University Medical Center of Princeton at Plainsboro

“PATIENT RIGHTS: EXERCISE OF RIGHTS CFR(s): 482.13(b) Patient Rights: Exercise of Rights This Standard is not met as evidenced by: 51038 Based on medical record review, staff interview, and review of facility documents, it was determined the facility failed to ensure that pain reassessment is completed in accordance with the facility policy in one of 10 medical records reviewed (MR1). Findings include: Facility policy titled, “Adult/Pediatric Pain Management” reviewed September 2022, stated, “ ... E. Pain will be reassessed: 1. Following the administration of pain medication to determine the amount of pain control or relief achieved in a time interval not to exceed 2 hours ...” A review of Patient (P)1’s medical record, revealed the following: On 2/1/25 at 10:56 AM, Staff (S)15 (Registered Nurse) administered Morphine (narcotic pain medication) 2mg IV. Upon further review, the medical record lacked documentation of an initial pain assessment and a pain re-assessment within 2 hours of administration of the medication morphine. On 2/5/25 at 3:15 AM, the Omnicell [medication storage] transaction record revealed that S14 withdrew Morphine 2mg [milligrams]/1ml [milliliters] 1ml injection for P1. On 2/5/25 at 3:16 AM, the “Pain Flowsheet” documentation by S14 indicated that Morphine 2mg IV was administered for “6/10 generalized pain [six out of 10 pain scale].” The medical record lacked evidence that a pain re-assessment was performed after the administration of pain medication per facility policy. On 3/24/25 at 1:58 PM, S7 (Nurse manager of ICU/Telemetry), S5 (Clinical Nurse Leader of Critical Care), and S1(Director of Patient Safety and Guest Relations) confirmed the above findings.”

“PHARMACY DRUG RECORDS CFR(s): 482.25(a)(3) Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. This Standard is not met as evidenced by: 50124 Based on observation, staff interview, and facility document review, it was determined the facility failed to ensure 1) the implementation of policies and procedures that address the Controlled Dangerous Substances (CDS) ordering and receipt process; 2) the implementation of policies and procedures that address the monitoring of Over-ride Reports for the Automatic Dispensing Cabinet (ADC). Findings include: 1. Facility policy titled, “Standard Operating Procedures for Controlled Drug Substances,” revised 3/2023, states, “ ...Receipt of Order ...4b. Wholesaler totes are unpacked in the receiving area by the assigned pharmacy personnel. Separation of duties between the person that ordered and received must be maintained ...” Facility policy titled, “Controlled Drug Substances,” date reviewed, 6/2022 states, “E. Procurement ...4. There is a separation of duties for ordering and receiving of CDS; the person ordering CDS is not the same person receiving the CDS.” On 7/1/24 at 10:12 AM, in the presence of Staff (S) #1 (S1), Regulatory Affairs Manager, S2, Patient Safety Analyst, S3, Interim Patient Safety Director, S4, Interim Pharmacy Director, and S5, Assistant Vice President (AVP), a discussion took place concerning the potential theft of 150 syringes containing Ketamine 50mg (milligrams)/ml (milliliters) (a CDS that is an anesthetic) from the pharmacy department on 6/13/24. S5 stated that on 6/17/24, he/she reviewed the video surveillance of the pharmacy department and tracked the box containing Ketamine, starting from the time it was delivered to the pharmacy receiving area, located in the pharmacy. On 7/1/24 at 11:33 AM, the video footage, captured on 6/13/24 from approximately 2:15 PM to 2:42 PM, that showed the movement of the box identified as containing the Ketamine syringes, was reviewed with S5, in the presence of S1, S2, S3, and S6, Security Training and Development Specialist. At this time, S5 confirmed this was the box that contained the Ketamine syringes. The video footage of the pharmacy receiving area, at 2:17:22 PM, showed S8, Business Pharmacist, opening the box containing the Ketamine syringes, taking out the packing slip invoice, looking at the packing slip invoice, and placing it back into the box. S5 confirmed the person shown in the video footage was S8. Review of the Fagron Sterile Service (FSS) (the company from which the Ketamine syringes were ordered) Purchase Invoice, dated 6/12/24, indicated the order was placed by S8. Review of the video footage and review of the Purchase Invoice, confirmed the Ketamine syringes were ordered and received by S8. This is not in accordance with facility policy. On 7/1/24 at 2:30 PM, S4 confirmed S8 was the staff member that ordered the 150 syringes of Ketamine 50 mg/ml on 6/12/24 and was identified as opening the order on 6/13/24. Facility policy titled, “Standard Operating Procedures for Controlled Drug Substances,” revised on 3/2023 states, “ ...Procurement ...4. CIII-CIV a. The purchasing of CIII-CIV controlled drug substances follows the department’s routine procurement procedures for ordering medications via the wholesaler or vendor. b. Invoices are matched to respective “receive” CII Safe inventory reports and are filed into binders for each DEA-registered location ...Receipt of Order ...5c. Transfer CDS product to narc [narcotic] vault immediately ...Adding to inventory 1. Inpatient Pharmacy a. CDS and CDS invoices are brought to the narc vault b. The designated pharmacy employee verifies the CDS invoice matches the controlled drug substances received under video surveillance...” Facility policy titled, “Controlled Drug Substances,” date reviewed 6/2022, states, “E. Procurement ...6. Invoices that accompany received CDS are dated and signed by 2 persons that are authorized to handle CDS.” On 7/1/24 at 11:33 AM, the video footage, reviewed with S5, showed that on 6/13/24 from 2:34:03 PM to 2:34:20 PM, the box containing Ketamine syringes that was left in the storage area by S8 was now being handled by S9, Pharmacy Technician Specialist. S5 confirmed the person on the video footage was S9. The surveillance video view, facing the entrance door to the pharmacy vault from the pharmacy floor, from 2:39:08 PM to 2:39:13 PM, showed S9 walk towards the pharmacy vault from storage area, place the box identified as containing the Ketamine syringes in the trash can located right outside the pharmacy vault, and walk into the cleanroom holding a piece of paper. S5 stated the piece of paper S9 was holding is presumed to be the packing slip invoice for the missing Ketamine syringes. S5 stated on 6/17/24, he/she reviewed the video footage that was captured on 6/13/24 throughout the day and observed multiple staff members lifting or touching the box in the trash can that potentially contained the Ketamine syringes. S5 believed the Ketamine syringes were removed from the box prior to it being put in the trash can. S5 stated that if the box was full, a staff member would have noticed and done something about it. S5 confirmed the box was never brought inside the pharmacy narcotic vault to be unpacked under video surveillance in accordance with facility policy. On 7/1/24, at 2:30 PM, the facility failed to provide the packing slip invoice for the Ketamine syringes that was received on 6/13/24, upon request. S4 confirmed the Ketamine syringes packing slip invoice, which documented the quantity sent by the wholesaler or vendor, was never located and proof of delivery was not obtained. S4 confirmed that checking a copy of the ordered invoice for the missing order is not proof that the order was received and that the correct quantity was shipped. A request was made to obtain the proof of delivery of the Ketamine received on 6/13/24. On 7/2/24 at 11:47 AM, a copy of the proof of delivery for the Ketamine syringes on 6/13/24 was obtained by the facility. On 7/2/24 at 12:00 PM, S4, confirmed the Ketamine syringes packing slip invoice was not found, therefore the Ketamine syringes packing slip was not matched to the medication ordered invoice report and the invoices were not signed by two authorized staff members, and were not filed by the facility. This is not in accordance with facility policy. 2. Facility policy titled, “Controlled Drug Substances,” date reviewed 6/2022, states, “ ...III. Policy ...N. Controlled Substance Oversight/ Preventative Measures ...3. The Department of Pharmacy performs at least weekly audits of medication use where ADC are used and monthly audits where ADC are not used within the organization to identify drug diversion. a. ADC audits include but are not limited to: 1) Over-ride audits ...” On 7/1/24 at 10:20 AM, the Over-ride reports, audited to ensure CDS accountability for the previous three months, were requested. On 7/2/24 at 1:05PM, the facility failed to provide proof of Over-ride audit reports. On 7/2/24 at 1:07 PM, S4, Interim Pharmacy Director, in the presence S2, Patient Safety Analyst, and S3, Interim Patient Safety Director, confirmed being aware that there are gaps in the audit trail. S4 confirmed that Over-ride audits have not been performed or monitored since 3/2024 or 4/2024 to the date of survey. This is not in accordance with facility policy.”

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 50124 Based on staff interviews, document review, and review of Midas Safety Reports (MSR), it was determined the facility failed to ensure 1) the implementation of policies and procedures that address the reporting of Controlled Dangerous Substances (CDS) discrepancies in the ADC (Automated Dispensing Cabinets) to pharmacy management within a 24 hour timeframe; 2) the development and implementation of policies and procedures that address Controlled Dangerous Substances (CDS) accountability for the Omnicell (an automated dispensing cabinet); and 3) the development and implementation of policies and procedures that address the use of Invistics (a drug diversion software) and other facility documents to monitor CDS accountability. Findings include: 1. Facility’s policy titled, “Controlled Drug Substances,” reviewed 6/2022, states, “ ...III. Policy ...M. Discrepancy Documentation 1. CDS discrepancies must be resolved as soon as possible but should not exceed 24 Hours. 2 ...If the discrepancy cannot be resolved immediately, the unit manager or designee should be notified. The unit manager or designee is responsible for facilitating resolution documentation at their device(s) within 24-hour timeframe. 3. CDS discrepancies that are unable to be resolved by the Unit Manger must be brought to the attention of the Pharmacy for further investigation and resolution.” Facility’s policy titled, “Standard Operating Procedures for Controlled Drug Substances,” revised 3/2023 states, “ ...Dispensing to Pyxis ...6. If discrepancies are identified, they need to be investigated as soon as possible by the respective person. If unable to be resolved, escalate to patient care discrepancies to the Pharmacy Tech Specialists and CII Safe discrepancies to Pharmacy Management ...Discrepancy Resolution ...3. If a discrepancy is identified, the pharmacy technician specialist is responsible for initial investigation. If unable to be resolved, this should be brought to the attention of pharmacy management as soon as possible ...The discrepancy should be resolved as soon as possible...” On 7/1/24 at 10:57 AM, Staff #10 (S10), Operating Room Pharmacist, was interviewed. S10 stated he/she monitors the CDS discrepancies for ADC in the procedural units, and that the ADC located in the Medical-Surgical (Med-Surg) Care Units and in the other Nursing Units are monitored by Pharmacy Technician Specialists. S10 confirmed he/she does not monitor or oversee the technician specialists. S10 stated that the Invistics software, used to monitor CDS discrepancies in Omnicell, sends alerts of the CDS discrepancies. S10 stated there is a delay of 72 hours from when the CDS discrepancy occurs to when the alert is sent. On 7/1/24 at 2:26 PM, S1, Regulatory Affairs Manager, also stated that the Invistics soft ware has a 72-hour lag time in sending alerts of CDS discrepancies. S1 confirmed CDS discrepancies are not identified immediately and may not be reviewed or resolved for several weeks or up to one month. This is not in accordance with facility policy. Review of The Midas Safety Reports (MSR) for the CDS discrepancies, created between 3/15/24 to 7/1/24, for 7 of 10 patients (P), P1, P3, P4, P5, P6, P7, and P8, identified the following: The MSR for the CDS discrepancy that could not be resolved for 7 of the 10 patients, P1, P3, P4, P5, P6, P7, and P8 were not created and sent to the Unit Manager (UM) by Regulatory Affairs (RA) within 24 hours of the date of occurrence of the CDS discrepancy. The CDS discrepancy for P1 occurred on 6/26/24 and the MSR for the CDS discrepancy was created and sent to UM on 7/1/24 by RA. This is not within 24 hours of the occurrence of the CDS discrepancy. The CDS discrepancy for P3 occurred on 6/4/24 and the MSR for the CDS discrepancy was created and sent to UM on 6/10/24 by RA. This is not within 24 hours of the occurrence of the CDS discrepancy. The CDS discrepancy for P4 occurred on 2/26/24 and the MSR for the CDS discrepancy was created and sent to UM on 3/15/24 by RA. This is not within 24 hours of the occurrence of the CDS discrepancy. The CDS discrepancy for P5 occurred on 5/25/24 and the MSR for the CDS discrepancy was created and sent to UM on 6/20/24 by RA. This is not within 24 hours of the occurrence of the CDS discrepancy. The CDS discrepancy for P7 occurred on 2/26/24 and the MSR for the CDS discrepancy was created and sent to UM on 3/18/24 by RA. This is not within 24 hours of the occurrence of the CDS discrepancy. The CDS discrepancy for P7 occurred on 5/22/24 and the MSR for the CDS discrepancy was created and sent to UM on 6/20/24 by RA. This is not within 24 hours of the occurrence of the CDS discrepancy. The CDS discrepancy for P8 occurred on 4/12/24 and the MSR for the CDS discrepancy was created and sent to UM on 5/6/24 by RA. This is not within 24 hours of the occurrence of the CDS discrepancy. The MSR for the CDS discrepancy for 5 of the 10 patients, P4, P5, P6, P7, and P8, lacked documentation of a follow-up resolution of the CDS discrepancy by a Unit Manager (UM) within 24-hour timeframe of being notified of the CDS discrepancy by RA. This is not in accordance with facility policy. The following was identified: The MSRs for P4, P6, and P7, lacked documentation of a follow-up resolution from the UM for the CDS discrepancy. The MSR for P5 was created for the CDS discrepancy on 6/20/24 by RA and the resolution for the CDS discrepancy was documented on 6/24/24 by the UM. This is not within 24 hours as required by facility policy. The MSR for P8 was created for the CDS discrepancy on 5/6/24 by RA and the follow-up was documented on 5/9/24 by the UM, however there was no documentation of resolution of the CDS discrepancy by the UM. The MSR for the CDS discrepancy for 4 of the 10 patients, P4, P6, P7, and P8, lacked documentation that they were resolved by the Unit Manager and were also not sent to Pharmacy Management for further investigation or resolution, as required by facility policy. On 7/2/24 at 10:55 AM, these findings were confirmed with S1, Regulatory Affairs Manager and S2, Patient Safety Analyst. On 7/2/24 at 11:19 AM, S1 and S2 confirmed the Midas Safety Reporting System (MSRS) is used by Regulatory Affairs (RA) to send unresolved CDS discrepancies to unit managers. An inquiry was made about the process for CDS discrepancies that are not resolved once sent to the MSRS. S4, Interim Pharmacy Director, confirmed not being sure and he/she was unable to the answer the question. S4 was asked if pharmacy management is made aware of the unresolved CDS discrepancies. S4 confirmed they are not made aware of unresolved CDS discrepancies. An inquiry was made as to who follows up with the unresolved CDS discrepancies. S1 stated there is no process to ensure that follow up on the resolution of CDS discrepancies is completed. S1 and S2 confirmed unresolved CDS discrepancies are not forwarded to pharmacy or brought to the attention of the pharmacy management. This is not in accordance with facility policy. On 7/2/24 at 11:21 AM, S4 confirmed there is a lapse in follow up by the pharmacy team regarding CDS discrepancy resolution. 2. On 7/1/24 at 10:49 AM, S4, Interim Pharmacy Director, stated the facility recently switched over from Pyxis (an automated dispensing cabinet) to Omnicell (a different automated dispensing cabinet) and the process was finalized sometime in 6/2024. A request was made for the facility policies and procedures, including CDS accountability, for the new Omnicell ADC system. On 7/1/24 at 12:20 PM, policy titled, “Omnicell Central Pharmacy Automation,” reviewed 2/2024, states, “ ...I. Purpose ...provides guidelines for the Pharmacy to follow during periods of equipment variances and downtime...” was received and reviewed. This policy lacked a process for maintaining CDS accountability with the Omnicell. On 7/1/24 at 2:30 PM, S4 confirmed the policy provided earlier titled, “Omnicell Central Pharmacy Automation,” date revised 2/2024, addressed Omnicell maintenance and did not address CDS accountability processes. S4 stated he/she will double check; however, was not sure there was a policy covering CDS accountability for the Omnicell. On 7/2/24 at 11:40 AM, S4, confirmed the use of the Omnicell ADC system began on 9/18/23, the floor stocking for Omnicell began on 10/8/23, and the total process for the conversion to Omnicell was completed on 6/5/24. S4 confirmed the policy and procedures for Omnicell that address the monitoring of CDS movement and accountability throughout the hospital are currently being worked on and have not yet been developed. The facility was using outdated policies that referred to the previous ADC reports and processes, Pyxis. 3. On 7/1/24 at 10:30AM, S4, Interim Pharmacy Director, stated the drug diversion software utilized by the facility is named Invistics Software. A policy and procedure for the utilization of the Invistics Software was requested. On 7/1/24 at 2:26PM, S1, Regulatory Affairs Manager, explained the CDS accountability process. S1 stated that the CDS accountability is monitored by the Pharmacy Technician (tech) Specialist for certain units and by S10, Operating Room Pharmacist on other units. S1 stated that the Invistics Software is linked with Omnicell (an automated dispensing cabinet) and sends reports of flagged alerts. The flagged alerts are monitored by S10, Operating Room Pharmacist for procedural units and the Pharmacy Technician (tech) Specialist for the Medical-Surgical (Med-Surg) Care Units and other Nursing Units. The flagged alerts that are not resolved are entered onto the facility created CDS Discrepancy Excel Report and sent to Regulatory Affairs. Regulatory Affairs staff members then review the CDS discrepancies. CDS discrepancies that cannot be resolved are sent using the Midas Safety Reporting Software (MSRS) to the Unit Manager (UN). On 7/1/24 at 2:35PM, A policy and procedure for the Invistics software and discrepancy review process were again requested. Reports and documentation of the process for CDS accountability and the audit trail for the previous 3 to 6 months, were requested and asked to be ready for review on 7/2/24. On 7/2/24 at 12:32PM, the facility failed to provide the policies and procedures that address the utilization of Invistics for monitoring CDS accountability. A request for these policies and procedures was made again. On 7/2/24 at 12:35 PM, S2, Patient Safety Analyst, stated that MSRS is mentioned in the policy titled, “Safety Event and Regulatory Reporting Policy,” effective date 3/2022. However, the policy was reviewed and the mention of MSRS was not found. S2 reviewed the policy and confirmed that it was not in this policy. On 7/2/24 at 1:04PM, S2 and S3, Interim Patient Safety Director, confirmed the facility failed to develop policies or procedures that address the utilization of the Midas Safety Reporting Software (MSRS) and Invistics Drug Diversion Software in monitoring CDS accountability. On 7/2/24 at 1:09 PM, S4 confirmed the facility failed to develop policies and procedures that address the utilization of the discrepancy excel report (DER) in monitoring CDS accountability”

“REPORTING ABUSES/LOSSES OF DRUGS CFR(s): 482.25(b)(7) Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate. This Standard is not met as evidenced by: 50124 Based on staff interview and document review, it was determined the facility failed to ensure the implementation of policies and procedures that address the filing of a written internal incident report when there is a loss or theft of facility property. Findings include: Facility policy titled, “Safety Event and Regulatory Reporting Policy, effective date 3/2022, states, “ ...II. POLICY STATEMENT Incident reports are used to document unexpected events which may occur... III. Definitions ...Examples would include but not limited to: ...Damage, theft, or loss of personal property belonging to a patient, visitor, or facility ... IV...Procedure/Reporting ... A. When to report All incident reports should be completed at the time of detection of the event ...C. How to Report ...Reports should be made electronically through the Incident Reporting database ...” On 7/1/24, at 10:14 AM, in the presence of Staff (S) #1 (S1), Regulatory Affairs Manager, S2, Patient Safety Analyst, S3, Interim Patient Safety Director, S4, Interim Pharmacy Director, and S5, Assistant Vice President (AVP), the facility’s loss of 150 syringes of Ketamine (a Controlled Dangerous Substance) was discussed. S4 stated that an incident report should have been filed for the event, and identified that S12, Pharmacist/Day Shift Supervisor, was overseeing the investigation and filed the initial facility incident report. On 7/1/24 at 11:20 AM, S12 was interviewed. S12 stated he/she did not file an incident report and was uncertain if an incident report was filed. S12 stated he/she assumed the incident report would be filed by S4. On 7/1/24 at 1:27 PM, S1 confirmed there was only a verbal mention of the incident, and the facility failed to file a internal incident report as required by facility policy when there is a loss or theft of facility property.”