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Based on medical record review, staff interviews, and review of documents, it was determined the facility failed to ensure that nursing services adhere to acceptable standards of practice and the facility's policies and procedures.

Findings include:

1. The facility failed to ensure that medications are administered in accordance with a physician's order. (Cross refer to Tag A-0405)

2. The facility failed to ensure that overridden medications are removed from the Pyxis in accordance with a valid physician's order. (Cross refer to Tag A-0405)

Based on review of four of seven medical records (MR4, MR5, MR8, MR10) reviewed for Controlled Dangerous Substance (CDS) administration, facility document review, and staff interviews, it was determined that the facility failed to ensure that: 1) medications are administered in accordance with physicians' orders; and 2) overridden medications are removed from the Pyxis (automated medication dispensing system) with valid physicians' orders.

Findings include:

1. During medical record review conducted on 5/25/23 between 2:00 PM and 3:15 PM with Staff (S)11, the Quality Manager/ Registered Nurse (RN), it was determined that four of seven medical records (MR4, MR5, MR8, and MR10), contained documentation that Hydromorphone (narcotic) for injection, a Schedule II CDS, was administered to patients without a corresponding physicians' order. The following was identified:

The Medication Administration Record (MAR) found in MR4 contained the following entries:
On 4/20/23 at 21:09 (9:09 PM), the MAR indicated that S14, a RN, administered "Hydromorphone (Dilaudid) 2mg(milligrams)/ml (milliliter) injection - ADS [Automated Dispensing Cabinet] Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override."

On 4/20/23 at 23:27 (11:27 PM), the MAR indicated that S14, administered "Hydromorphone (Dilaudid) 2mg/ml injection - ADS (Automated Dispensing Cabinet) Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override."

On 4/21/23 at 01:23 (1:23 AM), the MAR indicated that S14, administered "Hydromorphone (Dilaudid) 2mg/ml injection - ADS (Automated Dispensing Cabinet) Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override."

On 4/21/23 at 05:08 (5:08 AM), the MAR indicated that S14, administered "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override."

On 4/21/23 at 06:49 (6:49 AM), the MAR indicated that S14, administered "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override."

On 5/25/23, review of the Physician's Medication Orders found in MR4 in the presence of S11, failed to identify valid orders for the administration of Hydromorphone 2mg/ml injection to P4. This finding was confirmed by S1, the Vice President of Risk and Corporate Compliance Officer on 5/25/23 at 2:16 PM.

The MAR found in MR5 contained the following entries:
On 4/21/23 at 20:15 (8:15 PM), the MAR indicated that S14, administered "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override."

On 4/22/23 at 01:04 (1:04 AM), the MAR indicated that S14, administered "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override."

On 4/22/23 at 06:30 (6:30 AM), the MAR indicated that S14, administered "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override."

On 5/25/23, review of the Physician's Medication orders found in MR5 in the presence of S11, failed to identify valid orders for the administration of Hydromorphone 2mg/ml injection to P5.

The MAR found in MR8 contained the following entries:
On 4/25/23 at 21:35 (9:35 PM), the MAR indicated that S14, administered "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override."

On 4/25/23 at 21:30 (9:30 PM), the MAR indicated that S14, administered "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override."

On 4/26/23 at 03:23 (3:23 AM), the MAR indicated that S14, administered "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override."

On 5/25/23, review of the Physician's Medication orders found in MR8 in the presence of S11, failed to identify valid orders for the administration of Hydromorphone 2mg/ml injection to P8.

The MAR found in MR10 contained the following entry:
On 4/24/23 at 22:51 (10:51 PM), the MAR indicated that S14, administered "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override."

On 5/25/23, review of the Physician's Medication orders found in MR10 in the presence of S11, failed to identify valid orders for the administration of Hydromorphone 2mg/ml injection to P10.

During an interview on 5/25/23 at 3:14 PM, S11 explained the documentation identified on the MAR. The section on the MAR next to each medication that stated, "ADS Override Pull... Admin instructions:[blank space]," meant that the staff member removed the medication with an override from the Pyxis and the blank space next to the "Admin instructions:" meant that there was no physicians' order for that medication. S11 stated that the administration instructions would print on the MAR in that location if an order was entered.

2. Further review of three of seven medical records, MR4, MR9, and MR10 and corresponding Pyxis "All Transaction Activity Detail Reports" conducted on 5/25/23 with S11, indicated additional instances that Hydromorphone was removed from the Pyxis without a valid physicians' order, using an override. The following was identified:

The MAR found in MR4 dated 4/21/23 at 06:35 (6:35 AM), states, "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override." The MAR did not contain documentation that this medication was administered. However, the corresponding Pyxis "All Transaction Activity Detail Reports" for P4 dated 4/21/23 at 06:35:27 indicated that 1.5mg of the 2mg dose was wasted with a witness.
On 5/25/23, review of the Physician's Medication orders found in MR4 in the presence of S11, failed to identify valid orders for the removal of Hydromorphone 2mg/ml injection from the Pyxis.

The following documentation was identified on the MAR found in MR9:

On 4/24/23 at 19:44 (7:44 PM), the MAR indicated that S14, removed "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override" from the Pyxis. MAR 9 did not contain documentation that this medication was administered. However, the corresponding Pyxis "All Transaction Activity Detail Reports" for P9 dated 4/24/23 at 23:14 (11:14 PM) indicated that 1.5mg of the 2mg dose was wasted with a witness.

On 4/24/23 at 21:12 (9:12 PM), the MAR indicated that S14, removed "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override" from the Pyxis. MAR9 did not contain documentation that this medication was administered. However, the corresponding Pyxis "All Transaction Activity Detail Reports" for P9 dated 4/24/23 at 21:13 (9:13 PM) indicated that 1.5mg of the 2mg dose was wasted with a witness.

On 4/25/23 at 06:21 (6:21 AM), the MAR indicated that S14, removed "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override" from the Pyxis. MAR9 did not contain documentation that this medication was administered. The corresponding Pyxis "All Transaction Activity Detail Reports" for P9 dated 4/25/23 documented only the removal of the medication. There was no documentation that the dose was wasted or returned.

On 5/25/23, review of the Physician's Medication orders found in MR9 in the presence of S11, failed to identify valid orders for the removal of Hydromorphone 2mg/ml injection from the Pyxis.

The following documentation was identified on the MAR found in MR10:

On 4/25/23 at 01:10 (1:10 AM), the MAR indicated that S14, removed "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override" from the Pyxis. MAR10 did not contain documentation that this medication was administered. However, the corresponding Pyxis "All Transaction Activity Detail Reports" for P10 dated 4/25/23 documented on the removal of the medication from the Pyxis. There was no documentation that the medication was wasted or returned.

On 4/25/23 at 03:26 (3:26 AM), the MAR indicated that S14, removed "Hydromorphone (Dilaudid) 2mg/ml injection - ADS Override Pull... Admin instructions:[blank space] [S14 name]: cabinet override" from the Pyxis. MAR10 did not contain documentation that this medication was administered. However, the corresponding Pyxis "All Transaction Activity Detail Reports" for P10 dated 4/25/23 documented on the removal of the medication from the Pyxis. There was no documentation that the medication was wasted or returned.
On 5/25/23, review of the Physician's Medication orders found in MR10 in the presence of S11, failed to identify valid orders for the removal of Hydromorphone 2mg/ml injection from the Pyxis.

On 5/25/23 at 4:33 PM, S1 confirmed the findings that medications were removed from the Pyxis using an override without physicians' orders, and that the documentation found in MR4, MR5, MR8, and MR10 indicated that Hydromorphone 2mg/ml injection was administered without a physicians' order. However, S1 would not confirm that the Hydromorphone was administered to each of the patients, P4, P5, P8, and P10 based on the documented patient outcomes and the fact that S14 was under investigation for drug diversion.

Reference: Facility policy titled "Automated Dispensing Cabinets" dated 2/2/23, states, "...Override Function: A limited number of "emergency" medications have been approved by the Pharmacy and Therapeutics Committee for which the override function is available... Prior to attempting to override any approved medication, the nurse must ensure that: There is a new in-date active order for the desired medication..."

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

Findings include:

1. The facility failed to ensure the implementation of policies and procedures that limit and monitor the access to Controlled Dangerous Substances stored in the Pyxis, an Automated Dispensing Cabinet. (Cross refer to Tag A-0500)

2. The facility failed to ensure that expired or mislabeled medications are removed from active inventory. (Cross refer to Tag A-0505)

3. The facility failed to ensure that an incidence of Controlled Dangerous Substance (CDS) diversion was reported in accordance with facility policy. (Cross refer to Tag A-0509)

Based on the review of facility documents and staff interviews, it was determined that the facility failed to ensure the implementation of policies and procedures that limit and monitor the access to Controlled Dangerous Substances (CDS) stored in the Pyxis, an Automated Dispensing Cabinet.

Findings include:

During an interview conducted on 5/25/23 at 10:20 AM, Staff (S)1, Vice President of Risk and Corporate Compliance Officer, detailed the findings of the facility's investigation into a suspected drug diversion by S14, a Registered Nurse (RN). The facility determined that an update to the facility's Pyxis, an automated dispensing cabinet, software issued on or about 3/30/23, also changed the list of medications that may be overridden and removed by nursing staff. Prior to 3/30/23, Hydromorphone (Dilaudid)(narcotic) 2 mg (milligram)/ ml (milliliter) for injection was not included on the list of emergency medications available for override. However, after the software update, Hydromorphone 2mg/ml was available for emergency removal from the Pyxis with an override. On 5/25/23, during the facility tour of the Medical Intensive Care Unit (MICU), the Pyxis was inspected and Hydromorphone 2mg/ml was not included on the list of emergency drugs available with an override.

On 5/25/23, review of the Pyxis "All Transactions Activity Detail Report" for the time period of 3/30/23 through 4/28/23 indicated that the first time Hydromorphone 2mg/ml for injection was removed from the Pyxis with an override was on 4/16/23 at 00:27. Between 4/16/23 and 4/26/23, Hydromorphone 2mg/ml was removed from the Pyxis thirty times with an override.

On 5/25/23 at 12:25 PM, during a tour of the Pharmacy, S1 stated that S9, the Interim Director of Pharmacy, was responsible for the review of all the daily override reports that print in the pharmacy. These reports were found stored in a binder located in the pharmacy.

On 5/25/23 at 1:20 PM, during an interview conducted by phone, S10, a Pharmacist, stated that he/she thought that the first day the Anomalous CDS Usage reports were reviewed regarding S14, was 4/25/23. That was when he/she noticed that Hydromorphone 2mg/ml for injection was removed from the Pyxis with an override by S14. S10 confirmed that Hydromorphone should not have been accessed with an override, and started to investigate.

The facility failed to identify that Hydromorphone 2mg/ml for injection, a Schedule II CDS, was removed with an override thirty times over a ten day period. The facility failed to fully inspect the the daily override reports in accordance with facility policy.
This was confirmed by S10 on 5/25/23 at 1:35 PM.

Reference: Facility policy titled, "Automated Dispensing Cabinets" dated 2/2/23, states, "...Override Function; A limited number of "emergency' medications have been approved by the Pharmacy and Therapeutics Committee for which the override function is available regardless of the patient's medication profile... Override Review & Follow-up Procedure; Override Reports for each profile patient care unit will be automatically generated in the pharmacy on a daily basis. Each override report must be reviewed for appropriateness by the Pharmacy Manger or designee. Pharmacy Manager or designee is to ensure that: a. There was an in-date active order for the overridden medication. b. The drug was not already listed in the patient profile prior to override. c. An override that does not meet all of the above criteria will be considered an Inappropriate Override. For each questionable override, [the] Pharmacy Manager or designee will summarize the results of the override report review and send the results to the nurse manager for further review..."

Based on random observations, facility document review, and staff interviews, it was determined that the facility failed to ensure that expired or mislabeled medications are removed from active inventory.

Findings include:

During a tour of the Medication Room located on the Medical Intensive Care Unit (MICU) in the presence of Staff (S)2, a Registered Nurse (RN), on 5/25/23 at 11:30 AM, the following expired medications were found stored in the refrigerator:

One 100 ml (milliliter) container of Ferric Gluconate 125 mg (milligrams) in sodium chloride 0.9% with an expiration date of 5/23/23, labeled for Patient (P)1. On 5/25/23 at 2:05 PM with S11, a Registered Nurse (RN), the medication order details for this medication dated 5/17/23, found in the medical record stated, "..Order status: Completed Wed [Wednesday] May 17, 2023 0919, originally scheduled to end Thu [Thursday] May 18, 2023 0859..." The medical record also indicated that P1 was discharged on 5/22/23.

One opened vial of Semglee, insulin, with an expiration date of 5/7/23, labeled for P2. Review of Medical Record 2 on 5/25/23 at 2:10 PM with S11, a RN, indicated that P2 was discharged from the facility on 5/10/23.

On 5/25/23 at 11:40 AM, S1 and S3, a MICU RN, confirmed these findings and stated that the medications should have been removed from the refrigerator.

During a tour of the Medication Room located on the MICU in the presence of S2, on 5/25/23 at 11:30 AM, an opened needle punctured multi dose vial of Humalog, insulin, was found stored in the medication refrigerator without a patient specific label. This was not in accordance with facility policy referenced below.

During an interview on 5/25/23 at 11:50 AM, S7, the MICU Nurse Manager, stated that unopened multi dose vials of Humalog are stored in the Pyxis and when they are removed, a patient specific label prints out. Nursing staff are required to affix the patient specific label to the vial, and then store the vial in the patient specific medication drawer at room temperature once opened. S7 confirmed this finding and stated that the Humalog vial should have had a patient specific label and been stored in a patient specific drawer.

Reference: Facility policy titled, "Multiple Dose Containers Policy" dated 11/7/22, states, "...Insulin Vials in Inpatient Care Areas: Pharmacy will label each vial with 28 day expiration date immediately prior to placing the vials in ADC (automated drug cabinet). Humalog...insulin vials are store in the Automated Dispensing Cabinets (ADCs) on Inpatient Units. Upon removal of Humalog insulin vial from ADC for a specific patient by a nurse, a label in printed by the ADC, the nurse then proceeds to affix this patient specific label to the Humalog vial...Nurses will remove only one vial of Humalog insulin per specific patient and keep in in a locked patient's cassette for the duration of the patient's stay..."

Based on facility document review and staff interview, it was determined that the facility failed to ensure that an incidence of Controlled Dangerous Substance (CDS) diversion is reported in accordance with facility policy.

Findings include:

During an interview on 5/25/23 at 10:15 AM, Staff (S)1, Vice President of Risk and Chief Compliance Officer stated that the facility reported the incidence of drug diversion involving S14, a Registered Nurse, to all of the required State and Federal agencies. Documentation of that reporting was requested at that time.

On 5/25/23 at 4:20 PM, S1 was unable to provide documentation that the facility submitted the Healthcare Professional Responsibility and Reporting Enhancement Act Reporting Form for S14, as required by State regulation and facility policy. S1 stated that the Form was not submitted, however the facility would submit the Form on the survey day, 5/25/23.

Reference: Facility policy titled, "Diversion Program" dated 1/31/23, states, "...Reporting... In accordance with the NJ [New Jersey] Health Care professional responsibility and Reporting Enhancement Act- Healthcare Professional Responsibility and Reporting Enhancement Act Form must be filed out by the manager of the individual suspected in diversion..."

Reference: N.J.A.C. 13:45-E Healthcare Professional Reporting Responsibility states, " ... 13:45E-3.1 NOTIFICATION TO THE CLEARING HOUSE COORDINATOR BY A HEALTH CARE ENTITY a) Except as provided in (c) below, a health care entity shall file a report with the Clearing House Coordinator concerning a health care professional who is employed by, under contract to render professional services to, or has clinical privileges granted by that health care entity, or who provides such services pursuant to an agreement with a health care services firm or staffing registry if: 1) For reasons relating to the health care professional's impairment, incompetency or professional misconduct, which incompetency or professional misconduct relates adversely to patient care or safety, the health care entity: i) Summarily or temporarily revokes or suspends or permanently reduces, suspends or revokes the health care professional's full or partial clinical privileges or practice; ii) Removes the health care professional from the list of eligible employees of a health services firm or staffing registry; iii) Discharges the health care professional from the staff of the health care entity; or iv) Terminates or rescinds a contract with the health care professional to render professional services ... "