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Based on review 4 of 4 medical records (MR), MR2, MR4, MR5, and MR6, of patients treated in the Cardiac Catheterization Lab, facility document review, and staff interviews, it was determined the facility failed to ensure that verbal medication orders are documented.

Findings include:

On 1/8/24 between 1:25PM and 3:15PM, 4 of 4 medical records, MR2, MR4, MR5, and MR6, were reviewed with Staff (S) 5, scribe, and S6, the Nurse Director of the Cardiac Catheterization Lab. Written orders for the medications administered by nurses were not found in MR2, MR 4, MR5, and MR6. S6 stated that in the Cardiac Catheterization Lab, a procedural area, the medication orders are given verbally by the physician. The following was identified in each of the medical records:

The "Medication Events" (a medication administration record), dated 12/31/23, found in MR2 indicates that S14, a RN, administered Fentanyl IV [intravenous] (a Controlled Dangerous Substance (CDS)) 50 mcg (micrograms) at 10:56 AM, Heparin (a blood thinner) IV 5,000 units at 11:07 AM, and Heparin IV 1,000 units at 11:20 AM.

MR2 lacks documentation of the verbal medication orders as required by facility policy.

The "Medication Events", dated 12/15/23, found in MR4 indicates that S8, a RN, administered Benadryl (an antihistamine) IV 50 mg (milligrams) at 9:34 AM, Versed IV (a sedative CDS) 2 mg at 9:40 AM, Fentanyl IV 50 mcg at 9:40 AM, Versed IV 1 mg at 9:44 AM, Fentanyl IV 50 mcg at 9:44 AM, Versed IV 1 mg at 9:47 AM, Angiomax 15 ml (milliliters) at 9:51 AM, Narcan 0.4mg at 10:36 AM, and Romazicon 0.2 mg at 10:35 AM.

MR4 lacks documentation of the verbal medication orders as required by facility policy.

The "Medication Events," dated 12/27/23, found in MR5 indicates that S8, a RN, administered Aspirin PO (by mouth) 81 mg at 7:05 AM, Clopidogrel (a blood thinner) PO 75 mg at 7:05 AM, and Nitroglycerin SL (sublingual) 0.4 mg at 7:22 AM, and S6, a RN, administered Versed IV 1 mg at 7:35 AM, Fentanyl IV 50 mcg at 7:35 AM, Romazicon 0.2 mg IV at 7:51 AM, and Narcan IV 0.4mg at 7:51 AM.

MR5 lacks documentation of the verbal medication orders as required by facility policy.

The "Medication Events," dated 12/27/23, found in MR6 indicates that S8, a RN, administered Fentanyl IV 25 mcg at 3:37 PM, and Heparin IV 5,000 units at 3:45 PM.

MR6 lacks documentation of the verbal medication orders as required by facility policy.

On 1/8/24 at 3:58 PM, S4, the Director of Pharmacy, confirmed the above findings and stated that the medical records lacked the documentation of verbal medication orders required by the facility policy below.

Reference: Facility policy titled "Red Back Verbal/ Telephone Orders" dated December 2023, states, "... RNs [registered nurses] or other licensed staff receiving verbal orders during surgery, procedures, or other urgent clinical situations must repeat back and verify all verbal orders. The verbal orders are authenticated and entered into the EMR [electronic medical record] ordering system as soon as possible by the ordering provider...Verbal orders shall be signed before the member of the medical staff... leaves the area."

Based on observations, document review, medical record review, and staff interviews, it was determined the facility failed to ensure pharmacy services are provided in a safe manner.

Findings include:

1. The facility failed to ensure that a quality improvement plan for pharmacy services is developed and implemented to minimize medication errors and adverse events. (Cross Refer to Tag A-491)

2. The facility failed to ensure that unit inspections of medication storage areas are completed and record of these inspections are maintained, as required by State regulations. (Cross Refer to Tag A-491)

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

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

5. The facility failed to ensure the development and implementation of policies and procedures that address the monitoring of and accountability for CDS stored in each area of the facility. (Cross refer to Tag A-500)

6. The facility failed to ensure the development and implementation of policies and procedures that address the reporting, reviewing, and monitoring of adverse drug reactions and medication errors. (Cross refer to Tag A-508)

7. The facility failed to ensure the development and 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, review of facility documents, and staff interviews, it was determined the facility failed to ensure that 1) a quality improvement plan for pharmacy services is developed and implemented to minimize medication errors and adverse events; 2) unit inspections of all medication storage areas are completed and records of these inspections are maintained, as required by State regulations.

Findings include:

1. On 1/5/24 at 10:30 AM, the facility's written pharmacy services continuous quality improvement plan was requested. On 1/5/24 at 9:44 AM, Staff (S) 4, the Director of Pharmacy, provided a Performance Improvement Dashboard and other documentation that indicated the facility was tracking antibiotic usage, medication adverse events, medication barcode scanning, and the timely verification of physician orders in the Emergency Department, however, S4 failed to provide a written plan that directs the quality improvement plan monitoring, trending, and reporting for pharmacy services.

On 1/8/24 the "Bayonne Medical Center 2023 Quality/Performance Improvement Plan" was reviewed. The written quality improvement plan for the hospital indicated that the Pharmacy and Therapeutics Committee reported findings to the hospital quality performance improvement Medical Executive Committee, however the plan lacked documentation of the areas that the pharmacy services quality improvement plan was tracking and trending for 2023. It could not be determined what health system issues related to pharmacy services were identified and monitored, and what corrective actions were implemented to improve performance.

On 1/8/24 at 9:45 AM in the presence of S3, the Chief Hospital Executive, S4, and S9, the Director of Risk Management, S1 confirmed the facility did not have a written plan for pharmacy quality improvement.

2. On 1/5/24 at 9:45 AM, records of the unit inspections completed in the facility for the year 2023 were requested. S4, the Director of Pharmacy, stated that unit inspections were completed on a monthly basis and the reports were stored online, however there was an issue with their online vendor, Veriform, and the online database containing the unit inspection reports were not available since 12/23/2023.

On 1/8/24 at 9:57 AM S4 confirmed the unit inspection reports were still not available for review. Upon request, the facility failed to provide the unit inspection reports. It could not be determined if the facility completed the unit inspections in a timely manner for the year 2023, or if the facility addressed any problems identified during unit inspections.

Reference: New Jersey Board of Pharmacy Regulations N.J.A.C. 13:39-9.23 (b) states, " ...The pharmacist-in-charge or, where provided for in Department of Health rules, the director of pharmaceutical services shall establish a system of control for all drugs dispensed for use in the drug therapy of patients of the facility. Inspections shall be conducted of all medication areas located in the facility or any other service area of the facility at least once every two months to check for expiration or use by dates, proper storage, misbranding, physical integrity, security and accountability of all drugs. These inspections shall be fully documented. Written inspection reports shall be prepared and signed by the inspecting pharmacist or by the pharmacy technician, intern or extern and co-signed by his or her supervising pharmacist. The pharmacist-in-charge shall be responsible for ensuring that, prior to performing any inspections pursuant to this subsection, pharmacy technicians, interns and externs are trained and can successfully demonstrate competency. Procedures for the review of these reports shall be developed and instituted by the pharmacist-in-charge and can be incorporated into the overall quality assurance program of the health care facility ..."

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

Findings include:

1. During a tour of the Cardiac Catheterization Procedure Room (Cath Lab) on 1/5/24 at 11:20 AM, with Staff (S)4, the Pharmacy Director, S5, scribe, and S6, Nurse Director of the Cath Lab, the Pyxis was inspected. S4 stated that medications were removed from the Pyxis by selecting a patient name first, then the ordered medication. S4 stated that the patient list available on the Pyxis in the Cath Lab was the "global list" or the list of all patients currently in the facility. S4 stated that any medication could be removed for any patient on that list in the Cath Lab, because the patients were "not profiled" by the Pharmacy Department in procedural areas. S4 explained that during the profiling process, the Pharmacy reviews all medication orders for patients prior to the medication being available for withdrawal from the Pyxis and administered.

On 1/5/24 at 11:42 AM, S6 confirmed that medication, including CDS, could be removed from the Pyxis for any patient on the global list and that Cath Lab staff had to be careful not to withdraw medications under the wrong patient. S4 stated that "global list" of patients was available on the Pyxis located in the Emergency Department and the procedural areas, including, but not limited to, the Interventional Radiology Department. When questioned about how long patient names are active on the "global list," S4 stated he/she wasn't sure but thought the patient names in the Pyxis were removed upon patient discharge.

During a tour of the Interventional Radiology Department on 1/8/24 at 11:45 AM, S12, a radiology Registered Nurse, confirmed that the patient list available on the Pyxis located in the department was the "global list" and contained a list of all of the patients in the facility. S12 confirmed that medication, including CDS, could be removed for any of the patients listed.

Review of the Pyxis "All Transaction Activity Detail Report" for the Cardiac Cath Lab and the Vascular Procedural areas and their corresponding medical records conducted on 1/8/24 with S4, S5, and S6 identified that a medication was removed for a discharged patient (P), P8. The Pyxis "All Transaction Activity Detail Report" indicated that on 12/31/23 the following was removed for P8: at 6:18 AM - one vial of Heparin 1000 Units, at 6:18 AM - one vial of midazolam 2 mg (milligrams) / 2 ml (milliliters), and at 6:19 AM - one vial of Fentanyl 100 mcg (micrograms) / 2 ml.

Review of medical record (MR) 8 indicated that P8 was admitted to the facility Same Day Surgery Department on 12/29/23 at 6:11 AM, and discharged from the facility on 12/29/23 at 3:32 PM. Further review of MR8 included documentation on the Medication Administration Record (MAR) dated 12/31/23 that Fentanyl 100 mcg was administered to P8 at 6:18 AM, and midazolam 2 mg was administered to P8 at 6:19. The patient was not admitted to the facility on 12/31/23 when the medications were removed from the Pyxis and documented as administered.

These findings were confirmed by S4, S5, and S6 on 1/8/24 at 1:38 PM.

On 1/8/24, during the review of Pyxis "All Transaction Activity Detail Reports" dated 12/31/23 and 12/20/23, the procedural logs for the Cardiac Catheterization lab, and the corresponding medical records, MR7, MR8, MR9, and MR10, with S4 , S5, and S6, it was identified that CDS were removed from the Pyxis located in the Cardiac Cath Lab for patients who were not treated there. The following was identified:

The Pyxis "All Transaction Activity Detail Report," dated 12/31/23 at 6:20 AM, indicates 1 vial of Fentanyl 100 mcg/ 2 ml was removed for P7. Review of the Procedural Log dated 12/31/23 and MR7, confirmed that P7 was not treated in the Cardiac Cath Lab.

The Pyxis "All Transaction Activity Detail Report," dated 12/31/23 at 6:19 AM, indicates 1 - vial of Fentanyl 100 mcg/ 2ml, at 6:18 AM - 1 vial of midazolam 2mg/ 2 ml, and at 6:18 AM 1 - vial of Fentanyl 100 mcg. 2ml were removed for P8. Review of the Procedural Log dated 12/31/23 and MR8, confirmed that P8 was not treated in the Cardiac Cath Lab.

The Pyxis "All Transaction Activity Detail Report," dated 12/31/23 at 12:14 AM, indicates that 1- vial of Fentanyl 100 mcg/ 2ml was removed for P9. Review of the Procedural Log dated 12/31/23 and MR9, confirmed that P9 was not treated in the Cardiac Cath Lab.

The Pyxis "All Transaction Activity Detail Report," dated 12/30/23 at 7:18 PM, indicates that 1 - vial of midazolam 2mg/ 2ml and at 7:19 PM 1- vial of Fentanyl 100 mcg/ 2ml were removed for P10. Review of the Procedural Log dated 12/30/23 and MR19, confirmed that P10 was not treated in the Cardiac Cath Lab.

These findings were confirmed by S5 and S6 on 1/8/24 at 2:50 PM.

The facility policy and procedure for the maintenance of the Pyxis patient list was requested from S1 and S4 on 1/5/24. On 1/5/24 at 12:43 PM, S1 and S4 confirmed the facility did not have a policy that addressed the maintenance of the Pyxis patient list, as required by State regulations 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 ..."

Review of facility incident report documentation dated 12/31/23 observed time 10:16 AM, states, "On 12/31/23 ...There were also 21 opened Fentanyl vials and 2 Versed vials... Upon investigation it was determined that the employee removed a total of 50 vials of Fentanyl and 10 vials of Versed from the Pyxis medication dispensing cabinet. A total of 19 unopened Fentanyl vials and 1 unopened Versed vial was found in the employee's jacket. Medication retrieved and returned to pharmacy ... No additional narcotics found. There are 8 vials of versed and 10 vials of Fentanyl unaccounted for ..."

During an interview on 1/5/24 at 10:48 AM, S4 explained that S8 opened the Pyxis console using the patients' names from the "global list" while the Cath Lab was closed on 12/30/23 and 12/31/23. S8 then broke the plastic Pyxis cube doors to access the vials of Fentanyl and midazolam stored inside.

Interviews conducted with S1, the Quality Director, S3, the CEO, S4, Director of Pharmacy, and S9, Director of Risk Management, on 1/8/24 at 9:30 AM, confirmed there were CDS still unaccounted for: 7 vials of midazolam and 10 vials of Fentanyl. The facility could not ensure the accountability for these CDS.

2. During an interview on 1/5/23 at S4, the Director of Pharmacy stated that the facility had a policy and procedure in place to ensure that access to the medications stored in the Pyxis, is limited. S4 stated that employees in the Cardiac Catheterization Procedural Area (Cath Lab), have limited access to the two Pyxis medication consoles located in the Cath Lab and the adjacent Vascular Procedural Area, only. S4 stated that these employees did not have the ability to access medication stored in Pyxis consoles on other units.

During an interview on 1/8/24 at 2:15 PM, S6, Nurse Director of the Cath Lab, stated that staff members that worked in the Cath Lab and Vascular Procedural areas only had access to the Pyxis consoles located on those units.

Review of Pyxis "console privileges" for two of two full-time registered nurses, S6 and S8, that worked in the Cath Lab on 1/8/24 at 3:00 PM, indicated that both S6 and S8 had access to medications, including Controlled Dangerous Substances (CDS), stored in Pyxis consoles on 15 different units: 2R, 3R, 5R, Cardicath (Cath Lab), CCU (Critical care Unit), ED (Emergency Department), OR (Operating Room), PACU (Post Anesthesia Care Unit), Procedural, Psych (Psychiatric Unit), Radiology, Renal, SDS (Same day Surgery), Training, and TRCU (Transitional Care Unit). The staff access was not limited as required by facility policy referenced below. S4 confirmed this finding on 1/8/24 at 3:05 PM, and stated that he/she did not know that S6 and S8 had access to 13 more Pyxis consoles than expected. S4 stated that the facility needed to review the Pyxis console privileges for all clinical staff to ensure access was appropriate.

"All Activity Reports" for the Pyxis consoles in the facility were reviewed, and medication removals by S8 were only recorded for the 2 cabinets located in the Cath Lab and the Vascular Procedure Area.

Reference; Facility policy titled "Automated Drug Distribution System" dated 11/23, states, "...Access will be strictly controlled to ensure proper security of all medications, proper documentation and accountability for medication use, and confidentiality of patient information... Nursing and pharmacy privileges shall be determined by their respective supervisors..."

Reference: N.J.A.C. 13:39-10.3 (c)(5) New Jersey State Board of Pharmacy Regulations states," ... Authority to use Automated Medication System ... The pharmacist-in-charge shall be responsible for the following: ... Assigning, discontinuing or changing personnel access to the automated medication system ..."

3. On 1/5/24, review of facility polices and procedures addressing the control and accountability of Controlled Dangerous Substances (CDS) was conducted. Facility policy titled "Controlled Substance Ordering, Receiving, Storage and Handling" dated 6/23, states, "...11.0 Diversion Prevention, Detection, and Reporting... The pharmacy shall employ reports provided through the Pyxis CII Safe and Pyxis MedStation console... Routine Monitoring includes but is not limited to: ...Overrides (all overrides of controlled substances are reviewed and matched to a corresponding order and documentation of administration. If no documentation of administration is found, a medication error report is documented electronically in VERGE for area Manager review and follow up...)."

During an interview conducted 1/8/24, between 10:00 AM and 10:30 AM, with S4, Director of Pharmacy, the pharmacy process to monitor for CDS usage and diversion along with corresponding documentation were discussed and reviewed. S4 stated that pharmacy personnel review Pyxis medication discrepancy reports and medication override reports on a daily basis. However, it was discovered that there are units that did not generate Pyxis console medication override reports because the "global list of patients" are available and the medication orders in these procedural units are not profiled by the pharmacy department. These units are the Echocardiogram Department, Operating Rooms, Endoscopy Procedure Rooms, Interventional Radiology Department, Vascular Procedure Room, and the Cardiac Catheterization Lab.

S4 stated that the pharmacy personnel monitor the CDS accountability in the anesthesia Pyxis consoles located in the Operating Rooms and Endoscopy Procedure Rooms by reviewing all of the paper documentation, Pyxis reports, and corresponding medical records, for CDS administration and waste. This data was complied and reviewed at the Pharmacy and Therapeutics Committee meeting and any CDS discrepancy was documented in a VERGE incident report. Documentation for this process was received and reviewed.

However, S4 stated that the CDS usage on the other units, the Echocardiogram Department, Interventional Radiology, Vascular Procedure Room, and the Cardiac Catheterization Lab, used an electronic medical record, and the pharmacy personnel did not have a process in place to monitor the CDS accountability in these areas. On 1/5/24 it was determined that the Echocardiogram Department did not have a supply of CDS in their Pyxis console. The Pyxis consoles found in the Cardiac Catheterization Lab, the Vascular Procedure Room, and one of the consoles found in the Interventional Radiology Department contained CDS. On 1/8/24 at 3:52 PM, S4 confirmed these units are not included on the Pyxis console override reports and the facility does not have a process in place to monitor the CDS administration, waste and accountability, as required by State regulation and facility policy.

During an interview on 1/8/24 at 10:58 AM, S4 stated the facility monitors the CDS Accessed Inventory Reports to ensure staff complete the inventory of CDS stored in the Pyxis consoles at the change of each shift. Review of the Accessed Inventory summary report dated November 2023, indicated the facility was at an overall compliance of 95% for the required inventory of CDS, however it was identified that the eight anesthesia Pyxis consoles were not included on the report. S4 stated that the anesthesia Pyxis consoles were not included in the monitoring because the CDS inventory was completed by pharmacy technicians. On 1/8/24 at 11:15 AM, S4 confirmed the facility did not maintain oversight and ensure that the CDS accessed inventory was completed for the anesthesia Pyxis consoles. The accountability for the CDS stored inside could not be ensured.

Facility policies reviewed on 1/5/24 and 1/8/24 failed to include a written process for the monitoring of CDS inventory reports. This was confirmed by S4 on 1/8/24 at 11:15 AM.

Based on the review of facility documents and staff interviews, it was determined the facility failed to ensure the development and implementation of policies and procedures that address the reporting, reviewing, and monitoring of adverse drug reactions and medication errors.

Findings include:

On 1/8/24 at 3:30 PM during an interview, S4, Director of Pharmacy, stated that the facility has a Medication Incident Review Committee (MIRC) that reviews all medication errors and adverse events that occur in the facility.

When Medication Incident Review Committee Meeting minutes were requested, S4 provided documents titled "Bayonne Medical Center Department of Risk Management [date]." These documents were dated January 2023 through October 2023 and were in the form of charts that described each medication incident. S4 explained that the MIRC was previously under the direction of the Risk Management Department, however in about October of 2023 the MIRC was reassigned to the Pharmacy Department because the facility "had fallen behind" in the review of medication incidents. S4 stated that the MIRC was recently meeting weekly to "catch up." S4 provided a sign-in sheet document titled "BMC [Bayonne Medical Center] Medication Incident Review 2023" that indicated a MIRC meeting occurred on 10/27/23, 11/16/23, 12/7/23, and 12/21/23, however meeting minutes for these meeting were not recorded, it could not be determined which medication incidents were reviewed during these meetings or what actions were taken.

Review of the "Bayonne Medical Center Department of Risk Management [date]" documents dated 1/23 through 10/23, with S4 on 1/8/24 revealed that the most recent medication incidents reviewed occurred in May of 2023. On 1/8/24 at 3:45 PM, S4 confirmed the facility was approximately six months behind in reviewing medication incidents. At this time, the facility policy that addressed the review and monitoring of medication incidents was requested.

On 1/8/24 at 3:59 PM, S4 confirmed that the facility failed to develop a policy and procedure that addressed the process to review, report, and monitor medication incidents.

On 1/8/24 at 3:50 PM, S4 explained that although he/she did not have MIRC meeting minutes that documented the review and reporting of medication incidents occurring between 6/23 through 12/23, the medication incidents were reviewed and reported to the Patient Safety Committee. At this time, Patient Safety Meeting Minutes were requested.

On 1/8/24 at 4:04 PM, S1, Quality Director, and S4 stated that the Patient Safety Meeting minutes were not available for review because they were located on another staff member's computer, who was out of the office. S1 stated he/she would provide the meeting minutes via email on the next business day. The facility failed to provide the Patient Safety Meeting minutes from 6/23 through 12/23 upon request. It could not be determined if the facility reviewed, monitored, or reported medication incidents that occurred between 6/23 and 12/23.

Based on document review and staff interviews, it was determined the facility failed to ensure the development and implementation of policies and procedures that address the reporting of CDS loss or diversion to the required agencies.

Findings include:

On 1/5/24 at 9:45 AM, the facility's policy and procedure that addresses drug diversion reporting, and the documentation of the reporting an incidence of drug diversion that occurred on 12/31/23, to the required agencies, was requested.

The facility policy titled, "Controlled Substance Ordering, Receiving, Storage, and Handling" dated 6/23, states, "...Theft or loss of controlled substance or DEA 222 forms must be immediately be reported to the Pharmacist-in-charge... Theft or loss must be reported within 72 hours of the verification of the theft to the DEA and the State Board of Pharmacy. The ... DEA Form 106, must be completed..."

The policy fails to include the reporting of the theft or loss of the controlled substance to the appropriate professional State Board if a healthcare professional was involved. Review of facility documents identified that S8, a Registered Nurse, was involved in the loss of controlled substances on 12/31/23. On 1/5/24 at 10:30 AM, S1 confirmed that the facility did not notify the New Jersey Board of Nursing of the CDS loss using the New Jersey Office of the Attorney General, Division of Consumer Affairs, New Jersey Board of Nursing "Reporting Form for Diversion and Impairment."

The policy also failed to include the reporting of the theft or loss of CDS to the New Jersey (NJ) Drug Control Unit as required by New Jersey Controlled Dangerous Substances regulations N.J.A.C. 13:45 H-2.4(c) and 2.5(d), which state, "the registrant shall notify the Drug Control Unit of any theft or loss of any controlled substances upon discovery... The registrant shall also complete a DDC-52 form regarding any theft or loss. Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action is taken against them..." On 1/5/24 at 10:30 AM, S1 and S4 confirmed that the facility did not submit a Form DDC-52.

Review of facility documents on 1/5/24 identified that the facility failed to report the incidence of CDS theft or loss that occurred on 12/31/23 to the New Jersey Board of Pharmacy as required by facility policy referenced above. This finding was confirmed by S4 on 1/5/24 at 10:30 AM.