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Based on observation, interview and record review, the Governing Body failed to ensure the facility functioned effectively, by failing to:

1. Protect and promote patients' rights to ensure patients were free from staff abuse by failing to follow facility policies and procedures to report abuse and investigate allegations immediately. (A115, A145);

2. Ensure the implementation of a hospital-wide, data-driven quality assurance and performance improvement program to ensure high quality healthcare and a safe environment by failing to analyze and trend operating room humidity, analyze data regarding cool down of potentially hazardous foods, analyze medical records delinquency data, and analyze diversion reports to identify loss or diversion of CS (A267, A276);

3. Provide pharmaceutical services in a safe environment to meet the needs of the patients as evidenced by the facility's failure ensure accountability procedures were in place and implemented to control the use of all CSs, and to identify loss or diversion in a manner to minimize the time frame between actual loss or diversion to the time of detection, investigate out of range temperatures in the medication refrigerators timely, ensure clinical pharmacists were competent to perform clinical monitoring of all Target Medications in accordance with the facility's policy and procedure (A494, A500); and,

4. Provide safe food services to patients, staff and visitors by failing to monitor cool down of PHF, dietary staff did not know or follow the proper procedure for cooling PHF and disaster food supplies were not adequate to meet patients' needs in the event of a disaster. (Refer to A620, A701 and A749).

The cumulative effect of these systemic problems resulted in failure of the governing body to ensure patients were receiving quality care in a safe and effective manner.

Based on interview and record review, the facility failed to protect and promote patients' rights for two patients (Patients 311 and 312):

1. The facility failed to have staff immediately report two incidences of staff abuse to two patients. The facility failed to follow their abuse policies and procedures for reporting allegations of abuse immediately to a supervisor, resulting in a delay in reporting, investigating, and protecting the safety and welfare of the two patients, as well as other patients, from the alleged perpetrator (A 145).

2. The facility failed to implement abuse policies and procedures that included a comprehensive investigation, protection of the victims, and timely reporting of allegations of abuse, according to all applicable federal, state and local laws and regulations.

Specifically the facility failed to:

a. Ensure the safety of Patient 311 by failing to take measures to protect the victim and conduct a thorough investigation. As a result of the failure to take immediate action against the alleged perpetrator, the facility created the potential for abuse towards other patients within the facility;

b. Ensure the safety of Patient 312 by failing to take measures to protect the victim and conduct a thorough investigation. As a result of the failure to take immediate action against the alleged perpetrator, the facility created the potential for abuse towards other patients within the facility;

c. Protect Patient 311 and other patients from further contact with the alleged perpetrator;

d. Protect Patient 312 and other patients from further contact with the alleged perpetrator;

e. Implement a policy and procedure that was complete and included vital components necessary for an effective abuse prevention program (prevention, screening, identifying, training, protection, investigation, and reporting).

The cumulative effect of these systemic problems resulted in the failure of the facility to protect all patients' right to be free from physical abuse.

Based on interview and record review, the facility failed to ensure two patients were free from staff physical abuse (Patients 311 and 312). This failure had the potential for injury to patients when staff are expected to protect patients in the facility.

Findings:

On November 3, 2011, at 3:30 p.m., an unannounced visit was made to the facility to investigate two allegations of staff abuse towards two patients (Patients 311 and 312), that occurred on October 30, 2011.

1. On November 3, 2011, at 4 p.m., the CN was interviewed. The CN stated on October 30, 2011, at approximatley 11 a.m., RN 1 placed Patient 311 in vinyl four point restraints (leather restraints applied to both arms and legs). RN 1 informed the CN Patient 311 was assaultive and throwing things.

On November 3, 2011, at 4:25 p.m., RN 2 was interviewed. RN 2 stated Patient 311 was eating and she threw an empty pudding cup and hit RN 2's chair. RN 2 then went to administer medications to her patients. RN 2 returned and she saw RN 1 had Patient 311 on the floor with his knees on her shoulder. RN 1 grabbed Patient 311's arm and grasped Patient 311's hair. RN 1 was not assigned to the care of Patient 311, and was passing by when she threw the empty pudding cup.

On November 9, 2011,at 3:45 p.m., CNA 1 was interviewed. CNA 1 stated Patient 311 threw an empty pudding cup and CNA 1 was about to pick up the pudding cup. RN 1 came by and asked CNA 1 if Patient 311 threw the cup. CNA 1 confirmed Patient 311 threw the pudding cup. RN 1 told Patient 311 to pick up the pudding cup. CNA 1 stated RN 1 grabbed Patient 311 by the hair and pulled her to the ground. According to CNA 1, RN 1 pinned Patient 311 on the ground and put his knee on her back. RN 1 stated Patient 311 was trying to bite him and informed CNA 1 to get the restraints. CNA 1 stated Patient 311 was struggling and looked upset. Four point restraints were applied to Patient 311's wrists and ankles. Patient 311 was restrained approximately 30 minutes until she was transferred to another facility.

On March 5, 2012, at 2:30 p.m., RN 2 was re-interviewed. RN 2 stated when she returned from administering her medications, she observed RN 1 pulling Patient 311 out of the chair by her hair. RN 2 stated she thought the treatment of Patient 311 was unusual, and she wanted to think she did not see what she did. RN 2 stated Patient 311 was placed in four point restraints.

On March 5, 2012, at 2:55 p.m., RN 3 was interviewed. RN 3 stated she was in the room with another patient and heard RN 1 yelling at Patient 311 to, "Pick it up." RN 1 was speaking rudely to Patient 311. She observed RN 1 had Patient 311 pinned down with her face on the floor, her arm was pulled behind her back. RN 1 had his knee in Patient 311's back and had a handful of her hair in his hand. RN 3 assisted Patient 311 in bed. Patient 311 was restrained with four point restraints. Patient 311 was helpless. RN 3 stated this incident made her mad. RN 3 thought about reporting this incident, but she did not act on it. RN 3 did not report the incident immediately. RN 3 and RN 2 went to the Nursing Supervisor the following morning to report RN 1.

RN 3 stated RN 1 was "sarcastic and rude" and "got irritated easily". RN 1 and RN 3 worked together approximately seven months.

On March 5, 2012, the record for Patient 311 was reviewed. The facility document titled, "Emergency Department," was reviewed. The document, dated October 29, 2011, at 9 p.m. indicated, "...Patient says she has SI, tried to run into traffic to kill herself but denies current SI..." Patient 311 was transferred at 11:30 a.m. to another facility on October 30, 2011.

The facility form titled, "Ongoing Assessment/Treatment Response," was reviewed. The form indicated, "...0940 Pt. uncooperative-manic, refused to gown. Medicated as ordered, 0940 Status 1:1 sitter changed to 1:1 from SI precautions. 1050 Pt. sitting on gurney eating box lunch 11:30 Dc'd to ETS..."

There was no documentation of Patient 311's behavior. There was no documentation or physician orders for four point restraints. There was no documentation of monitoring the restraints.

On March 5, 2012, at 12:50 p.m., the Assistant DON was interviewed. The Assistant DON stated RN 2, RN 3 and the CN met with the Nursing Supervisor the morning of October 31, 2011. She stated they were putting the pieces together concerning the incidents with RN 1. On the morning of October 31, 2011, it was determined the incidents should have been reported immediately.

On March 5, 2012, the facility policy and procedure titled, "Abuse, Neglect, and/or Domestic Violence: Assessment and Reporting," was reviewed. The policy stipulated, "...Suspected Physical Assault, Rape, or Other Sexual Molestation or Act of Violence Against a Patient: Immediately report the suspicion to your manager/supervisor..."

2. On November 3, 2011, at 4 p.m., the CN was interviewed. The CN stated he was notified of an incident that occurred on October 30, 2011, at approximately 4 p.m. The CN was notified staff were putting Patient 312 in restraints. RN 1 informed the CN Patient 312 was trying to hit RN 1. Patient 312 started to cry, and stated RN 1 was lying. Patient 312 had requested to file a complaint in writing. CNA 1 had delivered the complaint form to the CN and informed him Patient 312 did not deserve to be put in restraints.

On November 3, 2011, at 4:25 p.m., RN 2 was interviewed. RN 2 stated she was coming out of a room when she observed RN 1 was holding down Patient 312's right arm on the bed with his left hand. RN 1 had his right arm around Patient 312's neck. Patient 312's eyes were red and tearing up. RN 2 stated CNA 1, who was the sitter for Patient 312, stated she was going to tell someone. RN 2 did not report the incident.

On November 9, 2011, at 3:45 p.m., CNA 1 was interviewed. CNA 1 stated she was a sitter for Patient 312. Patient 312 had a cell phone and requested to call his mother. Patient 312 was talking on the phone when RN 1 told him to end the call. Patient 312 stated he just wanted to talk a couple more minutes. CNA 1 stated RN 1 tried to grab the cell phone out of Patient 312's hands and Patient 312 tried to keep it out of RN 1's hands. RN 1 grabbed Patient 312 by the hair and laid him back on the gurney. RN 1 started choking Patient 312. CNA 1 stated RN 1 used his right hand and grabbed Patient 312 around his neck and started squeezing. CNA 1 stated RN 1 instructed her to get the restraints. CNA 1 stated Patient 312 was crying and upset. In a continuing interview with CNA 1, she stated Patient 312 completed the complaint form. CNA 1 turned the complaint form into the CN. CNA 1 stated she informed the CN what she had witnessed.

On March 5, 2012, at 1:15 p.m., the CN was re-interviewed. The CN stated CNA 1 gave him the complaint form from Patient 312. The CN stated he did not read the form. The CN stated he slipped it under the door of the Nursing Supervisor.

On March 5, 2012, at 2:30 p.m., RN 2 was re-interviewed. RN 2 stated she had observed RN 1's hand around the neck of Patient 312. RN 2 called RN 1's name. RN 2 told CNA 1 to notify the CN about the incident. RN 2 did not notify the CN about the incidents with Patient 312.

On March 5, 2012, at 2:55 p.m., RN 3 was interviewed. RN 3 stated she was in another room taking care of another patient. RN 3 and the family of the other patient heard RN 1 yelling at a patient not to use his cell phone. The family was uncomfortable when they heard RN 1 yelling. RN 1 was getting louder and RN 3 left the patient room. RN 3 observed Patient 312 crying and Patient 312 asked RN 1 why he tried to choke him. RN 3 did not notify the CN about the incidents with Patient 312.

RN 3 stated RN 1 was "sarcastic and rude" and "got irritated easily". RN 1 and RN 3 worked together approximately seven months.

On March 5, 2012, the record for Patient 312 was reviewed. The facility document, dated October 30, 2011, at 2:55 p.m., titled, "Emergency Department," was reviewed. The document indicated, "...Placed on 5150 (hold due to danger to self or others) by police for reported suicidality." Further review of nursing notes at 4:15 p.m., indicated, "...Instructed to end phone call due to escalation. Pt. refused. Phone taken from pt. to put away. Pt drew back to hit RN. Pt. then taken down and placed in 4 point restraints...4:37 p.m. Pt. removed from restraints per MD request...9:45 p.m. Pt. transported to ETS. No signs of distress."

On March 5, 2012, the facility document dated October 30, 2011, at 4:40 p.m., titled, "Grievance/Complaint Form," was reviewed. The form indicated, "...RN 1 allowed me to use my cell phone to contact my mother, the nurse told me my time was up and reached for the phone, and I moved it away. The nurse proceeded to pull my hair and choke me out. He claimed I swung at him..."

On March 5, 2012, the copy of the timecard for RN 1 was reviewed. The time RN 1 clocked out on October 30, 2011, was 7:26 p.m. RN 1 completed his shift from 7 a.m. to 7 p.m.

On March 5, 2012, the facility policy and procedure titled, "Abuse, Neglect, and/or Domestic Violence: Assessment and Reporting," was reviewed. The policy stipulated, "...Suspected Physical Assault, Rape, or Other Sexual Molestation or Act of Violence Against a Patient: Immediately report the suspicion to your manager/supervisor...The suspected perpetrator should be removed from providing direct patient care/contact during the investigation and until all suspicion has been removed..."

On March 5, 2012, at 12:50 p.m., the Assistant DON was interviewed. The Assistant DON stated RN 2, RN 3 and the CN met with the Nursing Supervisor the morning of October 31, 2011. She stated they were putting the pieces together concerning the incidents with RN 1. On the morning of October 31, 2011, it was determined the incidents should have been reported immediately.

On March 5, 2012, the facility document titled, "Employee Handbook," was reviewed. The document indicated, "...ABC's of Abuse Reporting and Emergency Actions Report to WHO: Charge Nurse, House Supervisor, Social Worker, Department Manager, Administration WHEN: Report immediately or as soon as practically possible by phone...WHAT: Report exactly what the patient says and/or what has been observed..."

Based on interview and record review, the facility failed to ensure the implementation of a hospital-wide, data-driven quality assurance and performance improvement program that ensured high quality healthcare and a safe environment because:

1. Facility data regarding operating room humidity was not subject to analysis and trending, resulting in the risk of persistent substandard operating room environment and substandard healthcare for patients obtaining service in the operating rooms; and data regarding the cool down process of PHF was not tracked and analyzed, resulting in the risk of an outbreak of foodborne illness due to improperly cooled down food (A267);

2. The PI program failed to ensure that data regarding medical records delinquencies formed the basis for improvement and change in the medical record process, creating the risk of substandard healthcare associated with incomplete medical records ( A276);

3. The facility failed to ensure there was a system in place for tracking all code blue events requiring CPR (emergency treatment for heart or lung failure), creating the risk of unrecognized emergency response failures for all patients requiring an emergency response (A286);

4. The facility failed to ensure all code blues were subject to analysis per facility policy, creating the risk of persistent poor healthcare practices and substandard healthcare for all patients using the facility (A287); and,

5. The facility failed to ensure reports used to identify loss or diversion of CS were analyzed to minimize the time frame from loss or diversion to the time of detection. (A276).

The cumulative effect of these systemic problems resulted in the failure for the facility quality assurance, performance improvement program to ensure high quality healthcare and a safe environment for all patients.

2. During the initial kitchen tour, on February 27, 2012, at 11 a.m., the Supervising Cook stated food was prepared a day in advance and items to be cooled were placed in the "Blast Chiller," (blast chiller cools by using a fan inside a traditional refrigerator or to circulate the cold air. Blast chillers cool food faster than a regular refrigerator or freezer) prior to placing in the refrigerator for storage. Attached to the outside of the blast chiller was a document that indicated:

"IMPROPER COOLING IS THE MAJOR CAUSE OF FOODBORNE ILLNESS." The document indicated hot food must be cooled from 140 °F to 70 °F within 2 hours and from 70 °F to 41 °F within 4 additional hours. Additional instructions on the document indicated:

On February 27, 2012, at 11:45 a.m., a copy of the facility's food cool down policy and procedure was requested. The Interim Food Services Manager, stated the facility staff were in the process of training for food cool down monitoring, and there was no policy and procedure for the cool down process. The Manager stated they started documenting temperatures for the cool down process on February 15, 2012.

In an interview with the Interim Food Service Manager, on February 27, 2012, at 3:30 p.m., the Manager stated if food items do not reach 70 °F in two hours they would continue to cool the item for another two hours. The Manager stated they would also place the items into smaller pans to promote cooling. The Manager stated the "Cooling Temperature Log," was new.

In an interview with the Interim Manager and the Assistant Hospital Administrator, on February 27, 2012, at 3:45 p.m., the Manager stated the kitchen staff started monitoring food cooling temperatures to comply with Hazard Analysis Critical Control Point principles.

On February 27, 2012, the facility's "Cooling Temperature Log," was requested. Forms dated February 15 through February 27, 2012, were received and reviewed. The form had instructions that indicated: "Record temperatures every 2 hours during the cooling cycle and once more when item is transferred to refrigerator. Record corrective actions, if applicable...The Food Service Supervisor/Supervising Cook will verify that the foodservice staff is cooling food properly by visually monitoring foodservice employees throughout their shift. The log will then be turned in to P.M. supervisor at the end of day for final review. Staff will notify supervisor of any corrective action taken..." The form had areas to document the date, the food item, employee name, starting temperature, temperature after two hours, temperature after four hours, employee name, temperature when transferred and initials and verification date. At the bottom of the form was an area for the supervisor to sign and date the form after review.

A review of the logs indicated the facility was not following instructions on the form. The following was noted on the "Cooling Temperature Log," forms dated February 15 through 27, 2012:

Items cooked on February 17, 18, and 19, 2012, were not documented on forms;

45 % of the entries had temperatures at two hours greater than 70 °F;

Five items had temperatures recorded that did not meet the internal temperatures required by policy and procedure for cooked foods.

20 % of the documented items had no temperature recorded at two hours.

In an interview with the Interim Manager on February 27, 2012, at 4:45 p.m., the Manager stated the staff were not fully trained in using the form. The Manager stated if an item was documented on the form it was a previously cooked, PHF. The Manager stated she was unaware the supervisory staff were not reviewing the "Cooling Temperature Log," and that staff were not reporting out of range temperatures.

During an interview with the Manager of the Food Service Department on February 27, 2012, at 5:33 p.m., the Manager stated the cool down process for PHF should be monitored to ensure the item reached the temperatures required to prevent the growth of harmful microorganisms that cause food borne illness.

According to the 2009 US Food and Drug Administration's Food Code (3-501.14 Cooling) safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of PHF had been consistently identified as one of the leading contributing factors to foodborne illness. During slow cooling, PHF were subject to the growth of a variety of pathogenic microorganisms. If the food was not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness. The Food Code provision for cooling provides for cooling from 135 °F to 41 °F or 45 °F in 6 hours, with cooling from 135 °F to 70 °F in 2 hours.

The facility's policy titled, "Food Preparation and Service," dated August 1, 2008, was reviewed on February 28, 2012. The policy stipulated:
"21. Cooked potentially hazardous food shall be cooled within 2 hours from 60 °C (140 °F) to 21 °C (70 °F)."

During an interview with the facility's quality committee on March 1, 2012, at 1:05 p.m., the committee stated each department was responsible for collecting, analyzing and reporting data, and the quality department assisted with the process. According to the committee members, the departments are responsible for determining projects, but it was recommended each department had one QA and one PI project. Information was passed to the QA committee.

The facility Plan for Improving Organizational Performance 2011/2012 was reviewed and page 5 read in part, " Hospital managers/directors are responsible for, " Developing, measuring, analyzing, reporting and improving performance indicators; Ensuring that all necessary and required quality control programs are in place; Leading performance improvement activities in their area(s) of responsibility and evaluating results ... "

On March 1, 2012, at 2 p.m., the Director of Quality Management, was interviewed. The Director stated the QA projects Food and Nutrition service included accuracy of diet order, nutrition assessment by a dietitian and other clinical studies. The Director stated she was unaware the Food Services Department was not documenting temperatures related to the cool down process. The Director stated monitoring the temperatures were quality controls and she would expect the department to be documenting that information.


26881

Based on interview and record review, the facility:

1. Failed to ensure that facility data regarding operating room humidity was subject to analysis and trending, resulting in the risk of persistent substandard operating room environment and substandard healthcare for patients obtaining service in the operating rooms; and,

2. Failed to ensure facility data regarding the cool down process of PHF was tracked and analyzed, resulting in the risk of an outbreak of foodborne illness due to improperly cooled down food.

Findings:

1. During a review of the OR humidity data for November 23 through December 31, 2011, the data showed that operating room humidity documented was repeatedly lower than required by federal regulations (which require humidity to be controlled between 35% and 60%). The OR humidity readings were as low as 7.82%. A review of the OR log for November 28, 2011, showed that 29 surgeries were scheduled on that date, even though the documented humidity was below the accepted range in each of the operating rooms.

In an interview on February 28, 2012, at 4:45 p.m., the plant operation representative stated the facility's policy was to maintain the humidity between 30 and 60%, however the hospital did not have a written policy to reflect that practice. The plant operation representative further stated a humidity report was printed every morning at 6 a.m. The plant operation representative stated if the humidity levels were out of range, they "would try to correct it." "Sometimes I can." He stated the facility had sensors that needed replacing, therefore some of the levels being recorded were not accurate.

In an interview with the surgery manager, on February 28, 2012, at 5:10 p.m., the Surgery Manager stated her department does not check the temperature and humidity in the operating rooms. The surgery manager stated the plant operation department was responsible for monitoring the humidity in the operating rooms, and was supposed to notify them if the humidity was out of range. The surgery manager stated they would cancel or postpone surgeries if the humidity is out of range, but were dependent on plant operations to notify them if that was the case. The surgery manager stated they had not been notified today about the humidity levels being out of range, and no surgeries were postponed or cancelled due to the humidity of the room.

During an interview with the facility's quality committee on March 1, 2012, at 1:05 p.m., the committee stated that each department was responsible for collecting, analyzing and reporting data, and that the quality department assisted with the process.

The facility Plan for Improving Organizational Performance 2011/2012 was reviewed and page 5 read in part, " Hospital managers/directors are responsible for, " Developing, measuring, analyzing, reporting and improving performance indicators; Ensuring that all necessary and required quality control programs are in place; Leading performance improvement activities in their area(s) of responsibility and evaluating results ... "

Based on interview and record review, the PI program failed to

1. Ensure that data regarding medical records delinquencies formed the basis for improvement and change in the medical record process, creating the risk of substandard healthcare associated with incomplete medical records; and,

2. Ensure the monitoring reports were reviewed consistently to identify loss or diversion of CS resulting in the risk of substandard healthcare due to the facility's inability to minimize the time frame from loss or diversion of CS to the time of detection.

Findings:

1. The Medical Records Department 2011 PI Indicators information regarding delinquent medical records was provided by the Director of Medical Records. The number of delinquent inpatient and outpatient records, and the delinquency rate was identified quarterly. The information was displayed in tabular and graph form. The quarterly delinquency rates for 2011 were 42.9%, 42.4%, 41.7%, and 43.2%. The actions to be taken were noted as, " Continuously provide physicians charts to complete in a secured area that is convenient for them." And the Next Steps were identified as, " Continue to provide charts in secured locations for completion, encourage physicians to use electronic signature timely when frequent dictation utilized. "

The PIC and MEC quarterly minutes for 2011 were reviewed. The minutes indicated the same actions were recommended to improve the medical record delinquency rate each quarter, despite a lack of improvement in the delinquency scores. There was no evidence of analysis to determine the cause of the failure to improve with those interventions.

In an interview with the Director of Medical Records on March 5, 2012, at 12:40 p.m., she stated delinquent medical records had been discussed at the Quality Committee, but no facility-wide response had been implemented. She stated the outcome of the actions listed on the PI Indicators report was no improvement, "status quo". She stated there was no schedule for the physicians to meet with medical records, and no documentation the physicians had been contacted regarding completing their records. She stated physicians were not suspended for failing to complete medical records within 14 days.

During a review of the Plan for Improving Organizational Performance 2011/2012 (MEC approved 7/14/11), the Plan read in part on page 7, "The Performance Improvement Committee functions is an oversight committee for all performance improvement activities in the clinical and service areas", and "The Committee has the following responsibilities: ...Providing direction in aggregating data/information, analyzing hospital wide performance improvement activities and assisting with follow-up actions", and "Identifying and recommending appropriate multidisciplinary team activity to continually improve care and service using the Plan, Do, Check, Act (PDCA) model."

2. On March 2, 2012, at 10 a.m., a review of the facility's monthly Proactive Diversion Report for the past year revealed the diversion monitoring was not consistent. The reports listed high users with the SD greater than two. The pharmacy review of the diversion report was limited to high users with SD greater than four. A few staff names with "terminated" written in ink next to their names was noted on the top portion of the report indicating access to CSs with greater frequency compared to their peers.

During a concurrent interview, Pharmacist 500 stated the nurses were "terminated" to indicate there was diversion of CSs by those users.

PT 500 also stated that the Proactive Diversion Report was reviewed by the Pharmacy every month as indicated in the facility's policy and procedure but was not consistently reviewed every month.

The report was reviewed for 14 months from January 2011 to February 2012. There was documentation of pharmacy reviews for April, July, August, and October, 2011. There was no documentation to indicate a pharmacy review for ten of the 14 months.

A review of the facility's policy and procedure titled, "Drug Diversion Monitoring and Reporting" indicated the following to be performed by nursing:

1. "A proactive Diversion Report will be printed by pharmacy and reviewed by the pharmacy manager (or designee), monthly, as a screening tool for ADC users that have removed larger than normal quantities of CSs. Pharmacy will review the previous month's findings. Managers may request the above report(s) at any time for review in the event of questionable employee behavior or other indices of suspicion."

2. "Based on the results from the Proactive Diversion Report, the pharmacy manager (or designee), will print and review an ADC Transaction Report for those ADC users statistically identified as being three SD above the mean for narcotic withdrawals. The review will focus on key points, excessive (or lack of) discrepancies, excess (or lack of) waste with the same witness, removals from multiple ADCs, or anything otherwise unusual."

During an interview on March 2, 2012, at 11:40 a.m., RN 502, a nurse manager, stated RN 503, one of the users on the Proactive Diversion Report with "terminated" written next to the name, was terminated as a result of suspicious activity reported to her by another nurse who witnessed RN 503 in the room of a patient not assigned to him on November 11, 2011.

RN 502 stated that investigation of RN 503's CS activity was conducted and that RN 503 eventually confessed to diversion of CSs. RN 502 stated that the investigation was still not completed (almost four months later) to determine the extent of diversion.

A review of the monthly Proactive Diversion Report revealed that RN 503 was consistently among the top users of CSs with a SD ranging from 4 to 5 going back to January 2011.

During a concurrent interview, DOP and RN 502 were unable to explain why it took 9 months or possibly longer to identify RN 503 was diverting CSs.

The facility was unable to provide evidence to indicate a timely investigation was conducted to minimize the duration of drug diversion.

Based on interview and record review, the facility failed to ensure a system was used to track all code blue events requiring CPR (emergency treatment for heart or lung failure), creating the risk of unrecognized emergency response failures for all patients requiring an emergency response.

Findings:

On February 27, 2012, the facility was presented with a list of requested documents, including a request for the record of code blues that occurred in the facility. On February 27, 2012, the facility provided a log labeled Code Blue Notification Log 2011. The log contained just one code blue in the emergency room (ER) for a 6 month period, during which approximately 50,000 patients were seen in the ER.

A more complete log was requested, and on February 28, 2012, a document labeled Code Blue Log August 2011 to January 2012 was presented, which again showed only one code blue in the ER during the same 6 month period. A more complete log was again requested, and the facility presented the AHA-GWTG Resuscitation Log, which included five code blues in the ER during the August 1, 2011 to January 15, 2012 time period, not including codes in which resuscitation was begun prior to arrival at the facility. Comparing the AHA-GWTG log to the facility code blue log, there were nine code blues requiring resuscitation that did not appear on the Code Blue Log August 2011 to January 2012. Conversely, there were 12 incidents on the Code Blue Log August 2011 to January 2012 that did not appear on the AHA-GWTG Resuscitation Log.

A third log, requested from the Medical Records Department, of the patients whose care included CPR (a treatment administered during a code blue). The logs were titled, "Inpt-CPR and Outpt-CPR (inpatient and outpatient cardiopulmonary resuscitation)." The Inpt-CPR log showed 22 inpatients having CPR during the August 1, 2011 to January 15, 2012 period. Of the 22 patients on the Inpt-CPR log during the August 1, 2011 to January 15, 2012, 13 were not on the Code Blue Log August 2011 to January 2012, and 11 were not on the AHA-GWTG Resuscitation Log. The Outpt-CPR log listed 28 code blue incidents in the ER during the August 1, 2011 to January 15, 2012 time period. The Outpt-CPR log contained two of the five ER code blues listed on the AHA-GWTG Resuscitation Log.

During an interview with the Quality Manager on February 28, 2012, at approximately 10 a.m., she stated she obtained information about code blues from overhead pages, copies of code records, code critiques and incident reports, which were supposed to be filed on all codes. She stated that the codes were verified and placed on the AHA-GWTG Resuscitation Log.

When the Quality Manager RN was asked about the discrepancies between the different logs regarding code blues, she stated the Code Blue Log August 2011 to January 2012 was the "master log".

The Code Blue Log August 2011 to January 2012 was reviewed and did not include the code blue of Patient 707 on October 28, 2011.

The QM stated the code blue of Patient 707 should have been included on the Code Blue Log August 2011 to January 2012. The QM RN was also shown the Inpt-CPR and Outpt-CPR logs, and she stated she had not seen the logs and was uncertain why there were inpatient CPR episodes that were not included in the code blue "master log".

The facility policy, Code Blue (revised January 22, 2010), read in part, "A Code Blue shall be called for all patients in respiratory and/or cardiac arrest except for patients who have a valid "Do Not Resuscitate" (DNR) order...", and "A Code Blue Critique will be completed for all Code Blue calls. All Code Blue Critique forms will be forwarded to Quality Management Department for review and aggregation of data."

Based on interview and record review, the facility failed to ensure all code blues were subject to analysis per facility policy, creating the risk of persistent poor healthcare practices and substandard healthcare for all patients using the facility.

Findings:

A code blue case was selected for review. According to the Interdisciplinary Patient Progress Notes, Patient 707 was the subject of a code blue on October 28, 2011, at 9:55 p.m. Prior to the code blue, at 9:30 p.m., the patient's oxygen saturation declined to approximately 40% (normal is greater than 94%), and she was noted to be breathing rapidly. At 9:45 p.m., the doctor was contacted, and stated that he would come to see the patient. Patient 707's oxygen saturation again decreased to the 30 % range prior to the code blue. The patient was transferred to the intensive care unit (ICU) at 10:45 PM.

During an in interview with the QA Mgr on February 28, 2012, at approximately 10 a.m., she stated that the QM RNs reviewed the medical records of all code blues for, among other things, missed opportunities for intervention prior to the code.

During an interview with the QM RN on March 1, 2012, at 3:20 p.m., she stated she was one of the nurses who reviewed code blues to see if there was a possible missed opportunity
for intervention prior to a code blue. She stated that she had not reviewed the case, but she thought that Patient 707 met criteria for a Rapid Response Team intervention. She stated the case should have been identified for review, but there was no evidence that it was sent for such review. Also, she stated because the code occurred outside of the ICU, it should have been sent for physician peer review. She stated she believed it had been sent for peer review, but was unable to give a date when it had been sent. She stated that usually the code blue incidents were reviewed within 30 days, but for Patient 707 there was no evidence of completed peer review 4 months after the incident.

The Medical Staff Peer Review Criteria (undated) read in part, "The medical staff of RCRMC has identified the following hospital-wide indicators, which will require peer review by all clinical departments/divisions. Hospital-wide indicators: ...Unexpected ICU admissions".

Based on interview and record review, the facility failed to ensure one of one PA who was granted privileges to perform moderate sedation (sedation of a patient prior to performing a procedure that, if done incorrectly, could result in airway, breathing, and cardiac complications) met the criteria established by the medical staff. This failure resulted in the potential for patients to be under or over sedated, and the potential for patient harm or death.

Findings:

The credential file for PA 1 was reviewed on March 5, 2012. The file indicated PA 1 requested and was granted ED privileges on November 2, 2010. The privileges included performing moderate sedation.

The privileging document indicated to be eligible for moderate sedation privileges, the applicant must:

1. Meet the qualifications as outlined in policy 628, Moderate Sedation/Analgesia;

2. View the Sedation Care training video or the online sedation training presentation;

3. Take and pass a written moderate sedation exam; and,

4. Successfully complete one proctored moderate sedation case under the direction of a facility practitioner holding the privilege.

The facility policy 628 titled, "Moderate (Conscious) and Deep Sedation/Analgesia," was reviewed on March 5, 2012. The policy indicated the following:

1. Moderate sedation would be provided to patients by appropriately qualified and competent staff;

2. The, "physicians," administering sedation would be qualified and have the appropriate credentials to manage the patient (there was no information regarding PAs); and,

3. Requirements for administering moderate sedation included being a MD or DO licensed independent practitioner, taking the moderate sedation course, passing a written exam, and completing one case under direct supervision.

There was no evidence in the credential file the PA was a qualified licensed independent practitioner, had taken a course, had taken and passed a written test, or had completed a case under direct supervision.

During an interview with the Medical Staff Administrator on March 5, 2012, the administrator stated the PA did not meet requirements for moderate sedation privileges and should not have been granted them.


26881

Based on interview and record review, the facility failed to ensure the medical staff enforced its bylaws by failing to ensure:

1. physicians completed medical records within 14 days, and there was no suspension of non-compliant physicians, creating the risk of substandard patient care due to incomplete documentation of medical conditions and treatments;

2. for two medical records (Patient 708 and 709), the physician signature was legible; and,

3. for one medical record (Patient 708), the handwritten progress note contained legible writing, creating the risk of substandard patient care due to inability to identify physician providers or the inability to read the progress note.

Findings:

1. A Provider Delinquency Summary, dated, March 2, 2012, was reviewed on March 5, 2012. The Summary presented a list of providers who were delinquent in completing medical records, and showed 207 providers to be delinquent in completing records, with 1121 of 1358 medical records associated with those providers to be delinquent, and an average duration of delinquency of 43 days.

During an interview on March 5, 2012, at 1:40 p.m., the Director of Medical Records concurred some charts were delinquent. She stated that there was no policy on actions to be taken if charts were not completed within 14 days. She stated that physicians could have charts that were 100 days delinquent without being suspended.

The Dir MR stated that the Medical Records Department attempted to obtain complete records by bringing the records to the physician when he or she was available, such as during a clinic time. She stated that the procedure was for medical records assistant to take the charts to where the physicians were, such as an outpatient clinic, and leave them in the clinic work room in the hope that the physicians would see that the records were there to be completed. She stated that there was no schedule for the physicians to meet with medical records, and no documentation that the physicians had been contacted regarding completing their records.

The CMO was interviewed on March 5, 2012, at 12:05 p.m., and he stated the availability of medical records that needed signatures was a problem, because the records might be in use in a clinic when the physician was available to sign them. He concurred the duration of the delinquencies listed on the Provider Delinquency Summary, which included records up to 587 days delinquent, could not all be explained by the medical record being in outpatient clinics. He stated that physicians were not given a list of delinquent medical records to follow up on. He stated that there were cases of physicians being disciplined for not completing the medical records, but that there was no policy to suspend or take other actions against noncompliant physicians.

The Medical Staff Bylaws 2011-2012 read in part, "8.3-4 Medical Records. Members of the medical staff are required to complete medical records within such reasonable time as may be prescribed in the Medical Staff Rules and Regulations. A limited suspension in the form of withdrawal of admitting and other related privileges until medical records are completed, shall be imposed by the medical director, or designee, after notice of delinquency for failure to complete medical records within such period. ...The Suspension shall continue until lifted by the medical director or designee. "

The Medical Staff Rules and Regulations 2011-2012 read in part, "12. Medical Record. All patients' charts shall be completed fourteen (14) days after discharge. "

2. The medical records of Patient 708 and 709 were reviewed on March 2, 2012. For Patient 708, a progress note on October 31, 2011, contained illegible writing and an illegible signature, and there was no signature stamp or printed signature to identify the author. For Patient 709, the ER record contained an illegible signature of a resident physician on a note dated November 3, 2011.

During an interview with the DTN RN Manager and an Administrative Staff on March 2, 2012, at 11:15 a.m., they reviewed the notes and concurred the October 31, 2011 note for Patient 708 was partially illegible, and the author's name could not be identified because the signature was illegible. They concurred that the signature of the physician on Patient 709 ' s ER record was illegible. The DTN RN Mgr stated that the first and last name were to be printed or stamped, per policy, to identify the author.

The Physician Reference Manual (page undated), page 49, was reviewed, and read in part, "All chart entries must be legibly written using black or blue ink. Entries are to be authenticated by an identifiable signature and printed name of the treating physician. Residents are provided a rubber stamp of their name ..."

Based on interview and record review, for one physician (DR 1), the facility failed to ensure physician training and experience were considered prior to granting privileges in surgical subspecialties because evidence of training and experience in those subspecialties was not documented. This created the risk of substandard healthcare services provided to patients cared for by that physician.

Findings:
The General Surgery Department Call Schedule for February 2012 was reviewed and indicated DR 1 was scheduled to be the on call attending surgeon for four 24 hour shifts.

The General Surgery Department Call Schedule was discussed with the Assistant Nurse Manager of the ED on March 1, 2012, at 9:50 a.m. He stated the on-call attending physicians stayed in the facility and responded to trauma cases during their call period.

The MEC minutes from October 13, 2011, were reviewed and showed DR 1 was approved for a provisional appointment in the general surgery department.

During a review of the credential file of DR 1 on March 2, 2012, the file contained a copy of privileges granted in general surgery and in adult and pediatric trauma surgery. However, the file did not contain evidence of specific training or experience in adult or pediatric trauma surgery. The records showed that DR 1 completed a residency in general surgery and had privileges in general surgery at another facility. There was no documentation of his participation in trauma cases.

In an interview with the MS Administrator on March 2, 2012, at 11 a.m., she stated there was no history of surgery activity in DR 1's file, and that his experience did not appear to be documented per facility policy.

In an interview with the CMO on March 1, 2012, at 2 p.m., he reviewed the contents of DR 1's file and concurred that there should be evidence of experience with trauma cases in the file.

The Medical Staff Bylaws 2011-2012 were reviewed, and they read in part, "7.2-2 Basis for Privileges Determination. Request for clinical privileges shall be evaluated on the basis of the member's education, training, experience, and demonstrated ability and judgment. The elements to be considered in making determination regarding privileges, whether in connection with periodic reappointment or otherwise, shall include education, training, observed clinical performance and judgment, performance of a sufficient number of procedures each year to develop and maintain the practitioner's skills and knowledge ..."

3. Patient 704's record was reviewed on February 29, 2012. Patient 704 was discharged from the facility on February 27, 2012. The record contained a Multidisciplinary Therapeutic Care Plan with several goals elaborated on pages 2 and 3, including, "Patient will state 3 reasons for not hurting self/others," "Will demonstrate (2) skills learned to redirect aggressions," and "verbalize 3 ways to cope with anger." The goals were initiated on February 22, 2012. A line was drawn across the goals and the note, "resolved February 27, 2012" was written next to the line.

During a review of the multidisciplinary daily notes, no subsequent assessment of Patient 704's ability to meet the specific goals was seen.

In an interview with the RN Manager ETS, she reviewed the medical record of Patient 704 and concurred no reassessment of the patient using the specific care plan goals was seen during the admission. She stated that specific goals should be reassessed each shift to determine whether the goals had been met.

The facility policy, "Treatment Planning", revised "7/23/07", read in part, "On a daily basis (or per specified discipline requirement), each discipline shall record in the progress notes the patient's progress in achieving the treatment goals and objectives."


25624

Based on interview and record review, the facility failed to ensure consistent assessments and documentation were completed; 1. For one patient that had a wound, (Patient 301), and 2. For one patient that had been identified with a pressure ulcer (Patient 307). This failed practice could contribute to lack of intervention, or further breakdown of skin integrity. The facility also failed for one of one patient, Patient 704, to ensure specific care plan goals were reassessed and reformulated, if needed during hospitalization, creating the risk of substandard therapy for that patient.

Findings:

1. On February 28, 2012, the record for Patient 301 was reviewed with RN 4. Patient 301 was admitted to the facility on January 12, 2012, with diagnoses that included tuberculosis and acute renal insufficiency. The record indicated the following:

a. The skin assessment for February 21, 2012, at 8:55 a.m., indicated, "Patient has oozing open areas to neck and under left armpit...";
b. The skin assessment for February 21, 2012 at 8:05 p.m., indicated, "Skin WDL yes...";
c. The skin assessment for February 22, 2012, at 8 p.m., indicated, "Skin assessment Patient has raised nodules to neck, armpit, and lower abdomen/groin..."; and,
d. The skin assessment for February 23, 2012, at 4:09 p.m., February 25, 2012, at 10:19 a.m., and February 26, 2012, at 9 p.m., "Skin WDL yes..."

In a concurrent interview with RN 4, she concurred the assessments and documentation for Patient 301's wound were not consistent.

2. On February 28, 2012, the record for Patient 307 was reviewed with RN 5. Patient 307 was admitted to the facility on February 13, 2012, with diagnoses that included chest pain, diabetes, and hypertension. There was no evidence of skin breakdown upon admission. The record indicated the following:

a. The facility document titled, "Interdisciplinary Patient Progress Notes," indicated on February 17, 2012, at 8:30 p.m., ..."Duoderm on sacrum/coccyx in place...";
b. The skin assessment for February 25, 2012, at 6:02 p.m., indicated, "Skin WDL yes...";
c. The skin assessment for February 25, 2012, at 8 p.m., indicated "...Pressure sores yes Pressure ulcer site 1 sacrum healing...";
d. The skin assessment for February 26, 2012, at 8:20 p.m., indicated, "...Skin WDL yes...";
e. The Progress Notes for February 26, 2012, at 10:25 p.m., there was no reference to Duoderm or a pressure ulcer; and,
f. The Progress Notes for February 27, 2012, at 8:45 a.m., indicated, "...Old healed scab on buttox and below old healed is new stage 2 x 2 dots open...Stage 2..."

There was no documentation the physician was made aware of Patient 307's skin integrity until February 27, 2012. There were no physician orders for wound care until February 27, 2012.
In a concurrent interview with RN 5, she concurred the assessments and documentation were not consistent for Patient 307. RN 5 was unable to determine the skin status for Patient 307.

On March 5, 2012, the facility policy and procedure titled, " Pressure Ulcer Prevention and Management, " was reviewed. The policy stipulated, "Reassessment: Skin/Wound: Reassess daily...Notify physician for: All new pressure ulcers..."

Based on observation, interview, and record review, the facility failed to ensure four of four ICU nurses (ICU CN 1, ICU RN 1, 2, and 3) demonstrated competence in recovering patients from surgery and anesthesia prior to assigning them the task. This failure resulted in the potential for complications related to surgery and anesthesia to go unrecognized and untreated, and the potential for harm and death to ICU patients.

Findings:

MH is a rare life threatening condition triggered by the use of general anesthetic agents that results in severe hyperthermia [high body temperature] the symptoms usually develop within one hour, but may even occur several hours later. The treatment includes IV dantrolene and must be started immediately upon recognition of the condition.

1. During a tour of the ICU on February 27, 2012, at 2:05 p.m., accompanied by ICU CN 1, the CN stated patients came to the ICU directly from the OR to be recovered. The CN stated the most common type of patient being recovered in the ICU included post operative carotid endarterectomies (a procedure used to prevent stroke by correcting narrowing of the carotid artery(ies)), tracheostomies (opening the windpipe through the neck to insert an airway), thoracotomies (cutting through the chest wall to allow access to the lung), patients on ventilators (breathing machines), and patients who went to the OR from the ICU.

The CN stated she had not received training specific to recovering patients from anesthesia, but she knew she should monitor for hypothermia (low body temperature). She stated she did not know what MH was, what medications were given for MH, or how to access a MH cart.

The employee file for ICU CN 1 was reviewed on March 2, 2012. There was no evidence in the file ICU CN 1 had received training or demonstrated competency in recovering patients from surgery and anesthesia.

2. During a tour of the ICU on February 29, 2012, at 11:25 a.m., the room for Patient 101 was observed to be empty. The patient's primary nurse, ICU RN 1, stated the patient went to the OR for an orthopedic surgery. ICU RN 1 stated the patient would return after surgery and would be recovered by him in the ICU. The RN stated he had not received specific training in recovering patients from anesthesia, but he knew he should monitor for hypothermia (low body temperature). He stated he did not know what MH was, what medications were given for MH, or how to access a MH cart.

The record for Patient 101 was reviewed on February 29, 2012. Patient 101, a 50 year old female, was admitted to the facility on February 26, 2012, with diagnoses that included multiple trauma, brain injury, and multiple fractures.

The record indicated the patient had surgery for repair of multiple fractures on February 29, 2012. The patient was transferred to the ICU to complete her postoperative recovery, and was assigned to ICU RN 1.

The employee file for ICU RN 1 was reviewed on March 2, 2012. There was no evidence in the file ICU RN 1 had received training or demonstrated competency in recovering patients from surgery and anesthesia.

3. During an interview with ICU RN 2 on March 1, 2012, at 10:35 a.m., the RN stated patients came directly to the ICU for recovery after surgery. The RN stated he had not received specific training in recovering patients from anesthesia. He stated he did not know what MH was, what medications were given for MH, or how to access a MH cart.

The employee file for ICU RN 2 was reviewed on March 1, 2012. There was no evidence in the file ICU RN 2 had received training or demonstrated competency in recovering patients from surgery and anesthesia.

4. The record for Patient 208 was reviewed on March 1, 2010. Patient 208, a 61 year old male, was admitted to the facility on February 27, 2012, with diagnoses that included perforated (punctured) gall bladder.

The record indicated the patient went to surgery for repair of the gallbladder on February 27, 2012, then was sent directly to the ICU for postoperative recovery and assigned to ICU RN 3.

The employee file for ICU RN 3 was reviewed on March 2, 2012. There was no evidence in the file ICU RN 3 had received training or demonstrated competency in recovering patients from surgery and anesthesia.

The facility policy titled, "Transfers: Adult Critical Care Unit - Post Operative," was reviewed on March 2, 2012. The policy stipulated the anesthesiologist in conjunction with the operating surgeon would designate which patients were to go directly to the ICU. The policy further stipulated patients eligible for direct transfer from the operating room to the ICU were patients who came from the ICU for surgery, patients who were critically ill and unstable, or patients who required prolonged mechanical ventilation (breathing machine).

During an interview with the ICU NM on March 5, 2012, at 10 a.m., the NM stated patients were recovered from surgery and anesthesia in the ICU. She stated the ICU nurses had not been trained or demonstrated competency in recovering patients from surgery and anesthesia.

Based on interview and record review, the facility failed to ensure ICU nurses administered sedation as ordered by the physician for one of one patients (Patient 101). This failure resulted in the potential for the patient to be under or over sedated, and the potential for harm to the patient.

Findings:

Definition: The Ramsay score is based on a scale that scores sedation at six different levels, according to how rousable the patient is. The scale indicates the level of sedation as follows:

1 - Patient is anxious and agitated or restless, or both;

2 - Patient is cooperative, oriented, and tranquil;

3 - Patient responds to commands only;

4 - Patient exhibits brisk response to light tap or loud stimulation;

5 - Patient exhibits a sluggish response to light tap or loud stimulation; and,

6 - Patient exhibits no response.

The record for Patient 101 was reviewed on March 1, 2012. Patient 101, a 50 year old female, was admitted to the facility on February 26, 2012, with diagnoses that included multiple trauma, brain injury, and multiple fractures.

The physician's orders for analgesia and sedation dated February 26, 2012, indicated the patient should receive propofol (for sedation) and the medication should be titrated to maintain a Ramsay score of three.

The ICU nursing flowsheet indicated the following:

1. On February 27, 2012, the patient was not assessed to determine a Ramsay score from admission to the ICU at 12:15 a.m., through 8 a.m.;

2.On February 27, 2012, the Ramsay score at 10 a.m., and at 12, 2, and 4 p.m. was four. There was no evidence the medication was titrated to change the score to three;

3. The Ramsay score at 8 p.m. was four. The medication was titrated down, and there was no repeat assessment to determine a Ramsay score until 7 p.m. on February 28, 2012 (23 hours later).

During an interview with the ICU NM on March 1, 2012, at 11:40 a.m., the NM stated the sedation should be titrated to attain the ordered Ramsay score, and the Ramsay should be documented on the flowsheet to ensure the sedation was effective, but not, "too much."

Based on interview and record review, the facility failed, for one patient, Patient 706, to ensure drugs were administered as ordered . Patient 706 was administered medication in excess of the physician-ordered dosage, creating the risk of a substandard health outcome for that patient due to overmedication.

Findings:

During a tour of the PACU on February 27, 2012, at 1:50 p.m., the record of Patient 706 was reviewed. The record contained a notation in the Post Anesthesia Record that Patient 706 received Dilaudid (a strong pain reliever) 1mg at 1 p.m. The pain scores documented on the same page indicated that Patient 706 had been found to have a pain score of 0/10 (no pain) at 12:55 p.m., 1:10 p.m., 1:25 p.m., and 1:40 p.m. The physician order for Dilaudid indicated Dilaudid .25 mg IV for mild pain (pain score 1-3), Dilaudid .5 mg IV for moderate pain (pain score 4-6) and Dilaudid 1 mg IV for severe pain (pain score 7-10).

During an interview on February 27, 2012, at 1:50 p.m., with RN 7, who was caring for Patient 706, she stated the patient had a pain score of 5/10. When asked why she had given the patient 1 mg of Dilaudid instead of the .5mg dose that was ordered for the moderate pain level, she stated, "because her vital signs were stable."

During an interview with the DPharm on March 5, 2012, at 2 p.m., he stated Patient 706 should not have been given medication in excess of the ordered dose, and should not have been given pain medication without a need for pain relief being established.

Based on interview and record review, the facility failed to ensure that medical records were completed within 14 days after discharge, creating the risk of substandard patient care for patients with those incomplete records, due to potential incomplete documentation of medical conditions and treatments.

Findings:

A Provider Delinquency Summary, dated March 2, 2012, which presented a list of providers who were delinquent in completing medical records, was reviewed on March 5, 2012, and showed 1121 of 1358 medical records associated with those providers to be delinquent, with an average duration of delinquency of 43 days.

During an interview with the Director of MR on March 5, 2012, at 1:40 p.m., she stated she did not believe the delinquency data was correct, but concurred that some charts were delinquent. She stated there was no policy on actions to be taken if charts were not completed within 14 days. She stated physicians could have charts that were 100 days delinquent without being suspended. The Director of MR stated that there were individual summaries of chart delinquencies by physician that were more accurate.

The individual chart delinquency summary of DR 2, who per the Provider Delinquency Summary had 13 delinquent records, an average of 56 days delinquent, was requested. Upon review of DR 2's summary, the number of delinquent records, and average number of days delinquency, appeared to be the same as on the Provider Delinquency Summary.

The Director of MR stated that the Medical Records Department attempted to obtain complete records by bringing the records to the physician when he or she was available, such as during a clinic time. She stated that the procedure was for medical records assistant to take the charts to where the physicians were, such as an outpatient clinic, and leave them in the clinic work room in the hope that the physicians would see that the records were there to be completed. She stated that there was no schedule for the physicians to meet with the Medical Records Staff, and no documentation that the physicians had been contacted regarding completing their records.

The CMO was interviewed on March 5, 2012, at 12:05 p.m., and he stated the availability of medical records that needed signatures was a problem, because the records might be in use in a clinic when the physician was available to sign them. He concurred that the duration of the delinquencies listed on the Provider Delinquency Summary, which included records up to 587 days delinquent, could not all be explained by the medical record being in outpatient clinics. He stated that physicians were not given a list of delinquent medical records to follow up on. He stated that there were cases of physicians being disciplined for not completing the medical records, but that there was no policy to suspend or take other actions against noncompliant physicians.

The Medical Staff Rules and Regulations 2011-2012 read in part, "12. Medical Record. All patients' charts shall be completed fourteen (14) days after discharge."

Based on observation, interview, and record review, the facility failed to provide pharmaceutical services that meet the needs of the patients as evidenced by the facility ' s failure to:

1. Review before dispensing of controlled substances of IV (intravenous) infusion upon refill request to ensure appropriate use;

2. Maintain proper temperature of the medication refrigerators located throughout the facility and investigate and resolve in a timely manner when identified as having issues with maintaining the temperature range;

3. Ensure Provision of pharmacy services that distributed and delivered all medications needed without potential delay of administration of medications;

4. Provide pharmacy services that included all clinical pharmacists with competency and knowledge to perform clinical monitoring of all Target Medications in accordance with the facility's policy and procedure;

5. Keep and provide emergency medication necessary to treat MH as recommended by the the MHAUS and in accordance with the facility's policy and procedure;

6. Ensure integrity of pharmacy compounded intravenous solutions by not including expiration dates on the pharmacy label in accordance with State regulations;

7. Place content lists that were readily visible from outside the "Intubation Box Trays", (A500);

8. Administer medication not in excess of the physician-ordered dosage for one patient, Patient 706, creating the risk of a substandard health outcome for that patient due to over-medication (A500);

9. Provide one patient, Patient 705 with instructions about medications upon discharge from the facility, and document accurate medication allergies, creating the risk of a poor health outcome from an allergic reaction or incorrect medication regimen (A500);

10. Ensure patient medications and information were secured and protected (A502);

11. Ensure that accountability procedures were in place and implemented to control the use of all controlled substances (CSs), and to readily identify loss or diversion of all CS in such a manner as to minimize the time frame between the actual loss or diversion to the time of detection and determination of the extent of loss or diversion (A494); and,
12. Ensure unusable medications were not available for use and failed to dispose patient's medications brought into the hospital from home that were not returned at the time of discharge in a timely manner according to the policy and procedure (A505).

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

Based on observation, interview, and record review, the facility failed to ensure accountability procedures were in place and implemented to control the use of all CS, and to readily identify loss or diversion of all CS. This failure resulted in the inability to minimize the time frame between the actual loss or diversion to the time of detection and determination of the extent of loss or diversion.

Findings:

On March 2, 2012, at 10 a.m., a review of the facility's monthly Proactive Diversion Report for the past year revealed the diversion monitoring was not consistent. The reports listed high users with the SD greater than two. Review of the diversion report was limited to high users with SD greater than four. It was also revealed that on the reports was written in ink, "terminated" next to a few names of staff appeared on the top portion of the report indicating access to CSs with greater frequency compared to peers.

During a concurrent interview, Pharmacist 500 stated the nurses were "terminated" to indicate there was diversion of CSs by those users.

During a concurrent interview with PT 500, a pharmacy technician, it was confirmed that the review consisted of only the users with SD greater than four. PT 500 also stated additional reports were generated for the nurse managers on the nursing units where suspected staff were assigned to for further investigation. PT 500 indicated that the pharmacy did not take any additional actions and nursing took over the investigation.

PT 500 also stated that the Proactive Diversion Report was reviewed by the Pharmacy every month as indicated in the facility's policy and procedure but was not consistently reviewed every month. A review of the reports from January 2011 through February 2012, indicated pharmacy reviews for April, July, August, and October 2011. For ten of the 14 months reviewed, there was no documentation to indicate the reports were reviewed by pharmacy.

A review of the facility's policy and procedure titled, "Drug Diversion Monitoring and Reporting" indicated the following to be performed by nursing:

"A proactive Diversion Report will be printed by pharmacy and reviewed by the pharmacy manager (or designee), monthly, as a screening tool for ADC users that have removed larger than normal quantities of CSs. Pharmacy will review the previous month's findings. Managers may request the above report(s) at any time for review in the event of questionable employee behavior or other indices of suspicion.

Based on the results from the Proactive Diversion Report, the pharmacy manager (or designee), will print and review an ADC Transaction Report for those ADC users statistically identified as being three SD above the mean for narcotic withdrawals. The review will focus on key points, excessive (or lack of) discrepancies, excess (or lack of) waste with the same witness, removals from multiple ADCs, or anything otherwise unusual.

After the pharmacy review, the Proactive Diversion Report, the ADC Transaction Report, and a cover letter will be sent to the appropriate manager with a brief assessment of any findings that the pharmacy review identified.

The manager will then investigate the employee(s) in question and assess the likelihood and/or extent of diversion. The manager will review the activities on the provided ADC Transaction Report compared to the charting activities in the electronic medical record of the patient's chart to determine if there is a need for further investigation or if there is sufficient evidence to confirm a diversion event."

During an interview on March 2, 2012, at 11:40 a.m., RN 502, a nurse manager, stated RN 503, one of the users on the Proactive Diversion Report with "terminated" written next to the name, was terminated as a result of suspicious activity reported to her by another nurse who witnessed RN 503 to be in the room of a patient not assigned to him on November 11, 2011.

RN 502 stated that investigation of RN 503's CS activity was conducted and that RN 503 eventually confessed to diversion of CSs. RN 502 stated that the investigation was still not completed (almost four months later) to determine the extent of diversion.

A review of the monthly Proactive Diversion Report revealed that RN 503 was consistently among the top users of CSs with a SD ranging from 4 to 5 going back to January 2011.

During a concurrent interview, DOP and RN 502 were unable to explain why it took 9 months or possibly longer to identify RN 503 was diverting CSs.

There was lack of documented evidence to indicate a timely investigation by the facility to minimize the duration of drug diversion. There was no documentation to indicate implementation of a proactive system to readily identify potential drug diversion.

Based on interview and record review, the facility failed to ensure drugs were controlled and administered in accordance with standards of practice to ensure patient safety by failing to:

1. Review before dispensing of controlled substances of IV infusion upon refill request to ensure appropriate use;

2. Maintain proper temperature of the medication refrigerators located throughout the facility and investigate and resolve in a timely manner when identified as having issues with maintaining the temperature range;

3. Ensure provision of pharmacy services distributed and delivered all medications needed without potential delay of administration of medications;

4. Provide pharmacy services that included all clinical pharmacists with competency and knowledge to perform clinical monitoring of all Target Medications in accordance with the facility's policy and procedure;

5. Keep and provide emergency medication necessary to treat MH as recommended by the the MHAUS and in accordance with the facility's policy and procedure;

6. Ensure integrity of pharmacy compounded intravenous solutions by not including expiration dates on the pharmacy label in accordance with State regulations;

7. Place content lists that were readily visible from outside the "Intubation Box Trays";

8. Administer medication not in excess of the physician-ordered dosage for one patient, Patient 706, creating the risk of a substandard health outcome for that patient due to over medication; and,

9. Provide one patient, Patient 705 with instructions about medications upon discharge from the facility, and document accurate medication allergies, creating the risk of a poor health outcome from an allergic reaction or incorrect medication regimen.

Findings:

1. During a tour of the facility's Pediatrics and PICUs on February 27, 2012, at 1:50 p.m., Patient 500's medical record was reviewed.

There was a physician order on February 21, 2012, at 1:15 p.m., for Dilaudid (narcotic pain medication) 0.6 mg per hour IV drip to be continuously administered to the patient. It was noted the pharmacy delivered Dilaudid 10 mg in 50 ml bag of normal saline. Given continuously at 0.6 mg per hour, each Dilaudid IV bag would last 16 hours.

A review of the patient's MAR indicated Dilaudid was started at 2 p.m., on February 21, 2012. It was also noted the second dose of Dilaudid 10 mg in 50 ml bag was started at 1 a.m., on February 22, 2012, a difference of only 11 hours.

During a concurrent interview, Pharmacist 505 stated Dilaudid was delivered only in 10 mg per 50 ml syringes.

During a concurrent interview, RN 504 stated according to the patient's MAR during the time the first bag was being administered, two as needed bolus doses of Dilaudid were given to the patient but RN 504 acknowledged that even with the bolus amount taken into account the second bag was started early. RN 504 was not able to find documentation of possible wasting of any remaining Dilaudid from the first bag before the second bag was started.

A review of the patient's I/O of fluid intake indicated the patient was receiving 3 ml (= 0.6 mg) Dilaudid since the order was started.

During a concurrent interview, RN 504 stated she would call the pharmacy technician working on the pediatric floor satellite pharmacy for refills.

During a concurrent interview, Pharmacist 505 stated the pharmacy technician would generate the label and if there was no problem the technician would take the label down to the main pharmacy on first floor and prepare the medication with pharmacist verification. The Pharmacist did not indicate there was an evaluation process taking place to see for what reason controlled substances were refilled early or late.

During a concurrent interview, the DOP indicated there was not a current process to review refills of controlled substances to determine whether early requests for refills were justified.

2. During the tour of the nursing units located on the fourth floor on February 27, 2012, starting at 10 a.m., the following medication refrigerators were observed to be out of the normal temperature range:

On the 4200 Nursing Unit, the temperature of the medication refrigerator displayed 10 °C.

On the Detention Unit, the temperature of the medication refrigerator (1 of 2) was displayed as 0 °C .

On the Detention Unit, the temperature of the medication refrigerator (2 of 2) linked to the Pyxis MedStation (ADC) displayed 10 °C.

A review of the facility's policy and procedure titled, "Drug Procurement and Storage" indicated, "Temperature ranges have been established as follows: Refrigerator: 2 °C to 8 °C."

During the tour of the Pediatric Nursing Unit on the third floor on February 27, 2012, at 1:50 p.m., it was observed the temperature of the medication refrigerator displayed 0.5 °C and quickly escalated. The temperature did not stabilize and fluctuated widely.

During an interview on February 27, 2012, at 2 p.m., the DOP acknowledged the temperature was out of range on these refrigerators and stated medication refrigerators were used throughout the facility in all nursing units. The DOP stated that these were not commercial/hospital grade and the temperature issue could be due to the "dorm room" refrigerators being used.

The DOP further stated the temperature monitoring system did not accurately display the temperature inside the medication refrigerators due to the metal probe/sensor was either touching the metal surface of the inside of the refrigerators or placed too close to the refrigerator doors which explained why the temperature went up significantly every time the refrigerator door was opened.

The DOP further acknowledged that existing equipment currently used would not be able to accurately maintain the proper temperature range.

A review of the "Medication Refrigerator Log" for 4200 Nursing Unit for February 2012, indicated, on February 13 and 15, 2012, Plant Op(erations) was notified the temperature was of range, but did not notify the Pharmacy.

A review of the "Medication Refrigerator Log" for 4400 Nursing Unit (Detention Unit) for February 2012, indicated on February 17, 26, and 27, 2012, the temperature was out of range. The log did not indicate the Pharmacy was notified of the out of range temperature.

The "Medication Refrigerator Log" indicated, "Engineering and Pharmacy must be contacted when the temperature is out of range (high or low)."

A review of the facility's policy and procedure titled, "Drug Procurement and Storage" indicated, "When receiving notification from nursing and pharmacy staff, pharmacist-in-charge will document the event in the "Out of Range Temperature Log" and any action(s) taken to resolve the issue."

The DOP and Pharmacist 500 were not able to provide evidence the Pharmacy was notified of the out of range temperature from the above Nursing Units. Also, the DOP and Pharmacist 500 were not aware the Pharmacy kept the "Out of Range Temperature Log." There was no indication by the DOP and Pharmacist 500 that there was any medication refrigerator temperature issue before the survey began.

A review of the facility's policy and procedure titled, "Drug Procurement and Storage" indicated, "Nursing will monitor the temperature of the Pyxis storage areas in their assigned work area as specified."

During an interview on February 27, 2012, at 3 p.m., the DOP acknowledged the Pharmacy did not have the ownership of the monitoring of the medications located in the medication refrigerators and currently maintaining the integrity could not be ensured.

On February 27, 2012, at 11:30 a.m., Pharmacist 500 stated the medication refrigerators linked to the Pyxis MedStation in each nursing units were monitored and recorded centrally in the Pharmacy.

A review of the printout of the temperature log for February 2012, for medication refrigerators being monitored in real-time indicated there were numerous times the medication refrigerators were out of range.

During an interview with Pharmacist 501 and PT 500 on March 2, 2012, at 10 a.m., PT 500 stated there were two stations in the Pharmacy with terminals that displayed the information when the temperature of any Pyxis linked medication refrigerators went out of range.

PT 500 stated messages indicating out of temperature range at various times accumulated for several days and were cleared from the screen when it was determined that the temperature out of range messages were no longer an issue. PT 500 stated she had no knowledge of how out of temperature range issues were resolved and how long the temperature was out of range.

During a concurrent interview, Pharmacist 506 did not indicate the numerous messages of out of temperature range were ever investigated and resolved by the pharmacy and did not indicate the pharmacist-in-charge was aware of the medication refrigerator temperature out of range issues.

3. Medication pass observation was conducted with RN 501 on February 29, 2012, at 8:45 a.m. and it was noted RN 501 was not able to locate an oral medication called donepezil (for dementia) 5 mg for Patient 503 in the patient's medication cassette drawer and it was not available in the Pyxis MedStation ADC located in Medication Room B.

During a concurrent interview, RN 501 stated the medication was not delivered by the pharmacy and that she would have to contact the Pharmacy and wait until the medication was delivered.

During a concurrent interview, Pharmacist 502 stated medications to be restocked in the ADCs and routine scheduled medications for inpatient use in ITS were delivered daily from the Pharmacy in the main hospital to the Pharmacy in ITS. Pharmacist 502 was not sure why the medication was not delivered and indicated the main pharmacy was responsible for restocking and sending the daily routine medications to ITS for inpatient use. Pharmacist stated most of the processed orders were for outpatient prescriptions.

A review of the medication inventory list of the Pyxis MedStation located in Medication Room B indicated, donepezil 5 mg was not listed to be available for Pyxis profiled patients.

A review of the packing list for medications delivered to the ITS Pharmacy indicated donepezil 5 mg was not listed.

During an interview on March 1, 2012, at 10 a.m., the DOP confirmed the Pyxis MedStation in Medication Room B did not stock donepezil 5 mg tablets and stated they should have been made available in Pyxis or delivered patient specific to the ITS Pharmacy so they could be available for timely administration.

4. On February 28, 2012, a review of the facility's policy and procedure titled, "Handling of High-risk (High-alert) Medications in Pharmacy Department" indicated, "Patients on a special group of high-risk medications identified by the organization as 'Target Medications' will be monitored by the clinical pharmacist routinely", and listed thirteen different medications.

On March 1, 2012, at 9:30 a.m., Pharmacist 500 stated all clinical pharmacists were competent and knowledgeable about monitoring the use of all medications listed in the policy and procedure as "Target medications."

A review of the facility provided list of clinical pharmacists listed Pharmacist 503 as a clinical pharmacist.

On March 1, 2012, at 10:10 a.m., during an interview, Pharmacist 503 was asked what Target Medications were and how they were being monitored. Pharmacist 503 did not know what target medications were.

On March 1, 2012, at 10:40 a.m., during an interview, Pharmacist 504, a clinical pharmacist, stated Target Medications were being monitored and documented on an excel spreadsheet in the "P" drive, a shared network drive, for clinical pharmacists to access during monitoring of Target Medications to input data. Pharmacist 504 stated all target medications patients were entered each day and all listed medications were reviewed.

A review of the monitoring spreadsheet for September listed Immunoglobulin IV (IVIG: a drug used for immune deficiency) prescribed for a patient as one of the medications being monitored.

During a concurrent interview, Pharmacist 504 stated, "The IVIG Monitoring Form" was completed each day to ensure no drug related adverse events occurred. He stated the completed forms were kept in the pharmacy. However, Pharmacist 504 was not able to provide the completed monitoring form as evidence of IVIG monitoring performed for the patient.

Pharmacist 504 also stated that not all clinical pharmacists were trained to monitor Target Medications and only a few besides Pharmacist 504 were able to do so.

A review of the Job Description for Clinical Pharmacist, indicated they were "...responsible for ... provision of pharmacy services to patient", and have "...advanced clinical training and are involved in the therapeutic management of patients."

5. During the tour of the facility's OB and L&D Units on February 28, 2012 at 2:45 p.m., it was noted there was an MH Cart (an emergency medication and supply cart for treatment of a life threatening condition from the exposure to certain anesthetic agent) with listed medications that did not match the current recommendations of MHAUS, a leading organization with a mission to promote optimum care and scientific understanding of MH and related disorders.

On its website, MHAUS published recommended medications to be readily available for immediate treatment of MH and among them were:

Four 4 ml injectable vials of furosemide (Lasix) 40 mg;
One 10 ml injectable vial of Regular Insulin 100 units per ml; and,
A minimum of 3000 ml (3 bags of 1000 ml) of refrigerated cold saline solution for IV (intravenous) cooling.

An inspection of the MH Cart revealed the above medications were not included in the cart.

The medication refrigerator was also inspected and it was noted that it did not have any Regular Insulin or refrigerated saline solution bags.

During a concurrent interview, the DOP stated the facility's policy was based on MHAUS guidelines. The DOP acknowledged he was not aware of the most recent MHAUS recommendations and confirmed there should have been three 1000 ml bags of cold normal saline solutions in the refrigerator.

A review of the facility's policy and procedure titled, "Management of Patients with Malignant Hyperthermia" indicated, "Cooling the patient is of vital importance. To reduce body temperature, infusion of iced saline solutions as fast as one liter per 10 minutes for 30 minutes may be required."

6. A tour of the facility's medication storage areas in nursing units located on the fourth floor was conducted on February 27, 2012, starting at 10 a.m.

In the 4100 Nursing Unit Medication Room there was a patient specific injectable 250 ml bag of 40 mEq potassium chloride (electrolyte supplement) in 0.9 percent normal saline on which a pharmacy label was attached without an expiration date.

In the 4100 Nursing Unit Medication Room there was a patient specific injectable 1000 ml bag of 20 meq potassium chloride in 0.9 percent normal saline on which a pharmacy label was attached without an expiration date. The overwrap was removed and the label was observed to be attached directly to the bag.

In the 4200 Nursing Unit Medication Room there was a patient specific injectable 200 ml bag of 2 gram magnesium chloride (electrolyte supplement) in 5 percent dextrose water on which a pharmacy label was attached without an expiration date.

During a concurrent interview, the DOP acknowledged no expiration date was either printed or written on the label and that did not meet the pharmacy labeling requirement. DOP and Pharmacist 500 agreed it would not be possible to tell the expiration date of the 1000 ml injectable bag once the overwrap was removed.

A review of the facility provided document from the manufacturer of the 1000 ml injectable bag indicated that it should not be outside the overwrap for 30 days or more.

A review of the facility's policy and procedure titled, "Labeling IV (by vein) Medications", indicated, "All IVs that are compounded in the IV hood will require an expiration date."

The same policy and procedure indicated, "Plain large volume IVs will require expiration date (30 days from removal of over wrap or otherwise stated by the manufacturer)."

California Business and Professions Code Chapter 9, Division 2, Section 4076(a)(9) stipulated as a requirement for labeling, "the expiration date of the effectiveness of the drug dispensed."

7. During the tour of the 4100 Nursing Unit on February 27, 2012 , at 10:20 a.m., it was noted located in the medication refrigerator there were two "Intubation Box Trays" containing injectable medications used for rapidly intubating (placing a breathing tube in the windpipe) patients.

The content list was not readily visible from the outside because it was covered by the expiration label and the contents of the tray could not be determined.

During a concurrent interview, the DOP stated the trays were emergency supplies and acknowledged the content list of the trays should have been visible from outside.

California Code of Regulations, Title 22, Section 70263(f)(2) stipulated emergency supply container's contents "shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."



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8. During a tour of the PACU on February 27, 2012, at 1:50 p.m., the record of Patient 706 was reviewed. The record contained a notation in the Post Anesthesia Record that Patient 706 received Dilaudid (a strong pain reliever) 1mg at 1 p.m. The pain scores documented on the same page indicated that Patient 706 had been found to have a pain score of 0/10 (no pain) at 12:55 p.m., 1:10 p.m., 1:25 p.m., and 1:40 p.m. The physician order for Dilaudid indicated Dilaudid .25 mg IV for mild pain (pain score 1-3), Dilaudid .5 mg IV for moderate pain (pain score 4-6) and Dilaudid 1 mg IV for severe pain (pain score 7-10).

During an interview on February 27, 2012, at 1:50 p.m., with RN 7, who was caring for Patient 706, she stated the patient had a pain score of 5/10. When asked why she had given the patient 1 mg of Dilaudid instead of the .5mg dose that was ordered for the moderate pain level, she stated, "because her vital signs were stable ".

During an interview with the PharmD on March 5, 2012, at 2 p.m., he stated Patient 706 should not have been given medication in excess of the ordered dose, and should not have been given pain medication without a need for pain relief being established.

9. During a tour of the PACU on February 27, 2012, at 1:45 p.m., RN 8 described Patient 705 as "ready to go." The medical record of the patient was reviewed, including the Outpatient Medication List. The pre-printed two-copy Spanish language form had boxes at the top checked to indicate that the patient read Spanish, no English, and she needed the services of an interpreter. The top line of the form was for allergies and contained the handwritten notation, NKDA (no known drug allergies). The form contained a handwritten list of seven medications, but the pre-printed boxes for telling the patient to continue or suspend the medications were left unchecked. The form was signed by the patient and nurse, but did not have a handwritten date or time.

A second form in Patient 705's medical record, titled Same Day Surgery Form, was also seen. That pre-printed form was signed by the physician and nurse on February 27, 2012. There were no check marks on the lines provided for indicating whether changes had or had not been made in the patient's medications. The form indicated that Patient 705 was allergic to Sulfa drugs.

During an interview with the PharmD on March 5, 2012, at 2 p.m., he stated the physician should have completed the section regarding continuing medications on the Same Day Surgery Form, and that the Outpatient Medication List should have been completed as well. He stated that the patient's allergies needed to be clarified.

The facility policy, "Medication Management, revised 7/19/11", read in part, "...Nursing staff will: a. document patient medication history; b. review the form for any discrepancies; c. communicate with the physician regarding any discrepancies."...Medication information will be collected in all patient settings. The medication reconciliation process is comprised of: ...d. Develop a list of medications to be prescribed. E. compare the current medications listed with the ordered medications. F. Make clinical decisions based on the comparison. Use the RCRMC Form# 105 Medication Reconciliation and Order Form Admission to document the disposition of each medication (continue or discontinue medication)."

The facility policy, Documentation of Patient Allergy Information, revised 10/2/02, read in part, "The nursing staff will be responsible for reviewing patient allergy history as documented and comparing this to current information. Discrepancies and/or questions will be clarified with the patient and physician as appropriate."

Based on observation and interview, the facility failed to ensure patient medications and information were secured and protected.

Findings:

1. During the tour of 3500 Nursing Unit with the DOP on February 27, 2012, at 1:30 p.m., a pharmacy labeled bag containing 2 tablets of topiramate (a drug for seizure disorder) 100 mg specific to Patient 501 was left on the top of the medication counter. The label had the patient's name, room number, and the name of the medication.

During an interview, RN 500 stated one tablet was taken out of the bag to give to the patient and she forgot to place the bag back in the medication cart before stepping away to give the medication to the patient. RN 500 stated the bag should not have been left unattended on the counter of the medication cart.

During a concurrent interview, the DOP acknowledged that the labeled bag should not have been left unattended because the patient information was on the label.

2. A medication pass observation was conducted with RN 500 on February 28, 2012, at 8:40 a.m. The RN placed the medicine cup containing medications to pass for that morning for Patient 510 on the bedside tray . RN 500 left the medication unattended and stepped out of the patient room to wash her hands.

During an interview on February 28, 2012, at 2 p.m., RN 500 acknowledged the medications were left unattended in the patient's room and stated that should not have happened.

Based on observation, interview, and document review, the facility failed to:

1. ensure unusable medications were not available for use; and,

2. dispose of patient's medications brought into the hospital from home that were not returned at the time of discharge.


Findings:

1. A tour of the facility's medication storage areas in nursing units located on the fourth floor was conducted on February 27, 2012, starting at 10 a.m.

In the 4100 Nursing Unit Medication Room there was a patient specific injectable 250 ml bag of 40 mEq of potassium chloride (electrolyte supplement) in 0.9 percent normal saline on which there a pharmacy label was attached without an expiration date.

In the 4100 Nursing Unit Medication Room there was a patient specific injectable 1000 ml bag of 20 mEq potassium chloride in 0.9 percent normal saline on which a pharmacy label was attached without an expiration date. The overwrap was removed and the label was observed to be attached directly to the bag.

The large volume 1000 ml injectable bags were protected by manufacturer sealed clear plastic overwrap

In the 4200 Nursing Unit Medication Room there was a patient specific injectable 200 ml bag of 2 gram magnesium chloride (electrolyte supplement) in 5 percent dextrose water on which a pharmacy label was attached without an expiration date.

During a concurrent interview, the DOP acknowledged there was no expiration date either printed or written on the label and that the label did not meet the pharmacy labeling requirement. The DOP and Pharmacist 500 agreed it would not be possible to tell the expiration date of the 1000 ml injectable bag once the overwrap was removed.

A review of the facility provided document from the manufacturer of the 1000 ml injectable bag indicated it should not be outside the overwrap for 30 days or more.

A review of the facility's policy and procedure titled, "Labeling IV (by vein) Medications" indicated, "All IVs that are compounded in the IV hood will require an expiration date."

The same policy and procedure indicated, "Plain large volume IVs will require expiration date (30 days from removal of over wrap or otherwise stated by the manufacturer)."

California Business and Professions Code Chapter 9, Division 2, Section 4076(a)(9) stipulated as a requirement for labeling, "the expiration date of the effectiveness of the drug dispensed."

2. A tour of the facility's medication storage areas in Detention Unit was conducted on February 27, 2012, at 11:30 a.m. and it was noted in the medication refrigerator in the Medication Room there was an injectable IV bag containing 2 grams of ampicillin (an antibiotic) in 0.9 percent normal saline 100 ml with the expiration date of 2/22/12 on the patient specific label.

During a concurrent interview, the DOP acknowledged the bag was expired and should have been returned to the pharmacy.

During a concurrent interview, RN 500 stated that the patient for which the IV bag was prepared had been discharged and no longer in the unit and acknowledged that the bag should have been removed and placed in the pharmacy return bin.

3. A tour of the facility's medication storage areas on the 3500 Unit on the third floor was conducted on February 27, 2012, at 1:30 p.m. In the medication refrigerator, it was noted there was an eye drop bottle of Travatan (for glaucoma) 2.5 ml that was dispensed to a specific patient on February 11, 2012 .

It was also revealed that the patient for which the eye drop was prepared by the pharmacy was discharged on February 17, 2012.

A review of the facility's policy and procedure titled, "Returned, Discontinued/Unused, Expired Drugs" indicated, "Upon discharge, the nursing units will return all medications in a patient's medication bin to the pharmacy."

During a concurrent interview, the DOP acknowledged the eye drop bottle should have been removed from the medication refrigerator and returned to the pharmacy for disposal.

4. A tour of the Pharmacy was conducted on March 1, 2012, starting at 10 a.m. In the CS Room there were three 5 gm bottles of morphine sulfate (narcotic pain medication) powder inside a plastic bag with the expiration date of 1/11.

During a concurrent interview, the DOP acknowledged the drug should not have been kept in the CS Room and should have been removed.

5. The Pharmacy located in ITS located in Riverside was toured on February 29, 2012, at 10 a.m. and it was noted the pharmacy kept patients' home medications. It was observed Patient 502's home medications were checked in to the pharmacy on December 17, 2011.

During a concurrent interview, Pharmacist 502 stated the process for home medications was to collect and place the medication in a plastic bag with a medication list sheet inside by nursing. The bag was sealed and sent to the pharmacy where it was kept until the patient was discharged with the medications. Pharmacist 502 stated if the home medications were not returned to the patient at the time of discharge, the medications should be kept in the pharmacy for 10 days after patient was discharged.

Pharmacist 502 stated the patient was discharged on January 13, 2012, and acknowledged the medications should have been destroyed.

A review of the facility's policy and procedure titled, "Patient's Personal (Home) Medications" indicated the following would take place regarding storage and destruction of home medications:

"Medications will be stored for up to 10 days after a patient's discharge, after which time they will be destroyed. The senior pharmacist is responsible to review stored medications for destruction on a monthly basis. Medications identified for destruction are to be placed in the appropriate bin for expired medications."

Based on observations, interviews and record reviews, the hospital condition of participation for food and dietetic services was not met as evidenced by:

1. The facility failed to ensure the daily management of the Food and Nutrition Services to provide patient, staff and visitors with safe food services when cooling of potentially hazardous foods was not monitored for safety, the dietary staff did not know the proper procedure for monitoring the cool down process for potentially hazardous foods, the staff did not follow procedures for cooling items and by failing to maintain adequate disaster food supplies to meet the needs of the patients in the event of a disaster. (Cross refer A-620, A-701 and A-749);

2. The facility failed to ensure the Food and Nutrition Services coordinated with the Infection Control Committee to ensure provisions and criteria for active monitoring and surveillance of high risk food handling procedures were implemented to ensure a sanitary environment and ensure safe food infection control handling practices were maintained. (Cross refer A-749); and,

3. The facility failed to ensure the dietary staff, responsible for safe food handling, was competent in their duties to ensure safe and sanitary food handling practices in the dietary department. (Cross refer A-622)

The cumulative effect of these systemic problems resulted in the inability of the hospital's dietary department to direct and staff in such a manner to ensure the nutritional needs of the patients were met in accordance with safe and acceptable standards of practice.

Based on observation, facility document reviews, and staff interviews, the facility failed to ensure the Director of Food and Nutrition Services was effective in the daily management of the dietary services by:

1. Failing to ensure the dietary staff monitored for the safe cool down of previously cooked potentially hazardous food;

2. Failing to ensure cool down of potentially hazardous food was conducted according to facility policies and procedures by failing to ensure items placed in the blast chiller were placed in shallow pans and allowed for maximum air circulation;

3. Failing to ensure the contracted food service provider for the acute psychiatric unit was monitoring the cool down temperatures of potentially hazardous foods;

4. Failing to ensure food items were discarded by their "use by," or expiration date;

5. Failing to ensure internal thermometers were available in all refrigerated storage units; and,

6. Failing to ensure the hospital disaster food supplies were adequate to meet the needs of the patients in the event of a disaster.

These failures had the potential to place patients at risk for a food borne illness due to improperly cooled or stored foods and the potential for inadequate supplies for patient nutrition in a disaster situation.

Findings:

In an interview with an Assistant Hospital Administrator, on February 27, 2012, at 9:50 a.m., the Administrator stated the facility had an Interim Food Services Manager, as the prior Manager left in August of 2011, (six months ago) and the position had not been filled.

1. During the initial kitchen tour, on February 27, 2012, at 11 a.m., the Supervising Cook stated food was prepared a day in advance and items to be cooled were placed in the "Blast Chiller," (blast chiller cools by using a fan inside a traditional refrigerator or to circulate the cold air. Blast chillers cool food faster than a regular refrigerator or freezer) prior to placing in the refrigerator for storage. Attached to the outside of the blast chiller was a document that indicated:

"IMPROPER COOLING IS THE MAJOR CAUSE OF FOODBORNE ILLNESS." The document indicated hot food must be cooled from 140 °F to 70 °F within 2 hours and from 70 °F to 41 °F within 4 additional hours.

On February 27, 2012, at 11:45 a.m., a copy of the facility's food cool down policy and procedure was requested. The Interim Food Services Manager, stated there was no policy and procedure for the cool down process and facility staff were learning to use the newly implemented cool down log. The Manager stated they started documenting temperatures for the cool down process on February 15, 2012.

During a tour of the kitchen on February 27, 2012, at 3:20 p.m., Cook 3 was observed placing one large pan (4 inches deep by approximately 18 inches long) of Spanish rice into the "Blast Chiller." Cook 3 stated she had cooked four pans of rice and was placing them in the chiller for cool down. Cook 3 stated "the temperature must reach 70 °F in 2 hours." Cook 3 placed two pans on one shelf and two more pans on the shelf directly below the other shelf.

A review of the "Cooling Temperature Log," for February 27, 2012, indicated the starting temperature of the four pans of rice was 190 °F. There was no time documented on the form to indicate when the items were placed in the blast chiller.

In an interview with the Interim Food Service Manager, on February 27, 2012, at 3:30 p.m., the Manager stated if food items do not reach 70 °F in two hours they would continue to cool the item for another two hours. The Manager stated they would also place the items into smaller pans to promote cooling.

On February 27, 2012, at 3:30 p.m., Cook 1 was observed taking temperatures on three pork loins that had come from the oven. The temperature of each of the prok loins was tested before the cook placed the pork loins in the blast chiller. The Cook documented the date, the name of the item, his name and the starting temperature on the "Cooling Temperature Log." The time the pork loins were placed in the blast chiller was not documented on the form.

In an interview with Cook 1, on February 27, 2012, at 3:40 p.m., the Cook was asked when he would be rechecking the temperature of the pork loins placed in the blast chiller. The Cook stated the evening staff would be checking the temperatures as he would be off duty. When asked how evening shift staff would know when to recheck the temperature, Cook 1 documented the time the pork loins were placed in the blast chiller, on the cooling log.

In an interview with the Interim Manager and the Assistant Hospital Administrator, on February 27, 2012, at 3:45 p.m., the Manager stated they started monitoring food cooling temperatures to comply with Hazard Analysis Critical Control Point principles.

In an interview with Cook 4, on February 27, 2012, at 4 p.m., Cook 4 stated items placed in the blast chiller should reach 70 °F within two hours. Cook 4 stated he was unsure what needed to be done if an item did not reach the 70 °F threshold within two hours.

On February 27, 2012, the facility's "Cooling Temperature Log," was requested. Forms dated February 15 through February 27, 2012, were received and reviewed. The form had instructions that indicated: "Record temperatures every 2 hours during the cooling cycle and once more when item is transferred to refrigerator. Record corrective actions, if applicable...The Food Service Supervisor/Supervising Cook will verify that the foodservice staff is cooling food properly by visually monitoring foodservice employees throughout their shift. The log will then be turned in to P.M. supervisor at the end of day for final review. Staff will notify supervisor of any corrective action taken..."

Each form reviewed had areas to document the date, the food item, employee name, starting temperature, temperature after two hours, temperature after four hours, employee name, temperature when transferred, initials and verification date. At the bottom of the form was an area for the supervisor to sign and date the form after
review.

During review of the "Cooling Temperature Log," forms on February 27, 2012, the following was noted:

a. On February 15, 2012:
· There were no times documented on the form.
· One item (eggs) had no temperatures documented.
· One item (marinara) had a starting temperature of 90 °F.
· Four items (including chicken, chili and rice) had documented temperatures greater than 70 °F at two hours.
· There was no documentation of corrective action taken.
· The form was not signed or dated (reviewed) by supervisory staff.

b. On February 16, 2012:
· There were no times documented on the form.
· Pork chorizo had a documented starting temperature of 141.9 °F. (Internal temperature should reach 145 °F after cooking).
· There was no additional temperature documentation for the pork.
· Rice was documented as having a starting temperature of 140 °F.
· Chicken was documented as having a starting temperature of 133 °F. (Internal temperature should reach 165 °F after cooking for chicken).
· The two hour temperature, four hour temperature and transfer temperature of the chicken was not documented.
· There was no documentation of corrective action taken.
· The form was not signed or dated (as reviewed) by supervisory staff.

c. On February 20, 2012:
· All five items had documented temperatures greater than 70 °F at two hours.
· There was no documentation of corrective action taken.
· The form was not signed or dated (as reviewed) by supervisory staff.

d. There were no "Cooling Temperature Log," forms dated February 17, 18, and 19, 2012.

e. On February 21, 2012:
· An item identified as "Chicken," had a starting temp of 133 °F and a two hour temperature of 75 °F.
· Three other items (beef, chili and pork) had temperatures greater than 70 °F at two hours.
· There was no documentation of corrective action taken.
· The form was dated, but not signed by supervisory staff.

f. On February 22, 2012:
· Three of the items did not have temperatures taken at two hours.
· Two items had temperatures greater than 70 °F at two hours.
· There was no documentation of corrective action taken.
· The form was not signed or dated (indicating reviewed) by supervisory staff.

g. On February 23, 2012:
· The documented "Temp after 2 hours," for four of nine items was greater than 70 °F.
· There was no documentation of corrective action taken.
· The form was not signed or dated (as reviewed) by supervisory staff.

h. On February 24, 2012:
· Temperatures were not taken after four hours or when items were transferred to the refrigerator.
· The form was not signed or dated (as reviewed) by supervisory staff.

i. On February 25, 2012:
· According to documentation on the form, the cool down temperature at two hours was 104 °F for beans and 95 °F for rice.
· The form contained initials and a date in the section for verification.
· There was no documentation about corrective action taken.

j. On February 27, 2012:
· Two items had two hour temperatures greater than 70 °F.
· The rest of the items had no documentation of temperatures at two hours.
· There was no documentation of corrective action taken.

None of the forms had documentation indicating the time cooking was completed, cooling had started or when items reached 70 °F or 41°F.

Documentation on the back of the "Cooling Temperature Log," form included the purpose, instructions for cooling, monitoring and corrective actions to be taken. The purpose was "To prevent foodborne illness by ensuring that all potentially hazardous foods are cooled properly."

In an interview with the Interim Manager on February 27, 2012, at 4:45 p.m., the Manager stated the staff were not fully trained in using the form. The Manager stated if an item was documented on the form it was a previously cooked, PHF. The Manager stated she was unaware the supervisory staff were not reviewing the "Cooling Temperature Log," and that staff were not reporting out of range temperatures. The Manager stated she was unaware items on the cool down log had not reached the required internal temperature. The Manager stated she was unaware there were corrective actions on the back of the form.

On February 27, 2012, at 5:33 p.m., a tour of the kitchen was conducted. The four rice dishes and the two pans of pork loins were observed in the blast chiller.

The "Cooling Temperature Log," for February 27, 2012, was reviewed. Temperatures were not documented for the items above. Following the instructions on the form, temperatures should have been taken prior to 5:30 p.m., for the items placed in the blast chiller prior to 3:30 p.m.

Cook 3 checked the temperature of the items in the chiller at 5:35 p.m. Three of four containers of rice were above 70 °F.

In a concurrent interview, the Manager of the Food Service Department stated the items could not be verified as safe. The Manager stated the cool down process for these items should be monitored to ensure they reached the temperatures to prevent the growth of harmful microorganisms that cause food borne illness. The Manager agreed there was no way to know if the rice had cooled from 140 °F to 70 °F in two hours based on the documentation on the cooling log and stated the rice would be discarded.

According to the 2009 US Food and Drug Administration's Food Code (3-501.14 Cooling) safe cooling required removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of PHF had been consistently identified as one of the leading contributing factors to foodborne illness. During slow cooling, PHF are subject to the growth of a variety of pathogenic microorganisms. If the food was not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness. The Food Code provision for cooling provided for cooling from 135 °F to 41 °F or 45 °F in 6 hours, with cooling from 135 °F to 70 °F in 2 hours.

The facility's policy titled, "Food Preparation and Service," dated August 1, 2008, was reviewed on February 28, 2012. The policy indicated:

"21. Cooked potentially hazardous food shall be cooled within 2 hours from 60 °C (140 °F) to 21 °C (70 °F)."

The facility's policy titled "HACCP Principles," dated August 1, 2008, was reviewed on February 28, 2012. The policy indicated the Food and Nutrition Services Department followed the principles of the Hazard Analysis Critical Control Point process to manage food safety.

On March 2, 2012, the job classification for the Assistant Dietary Services Manager was reviewed for the current Interim Food Services Manager. Examples of essential duties included (but not limited to):

"Assist in organizing, coordinating, and directing the activities of the Dietary Services staff; has major responsibility for formulating and revising policies and procedures...

Develops and implements training programs for staff; develops and reviews staff productivity measurement programs; recommends improvements in patient nutritional care programs."

2. During a tour of the kitchen on February 27, 2012, at 3:20 p.m., Cook 3 was observed placing one large pan (approximately four inches deep by 18 inches long) of Spanish rice into the blast chiller (a blast chiller cools by using a fan inside a traditional refrigerator or to circulate the cold air. Blast chillers cool food faster than a regular refrigerator or freezer). Cook 3 stated she had cooked four pans of rice and was placing them in the chiller for cool down. Cook 3 stated "the temperature must reach 70 °F in 2 hours." Cook 3 placed two pans on one shelf and two more pans on the shelf directly below the other shelf. The blast chiller had multiple shelves for placing items and a second chiller was observed.

Directions to staff, attached to the outside of the blast chiller, indicated the following:
"IMPROPER COOLING IS THE MAJOR CAUSE OF FOODBORNE ILLNESS." The document indicated hot food must be cooled from 140 °F to 70 °F within 2 hours and from 70 °F to 41 °F within 4 additional hours. Additional instructions on the document indicated:
"Shallow is better!
Separate foods into small quantities and place them into shallow pans made of aluminum or stainless steel. The food should be no deeper than 4 inches. (2 inches for thick food)..."


A review of the "Cooling Temperature Log," for February 27, 2012, indicated the starting temperature of the four pans of rice was 190 °F. There was no time documented on the form to indicate when the items were placed in the blast chiller.

In an interview with the Interim Food Service Manager, on February 27, 2012, at 3:30 p.m., the Manager stated if food items do not reach 70 °F in two hours they would continue to cool for another two hours. The Manager stated they would also place the items into smaller pans.

On February 27, 2012, at 3:30 p.m., Cook 1 was observed taking temperatures on three pork loins that had come from the oven. The temperature of each pork loin was tested before the cook placed the pan in the blast chiller. The pans of cooked pork loins were placed on a shelf directly above the pans of rice.

On February 27, 2012, at 5:33 p.m., a tour of the kitchen was conducted. The four rice dishes and the two pans of pork loins were observed in the blast chiller.

Cook 3 checked the temperature of the items in the blast chiller at 5:35 p.m. Three of four containers of rice were above 70 °F.

The facility's policy titled, "Food Preparation and Service," dated August 1, 2008, was reviewed on February 28, 2012. The policy stipulated:

"21. Cooked potentially hazardous food shall be cooled within 2 hours from 60 °C (140 °F) to 21 °C (70 °F).
22. Food Cooling shall be accomplished in accordance with the time and temperature criteria by using one or more of the following methods based on the type of food being cooled:
a. Placing the food in shallow pans;
b. Separating the food into smaller or thinner portions;
23. When placed in cooling or cold holding equipment, food containers in which food is being cooled shall be:
a. arranged in the equipment to provide maximum heat transfer through the container walls..."

In an interview with the Supervising Cook, on February 28, 2012, at 10:10 a.m., the cook stated rice should be placed in a "# 200 (two inch deep) pan," as those pans were shallow and allowed for quicker cooling. The Supervising Cook stated he had not been informed about the out of range temperatures documented on the cooling log.

On March 2, 2012, the job classification for the Assistant Dietary Services Manager was reviewed for the current Interim Food Services Manager. Examples of essential duties included (but not limited to):

"Develops and implements training programs for staff; develops and reviews staff productivity measurement programs; recommends improvements in patient nutritional care programs."

3. On February 27, 2012, at 3 p.m., during an interview with the Interim Manager of Food Services, the Manager stated an outside provider supplied the food services for the acute psychiatric patients, at the offsite psychiatric facility. According to the Manager, the offsite provider had been supplying food services since October 2011.

On February 28, 2012, the outside food services contract was reviewed. The contract indicated the outside food services would perform to the satisfaction of the facility and in "conformance to and consistent with the highest standards of firms /professional in the same discipline in the State of California."

In an interview with an Assistant Hospital Administrator, on February 29, 2012, at 10 a.m., the Administrator stated the Interim Manager and the Administrator evaluated the provider before the contract was awarded and they continued to visit the provider monthly.

On February 29, 2012, at 10:30 a.m., during an interview with the Director of Food Services from the contracted provider, the Director stated they prepared cooked food that was cooled then held cold, until placed onto trays then delivered to the facility.

On February 29, 2012, at 10:40 a.m., lunch trays for the ETS and ITS facilities were delivered from the contracted food services provider. The temperatures of several trays were tested and the trays were placed in the cooling/reheating units.

At 11:40 a.m., on February 29, 2012, facility staff checked the temperatures of several food items and began tray delivery.

On February 29, 2012, at 1 p.m., an onsite visit was made to the contracted food services provider. The tray line for the ETS and ITS facility was observed. The items placed on the trays included chicken, rice, carrots and black beans. All items had been precooked and were now cold, with measured temperatures of 40 °F or less.

The contracted provider's "Food Temperature Tracking Log Production," forms for February 26, 27, and 28 were reviewed on February 29, 2012. The form contained areas to document the date, menu item/recipe, meal, start time, end time, hot temperature, temp time, initial, cool temp, temp time, initial and manager signature. At the bottom of the form, were "Notes," that included "All food must be cooked to required internal temperatures and recorded in temp log. All food must be cooled to 41 degrees within two hours using the blast chiller and recording in temp log."

The following was noted on the "Food Temperature Tracking Log Production," form for Tuesday February 28, 2012:

Carne Asada had an end time of 12:30 p.m., with a recorded temperature of 167 °F. The next temperature recorded was taken at 4:30 p.m., four hours later. There was no temperature documented at the two hour mark.

Shredded Chicken had a recorded temperature of 189 °F at 12:30 p.m. The time of the next temperature was not recorded on the form.

Pollo Asado had a recorded temperature of 170 °F at 4:35 p.m. There were no additional temperatures documented for this item.

In an interview with the Assistant Hospital Administrator and the Director of the contracted food services, on February 29, 2012, at 1:30 p.m., both agreed the cool down monitoring of cooked potentially hazardous food should be monitored.

On March 2, 2012, the job classification for the Assistant Dietary Services Manager was reviewed for the current Interim Food Services Manager. Examples of essential duties included (but not limited to):

"Assist in organizing, coordinating and directing the activities of the Dietary Services staff; has major responsibility for formulating and revising policies and procedures... "

4. During an inspection of the kitchen on February 27, 2012, between 10 a.m. and 10:40 a.m., the following expired products were noted in the refrigerators: 16- four ounce containers of peach yogurt, expiration date February 24, 2012; and three containers of fat free milk, expiration date February 26, 2012.

5. During an inspection of the kitchen on February 27, 2012, between 10 a.m. and 10:40 a.m., the walk-in freezer was observed to have two outside displays for reading the freezer temperature. An internal thermometer was not observed.

During a concurrent interview with the Interim Manager of Food Services, the Manager stated the freezer was recently repaired and the thermometer may have been removed at that time.

The facility's policy and procedure for "Temperatures of Refrigerators & Freezers," with a revised date of August 1, 2008, was reviewed on February 29, 2012. The policy indicated "A thermometer is located in each refrigerator where it can be easily read."

6. The facility's disaster policy for food service was requested and reviewed on February 28, 2012. The policy, dated February 6, 2012, indicated "guidelines will be established for the Food and Nutrition Services Department in the event of a disaster where a failure might occur of electricity, steam, or gas." The following procedures were included in the policy:

"1. The Food and Nutrition Services Department will be responsible for feeding patients and staff in the event of a disaster (earthquake, plane crash, flood, and explosion such as chemical or bomb).

2. In case of disaster, either external or internal, the Food and Nutrition Services Departments' responsibility is to:
...Serve three meals per day to all in-house patients with close adherence to dietary orders...
...Provide adequate food..."

The policy contained two different menus. One menu to be followed when refrigeration and steam was available, or electricity or gas was available. The second menu indicated it was to be used when there was no steam, electricity or gas. The plan did not include the number of meals planned for or the inventory required to prepare those meals.

On March 1, 2012, at 10 a.m., the facility's disaster food supplies were observed with the Interim Manager and the Storekeeper. According to the Manager, the disaster food supplies were kept in the dry storage area. The Manager pointed to a shelf that contained 17 cans of baked beans, and eighteen - 43 ounce cans of tuna. The Manager stated other items were placed on the shelves throughout the dry storage area.

During a concurrent interview with the Storekeeper, he stated there was enough inventory for three to four days. The Storekeeper stated someone used the can of baked beans, but it would be replaced with the incoming delivery. The Storekeeper stated there were enough supplies on hand to feed 240 patients for one week, but there was no list of items needed for the disaster menus.

A calculation based on the daily census provided to the survey team, on February 27, 28, and 29, and March 1, 2, and 5, 2012, indicated the facility's average daily census was 321 patients (not including patients in the offsite acute psychiatric unit).

On March 2, 2012, the job classification for the Assistant Dietary Services Manager was reviewed for the current Interim Food Services Manager. Examples of essential duties included (but not limited to):

"The incumbent provides administrative and technical guidance to subordinate staff in various departmental programs..."

On March 2, 2012, the facility's policy and procedure titled "Table of Organization and lines of Responsibility and Accountability," with a revised date of August 1, 2008, indicated the responsibilities of the Food and Nutrition Services Department included safeguarding public health and providing food that was safe, unadulterated and honestly presented through the adoption of scientific based standards.

Based on observation, record reviews and staff interviews, the hospital failed to ensure:

1. The dietary staff, responsible for safe food handling, was competent in their duties to monitor the cool down process of PHF; and,

2. Cook 3 followed policy and procedure when cooling cooked, PHF.

These failures placed patients at risk for foodborne illness due to improperly cooled down food.

Findings:

1. During the initial kitchen tour, on February 27, 2012, at 11 a.m., the Supervising Cook stated food was prepared a day in advance and items to be cooled were placed in the "Blast Chiller," (blast chiller cools by using a fan inside a traditional refrigerator or to circulate the cold air. Blast chillers cool food faster than a regular refrigerator or freezer) prior to placing in the refrigerator for storage. Attached to the outside of the blast chiller was a document that indicated:

"IMPROPER COOLING IS THE MAJOR CAUSE OF FOODBORNE ILLNESS." The document indicated hot food must be cooled from 140 °F to 70 °F within 2 hours and from 70 °F to 41 °F within 4 additional hours.

On February 27, 2012, at 11:45 a.m., a copy of the facility's food cool down policy and procedure was requested. The Interim Food Services Manager, stated there was no policy and procedure for the cool down process and facility staff were learning to use the newly implemented cool down log. The Manager stated they started documenting temperatures for the cool down process on February 15, 2012.

During a tour of the kitchen on February 27, 2012, at 3:20 p.m., Cook 3 was observed placing one large pan of Spanish rice into the "Blast Chiller." Cook 3 stated she had cooked four pans of rice and was placing them in the chiller for cool down. Cook 3 stated "the temperature must reach 70 °F in 2 hours."

A review of the "Cooling Temperature Log," for February 27, 2012, indicated the starting temperature of the four pans of rice was 190 °F. There was no time documented on the form to indicate when the items were placed in the blast chiller.

In an interview with the Interim Food Service Manager, on February 27, 2012, at 3:30 p.m., the Manager stated if food items do not reach 70 °F in two hours they would continue to cool the item for another two hours. The Manager stated they would also place the items into smaller pans to promote cooling.

On February 27, 2012, at 3:30 p.m., Cook 1 was observed taking temperatures on three pork loins that had come from the oven. The temperature of each pork loin was tested before the cook placed the pork loins in the blast chiller. The Cook documented the date, the name of the item, his name and the starting temperature on the "Cooling Temperature Log." The time the pork loins were placed in the blast chiller was not documented on the form.

In an interview with Cook 1, on February 27, 2012, at 3:40 p.m., the Cook was asked when he would be rechecking the temperature of the pork loins placed in the blast chiller. The Cook stated the evening staff would be checking the temperatures as he would be off duty. When asked how evening shift staff would know when to recheck the temperature, Cook 1 documented the time the pork loins were placed in the blast chiller, on the cooling log.

In an interview with the Interim Manager and the Assistant Hospital Administrator, on February 27, 2012, at 3:45 p.m., the Manager stated they started monitoring food cooling temperatures to comply with Hazard Analysis Critical Control Point principles.

In an interview with Cook 4, on February 27, 2012, at 4 p.m., Cook 4 stated items placed in the blast chiller should reach 70 °F within two hours. Cook 4 stated he was unsure what needed to be done if an item did not reach the 70 °F threshold within two hours.

On February 27, 2012, the facility's "Cooling Temperature Log," was requested. Forms dated February 15 through February 27, 2012, were received and reviewed. The form had instructions that indicated: "Record temperatures every 2 hours during the cooling cycle and once more when item is transferred to refrigerator. Record corrective actions, if applicable...The Food Service Supervisor/Supervising Cook will verify that the foodservice staff is cooling food properly by visually monitoring foodservice employees throughout their shift. The log will then be turned in to P.M. supervisor at the end of day for final review. Staff will notify supervisor of any corrective action taken..."

Each form reviewed had areas to document the date, the food item, employee name, starting temperature, temperature after two hours, temperature after four hours, employee name, temperature when transferred, initials and verification date. At the bottom of the form was an area for the supervisor to sign and date the form after
review.

During review of the "Cooling Temperature Log," forms on February 27, 2012, the following was noted:

a. On February 15, 2012:
· There were no times documented on the form.
· One item (eggs) had no temperatures documented.
· One item (marinara) had a starting temperature of 90 °F.
· Four items (including chicken, chili and rice) had documented temperatures greater than 70 °F at two hours.
· There was no documentation of corrective action taken.
· The form was not signed or dated (reviewed) by supervisory staff.

b. On February 16, 2012:
· There were no times documented on the form.
· Pork chorizo had a documented starting temperature of 141.9 °F. (Internal temperature should reach 145 °F after cooking).
· There was no additional temperature documentation for the pork.
· Rice was documented as having a starting temperature of 140 °F.
· Cook 2 documented Chicken with a starting temperature of 133 °F. (Internal temperature should reach 165 °F after cooking for chicken).
· The two hour temperature, four hour temperature and transfer temperature of the chicken was not documented.
· There was no documentation of corrective action taken.
· The form was not signed or dated (as reviewed) by supervisory staff.

c. On February 20, 2012:
· All five items had documented temperatures greater than 70 °F at two hours.
· There was no documentation of corrective action taken.
· The form was not signed or dated (as reviewed) by supervisory staff.

d. There were no "Cooling Temperature Log," forms dated February 17, 18, and 19, 2012.

e. On February 21, 2012:
· An item identified as "Chicken," had a starting temp of 133 °F and a two hour temperature of 75 °F.
· Three other items (beef, chili and pork) had temperatures greater than 70 °F at two hours.
· Cook 3 documented "beef and chili," with two hour temperatures above 70 °F.
· There was no documentation of corrective action taken.
· The form was dated, but not signed by supervisory staff.

f. On February 22, 2012:
· Three of the items did not have temperatures taken at two hours.
· Two items had temperatures greater than 70 °F at two hours.
· There was no documentation of corrective action taken.
· The form was not signed or dated (indicating reviewed) by supervisory staff.

g. On February 23, 2012:
· The documented "Temp after 2 hours," for four of nine items was greater than 70 °F.
· There was no documentation of corrective action taken.
· The form was not signed or dated (as reviewed) by supervisory staff.

h. On February 24, 2012:
· Temperatures were not taken after four hours or when items were transferred to the refrigerator.
· Two items cooked and documented by Cook 3 had not reached the 70 °F threshold for cooling.
· The form was not signed or dated (as reviewed) by supervisory staff.

i. On February 25, 2012:
· According to documentation on the form, the cool down temperature at two hours was 104 °F for beans and 95 °F for rice.
· The form contained initials and a date in the section for verification.
· There was no documentation about corrective action taken.

j. On February 27, 2012:
· Two items had two hour temperatures greater than 70 °F.
· The rest of the items had no documentation of temperatures at two hours.
· Cooks 1, 2, and 3 had all documented items on this form.
· There was no documentation of corrective action taken.

None of the forms had documentation indicating the time cooking was completed, cooling had started or when the items reached 70 °F or 41°F.

Documentation on the back of the "Cooling Temperature Log," form included the purpose, instructions for cooling, monitoring and corrective actions to be taken. The purpose was "To prevent foodborne illness by ensuring that all potentially hazardous foods are cooled properly."

In an interview with the Interim Manager on February 27, 2012, at 4:45 p.m., the Manager stated the staff were not fully trained in using the form. The Manager stated if an item was documented on the form it was a previously cooked, PHF. The Manager stated she was unaware the supervisory staff were not reviewing the "Cooling Temperature Log," and that staff were not reporting out of range temperatures. The Manager stated she was unaware items on the cool down log had not reached the required internal temperature. The Manager stated she was unaware there were corrective actions on the back of the form.

On February 27, 2012, at 5:33 p.m., a tour of the kitchen was conducted. The four rice dishes and the two pans of pork loins were observed in the blast chiller.

The "Cooling Temperature Log," for February 27, 2012, was reviewed. Temperatures were not documented for the items above. Following the instructions on the form, temperatures should have been taken prior to 5:30 p.m., for the items placed in the blast chiller prior to 3:30 p.m.

Cook 3 checked the temperature of the items in the chiller at 5:35 p.m. Three of four containers of rice were above 70 °F.

In a concurrent interview, the Manager of the Food Service Department stated the items could not be verified as safe. The Manager stated the cool down process for these items should be monitored to ensure they reached the temperatures required to prevent bacteria growth and food borne illness. The Manager agreed there was no way to know if the rice had cooled from 140 °F to 70 °F in two hours based on the documentation on the cooling log.

According to the 2009 US Food and Drug Administration's Food Code (3-501.14 Cooling) safe cooling required removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of PHF had been consistently identified as one of the leading contributing factors to foodborne illness. During slow cooling, PHF were subject to the growth of a variety of pathogenic microorganisms. If the food was not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness. The Food Code provision for cooling provided for cooling from 135 °F to 41 °F or 45 °F in 6 hours, with cooling from 135 °F to 70 °F in 2 hours.

The facility's policy titled, "Food Preparation and Service," dated August 1, 2008, was reviewed on February 28, 2012. The policy indicated:

"21. Cooked potentially hazardous food shall be cooled within 2 hours from 60 °C (140 °F) to 21 °C (70 °F)."

The facility's policy titled "HACCP Principles," dated August 1, 2008, was reviewed on February 28, 2012. The policy indicated the Food and Nutrition Services Department followed the principles of the Hazard Analysis Critical Control Point process to manage food safety.

In an interview with the Supervising Cook, on February 28, 2012, at 10:10 a.m., stated he had not been informed about the out of range temperatures documented on the cooling log.

On March 2, 2012, the job classification for the Assistant Dietary Services Manager was reviewed for the current Interim Food Services Manager. Examples of essential duties included (but not limited to):

"Develops and implements training programs for staff; develops and reviews staff productivity measurement programs; recommends improvements in patient nutritional care programs."

On March 2, 2012, at 10 a.m., the Interim Manger of Food Services was interviewed. The Manager stated the competencies and inservices for Food Services staff were kept in the department. The Manager provided copies of forms titled "Equipment/Skills/Knowledge Competency Worksheet," for the cooks.

The "Equipment/Skills/Knowledge Competency Worksheet" forms for Cook 1, 2, and 3 were reviewed on March 2, 2012. According to documentation on the forms, the cooks had demonstrated competency in maintaining food at safe temperatures.

In an interview with the Interim Manager, on March 2, 2012, at 10:14 a.m., the Manager stated the staff needed more training about the cool down process and the form for monitoring the process.

2. During a tour of the kitchen on February 27, 2012, at 3:20 p.m., Cook 3 was observed placing one large pan (approximately four inches deep by 18 inches long) of Spanish rice into the blast chiller (a blast chiller cools by using a fan inside a traditional refrigerator or to circulate the cold air. Blast chillers cool food faster than a regular refrigerator or freezer). Cook 3 stated she had cooked four pans of rice and was placing them in the chiller for cool down. Cook 3 stated "the temperature must reach 70 °F in 2 hours." Cook 3 placed two pans on one shelf and two more pans on the shelf directly below the other shelf. The blast chiller had multiple shelves for placing items and a second chiller was observed.

Directions to staff, attached to the outside of the blast chiller, indicated the following:
"IMPROPER COOLING IS THE MAJOR CAUSE OF FOODBORNE ILLNESS." The document indicated hot food must be cooled from 140 °F to 70 °F within 2 hours and from 70 °F to 41 °F within 4 additional hours. Additional instructions on the document indicated:
"Shallow is better!
Separate foods into small quantities and place them into shallow pans made of aluminum or stainless steel. The food should be no deeper than 4 inches. (2 inches for thick food)..."

In an interview with the Interim Food Service Manager, on February 27, 2012, at 3:30 p.m., the Manager stated if food items do not reach 70 °F in two hours they would continue to cool for another two hours. The Manager stated they would also place the items into smaller pans.

On February 27, 2012, at 5:33 p.m., a tour of the kitchen was conducted. The four rice dishes were observed in the blast chiller.

Cook 3 checked the temperature of the items in the blast chiller at 5:35 p.m. Three of four containers of rice were above 70 °F.

The facility's policy titled, "Food Preparation and Service," dated August 1, 2008, was reviewed on February 28, 2012. The policy indicated:

"21. Cooked potentially hazardous food shall be cooled within 2 hours from 60 °C (140 °F) to 21 °C (70 °F).
22. Food Cooling shall be accomplished in accordance with the time and temperature criteria by using one or more of the following methods based on the type of food being cooled:
a. Placing the food in shallow pans;
b. Separating the food into smaller or thinner portions;
23. When placed in cooling or cold holding equipment, food containers in which food is being cooled shall be:
a. arranged in the equipment to provide maximum heat transfer through the container walls..."

In an interview with the Supervising Cook, on February 28, 2012, at 10:10 a.m., the cook stated rice should be placed in a "# 200 (two inch deep) pan," as those pans were shallow and allowed for quicker cooling.

The employee file for Cook 3 was reviewed on March 1, 2012. The Job Specific Competencies for Cook 3 dated June 5, 2008, indicated Cook 3 could perform without assistance in maintaining food at safe temperatures.

On March 2, 2012, the job classification for the Assistant Dietary Services Manager was reviewed for the current Interim Food Services Manager. Examples of essential duties included (but not limited to):

"Develops and implements training programs for staff; develops and reviews staff productivity measurement programs; recommends improvements in patient nutritional care programs."

Based on observation, document reviews and staff interviews, the hospital failed to ensure the overall environment was developed and maintained in such a manner that assured the safety and well-being of the patients when the Director of Food and Nutrition Services failed to maintain adequate disaster food supplies and an organized, detailed plan to meet the needs of the patients in the event of a disaster. This failure had the potential for disaster food supplies to be depleted or unavailable in the event of an emergency and the facility being unable to safely feed patients.

Findings:

The facility's disaster policy for food service was requested and reviewed on February 28, 2012. The policy, dated February 6, 2012, indicated "guidelines will be established for the Food and Nutrition Services Department in the event of a disaster where a failure might occur of electricity, steam, or gas." The following procedures were included in the policy:

"1. The Food and Nutrition Services Department will be responsible for feeding patients and staff in the event of a disaster (earthquake, plane crash, flood, and explosion such as chemical or bomb).

2. In case of disaster, either external or internal, the Food and Nutrition Services Departments' responsibility is to:
...Serve three meals per day to all in-house patients with close adherence to dietary orders...
...Provide adequate food..."

The policy contained two different menus. One menu to be followed when refrigeration and steam was available, or electricity or gas was available. The second menu indicated it was to be used when there was no steam, electricity or gas. The plan did not include the number of meals planned for or the inventory required to prepare those meals.

On March 1, 2012, at 10 a.m., the facility's disaster food supplies were observed with the Interim Manager and the Storekeeper. According to the Manager, the disaster food supplies were kept in the dry storage area. The Manager pointed to a shelf that contained 17 cans of baked beans, and eighteen - 43 ounce cans of tuna. The Manager stated other items were placed on the shelves throughout the dry storage area.

During a concurrent interview with the Storekeeper, he stated there was enough inventory for three to four days. The Storekeeper stated someone used the can of baked beans, but it would be replaced with the incoming delivery. The Storekeeper stated there were enough supplies on hand to feed 240 patients for one week, but there was no list of items needed for the disaster menus.

A calculation based on the daily census provided to the survey team, on February 27, 28, and 29, and March 1, 2, and 5, 2012, indicated the facility's average daily census was 321 patients (not including patients in the offsite acute psychiatric unit).

On March 2, 2012, the job classification for the Assistant Dietary Services Manager was reviewed for the current Interim Food Services Manager. Examples of essential duties included (but not limited to):

"The incumbent provides administrative and technical guidance to subordinate staff in various departmental programs..."

On March 2, 2012, the facility's policy and procedure titled "Table of Organization and lines of Responsibility and Accountability," with a revised date of August 1, 2008, indicated the responsibilities of the Food and Nutrition Services Department included safeguarding public health and providing food that was safe, unadulterated and honestly presented through the adoption of scientific based standards

Based on observation, interview, and record review, the facility failed to identify, investigate, and control potential sources of infectious disease by failing to adhere to a food cool down process that allowed food to be maintained at temperatures to minimize the risk of bacterial growth, creating the risk of infection for all patients consuming foods cooled in the facility kitchen.

Findings:

During the initial kitchen tour, on February 27, 2012, at 11 a.m., the Supervising Cook stated food was prepared a day in advance and items to be cooled were placed in the "Blast Chiller," (blast chiller cools by using a fan inside a traditional refrigerator or to circulate the cold air. Blast chillers cool food faster than a regular refrigerator or freezer) prior to placing in the refrigerator for storage. Attached to the outside of the blast chiller was a document that indicated:

"IMPROPER COOLING IS THE MAJOR CAUSE OF FOODBORNE ILLNESS." The document indicated hot food must be cooled from 140 °F to 70 °F within 2 hours and from 70 °F to 41 °F within 4 additional hours.

On February 27, 2012, at 11:45 a.m., a copy of the facility's food cool down policy and procedure was requested. The Interim Food Services Manager, stated there was no policy and procedure for the cool down process and facility staff were learning to use the newly implemented cool down log. The Manager stated they started documenting temperatures for the cool down process on February 15, 2012.

During a tour of the kitchen on February 27, 2012, at 3:20 p.m., Cook 3 was observed placing one large pan (4 inches deep by approximately 18 inches long) of Spanish rice into the "Blast Chiller." Cook 3 stated she had cooked four pans of rice and was placing them in the chiller for cool down. Cook 3 stated "the temperature must reach 70 °F in 2 hours." Cook 3 placed two pans on one shelf and two more pans on the shelf directly below the other shelf.

A review of the "Cooling Temperature Log," for February 27, 2012, indicated the starting temperature of the four pans of rice was 190 °F. There was no time documented on the form to indicate when the items were placed in the blast chiller.

In an interview with the Interim Food Service Manager, on February 27, 2012, at 3:30 p.m., the Manager stated if food items do not reach 70 °F in two hours they would continue to cool the item for another two hours. The Manager stated they would also place the items into smaller pans to promote cooling.

On February 27, 2012, at 3:30 p.m., Cook 1 was observed taking temperatures on three pork loins that had come from the oven. The temperature of each pork loin was tested before the cook placed the pork loins in the blast chiller. The Cook documented the date, the name of the item, his name and the starting temperature on the "Cooling Temperature Log." The time the pork loins were placed in the blast chiller was not documented on the form.

In an interview with Cook 1, on February 27, 2012, at 3:40 p.m., the Cook was asked when he would be rechecking the temperature of the pork loins placed in the blast chiller. The Cook stated the evening staff would be checking the temperatures as he would be off duty. When asked how evening shift staff would know when to recheck the temperature, Cook 1 documented the time the pork loins were placed in the blast chiller, on the cooling log.

In an interview with the Interim Manager and the Assistant Hospital Administrator, on February 27, 2012, at 3:45 p.m., the Manager stated they started monitoring food cooling temperatures to comply with Hazard Analysis Critical Control Point principles.

In an interview with Cook 4, on February 27, 2012, at 4 p.m., Cook 4 stated items placed in the blast chiller should reach 70 °F within two hours. Cook 4 stated he was unsure what needed to be done if an item did not reach the 70 °F threshold within two hours.

On February 27, 2012, the facility's "Cooling Temperature Log," was requested. Forms dated February 15 through February 27, 2012, were received and reviewed. The form had instructions that indicated: "Record temperatures every 2 hours during the cooling cycle and once more when item is transferred to refrigerator. Record corrective actions, if applicable...The Food Service Supervisor/Supervising Cook will verify that the foodservice staff is cooling food properly by visually monitoring foodservice employees throughout their shift. The log will then be turned in to P.M. supervisor at the end of day for final review. Staff will notify supervisor of any corrective action taken..."

Each form reviewed had areas to document the date, the food item, employee name, starting temperature, temperature after two hours, temperature after four hours, employee name, temperature when transferred, initials and verification date. At the bottom of the form was an area for the supervisor to sign and date the form after
review.

During review of the "Cooling Temperature Log," forms on February 27, 2012, the following was noted:

a. On February 15, 2012:
· There were no times documented on the form.
· One item (eggs) had no temperatures documented.
· One item (marinara) had a starting temperature of 90 °F.
· Four items (including chicken, chili and rice) had documented temperatures greater than 70 °F at two hours.
· There was no documentation of corrective action taken.
· The form was not signed or dated (reviewed) by supervisory staff.

b. On February 16, 2012:
· There were no times documented on the form.
· Pork chorizo had a documented starting temperature of 141.9 °F. (Internal temperature should reach 145 °F after cooking).
· There was no additional temperature documentation for the pork.
· Rice was documented as having a starting temperature of 140 °F.
· Chicken was documented as having a starting temperature of 133 °F. (Internal temperature should reach 165 °F after cooking for chicken).
· The two hour temperature, four hour temperature and transfer temperature of the chicken was not documented.
· There was no documentation of corrective action taken.
· The form was not signed or dated (as reviewed) by supervisory staff.

c. On February 20, 2012:
· All five items had documented temperatures greater than 70 °F at two hours.
· There was no documentation of corrective action taken.
· The form was not signed or dated (as reviewed) by supervisory staff.

d. There were no "Cooling Temperature Log," forms dated February 17, 18, and 19, 2012.

e. On February 21, 2012:
· An item identified as "Chicken," had a starting temp of 133 °F and a two hour temperature of 75 °F.
· Three other items (beef, chili and pork) had temperatures greater than 70 °F at two hours.
· There was no documentation of corrective action taken.
· The form was dated, but not signed by supervisory staff.

f. On February 22, 2012:
· Three of the items did not have temperatures taken at two hours.
· Two items had temperatures greater than 70 °F at two hours.
· There was no documentation of corrective action taken.
· The form was not signed or dated (indicating reviewed) by supervisory staff.

g. On February 23, 2012:
· The documented "Temp after 2 hours," for four of nine items was greater than 70 °F.
· There was no documentation of corrective action taken.
· The form was not signed or dated (as reviewed) by supervisory staff.

h. On February 24, 2012:
· Temperatures were not taken after four hours or when items were transferred to the refrigerator.
· The form was not signed or dated (as reviewed) by supervisory staff.

i. On February 25, 2012:
· According to documentation on the form, the cool down temperature at two hours was 104 °F for beans and 95 °F for rice.
· The form contained initials and a date in the section for verification.
· There was no documentation about corrective action taken.

j. On February 27, 2012:
· Two items had two hour temperatures greater than 70 °F.
· The rest of the items had no documentation of temperatures at two hours.
· There was no documentation of corrective action taken.

None of the forms had documentation indicating the time cooking was completed, cooling had started or when items reached 70 °F or 41°F.

Documentation on the back of the "Cooling Temperature Log," form included the purpose, instructions for cooling, monitoring and corrective actions to be taken. The purpose was "To prevent foodborne illness by ensuring that all potentially hazardous foods are cooled properly."

In an interview with the Interim Manager on February 27, 2012, at 4:45 p.m., the Manager stated the staff were not fully trained in using the form. The Manager stated if an item was documented on the form it was a previously cooked, PHF. The Manager stated she was unaware the supervisory staff were not reviewing the "Cooling Temperature Log," and that staff were not reporting out of range temperatures. The Manager stated she was unaware items on the cool down log had not reached the required internal temperature. The Manager stated she was unaware there were corrective actions on the back of the form.

On February 27, 2012, at 5:33 p.m., a tour of the kitchen was conducted. The four rice dishes and the two pans of pork loins were observed in the blast chiller.

The "Cooling Temperature Log," for February 27, 2012, was reviewed. Temperatures were not documented for the items above. Following the instructions on the form, temperatures should have been taken prior to 5:30 p.m., for the items placed in the blast chiller prior to 3:30 p.m.

Cook 3 checked the temperature of the items in the chiller at 5:35 p.m. Three of four containers of rice were above 70 °F.

In a concurrent interview, the Manager of the Food Service Department stated the items could not be verified as safe. The Manager stated the cool down process for these items should be monitored to ensure they reached the temperatures to prevent the growth of harmful microorganisms that cause food borne illness. The Manager agreed there was no way to know if the rice had cooled from 140 °F to 70 °F in two hours based on the documentation on the cooling log.

According to the 2009 US Food and Drug Administration's Food Code (3-501.14 Cooling) safe cooling required removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of PHF had been consistently identified as one of the leading contributing factors to foodborne illness. During slow cooling, PHF were subject to the growth of a variety of pathogenic microorganisms. If the food was not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness. The Food Code provision for cooling provided for cooling from 135 °F to 41 °F or 45 °F in 6 hours, with cooling from 135 °F to 70 °F in 2 hours.

The facility's policy titled, "Food Preparation and Service," dated August 1, 2008, was reviewed on February 28, 2012. The policy stipulated:

"21. Cooked potentially hazardous food shall be cooled within 2 hours from 60 °C (140 °F) to 21 °C (70 °F)."

The facility's policy titled "HACCP Principles," dated August 1, 2008, was reviewed on February 28, 2012. The policy indicated the Food and Nutrition Services Department followed the principles of the Hazard Analysis Critical Control Point process to manage food safety.

The facility's policy and procedure titled "Infection Control," with a revised date of January 16, 2012, was reviewed on February 28, 2012. The policy indicated its purpose was to prevent and control contamination and the spread of infection with the department and the hospital. According to the policy, the Manager was to develop written standards and work procedures for preparation and serving of food that minimizes contamination. The policy indicated the ICP would act as a resource person and the Infection Control Committee would review data concerning infections, practices and environmental cultures.

In an interview with the ICP on March 1, 2012, at 2 p.m., the ICP stated she was unaware the Food Services Department was not documenting cool down temperatures. The ICP stated cool down monitoring should be done as a quality control measure. The ICP stated if potentially hazardous food was not cooled properly the risk for bacterial growth increases.

Based on observation, interview, and record review, the facility failed to ensure surgical services were designed to assure and maintain high standards of patient care by:

1. Failing to monitor and ensure humidity levels were within acceptable ranges with current AORN standards (a nationally recognized organization) and federal statutes in the operating/procedure rooms, and

2. Failing to develop, maintain, and implement facility policy(s) that followed current AORN Standards and federal statutes in the operating and procedure rooms in monitoring temperature and relative humidity readings in order for the facility to identify any concern(s) that would require corrective actions.

These failures had the potential to result in the operating/procedure rooms' environment to be at a higher risk for fire, placing the patient at risk for injury and death, and potentially creating an environment with a higher risk for growth of microorganisms and aerosolize (diffuse) these microorganisms into the clean environment, which may result in patient infection(s).

Findings:

According to the AORN 2012, the relative humidity needed to be:

"Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas.

Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed."

According to the NFPA 101 (Federal Statutes) Life Safety Code Standard, "Anesthetizing locations are protected in accordance with NFPA 99, Standard for Health Care Facilities (b) Relative humidity is maintained equal to or greater than 35%."

On February 28, 2012, a review of the Panel Point Log Report: Humidity Readings was conducted. The printed records in the log revealed the humidity in operating/procedure rooms in 13 of 13 surgery rooms had been out of range (10 operating rooms, one procedure room, and two labor and delivery rooms). There was no record the OR staff had been notified and corrective actions had been implemented.

The form titled, "Humidity Readings", dated February 28, 2012, at 6 a.m., indicated the following:
OR #1 - 28.54
OR #2 - 30.92
OR #3- 11.78
OR #4 - 25.12
OR #5 - 27.54
OR #6 - 18.89
OR #7 - 22.16
OR #8 - 14.09
OR #9 - 26.54
OR #10 - 18.62
OR # 11 - 16.05
OR # A - 28.16
OR # B - 20.20
There was no record the OR staff had been notified and corrective actions had been implemented. There was no documentation the humidity levels had been re-checked using another form of humidity monitoring device.

A tour of the OR was done on February 28, 2012, at 4:45 p.m. There were no wall monitors to measure temperature and humidity in the operating rooms.

In a concurrent interview with the plant operation representative, he stated they did not have wall monitors in the rooms and that humidity was monitored by plant operations. The plant operation representative stated the facility's policy was to maintain the humidity between 30 and 60, however the hospital did not have a written policy to reflect that practice. The plant operation representative further stated a humidity report was printed every morning at 6 a.m. The plant operation representative stated if the humidity levels were out of range, they "would try to correct it." "Sometimes I can." The plant operation representative stated the facility had sensors that needed replacing, therefore some of the levels being recorded were not accurate.

In an interview with the surgery manager, on February 28, 2012, at 5:10 p.m. the surgery manager stated her department does not check the temperature and humidity in the operating rooms. The surgery manager stated the plant operation department was responsible for monitoring the humidity in the operating rooms, and was supposed to notify them if the humidity was out of range. The surgery manager stated they would cancel or postpone surgeries if the humidity was out of range, but were dependent on plant operations to notify them if that is the case. The surgery manager stated they had not been notified today about the humidity levels being out of range, and no surgeries were postponed or cancelled due to the humidity of the room.

There were 29 surgeries performed on this day, February 28, 2012.