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Based on observation, facility document review, medical record (MR) review, and staff interviews, it was determined the facility failed to ensure pharmacy services are provided in a safe manner. This failure resulted in an Immediate Jeopardy, posing a serious risk of harm to patients.

Findings include:

The facility failed to ensure that policies and procedures that address the accountability for, and control of, Controlled Dangerous Substances (CDS), are developed and implemented. 1) The facility did not have a process in place to limit staff access to CDS stored in the Pyxis; 2) the facility did not ensure that CDS were wasted in accordance with facility policy; 3) the facility failed to identify CDS diversion by failing to utilize their CDS monitoring tools.

A nurse accessed multiple Pyxis consoles and removed approximately 304 vials of Fentanyl (a CDS), during nine working shifts, between 1/22/2024 and 2/14/2024.

On 2/28/2024 at 2:17 PM an Immediate Jeopardy (IJ) was identified. The facility was made aware of the IJ, a copy of the IJ template was provided to the facility at 3:15 PM, and an immediate removal plan was requested.

On 2/29/2024 at 10:48 AM, an acceptable removal plan was received. The facility implemented the following: development of a new policy and procedure that addressed Controlled Dangerous Substance Monitoring and Audit process and Tracking Tool, and staff re-education. On 2/29/2024, during an onsite visit, the surveyors verified the implementation of the removal plan through staff interviews and review of facility documents, which included staff education.

On 2/29/2024 at 12:43 AM, it was determined the facility implemented the IJ removal plan.

Cross Reference:

482.25(b) Pharmaceutical Services: Delivery of Services

The facility failed to ensure the implementation of policies and procedures that address the monitoring of, and accountability for, CDS. (Cross refer to Tag A-500)

The facility failed to ensure the development and implementation of policies and procedures that address the limitation of staff access to the Pyxis, an automated dispensing cabinet, and the CDS stored inside. (Cross refer to Tag A-500)

The facility failed to ensure the implementation of policies and procedures that address the wasting of CDS. (Cross refer to Tag A-500)

The facility failed to ensure the development and implementation of policies and procedures that address the maintenance of the patient list in the Pyxis, and the accessibility of medications, including CDS, stored inside. (Cross refer to Tag A-500)

The facility failed to ensure implementation of policies and procedures that address the reporting of CDS loss or diversion to the required agencies. (Cross refer to Tag A-509)

Based on medical record review, facility document review, and staff interviews, it was determined the facility failed to ensure 1) the implementation of policies and procedures that address the monitoring of, and accountability for, Controlled Dangerous Substances (CDS); 2) the development and implementation of policies and procedures that address the limitation of staff access to the Pyxis, an automated dispensing cabinet, and the CDS stored inside; 3) the implementation of policies and procedures that address the wasting of CDS; and 4) the development and implementation of policies and procedures that address the maintenance of the patient list in the Pyxis, and the accessibility of medications, including CDS, stored inside.

Findings include:

1. On 2/27/2024 at 12:35 PM, an interview with Staff #5 (S5), the Director of Pharmacy, was conducted. When interviewed regarding the processes the facility follows to ensure the accountability of CDS, S5 stated the pharmacy staff did not have access to the corporate drug diversion software, Med Assist, however pharmacy staff performed randomized audits to ensure the accountability of CDS inventory and usage in patient care areas. During an interview on 2/28/2024 at 9:45 AM, S5 stated that S25, a pharmacy staff member no longer working in the facility, was in charge of monitoring CDS reports daily. S5 stated that since S25 left, they reviewed CDS accountability reports for the processes completed within the pharmacy department, such as monitoring the narcotic safe transactions. When questioned regarding the monitoring of CDS usage in patient care areas, S5 stated he/she monitored CDS overridable drug reports from patient care areas "randomly." S5 identified S16, the Information Technology (IT) Pharmacist, as the other staff member responsible for monitoring CDS reports. Policies and procedures that address the monitoring of CDS usage, including but not limited to, distribution, administration, and disposal (waste) in all areas of the hospital, were requested at this time.

On 02/28/2024 at 9:50 AM, the CDS monitoring, and audit documentation were requested.

On 02/28/2024 at 10:45 AM, S5 stated that while the pharmacy staff completed CDS usage monitoring, the facility did not maintain documentation of the CDS monitoring. The facility failed to provide evidence that the pharmacy staff were monitoring the CDS distribution, administration, and waste, in the facility.

On 02/28/2024 at 1:28 PM, S16, the Information Technology (IT) Pharmacist, was introduced by S5 as a staff member who was responsible for monitoring some of the CDS accountability reports. During an interview on 2/28/24 at 1:55 PM, S16 stated that while CDS reports should be monitored on a routine basis, he/she had not completed report monitoring in January or February of 2024. S16 also confirmed that the pharmacy staff did not have documentation to ensure that monitoring of CDS usage in the facility was completed on a routine basis.

On 02/28/2024 at 10:55 AM, S5 stated the facility did not have a current updated policy that outlined the process used to monitor the CDS usage in patient care areas, to ensure accountability. S5 provided a policy titled "Pyxis (Automated Dispensing Machine/ ADM) Controlled Substance Minimum Monitoring Standards," dated 6/15. S5 confirmed the facility followed the CDS monitoring found in this archived policy, however S5 could not provide documentation that the monitoring required in this policy was completed.

Further review of facility documents revealed the facility policy provided on 02/27/2024 at 10:15 AM, titled, "Controlled Dangerous Substance Management Procedure," dated 02/08/2024 states, "... Monitoring ... When possible, diversion detection software will be used to monitor user's CDS practice trends. If unable to utilize diversion detection software, the Department of Pharmacy will renew the controlled substance use on patients. The audit will be performed on a minimum of 10 patient charts/anesthesia records. The audit will compare the medication order with the record of administration (MAR, Anesthesia Record, and the controlled substance accountability report..." S5 was not aware of the content of this policy, when interviewed on 02/28/2024 at 10:55 AM.

During an interview on 02/27/2024 at 12:35 PM, Staff (S) S5, the Director of Pharmacy, stated she/he received an email from Staff #3, the Chief Nursing Office on 02/15/2024 that requested corporate security personnel generate a Pyxis CDS usage report for S24, a Registered Nurse (RN), using the corporate drug diversion software, as RNs working in the Interventional Radiology (IR) Unit brought up concerns to S9, the Director of Nursing for the IR unit, regarding S24's behavior.

On 02/28/2024, review of the facility's investigation, including the DEA (Drug Enforcement Administration) Form-106 and the Pyxis Reconciliation Report for S24, identified that S24, removed approximately 304 vials of Fentanyl 100 micrograms (mcg)/ 2 milliliters (ml) from the Pyxis consoles over the course of 9 working shifts, between 01/22/2024 to 02/14/2024. This discovery was identified by nurses who reported suspicious behavior, and was not identified by the routine audit of CDS usage. The facility failed to ensure the accountability of CDS.

On 02/28/2024 at 9:50 AM, S5 provided overridable drug list that applied to all Pyxis consoles in the facility which indicated Fentanyl was an overridable drug in all procedural areas including the Emergency Department (ED), Cardiac Catheterization Lab, Labor and Delivery Unit, Operating Room, and Interventional Radiology (IR). S5 stated that Pyxis consoles located in procedural areas, are not profiled by the pharmacy department, and all medications stored inside the Pyxis, could be removed with an override.

Review of Pyxis reports, dated 01/22/2024 to 02/14/2024, indicated the 304 vials of Fentanyl removed from the Pyxis by S24, were removed from consoles located in procedural or non-profiled areas, including the Interventional Radiology Unit and the Trauma Unit.

During an interview on 02/28/2024 at 1:25PM, when interviewed regarding how CDS administration and waste was monitored in the procedural areas, S5 stated there was no routine audit of CDS usage completed in the procedural areas. This is not in accordance with facility policy.

The facility policy titled, "Controlled Dangerous Substance Management Procedure," dated 02/08/2024 states, "... CDS overrides are audited routinely by a Registered Pharmacist providing coverage to the area. Upon identification of an override without a corresponding order, in the EMR [Electronic Medical Record], the Nurse Manager of the unit and Pharmacy Administration, will be notified, and the occurrence(s) will be investigated..."

On 02/28/2024 at 12:10 PM, six of eleven medical records (MR) reviewed, MR1, MR3, MR4, MR8, MR9 and MR10, in the presence of S18, the Clinical Informatics Site Manager, and S4, Assistant Vice President, lacked documentation of a physician's order for Fentanyl. Review of the corresponding Pyxis User Reports, dated 1/22/24 to 2/14/24, indicated Fentanyl was removed from the Pyxis console for P1, P3, P4, P8, P9, and P10, by S24. The following was identified:

Review of Pyxis medication removal reports for P1, dated 02/14/2024, indicate 4 vials of Fentanyl (a Controlled Dangerous Substance) 400 mcg (micrograms) was dispensed from the Pyxis located in the Trauma unit, at 17:06 [5:06 PM], by S24. MR1 lacked a physician order for Fentanyl on 02/14/2024.

Review of Pyxis medication removal reports for P3, dated 02/12/2024, indicate 2 vials of Fentanyl (a CDS) 200 mcg, was dispensed from the Pyxis located in the Trauma unit at 8:38 AM, by S24. MR3 lacked a physician order for Fentanyl on 02/12/2024.

Review of Pyxis medication removal reports for P4, dated 02/09/2024, indicate 2 vials of Fentanyl (a CDS) 200 mcg, was dispensed from the Pyxis located in the Trauma unit at 7:11 AM, by S24. MR4 lacked a physician order for Fentanyl on 02/09/2024.

Review of Pyxis medication removal reports for P8, dated 02/01/2024, indicate 2 vials of Fentanyl (a CDS) 200 mcg, was dispensed from the Pyxis located in the Trauma unit at 9:37 AM, by S24. MR8 lacked a physician order for Fentanyl on 02/01/2024.

Review of Pyxis medication removal reports for P9, dated 01/30/2024, indicate 2 vials of Fentanyl (a CDS) 200 mcg, was dispensed from the Pyxis located in the Trauma unit at 10:04 AM, by S24. MR9 lacked a physician order for Fentanyl on 01/30/2024.

Review of Pyxis medication removal reports for P10, dated 01/29/2024, indicate 2 vials of Fentanyl (a CDS) 200 mcg, was dispensed from the Pyxis located in the Interventional Radiology unit at 10:13 AM, by S24. MR10 lacked a physician order for Fentanyl on 01/29/2024.

These findings were confirmed by S4 and S18 on 2/28/24 at 1:20PM.

The CDS audit required by facility policy, was not completed. This discrepancy was not identified by the facility.

The facility policy titled, "Pyxis (Automated Dispensing Machine/ADM) Controlled Substance Minimum Monitoring Standards" dated 06/2015 states, "...Pyxis Console Overrides Review entire house for one 24-hour period twice per month..."

2. During a tour of the Trauma unit on 02/27/2024 at 10:30 AM, Staff #7 (S7), the Nurse Educator, stated staff nurses have access to all Pyxis consoles in each unit.

On 02/27/2024 at 11:10 AM, during an interview with S10, the Patient Care Coordinator, he/she stated that registered nurses (RNs) have access to all Pyxis consoles in the facility.

During an interview on 02/27/2024 at 12:35 PM, with Staff #5 (S5), the Director of Pharmacy, the facility's policies and procedures addressing the limitation of staff access to the Pyxis and Pyxis Console Access Reports for three RNs, were requested. A review of Pyxis Console Access Reports for S25, S26, and S27 indicated the three RNs could access the Pyxis, and the CDS stored inside, in 29 areas. S5 confirmed that all RNs could access any Pyxis console located in the facility. S5 stated the facility did not have policies and procedures that addressed the limitation of staff access to the Pyxis consoles, and the CDS stored inside, as required by State regulations.

On 02/28/2024 at 1:50 PM, S5 and S16, the IT Pharmacist, confirmed this finding.

Reference: N.J.A.C. 13:39-10.3 (c) (2) New Jersey State Board of Pharmacy Regulations state, "... The pharmacist-in-charge shall be responsible for the following: ... 2) Ensuring that there are written policies and procedures, which are reviewed and approved by the pharmacist-in-charge for system operation, safety, security, accuracy, and access, patient confidentiality and prevention of unauthorized access and malfunction, and ensuring compliance with such policies and procedures; ...5) Assigning, discontinuing or changing personnel access to the automated medication system; ..."

3. During an interview on 02/27/2024 at 10:40 AM S7, a RN Nurse Educator, stated that when a CDS needs to be wasted, a second RN is required to witness the waste of the partial dose or full unused doses of CDS, and the waste documentation should be completed immediately after the medication is removed from the Pyxis.

On 02/28/2024, the Pyxis "Dispense to Reconciliation Report," dated 01/22/2024 to 02/14/2024 for S24, a RN, was reviewed. The report indicated that 72 of 135 incidences of Fentanyl, a Schedule II CDS, wasting were completed more than one hour after the medication was removed from the Pyxis console. The late wasting of the Fentanyl occurred from 1.04 hours up to 9.41 hours after removal of the medication from the Pyxis console. This is not in accordance with facility policy.

The facility policy titled," Pyxis ES Medication Storage and Distribution System" dated 05/01/2022, states, "... Wasting medications 1. The waste function shall be utilized for both partial and full unused doses of CDS...2. Immediately upon determination that a CDS will not be administered, the item shall be wasted..."

This finding was confirmed by S1 and S5 on 02/28/2024 at 3:15 PM.

4. On 02/27/2024 at 10:40 AM, a tour of the Trauma Unit was conducted with S1, the Vice President of Quality, Safety, and Regulatory, S3, the Chief Nursing Officer, S4, the Assistant Vice President, S6, the Director of Nursing-Emergency Department, and S7, a RN Nurse Educator. S7 stated that the Trauma Unit has 2 Pyxis consoles on each side and staff nurses have access to all Pyxis in each unit. S7 stated that the patient list available in each Pyxis console was the complete patient list for the hospital, and to remove medication from the Pyxis, a nurse would select the patient's name from the list, then select the medication for removal.

On 02/28/24 at 11:00 AM, S5 stated the patient lists available in the Pyxis consoles included the entire patient census. S5 stated that a patient's profile could be accessed from any Pyxis console.

During an interview on 02/28/2024 at 1:30 PM, when interviewed regarding the management of the patient list available in the Pyxis console, S5 stated he/she thought that patient names were removed from the console after discharge, however he/she was not aware of the length of time the names, and their corresponding profiles, were available after discharge.

The facility policy and procedure for the maintenance of the Pyxis patient list was requested from S5 on 02/28/2024. On 02/28/2024 at 1:40 PM, S5 confirmed the facility did not have a policy that addressed the maintenance of the Pyxis patient list, as required by the State regulation below.

Reference: N.J.A.C. 13:39-10.3 (c) (2) New Jersey State Board of Pharmacy Regulations state, " ... The pharmacist-in charge shall be responsible for the following: ... Ensuring that there are written policies and procedures, which are reviewed and approved by the pharmacist-in-charge for system operation, safety, security, accuracy, and access, patient confidentiality and prevention of unauthorized access and malfunction, and ensuring compliance with such policies and procedures ..."

Based on review of facility documents and staff interviews, it was determined the facility failed to ensure implementation of policies and procedures that address the reporting of Controlled Dangerous Substances (CDS) loss or diversion to the required agencies.

Findings include:

On 02/27/2024 at 9:45 AM, during an interview, S1, the Vice President of Quality, Safety, and Regulatory, confirmed the facility identified and reported an incidence of potential drug diversion. The facility's policies and procedures that address drug diversion reporting and the facility's investigation documentation were requested at that time.

Review of facility documents on 02/27/2024 identified that the facility failed to report the incidence of CDS theft or loss, discovered on 02/15/2024, to the New Jersey (NJ) Board of Pharmacy and NJ Drug Control Unit as required by facility policy referenced below. The facility reported the event to these agencies on the day of survey, 02/27/2024, after documentation was requested.

This finding was confirmed by S5 and S1 on 02/29/2024 at 1:15 PM.

The facility policy titled," Controlled Dangerous Substance Management Procedure" dated 02/08/2024, states, " ... When a significant CDS diversion concern is identified, the Director of Pharmacy along with Nursing or Physician leadership must ensure that appropriate reports are made to the following agencies...External notification as the investigation dictates. Notified agencies may include: ... New Jersey Board of Pharmacy... New Jersey CDS ... "