HospitalInspections.org

Based on observation, interview and record review, the Governing Body failed to be responsible for the conduct of the hospital because:
1 The medical staff members' competence and judgement were not established as the basis for reappointment and re-privileging (cross reference A-0050).
2 A compounding pharmacy was allowed to provide medication to the facility without a contract or quality review by the hospital (cross reference A-0083).
3 An effective quality assessment performance improvement program had not been implemented to assist in establishing expected practices and outcomes, monitoring for aberrances and correcting deficient practices (cross reference A-0263).
4 An effective infection control program had not been designed and implemented to minimize the risk of the spread of infection and contagious disease (cross reference A-0747).
During interviews with Governing Body representatives on 12/17/15 and 12/18/15, they acknowledged historic and recruitment difficulties contributing to difficulty meeting performance standards.
The cumulative outcome of these failings meant the Governing Body did not ensure the safety and quality of healthcare provided in the hospital.

Based on interview and document review, the hospital failed to ensure that medical staff members' competence and judgement were established prior to reappointment because the ongoing provider performance evaluations were incomplete, creating the risk of substandard medical staff performance.
Findings:
During a review of six physician provider and one CRNA provider credential files, the files lacked specific information about medical staff performance. There were pre-printed forms on which it could be indicated by means of a check mark in a box, if there were concerns with physician performance in medical records, quality measure, and infection prevention. However, it was unclear what the basis for the check marks was. For example, the QAPI department's pre-printed form had the pre-printed statement, " There were no quality of care issues identified for this practitioner during the period requested. " However, it was unclear what data the QAPI department was reviewing before marking the box opposite the statement.
Similarly, the Infection Control Department was providing a pre-printed statement with boxes to check for, "no hospital infection statistics were identified for this practitioner during the period requested.", or "No data identified for this practitioner during the period requested."
In an interview with the Dir MS Services on 12/15/15 at 0915, she stated that the medical staff had a meeting eight days prior to discuss selecting criteria that can be collected to evaluate the medical staff, but there were no meeting minutes available for review.
In an interview with the ICP 1 on 12/16/15 at 1200, she stated that she believed there was a 6 month gap in surveillance for surgical site infections. She stated that she had not had the opportunity to retrospectively review surgical site infections by surgeon. She stated that a co-worker had been signing the documents from the infection prevention department that were used to support medical staff reappointment, but without current data.
In an interview with the Vice Chief MS and GB on 12/17/15 at 1430, he stated that the hospital was working to get the provider performance evaluation process going, including a mechanism to attribute surgical site infections to a particular surgeon, but that it was not yet available.
In an interview with the CEO on 12/17/15 at 1530, he stated that the ongoing provider performance evaluation process was broken, and that there were improvements in process.

Based on interview, the hospital failed to ensure the safety of a compounding pharmacy providing medication to the hospital, because there was no established contract with the pharmacy, creating the risk of substandard pharmaceutical services.
Findings:
In an interview with the Vice Chief MS and GB on 12/17/15 at 1410, he stated that all outside contracts were recorded on a grid and reviewed annually by the department head, MEC (Medical Executive Committee) and GB (Governing Body).
In an interview with the COO on 12/17/15 at 1412, he stated that the compounding pharmacy was providing its own QA data, but there was no contract with the pharmacy.

Based on interview and record review, for one patient, Patient 505, the hospital failed to ensure that documentation regarding the patient's desire for CPR was recorded in the medical record, creating the risk of the patient's wishes regarding emergency treatment not being followed.
Findings:
During a review of the medical record of Patient 505 on 12/14/15, the record contained a Physician's Orders sheet that was pre-printed with CPR orders that were to be selected by means of checking a box. The order sheet read, " Must be filled out at the time of admission and with any change in code status" . There were boxes to select either "full CPR" or "no CPR" , but neither was selected. The form bore a date and time, but no signature. The Emergency Admit form showed that the patient was 84 and being admitted for failure to thrive. A Pre-procedure Evaluation on 12/11/15 showed that she was awake and oriented.
During an interview with the Sr Mgr of Medical Records on 12/15/15 at 1050, she stated that the form should have been completed upon admission, and that she was not sure why it was not completed.

Based on observation, interview, and record review, the facility failed to provide privacy, as evidence by the following:

1. Patients' were physically exposed while receiving care.
2. Patients' clinical and demographic information was not protected.

Findings:

1. During a tour of the CCU and concurrent interview with the AS and charge nurse (CN) on 12/17/15 at 11:50 a.m., Patient N- 210 was receiving care without the room's window shades being closed, allowing people in the nurses's station to visualize the patient's exposed body from the middle of the nurses' station. The observations were shared with the AS and CN. They both agreed the nurse should have closed the window shades to provide the patient with privacy.

On the same date during a tour of the CCU at 3:25 p.m., Patient N-211 was observed during a procedure for which his body was exposed, the door and the window shades were not closed. Concurrent inteview with the AS was held, and the AS agreed the door and window shades need to be closed for patient's privacy. The patient's LN was interviewed at the time and she conceded Patient N-211's window shades and door should have been closed while the echocardiography technician (echo tech) performed the procedure.

2. During a tour of one of theTelemetry hallways and concurrent interview with the telemetry director (TD) on 12/15/15 at 4:20 p.m., a transferring packet containing clinical and demographic information of the patient that was being transferred out of the unit was sitting on top of the computer in front of room 232. The TD was questioned and conceeded the records should not be to the public.

The LN for the patient was interviewed a few minutes later.The LN agreed she shouldn't leave patient records available for public view.

Based on observation, interview and review of facility documents, the facility failed to ensure staff implemented the policies and procedures related to seclusion and restraints for two patients.
N 401 and N 402 were on 1:1 observation. However, staff assigned to the patients were not always present. These failures placed the patients at risk for injury from themselves or others.

Findings:

Facility policy titled, "Behavioral Restraints and Seclusion" dated 3/2014 indicated, "4.2.5.2 A patient in restraints or seclusion and restraints simultaneously requires a higher level of monitoring in which the patient is continually monitored face-to-face by an assigned staff member (one to one)."

During a tour of the behavioral health unit (BHU) on 12/14/15 at 4:10 p.m. , the charge nurse (LN 11)
identified N 402 as being on a one-to-one (1:1) observation and N 401 as having been on a 1:1 but ,"Since it was just a nursing order we decided to try him off...but after an hour we had to put him back on 1:1".

N 401 was observed in a bed, with no staff in attendance. In a second bed, N 402 was observed in a bed in four point restraints. A staff member (MHW 1) was seated at a table at the foot of the bed.

When asked where the staff member was who was assigned to N 401, LN 11 stated, "Oh, he (MHW) 2 is just down the hall if they need him."

N 401 was not receiving 1:1 observation as required by the facility's policy.

Based on observation, interview, and review of records the facility failed to ensure the physician documented an assessment of two patients in seclusion and/or restraints. Patient N 402 was on 1:1 observation and in four point restraints. Patient N 404 was in the locked seclusion room.

This failure placed both patients at risk for not being accurately assessed for the restrictions.

Findings:

Review of facility policy titled Behavioral Restraints and Seclusion" dated 3/2014 identified the following instruction: "4.2.4.6. ...The treating physician is required to record in the progress notes the seclusion/restraints episode within 24 hours."

1. During the tour of the 6th floor on 12/14/15 N 402 was observed in a room in four point restraints. (The wrists and ankles being tied to a bed). There was a staff member in attendance.

On 12/16/15 during a review of the record of N 402, the surveyor requested any seven consecutive days of physician progress notes. The dates given by the facility were 11/2/15 through 11/7/15. The patient was seen daily by the physician. The use of restraints was mentioned in one of six progress notes.

During interview and concurrent review of the notes with the chief clinical office (CCO) she stated, "Another doctor was covering for some of those days."

2. During continued tour of the 6th floor, N 404 was observed on a bed in the locked seclusion room. The mental health worker (MHW) stated N 404 was threatening staff and hurting himself. The room was used to reduce stimulation and calm him.

On 12/16/15 during a review of the record of N 404, the surveyor requested any seven consecutive days of physician progress notes. The dates given by the facility were 12/1/15 through 12/6/15. The patient was seen daily by the physician. The use of the seclusion room was mentioned in one of six progress notes.

During interview and concurrent review of the notes with the chief clinical officer (CCO) she stated, "Another doctor was covering for some of those days."

Based on observation, interview and record review, the facility failed to assess, monitor and document on Patient N 200, N 201, N 216, and N 217 who had non-behavioral restraints. Failure to monitor and assess for restraints puts patients at risk for negative complications during the use of restraints.

Findings:
During a tour of the facility on 12/15/15 from 11:00 a.m., to 12:00 p.m., Patients N 200, N 201, N 216, and N 217 were observed with restraints.

The clinical records of the patients were reviewed and contained incomplete "Non-Behavioral restratin order and flow sheets".

Patient N 201's clinical record had no documentation to indicate attempts or interventions were performed in order to remove the restraints.

Concurrent interview with RN 1 was held, and she was questioned as to the incomplete flow sheets. RN 1 stated if the sheets were incomplete that meant the patient was not assessed or monitored in the areas that were incomplete.

A review of the facility's policy and procedure titled: Non-Behavioral Restraints, PAT.048, dated 5/2015, in section 4.11 Restraint Application and Removal, indicated "Restraints will be released and rotated at least every 2 hours". In Section 4.14 Documentation, indicated "The following shall be documented: Integrity/Effectiveness of restraint, Skin integrity, Body alignment, Patient basic needs to include nutrition, hydration, elimination...".

The facility staff failed to implement policy when managing non-behavioral restraints with patients.

Based on observation, interview and review of documents the facility failed to ensure nursing staff followed policy and procedures related to assessing a patient in restraints. Nursing failed to document assessments hourly for N 402 as required.

These failures placed the patient at risk for not being accurately assessed for change of condition and safety while in four point restraints.

Findings:

Review of the facility policy titled, "Behavioral Restraints and Seclusion" identified the following requirement for RNs: "4.2.21 Patient assessment every hour." and "4.2.30 RN documentation on flow sheet every hour."

During observation of N 402 on 12/14/15 at 4:40 p.m. he was noted to be in four point restraints in bed. MHW 1 was in attendance as N 402 was on one-to-one (1:1) observation.

During review of the record of N 402 the following restraint flow sheets were noted to be incomplete, indicating an RN did not see and assess N 402 hourly as required: (military times)
12/11/15 2000, 2100, and 2200.
12/12/15 0900 and 1000
12/13/15 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, and 2100.
12/14/15 0700, 0800, 0900,1500, 1600, and 1700.

During concurrent review and interview with LN 11 on 12/15/15 at 9:35 a.m. LN 11 stated, "But there were 15 minute checks done by the MHW." "Looks like no RN assessed him, but a tech did."

Based on observation, interview and record review, the hospital did not ensure that a data-driven, hospital wide QAPI program was designed and implemented because:
1) Incidents and errors were not subject to review and analysis, and did not form the basis for performance improvement (cross reference A-0286).
2) The QAPI program did not collect or monitor hospital data regarding discharge planning, surgical site infection and staff influenza screening (cross reference A-0273).
3) The hospital did not focus on high risk, prevalent issue of suicidality among the hospital's patients, and did not analyze and use data regarding mortality, and falls to improve the quality of care provided (cross reference A-0283).
4)The Governing Body voiced awareness of the need to improve the QAPI program, but had not yet implemented changes needed to improve the program (cross reference A-0309).
The cumulative effect of these failings meant the hospital did not provide a QAPI program to ensure the quality and safety of the healthcare provided to the patients.

Based on interview and record review, the QAPI program did not collect and monitor data regarding hospital processes such as 1) discharge planning for psychiatric patients, 2) staff influenza vaccination and 3) surgical site infections , creating the risk of persistent poor practices and substandard healthcare.
Findings:
1) In an interview with the Hosp System Dir Quality on 12/17/15 at 1400, he stated that the data for the quality program was gathered from numerous sources, including the event reporting system, security and grievance logs, work orders and phone calls, and core measures routinely monitored. He stated that each department also had its own quality indicators.
During visits to the hospital from 12/14/15 through 12/18/15, the three facilities included a Van Nuys (VN) facility that consisted of 57 beds for psychiatric patients, and a facility with behavioral health units and a detoxification unit in addition to general medical care. QAPI program follow-up of the discharge services offered to patients with psychiatric and behavioral health problems were reviewed.
During a review of the medical record of Patient 509, from the VN facility, on 12/17/15, a long term goal for the patient included, "pt will maintain sobriety and follow up with AA and NA groups at discharge" .
During an interview with a BHU Staff member at the VN campus on 12/17/15 at 1210, he stated that the goals of the facility were to help the patients to relieve crises, and to put in place a support system for assistance prior to discharge.
In an interview with the Dir SS at the VN campus on 12/17/15 at 1215, he stated that the QAPI goals included ensuring that there was a social support person identified for each patient prior to discharge, and that the discharge plan was coordinated with that person. He stated that there were no routine follow-up calls or contacts to determine the efficacy of the discharge process. He stated that there had been a study regarding rapid re-hospitalization but it occurred years prior.
In an interview with the Coord of QM at the VN campus on 12/17/15 at 1205, he stated that he was not aware of any follow-up of the discharge process to verify the efficacy of the process.
2) During observations and interviews from 12/14/15 through 12/18/15, staff and medical staff were seen at all three facilities without masks or stickers indicating influenza immunization (see 749).
In an interview with the ICP 1 on 12/16/15 at 1200, she stated that the stickers were distributed by the medical staff office or by employee health to put on hospital name badges in indicate influenza immunization. She stated the expectation was that the staff member would wear a mask until documentation of vaccination was submitted. She stated that there was informal checking of the badges, but no study to determine if the stickers or masks were in use.
During a continuing interview with the IP Epidemiologist HW, he stated that there had been no study to verify the efficacy of the sticker system used to identify staff members who had the influenza vaccine.
In an interview with the QA Staff HW on 12/18/15 at 1200, she stated that people who were vaccinated elsewhere did not have stickers on their badges as the hospital ran out of stickers to give.
During a review on 12/15/15 of the credential and health files of DRs 9, 10, 11, 12, 13, 14 and CRNA 1, the files did not contain information about influenza vaccination or declination.
In an interview with the Dir MS Services on 12/15/15 at 0750, she stated that there was no influenza vaccine information in the files.
In an interview with the Dir Hosp System Quality on 12/17/15 at 0825, he stated that he thought the infection prevention department audited the badges. He stated that there had been a poor response from physicians regarding influenza vaccination requests, but that influenza vaccination tracking was not followed by the QAPI department.
3) The Quality Council Minutes from October 28, 2015, were reviewed, and showed that the report for infection prevention included the detail, "SSI rate is high", but no further information suggesting a breakdown by surgeon, equipment used, or other investigative parameters.
During a review of surgical site data for the year, the data were shown for infections in four locations, abdominal hysterectomy, colon, hip and knee. However, there were no benchmarks established to show what the comparative rate at other facilities was.
In an interview with the Adm Staff 1 on 12/16/15 at 1130, she stated that she was not sure what surveillance mechanisms were in place for identifying surgical site infections. She stated that there was a plan to validate the data that was collected, but that data was not yet being validated.
In an interview with the ICP 1 on 12/16/15 at 1200, she stated that she believed there was a 6 month gap in surveillance for surgical site infections. She stated that she had not had the opportunity to retrospectively review surgical site infections by surgeon.
In an interview with the Hosp Sys Dir Quality on 12/18/15 at 1310, he stated that he believed there was a two month gap in the surgical site infection data. He concurred that there was no surveillance of physicians to determine if there was an infection seen after discharge. He stated that IP personnel were to follow NHSN and CDC guidelines for surgical site infection surveillance.
The CDC Surgical Site Infection (SSI Event procedure-associated module) modified 4/15 showed "Post-discharge and ante-discharge surveillance methods should be used to detect SSIs following inpatient and outpatient operative procedures. These methods include;

* Direct examination of patients' wounds during follow-up visits to either surgery clinics or physicians' offices

* Review of medical records or surgery clinic patient records

* Surgeon surveys by mail or telephone

* Patient surveys by mail or telephone (though patients may have a difficult time assessing their infections).

Any combination of these methods was acceptable for use; however, the CDC criteria for SSI must be used.
In an interview with the ICP 1 on 12/16/15 at 1200, she stated that there was routine follow-up of NHSN designated procedures for possible surgical site infections through readmissions, culture review, staff reporting and notifications from other facilities. She stated that there was no system for contacting physicians for surveillance, there was no outpatient surgery clinic, and no outpatient clinical records were reviewed to identify infections. She stated that the process for identifying readmissions was a work in progress. She stated that there was no routine follow-up of surgical site infections that were not NHSN reportable infections.

Based on interview and record review the QAPI program failed to perform a quality review of the hospital ' s processes for 1) assessing and treating suicidal patients, 2) performing mortality reviews, and 3) addressing falls, creating the risk of persistent poor practices and poor health outcomes.
Findings:
1) During a review of the admitting diagnoses for patients at the VN facility on 12/17/15, 55 of 57 patients were admitted with suicidal ideation.
During an interview with the Admin VN and the BHU Staff VN on 12/17/15 at 1230, they were able to recall a couple of suicide attempts in the VN facility during recent months, including an attempted hanging and a cutting incident.
The hospital policy, Precautions BHU.053 (revised 6/2014) was obtained at the Van Nuys facility, and the hospital policy, Precautions (reviewed 8/2015), was obtained from the Culver City facility. The policies showed that the " Suicide Potential Rating Scale (addendum A) shall be completed as part of the Initial Nursing Assessment and daily assessment for each patient " , and that the score of the assessment would determine the level of observation provided and that a patient was to be placed on " suicide precautions " based on the information obtained from the history, legal holds, initial assessment, and Suicide Potential Rating Scale.
During reviews of medical records from the VN facility and the CC facility, several records of patients who presented with suicidal ideation were reviewed. The records did not contain Suicide Potential Rating Scale or resultant risk score (see A-286 and A-392).
In an interview with the Dir BHU on 12/17/15 at 1000, she stated that she had many concerns with the quality of documentation in the BHU. She stated that the BHU had been looking at the same quality indicators for years, and that they were not looking at the assessment information, including pain assessments. She stated that they had wanted to begin looking at new quality measures, but then the department director changed again. She stated that the change in personnel resulted in a delay in implementing the request for new quality measures. She stated that currently there was no auditing process for the behavioral health unit assessments because the charting was variable.
She stated that the behavioral health department met monthly, but that no one from quality attended the meetings, and that she reported informally to the quality department if issues arose.
In an interview with the Hosp Sys Dir Quality on 12/17/15 at 1510, he stated that the medical record audit tool used to review records was very generic, and not adequate to catch the missing suicide risk assessments.
2) The Quality Council Minutes from October 28, 2015, were reviewed and showed that " There would need to be a deeper analysis . " of the code blues, and there was an intention to address the follow-up and define the performance improvement process for mortality review.
The dashboard of code blue, mortality and rapid response team data for November, 2015, was reviewed, and showed that of seven code blues during the month, three occurred outside of the ER and critical care units, in the telemetry and medical-surgical areas of the hospital, where less acute patients are placed and hence code blues are typically unexpected. The only plan documented appeared to be, "Track and trend. Continue to monitor. Continue to consolidate, as well as reconcile RRT and code blue data from various sources in order to provide accurate reporting."
The Code Blue Log for the month of November was reviewed, and showed 100% mortality following code blues in the hospital.
In an interview with the ER RN Dir on 12/17/15 at 0900, a member of the Code Blue Committee, she stated that she recognized the high mortality rate with the code blues, but that they had not been able to drill down to see the causes, which could be population-related.
Patient 507 experienced a code blue while on the med-surg unit on 11/2/15, and did not survive the event. The incident was reviewed with the Adm Staff 1, and she stated that a code blue shouldn ' t happen outside the ICU, and that it should have been made an incident and reviewed by unit staff and an RCA completed, but this was not done.
In an interview with the Hosp Sys Dir Quality on 12/18/15 at 1310, he stated that the mortality review process was incomplete due to limited staff training.
3) The Quality Council Minutes from 10/28/15 were reviewed and showed that falls were identified as increasing and a number of interventions were proposed, including a new policy, education, and fall prevention mechanisms. The minutes stated that the goal is to get all of the units to be reported.
In an interview with the CNO on 12/17/15 at 1415, the CNO stated that falls data was based on facility, and that a task force had been created to improve the falls data, and that bed alarms had been implemented at the CC facility. She concurred that there was no coordination of individual facility falls data.
In an interview with the Coord QM VN on 12/17/15 at 1210, he stated that falls data from VN was presented annually, with quarterly presentations to a subcommittee. He stated that there was no benchmark developed for the expected number of falls, no analysis of why patients fell, such as due to medication, footgear or obstacles, and no intervention plan developed.
In an interview with the Adm Staff 1 on 12/17/15 at 1417, she stated that they had just begun the process of analyzing falls data and implementing interventions.

Based on interview and record review, the hospital did not ensure that all incidents were subject to review and made the basis for performance improvement, creating the risk of persistent substandard practices and poor health outcomes for patients using the hospital.
Findings:
In an interview with the Adm Staff 1 on 12/17/15 at 1445, she stated that the CNO and COO reviewed events and used the RCA process.
In an interview with the CNO on 12/17/15 at 1450, she stated that the results of incident reviews were not clearly documented in the incident reporting system yet.
In an interview with the CEO on 12/17/15 at 1500, he stated that the investigation documentation was not complete.
During an interview with the Hosp Sys Dir Quality on 12/18/15 at 1400, he stated that near misses and other incidents were to be reported through the incident reporting system. He stated that there was no method for double-checking whether incidents were actually being reported, such as checking billing or diagnosis codes against the incident reporting system to see if reportable incidents were actually reported.
Three incidents were selected from the incident reporting system for November, 2015, for review, and one was selected from the Code Blue Log for November, 2015. None of the incidents appeared to have been thoroughly reviewed, and none were used as the basis for performance improvement. Departures from hospital policy and from the standard of care for hospitalized patients were noted during a review of the four incidents.
1) An incident dated 11/14/15 was reviewed on 12/15/15, and showed that a patient, Patient 508, a 21 year old woman with schizoaffective disorder, was admitted to the behavioral health unit at Culver City, and reported an assault during a stay on one of the psychiatric units, "when I was in the other unit yesterday after I got my shoot (sic) Rayan came to the day room he grabbed my ass and kissed me behind the door". The patient reported two different names for the assailant. The only investigation documented appeared to consist of a review of unit patient names and an interview with one LVN, who stated "nobody witnessed anything". There was no documentation that the patient was questioned about the appearance of the alleged assailant, was asked to identify the assailant, or that the review of possible assailants included unit staff and other staff such as cleaning, kitchen, facility or medical staff who may have been in the unit. There was no documentation to support that other possible witnesses were interviewed.
The event was documented as forwarded to the CNO, Quality Staff 2, and Adm Staff 1, but the column for "review completed" was blank, there were no manager's comments and no proposed actions documented.
In an interview with the Adm Staff 1 on 12/15/15 at 1415, she stated that the department directors were supposed to respond to incidents, but there was no comment added in this case from the director. She stated that on the surface it looked like there were gaps in the investigation.
In an interview with the Dir BHU on 12/15/15 at 1445, she stated she started as the Dir BHU in October. She stated that she did not recall the case, and that she was not sure if there was follow-up of the incident. Documentation of further investigation was requested, but was not provided.
In another interview with the Adm Staff 1, on 12/17/15 at 1445, she stated that the investigation of the assault incident did not happen.
The record showed that Patient 508 did not receive a suicide risk assessment per hospital policy, and did not have a substance withdrawal risk assessment, despite the history of substance abuse (see A-392).
2) An incident dated 11/18/15 was reviewed and showed that a patient, Patient 503, was admitted to the behavioral health unit at Culver City, but remained in the ER overflow area. The nurse could not find the patient medications and profile.
The follow-up of the event was reviewed and showed that the ER RN Dir reviewed the incident. A delay of service was identified, and education was documented as the proposed action.
However, additional review of the record showed that numerous issues occurred in the care of Patient 503, and the issues were not documented as being identified pursuant to event reporting. The record showed that there was incomplete assessment, care planning and treatment provided to Patient 503 during the Culver City facility admission.
The record showed that the patient was transferred from the Van Nuys facility, but there were multiple omissions and inconsistencies in the patient's medical record (see A-392 and A-438).
In an interview with the Dir BHU on 12/6/15 at 1105, she stated that the patient had a suicide attempt 2 weeks prior to her 11/17/15 admission, and a previous hospital admission for a suicide attempt. She stated that the staff was supposed to do a suicide risk assessment at the Culver City facility, but that no such assessment was seen.
Transfer documents obtained from the Van Nuys facility included a Multidisciplinary After Care Instructions form dated 11/16/15 that showed that the patient was being transferred to the Culver City ER "due to breathing". According to the progress note written by the internal medicine physician on 11/18/15, Patient 503 was assessed on 11/18/15 at 1601, and was "still awaiting a bed on D team so she can continue using her CPAP." There was no documentation indicating that the patient was ever provided with the CPAP device for which she was transferred to the Culver City facility on 11/16/15.
In an interview with the Adm Staff 1 on 12/16/15 at 0950, she stated that she could not tell from the record if the patient had difficulty breathing or had CPAP during the Culver City facility stay.
In an interview with the Dir BHU on 12/16/15 at 1100, she stated that there was no order for the CPAP seen, and no documentation of the CPAP being used. She was not sure why the patient was transferred from the Van Nuys facility, but believed it was for the patient to obtain CPAP. In a second interview, on 12/16/15 at 1145, she stated that she was not sure if the ER triage initiated finding a CPAP machine for the patient, but should have.
In an interview with the Dir Hosp System Quality on 12/17/15 at 0825, he stated that the lack of suicide risk assessments for Patients 503 and 508 should have been picked up during the incident review process.
3) A third incident, dated 11/16/15, was reviewed and showed that a patient had seizure like activity while at the intensive outpatient psychiatric program, and was transported to the emergency room. The incident was forwarded to the CNO, Quality Staff 2, and the Adm Staff 1. However, the section for "review completed" showed that none of the three had marked that they reviewed the event, there were no comments in the "comments" section, and the section for Manager's Proposed Action did not have any actions indicated.
4) A fourth incident reviewed was selected from the Code Blue Log for the month of November. The log showed that Patient 507 experienced a code blue while on the medical-surgical unit on 11/2/15, and did not survive the event.
The medical record of Patient 507, a 58 year old man who had a procedure at the hospital, was reviewed and showed that his blood pressure was in the normal or elevated ranges on 11/1/15 and 11/2/15, but suddenly dropped to 90/66 on 11/2/15 at 1700. Similarly, his heart rate suddenly dropped from a normal range to 56 at 1804. There was no documentation to show that the abnormal vital signs were rechecked, that the physician was notified, that any orders were obtained or that any assessments or interventions were undertaken by the nurse to address the changes. The patient became pulseless and a code blue was initiated at 1845, but the patient expired.
In an interview with the Adm Staff 1 on 12/16/15 at 1120, she stated that the Code Blue Committee should look at events preceding a code blue. She stated it looked like a failure to rescue occurred, and that the time to call for a rapid response or to call the physician was when the change of condition occurred. She stated that a code blue shouldn ' t happen outside the ICU, and that it should have been made an incident and reviewed by unit staff and an RCA completed, but this was not done. In a second interview with the Adm Staff 1, on 12/17/15 at 1440, she stated there was no review of the 11/2 code blue yet.
In an interview with the Hosp Sys Dir Quality on 12/18/15 at 1310, he stated that the mortality review process was incomplete due to limited staff training.

Based on interview and record review, the Governing Body failed to ensure the QAPI program was designed, implemented and maintained to maximize the quality of the healthcare provided in the facility, creating the risk of persistent poor practices and substandard healthcare.
Findings:
In an interview with the CNO on 12/17/15 at 1450, she stated that the results of incident reviews were not clearly documented in the incident reporting system yet.
In an interview with the CEO on 12/17/15 at 1500, he stated that the investigation documentation was not complete.
In interviews with the CEO and the GB Member on 12/17/15 at 1515, they stated that they had established patient safety as a priority, but were still determining what was needed to move the quality program forward. They concurred that the implementation of changes had not caught up with the assessed need to advance the quality program.
In an interview with the Hosp Sys Dir Quality on 12/18/15 at 1400, he stated that there were still gaps in staffing the QAPI program, and that there had been little success in hiring. He stated that a salary study was underway to determine whether compensation was a significant issue.

Based on interview and record review, the medical staff failed to have an established process to ensure provider performance evaluations to ensure the ongoing quality of physician services and to inform the reappointment process, creating the risk of persistent poor physician practices and substandard healthcare.
Findings:
1) During a review of physician credential files for MD7, 10, 11, 12, and 13 on 12/15/15, the files contained a preprinted page on which the QAPI department indicated by means of checking a box, "There were no quality of care issues identified for this practitioner during the period requested". MD6's form showed that one incident, described as a category one incident was ascribed to him.
2)During a review of six physician provider and one CRNA provider credential files, the files lacked specific information about medical staff performance. There were pre-printed forms on which it could be indicated by means of a check mark in a box, if there were concerns with physician performance in medical records, quality measure, and infection prevention. However, it was unclear what the basis for the check marks was. For example, the QAPI department ' s pre-printed form had the pre-printed statement, " There were no quality of care issues identified for this practitioner during the period requested. " However, it was unclear what data the QAPI department was reviewing before marking the box opposite the statement.
Similarly, the Infection Control Department was providing a pre-printed statement with boxes to check for, " no hospital infection statistics were identified for this practitioner during the period requested. " , or " No data identified for this practitioner during the period requested. "
In an interview with the Dir MS Services on 12/15/15 at 0915, she stated that the medical staff had a meeting eight days prior to discuss selecting criteria that can be collected to evaluate the medical staff, but there were no meeting minutes available for review.
In an interview with the Adm Staff 1 on 12/15/15 at 0945, she stated that if a physician had a risk or quality of care issue, it was reported to the medical staff, but that there was no closure. She stated that she was unsure if investigation or follow-up occurred. She stated that the form sent to the medical staff office for the physicians at the time of reappointment were filled out by Quality Staff 2.
In an interview with the ICP 1 on 12/16/15 at 1200, she stated that she believed there was a 6 month gap in surveillance for surgical site infections. She stated that she had not had the opportunity to retrospectively review surgical site infections by surgeon. She stated that a co-worker had been signing the documents from the infection prevention department that were used to support medical staff reappointment, but without current data.
In an interview with the Vice Chief MS and GB on 12/17/15 at 1430, he stated that the hospital was working to get the provider performance evaluation process going, including a mechanism to attribute surgical site infections to a particular surgeon, but that it was not yet available.
In an interview with the CEO on 12/17/15 at 1530, he stated that the ongoing provider performance evaluation process was broken, and that there were improvements in process.

Based on interview and document review, the hospital did not ensure that a history and physical exam, including all pertinent documentation, was recorded for one patient, Patient 504, creating the increased risk of a poor surgical outcome for that patient.
Findings:
The hospital's Medical Staff Rules & Regulations (undated, page 3), read, "Each practitioner shall complete an H & P within the first twenty-four (24) hours of admission of his patient. The only exception to this requirement is for patients who have had an H&P examination performed within seven (7) days prior to admission and a durable, legible copy of this report is placed in the patient's medical record."
The medical record of Patient 504 showed that he was admitted to the hospital for outpatient surgery on 12/14/15. The record contained H&P documents from 8/5/15 and 11/17/15. The 11/17/15 document consisted of a pre-printed Outpatient Preoperative History and Physical Form on which some information had been handwritten regarding the 70 year old patient. However, the sections of the form to indicate diagnosis, proposed surgery, medications, review of systems, and physical examination were left blank. The section for indicating a problem history included COPD, hypertension and atrial fibrillation. The surgeon signed the form. However, the documentation completed by the anesthesiologist and the nurse showed the patient also had prostatic hypertrophy (enlarged prostate), history of a heart attack, elevated cholesterol, diabetes, asthma and anxiety, conditions not noted by the surgeon.
In an interview with the Sr Mgr Medical Records on 12/15/15 at 1050, she stated that the surgery department was to do its own audit of the H & Ps. She reviewed the medical record documented on 11/17/15 for Patient 504, and concurred that there was no physical exam, no review of systems and no medications listed, and that the history of an MI was not on the form.

Based on observation, interview and record review, the hospital failed to 1) Ensure that suicide risk assessments were performed and documented per policy, creating a risk to the safety of all patients presenting with suicidality, and failed to ensure that the treatment plan was followed for Patient 509, creating the risk of inadequate treatment, and failed to ensure medication was administered as ordered for one patient, Patient 504, creating the risk of substandard health care for that patient, and failed to ensure a timely response to a change in condition was provided to Patient 507, resulting in a possible failure to rescue the patient. 2) The hospital failed to have all ICU RN's (intensive care unit, registered nurses) nursing staff physically present within the ICU at all times, when RN assignments were split between the ICU unit and the MAC (medically acute care) unit. This failure has the potential of not having readily available the assigned RN to manage the care of the intensive care patient population.

Findings:
1) Patients did not receive suicide risk screening per hospital policy.The hospital policy, Precautions BHU.053 (revised 6/2014) was obtained at the Van Nuys facility on 12/17/15. The policy showed that the "Suicide Potential Rating Scale (addendum A) shall be completed as part of the Initial Nursing Assessment and daily assessment for each patient", and that the score of the assessment would determine the level of observation provided.
The hospital policy, Precautions (reviewed 8/2015), was obtained from the Culver City facility, and showed that a patient was to be placed on "suicide precautions" based on the information obtained from the history, legal holds, initial assessment, and Suicide Potential Rating Scale. The Suicide Potential Rating Scale was to be completed as part of the initial nursing assessment and daily assessment for each patient, and was to generate a risk score that would prompt different levels of observation.
The Suicide Potential Raking Scale appended to the policy included assessment of 8 parameters, including age, socialization support system, onset of suicidal ideation, plan, availability of means, symptoms, planned outcomes, and recent stressors. A score was to be determined for each parameter, and based on the total score, precautions were determined, including no precautions for a score of 4-9, Q15 minute rounds, " S/I " indicated on rounds board and documentation in progress notes each shift for a score of 10-19, and 1:1 monitoring until evaluation by attending for patients with scores of 20 or more. The Suicide Potential Rating scale had ratings for each parameter of 0-4 points, but with 20 points scored for a specific plan.
Review of the census list provided by the VN facility showed that almost all of the patients provided a plan that included a specific mechanism for self-harm, and therefore almost all would have qualified for 1:1 monitoring until released with an order by an attending physician.
An incident dated 11/18/15 was reviewed and showed that a patient, Patient 503, was admitted to the Van Nuys facility on 11/13/15, and transferred to Culver City on 11/16/15, but remained in the ER overflow area.
The Physicians Initial Assessment & Preliminary Treatment Plan dated 11/14/15 showed that the patient had been admitted due to suicidal ideation with a plan. However, no suicide potential rating scale results or score was found. The record showed that the patient was transferred to the Culver City ER on 11/16/15 and the ER MD Note indicated the patient was having suicidal ideation. The triage note from the ER on 11/16/15 showed the chief complaint was suicidal ideation, with a plan to cut herself. Patient 503 was subsequently admitted as an inpatient on 11/17/15 at 1219 (but remained physically in the ER). There was an admission assessment performed at the time of admission that showed for the item, suicide self-harm risk, "no risk" was written. There was no further suicide potential rating scale result found, and no score for suicide risk determined. The patient denied suicidal ideation on 11/18/15 at 1118, and requested discharge. She was documented to have been escorted from the hospital on 11/18/15 at 1212.
Patient 508, a 21 year old woman with schizoaffective disorder, was admitted to the behavioral health unit at Culver City, and her record was reviewed because she reported an incident.
The record showed that the patient was admitted for being a danger to self, as she had jumped from a balcony. The discharge summary indicated that patient had worsening depression with the intent to cut herself and had been hospitalized for suicidal behavior four times in the previous three weeks. During a review of the medical record, no Suicide Potential Rating Scale was found, and no suicide risk score was seen. The observation sheets did not have suicide risk indicated as a reason for observation, and there was no documentation of 1:1 observation seen.
In an interview with the Dir BHU on 12/16/15 at 0855, she stated that she did not see the suicide risk assessment for the patient. She stated that they had a paper form available to complete such an assessment during electronic health record downtime, but that there might not be such a form in the electronic health record.
Also, although the patient discussed previous consumption of 40 ounces of beer daily, the assessment item for potential for withdrawal problems showed "none known or evident", and the withdrawal risk assessment had not been completed.
In an interview with the Dir BHU on 12/17/15 at 0950, she stated there was no symptom screen related to the history of substance abuse for Patient 508. She stated that there were dual diagnosis patients on the P6 psychiatric unit, and that the staff should fill out the "miracle" substance abuse risk assessment, and that the assessment should be in the electronic health record.
On 12/17/15, at 1150, Patient 509 was observed in the hallway of the Van Nuys facility, and appeared smiling and calm. BHU STAFF VN stated that Patient 509 was about to be discharged.
The patient roster with diagnoses for the Van Nuys facility was requested. The roster showed that 55 of 57 patients were admitted with a plan to commit suicide. Patient 509 appeared on the census as being admitted for depression and suicidal ideation with a plan to overdose.
Patient 509's medical record was reviewed, and no Suicide Potential Rating Scale was found, and no suicide risk score was seen. Other rating scales, such as the Morse Fall Scale and the Braden skin risk assessment, were seen.
In an interview with BHU Staff VN on 12/17/15 at 1220, he reviewed the medical record of Patient 509 and stated that there was no scored suicidal ideation worksheet. He stated there was an assessment template in the electronic health record, but it was not equivalent to the worksheet described in the policy.
The medical record of Patient 510 at the VN facility was randomly selected for review on 12/17/15. The record showed that the patient presented with suicidal ideation with command hallucinations. However, the record did not contain the Suicide Potential Rating Scale described in the hospital policy.
During a concurrent interview with the Adnin VN and BHU Staff VN on 12/17/15 at 1245, they concurred that the suicide risk assessment was not being performed per policy. They stated that there had been a couple of suicide attempts in the facility in recent months.
In an interview with the CNO on 12/18/15 at 1505, she stated that she was not sure why the Suicide Potential Rating Scale assessment tool was not in use.
On 12/17/15, at 1150, Patient 509 was observed in the hallway of the Van Nuys facility, and appeared smiling and calm. BHU STAFF VN stated that Patient 509 was about to be discharged.
The treatment plan for Patient 509 at the Van Nuys facility was reviewed on 12/17/15, and showed that the plan of care initiated 12/9/15 contained items such as, "pt will identify 2 triggers that increase self-harm ideation and discuss with staff 2x week ", and "pt will identify 2 triggers that decrease positive mood and/or increase mania and/or increase anxiety", and "patient will id 2 triggers that increase risk of relapse and discuss with staff during 2x groups per day and during 1:1", and "case manager will encourage pt to identify 2 coping skills that increase/maintain in sobriety in 4x groups per day and during 1:1".
In an interview with BHU Staff VN on 12/17/15 at 1225, he reviewed the documentation in the electronic health record and was not able to find documentation that the goals were met during groups or 1:1 time during the patient's stay in the facility.
The record of Patient 507 was selected for review because the patient appeared on the Code Blue Log for the month of November. The log showed that Patient 507 experienced a code blue while on the med-surg unit on 11/2/15, and did not survive the event.
The medical record of Patient 507, a 58 year old man who had a procedure at the hospital, was reviewed and showed that his blood pressure was in the normal or elevated ranges on 11/1/15 and 11/2/15, but suddenly dropped to 90/66 on 11/2/15 at 1700. Similarly, his heart rate suddenly dropped from a normal range to 56 at 1804. There was no documentation to show that the abnormal vital signs were rechecked, that the physician was notified, that any orders were obtained or that any assessments or interventions were undertaken by the nurse to address the changes. The patient became pulseless and a code blue was initiated at 1845, but the patient expired.
In an interview MR Staff 1 on 12/16/15 at 1145, she reviewed the medical record of Patient 507 and stated that there were no nurses notes prior to the code blue, no evidence of physician notification, and that the last order for the patient recorded prior to the 1845 code blue was at 0813 in the morning.
The medical record of Patient 504 was reviewed on 12/14/15 and showed that he was to have outpatient surgery on 12/14/15. The Preoperative Orders included an order to "Instill one drop of the left eye every 5 minutes for 3 doses on call to OR: a) Marcaine 0.75% or equivalent topical anesthetic " . The other four eye drops ordered included Cyclogyl, Mydriacyl, Phenylefrin, and Ciprofloxacin. The record showed that those four drops were given, and the times of administration recorded, but not the Marcaine.
During an interview with the Sr Mgr Medical Records on 12/15/15 at 1050, she was unable to find documentation that the Marcaine was administered.




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2) On 12/17/15, at 9 a.m., during a tour and interview of the ICU, charge nurse (LN5) was questioned about patient N106's medical condition. LN 5stated, "That's RN3's patient." When asked where RN3 could be found the LN 5 stated, "I think she is caring for her other patient outside of the ICU." RN3 was located outside of the ICU, in room 305C in the MAC unit, RN3 was dressed in a protective isolation gown, caring for Patient N104 outside of the ICU.

During an interview with the DON1 on 12/17/15, at 9:15 A.M., DON1 was questioned as to the usual and customary staffing assignments. DON1 stated, "The staffing ratio is 1:2 (nurses to patients) and if the nurse is away from the unit, the charge nurse should know what is going on with the patient."
During an interview with RN3, RN3 was asked if she could visually see her ICU patients when she is working with a MAC patient in another unit, RN3 stated, "Obviously not, the patients are separated by walls and doors." RN 3 was questioned as to whether she gives report on her patients to other nurses in the ICU when she leaves the unit to care for her other assigned patients. RN3 stated, "I do when I go to lunch, otherwise if they need me they find me."

During an interview with the day supr LN8 on 12/17/15, at 3:35 p.m., the day supr LN8 was questioned regarding the practice of having an RN assigned to manage both an ICU patient and a MAC patient in two different units was appropriate. The day supr LN8 stated, "No, not really it would be difficult." When questioned if this was the only time he was aware of this type of staffing assignment, the day supr LN8 stated, "No I believe it has happened before."

On 12/17/15, at 4 p.m., a review of staffing assignment for ICU for one week (12/11/15 through 12/17/15) revealed that RN's were assigned to an ICU patient and a MAC patient on 19 separate occasions.
On 12/17/15, at 4:45 p.m., during an interview with the DON1 she was shown the assignment sheets indicating the RN assignments were split between two different units the ICU and the MAC units. The DON1 stated, "I didn't know this was happening".

Based on observation, interview, and record review, the facility failed to ensure nursing staff evaluated and implemented nursing care according to professional care standards for patients with Foley catheter devices as evidence by the following:

1. Foley Catheters were inserted without a doctor's order in the Critical Care Unit (CCU), Step Down unit and Emergency Department (ED).

2. Facility staff did not evaluate for urinary catheter insertion indication and daily neccessity as indicated per policy.

These failures have the potential to have a negative health outcome for patients' with a Foley Catheter.

Findings:

According to the California Nursing Practice Act, Scope of Regulation, Section 2, Chapter 6. Article 2, (b) (2) indicates "Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents, neccessary to implement a treatment, disease prevention, or rehabilitative regimen ordered by and within the scope of licensure of a physician...as defined by Section 1316.5 of the Health and Safety Code.

1. During a tour of the CCU and concurrent interview with Administrative staff (AS) and Charge nurse (CN) on 12/15/15 at 10:05 a.m., Patient N-200, N-201 were observed with a Foley catheter device. The AS and CN were asked to assist in locating in the clinical record an order for the device. The AS and CN confirmed there was not a doctor's order in the clinical record for 2 out of 2 patients with a Foley catheter.

Patient N-201's license nurse (LN 1) was interviewed on 12/15/15 at 10:30 a.m., she confirmed there was not an order for a Foley catheter and she did not look for an order because the Foley catheter was inserted on 12/9/15 in the ED. LN 1 stated "In the ED there was an order for an In & Out catheter to collect a urine specimen. I think the nurse inserted an indwelling foley catheter instead of an In & Out catheter and left it in, that's why there is not an order for a foley catheter in the unit."

During a tour of the Step-down unit and concurrent interview with AS and Telemetry director (TD) on 12/15/15 at 2:49 p.m., in a sample of 8 patients with Foley catheters, 7 out of 8 did not have a doctor's order for the device. Patients N 202, N 203, N 204, N 205, N 206, N 207, and N 209 were found without a Foley catheter order in their clinical record. The AS and TD agreed this was "not a good practice."

2. During the same tour of the Step-down unit, Patient N 208's Foley catheter order did not have an indication for the insertion of the device. At the time, the TD and LNs were interviewed and asked regarding the process of monitoring for the foley catheter neccessity and indication as indicated per their policy. The TD and LNs denied having a monitoring process in place in order to monitor for foley catheter devices. They only have a log where they document how many patients have a foley catheter but that's it. They were asked regarding the " Foley Catheter Daily Assessment" form as indicated per facility's policy. The form was shown to the staff and TD. They stated they had never seen the form and they don't know what the "Foley Catheter Daily Assessment' is or where to find it.

An interview was held with facility's infection control practicioners (ICP's) on 12/17/15 at 8:45 a.m., they were questioned regarding the facility's monitoring process for Foley catheter devices. ICP 1 stated she was new to the facility and is working on a project to take care of the Foley catheter device problem. ICP 2 stated he was aware of the Foley catheter device problem (lack of doctor's orders, insertion indication and device neccessity) monitoring from the last survey. Now the two ICPs are working on the problem.

A review of the facility's policy and procedure titled: Foley Catheter Need Assessment, SAA.029, dated 1/2014, indicated "Prevention of infection with any invasive device relies on ...using these devices only for an appropriate indication...and removing them promptly. Indwelling catheters can pose significant infection risks to patients." Furthe the policy indcated in section 4.2 Procedure: "Avoid unneccessary urinary catheters (see attached form Foley Catheter Nursing Evaluation) and Review urinary catheter neccessity daily and remove promptly (see attached form Foley Catheter Daily assessment)." According to the LNs they had never seen those two forms that were mentioned in the facility policy.

Based on interview and record review, the hospital did not ensure that nurse care planning was performed for Patient 503, creating the risk of substandard health care.
Findings:
Patient 503's medical record showed that the patient was transferred to the Culver City ER on 11/16/15 with conditions including COPD, hypertension diabetes mellitus, and pain. An ER MD Note indicated the patient was having suicidal ideation, and the triage note from the ER on 11/16/15 showed the chief complaint was suicidal ideation, with a plan to cut herself. The physician progress note dated 11/18/15 showed the patient had coronary artery disease, morbid obesity and obstructive sleep apnea, diabetes, and was awaiting transfer to the inpatient area to use a CPAP machine. Patient 503 was subsequently admitted as an inpatient on 11/17/15 at 1219 (but remained physically in the ER). According to MR Staff 1, no nursing care plans were found for the Culver City admission. The patient denied suicidal ideation on 11/18/15 at 1118, and requested discharge. She was documented to have been escorted from the hospital on 11/18/15 at 1212.

6. According to Daniels, Grendell, Wilkins "Fundamentals of Nursing", Second Edition, Chapter 30 - page 846: "The nurse should not give medications that have been removed from their unit dose package or drawn up...by anyone else."

During observation of the administration of a prn (as needed) medication, on 12/17/15, LN 9 assessed N 403 and determined at 9:55 a.m. the patient required a narcotic pain medication. LN 9 approached the charge nurse (LN 7) and followed LN 7 to the medication room.

LN 7 proceeded to sign out the narcotic (Norco) and handed the tablet to LN 9.

At 10:01 a.m. LN 9 went to N 403, scanned the patient's wrist band and the medication package. LN 9 then administered the medication and stated, "I'll be back in 30 minutes to see how you feel."

LN 7 then directed LN 9 to document the administration in the patient's medication administration record (MAR) in the electronic chart.

During interview with LN 9 at the time, when asked why he did not draw the narcotic from the automated medication cart, LN 9 stated, "I am registry and we cannot access narcotics."

During interview with LN 7 at 10:03 a.m., she stated, "He is registry and our policy says registry cannot access narcotics."

During interview at 3:10 p.m. with two supervising nurses (LN 6 and LN 8) LN 6 stated, "Registry cannot access narcotics. That is our policy." LN 8 added, "The charge nurse or supervisor withdraws the medication and the registry nurse administers it."

During a second interview with LN 9 at 4 p.m., LN 9 stated, "I was oriented to the system by the pharmacist. Then the pharmacist got me an access number. But I cannot access narcotics."

At 4:05 p.m. during a second interview with LN 8 she stated, "Charge or supervising RN has to draw it up. Then registry nurse administers." When asked if she thought it was good practice for a nurse to administer a medication drawn up by a different nurse, LN 8 said, "Yes, because that is our policy."

During an interview with RPh 1 at 5:30 p.m., he stated, "We do not have a policy on registry not accessing narcotics. We orient the registry nurses and call IT for an access code for them." He added, "I called my manager to discuss this and there is no reason they cannot access narcotics."

Review of the facility's policy titled, "Orientation and Competency Registry/Contract/Temporary Personnel" approved 3/2014 under 4.1.7 identifies the following:" By virtue of the agency nurse's licensure , he/she is deemed competent to perform the duties recognized by the State of California Board of Registered Nurses."

7. Upon administering a narcotic pain medication to N 403 on 12/17/15 at 10:01 a.m., LN 9 stated to N 403, "Ill be back in 30 minutes to see how you feel."

Review of the electronic medication administration record printed on 12/18/15 at 11:35 a.m. indicated LN 9 did not document the effectiveness of the pain medication given the prior morning.






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4. A clinical record review on 12/17/15, at 4:30 p.m., revealed Patient N104 received acetaminophen 325 mg (a pain medication) on 11/2/15, at 1:50 P.M., and again on 11/11/15, at 1p.m., for a fever, review of original prescription indicated to administer acetaminophen for complaints of pain. Further record review indicated there was no pain assessment for patient N104 at these times.
During a concurrent interview with LN4 on 12/17/15 at 4:30 p.m., while reviewing medication administration record of Patient N104, LN4 stated, "There was no order for this medication for fever, this was given for the wrong reason."

5. A review of the facility policy titled "Pain Management" effective 07/2004 last revised 10/2015 revealed under header "1.18 Documentation" indicated "Document pain... " iii. Correct Pain intensity use for each patient. iv. Reactions, interventions, and effectiveness of pain control."
During a concurrent review of Patient N105 medication administration record and interview with LN3 on 12/12/15, record revealed that Patient N105 received tylenol (pain medication) 650 mg on 12/13/15 at 10:43 a.m. There was no documentation of pre-assessment for pain or documentation of post medication administration assessment of pain. LN3 acknowledged there was no documentation in Patient N105 medical record.
During a concurrent review of Patient N101 medication administration record and interview with CNO on 12/15/15, record revealed that Patient N101 received hydrocodone-acetaminophen 5-325 mg (a medication used to treat pain) on 12/13/15. There was no documentation of pre-assessment for pain or documentation of post medication administration assessment of pain. CNO acknowledged there was no documentation in Patient N101 medical record adding, "They should have documented the post assessment within 60 minutes."






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Based on observation, interview, and record review, the facility failed to ensure medications were administered according to the prescriber's orders for two randomly observed patients (P100 and P101). Further the facility failed to prepare and administer medications in accordance with the facility's policies and procedures, as evidence by the following:

1. Intravenous medication tubing was not labeled as per policy.
2. Medications administered without indication or pain assessment.
3. Medications were withdrawn by one nurse and administered by a different nurse.

Patients potentially did not receive the full benefits of ordered treatments.
Failure to follow medication administration policy has the potential of resulting in a negative outcome to patient's health.

Findings:

1. During the observation of medication administration on the Telemetry Unit at Culver City, on 12/15/15 starting at 8:10 A.M., RN 2 was preparing pantoprazole (a medication for stomach ulcer) 40 mg injection for Patient P101. RN 2 stated the medication would be administered at 8:30 A.M.

At 8:36 A.M., RN 2 proceeded to administer the medication. The medication was administered over 40 seconds.

During the same observation, RN 2 verified Patient P101 had cefepime (an antibiotic) 1 g administered earlier and the infusion was complete. The facility used a system where the medication vial (a powder) was attached to an intravenous solution but the powder was not mixed. The nurse would activate the system to dissolve the powder, then mix it with the solution prior to administration. RN 2 noted there was approximately 2 mL of yellow solution left in the vial [the full dose was not mixed in the solution and therefore not administered].

Patient P101's clinical record was reviewed on 12/15/15 starting at 1:55 P.M. with RPh 4 and the VPP. The VPP stated pantoprazole should be administered over 2 minutes.

According to LexiComp, a drug information reference, which was also referenced by the facility, pantoprazole 40 mg should be administered "over at least 2 minutes."

2. During the observation of medication administration in the ICU (Intensive Care Unit) at Culver City, on 12/15/15 starting at 8:50 A.M., RN 1 was preparing medications for Patient P100. Medications were crushed, if they were solid, for administration via a tube. RN 1 prepared 12 different medications. Among the medications, one tablet of metoprolol 50 mg was prepared.

At 9:30 A.M., RN 1 stated the medication administration process was complete. It was then observed there was a small white fragment of medication left. RN 1 could not identify which medication was not fully administered.

During the same observation, RN 1 verified other intravenous (administered directly into the vein) medications present in the room, either the infusion was completed or ongoing. Diltiazem infusion was not present.

Patient P100's clinical record was reviewed on 12/15/15 starting at 1:55 P.M. with RPh 4 and the VPP.

On 12/10/15, Patient P100 was prescribed metoprolol 100 mg orally twice daily. RN 1 was observed administering only 50 mg.

On 12/8/15, Patient P100 was prescribed diltiazem (a heart medication) infusion. RPh 4 confirmed the order was still current and active. RN 1 verified earlier diltiazem was not being administered


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3.) During a tour of the Direct Observation Unit (DOU) and concurrent interview with AS on 12/17/15 at 3:40 p.m., in room 317, an antibiotic medication and primary IV line were missing labels to indicate when they were changed last. In room 310 another IV antibiotic tubing was observed being infused without the tubing being labeled. The AS agreed the IV tubings should be labeled to indicate when they need to be changed.

The LN caring for the patient in room 310 was interviewed on 12/1/7/15 at 3:55 p.m., he was questioned about the IV tubing not being labeled. The LN stated "I thought I labeled my IV tubing, Ok I will label it now" .
A review of the facility's policy and procedure titled: Intravenous Therapy-Initiation and Management of Peripheral Intravenous Lines, VAS.005, dated 11/20/2012, indicated "IV tubing set changes are every 96 hours." "Label tubing with date".

Based on, interview and record review, for one patient, Patient 505, the hospital failed to ensure that documentation regarding the patient's desire for CPR was recorded in the medical record and failed to ensure that transfer, assessment and treatment records were available in the medical record for one patient, Patient 503, transferred from the VN to the CC facility, creating the risk of the patient's wishes regarding emergency treatment not being followed. Further, the hospital failed to accurately reflect intensive out-patient admissions when they routinely and systematically readmitted every intensive out-patient every month despite the individual patients not being discharged from the program. This failure creates the potential of inaccurately reflecting the patients length of stay and episodes of care within the intensive out-patient program.

Findings:
1) During a review of the medical record of Patient 505 on 12/14/15, the record contained a Physician's Orders sheet that was pre-printed with CPR orders that were to be selected by means of checking a box. The order sheet read, "Must be filled out at the time of admission and with any change in code status". There were boxes to select either "full CPR" or "no CPR", but neither was selected. The form bore a date and time, but no signature. The emergency admit form showed that the patient was 84 and being admitted for failure to thrive. A pre-procedure evaluation on 12/11/15 showed that she was awake and oriented.
During an interview with the Sr Mgr Medical Records on 12/15/15 at 1050, she stated that the form should have been completed upon admission, and that she was not sure why it was not completed.
An incident dated 11/18/15 was reviewed and showed that a patient, Patient 503, was admitted to the behavioral health unit at Culver City, but remained in the ER overflow area. The nurse could not find the patient medications and profile.
The record showed that the patient was transferred from the Van Nuys facility, but there were no transfer documents found in the Culver City record. Records from the Van Nuys admission were requested and showed Patient 503 came to the Van Nuys hospital location on 11/13/16. The Physician's Initial Assessment & Preliminary Treatment Plan dated 11/14/15 showed the patient had schizoaffective disorder and was depressed, suicidal, and had the intention to overdose on pills. The Patient Transfer and Referral Record in the Van Nuys record showed the primary diagnosis as schizoaffective disorder, and did not include information about suicidality. The Multidisciplinary After Care Instructions dated 11/16/15 showed that the patient was to "transfer to ER Culver City due to breathing". The form showed that the absence of suicidal ideation was to be documented, but there was no indication of a psychiatric condition or suicidality documented on the form.
A treatment plan was formulated at the Van Nuys facility, including identification of triggers and coping skills. Medical record documentation at the Culver City facility did not include transfer documents and did not include the treatment plan from the Van Nuys facility. The record at Culver City showed that the patient was seen in the ER on 11/16/15 and the MD Note indicated the patient was having suicidal ideation. The triage note from the ER on 11/16/15 showed the chief complaint was suicidal ideation, with a plan to cut herself. Patient 503 was subsequently admitted as an inpatient on 11/17/15 at 1219 (but remained physically in the ER). There was an admission assessment performed at the time of admission that showed for the item, suicide self harm risk, "no risk" was written. There was no Suicide Potential Rating Scale found, and no score for suicide risk determined. According to MR Staff 1, no care plans were found for the patient's stay at the Culver City facility.
In an interview with the Dir BHU on 12/16/15 at 1110, she stated that Patient 503 was sent to the ER at Culver City, but there were no transfer orders found in the medical record. In a second interview, on 12/16/15 at 1145, she stated that she was not able to look at the medical records at the Van Nuys facility by computer from the Culver City facility, and that they had not received information from the Van Nuys facility.



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2) On 12/16/15, at 12 p.m, a review of Patient N107's medical record revealed Patient N107 was originally admitted to the intensive out-patient program on 8/20/14. Patient N107's Medical record included a new "face sheet" for every month since 8/20/14 indicating a subsequent new admission date (ex 9/2/2014, 10/2/2014, 11/2/2014 etc.......) During a concurrent interview with ADM4 staff, when asked if Patient N107 was discharged every month and readmitted? Adm4 stated, "We admit and discharge every month for billing purposes. Not sure why, but the patient is not technically admitted, discharged and readmitted." Adm4 was asked if this occurs with all patients, Adm4 stated, "Yes, but only on paper."
On 12/16/15 at 3 p.m., during an interview with Adm staff business office 1, when asked about the history of inaccurately reflecting new admissions every month, adm business office1 stated, "It was becoming a nightmare posting payments and applying them to the past by month, so we changed the system in 2012 to make it monthly. Effective today we will stop this." During a concurrent interview with behavioral health supr 1, she indicated she was not aware of this practice stating, "I am the interim and have only been here two months."

Based on record review and interview the facility failed to ensure confidentiality of patient records when they allowed MD12's hand written notes on Patient N107 to be faxed into the intensive out-patient services. The notes were written on the back of a sheet titled "Centrally stored medication and desturction record" and on another community health centers assessment sheet. There was no authorization for release of Patient N107 records from outside entity nor was there any authorization for release of non admitted patients medical information to be transmitted to the intensive out-patient services. This failure resulted in both Patient N107 and unknown other patient's rights to confidentiality of their medical information.

Findings:

On 12/16/15 at 12 p.m., the progress notes for Patient N107 (written by MD 12) were reviewed. The progress notes were hand written on pieces of unlined copied paper, or written on copies of notes from an outside community mental health center. Two months of the progress notes were handwritten on the backs of an outside pharmacy medication company title "Centrally stored medication and destruction record" with the names and medications of other non admitted patients.
During concurrent review of the progress notes and interview with adm4 when asked if MD12 actually evaluates patients on site of the intensive out-patient program, adm4 stated,"I am not sure he even see's patients here, this has been going on for about one and half years." Adm4 further added, that the notes are either faxed or hand delivered. Adm4 confirmed there was no confidentiality release on file from Patient N107 or unknown other patient to release/ accept medical records from outside entity.

Based on interview and review of records the facility failed to ensure physician entries in a medical record were legible. Physician progress notes in the records of N 401 were not legible.

These failures have the potential for staff not being aware of physician's plans for the patient, which could cause errors in treatment.

Findings:

1. Review of the record of N 401 on 12/17/15 identified three physician progress notes, dated 12/11/15, 12/12/15, and 12/14/15 which were not legible.

During concurrent review and interview with the chief clinical officer (CCO), she concurred that the notes were not legible. The director of the behavioral unit confirmed that the physician had not dictated progress notes for those dates.

Based on interview, record review and facility policy review the facility failed to ensure telephone orders for Patients N100, N101, N102, and N103 were authenticated by the ordering physician(s) within 48 hours, per facility policy.

Findings:

Review of facility policy entitled "Telephone Drug Orders" from medical staff rules and regulations page 28 indicated in part,"Telephone orders must be recorded promptly in the patient's medical record, noting the name of the person giving the telephone order and the signature of the individual receiving the order. The prescriber must countersign the order within 48 hours..."

1. On 12/15/15, at 9:15 a.m., during a review of Patient N101 clinical record, it was noted Patient N101 was prescribed ativan (a medication prescribed for anxiety) and restoril (a medication prescribed for insomina) by MD2 on 12/10/15, at 2:000a.m. via telephone. These medications, were noted to have no physician signature authentication.
2. On 12/15/15, at 9:15 a.m., during a review of Patient N101 clinical record, it was noted Patient N101 was prescribed seroquel (a major antipsychotic medication) by MD4 on 12/10/15, at 9:20 a.m., this order was not co-signed or authenticated by MD4.
3. On 12/15/15, at 9:15 a.m., during a review of Patient N101 clinical record, it was noted Patient N101 was prescribed over 17 medication orders by MD3 on 12/10/15 at 10 a.m., none of these orders were co-signed or authenticated by MD3.
On 12/15/ 15, at 9:15 a.m., during an interview with adm staff1 she stated, "The policy is that they be validated or authenticated by the doctor within 48 hours."
4. On 12/18/15, at 11:30 a.m., during a review of the clinical discharge record for Patient N100, Patient N100 was prescribed Phenobarbital by MD1on 9/27/15 entered by RN1 into electronic medical record, there was no physician e-signature authenticating the order.
5. On 12/15/15, at 3:15 p..m., during a review of Patient N102 clinical record, it was noted Patient N102 was prescribed tylenol for fever by MD5 on 12/10/15 at 10:33 p.m., there was no physician e-signature authenticating the order.
6. On 12/15/14, at 11:30 a.m., during a review of Patient N103 clinical record indicated in part that 8 different medications were prescribed to Patient N103 by MD6 on 12/12/15, at 5:30 p.m.. Review of record reveals there was no physician signature authenticating the order.
7. On 12/15/15, at 3:15 p.m., during an interview with LN3 while concurrently reviewing Patient N102's clinical record , LN3 stated, "This (signature) should have been done by the doctor."

3). During a concurrent review of the record of N 401 on 12/15/15 beginning at 9:35 a.m., with the chief clinical officer (CCO) there was no evidence of a consent for Seroquel (an anti-psychotic medication).

At 10 a.m. LN (LVN Jeannette) stated she would look in the thinned chart for the consent.

At 10:35 a.m. LN (Jeannette) confirmed there was no consent for the Seroquel.


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Based on record review and interview patient N104 and Patient N106 did not consent for procedures while being an in-patient at the hospital. Patient N401 did not consent for an antipsychotic.

Findings:

1) On 12/17/15, at 3 P.M., a review of Patient N106 clinical record indicated that Patient N106 received a central line (a catheter inserted into the arm or chest through the skin into a large vein) on 12/16/15, there was no consent found in the chart for this procedure.
2) On 12/17/15, at 3 P.M., a review of Patient N104 clinical record revealed Patient N104 had an upper endoscopy (a thin scope with a light is used to look at the upper digestive track ) on 11/30/15 there was no consent located in the medical record.
During an interview with LN5 and LN6 on 12/17/15, at 3:15p.m., they both acknowledged that these procedures required consents and they both acknowledged they were not able to locate the consent in the medical records .

During interview and record review the facility failed to ensure that Patient N101's practitioner reports of treatment were documented on a daily basis per facility policy. Patients N107 and Patients N109 admitted to the psychiatric intensive out-patient program did not receive monthly visits per facility policy. These failures have the potential of impeding on patients progress towards medical and therapeutic goals.

Findings:

A review of Medical Staff Rules and Regulations page 7 indicated under header,"2.7 Treatment of Patients. 2.7.2 Each patient in the Hospital shall be seen daily by his/her attending Practitioner or appropriately designated Physician Staff member, with documentation of that daily visit in the medical record......."
During a concurrent medical record review and interview with CNO of Patient N101 on 12/15/15, at 9:15 a.m., Patient N101 record indicated he was admitted on 12/10/15 with a diagnosis of encephalopathy (a brain disease that alters brain function or structure) and HIV (a virus that gradually attacks the immune system). A review of the record indicated that Patient N101 was initially seen in the emergency room, a telephone order from MD3 occurred on 12/10/15 to "Admit to the med surg unit" there was no time on the order. A review of the chart (on 12/15/15) indicated the patient had only one documented progress note on 12/13/15 by NP1 not co-signed by MD. During an interview with the CNO, she acknowledged the one visit by the NP, and stated patients are supposed to be seen "Daily"

A review of the psychiatric intensive out-patient program policy titled "Scope of Services," dated 09/12 revised 11/2012 under heading "2.4 Types of Treatment/Interventions" indicated in part, "At least monthly psychiatric visit for medication monitoring, treatment planning, assessments...."
During a six month record review (June 2015 to present) of Patient N107's record, the record reflected no MD visits for June, August, or November of 2015. All other notes were from outside the mental health environment.

During a six month record review (June 2015 until present) of Patient N109's record, the record reflected no MD visits for the months of July, August, September and November of 2015.

During an interview with the Behavioral health supr 1 on 12/16/15 at 3:00 p.m., when asked if she was aware of MD visits not following facility policy, the behavioral health supr 1 stated, "No, I was not aware. I am an interim supervisor and I have only been here for two months."

The hospital failed to ensure the Condition of Participation: CFR 482.25 Pharmaceutical Services was met by failing to:

1. Ensure (1) the temperatures for medication refrigerators were monitored as specified by policy; (2) out-of-range temperatures for medication refrigerators were acted upon; (3) inconsistent temperatures for medication refrigerators from two different thermometers were addressed; (4) two different medication strengths were not stored together; (5) medications were stored according to manufacturer's specifications; (6) the contents of the crash carts were accurate; (7) the pharmacist had oversight of the crash cart's contents; (8) renal dosing by the pharmacist was consistent; (9) medications were disposed of safely according to policy; and (10) medications were stored under conditions of sanitation. (Refer to A 0491)

2. Ensure records for scheduled drugs were accurate. (Refer to A 0494)

3. Ensure patients' safety by failing to follow recognized standards for safe management of high-alert medications, as well as failing to address the shortages of medications designated for emergency uses. (Refer to A 0500)

4. Ensure (1) compounded or repackaged medications were labeled with the appropriate beyond-use-dates (BUD, a date after which the medication should not be stored or used); (2) compounded or repackaged medications were stored in approved devices, or an evaluation was completed for suitable alternatives; (3) medications were compounded using approved formulas; and (4) staff involved in compounding was knowledgeable of the BUD. (Refer to A 0501)

5. Ensure the security of medications. (Refer to A 0502)

6. Ensure mislabeled and unusable medications were not available for patient use. (Refer to A 0505)

7. Maintain an accurate inventory, restock, and update the medication list for its after-hours medication supply (night locker). (Refer to A 0506)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Pharmaceutical Services.

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

1. The temperatures for medication refrigerators were monitored as specified by policy;

2. Out-of-range temperatures for medication refrigerators were acted upon;

3. Inconsistent temperatures for medication refrigerators from two different thermometers were addressed;

4. Two different medication strengths were not stored together;

5. Medications were stored according to the manufacturer's specifications;

6. The contents of the crash carts were accurate;

7. The pharmacist had oversight of the crash cart's contents;

8. Renal dosing by the pharmacist was consistent;

9. Medications were disposed of safely according to policy; and

10. Medications were stored under conditions of sanitation.

As a result, the medications were potentially unsafe or ineffective for the needs of all the patients at the facility.

Findings:

1. During a tour of the Pharmacy at Van Nuys on 12/16/15 at 2:20 P.M. with the VPP and DOP 1, the medication refrigerator temperature log was reviewed. The log indicated the temperatures was recorded twice daily on the weekdays, and not recorded on the weekends.

During a concurrent interview, DOP 1 stated she did not know if the temperatures were ever out of range on the weekend.

The contents of the refrigerator were inspected, and 11 doses of influenza vaccine were inside.

According to the facility's policy, "Medication Refrigerator Temperature Monitoring," effective 7/1/15, "Temperature will be checked and recorded once daily (twice daily for vaccine containing refrigerator)."

2a. During a tour of the Pharmacy at Culver City on 12/14/15 starting at 12:30 P.M. with the COO, VPP, and TS, the temperature range specified on the Main Rx (pharmacy) refrigerator was "36¢XF to 46¢XF or 2.2¢XC to 7.7¢XC," according to the Daily Temperature Log Sheet posted on the refrigerator.

According to the log, the temperatures were outside of the specified range on:

12/5/15 at 6:40 A.M., the temperature recorded was "2.1"
12/7/15 at 2 P.M., the temperature recorded was "1.9"
12/11/15 at 6:39 A.M., the temperature recorded was "2.1"
12/11/15 at 8:15 P.M., the temperature recorded was "2.0"

According to the "Refrigerated Drugs" list, provided by the facility, there were 57 medications, in various quantity, stored in the refrigerator. The list included medications for the heart, anti-infectives, vaccines, insulins, "chemo drugs" [medications to treat cancer], and other medications.

During a concurrent interview, TS stated the action taken was not documented and he would check with engineering to determine if the issue was reported or what was done to address the out-of-range temperatures.

2b. During a tour of the Store Room, which was part of the Pharmacy at Culver City, on 12/14/15 starting at 4:23 P.M with the COO, VPP, and TS, the temperature range specified on the Narc (narcotic) STN (station) refrigerator was "36¢XF to 46¢XF," according to the Daily Temperature Log Sheet posted on the refrigerator.

According to the log, the temperatures were outside of the specified range on:

12/9/15 at 10:40 A.M., the temperature recorded was "35.3"
12/10/15 at 10:40 A.M., the temperature recorded was "35.1"
12/12/15 at 10:30 P.M., the temperature recorded was "32.9" [near freezing]

During a concurrent interview, TS was not sure what action was taken to address the out-of-range temperatures.

According to the facility's policy, "Medication Refrigerator Temperature Monitoring," effective 7/1/15, out-of-range temperatures "should be documented with action documented/initialed and notified to engineering department. For situations where the refrigerator contains vaccines and the temperature is freezing or may have reached freezing, pharmacy action will be taken in accordance with manufacturer recommendation."

The facility was not able to provide documentation regarding actions taken when the temperatures were out of range at the conclusion of the survey.

3. During a tour of the Pharmacy at Hollywood with RPh 1 and the VPP on 12/16/15 starting at 12:15 P.M., the temperature log for the medication refrigerator was reviewed. According to the log posted on the refrigerator, the temperature range should be between 36¢XF and 46¢XF. On 12/8/15 at 1:04 P.M., the temperature was recorded at 35¢XF. The VPP stated there was no documentation of actions taken by staff to address the out-of-range temperatures.

The refrigerator contained various vaccines such as tetanus, hepatitis B, pneumococcal, influenza, according to the Vaccine Inventory Control Log posted outside the refrigerator.

The VPP provided an electronic temperature log for the refrigerator, indicating the temperatures were within range on 12/8/15.

During an interview on 12/17/15 starting at 8:50 A.M., the VPP stated when the temperature was recorded as out of range, the pharmacist logged into the electronic monitoring system and the temperature was within range, and therefore did not take any further action. The VPP stated there were two different thermometers used in the same refrigerator, and therefore it could not be established which thermometer was more accurate.

4. During a tour of the Pharmacy at Culver City on 12/14/15 starting at 12:30 P.M. with the COO, VPP, and TS, a medication bin labeled vancomycin 125 mg was observed in the refrigerator. Further inspection of the contents revealed four oral syringes of vancomycin 125 mg and two oral syringes of vancomycin 250 mg.

During a concurrent interview, the VPP stated there should be one storage bin for each strength of vancomycin [two different strengths should not have been stored together].

According to the facility's policy, "Medication Storage," reviewed 6/14, "Drugs shall be stored under proper conditions of ... segregation...."

5a. During a tour of the Pharmacy at Culver City on 12/14/15 starting at 12:30 P.M. with the COO, VPP, and TS, the observations were:

Octreotide (a hormone with various medical uses) 50 mcg per mL injections were outside the original carton, exposed to light; and

Haloperidol decanoate (a medication to treat psychiatric disorders) 100 mg per mL injections were exposed to light.

According to the manufacturer's directions printed on the medication carton for octreotide, the storage instructions stipulated, "Protect from light," and "Retain in carton until time of use."

According to the manufacturer's directions printed on the medication carton for haloperiodol, the storage instructions stipulated, "PROTECT FROM LIGHT," and "Keep in carton until empty."

During a tour of the Store Room, which was part of the Pharmacy at Culver City, on 12/14/15 starting at 4:23 P.M with the COO, VPP, and TS, ondansetron (a medication to treat nausea) 4 mg per 2 mL injections were exposed to light.

According to the manufacturer's directions printed on the medication carton for ondansetron, the storage instructions stipulated, "Protect from light," and "Retain in carton until time of use."

During the inspection of a crash cart (a medication cart containing medications for medical emergencies) in the Intensive Care Unit (ICU) at Culver City on 12/15/15 starting at 10:10 A.M. with the COO, VPP, and CN 1, verapamil (a heart medication) 2.5 mg per mL injections were exposed to light.

During the inspection of a crash cart in the Telemetry Unit at Culver City on 12/15/15 starting at 10:50 A.M. with the COO, VPP, and CN 3, verapamil 2.5 mg per mL injections were exposed to light.

According to the current manufacturer's prescribing information (PI) for verapamil, the storage instructions stipulated, "Protect from light by retaining in package until ready to use."

5b. During the inspection of a crash cart in the ICU at Culver City on 12/15/15 starting at 10:10 A.M. with the COO, VPP, and CN 1, vasopressin (a hormone with various medical uses) 20 unit per mL injection were stored in the crash cart at room temperature without a beyond-use-date (BUD, a date after which the medication should not be used or stored).

According to the current manufacturer's PI provided by the facility, the storage instructions stipulated, "Store between 2¢XC to 8¢XC ... Vials may be held up to 12 months upon removal from refrigeration to room temperature storage conditions .... Once removed from refrigeration, unopened vials should be marked to indicate the revised 12 months expiration date [BUD]."

5c. During a tour of the ICU at Culver City on 12/15/15, the medication room was inspected, starting at 9:54 A.M., with the COO, VPP, and CN 1. Lorazepam (a medication for seizure, anxiety) 2 mg per mL injections were stored at room temperature, with the BUD of 1/9/16.

During a concurrent interview, the VPP stated the BUD was 60 days when stored at room temperature. The facility was requested to provide evidence to support this practice.

During a tour of the Psychiatric Emergency Department Overflow area at Culver City on 12/15/15, the medication room was inspected with RN 4 and Dir 1 starting at 4:06 P.M. Lorazepam 2 mg per mL injections were stored at room temperature.

According to the current manufacturer's PI for lorazepam, the storage instructions stipulated, "Store in a refrigerator."

The facility was unable to provide evidence to support room temperature storage for lorazepam at the conclusion of the survey.

6a. During the inspection of a crash cart in the ICU at Culver City on 12/15/15 starting at 10:10 A.M. with the COO, VPP, and CN 1, the content list posted outside was compared to the actual medications stocked inside the cart, and the following discrepancies were observed:

D5W (dextrose solution) 150 mL was listed, but not stocked;
D5W 50 mL, quantity of 3 were stocked but not listed on the content list;
9% sodium chloride 1000 mL listed, and was stocked with 0.9% sodium chloride;
Flumazenil (a medication to reverse the effect of certain sedatives) 0.1 mg per mL 5 mL vial was listed, but stocked with 10 mL vial;
Lidocaine (a local numbing agent) 2% 30 mL was stocked, but not listed on the content list;
Procainamide (a heart medication) 1 g in 2 mL was listed, but not stocked; and
Procainamide 100 mg per mL 10 mL vial was listed, but not stocked.

6b. During the inspection of a crash cart on the Telemetry Unit at Culver City on 12/15/15 starting at 10:50 A.M. with the COO, VPP, and CN 3, the content list posted outside was compared to the actual medications stocked inside the cart, and the following discrepancies were observed:

D5W 150 mL was listed, but not stocked;
D5W 100 mL, quantity of 1 was listed, but 3 were stocked (2 extra);
9% sodium chloride 1000 mL listed, and was stocked with 0.9% sodium chloride;
Lidocaine 2% 30 mL was stocked, but not listed on the content list;
Procainamide 1 g in 2 mL was listed, but not stocked; and
Procainamide 100 mg per mL 10 mL vial was listed, but not stocked.

According to the facility's policy, "Crash Carts Emergency Medications: Inspection, Maintenance, and Exchange," revised 10/12, the Procedure/Purpose section stipulated, "... ensure that a standard and completely supplied cart of kit for all patient care and surrounding areas ...."

7. During the inspection of a crash cart in the ICU at Culver City on 12/15/15 starting at 10:10 A.M. with the COO, VPP, and CN 1, the content list posted outside was compared to the actual medications stocked inside the cart, and the following discrepancies were observed:

D5W 150 mL was listed, but not stocked;
D5W 50 mL, quantity of 3 were stocked but not listed on the content list;
9% sodium chloride 1000 mL listed, and was stocked with 0.9% sodium chloride;
Flumazenil 0.1 mg per mL 5 mL vial was listed, but stocked with 10 mL vial;
Lidocaine 2% 30 mL was stocked, but not listed on the content list;
Procainamide 1 g in 2 mL was listed, but not stocked;
Procainamide 100 mg per mL 10 mL vial was listed, but not stocked;
Vasopressin 20 unit per mL stored at room temperature without the BUD when the manufacturer specified to be refrigerated; and
Verapamil 2.5 mg per mL 2 mL injections were not protected from light as specified by the manufacturer.

In addition, the expiration dates for D5W 50 mL and D5W 100 mL were 1/16 (January 2016). The expiration date posted outside the crash cart was 3/1/16.

During the concurrent interview, RPh 3, who checked this particular crash cart earlier in the day, stated the expiration date was based solely on the non-intravenous (IV) medications. RPh 3 stated he did not consider IV medications to be "medications."

According to the Food and Drug Administration (FDA), D5W in various strengths and normal saline (salt solution) 0.9% are drugs/medications.

According to the facility's policy, "Crash Carts Emergency Medications: Inspection, Maintenance, and Exchange," revised 10/12, "The drug contents of the crash care (sic) shall be routinely inspected by a pharmacist monthly, and the name and date of the earliest expiring drug shall be posted on the outside of the tray."

8. Patient P101's clinical record was reviewed on 12/15/15 starting at 1:55 P.M. with RPh 4, and the VPP. The record indicated, on 12/9/15, the patient was prescribed cefepime (an antibiotic) 2 g every 12 hours and "Pharmacy to adjust for renal function."

RPh 4 was asked to demonstrate how he would "adjust for renal function" based on the patient's information available on the date the adjustment was made. RPh 4 was not the pharmacist who adjusted the dose on 12/9/15. RPh 4 calculated the dose to be 2 g every 24 hours.

The Medication Administration Record (MAR) indicated Patient 101 was receiving cefepime 1 g every 24 hours.

According to the facility's policy, "Renal Dosing Protocol," revised 10/12, "The purpose of this policy is to provide standardized drug dosing guidelines for renally eliminated drugs." The policy, however, did not include cefepime in the "Renal Dosing Table."

9. During a random observation of medication administration, on 12/15/15 starting at 8:50 A.M. in the ICU at Culver City, with RN 1 and the COO, RN 1 was observed preparing medications for Patient P100. Potassium chloride (KCl) oral solution was among the medications being prepared. RN 1 prepared the KCl dose, with approximately 7 mL left in the oral syringe. RN 1 then put the syringe with 7 mL KCl still left in it in a gray bin inside the room.

According to the facility's policy, "Return, Handling, and Disposal of Medication Waste," revised 10/12, Pharmaceutical Waste was defined as "prescription and non-prescription solid and liquid pharmaceuticals in greater than trace quantities ...Any opened vial or liquid bottle ... shall be placed in the regular Pharmaceutical Waste Containers."

During an interview on 12/15/15 at 3:15 P.M., Dir 1 identified "Pharmaceutical Waste" container as the "blue-white container."

10a. During a tour of the Pharmacy at Culver City on 12/14/15 starting at 3:25 P.M. with the COO, VPP, and TS, the storage bins containing the following medications were observed to be dusty:

Flumazenil 0.5 mg per 5 mL;
Haloperidol decanoate 100 mg per mL; and
D5W 500 mL.

10b. During a tour of the Telemetry Unit at Culver City, on 12/15/15 starting at 8:13 A.M., with CN 2 and COO, CN 2 agreed 8 out of 8 medication storage bins in the medication room were not clean. CN 2 also agreed the medication refrigerator was not clean.

According to the facility's policy, "Medication Storage," revised 6/14, "Drugs shall be stored under proper conditions of sanitation ...."

Based on interview, and record review, the facility failed to ensure records for scheduled drugs were accurate. As a result, midazolam, a scheduled IV medication (a DEA's designation, Drug Enforcement Administration, scheduled II has the highest abuse potential, and schedule V has the least abuse potential), was not destroyed and recorded accurately, because the facility did not have a policy to address the destruction and recording methods for scheduled III, IV, and V medications.

Findings:

During a tour of the Pharmacy at Hollywood, on 12/16/15 at 12:35 P.M., the record for midazolam 2 mg injection was audited with RPh 1 and VPP. According to the record, PT 1 was a witness for the destruction of midazolam on 8/20/15. PT 1 confirmed she was the witness, and stated the vial of medication was placed in the "red" container (which was used to store pharmaceutical waste that contained sharp objects) with the medication still inside the vial. PT 1 was again a witness for another destruction of midazolam on 9/24/15. PT 1 could not recall the destruction method on 9/24/15.

According to the facility's policy, "Controlled Substance System," reviewed 3/10/15, only the destruction of scheduled II medications was addressed. The policy stipulated, "The expired C-II [scheduled II] drugs shall then be ... added to the destruction log .... stored in the expired narcotic locker pending destruction by a pharmaceutical waste management service."

During an interview on 12/17/15 starting at 8:50 A.M., the VPP stated even though only scheduled II medications were addressed in the policy, the same practice applied to all scheduled medications. The VPP clarified that since midazolam was destroyed by pharmacy staff, it would not be in the destruction log pending destruction by a pharmaceutical waste management service.

Based on observation, interview, and record review, the facility failed to ensure patients' safety by failing to follow recognized standards for safe management of high-alert medications, as well as failing to address the shortages of medications designated for emergency uses. As a result, potential medication errors could occur when high-alert medications were not safely managed, and medications in the crash carts were potentially not available to patients in medical emergencies.

Findings:

1. According to the Institute for Safe Medication Practices (ISMP), a leading national organization in safe medication management, high-alert medications are those that "bear a heightened risk of causing significant harm when they are used in error .... the consequences of an error are clearly more devastating to patients." ISMP identified 22 classes/categories of medications, and 12 specific medications as high-alert medications. (https://www.ismp.org/tools/highalertmedications.pdf)

During a tour of Unit 1 at Van Nuys, a facility treating patients with psychiatric disorders, on 12/16/15 at 2:30 P.M., with the VPP and DOP 1, digoxin (a heart medication with narrow therapeutic range, a small change in the drug level could cause harm to the patient) was stored in an open drawer, and was separated from other medications by dividers (staff can mistakenly remove one medication for the other, since they were all available when the drawer was opened).

According to the facility's policy, "High Alert Medication Safety," revised 10/12, "High Alert Medications are drugs that have a high risk of causing injury, either as a result of a narrow therapeutic range or a historically high incidence of reported serious adverse events. Specific medications:

Insulin
Heparin
Hydromorphone Injection
Morphine Sulfate Injection."

During an interview on 12/17/15 starting at 8:50 A.M., the VPP stated warfarin (a blood thinner) was considered a "high-alert" medication, would only be dispensed from the pharmacy [to prevent medication errors], and would not be stocked in the Automated Dispensing Cabinet (ADC). The VPP then stated warfarin was stored in the ADC on Unit 1.

During the same interview, the VPP added, the facility would review the "ISMP" medication list with the Medical Staff.

2a. On 12/15/15 starting at 10:10 A.M., the crash cart (a medication cart containing medications for use in a medical emergency) in the Intensive Care Unit (ICU) at Culver City was inspected with CN 1, the COO, and VPP.

The contents of the crash cart were reviewed. The following discrepancies were observed:

Procainamide (a heart medication) 1 g per 2 mL was on the list of content, but not stocked; and
Procainamide 100 mg per mL 10 mL vial was on the list of content, but not stocked.

2b. On 12/15/15 starting at 10:50 A.M., the crash cart in the Telemetry Unit at Culver City was inspected with CN 3, the COO, and VPP.

The contents of the crash cart were reviewed. The following discrepancies were observed:

Procainamide (a heart medication) 1 g per 2 mL was on the list of content, but not stocked; and
Procainamide 100 mg per mL 10 mL vial was on the list of content, but not stocked.

During an interview on 12/15/15 at 3:50 P.M., the VPP and TS were interviewed. The VPP stated Procainamide had not been available. TS added it had not been available for six months, and had not been stocked in the crash carts since then.

The facility provided a document titled, "Drug Shortages," dated 10/24/15, which included Procainamide. The reason for the shortage was "MFG Backorder" [manufacturer backorder] and there was "No Release Date."

During an interview on 12/16/15 at 9:40 A.M., the VPP was asked what actions had been taken to address the drug shortage. The VPP stated she was not sure, but "doubtful" if anything was done.

According to the document published by the American Society of Health-System Pharmacist (ASHP, a nationally recognized organization establishing professional policies and practice standards) titled, "ASHP Guidelines: Minimum Standards for Pharmacy in Hospitals," under the topic of Drug Shortages, it stated, "The pharmacy should develop strategies for identifying alternative therapies...." (http://www.ashp.org/DocLibrary/BestPractices/SettingsGdlMinHosp.aspx)

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

1. Compounded or repackaged medications were labeled with the appropriate beyond-use-dates (BUD, a date after which the medication should not be stored or used);

2. Compounded or repackaged medications were stored in approved devices, or an evaluation was completed for suitable alternatives;

3. Medications were compounded using approved formulas; and

4. Staff involved in compounding was knowledgeable of the BUD.

As a result, medications were assigned inappropriate BUDs, not properly stored to ensure potency. Patients, therefore, were potentially exposed to expired, less potent, or incorrect medications.

Findings:

1a. During a tour of the Pharmacy at Culver City, on 12/14/15 starting at 12:30 P.M., with the COO, VPP, and TS, three syringes of epoetin alfa (Procrit, a medication to stimulate red blood cell growth) for three patients were stored in the Pharmacy.

During a concurrent interview, TS stated they were drawn out of the Procrit multi-dose vials, and have a BUD of 28 days.

During an interview on 12/14/15 at 3:25 P.M., the VPP, a pharmacist, stated the BUD of 28 days was based on the medication's "package insert." The package insert (PI) is the official document approved by the Food and Drug Administration (FDA) to accompany the approved medication. The VPP then stated she had no information to support this practice [because there was no information in the PI].

According to the current PI, revised 12/13, under section Preparation and Administration, "Store unused portions of PROCRIT in multidose vials at 36°F to 46°F (2°C to 8°C). Discard 21 days after initial entry." There was no relevant information regarding the practice of storing in syringes for future uses.

1b. During a tour of the Telemetry Unit at Culver City, the medication room was inspected with CN 2, and the COO on 12/15/15 starting at 8:13 A.M. A compounded medication, D5NS 30 mEq KCl (potassium diluted in intravenous fluid), was stored at room temperature. The labeling indicated the medication was prepared on 12/13/15 at 11 A.M., and had a BUD of 12/16/15 at 1 P.M. (74 hours BUD).

According to the facility's policy, "Sterile Compounding Products (CSP)," revised 10/12, this medication was in the "low-risk" category, and when stored at room temperature, the BUD should be 48 hours.

1c. During a random observation of medication administration on 12/15/15 at 8:36 A.M. with RN 2, a D5NS (salt-containing solution) was observed being infused at 75 mL per hour to Patient P101. The medication did not have any labeling other than the manufacturing labeling indicating what it was. RN 2 could not determine when the current medication bag was first used.

According to the facility's policy, "Intravenous [IV, administered directly into the vein] Therapy-Initiation and Management of Peripheral Intravenous Lines," reviewed 6/14, "IV Solution/Container solutions should be labeled with infusion rate, date and time hung, name of the person who prepared the solution. Apply the label so that it can be read when hanging on I.V. pole. Do not cover manufacturer's label."

2a. During a tour of the Pharmacy at Culver City on 12/14/15 starting at 12:30 P.M. with the COO, VPP, and TS, three syringes of epoetin alfa for three patients were stored in the Pharmacy.

On 12/14/15 at 3:25 P.M., in the presence of the COO, VPP, and TS, it was determined the epoetin alfa were stored in [brand] 1 mL injection syringes. The BUDs were 1/7/16 (one syringe), and 1/12/16 (two syringes).

2b. During a tour of the Pharmacy at Culver City on 12/14/15 starting at 12:30 P.M. with the COO, VPP, and TS, the observations were:

Vancomycin (an antibiotic) 100 mg per mL oral solution, in volumes of 1.25 mL and 2.5 mL, were stored in clear oral [brand] syringes. The BUDs were 12/25/15 (two syringes), and 12/1715 (four syringes);

Twelve prednisolone (medication for allergy or inflammation) 15 mg per 5 mL were stored in [brand] oral syringes; and
Ten promethazine (a nausea medication) 6.25 mg per 5 mL in [brand] oral syringes.

During an interview on 12/14/15 at 3:25 P.M., the VPP stated she was not aware of the issues associated with the [brand] syringes when used for storage of compounded or repackaged medications.

According to the company's alert dated 8/18/15, these syringes "are not to be used for drug storage...." In addition, according to the company's letter dated 9/1/15 to United States Customers, "... these syringes are being used for purposes for which they were not designed or cleared [approved by the FDA]."

According to the FDA, in a warning letter issued on 9/8/15 regarding compounded or repackaged drugs stored in the [brand] injection and oral syringes, "... certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately.... Not administer compounded or repackaged drugs that have been stored in any of these syringes unless there is no suitable alternative available."

3. During a tour of the Pharmacy at Culver City on 12/14/15 starting at 12:30 P.M. with the COO, VPP, and TS, vancomycin 100 mg per mL oral solution, in volumes of 1.25 mL and 2.5 mL, were stored in the medication refrigerator.

The compounding records and formulas were requested.

The facility provided an undated document titled "Vancomycin PO [oral] Formula," which included the ingredients used in compounding: vancomycin and sterile water for injection (SWFI), to produce a final concentration of 16.6 mg per mL, or 250 mg equals to 15 mL. The formula also included the use of "syringe" and "amber bottle" in the compounding process.

The compounding records indicated vancomycin was compounded to a final concentration of 100 mg per mL, or 250 mg equals to 2.5 mL and 125 mg equals to 1.25 mL. The records also did not include any information indicating SWFI was used, or the lot numbers for either products (vancomycin and SWFI), or any information regarding other equipments (such as syringes and amber bottle) used in the compounding process.

On 12/16/15 at 10 A.M., the policy for compounding of oral medications were requested from the VPP.

During an interview on 12/17/15 starting at 8:50 A.M., the VPP stated the policy for compounding of oral medications was part of the sterile compounding policy.

According to the facility's policy, "Sterile Compounded Products (CSP)," revised 10/12, "To compound medication, the pharmacy must have a written master formula sheet that includes the following elements: Active ingredients used, Inactive ingredients used, Process and/or procedure used to prepare the drug...." In addition, the policy stipulated for the Records of Compounded Drug Products, "A record for each compounded drug product includes the following:

Master formula record
...
Quantity of each component used in compounding the drug product
Manufacturer/supplier and lot number of each component.
Equipment used in compounding the drug product...."

4a. During a tour of the Pharmacy at Culver City, on 12/14/15 starting at 12:30 P.M., with the COO, VPP, and TS, three syringes of epoetin alfa for three patients were stored in the Pharmacy. One syringe had a BUD of 1/7/16, two syringes had a BUD of 1/12/16.

During an interview on 12/14/15 at 1 P.M., RPh 2 acknowledged she validated these syringes earlier in the day. RPh 2 stated, however, she was not sure what the BUD should be, "not 100% sure." RPh 2 further stated they might have been compounded at different times.

4b. During a tour of the Intensive Care Unit (ICU) at Hollywood, on 12/16/15 at 1:05 P.M., with the VPP, the medication room was inspected. Stored together in a plastic bag was one D5W (dextrose solution) 250 mL and two vials of norepinephrine (medication to increase blood pressure), 4 mg each.

During an interview on 12/16/15 at 1:17 P.M., RN 3 said she would compound norepinephrine (usually done by adding the contents of two vials into the solution), in an emergency after the pharmacy was closed. RN 3 stated she would "never put the expiration [BUD]" on the compounded product. RN 3 then stated she would assigned the BUD of 24 hours.

During an interview on 12/16/15 at 1:30 P.M., the VPP stated the requirements for BUD applied when the compounding was done by a nurse, and norepinephrine compounded in this situation would be considered for "immediate use."

According to the facility's policy, "Sterile Compounding Products (CSP)," revised 10/12, the Procedure/Purpose stated, "To ensure that compounding personnel, including pharmacy and nursing staffs are adequately educated, instructed and skilled to perform their compounding tasks. To prevent harm and death to patients treated with Compounded Sterile Products (CSP)." In addition, the Scope section stated, "This procedure applies to all departments and services licensed by the facility...." The policy defined "Immediate Use CSPs" as "...where there is need for emergency or immediate patient administration...." and "Unless immediately and completely administered and administration is witnessed by the preparer, the CSP shall bear a label containing the following information: ...the exact one hour beyond use date...."

Based on observation, interview, and record review, the facility failed to ensure the security of medications. As a result, medications were left at a patient's bedside unattended during a randomly observed medication administration.

Findings:

During a randomly observed medication administration in the ICU (Intensive Care Unit), on 12/15/15 starting at 8:50 A.M., RN 1 mixed 12 medications for Patient P100 together in a plastic bottle, including a gel capsule of docusate (a stool softener). RN 1 placed the plastic bottle on the bedside table with docusate still undissolved in some liquid, and left the room.

At 9:12 A.M., RN 1 came back to the room, docusate was still undissolved. The bottle contained approximately 100 mL of orange fluid. Since 12 medications were mixed in the bottle, the orange fluid potentially contained all 12 medications, including the undissolved docusate. RN 1 again placed the medications on the bedside table and left the room.

At 9:27 A.M., RN 1 came back to complete the medication administration for Patient P100.

During a concurrent interview and record review on 12/17/15 starting at 8:50 A.M., the VPP stated bedside storage of medication was only allowed when it was for self-administration (patient administers his or her own medication).

According to the facility's policy, "Medication Storage," reviewed 6/14, "Once removed [from the approved storage area], the medication must remain with the individual at all times and shall not be left unattended."

4.) The pharmacy label on an IV (intravenous) bag labeled "Levoved" (Levophed,a medication used to maintain blood pressure) indicated the medication was to be administered on 12/1/15. According to the nurse's documentation on the label, the medication was administered on 12/15/15.

During a bedside observation of Patient N-104 on 12/17/15 at 10:10 a.m., an IV bag labeled Levophed was noted to be empty and hanging on the IV pole. The pharmacy label indicated it was to be administered on 12/1/15.

During interview with RN 3 at the time, she stated, "Looks like it was given 12/15/15."

During interview with the pharmacist RPh 1 on 12/17/15 at 12:15 p.m. the same day, he confirmed the administration date on the label was 12/1/15. The pharmacist stated, "For that particular medication, after mixing it, it is stable for 24 hours." He added, "It is not safe to administer after 24 hours."
Based on observation, interview and review of records the facility failed to ensure outdated medications were available for use as evidenced by:




34709

Based on observation, interview, and record review, the facility failed to ensure mislabeled and unusable medications were not available for patient use. As a result, two medications were not labeled with the appropriate beyond-use-dates (BUD, a date after which a medication should be stored or use), and one medication was not stored in the overwrap (a wrap over an item for protection) as specified by the manufacturer. Another medication was used beyond its use.

Findings:

1a. During a tour of the Pharmacy at Culver City, on 12/14/15 starting at 12:30 P.M., with the COO and VPP, one folic acid (a supplement) 5 mg per mL 10 mL vial, a multi-dose vial, was observed with the labeled open date of 12/3/15 and BUD of 1/31/16 (59 days from the open date).

During the concurrent interview, the VPP stated the BUD should be 28 days, and the BUD assigned was more than 28 days.

1b. During a tour of the medication room in the Telemetry Unit at Culver City, on 12/15/15 at 8:13 A.M., with CN 2 and the COO, CN 2 stated the nurse would assign a BUD of 30 days to insulin vials after opening. One vial of insulin R, a multi-dose vial, was labeled with the open date of 12/2/15 and BUD of 1/3/16 (32 days from the open date).

According to the facility's policy, revised 10/12, "The expiration date assigned to opened multiple dose vials is twenty-eight days...."

3. During a tour of the medication room in the ICU (Intensive Care Unit) at Culver City, on 12/15/15 starting at 9:54 A.M., with CN 1, the COO, and VPP, one liter bag of D5 1/4 NS (salt-solution) was found without the overwrap and open date or BUD.

According to the current manufacturer's labeling, revised 6/13, "Do not remove overwrap until ready for use."

Based on observation, interview, and record review, the facility failed to maintain an accurate inventory, restock, and update the medication list for its after-hours medication supply (night locker) at the Hollywood campus. As a result, the supply was not restocked timely, the posted medication list did not reflect the current contents of the night locker, and there were two different versions of the medication list available.

Findings:

During a tour of the Pharmacy at Hollywood, on 12/16/15 at 12:50 P.M., with RPh 1 and VPP, RPh 1 stated the facility had a night locker, which contained certain medications and quantities.

During an inspection of the night locker on 12/16/15 starting at 12:55 P.M. with PT 1 and VPP, four terbutaline (asthma medication) 1 mg per 1 mL injections were inside. The undated Night Locker IV (intravenous, medication given directly into the vein) Medication List posted did not include terbutaline.

Further inspection revealed the night locker contained one Nitroglycerin (a heart medication) 50 mg per 250 mL, instead of two as specified by the posted list.

During a concurrent interview, in the presence of the VPP, PT 1 stated used medications would be restocked by the end of the day. The accountability log, a log showing when a medication was being removed for a patient, was reviewed with the VPP and PT 1. The log recorded medications being removed from the night locker from the presence and back to December 2, 2015. The VPP and PT 1 could not ascertain when Nitroglycerin was last used, but agreed it was used at least prior to December 2, 2015. The record of when Nitroglycerin was last used was requested, however, the facility did not provide the record at the conclusion of this survey.

According to the facility's policy, "After Hours Procurement of Medication," reviewed 3/10/15, "The pharmacy staff shall be responsible for the maintenance of the after hours medication supply by assuring that all drugs are properly labeled and stored. The after hours drug supply shall contain the type and quantity of drugs necessary to meet the immediate needs of patients ...." In addition, "... the nightlocker will be restocked and the PAR [amount that should be available at any time for an item] levels verified daily."

The policy also included a list of medications available in the night locker. This list was compared to the undated medication list posted in the night locker, and the following medications did not match:

D5 1/2 NS 20 mEq KCl 1,000 mL (potassium-containing IV solution);
Potassium Chloride oral liquid;
Albumin (a blood product) injection;
Mannitol (an osmotic agent) injection;
Merrem (an antibiotic) injection.

Based on observation, interviews, and record review, the facility failed to follow the lead apron testing procedures as indicated in their policies, as evidenced by the following:

1. One lead apron skirt with a hole was found in the Radiology Department.
2. Ten unlabeled, untested thyroid shields found in the Operating Room (OR) lead storage room.
3. Catherization Laboratory (Cath-lab) unable to account for a lead vest label "cath-lab' found in the OR lead storage room.
These failures have the potential of exposing personnel to radiation which can result in future negative health outcomes.

Findings:

1. During a tour of the Radiology Department and concurrent intervew with the radiology clinical coordinator (RCC) and radiology director (RadD) on 12/17/15 at 9:58 a.m., a blue lead skirt (item 8) was observed with a tear/hole. The RadD was questioned about the tear/hole on the lead skirt. RadD agreed that the lead skirt should be retired and he asked the RCC to remove the lead skirt from the radiology department.

The facility's policy and procedure titled: Lead Apron Testing for all Imagings CRTs, RAD 6-33, dated 3/6/09, indicated "There should be no cracks or tears... Any aprons or shields damaged will be repaired or retired promptly."

2. During a tour of the Operating Room (OR) lead storage room and concurrent interview with the radiology clinical coordinator (RCC) and radiology director (RadD) on 12/17/15 at 10:10 a.m., ten thyroid shields were observed stacked on top of a cabinet. The thyroid shields were not labeled and therefore the facility was unable to recognize if the shields had been tested for radiation. The RadD and RCC were questioned about the shields found on top of the cabinet. The RadD stated he did not know where those shields came from and he asked the RCC if he had tested the shields for radiation. The RCC stated "I don't know where these shields came from. I don't know if I tested them for radiation because these shields aren't attached to the lead vest. Normally the thyroid shields are attached to the vest and they are tested together for radiation."

3. During the same tour of the OR lead storage room, a green floral lead vest (label Cath-lab) with thyroid shield was observed. The RCC was asked when this vest & thyroid shield was tested for radiation. The RCC stated he did not recognize the vest & thyroid shield, he had not tested those lead items because they were not items from the Radiology Department. The lead items belong to the Cath-Lab.

During an interview with the Cath-lab director (CLD) on 12/17/15 at 10:40 a.m., he was questioned about the radiation testing for the green floral vest & thyroid shield. The CLD and his staff did not recognize the lead items, even though the vest was labeled (Cath-lab). A concurrent interview was held with the Cath-lab radiology technician (CLRT) who is responsible for testing all lead items. He stated he had not seen these lead items in the Cath-lab therefore the vest & thyroid shield had not been tested for radiation. The CLRT stated "This is a custom made lead vest, someone must have brought it in for their personal use." The CLD and RadD agreed there was a lead vest and thyroid shield that were not accounted for, tracked for and not tested for radiation.

The facility's policy and procedure titled: Lead Apron Testing for Cardiology/Cath Lab, CAT .021, dated 11/2012, indicated "All protective apparel shall be tested...on a semi-annual basis..."

Based on observation, interview and document review, the hospital failed to ensure the maintenance and functionality of the physical plant and hospital environment to ensure the safety and well being of patients.


1) The facility could not ensure the condition of the physical plant was sufficient to provide an acceptable level of safety and well being for patients (refer to A 701).

2) The facility could not ensure the proper storage and disposal of biohazard waste (refer to 713)

3) The facility could not demonstrate medications and lab specimens were stored in appropriate temperatures or that oxygen canisters were stored safely (refer to 724).

The cumulative effect of these failings meant the facility failed to ensure that safe healthcare was provided in a safe environment for patients obtaining care in the hospital.

3.) During a tour of the fourth floor on 12/17/15 beginning at 9 20 a.m. a crash cart was observed by the wall. Closer inspection revealed the defibrillator was plugged into a regular outlet, not a red outlet as required.

During interview with the supervisor, LN 10, she stated "Oh, Ill fix that."



26881

2.) During a tour of OR 1 on 12/18/15 at 1445, there was an hourly temperature and humidity monitoring log posted. The log had columns for recording temperature, humidity, time, initials of the recording staff member, and comments. The instruction on the log indicated that the acceptable range in the ORs and sterile rooms was to be 68 degrees F to 75 degrees F. The instructions included, "In the event temperature or humidity readings are out of range, please contact plant engineering and on call administrator immediately."
Review of the log showed that on 12/18/15, the temperature from 0:00 to 13:00 ranged from 65.8 degrees F to 70.5 degrees F, and that the humidity ranged from 16.5 to 22.2 percent. However, there were no notations in the "comment" column to indicate that engineering or the administrator were aware, or that any other action was being taken to correct the condition.
The log from OR 3 for 12/18/15 was also reviewed, and showed a temperature range of 62.1 degrees F to 66.2 degrees F, and a humidity from 17.2 to 27.9 percent. There was a notation at 0800 that the engineer came by to adjust the thermostat, and another at 1000 that the engineer was aware, but no comments after 1000 to indicate whether the engineer or administrator were being advised of the persistently out of range conditions.
In an interview with RN 5 on 12/18/15 at 1450, she stated that the staff should call engineering, but it was not documented.



35399

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

1) Ensure the temporary air handler unit feeding air to certain departments (e.g. 6th, 5th, partial of the 4th, and 2nd floor) was functioning well enough to provide heated air according to state regulations, or hospital policy and at a comfortable level for patients, staff and visitors.

2) The hospital did not ensure that follow-up of out of range OR temperature and humidity was documented, creating the increased risk of substandard OR environmental conditions and poor surgical outcomes.

3)The facility failed to ensure emergency equipment was properly maintained. The fourth floor crash cart had a defibrillator which was not plugged into a red plug to ensure battery was charged should there be a power failure.

Findings:

1) According to the facility's record review on 12/12/15 at 10:00 a.m., records indicate the facility had been using a temporary air handler unit since March, 2015. The facility was granted a permit on 12/9/15 from the office of statewide health planning and developement to begin installation of a new air handler unit. Meanwhile the facility is using a temporary air handler that is not providing heated air to patient's rooms in certain areas of the Pavilion (e.g. 6th, 5th, partial of the 4th, 2nd floor, etc.) and patients and staff are complaining that "they are cold".

During an interview on 12/15/15, at 10:27 a.m., the project manager (PM2) in charge of restoration of the air handler installation (OSHPD Project #S151262-19-00) stated that the temporary air handler feeds the air into the patient rooms of the Pavilion (hospital building). He stated that he had heard complaints about the rooms being "too cold" since last Tuesday (12/8/15). He stated that a possible solution to adding central heat to the rooms is to add a heating coil to the temporary air handler unit until the new permanent air handler is installed. He estimated that the new air handler would be installed in approximately five to six months.

During an interview at 4:07 p.m., on 12/15/15, the vice president of facilities services agreed that it was cold and stated that the facility will be adding a heating coil to the temporary air handling unit to provide central heat to the rooms.

During an interview at 8:32 a.m., on 12/16/15, with the regional compliance officer from OSHPD, he stated that the facility must provide heat between 70 to 75°F per state regulations. Furthermore he stated that the facility needed to add a heating coil to the current temporary HVAC system if the system was not providing enough heat.

On 12/15/15 various departments of the facility were toured accompanied by the plant operations lead. Observations validated that the current air handler was not providing heated air in patient's rooms as per state regulations (70 to 75°F).
a) At 4:05 p.m., plant operations lead staff (PO1) recorded the temperature in Room 628 with a handheld thermometer. The temperature in the room was 68.5°F and the thermostat in the room was set to "warm". Concurrent interview with the patient in the room was held and he stated that the room was "too cold and had been cold for three days". During an interview at 4:06 p.m., PO1 stated that there was no way to add heat to the room and the thermostat only turns off the cold air when it is set to warm.
b) At 4:19 p.m., PO1 measured the temperature in Room 630 it was 67.2°F. The thermostat in the room had a broken lever and PO1 could not adjust it.
c) At 4:21 p.m., PO1 measured the temperature in Room 634 to be 67°F.
d) At 4:30 p.m., PO1 measured the temperature of the air coming out of the supply air vent in Room 302 to be 61.6°F.
e) At 4:35 p.m., PO1 measured the temperature of the air coming out of the supply air vent in Room 311 to be 66.2°F.
f) At 4:37 p.m., PO1 measured the temperature of the air coming out of the supply air vent in Room 314A to be 63.8°F.
g) At 4:40 p.m., PO1 measured the temperature of the air coming out of the supply air vent in Room 315A to be 67.8°F.
h) At 4:45 p.m., PO1 measured the temperature of the air coming out of the supply air vent in Room 207 to be 67.6°F. The room's thermostat was set to warm.
i) At 4:47 p.m., PO1 measured the temperature of the air coming out of the supply air vent in Room 206 to be 60°F. The thermostat in the room had no operating button to adjust the settings. During an interview with the patient in the room he stated that the room was "cold".

On 12/15/15, at 4:49 p.m., records of room temperatures recorded by staff in the Pavilion (hospital building) areas were reviewed. The logs showed that staff were recording ambient room temperatures three times daily (at 6:30 a.m., 12:00 p.m., and 7:00 p.m.) and the acceptable temperature range on the log was listed as 68 to 75°F which was different than the state regulatory parameters 70 to 75°F but in any case still not met.

Sixth Floor:
a) Room temperatures fell below 68°F in 25 of 40 patient rooms on 12/15/15, with the lowest temperature of 64.4°F recorded at 12:00 p.m. in Room 633.
b) Room temperatures fell below 68°F in 8 of 40 patient rooms on 12/14/15, with the lowest temperature of 67.4°F recorded at 12:00 p.m. in Room 638.
c) Room temperatures fell below 68°F in 25 of 40 patient rooms on 12/13/15, with the lowest temperature of 65.2°F recorded at 6:30 a.m. in Rooms 631 and 632.
d) Room temperatures fell below 68°F in 6 of 40 patient rooms on 12/12/15, with the lowest temperature of 67°F recorded at 12:00 p.m. in Room 638.
e) Room temperatures fell below 68°F in 18 of 40 patient rooms on 12/2/15, with the lowest temperature of 66.5°F recorded at 6:30 a.m. in Room 639.

Fifth Floor:
a) Room temperatures fell below 68°F in 15 of 41 patient rooms on 12/13/15, with the lowest temperature of 66.1°F recorded at 6:30 a.m. in Rooms 536 and 540.
b) Room temperatures fell below 68°F in 8 of 41 patient rooms on 12/1/15, with the lowest temperature of 66.8°F recorded at 8:00 a.m. in Room 527.

Fourth Floor:
a) Room temperatures fell below 68°F in 8 of 19 patient rooms on 12/13/15, with the lowest temperature of 67.3°F recorded at 6:30 a.m. in Room 424.
b) Room temperatures fell below 68°F in 19 of 19 patient rooms on 12/12/15, with the lowest temperature of 65.4°F recorded at 6:30 a.m. in Room 406.

Second Floor (Unit P2):
a) Room temperatures fell below 68°F in 30 of 44 patient rooms on 12/12/15, with the lowest temperature of 65.2°F recorded at 6:30 a.m. in Rooms 223 and 230.
b) Room temperatures fell below 68°F in 20 of 44 patient rooms on 12/12/15, with the lowest temperature of 66.5°F recorded at 6:30 a.m. in Rooms 225 and 228.

On 12/17/15 at 9:15 a.m., another tour of the facility accompanied by the plant operations lead took place to validate the current air handler was not providing heated air in patient's rooms as per state regulations (70 to 75°F) and faciltiy policy 68-75 degrees F. The following was observed during the tour:
a) At 9:18 a.m., PO1 measured the temperature of the air coming out of the supply air vent in Room 201 to be 63.4°F. During an interview, the patient in the room stated the room was "chilly".
b) At 9:25 a.m., PO1 measured the temperature of the air coming out of the supply air vent in Room 204 to be 62.2°F.
c) At 9:30 a.m., PO1 measured the temperature of the air coming out of the supply air vent in Room 220 to be 62.2°F. During an interview, the patient in the room stated it was "cold".
d) At 9:35 a.m., PO1 measured the temperature of the air coming out of the supply air vent in Room 243 to be 61.3°F.
e) At 9:38 a.m., PO1 measured the temperature of the air coming out of the supply air vent in Room 241 to be 61.6°F. During an interview, the patient in the room stated it was "cold".
f) At 9:45 a.m., PO1 measured the temperature of the air coming out of the supply air vent in Room 226 to be 58°F.

Concurrent interview was held with the Director of Emergency Services who acknowledged that she can feel the "chill" in the North West wing of the second floor (patient room wing). She stated the rooms in that wing were much cooler than some of the other rooms.

On the same date at 11:00 a.m., Patient N 212 in room 432 was interviewed regarding the room being cold. Patient N 212 stated he had been "Cold for a week. Staff checks the temperature in the room, and gives him blankets but nothing is done to fix the heater".

On the same date at 11:10 a.m., Patient N 215 in room 406 was interviewed regarding the room being cold. Patient N 215 stated "It was cold last night, very cold so I pulled up the blankets".

On the same date at 11:15 a.m., Patient N 214 in room 409 was interviewed regarding the room being cold. Patient N 409 stated "It has been cold for 2 weeks, they turn up the heater but it doesn't work because it gets cold again".

On the same date at 11:05 a.m., in room 425 a bair hugger (forced air warming blanket like device) was observed on the bed. Concurrent interview with the charge nurse (CN 4) was held to inquire about the bair hugger device. CN 4 stated the patient in room 425 had been complaining she was very cold, so she was given the bair hugger.

During the above interview with CN 4 she was questioned regarding the cold temperatures in the unit. CN 4 stated the CN checks the temperatures in the rooms and asks patients if they can "tolerate the cold" and if they can't then they are given blankets. The CNs places a call to facilities or bio-med in order for someone to come and adjust the heat. But this cold temperature problem has "Been going on for a while".

On the same date after the tour, temperature logs that hospital staff recorded in patient rooms at 2:00 a.m., 4:00 a.m., and 6:00 a.m. were reviewed:
a) In P6 (Sixth Floor), temperatures in 15 of 40 patient rooms remained below 68°F from 2 a.m. to 6 a.m. with the lowest temperature of 65.2°F recorded at 2:00 a.m. in Room 635.
b) In P5 (Fifth Floor), temperatures in 12 of 41 patient rooms remained below 68°F from 2 a.m. to 6 a.m. with the lowest temperature of 65.8°F recorded at 6:00 a.m. in Room 534.
c) In P2 (Second Floor), temperatures in 9 of 44 patient rooms remained below 68°F from 2 a.m. to 6 a.m. with the lowest temperature of 64.5°F recorded at 6:00 a.m. in Rooms 224, 225, and 226.

Per these observations, interviews, and log reviews, the facility failed to ensure the provision of adequate central heating to the patient rooms either through the HVAC system or any other means. The temperatures remained under facility policy ranges and state regulations.

2. During a tour of the fourth floor of facility on 12/15/15 at 12:15 p.m., a bin marked biohazard waste was observed in a utility room. The lid was not covering the bin and two large red bags of biohazard waste were hanging out and over the side of the bin.

3. During a tour of the Hollywood facility on 12/17/15 at 12:15 p.m. upon entering a utility room, two five-gallon tubs marked "biohazard waste" were observed on top of a biohazard bin. One of the tubs was open, the lid resting half way off.

During an interview with the supervisor of manager of housekeeping at 11:10 a.m., he stated, "These should be closed at all times. I'll take care of it. Staff cannot touch these after they are in here."


35399

Based on observation, interview, and record review, the facility failed to maintain the bio-hazardous pharmaceutical waste in a designated area, as evidence by the following:
1. Pharmaceutical bio-hazard bins stored in a public parking lot.
2. Biohazard waste bin overflowing in a utility room.
3. One of two five gallon tubs marked bio-hazard waste was open.

These failures have the potential to expose persons in the public to bio-hazardous toxins resulting in negative health outcomes.

Findings:

1. During a tour of the facility and concurrent interview with two administrative staff (AS) on 12/14/15 at 4:02 p.m., 5 blue pharmaceutical bio-hazardous incineration bins full of medication waste were observed in a corner of the MRI building public parking lot. The two AS were questioned about the bins in the public parking lot. The two AS agreed those pharmaceutical bio-hazardous bins should not be in the public parking lot. One of the AS moved the bins to the inside of a mobile mini-storage unit but the storage area was not locked.

The environmental services director (EVSD) was interviewed on 12/16/15 at 3:05 p.m., he was questioned about the process of managing the facility's pharmaceutical bio-hazardous incineration bins. The EVSD admitted the current process to store and dispose of the bins needs some improvement. He stated the recycling company personnel are not doing what they should be doing in order for the bins not to sit in the MRI parking lot. He stated "I need to rewrite the process of managing the pharmaceutical bio-hazardous bins and educate my staff."

A review of the facility's policy and procedure titled: Return, Handing, and Disposal of Medication Waste, PHA.057, dated 10/2012, indicated "All pharmaceutical waste placed in the regular pharmaceutical waste containers and the RCRA hazadous waste containers will be disposed of through environmental services (EVS)". "The pharmaceutical waste containers... will remain in a designated area once picked up by EVS and will then be removed and disposed of by the hospital's designated services."

7) During a tour of the emergency room on 12/14/15 at 10:45 a.m., the "soiled utility room" housed patient belongings and three small portable oxygen tanks that were not secured but standing upright against the side of the wall.
During an interview with LN13 on 12/14/15 at 10:45 a.m., LN13 stated , "They (Oxygen tanks) shouldn't be there, they should be secured."
During a tour of the psychiatric emergency room "overflow" area, in the room unlabeled but identified by DIR1 as the "utility space," contained current patient belongings, donated belongings, clean linen and a refrigerator. Sitting to the left of the refrigerator unsecured were two small oxygen tanks with oxygen unlabeled tubing and unlabeled unbagged masks attached, one small unsecured oxygen tank was located behind three large empty water bottles. During a concurrent interview with the DIR1 she stated, "Respiratory should have taken those masks off and secured the tanks, because some of those tanks would be difficult to get to."
A review of facility policy titled "Oxygen Safety" dated, 02/2011 revised date of 11/2012 under heading "Policy" 4.2.2. "5. In the storage room, oxygen cylinders should be secured, preventing against tipping over."





34709

Based on observation, interview, and record review, the facility failed to maintain the medication refrigerators (refrigerators used to store medications) to ensure specified temperatures were maintained and laboratory refrigerators to ensure specimens are stored at accurate temperatures..Further the facility failed to secure oxygen tanks in two separate areas of the emergency rooms.

As a result, medications that were temperature-sensitive, including but not limited to vaccines, were not stored at the specified temperatures and unsecured oxygen tanks had the potential to cause a serious safety hazard.

Findings:

1. During a tour of the Pharmacy at Culver City, on 12/14/15 starting at 12:30 P.M., with the COO, VPP, and TS, the temperature range specified on the Main Rx (pharmacy) refrigerator was "36¢XF to 46¢XF or 2.2¢XC to 7.7¢XC," according to the Daily Temperature Log Sheet posted on the refrigerator.

According to the log, the temperatures were outside of the specified range on:

12/5/15 at 6:40 A.M., the temperature recorded was "2.1"
12/7/15 at 2 P.M., the temperature recorded was "1.9"
12/11/15 at 6:39 A.M., the temperature recorded was "2.1"
12/11/15 at 8:15 P.M., the temperature recorded was "2.0"

According to the "Refrigerated Drugs" list, provided by the facility, there were 57 medications, in various quantity, stored in the refrigerator. The list included medications for the heart, anti-infectives, vaccines, insulins, "chemo drugs" [medications to treat cancer], and other medications.

2. During a tour of the Store Room, which was part of the Pharmacy at Culver City, on 12/14/15 starting at 4:23 P.M., with the COO, VPP, and TS, the temperature range specified on the Narc (narcotic) STN (station) refrigerator was "36¢XF to 46¢XF," according to the Daily Temperature Log Sheet posted on the refrigerator.

According to the log, the temperatures were outside of the specified range on:

12/9/15 at 10:40 A.M., the temperature recorded was "35.3"
12/10/15 at 10:40 A.M., the temperature recorded was "35.1"
12/12/15 at 10:30 P.M., the temperature recorded was "32.9"

3. During a tour of the Telemetry Unit at Culver City, on 12/15/15 starting at 8:13 A.M., with CN 2, and the COO, the medication refrigerator was inspected.

4. During a tour of the Intensive Care Unit (ICU) at Culver City, on 12/15/15 starting at 9:35 A.M., with CN 1, COO, and VPP, CN 1 stated the medication refrigerator was leaking and was being removed from the medication room. The maintenance record for the refrigerator was requested.

On 12/16/15 at 10 A.M., the maintenance records for all four refrigerators were requested from the VPP.

On 12/17/15 at 8:50 A.M., the VPP stated there were no maintenance records for the following refrigerator: Telemetry, ICU, Narc Station. The VPP provided three documents titled, "Preventative Maintenance Work Order" (work order) for the Main Rx fridge, which were completed approximately six months apart.

According to the work order, the "Instructions" section specified eight elements were inspected during the maintenance, each with a "Pass" or "Fail" checkbox. The checkboxes were left blank. The "Comments" section indicated "PM [preventative maintenance] PASSED."

During an interview with BE 1 on 12/17/15 at 10:10 A.M., in the presence of the VPP, BE 1 stated he had been doing the PM for the Main Rx refrigerator, and described the process as comparing the temperature reading from the thermometer in the medication refrigerator, and his thermometer. If the difference between the two thermometers were within 0.5¢XC then it was "OK." When asked about the eight elements from the "Instructions" section, BE 1 stated they were not individually checked off on paper or documented because they were all in his head, pointing to his head. When requested to recall the eight elements, BE 1 was not able to do so.

On 12/17/15 at 11:07 A.M., the facility's policy for preventative maintenance of medication refrigerators was requested from the VPP.

On 12/17/15 at 11:25 A.M., the VPP stated there was no policy regarding preventative maintenance for medication refrigerators.



35399

5)During a tour of the Laboratory Services and concurrent interview with the laboratory director (LD) and the medical technologist (MedT) on 12/15/15 at 8:40 a.m., a refrigerator (R-2) containing chemistry serum specimens was observed having 2 thermometers inside with temperatures out of range. Temperature range should be 2-8 degrees celsius. According to thermometer 1's reading the temperture was 0 celsius. Thermometer 2's reading was 1 celsius. The LD and MedT were questioned about the temperature discrepancies. The LD stated one of the thermometers was not calibrated. The MedT stated "There is something wrong with the thermometers. I already call Bio-med." The Bio-med person arrived and confirmed refrigerator 2's temperature was 0 to -2 celsius. The LD agreed the refrigerator temperature is out of range and chemistry serum specimens should not be stored inside.
Facility's policy and procedure titled: Quality Assurance, Internal for Laboratory Quality Management, dated 2/2012, indicated the objective is "To assure that regulatory guidelines are followed and patient safety is maintained."
6) During the same tour and in the same refrigerator (2) urine specimens that were 5 days old were observed inside the refrigerator. Concurrent interviews with the LD and MedT were held. According to the LD and MedT urine specimens are good and only kept for 24 hours then specimens are discarded. LD agreed the urine specimens should have been discarded after 24 hours. He did not know what had happened or why the specimens were not discarded.
Facility's policy and procedure titled: Routine Urinalysis, HEM .308, dated 10/2015, section 4.3.1 Specimen, indicates "The specimen should be kept refrigerated and good for 24 hours."

Based on observation, interview, and document review, the hospital failed to ensure an effective, active system wide infection surveillance control program for prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving care in the hospital as evidenced by,
Facility failed to:

1. Provide active surveillance to identify policies and procedures that are not implemented correctly in an active infection control program. (Refer to A-0749

2. Ensure sanitary condition of the Operating Room Suites Environment.(Refer to A-0749)
a. Failed to provide effective monitoring to ensure staff was trained and competent to effectively sterilize hinged surgical instruments (refer to A- 0749)
b. Failed to provide for and monitor material covering operating room equipment, (i.e. patient gurney, arm board; failed to maintained in a condition that would permit the equipment to be disinfected).(Refer to A749)

3. Ensure the sterility of Surgical instruments and sterile supplies. (Refer to A-0749)
a. Failed to provide effective monitoring of sterile supplies and sterile surgical Instrument storage room. (Refer to A-0749)
b. Failed to ensure Sterile supplies were maintained in accordance with facility policy regarding event-related sterility standard (Refer to A-A-0749)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide infection control program; care in a safe and effective manner in accordance with the Condition of Participation for Infection Control Services. Thus, resulting in the facilities inability to provide patient care in a safe and effective manner as agreed in accordance with the Condition of Participation for Infection Control Services. The seriousness of which, resulted in an Immediate Jeopardy identified by the survey team.

Based on observation, interview and document review, the hospital failed to ensure that the policy regarding influenza vaccination was followed, and did not ensure that one medical staff member brought surgical instruments in advance for sterile processing prior to a procedure, creating the increased risk of the spread of infection. Further, the hospital failed to provide a functional and sanitary environment for the provision of surgical services, In order that the types of surgery conducted can be performed in a manner that protects lives and assures the physical safety of all individuals presented for surgery and the community in the event of an emergency need for surgery. The facility failed to ensure competent staff trained on job/duty specific current national recognized standards and facility policies regarding sterile processing of surgical instruments, the storage of sterile supplies and area specific, facility adopted infection control national recognized standards. Consequently, the facility failed to ensure:

1. Staff is trained and competent to effectively maintain sterile surgical Instruments, storage and the environment of care for the decontamination area according to nationally recognized standards and facility policy.
a. Failed to ensure restricted areas and traffic patterns in procedure areas are identified and maintained in accordance with nationally accepted standards of practice.

1.Traffic through the pass of decontamination to Sterile Storage is monitored for cross contamination. PPE is not changed and Hand Hygiene is not observed allowing for cross contamination.

2.The cleanliness of the area known as the Decontamination room.

3.The facility staff members were trained and competent to ensure surgical


2. The facility staff members were trained and competent to ensure surgical Instruments are effectively decontaminated to ensure the sterility process:
The facility failed to ensure:
a. Decontamination room maintained in accordance with nationally recognized standards adopted by the facility and the facilities policies.
b. Protect the clean items and detergents for the washers from debris.
c. Surgical instruments not reprocessed in accordance with nationally recognized standards.

3. Staff is trained and competent to effectively disinfect the sub sterile and sterile core environment.
a. Failed to ensure restricted areas and traffic patterns in procedure areas are identified and maintained in accordance with nationally accepted standards of practice.
1.Prevent cross contamination of the area in restrictive and semi restrictive area
2.Staff members were trained and competent to ensure the sub- sterile decontamination room environment is effectively disinfected.


On 12/14/2015 at 12;20 P.M., in an interview ICP and SPTECH 1 staff could not verbalize the facilities policy for Event-Related Sterility. ICP and the SPTECH1 indicated they were not sure what quality assurance policy the facility followed to ensure sterility of Instrument and sterile supplies.
On 12/14/2015 at 1:00 P.M. an observation of processed sterile instruments indicated the instruments were not maintained in a manner consistent with the facilities policy titled " storage of sterile supplies and sterile instruments " .

In a subsequent interview the ICP acknowledged the maintained condition of the supplies were not consistent with hospital policy. The ICP stated she is not aware of the term, " Event Related Sterility. " However, in a subsequent review of the facilities policy and procedure the ICP and the CNO acknowledged the facility followed, " Event Related Sterility " when processing and storing sterile surgical instruments. The ICP and CNO further acknowledged the Sterile Surgical Instruments and the Sterile Supplies were not maintained consistent with the facilities policy.

On 12/14/2015 at 1:45 P.M. with SPTech 1, CNO, ICP observed surgical trays packed inconsistent with Association of PeriOperative Registered Nurse (AORN) Standards all staff indicated they follow AORN standards.
Observed: four (4) Processed sterile surgical instruments in rigid trays.
Open and inspected:
2 laminectomy tray (instruments used for surgery on the back) also known as a Major Tray ready for transport to the operating room .
Assembled in tray 1:
· A stringer (typically, approximately a foot long 3 rod type device to assist with the positioning of instruments for sterilizing,
o 2 large instruments (approximately 12 inches with each handle approx. 2 inch wide) known as a retractor; stacked flat and inconsistent with standards.
§ Each retractor observed with discoloration spots and film build-up.
o 10 instruments observed wrapped in an absorbent towel and stacked on top of each other.
§ 10 out of 10 wrapped instruments observed with discoloration spots and bio-film.
· One (1) complete set of approximately 50 hinged instruments observed to have different combination of reddish, yellow, black color substance on the instruments.
o 36 of the 50 instruments observed with discoloration and heavily covered with substance and debris in the joints of the hinged instruments.
o 50 of 50 instruments covered with discoloration and bio film.
§ Each subsequent tray opened was observed to be in similar condition to the previous open package with reddish color debris and stains in the joints of the hinged instruments.
In a subsequent observation on 12/14/15 at 2:00 P.M, two smaller trays referred to as " Plastics " (instruments utilized for fine surgeries such as the hand) and identified as a minor tray was opened by SPTech1and revealed hinged instruments on a stringer in similar condition to the previous open packages with reddish color debris and stains in the joints of the hinged instruments.
Thus, four out of four trays were packed inconsistent with faciltiy policy following the National Recognized Standards to ensure the sterility of instruments.

In an interview with ICP and SPTECH1 they agreed this is the typical condition of the instruments. Both staff members acknowledge they were not aware of the facilities policy and procedure for packing surgical Instruments for sterilization. Policy and procedures for sterile processing of instruments were requested and not received by exit date.


On 12/14/2015 at 2:25 P.M, an interview with the ICP and CNO indicated all instruments are in the same condition as the ones viewed today. When asked if the condition of instruments identified with the discolorations were considered ready for the surgeon. The CNO stated, " We need to do something to replace them. " The ICP further acknowledged the facility does not currently have a process for quality assurance surveillance for facility-wide Infection Control program and specifically event related sterility policy.

On 12/14/2015 at 4:30 P.M., a subsequent review of records with SP TECH 1, revealed Association of PeriOperative Registered Nurse (AORN) Standards and Recommended Practices, 2013 edition. Standard adopted by the facility and in the absence of a facility policy.

Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment reviewed. Under Recommendation XII, the following information was provided: " Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces. Proper organization will facilitate sterilant contact on all surfaces and adequate drying.

During a concurrent Interview with the ICP and the SPTECH 1 they acknowledged the tray as assembled, failed to follow the facility standard to ensure sterility as per the National Recognized Standards the facility adopted. A facility policy and procedure was requested at the time of exit; a copy was not provided.

On 12/15/2015 during a tour at 10:05 AM, a tour of the restricted and semi restricted areas was conducted with the ICP1, ICPC, and the CNO.
Observation 1: observation of staff passing back and forth to the restricted area of the decontamination room of the SPU over to the restricted sterile side of the SPU was made. SP TECH 1 was observed to cross over from side to side of the units failing to practice hand hygiene per facility policy and Association of PeriOperative Register Nurses (AORN) standards. AORN is the national recognized standards identified by the ICP as the standard adopted by the facility for the policy regarding attire in restricted and semi-restricted areas.
In a subsequent interview, SP TECH 1 indicated that He was " ok " because the unit was not actively processing instruments at the current time.

Observation 2: ICP, ICPC and the CNO, SP TECH 1and SP TECH 2 did not utilize clean PPE and therefore wore the same scrubs back and forth between the decontamination room and the sterile storage room.
In a subsequent interview, SP TECH1 verbalized that visitors in the Sterile Processing room and decontamination room did not need to wear PPE unless active instrument processing was in progress.
After prompting, in a concurrent interview, the ICP 1 and CNO indicated they did not know the standard or policy. However, ICP felt that PPE was probably needed and escorted the survey team down the hall through a semi-restricted area into the restricted OR hallway to retrieve PPE to wear in the sterile Processing unit. One team member Donned scrubs supplied and 2 team members carried the disposable overalls as directed by the ICP. Subsequently, the team retraced steps as they were escorted back through the Restricted and Semi-Restricted hallway and into the open to visitor accessed hallways to the sterile processing unit. At this point the team Donned the PPE before continuing further into the sterile processing unit.
In review of policy and procedures, SP TECH 1 stated, " I have policies somewhere. " SP TECH 1 indicated he does not remember the last time he reviewed them. SP TECH 1 indicated that he did not receive on-going job specific infection control education.
On 12/15 /2015 at 10:30 A.M., In a concurrent observation and interview ICP revealed the expectation of the staff is to return to the OR restricted area to retrieve PPE each time employees require PPE to enter Sterile Processing. The CNO and ICP acknowledged the lack of signage indicating restricted and semi-restricted area. Both acknowledged the lack of appropriate PPE (Personal Protected Equipment) in the Sterile Processing room and agreed PPE was not readily available.

In a concurrent observation and interview the ICP acknowledged all personnel are not to enter the sterile room without proper hand hygiene and PPE (Personal Protected Equipment). 4 out of 6 random opportunities for observation revealed staff members did not utilize the hand hygiene products. The ICP indicated this was an opportunity for improvement.

Review of documentation:

Review of The Perioperative Standards and Recommended Practices published by the AORN (Association of perioperative Registered Nurses), 2014 edition indicated "Traffic patterns should be designed to facilitate movement of patients and personnel into, though, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. The semi-restricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and patients. The restricted area includes operating rooms, procedure rooms, and the clean core area. "

On 12/15/2014 at 10:00 A.M., during a tour on 2 occasions for random opportunity for observation the Wet time (amount of time a disinfectant must stay wet on the surface of the item being disinfected) in practice was observed:

2 out of 3 employees in the sterile and sub sterile core area did not observe and/or verbalize the wet time per the manufactures instructions and nationally recognized standards. Observed were the SPTECH1 SPTECH2 and SPTECH C.

On 12/17/2015 at 4:45 P.M., In a subsequent interview with ICP, the ICPC indicated that staff in the above documented observation did not follow the AORN standards or facility policies. ICP2 acknowledged the lack of understanding by the staff regarding the " wet time " , proper PPE and proper environmental care of the decontamination room.
AORN) Recommendation IV
Instruments should be kept free of gross soil during surgical procedures.
Blood and body fluids can cause pitting of instruments and, if left to dry, can be difficult to remove. If blood and body fluids are not removed, they can prevent adequate sterilization, which could be an avenue for transmission of other potentially infectious materials.
· IV.a. Instruments should be wiped as needed with sterile surgical sponges moistened with sterile water during the procedure to remove gross soil.
Blood and body fluids, as well as saline, are highly corrosive. Corrosion, rusting, and pitting occur when saline, blood, and debris are allowed to dry in or on surgical instruments. Dried blood and debris can be difficult, if not impossible, to remove from all surfaces during the decontamination process; therefore, subsequent disinfection or sterilization may not be achieved.

AORN, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, 2013: Instruments should be inspected for ...corrosion, pitting, burrs, nicks, and cracks ...wear and chipping of ...plated surfaces damage[d] protective surfaces of instruments, contribute to corrosion, impede sterilization surface corrosion damage ...can inhibit sterilization
Spotting, Staining, and Corrosion of Surgical Instruments
Surgical instrument Herbert J. Kaiser, PhD; Patrick Schwab, MBA; Jason F. Tirey, MA. (October 1, 2000). Spotting, Staining, and Corrosion of Surgical Instruments. Infection Control Today.
Retrieved from: spotting, staining, and corrosion are serious problems in many healthcare facilities ... Spotting, staining, and corrosion of surgical instruments can impair their function ... Spotting, staining, and corrosion also interfere with sterilization. Spores can be protected from destruction by the layers of iron oxide (rust). Corrosion can result in a shortened instrument life, which results in increased cost.
Stainless Steel
It is important to remember that stainless steel means stainless steel, not stain-proof steel. All types of stainless steel will eventually become corroded and stained. Also, while a surface of an instrument may look bright and shiny to the naked eye,
under microscopic examination the surface is actually very rough. The rough surface allows for entrapment of impurities from soils and water ....Spotting lies loosely on the surface. Staining is integral with the surface. Corrosion penetrates the surface... Stainless steel is indeed reactive, meaning that it will corrode and become stained under certain conditions.
(AORN) Recommendation IV
Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. ...Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible.

· IV.c. Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces.3 [3: Limited Evidence]
Sterilant contact is necessary for sterilization to be achieved.
· IV.e. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer ' s written and validated IFU specifies that disassembly is not required.3 [3: Limited Evidence]
Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant.3
· IV.f. Items to be sterilized that have concave or convex surfaces that create potential for water retention should be positioned within packages in a manner that prevents those surfaces from retaining water.3,4 [1: Strong Evidence]
Preventing water retention can help avoid the occurrence of wet packs and sterilization failure.
· IV.g. Towels placed within instrument sets should be lint-free, freshly laundered, and thoroughly rinsed by a health care-accredited laundry facility. [3: Limited Evidence]
Adequate rinsing reduces the risk of leaving chemical residues that could be transferred from the towels to instruments.28 Lint left on sterile instruments may be transferred to the surgical wound and may cause a foreign-body reaction.
· IV.h. Items to be sterilized should be placed in the package or tray in an open or unlocked position. [3: Limited Evidence]

AORN Standards - Recommended Practices for Selection and Use of Packaging Systems for Sterilization:
" Sterilized packages should be considered sterile until an event occurs to compromise the package barrier integrity.
Health care organizations should determine the best methods and materials for packaging sterile items, based upon the anticipated storage, handling, and environmental events that may be encountered. Loss of sterility of a packaged sterile item is event related. An event must occur to compromise package content sterility. Events that may affect the sterility of a package include, but are not limited to:
· multiple handling that leads to seal breakage or loss of package integrity
· compression during storage
· moisture penetration
· exposure to airborne and other environmental contaminants
· storage conditions (eg, type of shelving, cleanliness, temperature, humidity, traffic control)
· type and configuration of packaging materials used
· use of sterility maintenance covers and method of sealing
Sterile packages should be stored under environmentally controlled conditions. Sterile storage area temperature should be controlled and should not exceed 75ºF (24ºC). The humidity should not exceed 70. There should be a minimum of four air exchanges per hour, and the air flow should be under positive pressure in relation to adjacent areas.
Findings:
4. During an observation in the surgical corridor on 12/14/15 at 1230 p.m., a physician in scrub attire, MD9, was observed handing two large blue-wrapped trays to RN 7 at the desk. He told RN 7 that the trays were "already sterile".
In an interview with RN 7 at 1231 p.m., she stated that the trays were for a surgery scheduled for 1230, and that she was not sure why the surgeon brought them in right now. She stated the trays contained special retractors. She was asked to show on the surgical log which surgery they were for, and indicated that they were for a knee surgery scheduled for Patient 501 in OR 4.
In an interview on 12/14/15 at 1235p.m., with OR TECH 2 in OR 4, he stated that MD9 often brought his own instruments, such as a rondeur and handle.
The surgeon failed to bring instruments in a sufficient time prior to the surgery to allow for sterile processing of the instruments.
5. Employee health policies and procedures did not follow the facility adopted, nationally recognized CDC guidelines for immunizations of health care workers that state:
· "Healthcare workers include physicians, nurses, emergency medical personnel, dental professionals and students, medical and nursing students, laboratory technicians, pharmacists, hospital volunteers, and administrative staff " .
· " ( ...recommends that health care providers receive vaccinations for diseases for which routine vaccination or documentation of immunity is recommended because of risks in the workplace (i.e. hepatitis B, seasonal influenza, measles, mumps, rubella, pertussis, and varicella) "
· " Healthcare personnel should receive a single dose of Tdap (a vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis, that prevents the diseases of Diphtheria, Tetanus and Whooping Cough) as soon as feasible upon hire if they have not been vaccinated previously " .
· " Healthcare organizations should review health care provider vaccination and immunity status at the time of hire and at least annually thereafter " .

In an interview with the ICP 1 on 12/16/15 at 1200 p.m., she stated that the stickers were distributed by the medical staff office or by employee health to put on hospital name badges to indicate influenza immunization. She stated that some physicians use different badges, which are harder to check. She stated the expectation was that the staff member would wear a mask until documentation of vaccination was submitted, and that the medical staff were informed of the mandatory mask or immunization policy.
In an interview, conducted in a hospital conference room, with the IP Epidemiologist HW on 12/18/15 at 1150, he wore a hospital identification badge with his name, but no sticker to show that he was immunized against influenza. He stated that he had been vaccinated, but did not have the sticker to display because the person responsible for handing them out did not have them to give. During a concurrent interview with IP Staff HW, he stated that he had not had the influenza vaccine, and there was no sticker affixed to his identification badge. Neither staff member was wearing a mask.
In an interview with the QA Staff HW on 12/18/15 at 1200 p.m., she stated that people who were vaccinated elsewhere did not have stickers on their badges as the hospital ran out of stickers to give.
During an observation in the surgical corridor on 12/14/15 at 1230p.m., a physician in scrub attire, MD9, was observed not wearing a mask.
During a review on 12/15/15 of the credential and health files of MDs 6, 7, 8, 9, 10, 11 and CRNA 1, the files did not contain information about influenza vaccination or declination.
In an interview with the Dir MS Services on 12/15/15 at 0750 a.m., she stated that there was no influenza vaccine information in the files, and that the medical staff had been sent a letter in October about the necessity for providing vaccination information. She stated that the medical staff office sent out the letter and should track the influenza vaccination documentation.
In an observation at the VN facility on 12/17/15 at 1255, VN LVN had a badge with no sticker, and was not wearing a mask.
In a concurrent interview with VN LVN, she stated that she did not put the sticker on her badge, but had been vaccinated.
During a review on 12/15/15 of the credential and health files of MDs 6, 7, 8, 9, 10, 11, and CRNA 1, the files did not contain information about vaccination status for measles, mumps, rubella or hepatitis B.
In an interview with the Dir MS Services on 12/15/15 at 0750 a.m., she stated that physician health screening information was maintained by the infection prevention program.
In an interview with the ICP 1 on 12/16/15 at 1200 p.m., she stated that all hospital employees were required to present measles, mumps and rubella documentation on hire, but that measles, mumps and rubella were not being tracked for the medical staff as further health information was not required for them.
During a review on 12/15/15 of the credential and health file of MD9 the file did not contain evidence of tuberculosis screening. The file showed that the physician had been reappointed 4/24/14, and that there was a letter from the infection prevention department indicating that it had no concerns about the physician.
During a review on 12/15/15 of the credential and health file of MD6, the file contained a TB skin test from 3/12/13, but not thereafter. The physician was reappointed on 1/29/14.
In an interview with the Dir MS Services on 12/15/15 at 1:00p.m., she stated that there was no TB skin test in the file for MD9, and that there should have been a subsequent test in the file of MD6.
In an interview with the ICP 1 on 12/16/15 at 1200 p.m., she stated that she was not aware of medical staff members without current tuberculosis verification. She stated that she did not check to see if the verification of tuberculosis status was done.
In an interview with the ICP 1 on 12/16/15 at 1200 p.m., she stated that there was routine follow-up of NHSN designated procedures for possible surgical site infections through readmissions, culture review, staff reporting and notifications from other facilities. She stated that there was no system for contacting physicians for surveillance, there was no outpatient surgery clinic, and no outpatient clinical records were reviewed to identify infections. She stated that the process for identifying readmissions was a work in progress. She stated that there was no routine follow-up of surgical site infections that were not NHSN reportable infections.

Based on record review and interview the facility failed to arrange for initial implementation of hospice care for Patient N105, per patient N105's responsible party (family) requests. This failure created the potential for Patient N105's hospice care not to be initiated.

Findings:

A review of Patient N105's clinical record on 12/12/15, revealed that Patient N105 was admitted on 12/11/15 from a skilled nursing facility with a diagnoses to include failure to thrive, poor oral intake and dehydration.
Review of MD7's progress note dated 12/11/15 indicated in part, "The family states, after a few days of IV fluids we will put her on hospice care... To start hospice care when she returns to the SNF (skilled nursing care)."
A review of the "discharge planning record" dated 12/12/15 authored by adm2 under section: "discharge goal plan" the entry was "Return to same level of care." A review of the entire discharge planning document failed to indicate the patient and family's desire to change the level of care from skilled nursing level to hospice care.
During a concurrent review of the discharge planning document and interview with LN2 on 12/12/15, at 9:15 a.m., LN 2 was unable to locate any discharge planning in the clinical record (other than the MD note) to indicate the desire of the patient and family to change to hospice care.

Based on observation, interview, and record review, the facility failed to develop a staff education/training program in cooperation with the designated Organ Precurement Organization (OPO).

Findings:

During a tour of the CCU on 12/15/15 from 10:00 a.m. to 12:00 p.m., two CCU LNs were asked randomly regarding the organ precurement process in the unit. LNs knowledge regarding the process was minimal.

The CCU charge nurse (CCUCN) was interviewed on 12/16/15 at 10:50 a.m., and questioned regarding the organ precurement process in the CCU. The CCUCN was unclear of the entire process.

An interview was held with the facility's nursing supervisor (FNS) on 12/16/15 at 2:40 p.m. The FNS was unclear about the OPO process, she wasn't aware of the mode for identifying potential organ donor canditates, or who can declare the patient dead. The FSN was unaware of the medical staff to contact if needed, and didn't know about the education/training of patient care staff. FSN stated "I'm not sure about the whole process. I dont' know".

The facility's medical director was nearby during the FNS interview and stated if the OPO can provide staff education, then the designated OPO will be contacted to provide the facility's staff education.

An interview was held with the vice president of quality (VPA) on 12/17/15 at 10:03 a.m., the VPA confirmed the facility had not provided any education or training to staff regarding the OPO or process.

Based on interview and record review, the hospital did not ensure that general anesthetic agents were administered only by medical staff members privileged to do so, creating the increased risk of a poor anesthetic outcome.
Findings:
The Medical Staff Rules & Regulations (undated, page 43), showed that conscious sedation privileges were available to members of the medical staff who successfully passed a conscious sedation test or had such privileges at another facility.
The Moderate Sedation Self Learning Module employed by the medical staff to educate staff wishing conscious sedation privileges was reviewed, and did not contain information about which agents were considered conscious sedation agents, and which were general anesthetics. The Moderate Sedation Post-test and Request for Moderate Sedation Privileges was reviewed, and did not include discussion of which agents were considered moderate sedation vs general anesthetics. The test questions appeared to be simplistic and based on common knowledge, rather than based on specialized knowledge about sedation.
In an interview with the Dir Anesthesia on 12/15/15 at 1305, he stated that Ketamine and Propofol were not to be used for procedural sedation in the ER. He stated that if a patient needs moderate or deep sedation, anesthesia must be called to provide that service. He concurred that the test for conscious sedation did not mention specific medications to verify complete physician understanding.
The Dir 1, in an interview on 12/16/15 at 0900, stated that Propofol and Ketamine were used in the ER for procedural sedation, per the physician ' s choice. She stated that such procedures would be attended by the ER physician, and nurse, and a respiratory tech. She stated there was Ketamine in the ER pyxis, and that she was not aware of a policy on the use of Ketamine and Propofol.
In an interview with the VPP on 12/16/15 at 0920, she concurred that the policy on conscious sedation was unclear and should define when the ER physician can use Propofol, and when anesthesia staff were required.
A drug utilization report for the general anesthetic, Ketamine, was requested, and showed that the drug was used by non-anesthesiologists such as ER staff.
The medical record of Patient 506 was reviewed on 12/17/15 and showed that the 3 year old came to the ER on 8/26/15 with a finger injury requiring surgical repair. The orthopedist ' s procedure note included a description of the patient being unable to undergo the procedure under local sedation, and informed consent for conscious sedation being obtained from the patient ' s mother. The record contained an Authorization and Informed Consent for conscious sedation by the ER physician, DR 2, which was signed by a representative of the patient. The Medical Orders indicated that Ketamine was ordered " to bedside for conscious sedation " at 21:26. The Medical Orders and MD Notes showed that Ketamine 60mg IM, followed by 40 mg IM was administered by the ER physician at 2345, with IM administration used as IV was not available. An orthopedist performed the surgical repair. The record showed that the patient was documented as still sedated at 2348, and that the patient ' s care was transferred to the subsequent ER physician at 2358, and the patient was approved for discharge at 0127. There was no documentation to show that an anesthesiologist was present to provide the Ketamine, to monitor the patient, or to provide a post anesthetic assessment.
During a second interview with the Dir Anesth on 12/16/15 at 1240, via telephone, he stated that he was not aware the ketamine was being given by the ER physicians. He stated that the ER physicians were not privileged to provide general anesthetics, and that he needed to revisit the conscious sedation policy and to clarify the difference between conscious sedation and general anesthesia.

Based on interview and record review, the hospital did not ensure the integrity of the post-anesthesia evaluation for one patient, Patient 502, creating the risk of a substandard anesthetic outcome for that patient.
Findings:
During a tour of the PACU on 12/14/15 at 1130, with RN 6, she stated that Patient 502 had just arrived in the PACU.
Patient 502 was observed in the PACU on 12/14/15 at 1132 and appeared to be unmoving and asleep.
Patient 502 ' s medical record was reviewed at 1135. The Critical Care Flowsheet for the patient containing the PACU record was reviewed, and showed that the patient arrived in the PACU at 1129, and that assessments were completed at 1129 and 1135 with the level of consciousness recorded as " 0 " , indicating " not responding " , and the level of physical activity record as " 0 " , indicating " unable to move extremities voluntarily or on command ' , scores of " 1 " for respiration and oxygen saturation, indicating " limited breathing " and " needs oxygen inhalation to maintain oxygen saturation >90% " .
The record also contained a post-anesthetic assessment that indicated that the patient had recovered from anesthesia. The pre-printed note included the observations that " Patient ' s mental status is acceptable. " , and " Pain and nausea are adequately controlled " , and " Patient is determined to have stable airway patency and respiratory function including respiratory rate and oxygen saturation. " The note, observed at 1135, was signed by MD7 and timed 1229. The Anesthesia Record also contained a check mark indicating that there were no anesthesia complications.
In an interview with the OR Manager on 12/14/15 at 1135, she observed Patient 502. She concurred that the post-anesthesia assessment had already been signed, and stated that that the patient was sedated and sound asleep.

Based on observation, interview and record review the hospital failed to ensure that the outpatient services met the needs of the patients in acceptable standards when :

1) The facility failed to employ a qualified coordinator for the psychiatric intensive out patient services, per the facility job description qualification requirements. The facility failed to employ an adequate number of qualified professional staff at the psychiatric intensive out patient services. These failures resulted in two of three sampled patients and 22 of 52 unsampled patients lacking current individualized treatment plans for the previous six months, potentially impeding the patients progress towards therapeutic goals. (cross reference A-1079)

Based on interview and facility record review, the facility failed to employ a qualified coordinator for the psychiatric intensive out patient services, per the facility job description qualification requirements. The facility failed to employ an adequate number of qualified professional staff at the psychiatric intensive out patient services. These failures resulted in two of three sampled patients and 22 of 52 unsampled patients not having current individualized treatment plans for the last six months and potentially impeding the patients progress towards therapeutic goals.

Findings:

During a concurrent personnel record review and interview with human resource staff 1 on 12/16/15, at 3:40 p.m., personnel record review revealed that Adm4 staff last performance evaluation was for the period of 8/17/12 to 8/17/13 signed by Adm4 on 11/09/15. The evaluation indicated the minimum education requirements for the intensive outpatient program coordinator were "Master's degree in psychology and/or Social work" License requirements were"California LMFT (licensed marriage and family therapist), LCSW (licensed clinical social worked ) PHD, or current Ca RN License. Review of Adm4 personnel file indicated that Adm4 only had a bachelors degree in recreation. Human resource staff 1 acknowledged that Adm4 did not meet the minimum qualification of the job description.
During a review of facility policy titled, "Scope of Services" dated 09/12, last revised 11/2012. Under section 4.2 Procedure, mechanism for identifying patient care needs revealed in part... "Treatment plans are reviewed and revised monthly by the treatment team and psychiatrist." 4.2.1 "Staffing Information"
Brotman campus:
Program Director 1.0 FTE (full time equivalent)
Program Coordinator 1.0 FTE
Program Assistant 0.6 FTE
therapist 3.2 FTE'Ss
A therapist is responsible for providing care to twelve patients with a 1:12 ratio."
On 12/16/15, at 12 p.m., during a review of Patient N107's clinical record, the record indicated that patient N107 did not have any monthly updates to treatment plans since 5/29/15. During a review of Patient N108's record the record indicated that Patient N108 was admitted on 5/18/15, all monthly treatment plans since admission have nearly identical goals and all interventions noted were as follows: "Therapist will monitor or assist as needed." All treatment plans were signed by the therapist intern with no co-signature.
There were no "strengths" identified in the treatment plans.
Review of facility policy and procedure titled, "Interdisciplinary Treatment planning" effective date 10/11 revised 11/2012, indicated in part, under "Procedure" 4.2.4 "The clinician responsible for the patient serves as the treatment coordinator. This individual is responsible for ensuring that the appropriate documentation is entered on the treatment plan...."
During an interview with Adm4 on 12/16/15, at 12:15 p.m., and concurrent review of the treatment plans for Patient N107 and N108 Adm 4 was questioned as to why the treatment plans for Patient 107 were not initiated for over 6 months and why Patient N108's treatment plans were not updated or reviewed by licensed staff. Adm4 stated, "Honestly, we have been down by two therapists for over six months and the patients pulled were assigned to them and things didn't get done".

During a follow up interview with Adm4 and behavioral health supr1 at 4p.m., Adm4 indicated that since 6/1/15, there has only been one full time therapists and one half time intern. During this period the census was "around 52 patients". Adm4 acknowledged that 14 patients do not have an assigned therapist and the full time licensed therapist has not been able to supervise the intern in treatment planning. Eight patients have not had any treatment planning since 6/2015. Behavioral health supr1 was asked if she was aware of treatment planning not occurring, not being individualized or the vacancy of staff issues, behavioral health supr1 stated, "No, not aware, I am the interim and I have only been here two months." Behavioral health supr 1 acknowledged there was not enough staff and that the treatment planning that occurred and did not occur was a deficient practice.