HospitalInspections.org

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Based on document review, medical record review, and interview, the hospital failed to promote and protect patient rights.

Failure to promote and protect each patient's rights risks physical and psychological harm, and loss of patient dignity.


Findings included:

1. Failure to promptly and thoroughly investigate and resolve allegations of controlled substance diversion and failure to incorporate evidence based references into policy.

Cross Reference Tag # A0144


Due to the scope and severity of deficiencies under 42 CFR §482.13, the Condition of Participation: Patient Rights was NOT MET.

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Based on document review, medical record review, and interview, the hospital failed to ensure that staff nurses, nurse managers, and the chief nursing officer complied with hospital policies and procedures related to accountability of controlled substances in accordance with state and federal laws and regulations.

Failure to ensure compliance with policies and procedures for controlled substance places patients at risk for harm, poor pain control and potential staff diversion of controlled substances.

Findings included:

1. Failure to promptly investigate and resolve narcotic variances in a timely manner and failure to accurately maintain proactive diversion surveillance.

Cross Reference Tag # A0398


Due to the scope and severity of deficiencies under 42 CFR §482.23, the Condition of Participation: Nursing Services was NOT MET.

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Based on document review, medical record review, and interview, the hospital failed to ensure compliance with use and accountability of controlled substances in accordance with state and federal laws and regulations.

Failure to ensure accurate records for controlled substance accountability places patients at risk for harm, poor pain control and potential diversion by staff.

Findings included:

1. Failure to ensure a proactive diversion program for all staff members with access to controlled substances.

Cross-reference: Tag A0494


Due to the scope and severity of deficiencies under 42 CFR §482.25, the Condition of Participation: Pharmaceutical Services was NOT MET.

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Based on document review, interview, and review of hospital policies and procedures, the hospital failed to provide care in a safe environment by ensuring that allegations of controlled substance diversion were promptly and thoroughly investigated (Item #1) and to incorporate referenced recommendations in the Prevention of Retained Surgical Items policy (Item #2).

Failure to promptly and thoroughly investigate allegations of controlled substance diversion and to incorporate best practice recommendations into policies may lead to patient harm and death.


Item #1 Proactive Diversion Surveillance

1. Review of the hospital document titled, "Bluesight Nursing Review Process," v.5, dated 05/20 and active at the time of the diversion events, showed that once a month, unit leadership will check the IRIS Dashboard Rankings for their assigned areas and review details on the top 3 providers by deviation from the norm, to see if there is any suspicious activity. During the monthly review, the unit leader will:

a. Select each behavior metric to review information contributing to the IRIS score.

b. Complete and submit the review and attach the downloaded investigation data from the monthly review. Add department leadership and pharmacy as collaborators and submit.

2. Review of internal hospital documents showed that Staff #1, a registered nurse (RN), was employed by the hospital in the post-anesthesia care unit (PACU) from 11/27/23 until 07/29/24, when Staff #1 fled the hospital after discovering that their automated drug dispensing cabinet (ADC) access had been suddenly revoked.

3. On 02/05/25 between 11:00 AM and 2:00 PM, Investigator #1 reviewed internal hospital documents during separate interviews with the Director of Pharmacy (Staff #2) and the Director of Perioperative Services (Staff #7). The interviews and document review showed:

a. Between 11/27/23 and 07/29/24, Staff #1 diverted 62 vials of fentanyl (a narcotic pain medication) and 21 cartridges of hydromorphone (a narcotic pain medication), in addition to smaller quantities of other controlled substances.

b. On 07/16/24, The PACU Manager (Staff #9) stated that "a few" PACU RNs reported saftey concerns about Staff #1's handling of controlled substances, but Staff #9 attributed the concerns to differences in perception.

c. Staff #9 checked Staff #1's ADC discrepancies and found nothing wrong. Staff #9 did not follow the required Bluesight Nursing Review process for suspected diversion.

d. Staff #9 did not follow up on staff concerns by directly observing Staff #1, filing a patient safety alert, contacting the pharmacy, or escalating to the operating room (OR) or other surgical service leadership.

e. On review, Staff #7 found over 500 PACU controlled substance variances.


Item #2 Post Operative Instrument Counts


Based on document review, interview, and review of hospital policies and procedures, the hospital failed to adopt the practices referenced in its Retained Surgical Item Prevention policy.

Failure to ensure the use of referenced best practices places patients at risk for substandard care.


Reference:

Association of Perioperative Registered Nurses (AORN) Guidelines for Prevention of Retained Surgical Items (RSI)

1. Account for instruments in all procedures for which the likelihood exists that an instrument could be retained.

2. Count instruments for all procedures involving an open body cavity (i.e., thorax, abdomen).

3. The World Health Organization recommends that health care organizations determine which instruments will be counted and which procedures will have instrument counts, to include procedures involving open cavities.


Findings included:

1. Review of the hospital policy titled, "Retained Surgical Item Prevention," PolicyStat ID 15886689, effective 06/25/24, showed:

a. The policy information was adopted based on references found in the "Guideline for prevention or retained surgical items." In: Guidelines for Perioperative Practice. Denver, CO: AORN

b. In contrast to the AORN guidelines, the policy stated, "to preclude possible retention of a surgical instrument, intraoperative imaging, in lieu of instrument counts, will be performed before the patient is transferred from the operating room (OR)." No reference was provided.

2. On 02/06/25 at 11:20 AM, Investigator #1 observed a post-operative patient in the OR immediately following an open cardiac procedure. Investigator #1 interviewed the circulating registered nurse (RN)(Staff #8) about prevention of unintended retained surgical items (URI) in patients. Staff #8 stated that two people counted all soft goods such as sponges or packing, and sutures/needles. Staff #8 stated that they did not count surgical instruments because every patient received an x-ray after cavity closure to be sure that no operative instruments were inadvertently left inside.

3. On 02/06/25 at 12:00 PM, Investigator #1 interviewed the Director of Perioperative Services (Staff #7). Staff #7 confirmed that it was not the hospital's practice to perform post operative instrument counts.

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Based on document review, interview, and review of hospital policies and procedures, the hospital failed to ensure that staff nurses (RNs), nurse managers, and the chief nursing officer (CNO) followed proactive diversion detection policies and procedures as required by hospital policy.

Failure to follow proactive diversion detection policies and procedures places patients at risk for inadequate pain control, exposure to blood borne pathogens, and poor outcomes.

Findings included:

1. Review of the policy titled, "Controlled Substance Management Acute Care," PolicyStat ID 16814780, effective 11/12/24, showed:

a. The policy purpose was to establish a standardized process for the effective monitoring, analysis, and reporting of drug diversion activities to ensure safe medication practices and regulatory compliance.

b. The nurse manager or designee will receive a monthly report of all discrepancies and resolutions.

c. Any discrepancies in the controlled substance count will be investigated within 24 hours and an action plan regarding reconciliation will be completed within 72 hours. Reports should be resolved within 2 weeks.

d. The CNO or designee will follow up with each nurse manager to ensure appropriate and timely resolution of all discrepancies.

Review of the document titled, "ControlCheck Diversion Analytic Program Sop," PolicyStat ID 17033051, effective 11/12/24, showed:

a. Open variances (discrepancies related to the amount of controlled substance administered versus the amount dispensed) are reviewed within 72 hours at minimum. Unresolved variances should be entered into the hospital safety event review platform.

b. Nurse managers and directors must review the Individual Risk Identification Score (IRIS) monthly surveillance reports to identify staff with behavior abnormalities associated with diversion. Abnormalities must be investigated within 2 weeks.

Review of the hospital policy titled, "Event Reporting and Management Procedure, Clinical A-023P," PolicyStat ID 14655701, effective 10/23, showed that employees must immediately notify their department leader/designee of any event that appears to fall within the definition of a serious safety event and file a patient safety alert.

2. On 02/05/25 between 11:00 AM and 2:00 PM, Investigator #1 reviewed internal hospital documents in separate sessions with the Pharmacy Director (Staff #2) and the Perioperative Services Director (Staff #7). The documents showed:

a. While employed at the facility between 11/27/23 and 07/29/24, Staff #1 diverted 62 vials of fentanyl (a narcotic pain medication), 21 cartridges of hydromorphone (a narcotic pain medication), and smaller quantities of other narcotics and controlled substances.

b. In June 2023, two RNs verbally reported concerns to their unit manager about Staff #1's behavior, which included frequent unexplained absences from the unit, frequent and overlong trips to the restroom, and dozing while at their workstation. In July 2023, another RN reported the same concerns through email to to the unit manager. The unit manager did not follow the policy and procedure for suspected diversion. None of employees filed a patient safety alert.

c. Staff #1 continued to divert narcotics until 07/29/24, when Staff #2 revoked Staff #1's access to all automated drug dispensing cabinets. Staff #1 fled the hospital before they could be interviewed.

d. The hospital's investigation identified 498 patients who may have been exposed to blood borne pathogens as a result of Staff #1's diversion.

3. On 02/05/25 between 1:30 PM and 3:00 PM, Investigator #1 individually interviewed 2 Post Anesthesia Care Unit (PACU) RNs (Staff #10, Staff #11) and 3 Emergency Department RNs (Staff #12, Staff #13, Staff #14). None of the RNs interviewed stated that they would file a patient safety alert if they suspected a coworker of diversion.

4. On 02/05/25 at 3:30 PM, Investigator #1 interviewed the Director of Emergency Services (Staff #4). Staff #4 stated that they were unfamiliar with monitoring the IRIS surveillance report and did not know how to run the surveillance report using ControlCheck Software. Staff #4 did not recall receiving any recent training about diversion surveillance or how to run surveillance reports using Control Check software.

5. On 02/05/25 at 12:29 PM, Investigator #2 interviewed the critical care unit (CCU) manager (Staff #20) and the CCU supervisor (Staff #21) about the hospital's proactive diversion process. Staff #20 and Staff #21 stated that they review pharmacy variance reports daily. Staff #20 stated that if a variance occurs, she will send a screenshot of the variance to the nurse involved, and the nurse is expected to respond by then end of their next scheduled shift. Staff #20 and Staff #21 stated that they had not received training on how to run the Individual Risk Identification Score (IRIS) report and were not aware of any hospital requirements to do so.

6. On 02/05/25 at 3:00 PM, Investigator #2 interviewed the Procedural Services Manager (Staff #23) about the hospital's proactive narcotic diversion training process. Staff #23 stated that he knew how to run individual staff usage reports, but he had received no formal or recent education on the hospital's proactive diversion processes. Staff #23 was unaware of any policy or procedures requiring monthly surveillance report reviews.

7. On 02/10/25 at 11:07 AM, Investigator #1 interviewed the Regional Manager of Clinical Education (Staff #5), and reviewed diversion education documents produced and assigned to staff as follow-up to Staff #1's diversion event. Staff #5 stated that the diversion prevention education module was assigned to all bedside care registered nurses on 01/11/25, with an expectation of 100% completion within 30 days. At the time of interview, Staff #5 stated that 55% of bedside RNs had completed the education. Staff #5 confirmed that RN managers and directors had not been assigned the diversion education but was not sure why.

8. Investigator #1 reviewed the Medication Safety Committee (MSC) meeting minutes, dated 12/23/24. The minutes showed:

a. 91 staff members with Red IRIS user scores (IRIS score ranges from green (no anomaly) to red (most anomalous) when compared to peers waiting for investigation).

b. The group considered historical variances and decided to notify nursing and anesthesia leaders to document all variances greater than 30 days old as "closed, unable to reconcile, due to staff members likely to be unable to recall the circumstances that created the variance."

9. On 02/12/25 at 4:52 PM, Investigator #1 reviewed an email response from the Director of Pharmacy (Staff #2). The email showed that 4,142 historical event summaries (variances) occurring between 01/01/24 and 06/30/24 were archived without an investigation completed because the Medication Safety Committee didn't think that people would be able to remember specific circumstances surrounding each variance. Currently there is no ability to account for the medications in question, and no further analysis has been performed.

10. On 02/12/25 at 11:30 AM, Investigator #1 reviewed internal documents with Staff #2. Staff #2 stated that Control Check software was used for controlled substance surveillance monitoring. The software produced an "IRIS" report that flagged individual utilization as green (least anomalous), yellow, or red (most anomalous). The report was not as accurate as it could have been because Staff #2 did not yet have the list of nurses by unit necessary to compare usage among like groups. As of 02/10/25, the report showed 4 registered nurses who had flagged red. For the time period between 07/01/24 and 02/12/25, 83 event summaries remained unresolved.

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Based on observation, document review, interview, and review of hospital policies and procedures, the hospital failed to fully implement, monitor, and evaluate a proactive diversion monitoring program that included all clinical areas and services.

Failure to maintain a comprehensive proactive diversion program and ensure accurate records for controlled substance tracking places patients at risk for inadequate pain control and harm and provides opportunities for staff diversion of controlled substances.

Findings included:

1. Review of the policy titled, "Controlled Substance Management Acute Care," PolicyStat ID 16814780, effective 11/12/24, showed:

a. VMFH will sustain compliance to the Drug Enforcement Agency through processes and policies that require immediate detection, investigation and reporting, maintaining accountability and proper dispensing of all narcotics and controlled substances.

b. The policy establishes a standardized process for the effective monitoring, analysis, and reporting of drug diversion activities to ensure safe medication practices and regulatory compliance.

Review of the policy titled, "ControlCheck Diversion Analytic Program Sop," PolicyStat ID 17033051, effective 11/12/24, showed that the policy applied to inpatient nursing units and procedural areas where controlled substance medications are distributed and/or wasted through the automated dispensing cabinets (ADC). The policy failed to specify that it applied to credentialed providers responsible for the administration of controlled substances to patients.

Review of the policy titled, "Pharmacy Automated Drug Dispensing Devices," PolicyStat ID 16116801, effective 07/24, showed:

a. Automated Drug Dispensing Devices (ADDD) policies and procedures cover diversion prevention and monitoring in procedural areas.

b. Quality assurance activities include auditing of anesthesia records for one day each week.

2. On 02/05/25 at 11:30 AM, Investigator #1 reviewed a variance report and while interviewing the Pharmacy Director (Staff #2). Staff #2 stated that the anesthesiology diversion prevention process differed from the nursing process. The anesthesia department head was responsible for reviewing and ensuring reconciliation for all variances created by anesthesia providers. Staff #2 stated that the facility did not audit anesthesia records for one day each week as required by hospital policy. At the time of review, Staff #2 confirmed that for the time period between 11/01/24 and 01/31/25, the variance report for anesthesia providers contained 16 unresolved variances, with 8 unresolved for greater than 72 hours.

3. On 02/05/25 at 3:40 PM, Investigator #1 interviewed the Chief of Anesthesiology (Staff #3). Staff #3 stated that they did not receive or run diversion surveillance reports for anesthesia providers.

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