HospitalInspections.org

Based on document review and interview, the facility failed to ensure the QAPI (Quality Assessment and Performance Improvement) program focused on indicators related to the prevention and reduction of scheduled drug diversion.

Findings:

- Tag A-0283: The facility failed to investigate and escalate reports of potential narcotic diversion and/or staff impairment while on duty, in two (2) of three (3) reports.

- Tag A-0489: The facility failed to develop pharmaceutical policies and procedures (P&Ps) that minimize the potential for narcotic diversion.

Based on document review and interview, in two (2) of three (3) related suspected narcotic diversions, the facility failed to investigate and escalate reports of potential narcotic diversion and/or staff impairment while on duty.

This failure may have placed patients at increased safety risk due to staff's potentially compromised ability to provide safe care.

Findings:

The facility policy and procedure (P&P) titled, "Incident / Patient Safety Event Reporting," last dated 10/21/2020 stated, "An incident is a deviation from the routine operation of the hospital or...employee ...Any individual in any department identifying a potential safety issue or incident will immediately notify his or her supervisor and document the findings on an Incident Report."

1) Personnel File for Staff F (Registered Nurse/RN) revealed Staff F was suspected of working while impaired on 4/29/2020. An Incident Report was completed, and Staff F was administered a urine drug screen on 4/29/2020, that resulted negative on 5/2/2020.

2) Electronic mail from Staff H (Chief Nursing Officer/CNO) to Staff A (Director of Quality Assurance) dated 1/24/2022 at 11:04AM, stated that a letter [attached to the email] was hand-delivered to Staff H by Staff J (Chairman of Obstetrics/Gynecology) on 8/31/2021. The unsigned/undated letter was written by resident physicians who alleged that "for the past weeks to month, Staff F (RN) has been stealing morphine from post-cesarean section patients." The resident physicians described Staff F with "frequent mood shifts, drowsiness, and even noticeable pinpoint pupils."

As per the attached letter, the resident physicians observed the "impaired" behavior by the nurse for "weeks to a month," before reporting it to their director. No Incident Report was completed by the resident physicians or Staff J at the time the letter was submitted to Staff H on 8/31/2021.

The electronic mail from Staff H to Staff A also stated that Staff M (Assistant Chief Nursing Officer) "assessed" Staff F at the time the letter was submitted to Staff H [on 8/31/2021] and Staff M found "no signs or symptoms of impairment." No Incident Report was filed at the time Staff F was assessed, and no further investigation was performed of Staff F, who was previously suspected of working while impaired on 4/29/2020.

Upon request, no Incident Report or other documented evidence was furnished that this report of suspected staff impairment and narcotic diversion was escalated for monitoring or further investigated.

Per interview of Staff A on 1/24/2022 at 12:41PM, Staff A stated, "I only found out about this today," when asked if they were notified of Staff F's suspected impairment while on duty in August 2021. Staff A confirmed that an Incident Report would have triggered a formal investigation into these claims and that since no Incident Report was completed, no investigation was initiated.

Per interview with Staff K (Director of Human Resources) on 1/24/2022 at 12:25PM, Staff K stated, "This was never brought to my attention," when asked about Staff F's suspected impairment while on duty.

3) Electronic mail from Staff G (Head of the Diversion Committee) to Staff H (Chief Nursing Officer/CNO) dated 12/29/2021 at 10:13AM stated that during a review of Staff F's narcotic transactions, it was identified that on 10/8/2021 at 2:37PM, Staff F removed Butorphanol (Stadol) [a morphine-type opioid analgesic used to treat pain] 2mg/ml from the Labor and Delivery (L&D) PYXIS [a medication dispensing machine]. There was no documented evidence that this narcotic medication had been administered to the patient, returned or wasted [when a narcotic medication is partially administered or not administered, and the remaining amount is discarded]. The disposition of this medication was unknown.

Per interview of Staff A (Director of Quality Management) on 2/1/2022 at 12:56PM, Staff A confirmed these findings. Staff A also stated "Once a case of possible diversion is identified, the review is conducted and completed by Pharmacy and the Department of Nursing as appropriate. Additionally, HR [Human Resources] and/or CSEA [labor union] may get involved as we are a union facility. [The facility] does not have a formal policy delineating the investigation for suspected or actual narcotic diversion."

Per interview with Staff B (Director of Pharmacy) on 2/2/2022 at 11:45AM, Staff B acknowledged that no investigation was performed into the missing narcotic.

Staff F was found deceased on the L&D Unit on 12/19/2021 at 7:18AM. The Medical Examiner's (ME) Report of Autopsy, dated 2/28/2022 and reviewed 4/11/2022, identified Staff F's cause of death as "Acute intoxication by the combined effect of Ketamine [a short acting anesthetic with hallucinogenic effects] and Fentanyl [a scheduled narcotic opioid pain reliever medication]" The manner of death stated, "Accident."

Based on document review and interview, the facility failed to develop pharmaceutical policies and procedures (P&Ps) that minimize the potential for narcotic medication diversion.

Findings:

- Tag A-0494: The facility failed to maintain current and accurate records of the disposition of a scheduled drug.

- Tag A-0508: The facility failed to investigate and/or report drug administration discrepancies to the Quality Assessment Performance Improvement (QAPI) program.

Based on document review and interview, in one (1) of one (1) missing narcotic doses, the facility failed to maintain current and accurate records of the disposition of a scheduled drug.

This failure placed all patients at risk of not receiving pain medication as ordered.

Findings:

Electronic mail from Staff G (Head of the Diversion Committee) to Staff H (Chief Nursing Officer/CNO) dated 12/29/2021 at 10:13AM stated that a review of Staff F's (Registered Nurse/RN) narcotic transactions was performed. The review identified that on 10/8/2021 at 2:37PM, Staff F removed Butorphanol (Stadol) [a scheduled narcotic pain reliever medication] 2mg/ml from the Labor and Delivery (L&D) PYXIS [a medication dispensing machine]. No documented evidence that the medication was administered to the patient was found.

Per interview of Staff I (Assistant Executive Director) on 1/31/2022 at 1:10PM, there is no technical method in PYXIS to track scheduled medications removed that are not documented as administered.

Per interview of Staff B (Director of Pharmacy) on 2/2/2022 at 11:45AM, Staff B confirmed the pharmacy does not regularly trace the movement of scheduled drugs once they are removed from the PYXIS, except for waste or returns. The record of distribution of controlled medications from dispension to patient administration are not kept in a readily retrievable manner to facilitate reconciliation of all scheduled drugs. Staff B added that "there is a level of trust once the nurse removes the meds from the PYXIS" that they are going to administer it to the patient.

Per interview of Staff A (Director of Quality Management) on 2/1/2022 at 12:56PM, Staff A stated that MARs (Medication Administration Records) are not regularly compared to PYXIS narcotic withdrawals or routinely monitored by either Pharmacy or the Department of Nursing.

Based on document review and interview, in two (2) of two (2) discrepant narcotic transactions, the facility failed to investigate and/or report drug administration discrepancies to the Quality Assessment Performance Improvement (QAPI) program.

Findings:

The facility's Report of Staff Death on Premises, dated 12/19/2021 at 1:51PM, documented that Staff F (Registered Nurse) was found deceased by a suspected overdose on 12/19/2021 at 7:18AM in the Labor and Delivery (L&D) Unit. The police were notified and responded, establishing the area as a crime scene. A syringe was found on the bathroom floor and "prescription pills / paraphernalia" were inside her handbag. The body was removed at 11:45AM by the Medical Examiner (ME).

Per interview of Staff L (Chair of Anesthesiology) on 1/24/2022 at 11:00AM, Staff L stated that Fentanyl [a scheduled narcotic opioid pain reliever medication] is only accessible by the Anesthesiologists from the Anesthesia PYXIS [a medication dispensing machine] via fingerprint access. The Fentanyl is not stored in any Nursing PYXIS machines and the facility nurses do not have access to the Anesthesia PYXIS.

(1) Email communication from Staff G (Head of the Diversion Committee) to Staff H (Chief Nursing Officer/CNO) dated 12/29/2021 at 10:13AM, identified that on 12/17/2021, Staff F (Registered Nurse/RN) and Staff E (RN) wasted [when a narcotic medication is partially administered or not administered, and the remaining amount is discarded] 100mcg of Fentanyl.

(2) The review also identified that on 10/8/2021 at 2:37PM, Staff F removed Butorphanol (Stadol) [a morphine-type opioid analgesic used to treat pain] 2mg/ml from the nursing Labor and Delivery (L&D) PYXIS [a medication dispensing machine]. There was no documented evidence that this medication was administered to the patient, wasted, or returned to Pharmacy.

The facility policy and procedure (P&P) titled "Administration of Medications," last dated 7/8/2021 stated, "The nurse may not have controlled drugs in his/her possession unless she is administering them to a patient ..."

Upon request, the facility could not furnish documented evidence an investigation was conducted by Pharmacy or QAPI for the Fentanyl wasted by the nurses, or the missing Stadol, upon their discovery by the facility.

Upon request, the facility could not furnish a P&P delineating the investigation of suspected or actual diversion.

Per interview of Staff A (Director of Quality Management) on 1/24/2022 at 1:56PM, Staff A confirmed this finding.

Per interview of Staff B (Director of Pharmacy) on 2/2/2022 at 11:45AM, Staff B acknowledged there was no documented investigation into the narcotic discrepancies.
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The ME's Report of Autopsy, dated 2/28/2022 and reviewed 4/11/2022, identified Staff F's cause of death as "Acute intoxication by the combined effect of Ketamine [a short acting anesthetic with hallucinogenic effects] and Fentanyl," and the manner of death as "Accident."