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Based on observation, staff interview, and document review, the hospital failed to employ a Dietetic Services Supervisor full time for the hospital's main campus as specified in the California Code of Regulations, Title 22, Division 5, Chapter 1. State requirements as Section 70275 (A) and Health and Safety Code at 1265.4 specify registered dietitian shall be employed full time, or part time providing guidance to the supervisor and staff of the dietetic service, approve of menus, participation and revision of dietetic policies and procedures. State requirement at Section 70275 (b) specify that if a dietitian is not employed full time, a full time person who is a graduate of a state approved course that provides 90 or more hours of classroom instruction in food service shall be employed to be responsible for the operation of the food service. This failure placed patients at the main campus at risk of not having its patients' nutritional needs met by a full-time qualified Food Services Supervisor (FSS).

Findings:

A review of the hospital's food and nutrition organizational chart, dated 10/10, revealed the Director of Nutrition and Food Service (DNFS) was responsible for the oversight of both the Food Service Supervisor (FSS) at the southwest campus and the Dietary Services Supervisor (DSS) at the main campus.

During an interview with the DNFS, on 10/31/11, at 10:25 AM, he stated he was a qualified dietary services manager. He stated he had oversight over the dietary departments at both the campuses. He further stated the FSS at the southwest campus was responsible for the day to day operations of that kitchen and, was a qualified dietary supervisor. The DSS at the main campus was not a qualified dietary supervisor, but he had been providing oversight for the main campus. He further stated the main campus did not have a full time registered dietician staffed.

A review of the employee file for the DNFS revealed he received his certification as a Dietary Services Manager in 2006 from a state approved program. The job description
for his position at the hospital was the Director of Food and Nutrition Services who was responsible and accountable for staffing, directing, organizing, planning, and evaluating the activities of the dietary department in both campuses.

Based on record reviews and staff interviews, the hospital failed to measure, analyze, track quality indicators of its nutrition and food services. This affected the hospital's ability to identify opportunities for improvement.

Findings:

During a concurrent interview and record review with both the Clinical Nutrition Manager (CNM) and the Director of Nutrition and Food Services (DNFS) on 11/2/11, at 11:35 AM, the department's Performance Improvement (PI) plan was reviewed. The DNFS stated the department was tracking the accuracy of patient meal trays to determine they were assembled in accordance with the patient's specific diet order. He further stated the data collected indicated the hospital's dietary services had 100% compliance and had been consistently met since 7/29/11. He went on to explain 100% compliance was achieved by capturing all fallouts and correcting them before trays left the kitchen. Therefore, with complete compliance no improvement would be needed.

A concurrent review of the PI plan quality indicator for tray accuracy showed 15 trays per week per campus were checked for accuracy. These trays were then corrected for errors before leaving the kitchen by the data collector and recorded as compliant. Therefore, 100% compliance was consistently met even though without the monitoring process, some trays would have left the kitchen with inaccuracies. The DNFS confirmed data collection after errors were corrected did not accurately capture the error occurred in the kitchen.

The DNFS stated the department was also tracking to be sure all foods requiring cooling would be cooled in accordance with HACCP (Hazard Analysis Critical Control Points - a management program in which food safety is addressed) requirements.

The hospital's HACCP Cooling Log for October 2011 was reviewed. The Cooling Log instructed the staff "Foods not used for immediate service must be cooled from 135?F TO 70?F within 2 hours and from 70? F to 41?F within an additional 4 hours for a maximum total cooling time of 6 hours.

According to the 2009 Food Code, excessive time for cooling or inappropriate cooling process of potentially hazardous foods (PHF) could cause food borne illness.

The DNFS stated this data collection was simply based on reviewing the documentation on the cooling logs to determine the non-compliance. He stated the audit could not capture cooked PHF not logged on the "Cooling Log." In addition, he stated the actual cooling process was not observed for appropriateness to ensure the staff followed the hospital's cooling procedures.

A review of the hospital's policy titled, "Organizational Performance Improvement Plan (PI Plan)," dated August 2011, on 11/1/11, revealed the purpose of the PI Plan was to ensure the Governing Body, medical staff, and professional staff demonstrate a consistent endeavor to deliver safe, effective and optimal patient care and services in an environment of minimal risk. It allowed for a systemic, coordinated, continuous, data-driven approach to improving performance focusing on process and mechanisms that address these values. It further stated monitoring is undertaken in order to identify and resolve any breakdown that may result in suboptimal patient care and safety, while striving to continuously improve and facilitate patient outcomes.

During an interview with the Director of Quality (DQ) on 11/2/11, at 3:30 PM, she stated she directed the DNFS to correct the trays for accuracy before the trays left the kitchen during the data collection process, then capture that data as being 100% in compliance. She was unable to state how this system of data collection was effective in monitoring the actual process to identify areas of needed improvement when the studies were consistently 100%. She further was unable to explain how the cooling process for previously cooked, potentially hazardous foods could be monitored without observing for potential fall-outs in the refrigerator, not just record reviews.

Based on document review and staff interview, the hospital failed to ensure that members of the medical staff were suspended for failure to complete medical records, in accordance with a provision of their bylaws.

Findings:

The Medical Staff Bylaws, Rules and Regulations were reviewed on 11/1/11. Section 6.4-4 states: "Members of the Medical Staff are required to complete medical records within such reasonable time as may be prescribed by the Executive Committee. A limited suspension in the form of withdrawal of admitting and other related privileges until medical records are completed shall be imposed...." Section VII. N. of the Medical Staff Rules and Regulations states that the patient's medical record shall be complete at the time of discharge. If the record remains incomplete for fourteen (14) days after discharge...the practitioner shall be suspended until the records have been completed.

The 11/1/11 suspension list was reviewed that afternoon. There were 14 physicians who had been suspended due to failure to complete medical records. On the afternoon of 11/2/11, a report listing all the physicians who had delinquent charts (those not completed within 14 days after discharge) was reviewed with the Health Information Management Director (HIMD). There were more than 190 physicians with delinquent records. The HIMD was unable to explain why only 14 physicians had been suspended.

Based on observation and interview, and document review, the hospital failed to safely store liquid narcotic pharmaceutical waste in a secure manner in three hospital areas, which had the potential for unauthorized individuals the access to the narcotic.

Findings:

During an observation on 10/31/11, at 11:55 AM, of the Four West Nursing Station, there was a small blue and white container, called "Pharma Safe," next to the Omnicell (an automatic medication dispensing unit) locked and secured to the wall, with a four inch yellow top opened for nurses to dispose of liquid narcotic pharmaceutical waste. Directly under the opening was a filter secured in place with black tape. The filter contained approximately an ounce of crystallized medication that was brown and yellow in color. The same small blue and white containers were also observed on the second and third floor nursing stations next to the Omnicell. They contained the same type of filter, and each contained approximately an ounce of crystallized medication that was brown and yellow in color. This crystallized matter was accessible by merely opening the yellow top of the waste container.

During an interview with the second floor Nurse Manager 2, on 10/31/11, at 11:53 AM, at the second floor nurses station, she stated, "These receptacles are just for liquid medications but sometimes we crush pills, clearly these wasted pills have not dissolved. It was created for narcotic waste."

During an interview with Registered Nurse A, on 10/31/11, at 11:53 AM, she stated, "We use these (Pharma-safe waste containers) to waste liquid narcotics. The box locks. We also waste crushed narcotics in this. I don't know what that dark stuff is in that filter."

During an interview with the Director of Pharmacy on 11/01/11, at 11:53 AM, referring to the Pharma-safe boxes, he stated, "We added the filter to these. It was used to prevent glass from going in there. These should be used for liquid narcotic dispensing only and we were having a problem with syringes and glass being thrown in them."

During an interview with the Environmental Services Director on 10/31/11, at 2:40 PM, he stated "I created the filters because people were throwing syringes in the Pharma-safe containers. I did it based on recommendations from the floor managers and the Pharmacist."

The hospital policy and procedure titled, "Pharmaceutical Waste", dated 2/11, indicated, "Small Blue and White Containers (Controlled Substances), Narcotic waste from partial unit doses, must be drained or squirted in this unit only. Unused narcotic oral medications should be crushed, mixed with a small amount of water and a slurry wasted into this unit only. EVS (Environmental Services will dispose of these units once weekly.)"

Based on observation and interview, the hospital failed to ensure that outdated and contaminated medications were removed from one location in the hospital, which had the potential for these deteriorated medications being available for use.

Findings:

During an inspection tour of the inpatient pharmacy located at the basement of the main campus with Director of Pharmacy (DPH) on 11/2/11, at 2:55 PM, a reconstituted (mixed with water) bottle of Cephalexin (medication used to treat infections caused by bacteria) 250 milligrams (mg) per 5 millimeters (ml) suspension was found on the bottom shelf inside the refrigerator across from the compounding intravenous room. The bottle was dated with an expiration of 10/30/11. In an interview with DPH at 3:03 PM, he acknowledged the content inside the bottle was expired and it was ready to be removed from the refrigerator.

Based on staff interview and document review, the hospital failed to provide qualified Registered Nurses (RN) in the GI (gastrointestinal) laboratory to perform circulating duties during surgical procedures in accordance with the State law, hospital policy, and nationally accepted standards for three of forty-five records reviewed. Such failure had placed patients' safety at risk when immediate nursing interventions would potentially not be available when needed.

Findings:

Review of the intra-procedural records for Patients 15, 24, and 25 on 11/2/11 indicated the signatures on their surgical records included a sedation RN (a nurse who administers sedatives), a scrub technician (or a surgical technologist who is responsible to assist the surgeon during procedures to make the procedure as smooth and efficient as possible), and a physician. No circulating registered nurses' signatures were found.

An interview was conducted with the GI Nurse Manager (GIM) on 11/2/11, at 11:45 AM, regarding staffing a RN circulating nurse during GI procedures. The GIM stated, "Only one licensed person (nurse) is necessary if moderate sedation is being provided. The (sedation) RN can provide minimal assist (meaning to assist the technician providing scrub/assist) if needed."

Review of the hospital policy titled, "Procedural Sedation," revised 03/11, under the section "Procedure," it read: "All moderate or deep sedation will be ordered and supervised by a qualified physician with procedural sedation privileges. A Registered Nurse (RN) with procedural competencies will monitor the patient and administer medications as ordered by and under the direct supervision of the physician. The monitoring RN will not be involved in the procedure or circulate."

A position statement from the California Board of Registered Nurses (BRN), effective January 2011, read, "The Board of Registered Nursing interprets any individual not licensed to practice professional nursing who performs scrub nursing functions may do so only as an assigned technical function under the direct supervision of a perioperative registered nurse."

The 2011 AORN Guidance Statement on Perioperative Staffing was reviewed 11/2/11. The Guidance recommended the minimum intraoperative requirements as: One RN per patient per OR in the role of the circulating nurse. One scrub person per patient per room (RN, LPN, or surgical technologist); in some circumstances a scrub person may not be required. One dedicated RN to manage moderate sedation different from the dedicated RN circulator.

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

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

This failure placed patients requiring moderate sedation at increased risk due to the inability of the sedation RN to detect potential complications early for during GI procedures.

Based on record reviews and staff interviews, the hospital failed to measure, analyze, track quality indicators of its nutrition and food services. This affected the hospital's ability to identify opportunities for improvement.

Findings:

During a concurrent interview and record review with both the Clinical Nutrition Manager (CNM) and the Director of Nutrition and Food Services (DNFS) on 11/2/11, at 11:35 AM, the department's Performance Improvement (PI) plan was reviewed. The DNFS stated the department was tracking the accuracy of patient meal trays to determine they were assembled in accordance with the patient's specific diet order. He further stated the data collected indicated the hospital's dietary services had 100% compliance and had been consistently met since 7/29/11. He went on to explain 100% compliance was achieved by capturing all fallouts and correcting them before trays left the kitchen. Therefore, with complete compliance no improvement would be needed.

A concurrent review of the PI plan quality indicator for tray accuracy showed 15 trays per week per campus were checked for accuracy. These trays were then corrected for errors before leaving the kitchen by the data collector and recorded as compliant. Therefore, 100% compliance was consistently met even though without the monitoring process, some trays would have left the kitchen with inaccuracies. The DNFS confirmed data collection after errors were corrected did not accurately capture the error occurred in the kitchen.

The DNFS stated the department was also tracking to be sure all foods requiring cooling would be cooled in accordance with HACCP (Hazard Analysis Critical Control Points - a management program in which food safety is addressed) requirements.

The hospital's HACCP Cooling Log for October 2011 was reviewed. The Cooling Log instructed the staff "Foods not used for immediate service must be cooled from 135?F TO 70?F within 2 hours and from 70? F to 41?F within an additional 4 hours for a maximum total cooling time of 6 hours.

According to the 2009 Food Code, excessive time for cooling or inappropriate cooling process of potentially hazardous foods (PHF) could cause food borne illness.

The DNFS stated this data collection was simply based on reviewing the documentation on the cooling logs to determine the non-compliance. He stated the audit could not capture cooked PHF not logged on the "Cooling Log." In addition, he stated the actual cooling process was not observed for appropriateness to ensure the staff followed the hospital's cooling procedures.

A review of the hospital's policy titled, "Organizational Performance Improvement Plan (PI Plan)," dated August 2011, on 11/1/11, revealed the purpose of the PI Plan was to ensure the Governing Body, medical staff, and professional staff demonstrate a consistent endeavor to deliver safe, effective and optimal patient care and services in an environment of minimal risk. It allowed for a systemic, coordinated, continuous, data-driven approach to improving performance focusing on process and mechanisms that address these values. It further stated monitoring is undertaken in order to identify and resolve any breakdown that may result in suboptimal patient care and safety, while striving to continuously improve and facilitate patient outcomes.

During an interview with the Director of Quality (DQ) on 11/2/11, at 3:30 PM, she stated she directed the DNFS to correct the trays for accuracy before the trays left the kitchen during the data collection process, then capture that data as being 100% in compliance. She was unable to state how this system of data collection was effective in monitoring the actual process to identify areas of needed improvement when the studies were consistently 100%. She further was unable to explain how the cooling process for previously cooked, potentially hazardous foods could be monitored without observing for potential fall-outs in the refrigerator, not just record reviews.

Based on record reviews and staff interviews, the hospital failed to measure, analyze, track quality indicators of its nutrition and food services. This affected the hospital's ability to identify opportunities for improvement.

Findings:

During a concurrent interview and record review with both the Clinical Nutrition Manager (CNM) and the Director of Nutrition and Food Services (DNFS) on 11/2/11, at 11:35 AM, the department's Performance Improvement (PI) plan was reviewed. The DNFS stated the department was tracking the accuracy of patient meal trays to determine they were assembled in accordance with the patient's specific diet order. He further stated the data collected indicated the hospital's dietary services had 100% compliance and had been consistently met since 7/29/11. He went on to explain 100% compliance was achieved by capturing all fallouts and correcting them before trays left the kitchen. Therefore, with complete compliance no improvement would be needed.

A concurrent review of the PI plan quality indicator for tray accuracy showed 15 trays per week per campus were checked for accuracy. These trays were then corrected for errors before leaving the kitchen by the data collector and recorded as compliant. Therefore, 100% compliance was consistently met even though without the monitoring process, some trays would have left the kitchen with inaccuracies. The DNFS confirmed data collection after errors were corrected did not accurately capture the error occurred in the kitchen.

The DNFS stated the department was also tracking to be sure all foods requiring cooling would be cooled in accordance with HACCP (Hazard Analysis Critical Control Points - a management program in which food safety is addressed) requirements.

The hospital's HACCP Cooling Log for October 2011 was reviewed. The Cooling Log instructed the staff "Foods not used for immediate service must be cooled from 135?F TO 70?F within 2 hours and from 70? F to 41?F within an additional 4 hours for a maximum total cooling time of 6 hours.

According to the 2009 Food Code, excessive time for cooling or inappropriate cooling process of potentially hazardous foods (PHF) could cause food borne illness.

The DNFS stated this data collection was simply based on reviewing the documentation on the cooling logs to determine the non-compliance. He stated the audit could not capture cooked PHF not logged on the "Cooling Log." In addition, he stated the actual cooling process was not observed for appropriateness to ensure the staff followed the hospital's cooling procedures.

A review of the hospital's policy titled, "Organizational Performance Improvement Plan (PI Plan)," dated August 2011, on 11/1/11, revealed the purpose of the PI Plan was to ensure the Governing Body, medical staff, and professional staff demonstrate a consistent endeavor to deliver safe, effective and optimal patient care and services in an environment of minimal risk. It allowed for a systemic, coordinated, continuous, data-driven approach to improving performance focusing on process and mechanisms that address these values. It further stated monitoring is undertaken in order to identify and resolve any breakdown that may result in suboptimal patient care and safety, while striving to continuously improve and facilitate patient outcomes.

During an interview with the Director of Quality (DQ) on 11/2/11, at 3:30 PM, she stated she directed the DNFS to correct the trays for accuracy before the trays left the kitchen during the data collection process, then capture that data as being 100% in compliance. She was unable to state how this system of data collection was effective in monitoring the actual process to identify areas of needed improvement when the studies were consistently 100%. She further was unable to explain how the cooling process for previously cooked, potentially hazardous foods could be monitored without observing for potential fall-outs in the refrigerator, not just record reviews.