HospitalInspections.org

Based on observation, interview and document review, the facility's Governing Body failed to effectively carry out their role and responsibility to provide a safe and secure environment for patients when:

1. The Pharmacy Services failed to achieve the highest standards of patient care for the following:
a. To ensure standardized processes across the two hospital campuses (Hospital A and Hospital B);
b. To oversee clear policies were developed and followed across the two hospital campuses (Hospital A and Hospital B); and
c. To ensure the pharmaceutical services developed policies to minimize drug errors and avoid drug diversion.
See A0489, A0494, A0500, A0501, A0502, A0503, and A0505.

2. The QAPI department did not monitor all services provided to patients and did not focus on indicators related to improved health outcomes and the prevention of medical errors. See A0263

3. The governing body failed to hold the medical staff accountable for the quality of medical care provided to patients. See A0049

4. The governing body failed to ensure significant events were reported to the State Agency and the Centers for Medicare/Medicaid Services within the required time frame. See A0175, A0213

5. The governing body failed to ensure the nursing staff was well organized and fully supervised by a registered nurse. See A0385

These deficient practices together resulted in the Condition of Participation for Governing Body being NOT MET.

Based on interview and record review, the facility failed to ensure a RN documented vital signs (temperature, pulse, blood pressure and respiration rate) every 15 minutes for 1 unsampled patient (91) who was placed in restraints, as required per facility policy.

As a result, there was potential for an unidentified change of condition for Patient 91.

Findings:

Patient 91 was admitted to the facility on 3/22/18 with diagnoses which included schizophrenia (serious mental disorder) with catatonic symptoms (speechless, motionless), per the admission H & P, dated 3/22/18.

According to a Nursing Narrative note, dated 3/23/18, Patient 91 was placed in 4 point (4 limbs) restraints at 6 P.M.

According to the nursing documentation in the Violent Restraint flow sheet, dated 3/23/18, Patient 91 was assessed every 15 minutes while in restraints, but the only vital sign included in the assessment was a respiratory rate.

On 4/11/18 at 9 A.M., NM 52 stated if a RN was not able to obtain vital signs for a patient in restraints, the RN documentation should reflect the vitals signs were not obtained and include the reason why.

On 4/11/18 at 11:06 A.M., RN 51 stated she was not able to obtain any other vital signs except for a respiration rate for Patient 91 while in restraints because the patient flailed about and wouldn't hold still in order to assess.

According the facility policy, entitled, Restraint for Violent and Self Destructive Behavior, effective 8/30/17,"...The patient is assessed by the RN at the initiation of restraint...and every 15 minutes thereafter...The initial and every 15-minute assessment included vital signs..."

Based on interview and record review, the facility failed to timely report the death within 24 hours of restraint removal for 1 unsampled patient (91) to their CMS regional office.

As a result, there was a delay in regulatory required reporting of a death.

Findings:

Patient 91 was admitted to the facility on 3/22/18 with diagnoses which included schizophrenia (serious mental disorder) with catatonic symptoms (speechless, motionless), per the admission H & P, dated 3/22/18.

According to a Nursing Narrative note, dated 3/23/18, Patient 91 was placed in 4 point (4 limbs) restraints at 6 P.M. and the restraints were removed at 7:10 P.M.

According to a Rapid Response Record, dated 3/23/18, the RRT was notified at 7:20 P.M. Patient 91 was agitated, restless, had a heart rate of 130 (normal = 60 - 100), was lethargic (drowsy/sluggish), in respiratory distress, unresponsive and had a respiration rate of 30 (normal at rest = 12 - 20). Per the same note Patient 91 received emergency medications and was cardioverted (use of electricity to restore normal heart rate) at the facility and then discharged via EMS to the facility's emergency room.

According to the local fire department Prehospital Patient Record, dated 3/23/18, the EMS staff arrived to the facility at 7:52 P.M. and en route to the ambulance Patient 91 stopped breathing and CPR was initiated.

Per the Emergency Physician Documentation, dated 3/23/18, after unsuccessful resuscitative efforts in the emergency room, Patient 91 was pronounced deceased at 8:51 P.M., which was less that 2 hours after being removed from restraints.

Patient 91's death of 3/23/18 was reported to the Department, on 4/3/18, which was 11 days after the event occurred.. In addition, the hospital did not report Patient 91's death to the CMS Regional Office.

The DQPSIPR stated in an interview on 4/4/18 at 12:05 P.M., facility leadership staff were not aware of the reporting requirements.

Based on observation, interview, and document review, the governing body did not hold the medical staff accountable for the quality of care provided by pharmaceutical services. The medical staff failed to ensure that pharmaceutical services developed and implemented policies in the following:
1. To standardize services between the two hospital sites (Hospital A & Hospital B);
2. To minimize drug diversion
3. To ensure the highest standards of patient care
See A0489

This resulted in patients experiencing inadequate pain control as well as risk from drug errors. It also contributed to multiple cases of drug diversion of controlled substances by staff.

Findings:

On 4/12/18 at 9:05 A.M., an interview was conducted with the hospital's Quality Assurance and Performance Improvement (QAPI) committee members.

The issue related to the drug diversion in July 2017, which involved a Pharmacist was discussed. The team members stated they were not aware of the extent of the drug diversion investigation until the April 9, 2018. The Pharmacy Director stated he investigated the drug diversion within the Department of Pharmacy and further stated he did not provide the entire investigation to the QAPI committee.

The team members were asked of their involvement of the drug diversion in January 2018, which involved a Registered Nurse. The team members were aware of the incident, however were unable to provide the action items identified from the incident.

The committee members were asked to describe the functions of their committee when determining issues to discuss during their monthly meetings. The committee members were unable to clearly articulate how issues were brought to the QAPI meetings. When asked if the committee members were involved in the drug diversion root cause analysis investigations, the members stated there was no "Formal Root Cause Analysis".

The committee members were asked what type of data is reviewed during their monthly meetings. The Pharmacy Director stated he collects data, however, did not provide the information regarding the drug diversion incidents to the committee. The Pharmacy Director stated he recognized his department, has "opportunity for improvement."

A review of the role and responsibility of the QAPI committee was discussed, which identified their responsibility to oversee high risk, problem prone issues within the organization. When asked how was the drug diversion issues determined, the committee members were unable to articulate clearly the drug diversion issues heightened to a level of high risk and/or problem prone.

A meeting with members of the governing body was held on 4/12/18 at 11 A.M. The Vice Chair of the board discussed some of the actions being taken to correct some of the issues identified during survey (standardization of Pharmacy processes at both hospitals). She admitted the hospital needed to improve auditing (monitoring) to be more proactive and was concerned there was a delay in the reporting of significant events through the committees up to the Board of Directors. Although she discussed the action plans for these items, the deficient practices were ongoing at the start of the survey.

Based on observation, interview, record, and document review, hospital B failed to ensure a Registered Nurse (RN) documented a Nursing shift assessment and the Registered Nurses (RNs') documented the re-assessment of pain after the administration of a medication (Morphine-pain medication) for 3 of 56 sampled patient's (6, 22, 23). The lack of documented evidence did not ensure evaluation of the patient's care needs were re-assessed and communicated amongst health care professionals and providers in accordance with Nursing Professional Standards of Care.

Findings:

1. On 4/9/18 at 10:50 A.M., a tour of the Sixth Floor Medical unit and joint interview was conducted with a Nurse Educator (NE) 22, and a Nurse Manager (NM) 24, and RN 21. During the interview, RN 21 stated she was assigned to care for four patients and had not documented her patient's nursing assessments in the medical records.

On 4/9/18 at 3:00 P.M., a review of RN 21's Nursing shift assessments and joint interviews were conducted with NE 22 and NM 24. Patient 23, who was under the care of RN 21, had a Nursing shift Assessment documented by RN 21 as performed on 4/9/18 at 1:13 P.M. NM 24 stated the hospital expected Nurses documented patient shift assessments within six hours of the start of the 7:00 A.M. shift.

The hospital's document entitled Standards of Patient Care for the Adult Inpatient, dated 1/25/17, indicated "IV. 3. The ongoing shift assessment will be documented within 6 hours of the beginning of the shift."

The Professional Standards were not implemented when there was no documented evidence a patient's shift Nursing Assessment was performed within the first six hours of a RN's shift in accordance with Nursing Professional Standards of Care.

2. On 4/9/18 at 10:50 A.M., a tour of the Sixth Floor Medical unit and review of Patient 22's medical record was conducted with a Nurse Educator (NE) 22, and a Nurse Manager (NM) 24.

Patient 22 was admitted to hospital B on 4/6/18 per the Facesheet.

Per Physician's orders, dated 4/6/18, Morphine 15 milligram (mg) tablet by mouth was ordered routinely every 12 hours for Patient 22's pain.

Per the Medication Administration Record (MAR), RN 26 administered Patient 22 Morphine 15 mg on 4/10/18 at 12:04 A.M. for a pain score of seven (severe pain).

Per the MAR, Patient 22's pain re-assessment was documented as performed on 4/10/18 at 3:47 A.M.

RN 26 was not available for interview on 4/9/18. NE 22 and NM 24 stated, the hospital expected Nurses re-assessed patient's pain medication effectiveness within an hour of administration by mouth.

There was no documented evidence Patient 22's re-assessment of pain was performed until more than three hours after the pain medication was administered.


29509


3. Patient 6 was admitted to the hospital on 4/8/18, with an admitting diagnosis of leg pain.

On 4/10/18 at 2:18 P.M., a concurrent interview and record review was conducted with RN 6.

The physician ordered Morphine injectable (pain medication), 2 milligrams IV Push (Intravenous-directly into the vein), every 3 hours for pain; Mild pain 1-3 (0= no pain; 10=severe pain).

On 4/9/18 at 4:07 A.M., Patient 6's pain level was 8 out of 10 and received Morphine 2 milligrams IV Push. The RN documented at 4:22 A.M., the patient was asleep and the pain level re-assessment was not obtained.

On 4/9/18 at 8:40 A.M., Patient' 6's pain level was 8 out of 10; her pain re-assessment was performed at 8:55 A.M. Patient 6's pain level was 6 out of 10.

On 4/9/18 at 10:23 A.M.,(nearly two hours later), the patient's pain level was 8 out of 10. A new physician's order was obtained for Morphine injectable 4 milligrams IV Push. There was no re-assessment of the patient's pain level until 11:31 A.M.

According to the facility's policy and procedure entitled Pain Assessment and Management, "III. Standards of Practice G...practice expectations are that pain will be reassessed following treatment of the symptom: 1. Within 30 minute after an IV medication..."

RN 6 confirmed, the nurse did not follow the hospital's policy and procedure for patient re-assessment of pain within 30 minutes of administration.

Based on interview and record/document review the hospital failed to implement written policies and procedures for one of 56 sampled patients (Patient 41). Patient 41's document for informed consent for treatment was not completed in accordance with the hospital policy and procedure. The informed consent had the incorrect name of the physician performing the procedure. This failure did not ensure documented evidence that the patient was provided with accurate consent information.

Findings:

Resident 41 was admitted to the hospital on 3/23/18 with diagnoses, which included acute severe pancreatitis per the History and Physical dated 3/23/18.

A review of Patient 41's records was conducted with the Clinical Nurse Specialist (CNS) 41 on 4/10/18 at 8:25 A.M. An informed consent for a tunneled hemodialysis catheter placement with possible sedation dated 4/10/18 was reviewed. The consent had the incorrect name of the physician performing the procedure.

On 4/11/18 at 3:55 P.M., an interview with the Cath Lab Supervisor (CLS) was conducted. The identified consent document was reviewed with the CLS. The CLS stated consents should contain accurate information. The CLS further stated, "This consent (looking at Patient 41's consent form) was not completed accurately, the correct name of the physician performing the procedure should have been written."

A review of the hospital's undated document titled Consent or Informed Consent for Surgery or Special Procedures was conducted. This document indicated, " ...II.G. Informed Consent .... The hospital's role in the informed consent process is to verify that the physician obtained the patient's informed consent before the physician is permitted to perform the procedure ..."

On 4/11/18 at 4 P.M., an interview with the Interim Director of the Cardiopulmonary, Cath lab and Interventional Radiology (DIR) was conducted. The identified consent document was reviewed with the DIR. The DIR acknowledged the identified consent had not been completed in accordance with hospital policy.

Based on interview and record review, the hospital failed to ensure a physician's order was documented in the medical record, verified and followed by registered nurses in the care of surgical drains for one of 56 sampled patients (Patient 45). The lack of documentation of a physician's order could lead to inconsistencies in implementing nursing or medical interventions and monitoring for any potential changes to Patient 45's post-surgical status.

In addition, the hospital failed to ensure a physician's order for tube feeding was carried out for one of * sampled patients (41). Failure to administer Patient 41's tube feeding per nasogastric/oral (NG/OG) tube in a timely manner had the potential for delayed identification of changes in health status and did not ensure all elements to the delivery of care to Patient 41 were performed in an effort to provide continuity of patient care.

Findings:

1. Patient 45 was admitted to the hospital on 4/4/18 with diagnoses that included cardiomyopathy (disease of the heart muscle that makes it harder for your heart to pump blood to the rest of your body) per the History and Physical dated 3/19/18.

On 4/10/18 at 2:45 P.M., a review of Patient 45's records was conducted with the Clinical Nurse Specialist (CNS). These records indicated Patient 45 underwent a Coronary Artery Bypass Graft (CABG - surgery that can create new routes around narrowed and blocked coronary arteries, permitting increased blood flow to deliver oxygen and nutrients to the heart muscle) surgery.

Additional records were reviewed with the CNS on 4/4/18 at 3:15 P.M. A record titled Flowsheet, Surgical Tubes and Drains was reviewed. This record indicated Patient 45 had three surgical drains (Blake drains- special type of silicon, radiopaque drain used for post-open-heart surgery to help patients recover by removing excess fluid around the lungs). This flowsheet indicated inconsistencies in the periods of recording the output from the surgical drains.

On 4/10/18 at 3:30 P.M., an interview with the Registered Nurse (RN) 45 was conducted. RN 45 acknowledged there was no documented evidence of a physician's orders for the care of surgical drains. RN 45 further stated she should have called the physician and verified orders for the care of these surgical drains.

On 4/11/18 at 3:30 P.M., an interview with the Progressive Care Unit Manager (PCUM) was conducted. The PCUM stated it was her expectation for staff to verify physician's order for the care of post-surgical drains and that it should have been documented in the medical record.



2. Resident 41 was admitted to the hospital on 3/23/18 with diagnoses, which included acute severe pancreatitis per the History, and Physical dated 3/23/18.

A review of Patient 41's records was conducted with the Clinical Nurse Specialist (CNS) 41 on 4/10/18 at 8:25 A.M. A physician's order indicated, "Start date and time: 4/4/18 14:52 PDT (Pacific Daylight Time). Tube feeding route Per OG tube. Tube feeding type Vital 1.5 (semi-elemental/ fluid restric. Tube feeding rate 20 ml/ hr (milliliters/hour)."

Additional records were reviewed with CNS 41 on 4/10/18 at 8:50 A.M. A record titled Flowsheet, Nutritional, and Gastric Tube Feeding (Gastrostomy tube Oral ...) was reviewed. This record indicated Patient 41 did not receive any tube feeding via OG tube on 4/4/18 as ordered.

A review of the hospital's document titled Adult Inpatient Standards-IView Bands of Physical Assessment Supports Standards of Patient Care for the Adult Inpatient dated 3/17 was conducted. These standards indicated, " ... Gastrointestinal, Documentation ... "Document initiation of tube feedings... - enter rate and tube feeding type of formula."

On 4/10/18 at 9:40 A.M., an interview with registered nurse (RN) 41 was conducted. RN 41 stated he reviewed the tube feeding orders for Patient 41 on 4/4/18 at 15:29 P.M. RN 41 further stated he did not carry out this order and had spoken to the physician about it. However, there was no documented evidence of a reason why the tube feeding orders was not started and administered as ordered by the physician.

On 4/10/18 at 10:25 A.M., an interview with the Director of the Intensive Care Unit (DICU) was conducted. The DICU stated it was her expectation of the nurses in her unit to carry out orders timely, and if there was a delay or omission, a reason should have been reported and documented.

Based on observation, interview, and document review, the hospital failed to ensure pharmaceutical services were provided to meet the needs of the patients when:

1. The hospital failed to ensure current and accurate records were kept for all controlled drugs to prevent diversion (unauthorized use of controlled drugs), and minimize the time frame between actual loss and detection. See tag A0494.

2. The hospital failed to ensure drugs are controlled and distributed to ensure the safety of the patients. Twenty-eight (28) vials of nalbuphine 10 mg per mL were unaccounted for, and were possibly diverted (unauthorized removal or use) by RN 72 from 12/2017 to 2/2018. See tag A0500.

3. The hospital failed to ensure the quality of sterile compounded products prepared by the pharmacy, as well as those prepared by an outsourced facility. See tag A0501.

4. The hospital failed to ensure policies and procedures to seal the emergency medication cart (Postpartum Hemorrhage cart) were consistent with practice. See tag A0502.

5. The hospital failed to ensure scheduled drugs were locked in the Pharmacy. See tag A0503.

6. The hospital failed to ensure unusable medications were not available for use. See tag A0505.

These failures, together, resulted in the condition of Pharmaceutical Services being NOT MET.

Based on observation, interview, and document review, the hospital failed to ensure current and accurate records were kept for all controlled drugs to prevent diversion (unauthorized use of controlled drugs), and minimize the time frame between actual loss and detection:

1. Seventy-five (75) vials of lorazepam (schedule IV medication to treat anxiety or seizure) 2 mg per mL injection were unaccounted for, over a period of five (5) years, from 4/2013 to 4/2018.

2. A pharmacist, who was an employee, diverted controlled drugs ranging from schedule II to schedule V. This activity was not detected for approximately six months, from 1/2017 to 7/2017. In addition, a complete inventory of controlled drugs was not performed after diversion was detected to determine the full scope of the diversion.

3. A registered nurse (RN), who was an employee, diverted schedule II drugs. This activity was not detected for approximately eight months, from 5/2017 to 1/2018.

In addition, the hospital failed to implement its policy when:

4. The hospital did not report actual loss of controlled drugs to law enforcement (the police).

As a result, the hospital could not ensure all controlled drugs were accounted for, to prevent misuse or abuse.

Findings:

1. The Pharmacy at Hospital A was inspected with the DOP and Pharm 1 on 4/10/18 at 2:15 P.M. Pharm 1 was the Pharmacist-in-Charge (PIC, a pharmacist responsible for ensuring compliance with the California Board of Pharmacy laws and regulations).

Pharm 1 stated he last conducted a physical inventory of controlled medications on 3/26/18, using a one-person system (Pharm 1 counted controlled medications by himself, instead of counting with another pharmacist or authorized pharmacy staff).

The current physical inventory of lorazepam 2 mg per mL was inspected. The actual lorazepam inventory included 750 vials in a plastic tote in the refrigerator, and 54 vials in another locked compartment in the refrigerator. The total was 804 vials.

Hospital A's inventory record (theoretical count) indicated there were 825 vials of "Secured" and 54 vials of "Accessible" stock. The total was 879 vials.

"Secured" stock was considered overstock inventory, and "Accessible" stock was active inventory.

The theoretical count and actual count indicated 75 vials of lorazepam were unaccounted for.

Pharm 1 then stated the monthly physical inventory did not include a count of "Secured" stock.

During a group interview on 4/10/18 at 7:12 P.M., the DOP acknowledged 75 vials of lorazepam were still unaccounted for.

During a group interview on 4/11/18 at 8:15 A.M., the DOP stated the physical inventory at Hospital A's Pharmacy was "done differently," and staff did "...not following procedures..." and "...did not count 'Secured' inventory...." The DOP explained there were three separate incidents, in 4/2013, in 1/2015, and in 7/2015, which resulted in a discrepancy of 75 vials of lorazepam. This occurred under the tenure of three separate PICs, and all of them "...did not understand this [the system used for inventory tracking]...." Ultimately, the discrepancies were the results of inaccurate accounting for controlled drugs over five years.

During the same interview, the DOP acknowledged the hospital did not ensure the PICs were trained and competent to ensure the records for all controlled substances were accurate.

According to the hospital's policy, Investigation and Reporting of Drug Diversion, dated 3/10/18, "A complete inventory of the controlled substances in the automated vault is done quarterly... Two members of the pharmacy staff must count all Controlled Substances...."

2. During an interview on 4/9/18 at 1:55 P.M., the DOP stated he became aware Pharm 2 had diverted controlled drugs in the Pharmacy in 7/2017. The DOP stated Pharm 2 admitted to diverting controlled drugs in the expired medication bin in the Pharmacy vault. This was discovered during the periodic destruction of expired controlled drugs. The DOP explained this was done "periodically" when the expired bin filled up, meaning "every few months." The DOP stated the hospital had changed this practice to "monthly." In addition, the DOP stated Pharm 2 worked at both Pharmacies, at Hospital A and Hospital B.

During a group interview on 4/11/18 at 8:15 A.M., the DOP stated Pharm 2 worked mostly in the evenings by herself at Hospital A's Pharmacy.

A group interview was again conducted on 4/11/18 at 10:20 A.M., including the DOP and Pharm 3 (a PIC at Hospital B). They stated the hospital became aware Pharm 2 was subject to disciplinary proceedings by the California Board of Pharmacy (BoP) on 4/18/17.

According to the public record, available on the BoP's website, Pharm 2's disciplinary action involved a schedule I substance. The Drug Enforcement Agency (DEA) deemed schedule I substance an illegal substance.

The DOP and Pharm 3 stated Pharm 2 continued to work at Hospital A's Pharmacy alone as a pharmacist. In addition, Pharm 2's access to controlled drugs were not restricted after they became aware of Pharm 2's acitvity involving Schedule I substance.

They stated Pharm 2 diverted controlled drugs from both campuses, Hospital A and Hospital B. Pharm 2 started diverting controlled drugs at Hospital A's Pharmacy from 1/2017 to 7/2017, and at Hospital B's Pharmacy from 2/2017 to 7/2017, after the hospital was aware of Pharm 2's activity involving Schedule I substance.

According to the documents provided by the hospital, the controlled drugs diverted included schedules II to V.

In addition, they stated the only measure put in place after the diversion was detected was to change the inventory of the expired medication bin to "monthly." They stated it was effective to detect and prevent diversion.

During an interview on 4/11/18 at 1:55 P.M., the DOP stated after the diversion was detected, a complete inventory of controlled drugs was not performed at Hospital B until 9/20/17, approximately two months after.

According to the hospital's policy, Investigation and Reporting of Drug Diversion, dated 2/17/17, "... to identify persons responsible for monitoring drug diversion and execution of appropriate reporting and disciplinary actions... Report will be printed and reviewed at least every three days to all activities during the previous day(s) which will compare narcotics [controlled drugs] removed from the... narcotic returns and wastes...."

3. During an interview on 3/21/18 at 9:30 A.M., Director of Critical Care (DIR 71) stated she first learned RN 71 was diverting controlled drugs on 1/7/18. DIR 71 stated RN 71 admitted to her she had been diverting fentanyl (a schedule II drug) from approximately 5/2017, by removing the drug from the container and replaced with normal saline (salt solution), then used leftover to administer to her patients. DIR 71 stated RN 71 admitted things "spiraled" the last weeks, and when she did not have assigned patients on fentanyl, she would opened the ADC, using the patient's identification, then would "cancel" the transaction after she had access to the medication. DIR 71 stated RN 71 also used the "override" function in the ADC (to remove medications for life-saving situations, without the pharmacist's approval). In addition, DIR 71 stated RN 71 also admitted to diverting partial doses of hydromorphone (a schedule II drug).

Pharm 3 was also interviewed on 3/21/18 at 9:30 A.M. Pharm 3 stated she sent three fentanyl containers to test, and the result came back on 1/21/18 indicating fentanyl was practically not present in the solution. This indicated three containers of fentanyl were replaced with another solution.

During the interview on 3/21/18 at 9:30 A.M., DIR 71 stated on 1/23/18, she "realized she [RN 71] had diverted more than previously stated."

The DOP was interviewed on 3/21/18 at 9:30 A.M. The DOP stated RN 71 accessed the information of 28 patients who were not assigned to her, and she had five patients assigned to her with fentanyl from 4/2017 to 1/2018. The DOP estimated RN 71 could have potentially tampered with drugs that were eventually administered to 73 patients, and five of her patients.

The DOP, DIR 71, and Pharm 3 were interviewed together on 3/21/18 at 11:04 A.M. They stated the Cancelled Transaction Report from the ADC was reviewed monthly in 2016 and 2017, but it was not "sensitive" enough to detect RN 71's activity.

According to the hospital's policy, Investigation and Reporting of Drug Diversion, dated 2/17/17 and 8/11/17, "... to identify persons responsible for monitoring drug diversion and execution of appropriate reporting and disciplinary actions...Cancelled Transaction Report: This report identifies [ADC] transactions that occur that ultimately are cancelled. This transaction gives access to a medication pocket and may represent an attempt at pilferage. Organizations should monitor these reports to watch for potential pilferage of medications... to audit users for excessive number of cancelled transactions as compared to other similar [ADC] users as well as excessive numbers of the same drug being cancelled...."

The DOP was interviewed on 4/9/18 at 1:55 P.M. The DOP stated a new Cancelled Transaction Report was created after 1/2018, and it only included drugs that could be tampered with such as fentanyl (which was tampered with by RN 71).

The DOP and Pharm 3 were interviewed on 4/9/18 at 3:55 P.M. They stated if the ADC user appeared once on the new monthly Cancelled Transaction Report, then that was OK. They stated they did not track those users over time for patterns.

4a. During an interview on 4/9/18 at 1:55 P.M., the DOP stated he became aware Pharm 2 had diverted controlled drugs in the Pharmacy in 7/2017. The DOP stated Pharm 2 admitted to diverting controlled drugs in the expired medication bin in the Pharmacy vault. This was discovered during the periodic destruction of expired controlled drugs.

A group interview was conducted on 4/11/18 at 10:20 A.M., including the DOP and Pharm 3.

They stated Pharm 2 diverted controlled drugs from both campuses, Hospital A and Hospital B. Pharm 2 started diverting controlled drugs at Hospital A's Pharmacy from 1/2017 to 7/2017, and at Hospital B's Pharmacy from 2/2017 to 7/2017.

According to the documents provided by the hospital, the controlled drugs diverted included schedules II to V.

A joint interview was conducted on 4/11/18 at 3 P.M. with the DOP and Pharm 3. They stated they did not document why Pharm 2's diversion activities were not reported to the police department because they "...did not have a process...."

According to the hospital's policy, Investigation and Reporting of Drug Diversion, dated 2/17/17, "... to identify persons responsible for monitoring drug diversion and execution of appropriate reporting and disciplinary actions... Reporting to... Local Police Department when appropriate after consultation with the investigative team (Pharmacy)."

4b. During an interview validated during a previous complaint investigation, on 3/21/18 at 9:30 A.M., Director of Critical Care (DIR 71) stated she first learned RN 71 was diverting controlled drugs on 1/7/18. DIR 71 stated RN 71 admitted to her she had been diverting fentanyl (a schedule II drug) from approximately 5/2017, by removing the drug from the container and replaced with normal saline (salt solution), then used the leftover to administer to her patients. DIR 71 stated RN 71 admitted things "spiraled" the last weeks, and when she did not have assigned patients on fentanyl, she would opened the ADC then would "cancel" the transaction after she had access to the medication. DIR 71 stated RN 71 also used the "override" function in the ADC (to remove medications for life-saving situations, without the pharmacist's approval). In addition, DIR 71 stated RN 71 admitted to diverting partial doses of hydromorphone (a schedule II drug).

Pharm 3 was also interviewed validated on a previous complaint investigation, on 3/21/18 at 9:30 A.M. Pharm 3 stated she sent three fentanyl containers to test, and the result came back on 1/21/18 indicating fentanyl was practically not present in the solution. This indicated three containers of fentanyl were replaced with another solution.

During the interview on 3/21/18 at 9:30 A.M., DIR 71 stated on 1/23/18, she "realized she [RN 71] had diverted more than previously stated."

A joint interview was conducted on 4/11/18 at 3 P.M. with the DOP and Pharm 3. They stated they discussed and decided to report RN 71 to the police department.

During an interview on 4/12/18 at 11:45 A.M., the DOP stated RN 71's diversion activities were not reported to the police department.

According to the hospital's policy, Investigation and Reporting of Drug Diversion, dated 8/11/17, "... to identify persons responsible for monitoring drug diversion and execution of appropriate reporting and disciplinary actions... Reporting to... Local Police Department when appropriate after consultation with the investigative team...."

Based on interview, and document review, the hospital failed to ensure drugs are controlled and distributed to ensure the safety of the patients. Twenty-eight (28) vials of nalbuphine 10 mg per mL were unaccounted for, and were possibly diverted (unauthorized removal or use) by RN 72 from 12/2017 to 2/2018.

These failures had the potential to affect the safety of the patients if the nurse was under the influence of nalbuphine while providing care to them.

Findings:

A joint interview was conducted on 4/9/18 at 11:30 A.M. with the DOP, Nurse Manager for Labor and Delivery (NM 71), and Director of Women's Services (DIR 72).

RN 72 had been a nurse in L&D since 6/2017. The hospital discovered RN 72 was diverting nalbuphine on 2/23/18.

The hospital determined RN 72 had been accessing the ADC to remove nalbuphine without patient-care purposes (not for administration to patients).

The hospital determined from 12/2017 to 2/2018, RN 72 accessed 128 patient records, and removed 28 vials of nalbuphine.

The hospital was still investigating, and therefore could not determine the scope of the diversion as of 4/9/18.

The Blind Count feature was not on for nalbuphine prior to 2/23/18. Blind Count was a feature of the ADC that required an input of the physical count of the inventory without the user knowing the expected count.

They described the process to proactively detect diversion included monitoring the usage of scheduled drugs only. Therefore, nalbuphine was not monitored.

During a group interview on 4/12/18 at 9:05 A.M. with members of the Quality Assurance and Performance Improvement (QAPI), they stated they exptected all medications should have been accounted for, not just controlled drugs.

According to the hospital's policy, Investigation and Reporting of Drug Diversion, dated 8/11/17, "... to identify persons responsible for monitoring drug diversion and execution of approriate reporting and disciplinary actions... Weekly Auditing...target [schedules] II-V [II to V]... Monthly Auditing... screening tool for [ADC] users that have removed larger than normal quantities of [scheduled] drugs...."

Based on observation, interview, and document review, the hospital failed to ensure the quality of sterile compounded products prepared by the pharmacy, as well as those prepared by an outsourced facility:

1. Out-of-compliance pressure differentials (difference in pressure in different areas to prevent contamination) for the sterile medication compounding area (IV room, where medications were prepared for administration directly into the vein) were not monitored and corrected for approximately 2.5 months.

2. The compounding records for sterile medications prepared by the Pharmacy did not contain the BUD.

3. The extended BUD information from an outsourced facility was not evaluated prior to using the medication.

As a result, the hospital could not ensure sterile compounded products were safe for administration.

Findings:

USP <797> definitions:

Ante-area: a transition area where pressure is maintained so that air flows from clean to dirty area (such as the general pharmacy area).

Buffer area: where the compounding hood (equipment to ensure clean air is maintained) is located, and should be the same or cleaner than the ante-area.

Positive pressure room: a room that has higher pressure than the adjacent space to ensure air flows out of the room.

Negative pressure room: a room that is lower pressure than the adjacent space, and air flows into the room.

1. A tour of the Pharmacy at Hospital B was conducted on 4/9/18 at 10:40 A.M. with the DOP, Pharm 3, and Pharm 4.

The pressure differential monitoring reports for the IV room was requested.

The reports were reviewed with the DOP and Pharm 4 on 4/9/18 at 3:55 P.M. They stated when the pressure monitoring indicated the pressure differentials did not meet specifications or "failed," an email would be sent to the Pharmacy Technician Supervisors (Tech), and they would check the IV room. They stated the Tech did not document the investigation or resolution. The reports for 3/2018 indicated failures in the following areas:

Ante-room: failed 3 times;
Positive pressure buffer room: failed 2 times; and
Negative pressure buffer room: failed 24 times.

They stated these failures were not reported to a pharmacist. They also stated they did not routinely review the pressure differentials.

They also stated the IV room was certified by an outside vendor on 1/22/18. The certification report was requested.

A group interview was conducted on 4/9/18 at 5:25 P.M. with Pharm 3, Pharm 4, Director of Regulatory Affairs (DRA). They stated the person(s) entering the pressure differentials "...had to know it [pressure reading] was out of range..." and should have notified the manager (Pharm 3).

During an interview on 4/10/18 at 11:10 A.M., the DOP and Pharm 4 stated an outside vendor was onsite to address the pressure differential failures in the negative pressure buffer room.

The certification report from 1/22/18 was reviewed with the DOP on 4/12/18 at 1:25 P.M. The report indicated the pressure differentials for the negative pressure buffer room was "OOC" (out of compliance) with the remarks, "...out of compliance. Action should be taken to bring into acceptable range...." The DOP stated he was not aware of the "OOC" until "this week."

According to USP <797>, Pressure Differential Monitoring "... the results shall be reviewed and documented on a log at least every work shift (minimum frequency shall be at least daily)...."

2. During an interview on 4/9/19 at 5:25 P.M. with the Director of Regulatory Affairs (DRA), the compounding records for hazardous drugs for the past 30 days were requested.

These compounding records were reviewed with the DOP on 4/10/18 at 11:10 A.M. The DOP acknowledged the BUD was not documented on the compounding records, and they should have been.

According to the hospital's policy, Pharmacy Sterile Compounding Service, dated 8/14/17, "... To describe the Pharmacy ... Service including the standards and processes for ... preparation, verification, delivery and quality control for IV [medications administered directly to the veins] admixtures... Labeling...Beyond use date [BUD]... Compounding Records... Preparation of All sterile compounded products must be documented on the compounding log...."

3. Medication Room B on 9 East was inspected on 4/9/18 at 9:30 A.M. with Pharm 3 and Pharm 4.

Four syringes of labetalol (medication to treat high blood pressure or heart rate) injection 20 mg per 4 mL were stored inside the Medication Room.

The label indicated it was compounded by Pharmacy C, an outside vendor. The medication was compounded on 1/30/18 and the BUD was 5/30/18 (4 months after the compounding date).

The justification for the 4-month BUD was requested.

During an interview on 4/10/18 at 9:35 A.M. with the DOP and Pharm 4, they stated the BUD was a combination of sterility (microbial growth) and stability (deterioration), and would be the shorter of the two. They stated, USP <797> standards were used to determine sterility.

The Stability Report from Pharmacy C was reviewed with the DOP during an interview on 4/12/18 at 11:45 A.M. The DOP stated USP <71> standards were followed to determine sterility in case the BUD would be extended beyond USP <797> standards. The DOP added, he would expect the vendors (such as Pharmacy C) to follow the same standards. The DOP acknowledged it was unclear if Pharmacy C followed USP <71> to determine sterility for extended BUD. The report from Pharmacy C was dated 4/10/18, after a request was made regarding the justification for the 4-month BUD, and after the medication was stocked for use at the hospital.

The DOP was interviewed on 4/12/18 at 1:25 P.M. The DOP acknowledged the hospital did not have enough information available to support the BUD of 4-month for labetalol from Pharmacy C.

Based on observation, interview, and document review, the hospital failed to ensure policies and procedures to seal the emergency medication cart (Postpartum Hemorrhage cart) were consistent with practice. As a result, the hospital could not ensure medications were consistently sealed for security and availability during a medical emergency.

In addition, the hospital failed to ensure 1 of 56 sampled patient's (25) medications secured on a Registered Nurse's (RN 24) computer, which was observed in a patient care hallway. The lack of attention to the medications, did not ensure the medications were safeguarded in an effort to ensure there was no risk for misplacement or ingestion by someone other than the intended, Patient 25. Nalbuphine (also known as Nubain) is a pain medication with similar properties to morphine (a schedule II, strong pain medication). It is usually used to treat pain in Labor and Delivery (L&D). According to the the manufacturer, its potency to treat pain is equal to morphine on a milligram basis up to 30 mg. Nalbuphine is not a scheduled drug.

Findings:

1. The contents of the Postpartum Hemorrhage cart was inspected on 4/9/18 at 9:53 A.M. with the DOP and Nurse Manager (NM) 71.

The cart was sealed with a red lock with the serial number.

They were unable to determine when the lock was put on to seal the cart, whether the original lock had been replaced, or whether the medications in Drawer 7 were used.

The hospital's policy, Obstetrical Emergency: Postpartum Hemorrhage, dated 12/7/16, was reviewed with the DOP, Pharm 3 and Pharm 4 on 4/9/18 at 3:55 P.M. They acknowledged the policy indicated "tape" should have been used, instead of the red lock. According to the policy, "...add tamper resistant tape to drawer...." They added, the policy did not require the nurse to verify the lock serial number to ensure the medications were not tampered.

The DOP and Pharm 3 were interviewed on 4/11/18 at 4:25 P.M. They acknowledged the process was not clearly defined. They stated the practice was changed nine months ago to use the red lock with a serial number, but did not update the procedures to reflect the current practice.

2. On 4/10/18 at 4:40 P.M., a tour of the Ninth Floor Medical Unit was conducted with the Ninth Floor Nurse Manager (NM) 23. During the tour, a computer which belonged to RN 24 was observed with two unattended containers of Lactulose (medication for liver disease).

On 4/10/18 at 4:45 P.M., an interview was conducted with RN 24. RN 24 stated she was aware the medications were left unattended. In addition, she stated she kept the medications on her computer because the patient (24) previously refused the medication administration and she wanted to have it readily available for another attempt. Furthermore, RN 24 stated she was aware of the hospital's medication administration and storage Policy.

Patient 25's medical record was reviewed on 4/10/18.

Per the History and Physical, dated 4/8/18, the physician's assessment and plan indicated, Patient 25 had orders to receive Lactulose.

The hospital's Policy entitled Medication Storage and Safety, dated 10/1/17, indicated "IV. 2. Medications will be stored under secure conditions away from patient access."

This Policy was not implemented when, patient medications were not safeguarded in an effort to ensure there was no risk for misplacement or ingestion by someone other than the intended patient.

Based on observation, interview, and document review, the hospital failed to ensure scheduled drugs were locked in the Pharmacy.

As a result, the hospital could not prevent unauthorized access and use (diversion).

Findings:

The Pharmacy at Hospital A was inspected with the DOP and Pharm 1 on 4/10/18 at 2:15 P.M.

750 vials of lorazepam (medication to treat seizure and anxiety, a schedule IV medication) 2 mg per mL were in the unlocked refrigerator.

During an interview on 4/10/18 at 7:12 P.M., the DOP acknowledged the medication was not locked.

During an interview on 4/11/18 at 3 P.M., the DOP stated he expected lorazepam to be stored in a locked compartment.

According to the hospital's policy, Controlled Substances, dated 8/11/17, "To establish procedures for the procurement, storage, and administration of controlled substances in the pharmacy... All controlled substances are stored in the Pharmacy in the Controlled Substance Vault or similar locked area...."

Based on observation, interview, and document review, the hospital failed to ensure unusable medications were not available for use:

1. Medications were not labeled with the appropriate BUD;

2. Expired medications were not discarded; and

3. Medications were not stored according to manufacturer's specifications.

As a result, the hospital could not ensure medications were safe for administration to its patients.

Findings:

1a. Medication Room B on 9 East was inspected on 4/9/18 at 9:30 A.M. with Pharm 3 and Pharm 4.

Four units of normal saline (salt solution) 50 mL were outside of the manufacturer's protective overwrap (to prevent evaporation). They did not contain the BUD.

They stated the medication should have been labeled with a 15-day BUD.

1b. Medication Room B on 5 West was inspected with the DOP, Pharm 3 and Pharm 4 on 4/9/18 at 10:20 A.M.

Five units of normal saline (salt solution) 50 mL were labeled with the BUD of "5/23/18."

They stated the medication should have been labeled with a 15-day BUD.

According to the manufacturer's specifications, once removed from the protective overwrap, normal saline would have a BUD of 15 days.

1c. The Pharmacy at Hospital B was inspected with the DOP, Pharm 3 and Pharm 4 on 4/9/18 at 10:40 A.M.

One unit of vancomycin (antibiotic to treat infection) 1 g was in the refrigerator without the BUD.

They stated the medication should have been labeled with the BUD of 30-day once removed from the freezer and stored refrigerated.

According to the manufacturer's specification, vancomycin 1 g should have been labeled with a 30-day BUD once removed from the freezer and stored in the refrigerator.

According to the hospital's policy, Pharmacy Sterile Compounding Service, 9/28/17, "To describe the Pharmacy IV [intravenous, medications administered directly into the vein] Admixture Service including the standards and processes for ordering, prioritization, preparation, verification, delivery and quality control for IV admixtures... Labeling... The following information is required on each label... beyond use date...."

2a. Medication Room A on 4 East was inspected with the DOP, Pharm 3 and Pharm 4 on 4/9/18 at 10:25 A.M.

One unit of normal saline (salt solution) 50 mL had the BUD of 4/8/18.

The DOP acknowledged the medication expired on 4/8/18 (the previous day) and should not have been stored there.

2b. The Pharmacy at Hospital B was inspected with the DOP, Pharm 3 and Pharm 4 on 4/9/18 at 10:40 A.M.

Insulin R (regular insulin, to treat high blood sugar) 500 unit per mL was in the medication refrigerator, and labeled with the BUD of 3/31/18.

They acknowledged the medication expired (approximately 9 days prior) and should not have been stored there.

According to the hospital's policy, Medication Storage and Safety, dated 10/1/17, "All outdated and deteriorated medications from all areas of the hospital will be returned to pharmacy...."

3. Medication Room B on 9 East was inspected on 4/9/18 at 9:30 A.M. with Pharm 3 and Pharm 4.

Four syringes of labetalol (medication to treat high blood pressure or heart rate) injection 20 mg per 4 mL were stored under ambient light.

The storage instruction printed on the medication indicated, "Protect from light."

The DOP and Pharm 3 were interviewed on 4/11/18 at 4:25 P.M. They stated the medication should have been protected from light.

According to the hospital's policy, Medication Storage and Safety, dated 10/1/17, "Medications requiring special conditions for storage to ensure stability will be properly stored in all locations... Light sensitive medications will be protected from light...."

Based on observations, staff interviews and review of hospital documents, the hospital failed to ensure that the person responsible for the day-to- day management of the food and nutrition department in the Downtown campus met the minimum educational requirements for the position.

Findings:

During observations at the Hospital A's kitchen on April 11, 2018 starting at 11:50 am, the interim director of food and nutrition services (IDFN) introduced the interim operations manager (IOM) as the person responsible for the day-to-day operations of the campus. During the inspection, IOM answered all questions related to the operations of the kitchen.
According to interviews with the interim director of food and nutrition services (IDFN) on April 11, 2018 at 2:00 PM, the former director of food and nutrition services at the Downtown Campus recently left the position about a month earlier. IOM, a supervisor from the Escondido Campus was then promoted to the position of operations manager for the Downtown campus. The Downtown campus did not have a full -time registered dietitian responsible for the day-to-day operation of the food and nutrition services.
During a concurrent interview at 2:30 PM with IDFN, the IDFN acknowledged the new manager had not completed any of the educational requirements. IDFN stated IOM was currently enrolled in an online program to meet the requirements of the Certified Dietary Managers Program but had not yet completed the course and the certifying examination.
A review of the department's organizational chart validated the observations and interview. The organizational chart showed the IOM as the operations manager for the campus.

The hospital failed to ensure that the manager at the Downtown Campus met any of the minimum educational requirements.

Based on review of clinical records, staff interviews and review of facility documents and professional association standards of care recommendations, the facility failed to ensure that nutritional care was provided that was in accordance with recognized medical nutritional therapy standards to two sampled patients, (Patients 81 and 82). This deficient practice had the potential to result in inadequate intake of calories and protein necessary for wound healing, medical nutrition therapy, and education.

Findings:

1. Patient 81 was admitted to the hospital with diagnoses including sepsis due to urinary tract infection, multiple pressure ulcers (Stage III and IV), insulin dependent - type 2, spinal bifida with chronic paraplegia, binge alcohol and drug use. Patient 81 is 61 inches tall and weighed 86.4 kilograms (190 pounds (lbs.)

Sepsis is a condition that arises when the body's response to infection causes injury to its own tissues and organs. A urinary tract infection typically occurs when bacteria enters the urinary tract through the urethra and begin to multiply in the bladder. A pressure ulcer is localized injury to the skin and/or underlying tissues, usually over a bony prominence because of pressure, or pressure in combination with shear and/or friction. A Stage III pressure ulcer is a
full thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling. Stage IV is a full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present on some parts of the wound bed, but often include undermining and tunneling. Insulin dependent - type 2 diabetes is a disease in which the body's ability to produce or respond to the hormone insulin is impaired, resulting in abnormal metabolism of carbohydrates and elevated levels of glucose in the blood and urine. Spinal bifida is a birth defect where there is incomplete closing of the backbone and membranes around the spinal cord resulting in paralysis of the lower limbs. Chronic paraplegia is paralysis of the legs and lower body, typically caused by spinal injury or disease. Binge alcohol drinking is defined by the Centers for Disease Control and Prevention (CDC) as "men drinking 5 or more alcoholic drinks within a short period of time or women drinking 4 or more drinks within a short period of time ..." and drug use.

A review of Patient 81's nutritional assessment completed by one of the hospital's registered dietitian (RD 1) showed Patient 81's calculated needs as: 2420 calories (kcal) based on "28 kcal per kilogram body weight per day (kg/BW/day) for paraplegia". The estimated protein needs were also calculated as: 56 - 69 grams (g) based on 1.25 -1.5 g/kg ideal body weight (IBW) per day for Stage 4 PI (pressure injury/ulcer). The calculation used to estimate the caloric and protein needs were not in line with professional nutrition assessment standards.

According to the nutrition and dietetics professional organization, the Academy of Nutrition and Dietetics (AND) Evidenced based Library titled "Spinal Cord Injury (SCI) (2009) Evidenced Based Nutrition Practice Guideline", different calculations are recommended for these conditions than the ones used by RD 1.
For example, the estimation of ideal body weight for persons with spinal cord injury and pressure ulcer, AND suggests the RD use the 30 to 40 calories of body weight per day or Harris- Benedict equation times stress factor of 1.5 for Stage III and IV ulcers. Based on these recommendations, Patient 81's estimated caloric needs should have been 2592 and 3456 calories, using 30 -40 kcals/kg/ body weight) or 3308.4 calories, using the Harris Benedict equation and stress factor of 1.5 and activity factor of 1.2. RD 1's calculation was 888 calories less than what was recommended.
The 28 kcal/kg body weight calculation used by RD 1 is recommended by AND only when a patient with paraplegia does not have pressure ulcers. RD 1 failed to consider the pressure ulcer diagnosis in the calculation.
For the estimation of protein needs, AND recommends the protein needs for persons with Spinal Cord Injury with Pressure Ulcers is "1.5 g to 2.0 of protein for kg body weight per day (Stage III and IV ulcers). Persons with spinal cord injury with pressure ulcers have higher protein needs than persons with pressure ulcer and no pressure ulcers. Evidence suggests that additional protein is needed for optimal healing of pressure ulcers".
Based on AND's recommendation for persons with SCI, Patient 81's estimated protein needs should have been calculated as 129.6 g to 172.8 g of protein per day. This amount is twice the amount calculated by RD1. If there were extenuating circumstance such as decreased kidney function that could cause this amount of protein to be harmful, the RD did not include it in her assessment documentation.
In an interview on April 12, 2018 at 2:30 PM, with the interim Director of Food and Nutrition and RD 1, RD 1 explained that the sources of the assessment used for the calculation were based on the hospital's policy, titled "Assessing Nutritional Requirements in Adults", AND, and ASPEN (American Society for Enteral and Parenteral Nutrition) Nutrition Support Core Curriculum, Third Edition. A review of the ASPEN reference used recommended the use of "1.25 -1.5 g of protein/ kg body weight daily for adults with an existing pressure ulcer who are assessed to be at risk of malnutrition ...". This calculation is based on actual body weight and not ideal body weight, which RD 1 used. This recommendation also did not indicate use with persons who have spinal cord injury. However, if RD 1 had followed this recommendation, the estimated protein need for Patient 81 would have been 108 grams to 129.6 grams of protein and not 56 to 69 grams of protein.
A review of the hospital policy showed no guidelines provided for the protein needs and the resting metabolic rate (RMR) using the Mifflin-St. Jeor equation for patients with SCI-paraplegia. For patients with Stage II - IV pressure ulcer, the recommendation is 1.2 -1.5g IBW and for caloric needs, 1.4 - 1.5 RMR (Mifflin-St. Jeor). The use of actual body weight was designed for underweight and normal weight patients with BMIs of < or =25.
According to the information provided by the hospital, Patient 81 was provided a CCHO (consistent carbohydrate diet, used for persons with diabetes) diet, which should have met his needs because it had 2000 to 2400 calories and about 75 to 90 grams of protein. Patient 81 was also provided one hard-boiled egg (7 grams of protein) in between meals. The total amount of protein would be between 96 grams and 111 grams per day. This diet amount may or may not meet his needs.
The danger with the calculation used by RD1 is that the CCHO diet is based on the patient consuming 100% of his meals consistently. If the patient does not consume 100% of the meals served, the RD will not be concerned because the assessment was based on a low, incorrect estimation of protein needs. This could result in a delay in wound healing.
In addition, AND's Practice guidelines on SCI recommend that the RD assess anthropometric, nutrition and lifestyle factors .... and smoking history for persons with SCI. Evidence suggests that the risk of developing pressure ulcers is reduced in individuals who maintain a normal weight, consume adequate amounts of nutrients and do not have a history of smoking or alcohol abuse. Review of RD 1's nutrition assessment notes did not include any documentation of any of the lifestyle factors that affect and may continue to affect the nutrition and health status of Patient 81.

2. Patient 82 was admitted with diagnoses including stroke, Stage II pressure ulcer on coccyx (tail bone area) and stage I on ankle. Patient 82 weighed 58.9 kilograms (kg) or 129.5 lbs.
Nursing assessment described the pressure ulcer on the coccyx as 4 x 0.1 x 4 cm, non-blanchable (when a patient's skin does not loses redness with pressure) redness. There was an order in the electronic medical record for a nutrition consult for wound related to the presence of a pressure ulcer on April 7, 2018 at 12 noon.
On April 7, 2018 at 2:14 PM, the registered dietitian (RD 2) completed a nutrition assessment and documentation in the electronic medical record indicated that consult related to the wound had been completed on 4/9/18. Review of the completed nutrition assessment notes, did not include an assessment of the nutritional needs related to the presence of a pressure ulcer. The estimated caloric needs for Patient 82 was 1482 to 1770 calories; this was based on 25 - 30 kcal/kg current weight. The estimated protein needs were 71 grams based on a 1.2 g/ kg current weight calculation, and fluids per MD.
RD 2's calculation was not in line with the hospital's policy titled "Assessing Nutritional Requirements in Adults" which directs the RD on how to calculate caloric and protein needs in the presence of Stage II pressure ulcer. According to this document, caloric needs should have been estimated as 30 - 35 kcals/ kg/daily weight (not 25 - 30 kcal/kg).
In an interview conducted on April 10, 2018 at 11:52 AM with RD 2 in the presence of the IDFN, RD 2 indicated that she had not been aware of the presence of pressure ulcers and the nutrition consult for wound. RD 2 re-calculated the nutritional needs of Patient 82. The reassessed need increased to 1767 -2062 calories, a difference of 285 - 292 calories. This difference in calories could result in approximately ½ lb. of weight loss in a week. RD 2 re-calculated Patient 82's protein need as 74 - 88 grams of protein, a difference of 3 grams to 17 grams. 17 grams is equivalent to 2.4 ounces of protein. These errors in calculation could result in delayed wound healing.

Based on observation, interview and document review, the facility failed to maintain a system for controlling sources of infections in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and regulations, when:

1. Employees in restricted areas did not follow facility policy or nationally recognized infection control standards for surgical attire.
2. Surgical instruments, ready for use in surgery, did not meet national infection control standards.
3. An employee health record did not contain evidence of influenza vaccine.
4. the facility failed to ensure prompt placement of isolation precautions for 1 of 56 sampled patients (51) with suspected meningitis (inflammation in the brain which could be caused by a bacterial or viral infection). In addition, the facility failed to ensure visitors followed posted isolation precautions for 1 of 56 sampled patients (51), with suspected meningitis.
5. Ensure safe and sanitary practices for handling food and water when:
a. Food temperatures were not adequately monitored for items stored in a warmer and on the steamtable.
b. The ice machine contained metallic, dark grayish sediments inside the water trough that drained into the main ice bin. These failures had the potential to cause widespread foodborne illness in patients, staff and visitors who consume food from the hospitals' Food and Nutrition Department.

As a result, there was potential for cross-contamination to other patients and visitors.

Findings:

1. On April 9, 2018 at 9:30 a.m., in Operating Room 7, MD 1 was observed to be holding a mask over his face and to have hair protruding from under the surgical cap covering the nape of his neck while conversing with the anesthesiologist. OR Tech 1 was observed to be wearing only a surgical mask and no appropriate beard cover for his facial hair. OR tech 2 was observed to be wearing a surgical cap with a bouffant head cover not being utilized appropriately, covering hair at the back of her head, with visible hair protruding below the cap and the bouffant on the nape of the neck. This was validated with IP and OR Mgr.

On April 9, 2018 at 9:30 a.m., OR Mgr and IP stated that the facility adopted AORN (Association of peri-Operative Nurses) Guidelines for Perioperative Practice as one of the nationally recognized guidelines for their infection control program.
According to facility policy entitled Standards for Surgery Attire dated April 11, 2017: Proper attire in the restricted areas (surgical suites) includes: Cloth caps may be worn if covered by a disposable cap when in the ...restricted areas. Caps must cover all hair. Disposable beard covers must be worn by individuals with facial hair.

According to AORN Guidelines for Perioperative Practice (2018), Guideline for Surgical Attire: The surgical mask should cover the mouth and nose and be secured in a manner that prevents venting at the sides of the mask; Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair. A clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn.

2. On April 9, 2018 at 10:45 a.m. during a tour of the sterile supply department, a minor instrument tray (tray of surgical instruments used for surgery) was opened and inspected in the presence of SPD Sup and IP. Of a total of 66 instruments, 10 were observed to have old tape in place that was dry and brittle; 1 instrument had engraving; 1 hinged instrument was difficult to open.

On April 9, 2018 at 9:30 a.m., OR Mgr and IP stated that the facility adopted AORN (Association of peri-Operative Nurses) Guidelines for Perioperative Practice as one of the nationally recognized guidelines for their infection control program.

According to AORN Guidelines for Perioperative Practice (2018), Guideline for Cleaning and Care of Surgical Instruments: Items that are not clean or do not function correctly can put a patient at risk for SSI or injury. Inspection and evaluation provide an opportunity to identify soiled or damaged instruments and to remove these items from service until they are cleaned or repaired. Items should be inspected and evaluated for cleanliness; correct alignment; corrosion, pitting, burrs, nicks, cracks; wear and chipping of inserts and plated surfaces; missing parts; correct functioning; and other defects.

3. On April 10, 2018 at 3:00 p.m. during a review of 5 employee health files (OR Tech 1, OR Tech 2, Endo Tech, SPD Tech, EVS Tech) with Ee Health Mgr, one file (OR Tech 1) out of five reviewed did not have evidence of current immunization vaccination or declination for the influenza vaccine. This was validated by Ee Health Mgr.

According to the facility policy entitled Vaccines for Healthcare Personnel, dated September 13, 2017: Assess vaccination candidate health condition ...educate candidate regarding occupational risk for the disease and disease information, based on history recommend vaccination, screen for possible contraindication and precautions to vaccines, obtain content and provide a current Vaccine Information Statement. Obtain signed declination if vaccines are refused.


29707


4a. Patient 51 was admitted to the facility on 4/7/18, per the face sheet.

According to an Emergency Physician Documentation note, dated 4/7/18 at 7:24 P.M., Patient 51 presented to the emergency room with complaint of a headache for 2 days. was light and noise sensitive and had nausea and vomiting. Patient 51's physician documented in the note that the patient had signs and symptoms consistent with meningitis.

According to another physician's Emergency Physician Documentation note, dated 4/7/18 at 7:49 P.M., the physician agreed with the above mentioned physician's assessment of meningitis.

There was no documentation in Patient 51's medical record that isolation precautions were implemented in the emergency room.

Patient 51's medical record reflected a facility LN documented isolation precautions were placed at midnight on 4/8/18, over 4 hours after the physician documented the patient had symptoms of meningitis.

The facility DQPSIPR stated on 4/12/18 at 8:20 A.M., it was the facility's expectation that when meningitis was suspected the staff should immediately place a mask on the patient and the patient should be placed on droplet precautions (safety precautions against organisms that could be generated during coughing, sneezing, talking or performing procedures). The DQPSIPR stated, once a patient was placed in a room, the patient could remove the mask, but anyone entering the room must wear the proper protective equipment, which included a mask. The DQPSIPR also said the staff in the emergency room were supposed to document in a patient's medical record when isolation precautions were placed.

According to the facility policy, entitled, Transmission-Based Precautions, effective 3/13/18, "Droplet Precautions: In addition to Standard Precautions use Droplet Precautions for patients known or suspected to be infected with...meningitis ..."

4b. Patient 51 was admitted to the facility on 4/7/18, per the face sheet.

According to an Emergency Physician Documentation note, dated 4/7/18 at 7:24 P.M., Patient 51 presented to the emergency room with complaint of a headache for 2 days and was light and noise sensitive and had nausea and vomiting. Patient 51's physician documented in the note that the patient had signs and symptoms consistent with meningitis.

According to another physician's Emergency Physician Documentation note, dated 4/7/18 at 7:49 P.M., the physician agreed with the above mentioned physician's assessment of meningitis.

On 4/9/18 at 2:20 P.M., a tour of the 7th floor West was conducted with CNS 51 & CNS 52. Located on the outside of the door to the room was a sign that read, "STOP VISITORS SPEAK WITH THE NURSE BEFORE ENTERING ROOM." In addition, per the sign, "To prevent the spread of infection, ANYONE ENTERING THIS ROOM MUST: ...WEAR A SURGICAL MASK." While standing outside the room, a female peered from around the curtain inside the room and was not wearing a surgical mask. Upon entering the room, there was the same female and a male visitor inside the room and neither was wearing a mask. When asked about wearing a mask, both stated they were never informed or instructed by the staff to wear a mask when entering the room.

On 4/9/18 at 2:22 P.M., Patient 51's medical record was reviewed with CNS 51 and 52, as well as with NM 51. There was no documentation in the patients' medical record to show visitors were educated about wearing a mask upon entering the room. NM 51 stated the LNs were supposed to re-educate visitors, if found not wearing the PPE. NM 51 also said the LNs were supposed to document the education was provided and document if visitors refused to wear the PPE.

According to the facility policy, entitled, Transmission-Based Precautions, effective 3/13/18, "Droplet Precautions: In addition to Standard Precautions use Droplet Precautions for patients known or suspected to be infected with ...meningitis ..." The policy did not address visitors in regards to transmission precautions.


10933

5a. On 4/10/18 starting at 4:36 P.M., an observation of the Hospital B's cafe kitchen and interview with the lead Cook, CK1, was conducted. CK1 and a surveyor using separate thermometers took the temperatures of several food items on the steamtable, including chicken breasts, pasta noodles, yellow squash, and rice. After CK1's thermometer read 157 degrees Fahrenheit (?F) for the chicken breasts and the Surveyor's thermometer was 148 ?F, CK1 calibrated his thermometer.

After CK 1 was calibrated his thermometer, the temperature of the pasta noodle inside the food warmer was taken. The pasta noodles were 125-126?F on both CK1's and the surveyor's thermometers. CK1 confirmed the 125-126?F temperature on his thermometer. The inside temperature of the warmer was then taken after the food items were removed and the temperatures averaged 126?F on both thermometers. CK 1 explained that items are prepared and stored in the warmer; as these items are needed for replenishment; new items are moved to the steam table from the warmer.

CK 1 indicated that he was unsure when the cooked items were placed in the food warmer because the cook who worked before him had prepared the items and had left for the day. The time the items were placed in the warmer is of significance because to prevent the growth of bacteria that could cause food borne illness, food cannot be stored in the food danger zone for more than four hours. The food danger zone is any temperature between 41 and 135 degrees F. The temperature of the pasta noodles was 125 ?F , which was in the food danger zone.

In a concurrent observation, CK 1 was interviewed on how items from the warmer that was reading 126 ?F could read 148 degrees Fahrenheit on the steamtable. CK 1 stated a new batch of pasta noodles that had a temperature of 140?F, was brought to the steamtable at 4:00 P.M, approximately 30 minutes earlier. CK1 explained that as patrons in the café serve food from the steamtable, batches of food (pans) are replaced throughout the day and during any meal. The expectation of temperature monitoring would include several food temperatures to correspond with each of the items placed on the steamtable.

A review of the food temperature log titled "Café Production Hot Holding Temperature Log", showed only two food temperatures recorded for each entrée offered at each meal. For example, for breakfast, the column for temperature recording has two times: 6:30 AM and 8:30 AM. Lunch has two times: 11:30 AM and 12:30 PM, and dinner had only one time: 5:00 PM.

CK 1 was then asked what the correct holding temperature should be for the entrée meals and foods placed on the steamtable, and he said "140?F." CK 1 was unable to validate the food placed on the steamtable from the warmer had reached the proper safe temperature because there was no documentation of temperature or time monitoring of the food transition from cooking equipment to warmer to steamtable.
A review of the food temperature log titled "Café Production Hot Holding Temperature Log", log did not include the pasta noodles that CK 1 indicated he had placed in the warmer at 4:00 PM. CK 1 stated that he checked the temperature of the food prior to placing it on the steamtable but the temperature was not recorded anywhere.
The 2017 US Food Code, Section 3-501.19 states " (A) if time without temperature control is used as the public health control for a working supply of TIME/TEMPERATURE CONTROL FOR SAFETY FOOD ..., up to a maximum of 4 hours (can lapse under the following conditions) :
(1) The FOOD shall have an initial temperature of 5ºC (41ºF) or less when removed from cold holding temperature control, or 57°C (135°F) or greater when removed from hot holding temperature control; (2) The FOOD shall be marked or otherwise identified to indicate the time that is 4 hours past the point in time when the FOOD is removed from temperature control ..."

Further review of the food temperature log for the month of April (1- 10) 2018 indicated that food temperatures were recorded only twice per meal for all the entrees that are served in the café. There was an average of three hot entrees served each meal. The log had columns for two Entrées, a starch, vegetable, Pasta, Sauce, Soup 1 and Soup 2. A retrospective review of the log would not indicate what items were served and whether more than one pan of the entrée was prepared or whether proper temperatures were maintained throughout service. The food temperature logs did not truly reflect the practices of the operations or help identify if there were any temperature or equipment concerns.
The form the hospital used is designed for a system where temperature is used to ensure food safety; where a large batch of food is prepared and checked once or twice to ensure that safe food temperatures were maintained during hot holding. Temperature monitoring (i.e. record temperatures of ? 135 ?F) will occur every 2-4 hours.
On April 11, 2018 at 11:50 AM, a review document titled " Facility Work Order #29212 document dated 4/11/18, from an outside vendor stated " ...3rd floor warmer ...found thermometer needing calibration + thermostat is intermittent ...Need to order."
The failure to consistently monitor and document each item taken from the warmer to the steam table prevented the identification of the temperatures within the warmer, which was not holding food temperatures adequately. Maintaining a system that does not provide proper tracking of hot food holding temperatures puts patients, guests, and staff at risk.

5b. On 4/11/18 at 2:00 P.M., during a kitchen walk through in Hospital A, an observation of the ice machine and interview with the Interim Director of Food and Nutrition (IDFN) and Interim Operations Manager (I0M) was conducted. The IDFN stated the ice machine cleaning included wiping the exterior, and inside the ice bin area. The IOM stated the facilities department was responsible for cleaning the ice machine and conducted cleanings "on a regular basis".

The Lead Plant Operator (LPO) in the presence of the Facilities Operations Manager (FOM), opened the ice machine for inspection. After the inside cover of the ice machine was removed, a large silver metallic colored screw was found in the water trough drainage bin. The FOM and LPO confirmed the presence of the black, metallic colored residue sediments inside the water trough. The FOM acknowledged the ice machine may not have been cleaned according to manufacturer's guidelines because of the screw sediments observed in the water trough bin.
A review of facility document dated 3/8/16, titled "Ice-O-Matic ICE Series Cleaning and Sanitizing" states "...9. Remove the splash curtain and inspect the evaporator and water spillway to verify that all mineral residue has been removed. ...remove any remaining mineral residue from the evaporator, spillway and other water transport surfaces with a clean soft cloth."
A review of the 2017 U.S. Federal Food Code states " ...equipment such as ice bins and enclosed components of equipment such as ice makers, should be cleaned at a frequency specified by the manufacturer, or at a frequency necessary to reduce the accumulation of soil or mold."
Patients, staff, and guests who consume ice from this ice machine would be at risk of exposure to contaminated ice that contained dark gray, metallic sediments.

Based on interview, record, and document review, Hospital B failed to ensure an Initial Case Management Assessment was documented in the medical record in accordance with the hospital's Policy for 1 of 56 sampled patient's (23). The lack of documented evidence, did not ensure initiation of the patient's discharge needs were assessed and communicated amongst health care professionals and providers at the time of the patient's admission.

Findings:

Patient 23's medical record was reviewed on 4/11/18.

Patient 23 was admitted to Hospital B on 4/5/18 per the Facesheet.

A History and Physical, dated 4/5/18, indicated Patient 23 verified the Durable Power of Attorney (DPOA-appointed decision maker)

A Case Management Note, indicated the Initial Case Management Note was documented as performed on 4/8/18. In addition, information obtained in the note was not obtained from the patient's DPOA.

On 4/12/18 at 12:00 P.M., an interview was conducted with a Case Manager (CM) 25. During the interview, CM 25 stated Initial Case Management Notes were performed and documented in the patient's medical record within 24 hours of admission. In addition, CM 25 stated the hospital expected the Initial Case Management Notes were implemented in accordance with the hospital's Policy.

The hospital's Policy entitled Discharge Planning and Instructions, Documentation of, dated 2/20/14, indicated "III. Initial assessments begins with the History and Admission Assessment..."

This Policy was not implemented when an Initial Case Management Note was documented three days after the patient's admission to the hospital.