review.

7. The hospital failed to ensure the safe and effective use of automated dispensing cabinets. There was no system in place to ensure that medications were removed from Pyxis (an automated dispensing cabinet) after the medication orders were reviewed and approved by pharmacists. The hospital did not have a system to track medications removed from Pyxis without a physician ' s orders.

8. The hospital failed to maintain an established pharmacy and therapeutics committee when different levels of membership, as defined by voting rights, between physicians, pharmacists, nurses, and administrators were warranted within the committee.

9. Pharmacists failed to review and verify physicians ' orders in accordance with hospital policy when a pharmacist did not review labs and/or allergies for three separate patients that were on Caffeine Citrate, Vanomycin, and Depakote.

10. Failure to ensure that emergency medication supply is readily available for the management of malignant hyperthermia.

11. Failure to monitor patients on clozaril for agranulocytosis in accordance with manufacturer ' s prescribing information and the FDA issued boxed warning to ensure patient safety.

12. Failure to ensure the proper storage of medication to ensure the integrity and efficacy of drugs and biologicals.

13. Failure to ensure that emergency drug supply was sealed by pharmacist in such a manner that a seal must be broken to gain access to the drugs.

Findings:

1a. A review of Patient 63 ' s clinical record showed that the patient was admitted to the hospital on 2/27/10 for compression fracture. Patient 63 was not on any narcotic (opioid) medications prior to admission. Patient 63's usage of narcotic (opioid) medications for pain control was as follow:

On 2/27/10, Patient 63 was administered one tablet of hydrocodone 5mg/acetaminophen 325mg (Norco 5) at 2:25 a.m., 12:25 p.m. and 10:40 p.m.

On 2/28/10, Patient 63 was administered Norco 5 at 2:30 a.m., 8:40 a.m. and 11:20 p.m.

On 3/1/10, Patient 63 was administered Norco 5 at 6:50 a.m., 1:01 a.m. and 7:25 p.m.

On 3/2/10, Patient 63 was administered Norco 5 at 12:05 a.m. and 9:30 a.m. One half of a fentanyl 25mcg/hr patch was applied at 12:50 p.m.

A review of the Pyxis (an automated dispensing cabinet) dispensing record at approximately 3:00 p.m. on 3/17/10 showed that one fentanyl 25mcg/hr patch was removed by RN 80on 3/2/10 but only 12mcg was documented as administered. Fentanyl transdermal patch is designed to delivery the medication through the skin at a constant rate. When a fentanyl patch is cut or sliced in any way, the drug delivery system is compromised and loses the ability to control the fentanyl release rate. The copolymer membrane in the patch acts like a security gate, allowing only so many molecules of the drug to pass through. When that security gate is damaged, the patch delivers a larger dose of the drug more rapidly. Cut or damaged fentanyl patches may cause the entire content of the system (patch) to be delivered at one time causing serious harm, or fatality.

During an interview at approximately 3:40 p.m. on 3/17/10, RN 80 stated that she removed a fentanyl 25 mcg/hr patch from Pyxis, cut it in half and applied the half patch to Patient 63 ' s skin on 3/2/10. RN 80 also stated that she could not remember if there was a hospital policy and procedure on the use of fantanyl patches.

Based on the opioid usage prior to the administration of the fentanyl patch, Patient 63 was prescribed and administered fentanyl transdermal patch not in accordance with the manufacturer's prescribing information to minimize potentially fatal side effects of the medication. Patient 63 had been on low dose of opioid analgesics for 4 days (2/27/10 to 3/2/10) prior to the initiation of fentanyl patch on 3/2/10. Patient 63 was not opioid tolerant prior to the administration of the fentanyl patch on 3/2/10.

According to the manufacturer' s prescribing information, a boxed warning (Black Box Warning) was issued on fentanyl patches which indicated that (1) fentanyl patch is indicated for management of persistent, moderate to severe chronic pain. (2) fentanyl patch should ONLY be used in patients who are receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr. Patient who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60mg of morphine daily, or at least 30 mg of oxycodone daily, or at least 8mg of oral hydromorphone daily or an equianalgesic dose of another opioid. (3) Fentanyl transdermal system is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid-tolerant patients may lead to fatal respiratory depression.

FDA issued a Public Health Advisory in July 2005 emphasizing the safe use of fentanyl transdermal system, also known as the fentanyl patch (marketed as Duragesic and generics). The fentanyl patch is a potent narcotic (opioid) pain medicine applied to the skin for treating persistent moderate to severe pain in opioid-tolerant patients who needed to be on a narcotic pain medicine around-the-clock. Despite the advisory issued in July 2005, FDA continued to receive reports of death and life-threatening side effects in patients who were prescribed fentanyl patches. On 12/21/2007, FDA again issued a Public Health Advisory to alert patients, caregivers, and healthcare professionals of important information on the safe use of fentanyl transdermal patch. On the public health advisory, FDA indicated that fentany patch was only intended for treating persistent, moderate to severe pain in patients who were opioid-tolerant, meaning those patients who took a regular, daily, around-the-clock narcotic pain medicine. Patients who were opioid-tolerant were more resistant to the dangerous side effects of narcotic pain medicines than patients who only occasionally took these medicines. For patients who were not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects, such as respiratory depression (severe trouble breathing or very slow or shallow breathing) and death.

An immediate jeopardy situation was declared pertaining to the failure of the hospital to ensure the safe use of fentanyl patches at 1:30 p.m. on 3/18/10 in the presence of the hospital Senior Director and the Director of Pharmacy.

The immediate jeopardy was abated at 1:30 p.m. on 3/19/10 after an immediate corrective action plan was accepted by the Department.

1b. A review of Patient 60 ' s record showed that the patient was admitted to the hospital on 3/9/10. Patient 63 ' s admission medications (home medications) list showed that the patient was not on any opioid pain medications prior to admission. Patient 63 ' s usage of narcotic (opioid) medications for pain control was as follow:

On 3/10/10, Patient 60 was administered morphine sulfate 1mg IV (intravenously) at midnight, and morphine sulfate 2mg IV at 10:01 a.m., 2:10 p.m.

On 3/11/10, Patient 60 was administered morphine sulfate 2mg IV at 4:45 a.m.

On 3/12/10, Patient 60 was administered a fentanyl 12mcg/hr patch at 2:02 p.m.

On 3/13/10, Patient 60 did not receive any additional opioid medication

On 3/14/10, Patient 60 was administered morphine 1mg IV at 9:30 a.m.

On 3/15/10, Patient 60 ' s fentanyl patch dose was increased from 12mcg/hr to 25 mcg/hr

During an interview at approximately 12:55p.m. on 3/17/10, Physician 80 stated that fentanyl patch was prescribed for Patient 60 because of concerns that the patient refused oral medications and may not be able to verbally express pain due to language barrier. Physician 80 also stated that a staff pharmacist called and asked her if Patient 60 was opioid naive, Physician 80 answered " no " because the patient had been on IV push of morphine.

During an interview at approximately 3:45 p.m. on 3/17/10, Physician 81, Patient 60's attending physician, stated that prescribing fentanyl patch to Patient 60 was appropriate because the patient was in pain but refused oral medications.

A review of Patient 60 ' s pain assessment record showed no documented pain (pain score =0) from 5:00 a.m. on 3/10/10 through 12:00 a.m. on 3/14/10.

During an interview at approximately 3:55 p.m. on 3/17/10, DOP1 stated that intravenous pain medication would be an alternative since Patient 60 was discharged on intravenous antibiotics which would provide line access for the administration of pain medication.

Patient 60 was prescribed and administered fentanyl transdermal patch unsafely and inappropriately according to the manufacturer ' s prescribing information and based on the patient ' s opioid usage prior to the administration of the fentanyl patch. Patient 60 had been on opioid analgesics for 3 days (3/10/10 to 3/12/10) prior to the initiation of fentanyl patch on 3/12/10. Patient 60 did not receive opioid equivalent to 60mg of morphine daily and therefore, Patient 63 was not opioid tolerant prior to the administration of the fentanyl patch on 3/2/10. In addition, Patient 60 ' s pain assessment record showed that Patient 60 was not in persistent, moderate to severe pain when the fentanyl patch was prescribed.

2a. During a tour of the Pediatric Intensive Care Unit (PICU) at approximately 10:15 a.m. on 3/19/10, a syringe labeled as follow was found in Patient 62 ' s medication drawer:

" Potassium chloride injection syringe (1 mEq/ml)
Dose = 20 mEq per syringe = 20ml
Dilute and infuse over: _____

Alert: Concentrated electrolyte. Must be diluted "


A review of the hospital pediatric IV medication dilution/rates chart at approximately 10:15 a.m. on 3/19/10 showed that potassium chloride should be diluted minimally to a concentration of 0.2 mEq/ml for infusion.

During an interview at approximately 10:15 a.m. on 3/19/10, the registered nurse who was assigned to provide care to Patient 62 on that day, RN 82, was asked about how she would administered the potassium chloride. RN 82 answered that she would draw the content of the potassium chloride syringe into a larger syringe and dilute with equal amount (20 ml) of sterile water before administering the medication via Pateint 62 ' s central line. Based on RN 80 ' s answer, the final concentration of Patient 62 ' s potassium chloride infusion would be 0.5 mEq/ml, exceeded the potassium concentration for safe infusion per hospital policy.

Patient 62 ' s potassium chloride was prepared by the pharmacy in a concentrated form (required further dilution for safe administration).

Concentrated potassium chloride has been identified as a high risk medication by organizations worldwide. In the United States, ten patient deaths from misadministration of concentrated potassium chloride (KCl) solution
were reported to the Joint Commission in the first two years of its sentinel event reporting program from 1996 to 1997. The Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) issued a Sentinel Event Alert in February 1998, suggesting hospital facilities not make concentrated potassium chloride available outside of the pharmacy unless appropriate specific safeguards are in place.

In July 2002, JCAHO developed the six high priority national patient safety goals for 2003. One of them was to "Improve the Safety of Using High-Alert Medications" with one of the recommendations to remove concentrate electrolytes (including, but not limited to, potassium chloride, potassium phosphates, sodium chloride >0.9 percent) from patient care units. In addition, the Institute for Safe Medication Practices (ISMP), a national non-profit independent organization established to promote medication safety, has published many articles and alerts on the high risk of using potassium chloride since 1990s. The most effective way to avoid potassium chloride accidents is the function of removing KCI concentrate from patient care areas.

According to the American Society of Health-System Pharmacist (ASHP) published guidelines on Minimum Standard for Pharmacies in Hospital, medications shall be available for patient use in a ready-to-administer form whenever possible. Manipulation of medications before administration by final users should be minimized.

Lexi-Comp, a national provider of drug information to health care professionals, indicates that the maximum concentration for central line infusion of potassium chloride is 20-40 mEq/100 mL (0.2 to 0.4 mEq/mL).

Patient 62's potassium chloride was distributed to the nursing unit in a concentrated form which required a 5 times dilution by the final user before it could be safely administered to patients. In addition, no dilution instruction was provided on the label to ensure proper dilution of the product by nursing staff prior to administration. There were no safeguards in place to minimize the risk of fatal misadministration of this high risk medication.

2b. A review of Patient 62 ' s clinical record on 3/19/10 showed the following medication order dated 2/26/10:

Potassium chloride injection syringe (1 mEq/ml) 20 meq per syringe, infuse 40 mEq over one hour, prn (as needed for) potassium < (less than) 3.0, recheck potassium after bolu given.

A hospital policy and procedure titled " Guidelines for Ordering, Administration and Monitoring Intravenous Potassium " was reviewed on 3/22/10. The guidelines indicated that 20 mEq/hr was the maximum rate for patients with life-threatening dysrhythmia (irregular heart rhythm) and was seldom needed.

During a review of Patient 62 ' s electronic medical record with DOP1 at approximately 10:30 a.m. on 3/22/10, DOP 1 stated that potassium infusion rate should not exceed 20 mEq/hr. DOP 1 also stated that the hospital electronic physician order system did not have preset infusion rates to guide physician on ordering of potassium infusion. Patient 62 ' s electronic clinical record also indicated that the hospital pharmacy did not identify Patient 62 ' s usual potassium order and clarify the order with the prescribing physician accordingly.

3a. During an inspection of medication storage refrigerator located in the surgical department at the Pacific campus at approximately 3:30 p.m. on 3/16/10, the following cardioplegic solution were observed stored in the refrigerator with other medications:

One 1-liter bag of cardioplegic solution which contained 150 mEq of potassium chloride
Two 1-liter bags of cardioplegic solution which contained 80 mEq of potassium chloride
Two 1-liter bags of cardioplegic solution which contained 50 mEq of potassium chloride

The cardioplegic solutions were accessible to all operating room staff who had access to the medication storage room.

Cardioplegic solution is a solution used to arrest (stop) the heart during open heart surgery and cardiac transplantation. The potassium ions in the solution partially depolarize the cell membrane and acheive arrest of the heart. This solution should only be used by those trained to perform open heart surgery or cardiac harvesting for transplant such as perfusionist or cardiac surgeon. The solution is not for intravenous use. Cardioplegic solution is identified by the Institute for Safe Medication Practices (ISMP) as a high alert medication. Special safeguards should be in place to reduce the risk of misadministration such as limiting access to this type of medications.

3b. During an inspection of the medication storage refrigerator located in the sterile corridor of the surgical department at the Pacific Campus at approximately 4:05 p.m. on 3/16/10, 10 bags of Viaspan were observed being stored in the refrigerator with other chilled IV solution for the emergeny managemeny of malignant hyperthermia.

Viaspan is a prescription organ preservation solution used in transplant surgery or organ harvesting. It contains high concentration of potassium (125 mEq/liter) and is not for systemic administration by direct injection or intravenous infusion. Inadvertent systemic administration of Viaspan may lead to life-threatening side effects.

During an interview at the same time of the inspection, DOP 2 stated that he did not know what Viaspan was for and was unsure how it was distributed in the hospital.

During a group meeting at approximately 10:20 a.m. on 3/17/10, the hospital Senior Director stated that all Viaspan were removed from the OR refrigerator and were secured in the pharmacy as of 4:40 p.m. on 3/16/10. The Senior Director further stated that an investigation conducted on 3/16/10 revealed that Viaspan had been ordered by material services and were delivered directly to the surgical department with no oversight in distribution of the product by the pharmacy department.

The hospital failed to ensure that the pharmacy provided oversight on the distribution of concentrated electrolytes in the hospital to ensure patient safety.

4. During an interview on 03/16/10 in-between 3:30-4:10 pm the Pharmacy Technician 70 and 71 both stated that the pharmacy technicians where responsible for refilling the Pyxis machines (automated dispensing cabinets). They also stated that when there were missing doses or excessive doses of medications found in the Pyxis machines they would not communicate directly to any hospital staff of the missing or excessive doses, however they would enter into the Pyxis computer that the doses were missing or in excess.

In an interview on 03/17/10 at 10:34 am the Pharmacy Systems Manager stated that he was responsible for running the daily Pyxis reports. He also stated that he had the capability to run the non-narcotic discrepancy reports but he did not run the reports and was not aware of any daily missing or excessive doses of medications for non-narcotics. He said the reports were not being reviewed for non-narcotic discrepancies. The non-narcotic discrepancy report would have notified hospital staff of the missing or excessive doses entered into the Pyxis computer by the Pharmacy Technicians.

A review of a hospital document dated 03/19/10 indicated the quantity of un-reconcilable medications categorized as missing and excessive doses of medications for a one day audit on 03/15/10. The audit indicated that there were 112 doses of medications in excess and 107 doses of missing medications.

The interviewed Pharmacy Systems Manager stated on 03/17/10 at 4:00 pm that he was not aware of the actual causes of the missing and excessive doses because it had not been investigated. He stated that it could have been refilled or entered in the Pyxis incorrectly. He also stated that the missing and excessive doses could have been medication errors. He said that the errors could have been administration of to much medication (patient given extra doses), not administering medications to patients, or giving the wrong medication to a patient. He acknowledged when patients were given too much medication, not administered medication or given the wrong medication could cause significant harm patient or death.

5. According to the American Society of Health-System Pharmacists, a nationally recognized professional organization, in the titled document Minimum Standard for Pharmacies in Hospitals indicates "All medication orders shall be reviewed by a pharmacist and assessed in relation to a medication profile before administration ...all prescriber's medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed. Any questions regarding the order must be resolved with the prescriber at this time, and a written notation of these discussions must be made in the patient's medical record or pharmacy copy of the prescriber's order. Information concerning changes must be communicated to the appropriate health professional".

According to the hospital policy and procedures titled Medication Administration and Safe Practices indicated "All newly ordered medications require pharmacy verification prior to drug withdrawal from Pyxis."

During an interview on 03/15/10 at 10:00 am Director of Pharmacy (DOP) 1 and DOP 2 both stated that nurses had access to all the medications in the Pyxis machines at anytime, however nurses were told to wait 30 minutes so that the pharmacists could review the orders prior to the nurse administering the medication. They stated that the pharmacists had 30 minutes to review and verify the orders before the nurses would administer the medication.

A review of a hospital document of a one day audit dated 03/19/10 indicated 537 medication orders that were reviewed by Pharmacists beyond 30 minutes. There were up to 537 medication orders were Nurses administered the medication prior to a pharmacist's review.

According to the hospital policy last revised on 12/09 titled Medication Order Processing indicates "The pharmacist will perform an ON-LINE review of the medication order...The pharmacist shall base the review of the medication order upon available patient database, which includes information about patient's age, sex, medication profile, diagnosis, allergy/drug intolerances, height and weight and relevant laboratory values and if appropriate patient's pregnancy or lactation status ...The review will include an evaluation of:
*The completeness of the medication order ...
*The appropriateness of the medication according to diagnosis or indications
*The appropriateness of the dose and concentration of the medication ...
*Any potential drug interactions
*Any potentially problematic therapeutic duplication
*Any unapproved medical abbreviations
*Any potential allergic complications or drug intolerances
*Any duplication of medication orders
*The appropriateness of administration time
*Any potential contraindications
*Any variations from organization policies or other medication related issues or concerns "

There were up to 537 medication orders that were not reviewed by a pharmacist as defined by the above policy before the Nurses administered medications to patients.

The hospital failed to have a system in place to ensure that physicians ' medication orders were reviewed by pharmacists prior to the administration of the first dose by the nursing staff.

6. According to the American Society of Health-System Pharmacists, a nationally recognized professional organization, in the titled document Minimum Standard for Pharmacies in Hospitals indicates "All medication orders shall be reviewed by a pharmacist and assessed in relation to a medication profile before administration ...all prescriber's medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed."

During an interview on 03/15/10 at 10:00 am Director of Pharmacy (DOP) 1 and DOP 2 both stated that the nurses had access to all the medication in the Pyxis machines at anytime. They stated that the pharmacists had 30 minutes to review and verify the orders before the nurses would administer the medication.

According to the hospital policy last revised on 01/10 titled Medication Administration indicated "Administration of "stat" orders is to be within 15 minutes from the time of the order. "Now" and routine orders are to be executed within 30 minutes from the time of order."

The above policy indicated it was allowable to administer medications prior to a pharmacists' review of the medication orders.

In an interview the DOP 1 stated that it had been discussed in Pharmacy and Therapeutics committee however the policy had not been amended. She acknowledged that the policy as written would allow for nurses to administer medications prior to pharmacists reviewing medication orders.

The interviewed DOP 2 stated that it was not acceptable to administer medications prior to a pharmacists review. He also stated it was important to review the medications prior to administration to prevent medication errors, promote patient and medication safety, and to protect patients.

7. During an interview at approximately 10:20 a.m. on 3/15/10, DOP 2 stated that the pharmacy did not have a list of medications that could be removed from Pyxis by the override function because all medications stored in Pyxis could be removed by nursing staff without the use of an override function. Pyxis did not capture any removal of medications that took place prior to the pharmacists ' review and approval of the orders or in the absence of a physician ' s order.

A review of Patient 59 ' s clinical record at approximately 10:40 a.m. on 3/16/10 showed that Patient 59 was admitted to the hospital on 3/15/10. Patient 59 ' s medication administration record (MAR) on the Critical Care Flow Sheet showed that Patient 59 was administered morphine 2mg intravenously at approximately 5:00 p.m. on 3/15/10. Patient 59 did not have a physician ' s order for morphine 2mg.

During an interview at approximately 11:25 a.m. on 3/16/10, RN 81 stated that she removed the morphine 2mg syringe from Pyxis and administered to Patient 59 at approximately 5:00 p.m. on 3/15/10 because she recalled that Patient 59 was complaining of pain. RN 81 also stated that Patient 59 ' s epidural pain control medication was increased at 3:00 p.m. on that day and therefore she decided to only give morphine 2mg instead of the physician ordered dose of morphine 4mg.

An audit of the pharmacy order review of 03/19/10 indicated that up to 537 medication orders were removed from Pyxis prior to a pharmacist's review.

The American Society for Health System Pharmacist (ASHP) published Guidelines on the Safe Use of Automated Medication Storage and Distribution Devices indicated that. all medication distribution systems have medication withdrawal functions that allow nurses and other caregivers limited access to certain medications before order review and approval by a pharmacist, especially in cases of patient emergencies. This function is typically referred to as an " override. " Clearly stated organizational policies and criteria for system overrides should be developed that limit access to medications before orders have been reviewed and approved by a pharmacist. Override access to medications should be limited to cases in which the drug product has been approved by a multidisciplinary committee of physicians, pharmacists, and nurses as having a clinically urgent need for the medication that outweighs the potential risk of medication error. Subsequent order-based retrieval of the same medication should cause the user to be reminded that an override supply of medication was recently dispensed for the patient. Provision should be made for the retrospective review and reconciliation by a pharmacist of orders that were initiated without a pharmacist ' s review and approval. Override data (e.g., name of medication, quantity, location of the automated device, and any associated adverse drug events) should be routinely reviewed to help evaluate and manage those medications approved for override access. Override data evaluation can aid an organization in improving the outcomes of automated dispensing device use by decreasing medication errors and potential adverse drug events and should be considered part of the routine performance management process for automated dispensing device.

8. According to the American Society of Health-System Pharmacists (ASHP), a nationally recognized professional organization, in the titled document Minimum Standard for Pharmacies in Hospitals indicates "The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital ...Policies and procedures governing these functions shall be developed by the pharmacy with input from other appropriate hospital staff and committees."

According to title 22 70263 (c) Pharmaceutical Services General Requirements stipulates "A pharmacy and therapeutics committee, or a committee of equivalent composition, shall be established. The committee shall consist of at least one physician, one pharmacist, the director of nursing service or her representative and the administrator or his representative."

According to an ASHP statement on the P & T Committee published on 11/20/1991 indicates, "The P & T committee should be composed of at least the following voting members: physicians, pharmacists, nurses, administrators, quality-assurance coordinators, and others as appropriate."

A review of the list of members indicated eight voting physician members and 5 non-physician members that did not have voting rights.

During an interview on 03/16/10 at 1:41 pm the DOP 1 stated there were voting members and non-voting members on the Pharmacy and Therapeutic (P&T) Committee. She also stated that the physicians were the only members to vote. The non-physicians members did not have the right to vote on policy changes. The physicians were the only members to accept or deny changes in hospital policy. She agreed it would helpful to vote in order to implement changes necessary to improve pharmacy services. She acknowledged that title 22 did not allow for differing levels of membership for the P&T committee as defined by voting rights.

9. According to the hospital policy titled Medication Order Processing dated last reviewed 01/10 indicated "The pharmacist will perform an ON-LINE review of the medication order ...The pharmacist shall base the review of the medication order upon ... information about patient's ...allergy/drug intolerances ...relevant laboratory values ...Should the electronic medication order be incomplete or unclear for any reason, the pharmacist shall contact the physician to clarify the intent of the order."

A review of the clinical record for Patient 70 indicated the patient was a neonate. She was started on Caffeine Citrate to improve breathing.

According to Lexi-Comp Online, a nationally recognized drug information resource, indicates for Caffeine Citrate " May need to monitor serum caffeine concentrations periodically during therapy to avoid toxicity ...Warnings potentially fatal necrotizing enterocolitis reported in neonates receiving caffeine citrate ...Use with caution in infants with cardiovascular disease ...seizures reported with caffeine overdosage; use with caution in infants with seizure disorders. "

During an interview on 03/15/10 at 9:30 am Staff Pharm

Based on interview and record review, the facility failed to ensure that one per diem radiologic technologist (RT) had a radiation exposure badge. The deficient practice circumvented an occupational safety measure for the affected staff.

Findings:

Comparison of the roster of RT's to the radiation exposure badge reports presented by the facility indicated that RT 1 was not included in the report.

In an interview on 3/15/10 at 1:44 p.m., Staff E stated that RT 1 was a per diem employee who usually worked at another facility operated by the governing body and that he brought his badge with him whenever he worked at the facility. In an interview on 3/15/10 at 2:24 p.m., Staff E stated that RT 1 was a magnetic resonance imaging (MRI) technologist and therefore did not have a radiation exposure badge. In an interview on 3/15/10 at 3:30 p.m., Staff E stated that RT 1 didn't have a badge, that he was hired at the other facility as an MRI tech but had floated as a radiologic technologist to the facility being surveyed on a per diem basis. She stated that not providing RT 1 with a radiation exposure badge had been an oversight.

Review of an e-mail from the exposure badge vendor indicated that the facility had ordered a radiation exposure badge for RT 1 on 3/15/10.

Based on interview and record review, the facility failed to include provisions in its transfusion lookback policy that would require notification of the legal representative or relative if the recipient of potentially infectious blood products were already deceased at the time of the transfusion lookback. The deficient practice had the potential to limit deceased patients' relatives and legal representatives ability to exercise rights granted them by federal regulations.

Findings:

Review of the facility's transfusion lookback policy indicated that the facility's recipient notification efforts would end if the facility determined that the transfusion recipient was deceased.

In an interview on 3/16/10 at 2:29 p.m., Staff F stated "A deceased patient stops lookback notification."

Based on observation, staff interview, as well as medical record and document reviews the Condition of Food and Dietetic Services is not met due to:

i) The failure of the hospital to ensure that the director of dietetic services had been responsible for the daily operations of the department so as to ensure adherence to both nutrition care and foodservice standards with respect to patient heath and safety (A 620) ;

ii) The failure of the hospital to ensure that there had been competent departmental administrative and support staff to have food quality as well as systems for the prevention of cross-contamination and foodborne illness. (A 622); and

iii) The failure of the hospital to ensure that the nutritional needs of patients were met in conformance with physician orders, recognized dietary practices and standards for therapeutic diets as stipulated in the hospital's adult and pediatric diet manuals, support references and menus as well as policies and procedures (A 629 and A 630).

Based on observation, staff interview and document review the hospital failed to ensure that the director of dietetic services had been responsible for the daily operations of the department so as to have provided sufficient safe, healthful foods. By not having ensured food safety as well as healthful and appealing foods, there was the potential for foodborne illness, foods of diminished quality and risk of unmet nutritional needs in a hospital with a licensed bed capacity for 612 patients.

Findings:

1. On 3/17/10 between 4 p.m. and 4:15 p.m. while in an administrative conference room, a summary of concerns identified between 3/15/10 and 3/17/10 was presented to both Dietary Management Staff 7 and Dietary Management Staff 17. The concerns included: the failure to have maintained a safe, sanitary foodservice and foods of quality--most markedly at the Pacific Campus; the failure to have identified and sought consultation with remediation of foodservice safety and sanitation concerns in both the hospital kitchens and ancillary foodservice operations through the Infection Control Committee membership; the failure to have included foodservice sanitation projects in the quality assurance program; the observed under-utilization of registered dietitians in guiding the foodservice staff with respect to food safety and accuracy in meal delivery; and the failure to have ensured that all diets and nutrition support regimes (i.e. enteral tube feeding) had been prescribed and implemented in accord with Federal and State regulations and hospital standards, inclusive of those in hospital diet manuals and support references.

At 4:15 p.m. upon review of the departmental documents, Dietary Management Staff 7 stated that there was no additional documentation to demonstrate on-going surveillance, focused training, interdepartmental correspondence, remediation plans and/or other materials useful in addressing the daily operations in both foodservice and nutrition care.


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2 During initial tour on 3/15/10 beginning at 10:35 a.m. the following was noted:
a. In the walk in vegetable refrigerator there was a tray of sandwiches, plates of deli meat, and a 5 pound container of cottage cheese with a use by date of 3/14/10. It was also noted there was jicima that was covered with a grey fuzzy material, resembling mold. Additionally there was a 5 pound container of honey mustard dressing with no open date.

b. In the walk-in meat refrigerator there were 2 packages of hamburger with a pull date of 3/8 and a use date of 3/11 (4 days prior). There was also a thawed filet that was undated.

In a concurrent interview with Dietary Staff 1 she stated that the expired items should have been discarded and that the jicima was likely received the previous week.

c. In the dry storage there was a bag of bulgar that was opened and in the original packaging. In an interview with DS 1 she stated that the items should have been removed and placed in another container.

3. During general kitchen observation on 3/15/10 at 2:45 p.m., it was noted there were numerous containers of spices over the food production area. It was also noted that the majority of the spices were dated as being opened during the months of March-May. It was also noted that the cloves had a use by date of 5/1/10, however were received by the facility on 3/14/07. Similarly Chinese spice had a use by date of 5/14 with a receipt date of 8/09. Additionally it was noted that staff were storing a 5-spice combination in a container labeled sesame seeds. It was also noted that while many of the spices had a use by date between March and May 2010, many of them did not have a receipt date. It would also not be within the standard of practice to re-use containers, such as plastic spice containers, intended for single use (Food Code, 2009).

In a concurrent interview with DS 1 she stated that the hospital policy was to discard spices after 6 months. She also acknowledged that it was not likely that the use by dates of the observed spices were all accurate nor would it be possible to ensure that those spices with no receipt date were received within the previous 6 months.

Based on observation, staff interview and document review the hospital failed to ensure that both administrative and support staff had been trained and ensured timely and comprehensive job-specific training for both clinical nutrition and foodservice staffs. Additionally, there was the failure to ensure that dietary staff responsible for the cleanliness and maintenance of their work areas had been trained in methods to ensure effective sanitization of foodservice surfaces. By not having ensured that administrative and support staff were competent, there was the potential for errors in the delivery of nutritional care, cross-contamination at food preparation and service areas as well as potential for development of foodborne illness in a hospital with a licensed bed capacity for 612 patients.

Findings:

1. On 3/17/10 between 3:45 p.m. and 4 p.m. and again on 3/18/10 between 2:55 p.m. and 3:10 p.m. while in an administrative conference room review of the personnel and health files of eight members of the dietetic service staff was done and verified with the assistance of Human Resources Staff 15 and Occupational Health Staff 27. The files were those of varied responsibilities: management (Dietary Management Staff 7, Dietary Management Staff 17 and Department Manager 29), professional and paraprofessional clinical nutrition care (Registered Dietitian 4, Registered Dietitian 5 and Dietary Staff 23) and foodservice (Dietary Staff 1 and Dietary Staff 10). Although there were no departures from hospital standards with respect to occupational health, there was a lack of documentation to demonstrate that there had been sufficient training to have precluded the deficient practices and conditions observed and reviewed between 3/15/10 and 3/18/10.

Review of the personnel files of Dietary Management Staff 7 and Dietary Management Staff 17 revealed that both had failed to be informed and to educate clinical nutrition staff, e.g. registered dietitians and paraprofessional support staff regarding the need to have the legally authorized practitioners ( i.e. physicians) responsible for the diet and tube feeding orders. Additionally, Dietary Management Staff 7 and Dietary Management Staff 17 had been remiss in not ensuring a comprehensive quality assurance plan to encompass food safety and sanitation for both campus kitchens, ancillary foodservice operations and three contracted services (i.e. vending, dishmachine and pest control) to prevent the potential for the growth of foodborne microorganisms and toxin development. Also, there had been the failure to evaluate the surveillance systems for not only foodservice safety and sanitation, but the accurate delivery of physician prescribed therapeutic diets--specifically those identified during medical record reviews, e.g. Full Liquid, Neutropenic and Low Phosphorus as well as adherence to NPO (Nothing by Mouth)

These failures contributed to the departures from standards identified in the hospital's dietetic service policies and procedures, approved diet manuals, references, menus and recognized standards of practice, e.g. the 2009 Food Code.



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2. During review of sanitizing processes on 3/17/10 at 3 p.m., DS 3 was asked to describe how he cleaned kitchen surfaces. He stated that he used a sanitizing solution that was stored on the counter tops. The surveyor asked how he ensured that the strength of the sanitizer was adequate. He replied that he obtained sanitizer from a dispensing unit located at the manual dish washing sink. The surveyor asked if he tested the strength of the solution, he replied that he did not as he did not know how to do that. In a concurrent interview with DS 1 she acknowledged that line staff were not trained to test the strength of sanitizer.

Review on 3/18/10 at 9 a.m., of hospital training documents confirmed that the hospital had not provided training on testing the strength of chemical sanitizers.

Based on Registered Dietitian and physician staff interview and medical record review, the hospital failed to ensure physician approval of diet orders prior to implementation as evidenced by 1) nursing initiation of tube feeding goal rates for 2 of 2 enteral feedings (Patients 5 and 65) without physician signature and 2) implementation of nutrition supplements for 1 patient prior to obtaining physician approval (Patient 6). Failure of the physician to order diets may result in further compromising the clinical status of patients.

Findings:

Pacific Campus

1. Patient 5 was admitted with diagnoses including diabetes and end stage renal disease with dialysis treatments. It was also noted that the patient was admitted with an enteral feeding (feeding through a tube placed in the stomach) in place. Medical record review was conducted on 3/17/10 beginning at 10:15 a.m. A nursing nutrition screening assessment dated 3/15/10 triggered a nutrition consult. Admission physician order dated 3/15/10 noted an order for physicians' enteral tube feeding protocol "A" with Nepro (a nutritional supplement), "Dietitian to determine appropriate TF and goal rate."

A comprehensive nutrition assessment dated 3/15/10 and completed by the RD noted that documentation for the current diet order. The RD recommended a feeding goal rate at 30 cc's/hour "per TF [tube feeding] protocol."

Review of hospital copy titled "Daily Orders Summary" for 3/15/10 revealed that at 11:04 a.m., the RD entered an order into the computer system as a written order entered for the physician. There was no additional electronic physicians ' signature. Review of the hospital document titled "Critical Care Flow Sheet" dated 3/15/10 revealed that nursing staff implemented the tube feeding order beginning at 1 p.m., as a result of the order entered into the PCIS (Patient Centered Information System).

In an interview on 3/17/10 beginning at 10:30 a.m., with RD 4 she was asked to describe how Patient 5's order would be interpreted by the RD. She stated that she would complete a comprehensive assessment and determine the desired rate of feeding. She also stated that the hospital had developed a tube feeding protocol to allow RD's to implement the order. She further stated that she believed that since the physician wrote the order for the RD to determine the rate it would allow the RD to input the order with the expectation that nursing would implement the order without additional contact with the physician.

Review of hospital document on 3/17/10 titled "CMPC Tube Feeding Protocols (2009)" noted that the general guidelines described that the RD would complete a nutritional assessment within 24 hours after receipt of the tube feeding order. The policy also noted 2 separate tube feeding protocols. Protocol "A" which guided staff to begin tube feeding at a rate of 25 cc's/hour. It also guided nursing staff to advance the feeding until a goal rate is reached. It further noted that "If the Dietitian has not yet determined the goal rate, advance to a maximum of 75 ml/hr." Protocol "B" which described a bolus feeding (intermittent feedings at various intervals) guided nursing staff to implement the feeding "in the amount determined by the M.D. and/or dietitian."

In an interview on 3/18/10 at 11:45 a.m., with Physician 5 and RD 12 the surveyor asked them to describe the intent of the implementation of the tube feeding protocol. Physician 5 stated that the protocol was initiated in an effort to assist physicians in determining enteral support for patients. He stated the intent was to initiate feeding at a slow rate as soon as the feeding was ordered and the RD would determine the rate of the formula. He also stated that it was his expectation that the RD contact him to obtain a verbal order prior to implementation of the feeding.

2. Patient 65 was admitted with diagnoses including right sided bleeding in the brain. Medical record review was conducted on 3/17/10 beginning at 2 p.m.

Admission diet order dated 3/8/10 was NPO (nothing my mouth). A follow up physicians' order dated 3/10/10 was for an enteral feeding (feeding through a tube placed in the stomach). The enteral feeding was for Jevity 1.2, RD to determine appropriate TF and goal rate.

A comprehensive nutrition assessment dated 3/11/10 and completed by the RD noted a recommendation for the goal rate to be 75 cc's/hour. It was also noted that the RD entered the recommendation in the computerized patient orders on 3/11/10 at 13:33 p.m. The entered order read " Enteral TF Protocol A, formula: Jevity 1.2, change enteral TF rate to: Maximum TF rate of 75 ml/hour. It was also noted that the system allowed RD 4 to enter the recommendation as a "written order" on behalf of Patient 65's physician.

Review of hospital document titled "Critical Care Flow Sheet" dated 3/11/10 noted that nursing staff increased the tube feeding delivery from 50 cc's/hour to 75 cc's/hour based on the RD's recommendation. There was no documentation that the physician signed the order prior to implementation by the RD or nursing staff.

3. Patient 6 was admitted with diagnoses including malnutrition and pressure ulcers. A nursing admission assessment dated 3/16/10 noted the presence of the wounds, weight loss, poor dietary intake and the patients' emaciated appearance. Admission diet order was a regular diet. Physicians' orders dated 3/16/10 requested an RD consult. The order also guided the RD to "provide nourishments/supplements as appropriate."

In an interview on 3/17/10 at 10 a.m., with RD 4, the surveyor asked her to describe how she would implement such an order. She stated that after completing an assessment if the RD thinks that the patient needed a supplement she would provide it. She further stated that if she determined the necessity for a supplement she would enter it as an order into the computer.

Review of hospital policy titled "Intake support (Patient Nourishments)" dated 9/09 noted that while the policy allowed the RD to "offer and provide food/nourishments within the confines of the physician-prescribed diet order and the American Dietetic Association's Nutrition Care Manual, there was no documentation that the physician approved nutrition care manual was modified to specify supplements that may be ordered and guidance for when they may be implemented.



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Based on observation, staff interview as well as medical record and document reviews the hospital failed to ensure that the nutritional needs of patients were in conformance with recognized dietary practices as identified in hospital manuals and references as well as having been in accordance with the orders of the physicians responsible for the care of the patients. By not having had this conformance there was the potential for unsafe, inadequate provision for adult, adolescent and pediatric patients. (Patients 1, 2, 4, 8, 9, 66, 67, 68, 69) within a hospital with a licensed bed capacity for 612 patients.

Findings:

1. Patient 1 was an adult male admitted 3/9/10 and who expired 3/16/10. Patient 1's medical history and diagnoses included progressing renal failure, portal hypertension, acute hepatic failure, alcoholism with cirrhosis, decline in level of consciousness/encephalopathy, atrial septal defect, wounds, arthritis, post-traumatic stress disorder, cocaine use and mild facial and temporal wasting. At the time of admission, nursing staff had entered his height as five feet eight inches and documented weight, 84.24 kg.(168.48 lbs) on the Nursing Baseline Assessment (form) although the Patient Care Summary (form) utilized by the interdisciplinary clinical services had his admission height as five feet five inches and admission weight, 93.6 kg (187.2 lbs) .
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Although determined to be at moderate nutrition risk on 3/10/10 based on admission data, Patient 1 had a referral from nursing to a registered dietitian due to the recent history of poor intake. During the duration of stay, Patient 1 had been bedbound, ventilated and had a physician's order for an individualized tube feeding of Nepro (an enteral tube feeding formula for dialysis patients which has a higher protein content than formulas for non-dialyzed renal patients) effective 3/11/10 and carried forth onto 3/13/10 when goal rate of 55 cc's per hour had been achieved.. The provision was in addition to intravenous fluids which had been assessed by Registered Dietitian 26 who classified him at high nutritional risk and who had established the goal rate of 55 cc's of Nepro over 24 hours without having determined overall downtime, then further had based her recommendations (which were intended to be part of the 3/11/10 order per a tube feeding protocol) upon a physician consult of 3/10/10 indicating "eventual dialysis".

However, on 3/15/10 (Monday) between 10:34 a.m. and 12:50 p.m. medical record review indicated that the tube feeding of Nepro had been stopped and that Patient 1 was considered for comfort care measures. Between 11:25 a.m. and 11:40 a.m. Registered Dietitian 26 stated that she had based her 3/11/10 recommendations for Nepro on the 3/10/10 physician consult rather than reviewing the current physician orders, reference to the nursing care plan and consideration of possible daily downtime of at least one hour and twenty minutes. As a consequence Registered Dietitian 26 stated she had been unaware until rounds on 3/15/10 that there was no intent to dialyze Patient 1 and that he was to be on yet unspecified comfort care measures consisting of intravenous fluids.

Additionally, at 11:45 a.m. Nursing Staff 32 with the input of Nursing Staff 33 took Patient 1's weight and determined using subtracted weights of additional items to be 205.96 lbs with a then-observed error of at least one and one-half pounds due to not subtracting the weight of two heel protector boots. At 11:50 a.m. Nursing Staff 32 re-measured Patient 1 given that there had been a failure on the part of both nursing and dietary staffs to re-check his height when there was a discrepancy of three inches between the Nursing Baseline Assessment (form) which had his height as five feet eight inches and the Patient Care Summary (form)which had his height as five feet five inches. Registered Dietitian 26 had documented Patient 1's height as five feet eight inches in the 3/11/10 nutrition assessment. Although Patient 1 was found to be five feet seven inches when re-measured and the discrepancy of one inch of minor significance for assessment of weight relative to height, the failure to re-check was of concern as there had also been the use of the admission weight of 84.2 kg (185.24 lbs) by Registered Dietitian 26 in conducting the 3/11/10 nutrition assessment --which involves calculations of nutritional needs based upon status as the Patient Care Summary (form) had admission weight as 93.6 kg. (205.92 lbs) and there had been a failure to verify Patient 1's actual admission weight.

Further, Registered Dietitian 12 entered a 3/15/10 follow-up nutrition note at 3 p.m. stating: the tube feeding had been stopped "since this weekend"; there was an overall weight gain of 16 kg (35.2 lbs) in six days; the poor prognosis; and for nutritional care, "Diet per MD/family". On 3/16/10 at 115 p.m. while in transport to the Pacific Campus, Dietary Management Staff 17 stated that the round report for 3/15/10 "hasn't been found" and that overall, there needed to be a communication system to alert the registered dietitians when patients were undergoing (or not undergoing) dialysis so as to not have nutritional assessments and potential follow-through on recommendations which were not commensurate with current intervention/intensity of care (e.g. dialysis for the purpose of removing nitrogenous wastes, the end-product of protein metabolism.)

2. Patient 2 was an adult female admitted 3/9/10 with Neutropenia (which is caused by subnormal levels of white cells--specifically, neutrophils in the blood) which indicates a compromised immune system with risk for infection and a medical history significant for metastasized uterine cancer to the lung with recent (3/2/10) chemotherapy, oral sores with pain and inability to eat. As of 3/11/10 Patient 2 had had been prescribed a Full Liquid Diet, inclusive of Ensure (a liquid nutritional supplement) BID (twice daily) --at breakfast and dinner having been prescribed a Neutropenic Diet on 3/9/10.

On 3/16/10 between 10:10 a.m. and 10:50 a.m. while on a Med-Surg floor which typically provides care for oncology (cancer) patients, review of Patient 2's medical record indicated that there were departures from the prescribed diet ( Full Liquid) as compared to the hospital diet manual standard. Further, at 10:20 a.m. Dietary Management Staff 17 stated that the dietary standards for the Neutropenic Diet were not immediately available on the unit for nursing staff to reference although both she and Registered Dietitian 34 stated that it was not uncommon to have cancer patients as well as other immuno-compromised, immuno-suppressed patients there who might be on the Neutropenic Diet. Dietary Management Staff 17 stated that although there were no patients in this unit currently on the diet, "the information should be here."

At 10:30 a.m. Dietary Management Staff 17 presented an undated in-house publication, which did not have a diet manual reference titled,."Neutropenia--Foods to Avoid". Additionally, review indicated that there had been a failure to ensure that a food, juk (a Chinese rice porridge) brought into the hospital by Patient 2's family upon the change in the diet prescription was appropriate for the the Full Liquid Diet . This was a concern as the juk brought in by the family could be of a different consistency than what is prepared by the hospital foodservice and therefore might not be comparable to the "thin cereal or gruel" allowed on the diet. The latter was of significance as the policy ,"Food Brought in to Patients From Outside the Hospital", last revised 1/06 stipulates that if the dietitian is not available to decide, the authorized diet manual is to be utilized as the reference in determining "the appropriateness of the item".

At 10:42 a.m. Dietary Management Staff 17 presented the excerpt, "Full Liquid Diet" from the hospital diet manual which was the 2008 edition from the American Dietetic Association. As described, the diet allowed clear liquids, milk and small amounts of fiber with the provision for thin cereal or gruel and that it was a transitional diet from clear liquids to a soft diet. However, at 10:45 a.m. both Dietary Management Staff 17 and Registered Dietitian 34 stated upon review of Patient 2's medical record and the diet description that there had not been prescribed allowance or an in-house substitution list for items on the Full Liquid Diet which included the juk.

3. On 3/17/10 between 11:25 a.m. and 11:35 a.m. while in a California Campus dietetic service department office, discussion ensued with Dietary Management Staff 17 and Dietary Staff 23 regarding the list of pediatric patients on prescribed diets, the title of diets in the hospital's approved pediatric diet manual and the role of Dietary Staff 23 (who was neither a registered dietitian nor a diet technician,.registered working under the purview of a registered dietitian) in verifying the accuracy of the planned delivery of meals, supplements and nourishments as well as substituted cafeteria foods as compared to the physician's orders.

At 11:40 a.m. Dietary Staff 23 stated that while there had not been accuracy in the titles of some prescribed regular texture diets she had been making adjustments as to texture based on age, e.g. to chop foods for toddlers and to not serve whole round foods, e.g. hot dog and sticky foods, e.g. peanut butter to children "under two years of age" given the potential for choking and ensuring that whole milk was provided in accord with standards for age (given the importance of essential fatty acids and the role in neurologic function and growth). Dietary Staff 23 also stated she was responsible for ensuring that if the cafeteria foods were provided as substitutes and if there was a note to such effect in the patient's cardex that there was conformance to the prescribed diets. Also, Dietary Staff 23 stated that typically "on the California Campus" there were "at least three to five patients" who received cafeteria foods on a daily basis.

On 3/17/10 between 11:42 a.m. and 11:46 a.m. while in the departmental office comparing physician diet orders to the diet manual indicated that there were non-specific diet orders for four of four pediatric patients on regular texture diets without therapeutic modification. These were: "Regular Appropriate for Age" for two adolescents, Patient 66 and Patient 67 as well as a patient under one year of age, Patient 68 and "Regular as Tolerated" for another adolescent, Patient 69. The non-specificity was of concern, given that there are special dietary needs (e.g. for Calories, protein and nutrients) for pediatric and adolescent patients separate from those of adults on regular texture diets, given stage of growth.

On 3/18/10 between 8:45 a.m. and 8:50 a.m. while in a Pacific Campus conference room review of the job description of Dietary Staff 23 indicated that she did not have the authority to independently determine the adjustments in prescribed diets. Further, at 8:55 a.m. Dietary Management Staff 17 stated that Dietary Staff 23 had been limited by the availability of other information related to diagnoses and conditions which might impact food selection, e.g. severity of developmental disability as much of the information available to Dietary Staff 23 was "paperless"--meaning that if not already in the cardex, information was available via the automated system. The latter was of concerns as on 3/17/10 at 11:47 a.m. Dietary Staff 23 had stated that she had "to make the adjustments" (i.e. interpret the diet order as written) as the physicians "consistently write prescriptions for diets not identified in the hospital diet manual."

4. On 3/17/10 between 2:25 p.m. and 2:30 p.m. while in a Pacific Campus dietetic service department office, review of the recipes used for cafeteria service indicated that one planned entree for the day containing lamb as well two other recipes for other days (i.e. Bourbon Glazed Chicken and Coq au Vin with New Potatoes) presented on 3/17/10 at 11:20 a.m. while in a departmental office at the California Campus indicated that the recipes included alcohol-containing ingredients (i.e. Guinness, Burgundy and Bourbon respectively). However, the recipes did not specify at what temperature, special techniques and for how long the foods would be cooked to ensure that the alcohol would be completely cooked off. For the Coq au Vin with New Potatoes, although the recipe stated it would be cooked initially to boiling for an unstated time following the addition of Burgundy before baking with the implication that all alcohol would be removed, there was potential for service to patients who did not want any alcohol in their foods. Likewise, the other chicken recipe while specifying that upon the addition of "bourbon whiskey" it would be ignited and then cooked for at least forty minutes had similar potential for service to those for whom it could be contraindicated.

Although both Dietary Management Staff 17 and Dietary Staff 28 stated at 2:31 p.m. that the registered dietitians responsible for the in-patient nutritional care of patients with liver disease and/or a known history of alcoholism had reviewed both the hospital and cafeteria menus to ensure that foods served to these patients did not include any alcohol, interview revealed that patients with other considerations (e.g. special medications, pregnancy, breastfeeding, youth as well as cultural and religious beliefs) had the potential for receiving foods prepared with alcohol as cafeteria foods were available as alternates to the hospital menu and there was the possibility that visitors could purchase these foods for the patients without the patients, physicians, nursing staff and visitors aware that the foods had been prepared using alcohol.





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Pacific Campus

5. Patient 8 was admitted with diagnoses including lung cancer. An admission nursing nutrition screening dated 3/12/10 was noted to be incomplete; however a RD consult was requested. Admission diet order dated 3/12/10 was noted to be NPO (nothing by mouth). Admission lab work dated 3/12/10 revealed an albumin (a measure of protein stores) of 2.2 gm/dl (normal 3.4-5.0 gm/dl).

A comprehensive nutrition assessment, completed by the RD, dated 3/14/10 noted that Patient 8 was at high nutritional risk. It was also noted that the patient had lost 38 pounds within the previous 4 months. The RD also provided guidance for estimated nutritional needs for total parenteral nutrition (nutrition through a vein). There was no mention of the depleted albumin value.

Follow up lab work dated 3/14/10 noted the albumin value decreased to 2.0 gm/dl. Additional lab work dated 3/15/10 and 3/16/10 noted albumin values of 1.8 and 1.7 gm/dl respectively. There was no additional nutrition assessment despite the severely depleted albumin stores. In an interview on 3/17/10 at 2 p.m., RD 34 stated that patient risk was determined by diet office staff at the time of admission. She also stated that albumin was an element in determining nutritional risk at the time of admission; however there was no system to notify the RD 's if albumin values decreased during the course of hospitalization.

Review on 3/18/10 at 9 am, of hospital policy titled "Nutrition Screening/Assessment" dated 7/09 revealed that depending on a patients' assigned nutritional risk at the time of admission depleting nutritional stores may not be evaluated until 4-7 days after the initial screening. There was no system to ensure evaluation by the RD if the patients' nutritional status changed.

6. During tray line observation on 3/15/10 beginning at 11:30 a.m., it was noted that Patient 4 had a physician ordered diet restricting phosphorus. It was also noted that the tray ticket that Patient 4 was given was a renal diet.

ON 3/15/10 at 1:50 p.m., the surveyor asked diet office staff to demonstrate the physician ordered diet for Patient 4. It was noted that upon admission the physician ordered the diet to be restricted in phosphorous to 600-900 mg/day. In a concurrent interview with DS 8 and 9 they were asked to demonstrate how they would review this diet order. They stated that they would use a renal diet. The surveyor then asked why they would choose a renal diet, to which they replied that they knew it was low in phosphorus. The surveyor also asked the amount of phosphorus in the renal diet plan, to which they replied they did not know.

In an interview on 3/15/10 at 2 p.m., with RD 6, the surveyor asked her to demonstrate a meal plan for a phosphorus restricted diet in the hospitals' diet manual. RD proceeded to obtain a copy of the phosphorus content of foods from the American Dietetic Association Online Nutrition Care Manual. It was also noted that this document noted that the "handout may be duplicated for client education." She also stated that a low phosphorus diet would limit phosphorus via the limitation of dairy and chocolate. The surveyor asked RD 6 if the hospital specifically had a low phosphorus diet, to which she replied they did not. She was also asked how the hospital would ensure that the physicians' order was met for this specific, diet to which she answered that she was unsure. She also acknowledged that while the nutrition care manual had guidelines, it did not contain parameters for specific diets ordered by the hospitals' physicians.

Review on 3/17/10 at 5 p.m. of the Nutrition Care Manual (nutritioncaremanual.org, 2010) indicated that the basis of the manual is to provide client education, nutritional calculations, a nutritional supplement formulary and evidenced based resources; however there was no indication that this document defined the physician ordered diet or that the information was consistent with the hospitals' menus.

In an interview on 3/18/10 at 10 a.m., Dietary Management Staff 7 was asked how the hospital oriented and supervised the hospital diet office staff. She stated that diet office staff would be trained by another senior diet office staff member and that the new employee would spend 2 hours with the Director of Clinical Nutrition. She also stated that the RD's conducted independent competency assessments initially within the first several months and at their yearly evaluation. She said that there was no daily supervisory oversight of the diet office staff, and that they would rely on individual diet office staff to ask for clarification.

Review on 3/15/10 at 2:30 p.m., of Patient 4's nutritional screening card, maintained in the diet office, indicated that on 3/11 and 3/12 the RD reviewed the card noting the low phosphorus diet; however there was no indication that the RD provided guidance to diet office staff to clarify the physicians' order or ensuring that the patients' daily menu was consistent with the physicians' order. Review of hospital policy titled "Review and Approval of Diet Manual" dated 9/09 indicated that while the American Dietetic Association Nutrition Care Manual was presented to the medical staff and the pharmacy and therapeutics committee there was no indication that the approval bodies were informed that this document did not contain all of the elements of a diet manual.

Medical record review was conducted on 3/16/10 beginning at 2 p.m. Review of undated hospital document titled "Nutrition Note" which was completed by the Diet Assistant indicated that the assistant noted the current diet order as being a low phosphorus diet. The RD reviewed the note on 3/13/10 and also noted that the low phosphorus diet per the MD; however there was no indication that the RD alerted diet office staff to the diet or evaluated the patient selected menu to ensure that the physician ordered diet was followed.






20245

California Campus

7. Patient 9 had diet order " NPO " (Nothing By Mouth) commencing at one minute after midnight on 3/16/10. Prior diet order was " Low Residue. " On 3/16/10 at 12:50 p.m., Dietary Staff 23 was observed in the diet office preparing tray cards. During an interview, DS 23 revealed the " Room Service " tray line allowed patients to call the diet office before each meal and give their food order. DS 23 stated she checked the physician ' s diet order and the patient tray card to be sure the foods were allowed, then took the traycard out to the trayline for preparation and delivery to the patient. DS 23 provided several tray cards that had already gone through the process. Patient 9 had been sent a Low Residue diet. On 3/16/10 at 1:05 p.m., Nursing Staff 24 stated " I saw the tray, and took it before the patient got it. " During an interview Registered Dietitian 25 acknowledged the tray should not have been sent to the " NPO " patient.

Based on observation, interview, and document review, the hospital failed to ensure adequate food supplies were available to provide for the nutritional needs of patients and staff during a disaster that required the hospital to be self-sufficient. The disaster menu did not include a food plan for the entire licensed bed capacity and staff.

1. On 3/15/10 beginning at 2:45 p.m. while at the Pacific Campus, review of disaster preparedness for meal service was reviewed in the presence of DS 1. In a concurrent interview the surveyor asked DS 1 to describe the plans for meal preparation during a disaster. She stated that they had a 3-day menu that relied partially on designated disaster foods as well as foods that were stored in the refrigerator and freezer. It was also noted that there were numerous cases of 16-ounce water bottles. DS 1 was asked to demonstrate the quantities of the stored items. She stated that it would be difficult to do at that time as there were numerous items stacked in front of the disaster supplies.

A follow up review of supplies on 3/16/10 at 10:20 a.m., revealed that DS 1 was able to find the requested designated entree items. In addition the surveyor requested DS 1 to find the powdered dried milk. It was noted there were only 130 servings of dried milk present in the hospital. The surveyor also asked DS 1 to describe the number of people that would be fed. She stated that the hospital planned on feeding 227 patients. She further stated that they had not planned on feeding staff working at the hospital during the disaster. She also stated she was unsure how many staff members were on the campus during a typical weekday.

Concurrent review of the menu revealed that the plan consisted of items such as roast beef, cheese, turkey and egg sandwiches as well a cold deli-type meat plates. DS 1 also stated that the majority of the items would require some degree of preparation, such as slicing or mixing in addition to individual portioning of the items. The surveyor asked if that in the event of a disaster the hospital would readily be able to implement a menu that required the described level of food production activities, to which she replied that "likely not." The surveyor also asked if the hospital had evaluated the functionality of the menu. DS 1 replied that a dietary staff member from an affiliated hospital service represented the dietary department on the hospitals' safety committee; however it was not likely that the presented menu was evaluated for functionality.

It was also noted that the departments' on-site water supply was limited to 426 gallons of water. It was also noted that the hospitals' licensed bed count was 295 general acute care beds. Additional information submitted by the hospital on 3/15/10 also revealed that a typical day shift had the Pacific campus had 800 exempt and non-exempt staff, totaling 1100 staff that may require food and water during a wide spread disaster. It was also noted that the hospital designated that there would be 2 quarts of water per person/per day for hydration. This would have required 550 gallons of water. It was also noted that the menu called for items such as hot cereal and milk which would require additional water.





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2. At the California campus on 3/16/10 at 2:30 p.m., review of the hospital disaster menu and corresponding food supplies at that location indicated the hospital plan did not include a food plan for the entire licensed bed capacity as well as staff. DSM18 acknowledged the plan was for the average census not the licensed bed capacity, and did not include food for staff who would be on-site and taking care of patients.

Based on observation, interview, and record review, the Condition of Infection Control is not met due to:

1. The facility failed to implement its Hand Hygiene policy when a hospital technician was observed removing soiled linen from a gurney without wearing gloves until told to do so by another staff member, disposing of the soiled linen, removing his gloves and not washing his hands, and when a licensed vocational nurse was observed checking the blood sugar level of a patient, removing her gloves and writing in the medical record without washing her hands. The facility also failed to implement its Hepatitis B Vaccine policy when a registered nurse received three doses of the Hepatitis B vaccine and was not tested after vaccination to determine HBsAB status. (A-0748)

2. The hospital failed to ensure that there were infection control measures to prevent the development of foodborne illness and cross-contamination in the kitchens and ancillary food service operations, failed to have a thorough infection control surveillance system to monitor the conditions and practices of dietetic service staff as well as outsourced contractors and failed to identify breaches in infection control practices exposing patients to an unsafe environment that could be a source of infection and cross contamination when: the nurses in the labor and delivery unit were rinsing the used vaginal instruments in the sink in the patients' room, the facility was not aware of the shelf life of the Sani-Cloth sanitizer, the cranberry juice container was left to thaw in the hand washing sink and when the housekeeping staff diluted the premixed sanitizing chemical which reduced its sanitizing action. (A-0749)

The cumulative effects of these systemic problems resulted in the facility's inability to provide a sanitary environment and avoid sources and transmission of infections.

Based on observation, interview and record review, the facility failed to implement its Hand Hygiene policy when a hospital technician was observed removing soiled linen from a gurney without wearing gloves until told to do so by another staff member, disposing of the soiled linen, removing his gloves and not washing his hands, and when a licensed vocational nurse was observed checking the blood sugar level of a patient, removing her gloves and writing in the medical record without washing her hands. The facility also failed to implement its Hepatitis B Vaccine policy when a registered nurse received three doses of the Hepatitis B vaccine and was not tested after vaccination to determine HBsAB status.

Findings:

1. In the operating room on 3/16/10 at 11.25 a.m., HP 1 (hospital technician) was observed starting to remove soiled linen from a gurney without wearing gloves. He was told by another staff member to put on gloves to finish removing the linen. After he disposed of the linen, he removed his gloves and did not wash his hands.

In an interview on the same date and time, the operating room manager who was accompanying the surveyors acknowledged that HP 1 had not followed the Hand Hygiene policy. He did not wear gloves while removing soiled linen from a gurney until he was told to do so by another staff member and he failed to wash his hands after he removed his gloves.

The facility's Hand Hygiene policy was reviewed on 3/17/10 at 2:15 p.m. and indicated the following:

Policy

Hand hygiene is indicated before and after routine patient care activities and after hand-contaminating activities.

All staff and physicians having direct patient care must cleanse hands at the following times:

Before and after direct contact with patients, blood or body fluids, mucous membranes, non-intact skin, and objects likely to be contaminated.

After removing gloves.


16951

2. On 3/15/10 at 12:08 p.m., LVN 1 (licensed vocational nurse) was observed checking the blood sugar level of Patient 36 in the nursery while wearing gloves. LVN 1 returned the glucometer to it's case, removed her gloves and proceeded to write in the medical record. She did not wash her hands or use antiseptic hand rub. When asked if she was supposed to wash hands after removing her gloves, LVN 1 stated "Yes, and I did not".

The facility's hand hygiene policy with revision date 10/09 indicated the purpose of hand hygiene is to remove dirt, organic material, and transient microorganisms from the hands in order to decrease the risk of cross contamination from patients, patient care equipment, and the environment. The policy also indicated "All staff and physicians having direct patient care must cleanse hands at the following times ... before and after direct contact with patients, blood or body fluids, mucous membranes, nonintact skin, and objects likely to be contaminated ... after removing gloves.

3. On 3/18/10, 6 employee files were reviewed. One (RN 4) of six showed employee files indicated RN 4 had received three doses of Hepatitis B vaccine with last dose administered on 4/8/99. The tracking form indicated RN 4 was not retested for HBsAB.

Review on 3/18/10 of the facility's Infection Control policy on Hepatitis B Vaccine with revision date of 3/04, indicated under section D Post-Vaccine Procedure " The employee will be tested for HbsAb 6-8 weeks after completion of the vaccine series to determine the effectiveness of the vaccine".

The Occupational Health Nurse Practitioner (Staff 27) was interviewed on 3/18/10 at 3:15 p.m. and stated that RN 4 should have been tested for HbsAb after vaccination. Staff 27 was unable to explain why RN 4 was not tested.

Based on observation, staff interview and document review, the hospital failed to ensure that there were infection control measures to prevent the development of foodborne illness and cross-contamination in the kitchens and ancillary foodservice operations. Also, the hospital had failed to have a thorough infection control surveillance system to monitor the conditions and practices of dietetic service staff as well as outsourced contractors. By not having these measures and a thorough surveillance system, potentially hazardous foods had been stored, prepared, distributed and served under unsafe, unsanitary conditions and there was potential for such continuation in the absence of identification and remediation in a hospital with a licensed bed capacity for 612 patients.

The hospital also failed to identify breaches in infection control practices exposing patients to an unsafe environment that could be a source of infection and cross contamination when: the nurses in the labor and delivery unit were rinsing the used vaginal instruments in the sink in the patients' room, the facility was not aware of the shelf life of the Sani-Cloth sanitizer, the cranberry juice container was left to thaw in the hand washing sink, and when the housekeeping staff diluted the premixed sanitizing chemical which reduced its sanitizing action.

Findings:

Pacific Campus

1. During food storage observation on 3/15/10 at 10:55 a.m., it was noted there were 4 pieces of cooked meat, each weighing approximately 2 pounds. The internal probed temperature of the items was noted to be 42?F and 43?F respectively. It was also noted that there was one pan each of cooked quinoa and lentils with temperatures of 39?F respectively.

In a concurrent interview with DS 3 the surveyor asked him to describe the preparation process for the meat. He stated the meat was cooked the previous day. He described that the meat cooking was finished at 3 pm, after which he cut it into several smaller pieces and placed it in the refrigerator. He further stated that he did not do any additional monitoring of the item. He further stated that to ensure safety he would ensure the items was properly heated the following day.

In an interview on 3/15/10 at 11 a.m., with DS 10 he was asked how as the supervisor he ensured previously cooked foods were safe to use at a later time. He stated that after cooking staff was instructed to place items in the freezer after which supervisory staff would monitor the cool down of the foods. DS 1 was also present at the interview and she stated that the department had recently started monitoring cool down of PHF's and that it was a new concept to staff. The surveyor also asked DS 10 to describe the process he followed. He stated that he believed that he took the first temperature between 3 p.m. and 5 p.m. on the previous day and took the follow up temperature 4 hours later; however was unable to recall the accurate timing of the temperatures.

Concurrent review of hospital document titled "Food Cooling Audit" noted that there were 3 items on the log. It was also noted that the policy guided that the supervisor to record the temperature of each food item 2 hours after it was prepared and to check again 6 hours after it was prepared. However, it was noted that there was no indication of the time food temperatures were taken. It was also noted that the first temperature recorded was 65?F and the second temperature was recorded as 30?F. DS 10 was asked to explain the second temperature to which he replied that DS 3 had placed the item in the walk-in freezer.

In a follow up interview with DS 3 on 3/15/10 at 11:15 a.m., he stated that he did not place the item in the freezer; rather he placed it in the walk-in vegetable refrigerator. Hospital staff was unable to explain the recorded 30?F temperature in a refrigerator that was observed to have an ambient air temperature of 38?F. It was also noted that there was no cool down monitoring of the observed lentils and quinoa.

2. During food production observations on 3/15/10 beginning at 11:40 a.m., DS 11 was observed cutting cooked meat into slices wearing gloves. It was also noted that he repeatedly would touch kitchen appliances as well as leave his work area to go to the cafeteria after which he would rinse his gloved hands with water and return to touching the cooked meat.

In an interview on 3/15/10 at 11:45 a.m., with the Infection Control Preventionist (ICP) she was asked to describe infection control oversight in food services. She stated that the department received semi annual environmental rounds; however these rounds did not evaluate food production practices. She also stated that she provided periodic in-service to staff that included personal hygiene and hand washing. The standard of practice would be to change gloves when there is a break in a task (Centers for Disease Control, 2010).

3. During general kitchen observation on 3/15/10 at 10:45 a.m., it was noted that DS 2 was preparing cantaloupe. It was also noted there were 3 cantaloupes in a stainless steel bowl filled half way with water, after which he would cut them.

In a concurrent interview with DS 2 he was asked how the item was prepared. He stated that he obtained the item from the walk-in refrigerator after which he placed them in the bowl "to wash" prior to cutting.

Cantaloupe is considered to be a potentially hazardous food (PHF). PHF's are those foods capable of supporting bacterial growth associated with food borne illness. The standard of practice for washing raw produce would be to place under running water prior to cutting (Food Code, 2009).

4. During food production observations on 3/15/10 beginning at 11:30 a.m., it was noted that dietary staff were storing chemical sanitizer buckets on the counters of food production areas. It was also noted that in the bucket adjacent to the stove, dietary staff was storing food production utensils such as knives. Further observation noted that dietary staff would remove the knife from the bucket and use it in food production activities without additional cleaning/sanitizing. Follow up observations on 3/16/10 beginning at 10 a.m., noted the buckets were again stored on food production surfaces.

In an interview on 3/17/10 at 11:30 a.m., with DS 1 she stated that she felt it was appropriate to store the chemical sanitizer on the surface since it was deemed to be a food safe chemical. She also stated that a county health inspector guided them to store utensils in the sanitizer when not in use. The surveyor asked the hospital to provide a reference for this standard of practice. In a follow up interview on 3/18/10 at 1 p.m., with DS 1 she stated she was unable to locate a reference for the practice.

5. During general kitchen observation on 3/15/10 beginning at 2:30 p.m., it was noted that none of the kitchen sinks had air gaps, rather were directly plumbed into the hospital's waste water system. In a concurrent interview the surveyor asked DS 1 to point out the food production sinks. She stated that the primary production sinks was the one near the stove as well as the sinks adjacent to each of the two walk-in refrigerators. It was also noted that there were observed food stuffs in each of these sinks, indicating that were readily used.

The presence of air gaps prevents the cross contamination of food production sinks should there be a back flow of waste water. The standard of practice would be to ensure that all food productions sinks and food storage equipment contain air gaps (Food Code, 2009).

6. During tray line observation on 3/15/10 beginning at 11:30 a.m., and general kitchen observation on 3/16/10 at 11 a.m., noted that there were greater than 20 patient meal trays that had cracked plastic corners. It was also noted that the blender used to pureed foods had numerous cracks on the blender body as well as the plastic blade on the inside. In a concurrent interview with DS 1 she stated that she has on several occasions asked staff to discard compromised equipment, however they had a difficult time throwing away items they considered to be useful.

Review on 3/17/20 at 3 p.m., of dietary staff in-service documents failed to reveal training related to the maintenance of food production equipment. Compromised food production surfaces may harbor water and bacteria and can no longer be thoroughly leaned and sanitized (Food Code, 2009).

7. During general kitchen observation on 3/16/10 beginning at 11:15 a.m., it was noted that there was a bottle of bleach in the dish room. In a concurrent interview with DS 1 she was asked the purpose of the bleach, to which she responded that the item was used to sanitize the plastic cutting boards. Concurrent review of the label on the bottle revealed that while the bleach was acceptable use for food equipment, it was limited to use on hard, non-porous surfaces such as " porcelain, glass and utensils." There was no indication that it would be an effective sanitizer for plastic surfaces.

In a concurrent interview with the ICP she stated that while the Infection Control Department reviewed the chemicals and appropriate usage of chemicals in housekeeping, the department did not review those used in dietary.


20245

California Campus

8. On 3/15/10 during the initial tour of the kitchen at the California campus commencing at 10:45 a.m. the following observations were made:

a.. In the refrigerator used by the cafeteria, and where food could be obtained for patients, there was one-half loaf of undated bread, an undated muffin, and a stainless steel pan of undated, unlabeled dark meat.

b. In the walk-in freezer there was an undated five pound piece of ground meat, and four tubs of undated, unlabeled substance that DMS 18 stated was minestrone soup. The plastic covering of one of the tubs was torn, and the product exposed to the freezer climate.

c. In Refrigerator box 9, there were two stainless steel pans of undated, prepared egg salad, and an undated pan of mandarin orange segments.

On 3/15/10 Dietary Management Staff 18 provided the facility policy B005 for Refrigerated Storage that revealed " Items shall be dated with the date that the item is to be used or discarded. "

d. At 11:30 a.m. in the under the counter refrigerator #10 the internal, free-standing thermometer read 44?F. The temperature of the foods inside were taken by DMS 18 and noted as follows:

An opened five pound container of sour cream 48?F,
Opened stainless steel pan of sliced peaches 54?F,
Two pans of sliced pears 42.4?F and 42.5?F respectively, and
A pan of Cherries 41.2?F.
An unopened half gallon of milk located at the rear of the refrigerator 46?F.

During a concurrent interview, DMS 18 identified Dietary Staff 19 as the regular user of this work station. At 11:30 a.m., DS19 stated the foods were all in there when she arrived in the morning and that she had last been at the station at 10:30 a.m. She stated she had used just " a few " peaches for breakfast and the pan had been returned to the refrigerator at 6:30 a.m., so they had been refrigerated for five hours. DMS 18 provided the " Refrigerator Temperature Log " that revealed the temperature of the refrigerator was 38?F-40?F at 5:00 a.m. and 38?F-40?F when the kitchen closed, for the past three days. DMS 18 stated the facility did not have a food safety policy to monitor the time and temperature during the day, or to measure the temperature of actual foods to ensure potentially hazardous foods were kept below 41 ?F during the course of the day as the refrigerator was used, and acknowledged there was no way to know how many hours the foods had been at an unsafe temperature. DMS 18 stated the foods would be discarded and the refrigerator placed out of service.

9. In under-the-counter cooks deli refrigerator #12, an internal free-standing thermometer recorded 26?F, although no products were observed to have ice crystals. The following food temperatures from foods in the deli refrigerator were obtained by DMS 18:
Raw shrimp: 41.4?F
Raw chicken: 41.4?F
A pan of cooked pasta: 47?F

DMS 18 calibrated the thermometer used and stated: " those are the right temperatures. " DMS 18 stated " I took the temperature of this refrigerator myself this morning at 5:00 a.m. There was product here then. " The temperature of the refrigerator at a.m. and p.m. was observed to be 38?-39?F for the past three days as observed on the " Refrigerator Temperature Log. " DMS 18 acknowledged there was no policy to monitor time/temperature of potentially hazardous foods during the day, nor the temperature of actual refrigerated foods and had the foods discarded and the refrigerator placed out of service.

10. On 3/15/10 at 1:45 p.m. the ice bin was observed to have a film on the interior surface. During a concurrent interview, DMS 18 stated that both dietary staff and Engineering staff were responsible for cleaning the ice machine. At 1:47 p.m. Dietary Staff 20 identified the product he used to clean the ice bin as Oasis 133, an all-purpose cleaner and de-greaser to clean the machine, followed by a sanitizing step. At 1:55 p.m. during an interview, facility Engineer 21 identified the product he cleaned the ice bin with as " Foaming Lotion Skin Cleanser " , followed by a sanitizing step. Review of the manufacturer ' s cleaning directions revealed the ice bin should be cleaned with Calgon-Ice Machine Cleaner or equivalent. During a literature review of the product Ice Machine Cleaner, it was revealed the product was a descaling product. Neither the Oasis 133 nor the Foaming Lotion Skin Cleanser was identified by their manufacturers ' as descaling agents.

11. On 3/16/10 at 10:45 a.m. during observations in the kitchen food preparation area, all food preparation sinks where food might be placed prior to preparation for serving, were observed to be directly plumbed to the sewer lines, and without air gaps that would prevent a sewer backflow from discharging contaminated water into the food preparation sinks.

12. On 3/16/10 at 11:10 a.m. during observations of the preparation of fresh melons for patient meal service, Dietary Staff 22 was observed to reach into clear solution in a red bucket and remove a spoon. DS 22 stated the spoon would be used to scoop out the seeds from the cut melon prior to serving. DS 22 further stated the clear solution was sanitizer, which she changed every four hours, and had just changed " one hour ago. " It ' s good. " DS 22 checked the sanitizer concentration when requested by the surveyor. DS 22 immersed a strip in the solution for a count of 30 and stated she would leave it in there " until it changed. " The strip did not change color and when compared to the colorimetric chart was noted to have sanitizer concentration on " 0 " . DMS 18 provided a training document outlining "Survey Readiness" training given to dietary staff on 1/29/10. One of the training items was " To test the correct concentration of the sanitizing solution, dip paper strip in solution for 10 seconds and compare to color chart. Color should be at 200. " Review of the sign-in sheet for the training revealed DS 22 was not in attendance.


05041

Pacific Campus and California Campus--Ancillary Foodservice Operations

13. On 3/17/10 between 1:40 p.m. and 2:50 p.m. inspection of the Pacific Campus ancillary
foodservice operations revealed that there were unsanitary, unsafe conditions and staff practices. These were of concern as visitors can purchase foods from these areas for patients and the facility utilizes the cafeteria foods as alternative selections from the standard hospital menus. On 3/17/10 between 1:40 p.m. and 2:50 p.m. Dietary Management Staff 17 confirmed this in the varied locations with dietetic service staff and determined that on 3/17/10 there were one or two patients on this campus receiving cafeteria foods and that the number of patients receiving foods from the other locations was unknown..

a. At 1:40 p.m. inspection of the vending machine area revealed that there was a unit containing frozen potentially hazardous (non-acidic, protein-containing) foods, e.g. meat-containing burritos, sandwiches and pasta entrees. At 1:40 p.m. upon inspection and finding that there was no internal thermometer, Dietary Staff 1 stated that there had been no surveillance of operation and that the hospital had been dependent upon the contracted service for safe operability and repletion. Further, Dietary Staff 1 stated that she had only learned how to activate the digital temperature display, the target temperature parameters and conditions under which the unit would shut-down "this morning". Also, Dietary Staff 1 stated that she had not received reports from the contracted service.

b. At 1:50 p.m. inspection at the kiosk hot beverage service revealed that there were four carafes containing potentially hazardous (non-acidic, protein-containing) beverages which were above the maximum service temperature of 41 degrees F and which had been poured from an under-counter reach-in refrigerator that had an ambient temperature of 48 degrees F for an unknown period of time and for which an unopened quart carton of half-and-half was at 47.6 degrees F. The four beverages and respective temperatures were: non-fat milk at 50 degrees F, half-and-half at 54.4 degrees F, whole milk at 56 degrees F and soy milk at 60.2 degrees F.

At 1:55 p.m. Dietary Staff 14 stated that she had not been aware of the temperature elevation in the refrigerator and attributed it to frequent opening over an unspecified time. Further, Dietary Staff 14 stated that she had not been checking the temperatures of the beverages and stated that the beverages held in the carafes would only be elevated for "thirty minutes" during service as constant repletion was necessary. At 1:59 p.m. Dietary Staff 1 stated that there needed to be "monitoring" in the kiosk to ensure "safety" and that the beverages in both the refrigerator and carafes would have to be discarded and the refrigerator "checked".

c. Between 2 p.m. and 2:04 p.m. inspection of the kiosk also revealed that there were no test strips to check the efficacy of the QAC (Quaternary Ammonium Chloride) sanitizing solution used on the counters although Dietary Staff 14 stated that the solution was last "mixed about 15 to 20 minutes ago and should be at two hundred <200 ppms>". However, when test strips were located elsewhere and brought to the kiosk, the strength of the solution was only 100 ppms. At 2:04 p.m. Dietary Staff 14 stated that she was "surprised" and that "a new batch is needed now".

d. Between 2 05 p.m. and 2:10 p.m. in the cafeteria at the self-serve salad bar, there were two salad dressings above the maximum for safely chilled foods, 41 degrees F. One was Ranch Dressing at 51.6 degrees F and the other was Caesar Dressing at 50.8 degrees F. Both salad dressings were in ceramic containers at least one-half inch thick and not deeply submerged in the ice-bed set-up. At 2:10 p.m. Dietary Staff 1 stated that the dressings had been in the salad bar for at least two hours and that there had not been any temperature tracking from the time the dressings had been removed from a kitchen refrigerator, original set-up and during duration of service. As such, Dietary Staff 1 stated that the dressings would have to be discarded.

e. Between 2:12 p.m. and 2:16 p.m. inspection of the cafeteria sandwich bar revealed that there were four potentially hazardous (non-acidic, protein-containing) foods above the maximum for safe chilling, 41 degrees F . The foods and respective temperatures were: roast beef at 47.9 degrees F, tuna salad at 44.6 degrees F, turkey at 44.8 degrees F and salami at 50 degrees F. All four foods were in containers that were not submerged in the ice-bed set-up or otherwise chilled. Also, there was no means to verify the pH of the tuna salad which Dietary Staff 1 reported had acidic ingredients which would have had a protective effect and reduced the likelihood of the growth of microorganisms. At 2:15 p.m. Dietary Staff 1 stated that the foods "should be lower ", but there was no evidence of temperature tracking from the time the foods were pulled from the kitchen walk-in refrigerator. Also, although the refrigeration for these foods when checked by a surveyor at 2:25 p.m. was at the safe ambient temperature of 38 degrees F, there was remaining uncertainty to how long the meats and tuna salad had been above 41 degrees F.

Also, in checking the temperature of another potentially hazardous food, fresh spinach leaves with cut stems, at the same set-up, they were at 51 degrees F although Dietary Staff 1 stated that they had not been placed there "beyond thirty-five to forty-five minutes". Also, the container of spinach was not submerged in the ice-bed set-up. At 2:25 p.m. upon a surveyor checking the kitchen walk-in refrigerator where the fresh spinach leaves had been stored earlier, it was found to have an ambient temperature of 36 degrees F to 40 degrees F. At 2:16 p.m. Dietary Staff 1 stated that monitoring was "needed". Additionally, Dietary Staff 1 stated that while she was confident that there had not been time/temperature abuse leading to potential for foodborne illness-- although there had not been any tracking of temperature since removal from the refrigerator and the time interval between removal and set-up was unknown--she stated that spinach was "something to check" because of potential risk for pathogenic development and because of the defined risk of fresh spinach as stipulated in the 2009 Food Code.

f. Between 2:40 p.m. and 2:50 p.m. in the cafe there were three indications for insufficient surveillance. There was a reach-in freezer containing ice cream which had an accumulation of frost at least one and one-half inches thick on the interior and which lacked an internal thermometer. There was a reach-in refrigerator which while having an internal thermometer registering 40 degrees F and for which a randomly selected individual carton of milk was at 41 degrees F, the log for January 1 through March 17 showed untimed daily temperatures below the freezing point (32 degrees F), i.e. 24, 25, 26 degrees F, 27 and 28 degrees F for a total of 41 times. Also, although the QAC (Quaternary Ammonium Chloride) sanitizing solution used on the counters was found to be at 200 ppms--which is what Dietary Staff 16 stated was "expected", there had not been any test strips retained in the cafe to demonstrate the practice of on-going testing.

At 2:50 p.m. Dietary Staff 1 stated that the lack of a thermometer in the freezer and the lack of test strips in the cafe were of concern. At 2:50 p.m. Dietary Staff 16 stated that the log for the reach-in refrigerator had contained errors as when she examined the internal thermometer she stated had likely misread the temperatures by ten degrees and that the entries were likely "around thirty-six <36 degrees F> and thirty-seven <37 degrees F>".

14. On 3/17/10 between 10:50 a.m. and 12:20 p.m. inspection if the California Campus ancillary foodservice operations revealed that there were unsafe, unsanitary conditions and staff practices. These were of concern as these food items can be purchased by visitors for patients and cafeteria menu items are available as an alternative to patients who are provided hospital menus.

a. At 10:50 a.m. inspection of the vending area revealed that there was a unit containing frozen potentially hazardous (non-acidic, protein-containing) foods, e.g. meat containing burritos, burgers, pasta and assorted frozen desserts. At 10:50 a.m. Department Manager 29 stated that there had never been an internal thermometer in the unit and that he did not know how to operate the digital display for temperature. Further, at 10:52 a.m. Department Manager 29 stated that there had not been any surveillance of the unit as they were dependent upon the services of the outside contracted vending service. Additionally, Department Manager 29 stated that he did not know the target temperature, temperature parameters and conditions for automatic shut-off. Department Manager 29 stated that he did not know if he could manually shut-down the unit and that he would look for documentation pertaining to both operations and servicing reports. However, by 3/18/10 at 3 p.m. while the operational information was available for review, no servicing reports were forthcoming.

b. Between 11:48 a.m. and 11:55 a.m. inspection of the cafeteria service line revealed that there were six potentially hazardous (non-acidic, protein-containing) chilled foods retained above 41 degrees F. These foods and and respective temperatures were: chicken breast at 50.2 degrees F, tuna salad at 43.1 degrees F, turkey at 47.5 degrees F, ham at 49.1 degrees F, Humus (a spread containing garbanzo beans) at 49 degrees F to 50 degrees F and Provolone at 54.9 degrees F. According to Dietary Staff 1 the foods had been taken from refrigeration prior to set-up in an ice bed at 11:15 a.m. However, although the two walk-in refrigerators which had contained these foods were between at 34 degrees F to 39 degrees F per surveyor inspection at 11:54 a.m. of internal thermometers used to detect ambient air temperature, there had not been submergence of the containers of food in the ice and there was no time/temperature tracking done or planned during service. As such, at 11:55 a.m. Dietary Staff 1 stated that the foods would be discarded and "monitoring" done.

Further, at noon Dietary Staff 1 stated that although the tuna salad had acidic ingredients, e.g. lemon juice, relish and mustard she stated that she did not have a means to show that the pH was at or below 4.6 as this would have indicated a protective step in the event of time/temperature abuse.

c. Between 12:10 p.m. and 12:20 p.m. inspection of the records for foods prepared for cafeteria service revealed that there were none for cold foods and beverages. As randomly selected set-up cold foods had been found above the desired service temperature of 41 degrees F and the log indicated that there had been sufficient entry blanks, Dietary Staff 1 upon confirmation with Dietary Management Staff 18 stated that this had been on-going and that such checking was "important" so as to ensure food safety.

15. On 3/18/10 between 10 a.m. and 10:40 a.m. while in a Pacific Campus administrative conference room interview with Registered Dietitian 30 revealed that in addition to limited semi-annual surveillance of the hospital kitchens and kitchen areas as well as aspects of the cafeteria service at both the Pacific Campus and California Campus within the past year, there had not been any surveillance of the other ancillary areas, i.e. vending operations, a kiosk and a cafe. Additionally, at 10:40 a.m. Registered Dietitian 30 reported that she had neither ensured that there were representatives from the dietetic service department on the Infection Control Committee and interdepartmental rounds nor that criteria for evaluation of the dietetic service had included such elements as safe cool-down and re-heating of potentially hazardous (non-acidic, protein-containing foods, correct usage of sanitizing chemicals as well as other measures to prevent foodborne illness and cross-contamination.

Likewise on 3/18/10 at 9:52 a.m. and again at 10:55 a.m. the Infection Control Preventionist stated that there had not been the level of surveillance needed to ensure food safety and sanitation in the kitchens and ancillary foodservice operations at both the Pacific Campus and the California Campus. Overall, between 3/15/10 and 3/17/10 there were concerns regarding: inconsistent labeling and dating practices; inattention to cool-down, holding, distribution and service temperatures of potentially hazardous foods; not having ensured safe operations of equipment, e.g. refrigerators; not having provided safe air gaps and not having overseen correct use of sanitizing solutions, e.g. for counters and ice machines. These were of additional concern as they had been departures from policies and procedures with overt inattention to those pertaining to food temperatures, e.g. "Food Handling Guidelines" and "Food Preparation and Production for Cafeteria and Catering" and that those items identified as problematic were also not categories for evaluation on the "Food and Nutrition Services Daily Sanitation/Patient Safety Audit"

Based on interview and record review, the facility failed to have the job descriptions of the nuclear medicine technologists approved by the medical director of the service and by the medical staff. The deficient practice circumvented a regulatory requirement.

Findings:

Review of the facility's job description for Nuclear Medicine Technologist I revealed no indication that the language had been approved by the medical director of the service or by the medical staff.

In an interview on 3/15/10 at 11:04 a.m., Staff E stated that the job description had been approved by the department, but the medical director was not involved. She stated that the medical director gives feedback regarding the performance of the nuclear medicine technologists.