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Based on observation, interviews, and document review, the Governing Body, legally responsible for the conduct of the hospital, did not ensure the medical staff was accountable to the Governing Body for the quality of care and services provided to patients when medical staff reports to the Governing Body did not include information regarding discrepancies in the accounting practices of controlled medications (medications classified by government agency as having the potential for abuse or addiction). (Refer to A-049, A-0263, and A-0489)

This failure had the potential to permit staff to divert (unauthorized removal) controlled medications from patients resulting in patients not receiving medications needed to alleviate pain or staff working in an impaired condition. This failure also resulted in facility being unable to determine potential theft of controlled medication. This failure had the potential to impact the care of 777 patients who received care at the facility in 2024.

The cumulative effect of these systemic problems resulted in the inability of the Hospital to comply with the statutorily mandated Condition of Participation for Governing Body.

Based on observations, interviews and record review the hospital failed to implement and maintain an effective, ongoing, data-driven quality assessment and performance improvement program (QAPI) when:

1. The "Pharmacy Discrepancy Reports" for Scheduled II controlled substance (drug) oxycodone (narcotic) from 2024 were not analyzed when the report included 32 unresolved (no documentation of investigation and closure) oxycodone issues and the "Controlled Substance Tracking Log-Minimal Loss Log (documentation of accounting issues)" from 2024 showed issues with 30 oxycodone events (Refer to A-273);

2. Unresolved scheduled drug discrepancies initiated on the nursing units were not measured or tracked when Event Reports were not completed in accordance with policies and procedures (Refer to A-273);

3. The hospital's quality assurance and performance improvement (QAPI) program did not initiate performance improvement activities in 2024 and early 2025 to identify and reduce scheduled drug discrepancies (Refer to A-286);

4. The hospital's Governing Body (Board of Managers) and Medical Staff did not maintain a program of quality improvement and patient safety to include resolved and unresolved scheduled medication discrepancies (Refer to A-309).

These combined failures resulted in the potential for preventable, narcotic related events such as drug diversion, overdose and medication errors leading to compromised patient care and harm.

The cumulative effects of these systemic problems resulted in the hospital's inability to maintain an effective QAPI program in accordance to the statutorily and mandated Conditions of Participation for QAPI.

Based on observation, interview, and record review, the hospital failed to ensure accurate documentation of Scheduled II controlled substance (drug) oxycodone (strong narcotic) medication accounting and reconciliation when the tracking process included an ADM (Automated Dispensing Machine) Pharmacy Discrepancy Report (differences between what is expected to be in the ADM and actual count) and the report revealed 32 unresolved (no documentation of investigation and closure) oxycodone issues in 2024 and the hospital's 2024 Controlled Substance Tracking Log-Minimal Loss Log (documentation of accounting issues) showed accounting issues with 30 oxycodone events.(Refer to A-0494)

These failures resulted in the potential for preventable oxycodone diversion (unauthorized removal). In addition, these failures had potential for medication errors that may cause or lead to inappropriate medication use or patient harm for 777 patients admitted to the Hospital in 2024.

The cumulative effect of these systemic problems resulted in the inability of the Hospital to comply with the statutorily-mandated Condition of Participation for Pharmaceutical Services.

Based on interview and record review, the hospital failed to ensure the medical staff was accountable to the Governing Body (GB) for the quality of care and services provided to patients when reports from the Medical Executive Committee (MEC) and from the Chief Executive Officer (CEO) reporting on the behalf of the Medical Director did not include information about the hospital's failure to account for 32 discrepancies of controlled medications (medications classified by government agency as having the potential for abuse or addiction) dispensed on nursing units and 30 discrepancies within the pharmacy records.

This failure had the potential to permit staff to divert (unauthorized removal) controlled medications from patients to staff resulting in patients not receiving medications ordered by medical staff or staff working in an impaired condition for potentially 777 patients admitted in 2024.

Findings:

During an interview on 7/7/2025 at 10:40 a.m. with the CEO, the CEO stated medication safety issues were discussed at the Patient Safety & Quality Committee (PS&QC). The CEO stated the minutes of the PS&QC were reported to the MEC. The minutes of the MEC meeting were reported to the GB.

During an interview on 7/7/2025 at 1:00 p.m. with a member of the Governing Body (MGB1), a member for about 3 years, MGB1 stated the GB is legally responsible for the conduct of the hospital. MGB1 stated quality information is presented to the GB by the CEO. MGB1 stated the Board became aware of possible controlled substance count discrepancies when the Drug Enforcement Agency (DEA) showed up at the hospital in April 2025. MGB1 stated the GB was told the Pharmacy would investigate the issues with the machine that dispensed ordered medication to nurses and the possible drug diversion. MGB1 stated the CEO reviewed the quality information at the GB meetings based on quality and safety issues the Medical Director and the CEO discussed in their biweekly meetings. MGB1 stated the Medical Director did not present quality and safety issues to the GB directly. When asked how the GB provides good oversight to ensure patients receive quality care in a safe environment, MGB1 stated, "We take what is given at the meetings."

During an interview on 7/8/2025 at 1:00 p.m. with the Medical Director, the Medical Director stated his roles and responsibilities were to "oversee the quality of care." He stated his report to the GB was limited to credentialing and privileging issues. "The Medical Director stated he does not discuss quality issues with members of the board. When asked why the GB minutes reflect the CEO reported information about the quality of care and patient safety, the Medical Director stated, "That's their [managing organization name] format. What they want."

During continued conversation, the Medical Director stated discrepancies in counts of controlled medications were reported in Pharmacy and Therapeutics committee by the Director of Pharmacy who then, "developed action plans to identify patterns and plans. There were a few minor issues ever since the beginning. These were either resolved or education was provided to nurses." The Medical Director stated he had never presented those findings, nor did anyone else present those findings to the GB.

During a review of Medical Staff Bylaws and Rules and Regulations (R&R), titled "[Hospital Name]", approved 9/14/2023, R&R indicated the MEC was responsible for reviewing and assessing aspects of the quality of care being provided. R&R indicated the MEC was responsible for, "Maintaining close communication with the Hospital's quality improvement activities to assure close coordination of the Hospital's evaluation program and to evaluate potential areas of improvement, ... recommending a plan of action, as indicated from the analysis of review and study findings to facilitate programs for improvement, [and was responsible for]... safety procedures and all the matters relating to drugs in the hospital."

During a review of the MEC minutes for meetings 5/8/25 and 6/16/25 immediately following the DEA visit to the facility, the minutes did not include mention of any possible controlled substance count discrepancies or any other related topic.

During a review of the Board of Managers meeting minutes from 1/16/2024 through 4/30/2025, the minutes showed the "CEO Report" included a report on the hospital Quality Assurance and Performance Improvement (QAPI) but did not include discussion and updates regarding controlled medication discrepancies. The Medical Director report focused on credentialing activities, appointments, and staffing issues.

Based on observations, interviews and record review, the hospital's quality program failed to adequately identify, collect, analyze and track unresolved scheduled (controlled) medications (drugs with a potential for abuse and dependency) data for 777 patients admitted in 2024 when:

1. The hospital failed to ensure accurate documentation of Scheduled II controlled substance (drug) oxycodone (strong narcotic) medication accounting and reconciliation when the tracking process included an ADM (Automated Dispensing Machine) Pharmacy Discrepancy Report (differences between what is expected to be in the ADM and actual count) and the report revealed 32 unresolved (no documentation of investigation and closure) oxycodone issues in 2024 and the hospital's 2024 Controlled Substance Tracking Log-Minimal Loss Log (documentation of accounting issues) showed accounting issues with 30 oxycodone events; and

2. Unresolved scheduled drug discrepancies initiated on the nursing units were not measured or tracked when Event Reports (incident occurrence report) were not completed in accordance with policies and procedures. As a result of this failure, the hospital did not adequately assess and monitor controlled drug related events or the safety of controlled drug administration.

These failures resulted in the potential for preventable oxycodone diversion (unauthorized removal). In addition, these failures had potential for medication errors that may cause or lead to inappropriate medication use or patient harm for 777 patients admitted to the Hospital in 2024.

Findings:

According the 2025 United States Drug Enforcement Agency Administration publication, "Drug Scheduling" (www.dea.gov), scheduled medications are defined as drugs with a high potential for abuse. Schedule II medications include narcotics, such as hydrocodone (Vicodin) and oxycodone (OxyContin). Schedule II controlled substances are also associated with a high incidence of drug overdose...A drug discrepancy can occur on a hospital when the quantity of controlled medication on hand (in the ADM) does not match the expected quantity. A drug discrepancy may occur for multiple reasons, including administration errors or diversion.

According to a review of facility policy titled, "Patient Safety Plan", dated 3/21/23, "The scope of the Patient Safety Plan (Quality Plan) includes an ongoing assessment, using internal and exterrnal knowledge and experience to prevent error occurrence [and] maintain and improve patient safety. Patient safety occurrence information from aggregated data reports and individual incident occurrence reports is reviewed by the Quality Council to prioritize organizational patient safety activity efforts".

1. During an interview on 7/7/25 at 10:35 a.m., in the pharmacy, Director of Pharmacy (DOP) was asked to describe the hospital's pharmaceutical services. DOP's description included that scheduled medications were secured in ADM devices. DOP stated there were five devices, one located at each of the four nursing stations, and one in the inpatient pharmacy. DOP stated the ADM recorded the access and use of scheduled medications. Continuing the interview, DOP was asked how the facility ensured scheduled medications were accounted for and the DOP stated an ADM report titled "Pharmacy Discrepancy Report" can be generated. A request was made to the DOP to provide the Pharmacy Discrepancy Report for all oxycodone scheduled medications between 1/1/24 and 12/31/24.

During a concurrent observation and interview, on 7/8/25 at 9:55 a.m., in the 1 West medication room, DOP was requested to demonstrate how the ADM tracked scheduled medications. During the demonstration the ADM prompted input of a count of the medication remaining in the bin. The demonstration included entering the wrong count into the ADM. The incorrect count triggered the ADM to create a discrepancy.

During a concurrent interview and record review, on 7/8/25 at 11:30 a.m. in the pharmacy, DOP identified the Pharmacy Discrepancy Report, dated 7/8/25 at 11:18 a.m. A review of the report showed oxycodone discrepencies that were both resolved and unresolved. The Pharmacy Discrepancy Report revealed 32 unresolved oxycodone discrepancies between 1/1/2024 and 12/31/24. The hospital was requested to provide documentation for the unresolved items. .

During a concurrent interview and record review, on 7/8/25 at 4:15 pm, the Chief Executive Officer (CEO) identified and reviewed the Pharmacy & Therapeutics (P & T) Committee (manages medications and their use) Meeting Minutes from 4/11/24, 7/16/24, and 10/24/24. CEO was asked to show 2024 oxycodone unresolved data from the "Pharmacy Discrepancy Report" reported to the P & T Committee. He stated there was no documentation showing the 2024 oxycodone unresolved data was reported to the P & T Committee.

During a concurrent interview and record review, on 7/9/25 at 3 pm, Director of Quality Management (DQM) identified the Quality Council Committee (committee responsible for QAPI) minutes from 2/16/24, 5/2/24, 7/31/24, and 10/31/24. DQM inspected the minutes for unresolved 2024 oxycodone data from the "Pharmacy Discrepancy Report". DQM stated that the unresolved 2024 oxycodone data was not reported to the Quality Council Committee.

During an interview on 7/10/25 at 9:45 am, the DQM stated she was not aware of the analysis of the "Pharmacy Discrepancy Report" 2024 unresolved oxycodone data.

A record review of the Pharmacy and Therapeutics Medication Safety Committee Meeting Minutes, dated 7/16/2024 and 10/24/2024, did not show "Pharmacy Discrepancy Report" unresolved oxycodone discrepancies were reported.

A record review of the "Pharmacy Discrepancy Report", showed 32 unresolved oxycodone discrepancies between 1/1/2024 and 12/31/24.

A record review, of the "Controlled Substance Tracking Log-Minimal Loss Log" (3/5/2024-12/18/2024) showed 30 oxycodone accounting issues out 47 total.

A record review of the Quality Council (QC) Committee Minutes from 2/16/2024, 5/2/2024, 7/31/2024, and 10/31/2024, did not show unresolved 2024 oxycodone data was reported to the QC Committee. Continued review did not show the QC Committee directed the data to be analyzed.

A record review of the Policy and Procedure for "Automated Dispensing Machines (ADM)-Controlled Substances" (Policy MM 170, Effective Date: 3/21/2023) showed A. "The purchase, storage, distribution, and accounting of controlled drugs are completed in accordance with all federal and state laws and standards of professional practice, to maintain optimal quality control over these high-risk (heightened risk of causing significant patient harm when used in error) substances and to prevent diversion. The Pharmacy Department is responsible for compliance with this policy. B. A transaction record for all controlled substances in schedules II, III, and IV (C-II, C=III, CIV, and C-V) is maintained by the hospital. All controlled drug records maintained for three years (3) as required by law are readily retrievable." Continued review showed, 6. "Controlled substance discrepancies are resolved at the time of discovery or by the change of shift." Further review showed, 9. "When a discrepancy occurs in the inventory count which cannot be explained on investigation, the discrepancy is reported using the hospital's routine risk management reporting system and the Pharmacist in Charge is notified. These reports are reviewed monthly by the Pharmacy and Therapeutics committed and the Pharmacist in charge."

2. In accordance with a facility policy titled, "Event Reporting", dated 3/21/23, the purpose of an Event Report is to "assure that adequate documentation and notification is provided for events or circumstances involving patients not consistent with routine care for the patient and/or routine operations of the hospital...It is the policy of the hospital that any employee,...should report any incidents, accidents, or near misses involving the care of patients and/or any incident related to employees or visitors...All incidents are to be documented and investigated, and the information analyzed in an effort to resolve an untoward incident, improve processes, and/or systems that may be causatitive factors related to the untoward event(s) or incident(s)...An Event Report is completed by the staff member who reported the incident, by the end the staff member's shift, but no later than 24 hours after incident".

According to a review of a 3/21/23 policy titled, "Automated Dispensing Machines-Controlled Substances", "If the nurse retrieves the dose from the controlled drug stock inventory in the Automated Dispensing Machine, the record of dispensing is made on the automated dispensing machine computer system...The automatic dispensing computer system prompts the user to complete an inventory count and enter the number before a controlled substance is removed. If the count is incorrect per the system, the user is prompted to perform a recount witnessed by a second licensed nurse/pharmacy staff. If the recount remains incorrect, a discrepancy is created and is communicated to the Director of Pharmacy/Pharmacist in Charge and Nurse Manager...When a discrepancy occurs in the inventory count which cannot be explained on investigation, the discrepancy is reported using the hospital's routine risk management reporting system and the Pharmacist in Charge is notified...The Pharmacy Department notifies the Director of Nursing and Nurse Manager when discrepancies are not resolved by the end of a shift".

A concurrent interview and review of the 2025 Schedule II controlled medication, "Pharmacy Discrepancy Report" (a list of ADM transactions listing discrepancies initiated on the nursing units only), was conducted with the CEO on 7/9/25 at 12:50 p.m. The 2025 "Pharmacy Discrepancy Report" reflected the following information upon nurse access to ADM Bin #33367:
An unresolved discrepancy on 1/26/25 at 3:08 a.m. for "oxycodone IR [immediate release] 5 mg [milligram] tab" in ADM Bin #33367.
An unresolved discrepancy on 1/26/25 at 8:05 a.m. for "oxycodone IR 5 mg tab" in ADM Bin #33367.
Discrepancy resolved, 31 days later, on 2/25/25 at 4:05 p.m. for "oxycodone IR 5 mg tab" in ADM Bin #33367.

The CEO stated he could not find the corresponding Event Report. He acknowledged that according to policy and procedure an Event Report should have been submitted for the unresolved oxycodone discrepancy within 24 hours.

A review of the 2024 Schedule II controlled medication "Pharmacy Discrepancy Report" (a list of ADM transactions listing discrepancies initiated from nursing units only) revealed the following:
An unresolved discrepancy on 9/17/24 at 8:19 a.m. for "oxycodone IR 5 mg tab" in ADM Bin #33375.
An unresolved discrepancy on 10/4/24 at 8:20 a.m. for "oxycodone IR 5 mg tab" in ADM Bin #33375.
An unresolved discrepancy on 10/4/24 at 8:37 a.m. for "oxycodone IR 5 mg tab" in ADM Bin #33375.
Further review of the 2024 "Pharmacy Discrepancy Report", indicated the discrepancy remained "unresolved". No corresponding Event Report was provided.

During an interview with the DQM on 7/10/25 at 11:15 a.m., the DQM explained she becomes aware of controlled drug discrepancies through the event reporting system. She stated "we encourage" the nurses to submit Event Reports for unresolved controlled drug discrepancies when they occur.

Despite numerous requests, the hospital was unable to provide Event Reports submitted by nursing for unresolved scheduled medications from 2024 and 2025.

Based on interviews and record review, the hospital's quality assurance and performance improvement (QAPI) program failed to initiate performance improvement activities in 2024 and early 2025 to identify and reduce controlled substances (scheduled drugs) discrepancies (does not match the expected quantity).

This failure put patients at an increased risk of adverse drug events, medication administration errors and compromised patient safety. In addition, the lack of performance improvement activity resulted in the potential for preventable narcotic diversion (unauthorized use).

Findings:

According the 2025 United States Drug Enforcement Agency Administration publication, "Drug Scheduling" (www.dea.gov), scheduled medications are defined as drugs with a high potential for abuse. Schedule II medications include narcotics, such as hydrocodone (Vicodin) and oxycodone (OxyContin). Schedule II controlled substances are also associated with a high incidence of drug overdose.

According to a review of facility policy titled, "Patient Safety Plan", dated 3/21/23, "The Quality Council (QC) is responsible for the oversight of the Patient Safety Plan...All departments with the organization (patient care and non-patient care) are responsible to report patient safety occurrences and potential occurrences to the Director of Quality Management (DQM), who aggregates occurrence information related to type of occurrence, severity of the occurrence, number/type of occurrences per department, impact on the patient, remedial actions taken and patient outcome. The QC analyzes the report information and determines further patient safety activities".

During an initial interview with the DQM on 7/8/25 at 11:15 a.m. she explained, in theory, any issues about scheduled medication discrepancies would be reported at the QC Committee meeting by the Pharmacy and Therapeutics representative. DQM continued, again speaking theroretically and in generalities, she also received medication discrepancy issues through the event reporting system. DQM reported she hadn't received an recent event reports in regards to controlled drug discrepancies, nor did she participate in any narcotic discrepancy investigations."I haven't been notified of any diversion vulnerabilities," DQM said.

During a concurrent interview and record review, on 7/9/25 at 3 p.m., DQM identified the Quality Council Committee (committee responsible for QAPI) minutes from 2/16/24, 5/2/24, 7/31/24, and 10/31/24. DQM inspected the minutes for oxycodone (schedule II medication) data from the "Pharmacy Discrepancy Report" and stated the unresolved 2024 oxycodone data was not reported to the Quality Council Committee.

During a concurrent interview and record review with the DQM on 7/10/25 at 11:45 a.m., DQM explained the 2025 Patient Safety/Quality Council Summary (in the form of a spreadsheet) listed Key Quality Indicators (KQI) from January of 2025 to May 2025. The DQM acknowledged the Patient Safety/Quality Council Summary did not include data collected for scheduled medication discrepancies, either resolved or unresolved.

The facility provided the Department with a Discrepancy Flowsheet that was limited to medication (all) discrepancies from April 1, 2025 to July 8, 2025.

Despite multiple requests for documented evidence of quality assurance and performace improvement activities (metrics, analytics, tracking, preventative action plans and feedback) from 2024 and early 2025, regarding scheduled medication (resolved or unresolved) discrepancies, the DQM was unable to provide them.

Based on interview and record review, the hospital's Governing Body (Board of Managers) and Medical Staff failed to maintain a program of quality improvement and patient safety to include resolved and unresolved scheduled medication (controlled drug) discrepancies (medication count does not match the expected quantity).

As a result of this failure, the hospital did not adequately assess and monitor controlled drug related events or the safety of controlled medication administration. In addition, the lack of oversight resulted in the potential for preventable drug diversion (unauthorized use) or patient safety concerns.

Findings:

According the 2025 United States Drug Enforcement Agency Administration publication, "Drug Scheduling" (www.dea.gov), scheduled medications are defined as drugs with a high potential for abuse. Schedule II medications include narcotics, such as hydrocodone (Vicodin) and oxycodone (OxyContin). Schedule II controlled substances are also associated with a high incidence of drug overdose.

According to a review of the facility policy titled, "Patient Safety Plan (Quality Plan)", dated 3/21/23, the policy included, "As patient care, and therefore the maintenance and improvement of patient safety is a coordinated and collaborative effort, the approach to optimal patient safety involves multiple departments and disciplines in establishing plans, processes and mechanisms that compromise the patient safety activities. The Patient Safety Plan developed by the interdisciplinary team under the auspices of the Quality Council and approved by the medical staff, the Board of Managers..."

During an interview with Member of the Governing Body (MGB1; member for 3 years) on 7/7/2025 at 1 p.m., MGB1 stated the Governing Body (GB) was legally responsible for the conduct of the hospital. MGB1 stated quality information was presented to the GB by the Chief Executive Officer (CEO). MGB1 revealed the Board of Managers only became aware of possible controlled substance discrepancies at the hospital in April of 2025. When asked how the GB provided oversight to ensure patients received quality care in a safe environment, MGB1 stated, "We take what is given at the meetings".

During a review of the Board of Managers Meeting Minutes, dated 1/16/2024 through 4/30/2025, all meeting minutes showed that the QAPI program was part of a standing agenda titled, "CEO Report." Further review of the Board of Manager Meeting Minutes reflected the Medical Director reported only on aspects of credentialing, appointments, and staffing.

During an interview on 7/8/2025 at 1 p.m. with the Medical Director (MD 1), the MD 1 stated his roles and responsibilities were to "oversee the quality of care." MD 1 stated he met with the GB but was not consulted about quality matters by members of the Board. MD 1 stated he was informed about possible controlled medication discrepancies in April 2025 and was "surprised when the new issue and discrepancies came up." MD 1 stated he was not involved in any hospital-specific investigation, root cause analysis (a means of determining why mistakes happen) or plan of correction to address controlled medication discrepancies at the hospital. MD 1 recalled a few discrepancies in controlled medication counts in the past. He said, the hospital experienced "a few minor issues ever since the beginning. Those discrepancies were either resolved or education was provided to nurses." The MD 1 stated neither he nor anyone else presented those discrepancy findings to the Board of Managers.

During a review of hospital's Medical Staff Bylaws, Rules and Regulations, approved 9/14/2023, "Page 45, Section B1c" indicated the Medical Executive Committee (MEC) was responsible for reviewing and assessing aspects of the quality of care provided at the hospital. "Section B1d" indicated the MEC was responsible for "maintaining close communication with the hospital's quality improvement activities to assure close coordination of the hospital's evaluation program and to evaluate potential areas of improvement". "Section B1e" indicated the MEC was "responsible for recommending a plan of action, as indicated from the analysis of review and study findings to facilitate programs for improvement." Review of page 47, "Section B4", the Bylaws indicated the MEC was responsible for "... safety procedures and all the matters relating to drugs in the hospital".

During a review of MEC Minutes, it was noted the 5/8/25 meeting minutes made no mention of controlled substance discrepancies or any other related issue. The 6/16/2025 MEC meeting was not held.

Based on observation, interview, and record review, the hospital failed to ensure accurate documentation of Scheduled II controlled substance (drug) oxycodone (strong narcotic) medication accounting and reconciliation when the tracking process included an ADM (Automated Dispensing Machine) Pharmacy Discrepancy Report (differences between what is expected to be in the ADM and actual count) and the report revealed 32 unresolved (no documentation of investigation and closure) oxycodone issues in 2024 and the hospital's 2024 Controlled Substance Tracking Log-Minimal Loss Log (documentation of accounting issues) showed accounting issues with 30 oxycodone events.

These failures resulted in the potential for preventable oxycodone diversion (unauthorized removal). In addition, these failures had potential for medication errors that may cause or lead to inappropriate medication use or patient harm for 777 patients admitted to the Hospital in 2024.

Findings:

During an interview on 7/7/25 at 10:35 a.m., in the pharmacy, Director of Pharmacy (DOP) was asked to describe the hospital's pharmaceutical services. DOP's description included that scheduled medications were secured in ADM devices. DOP stated there were five devices, one located at each of the four nursing stations, and one in the inpatient pharmacy. DOP stated the ADM recorded the access and use of scheduled medications. Continuing the interview, DOP was asked how the facility ensured scheduled medications were accounted for and the DOP stated an ADM report titled "Pharmacy Discrepancy Report" can be generated. A request was made to the DOP to provide the Pharmacy Discrepancy Report for all oxycodone scheduled medications between 1/1/24 and 12/31/24.

During a concurrent observation and interview, on 7/8/25 at 9:55 a.m., in the 1 West medication room, DOP was requested to demonstrate how the ADM tracked scheduled medications. During the demonstration the ADM prompted input of a count of the medication remaining in the bin. The demonstration included entering the wrong count into the ADM. The incorrect count triggered the ADM to create a discrepancy.

During a concurrent interview and record review, on 7/8/25 at 11:30 a.m. in the pharmacy, DOP identified the Pharmacy Discrepancy Report, dated 7/8/25 at 11:18 a.m. A review of the report showed oxycodone discrepencies that were both resolved and unresolved. The hospital was requested to provide documentation for the unresolved items.

A record review of the Pharmacy Discrepancy Report, showed 32 unresolved oxycodone discrepancies between 1/1/2024 and 12/31/24.

During a concurrent interview and record review, on 7/8/25 at 2:24 p.m., in the pharmacy, DOP identified the Pharmacy Discrepancy Report. The hospital was requested to provide documentation of 2024 unresolved items. DOP stated the documentation did "not exist in the pharmacy".

A record review of the [Hospital Name] Controlled Substance Tracking Log-Minimal Loss Log, dated 3/5/2024- 12/18/2024, showed 30 oxycodone accounting issues of 47 total scheduled medications.

During a concurrent interview and record review, on 7/8/25 at 4:15 p.m., the Chief Executive Officer (CEO) identified and reviewed the Pharmacy & Therapeutics Committee (manages medications and their use) Meeting minutes from 4/11/24, 7/16/24, and 10/24/24. CEO stated there was no documentation indicating the 2024 oxycodone unresolved data was reported to the committee.

A record review of the Policy and Procedure for Automated Dispensing Machines (ADM)-Controlled Substances (scheduled drug) (Policy MM 170, Effective Date: 3/21/2023) directed, "A. The purchase, storage, distribution, and accounting of controlled drugs are completed in accordance with all federal and state laws and standards of professional practice, to maintain optimal quality control over these high-risk (heightened risk of causing significant patient harm when used in error) substances and to prevent diversion. The Pharmacy Department is responsible for compliance with this policy. B. A transaction record for all controlled substances in schedules II, III, and IV (C-II, C=III, CIV, and C-V) is maintained by the hospital. All controlled drug records maintained for three years (3) as required by law are readily retrievable." Continued review showed, "...Controlled substance discrepancies are resolved at the time of discovery or by the change of shift." Further review showed, "...When a discrepancy occurs in the inventory count which cannot be explained on investigation, the discrepancy is reported using the hospital's routine risk management reporting system and the Pharmacist in Charge is notified. These reports are reviewed monthly by the Pharmacy and Therapeutics committed and the Pharmacist in charge."