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Based on review of facility documents and staff interviews, it was determined that the facility failed to ensure the development and implementation of policies and procedures that outline the processes utilized for the monitoring for, and investigation of drug diversion.

Findings include:

During an interview conducted by phone on 8/30/23 at 11:55 AM, Staff 3 (S3), the Drug Diversion Specialist, explained that the facility utilized an analytic software called "Fair Warning" to monitor the administration and disposition of Controlled Dangerous Substances (CDS). S3 stated that the facility had a contract with the vendor for the "Fair Warning" software for a "few years," however they had only started utilizing the reports in the past year or so.
S3 explained that the "Fair Warning" software identified potentially concerning CDS behaviors and produced reports that allowed the facility to investigate practices surrounding the utilizations of CDS by specific staff members. One of the reports that the software compiled is "Fair Warning [name of specific type] Memorandum" which would be emailed to the Drug Diversion Specialist and the specific Unit Manager. During the interview, S3 explained that the specific Unit Manager would be responsible for addressing the issue identified in the emailed Memorandum, for example: delayed CDS waste, excessive CDS waste, or other issues with CDS documentation, with the staff member identified.
The Fair Warning Memorandums state, "... Response is required within 7 business days. A failure to respond will result in your supervisor being included on the follow up inquiry email... Your response will be forwarded to the Drug Diversion Specialist. If the response requires additional actions, they will reach out to you directly..."
During an interview on 8/30/23 at 2:10 PM, S16, the Nurse Clinical Director, explained the process he/she followed when a Fair Warning Memorandum was received. S16 stated that he/she reviewed the information, the Omnicell, an automated dispensing cabinet, medication withdrawals and corresponding medical records. S16 stated that he/she would interview the staff member involved, provide education regarding facility policy if required, and provide a response to the Fair Warning Memorandum with the results of his/her investigation. During the interview, S16 was asked to provide documentation of the responses to the Memorandums sent for S5 and S6, both Registered Nurses. S16 confirmed that he/she knew that the responses to the Memorandums were due within seven days of receipt. S16 stated that he/she frequently could not respond to the Fair Warning emails within seven days. S16 failed to provide documentation of the required responses to the Fair Warning Memorandums for S5 and S6 on 8/30/23 at 2:15 PM.

During an interview on 8/31/23 at 2:06 PM, S3, the Drug Diversion Specialist, was asked about the process he/she follows when utilizing the staff specific Fair Warning Memorandums for investigating concerning CDS practices. S3 stated that he/she had to wait for the Unit Managers to complete the initial investigation with the staff member in question, prior to acting on the Memorandum and starting his/her own investigation.
On 8/31/23 at 1:15 PM, a policy addressing the utilization of the Fair Warning Software and the documentation of the required investigation was requested.
On 8/31/23 at 2:10 PM, S3, the Drug Diversion Specialist, S4, the Director of Pharmacy, and S10, the Pharmacy Clinical Director, confirmed that the facility did not have a policy that addressed the utilization of the Fair Warning software or the follow up required by the Unit Managers. S3 stated that even though the software was in use for at least a year, he/she didn't think a policy was needed because the facility wasn't sure if they were going to keep the analytic software.

Based on review of facility documents and staff interviews, it was determined that the facility failed to ensure that Controlled Dangerous Substance (CDS) diversions are reported in accordance with facility policy and State and Federal regulations.

Findings include:

During an interview on 8/30/23 at 10:00 AM, documentation of the reporting of suspected drug diversion index case to the required State and Federal agencies was requested from Staff 1 (S1), the AVP of Accreditation/Regulatory and Patient Safety, and S2, Regulatory and Safety Coordinator.
During an interview conducted by phone on 8/30/23 at 12:12 PM, Staff 3 (S3), the Drug Diversion Specialist, confirmed that the facility had two staff members, S5 and S6, both Registered Nurses (RNs), that were recently terminated due to two separate drug diversion investigations. The reporting documentation for both incidences of drug diversion were requested.

On 8/31/23, the Health Care Professional Responsibility and Reporting Enhancement Act Reporting Forms submitted for S5 and S6 were reviewed. The Form states, "Reports are to be submitted within seven (7) days of reportable action or event to ... New Jersey Division of consumer Affairs..." The Form submitted for S6 was dated 8/8/23, however the DEA (Drug Enforcement Administration) Form 106, related to the incident with S6, states that the, "Date of the Theft or Loss" was 7/12/23. During an interview by phone with S3, the Drug Diversion Specialist, on 8/30/23 at 12:15 PM, it was confirmed that the police were called and S6 was arrested on 7/12/23. This is more than 7 days before the Health Care Professional Responsibility and Reporting Enhancement Act Reporting Form was submitted. The facility failed to submit the Form within the required time frame.

On 8/31/23, the facility failed to provide documentation that S5, a RN, or S6, a RN, were reported to the New Jersey Board of Nursing for their involvement in drug diversion, as required by facility policy referenced below. This was confirmed by S1, the AVP of Accreditation/Regulatory and Patient Safety, on 9/5/23 by email.

Reference: Facility policy titled "Prevention and Suspected Drug Diversion, Theft, Loss, and Reporting Policy" dated 12/19/22, states, "... Individuals who possess, sell, use, or divert controlled substances or medications, shall be reported to their state licensing board (e.g. ...Board of Nursing, etc.) where applicable, and to state or federal law enforcement... DEA [Drug Enforcement Administration]: Pharmacy Director(s) will submit Form #106 to report loss, or theft of controlled substances to the DEA within an acceptable timeframe... Human Resources shall report to the New Jersey Division of Consumer Affairs for any licensed... healthcare provider subject to reporting under the NJ [New Jersey] Healthcare professional Responsibility and Reporting Act..."