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Based on interview and record review, the GB failed to ensure all hospital policies were approved by the GB before its implementation. This increased the risk of the GB not governing all hospital functions and could result in poor patient care outcomes.

Findings:

Review of the hospital's Amended and Restated Bylaws of Mission Hospital Regional Medical Center dated 3/23/20, showed in part, " ...Article X. The Board of Trustees shall require ...(b) That the person responsible for each basic and supplemental medical service cause written policies and procedures to be developed and maintained and that such policies be approved by the Board of Trustees ..."

Review of the Southern California Community Ministry Board Uniform Charter dated 3/23/20, showed in part, "The board shall provide leadership and governance in the oversight and performance of the service area in the areas of mission alignment and community engagement, quality oversight, medical staff and physician and caregiver engagement ...Assure compliance aspects of community health are discussed regarding regulatory, federal and state requirements ...Approve hospital policies as required by regulatory bodies including Centers for Medicare and Medicaid Services ("CMS") and the Conditions of Participation ..."

Review of the MH Pharmacy & Therapeutics Mission Hospital Virtual Meeting 6/2/21,
showed in part, " ...Patient care policies/ protocols guidelines ..." Several new policies were listed including: Inpatient Controlled Substance Management, Controlled Substances RX-411, Controlled Substance Discrepancy Report, and Anesthesia Controlled Substance Reconciliation. " ...Upon motion made, seconded and carried without opposition, the policies & procedures as noted in the documentation portion of the minutes were approved for immediate adoption ..."

Review of the hospital's P&P titled Controlled Substances, RX-411, showed, "In keeping with the mission and values of Providence St. Joseph Health, Providence Mission Hospital adopts PSJH system-wide policy for "Inpatient controlled substance management." The scope of this policy covers both inpatient and outpatient areas that are serviced by Providence Mission hospital ...Attachments: Controlled Drug Discrepancy report ..."

* However, the report form did not provide documented evidence the GB had approved the form.

Review of the hospital's P&P titled Procedure: Anesthesia controlled substance reconciliation showed that inititated by the POM and revised by the CPM.

* However, there was no documented evidence the GB had approved this P&P.

Review of the hospital's P&P titled Inpatient Controlled Substance Management showed the P&P had been approved by the Operations & technology Council and the Pharmacy Governance Council.

* However, there was no documented evidence the GB had approved this P&P.

During an interview with the ADP on 6/21/21 at 1100 hours, he stated the pharmacy used the new audit tool to perform the anesthesia record audits. He was unable to show documented evidence the audit tool was approved by the GB before implementation. He stated when the MEC had approved a P&P, it was an active P&P. He stated once the P&T committee approved a policy, they considered the policy would be ready for use before the MEC or GB reviewed and approved it.

During an interview with the Executive Director of Quality on 6/22/21 at 0845 hours, she was asked if the GB had approved the new audit form that the pharmacy used. She stated the MEC had virtually approved the pharmacy P&P.

Based on interview and record review, the GB failed to ensure the contracted services provided in the hospital were evaluated to ensure compliance with the CMS COP requirements. This failure created the increased risk of substandard services being provided.

Findings:

Review of the hospital's Amended and Restated Bylaws of Mission Hospital Regional Medical Center dated 3/23/20, showed in part, "...Article X. g. Such other measures as the Board of Trustees ...deem necessary for the preservation and improvement of the quality and efficiency of patient care ...Review of Attachment A- Mission Hospital Community Board Charter dated 3/23/20, showed in part, "...Roles and Responsibilities. The Board shall provide leadership and governance in the oversight and performance of the service ...Assure compliance aspects of community health are discussed regarding regulatory, federal and state Requirements ...Oversee the quality of care provided to patients in our service area by the organized medical staff ...Resolved, that the board shall continue to function as the governing body ...meeting Medicare Conditions Of Participation requirements ..."

Review of the hospital's list of contracted services provided by the hospital on 6/21/21, showed there were 539 contracted services listed. However, the list of contracted services was incomplete because it did not include the "hire right" contracted service which was used for pre-employment background check by the hospital.

Review of the hospital's QOC meeting minutes dated 12/8/20, showed in part, "... A listing of all Patient Care Contracts at Mission Hospital was provided to the Quality and Regulatory Managers for their review, and all were compliant in meeting quality metrics ..." The list of 24 Patient Care contracts were included in the QOC meeting minutes. However, there was no documented evidence the QOC or GB had evaluated the contracted services to ensure they complied with the CMS COP requirements.

Review of the hospital's Quality Operations Committee (QOC) meeting minutes between 6/24/20 and 5/12/21, showed no documented evidence the 539 contracted services were evaluated by the QOC or the GB to ensure they complied with the CMS COP requirements.

Review of the Mission Hospital Community Ministry Board (GB) meeting minutes from 4/26/20 to 6/22/21, showed no documented evidence the GB had evaluated the contracted services to ensure they complied with the CMS COP requirements.

During an interview with the DRPP on 6/23/21 at 1110 hours, she stated there was no policy regarding evaluation of contracted services. The DRPP was asked to provide the most recent evaluations for four contracted services selected from the list of 539 contracts. Four selected contracted services were as follows:

- Anesthesia group contracted service
- Physician A contracted service - Quality Review committee
- Physician B contracted service - Chairman of quality management
- 340B pharmacy services contracted service

However, the hospital was unable to provide documented evidence the GB had evaluated the contracted services to ensure they complied with the CMS COP requirements.

During an interview with the Mgr. Contract Ops on 6/23/21 at 1145 hours, she stated she managed the Patient Care Contracts, the list of 24 contracted services, documented in the 12/8/20 QOC meeting minutes. She stated she sent the contracted service evaluation forms to each contract owner of the contracted service and brought the completed evaluation forms to the Chief Financial Officer for review. She was unable to provide documented evidence the GB ensured the contracted services complied with the CMS COP requirements.

During an interview with the Board Chair, he was asked to describe the process that the GB used to evaluate the hospital's contracted services. The Board Chair stated, "We know some of contracted services. We receive reports but the GB doesn't have to sign off." When asked about the list of contracted services, he stated, "We don't see the list."

Based on interview and record review, the GB failed to ensure the contracted services provided in the hospital were evaluated for safety and effectiveness. This failure created the increased risk of substandard services being provided.

Findings:

Review of the hospital's Amended and Restated Bylaws of Mission Hospital Regional Medical Center dated 3/23/20, showed in part, "...Article X. g. Such other measures as the Board of Trustees ...deem necessary for the preservation and improvement of the quality and efficiency of patient care ..."

Review of Attachment A-Mission Hospital Community Board Charter dated 3/23/20, showed in part, "...Roles and Responsibilities. The Board shall provide leadership and governance in the oversight and performance of the service area in the areas of mission alignment and community engagement, quality oversight ...Quality and patient safety. Oversee the quality of care provided to patients in our service area by the organized medical staff ..."

Review of the Mission Hospital Quality Assessment and Performance Improvement Plan 2018 - 2023, showed in part, "...Ensuring MH meets regulations, standards and guidelines related to quality assessment and performance improvement established by regulatory agencies and accrediting body organizations. Governance Infrastructure. Board of Trustees: Bears ultimate accountability for the quality, safety, experience and value of all patient care services provided by MH ..." However, further review showed no documented evidence that the evaluation of contracted services was mentioned in this document.

Review of the hospital's list of contracted services provided by the hospital on 6/21/21, showed there were 539 contracted services listed. However, the list of contracted services was incomplete because it did not include the "hire right" contracted services, for which the hospital used for preemployment background checks.

Review of the hospital's QOC meeting minutes dated 12/8/20, showed in part, "...A listing of all Patient Care Contracts at Mission Hospital was provided to the Quality and Regulatory Managers for their review, and all were compliant in meeting quality metrics ..." The list of 24 Patient Care Contracts were included in the QOC meeting minutes.

Review of the hospital's Quality Operations Committee (QOC) meeting minutes between 6/24/20 and 5/12/21, showed no documented evidence the 539 contracted services were evaluated by the QOC or GB.

Review of the Mission Hospital Community Ministry Board (GB) meeting minutes from 4/26/20 to 6/22/21, showed there was no documented evidence the GB had evaluated the contracted services.

During an interview with the DRPP on 6/23/21 at 1110 hours, she stated there was no policy regarding evaluation of contracted services. The DRPP was asked to provide the most recent evaluations for four contracted services selected from the list of 539 contracts. Four selected contracted services were as follows:

- Anesthesia group contracted service
- Physician A contracted service - Quality Review committee
- Physician B contracted service - Chairman of quality management
- 340B pharmacy contracted service

However, the hospital was able to only provide the evaluation for Anesthesia group but not other selected three contracted services.

During an interview with the Mgr. Contract Ops on 6/23/21 at 1145 hours, she stated she managed the Patient Care Contracts, the list of 24 contracted services documented in the 12/8/20 QOC meeting minutes. She stated she sent the contracted service evaluation forms to each contract owner of the contracted service and brought them to the Chief financial officer for review. During a concurrent interview with the CMO, she stated the QOC sent a report to the MEC, then the MEC sent a report to the GB, that how the GB knew about the quality of the contracted services. There was no documented evidence the GB evaluated the contracted services to ensure the contracted services provided in a safe and effective manner.

During an interview with the Board Chair, he was asked to describe the process that the GB used to evaluated the hospital's contracted services. The Board Chair stated, "We know some of contracted services. We receive reports but the GB doesn't have to sign off." When the Board Chair was asked about the list of contracted services, he stated, "We don't see the list."

Based on interview and record review, the GB failed to ensure the hospital had a complete list of all contracted services. This failure created the increased risk of substandard services being provided.

Findings:

Review of the amended and restated bylaws of Mission Hospital regional medical center, dated 3/23/20, showed in part: " ...Article X. g. Such other measures as the Board of Trustees ...deem necessary for the preservation and improvement of the quality and efficiency of patient care ...11.1. Contracts. Resolved, that the board shall continue to function as the governing body ...meeting Medicare conditions of participation requirements ..."

Review of Attachment A-Mission Hospital Community Board Charter dated 3/23/20, showed in part: " ...Roles and Responsibilities. The Board shall provide leadership and governance in the oversight and performance of the service area in the areas of mission alignment and community engagement, quality oversight ...Quality and patient safety. Oversee the quality of care provided to patients in our service area by the organized medical staff ...

Review of the Mission Hospital Community Ministry Board Meeting minutes from 4/26/20 to 6/22/21, showed no documented evidence the GB had evaluated contracted services.

Review of the list of contracted services provided by the hospital on 6/21/21, showed there were 539 contracted services listed. When asked on 6/23/21, the Mgr. Contract Ops provided a list of contracted services that showed only 24 contracted services. Comparison of the two contracted services lists showed there were 10 contracted services that appeared on both lists.

Review of the 12/8/20 Quality Operations Committee Meeting minutes showed in part, " ...Patient care contracts. Discussion. A listing of all patient care contracts at mission hospital was provided to the Quality and Regulatory Managers for their review, and all were compliant in meeting quality metrics ..." This list showed 24 patient care contracts.

During an interview with the Mgr. Contract Ops on 6/23/21 at 1145 hours, she stated she managed the Patient Care Contracts and provided the list of 24 contracted services documented in the 12/8/20 QOC meeting minutes. When the Mgr. Contract Ops was asked who evaluated the remaining contracts, she stated, "Someone else."

During an interview with the Board Chair on 6/24/21 at 1400 hours, he was asked to describe the process that the GB used to evaluate the hospital's contracted services. The Board Chair stated, "We know some of contracted services. We receive reports but the GB doesn't have to sign off." When the Board Chair was asked about the list of contracted services, he stated, "We don't see the list."

Based on interview and record review, the hospital failed to maintain an effective, on-going, and comprehensive QAPI program as evidenced by:

1. The QAPI program failed to take timely actions to ensure safe and effective patient care. Cross references to A283, A489, A494, A500.

2. Failure to ensure the safe and effective distribution of all controlled substances (CS, medication that have a high potential for abuse and misuse). Cross references to A283, A489, and A494.

3. Failure to ensure the drugs were controlled and distributed in accordance with the standards of practice and hospital's P&P. Cross references to A283, A489, A500, examples #1 and 2.

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the QAPI program failed to take timely actions to ensure safe and effective patient care. This failure had the potential to result in lack of administrative oversight, an increased risk of drug diversion (illegal use), and/or increased risk of an impaired clinician providing patient care for a universe of 367 patients in the hospital.

Findings:

During a review of facility emails, the email titled "Ongoing investigation" indicated the hospital's leadership team had been aware of the hospital's drug diversion concerns since 4/15/21.

During a review of the facility's "[name of hospital] Quality Assessment and Performance Improvement Plan 2018 to 2023" showed the "QAPI Plan has been designed to meet and/or exceed the Centers of Medicare and Medicaid Services (CMS) Conditions of Participation (COP) ...California Department of Public Health Title 22."

During a review of the ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, copyright © 2013, the guidelines showed, "There shall be policies and procedures to ensure control of the distribution and use of controlled substances and other medications with a potential for abuse. These policies and procedures shall be consistent with applicable laws and regulations and shall include methods for preventing and detecting diversion."

During a review of the "ASHP Guidelines on Perioperative Pharmacy Services," copyright © 2019, in the section of Controlled Substance Management and Surveillance, the guidelines showed, "As with all controlled substances, anesthesia controlled substances must be: ...Accountable from the time the controlled substance is dispensed to (received by) the ACP [anesthesia care provider] to its final disposition (i.e. administration to patient, returned, or wasted), with amounts documented. The total amount administered, returned, and wasted must equal the total amount dispensed to (received by) the ACP ... Pharmacy should reconcile all anesthesia controlled substances. Reconciliation should be timely, with prompt notification to the ACP if a discrepancy is discovered. Resolution should occur within 24 hr [hours]. When circumstances do not allow for resolution within 24 hr, the time period for resolution should not exceed 72 hr. If a discrepancy cannot be resolved, it is reported to the drug diversion compliance officer or team as well as appropriate internal anesthesia team member(s) ...Pharmacy reconciliation of all anesthesia controlled substances and records ..."

During a review of the "ASHP Guidelines on Preventing Diversion of Controlled Substances," copyright © 2017, in the section of Monitoring and Surveillance the guidelines showed, "A process is in place to resolve CS discrepancies and specify the time in which discrepancies must be resolved ...Pharmacy is immediately notified of and supports the reconciliation investigation when an unresolvable discrepancy is discovered, and a pharmacist is responsible for overseeing the investigation of the discrepancy ...A trend of poor documentation practices by HCWs is reviewed for possible diversion ...Pharmacy reconciles CS in high-risk areas, such as surgery and anesthesia areas, by comparing the amount dispensed with the amount documented on the CS administration record and the amount documented as wasted ...The organization should identify high-risk areas (e.g., surgery, anesthesia, ...) and include an assessment of risk for diversion ...ease to detection ...and probability of harm ...The pharmacist should be responsible for all drugs and CS dispensed and distributed in the setting."

During a review of the hospital's P&P titled Policy, Procedure, Protocol and Clinical Guidelines Management dated 10/29/20, the P&P showed, "Order of approval is as follows: responsible Director (or above), Policy and Procedure Committee, MedStaff committees and subcommittees, Nursing committees and subcommittees, Medical Executive Committee and the Board of Trustees." On page 4, the policy indicated "References ...Pharmacy ...Policies are approved by the governing body."

During an interview with the Board Chair on 6/24/21 at 1615 hours, the Board Chair stated the Governing Board had not reviewed any pharmacy policies after April 2021.

During the QAPI meeting on 6/24/21 at 1630 hours, the Regional Executive Director of Pharmacy (REDP) stated the hospital followed the ASHP (a nationally recognized professional standard of practice) guidelines.

Based on observation, interview, and record review, the hospital failed to ensure the provision of pharmaceutical services met the needs of patients as evidenced by:

1. Failure to ensure the accurate reconciliation and accountability of all controlled substances (CS, medication that have a high potential for abuse and misuse). Cross reference to A494.

2. Failure to ensure the drugs were controlled and distributed in accordance with the standards of practice and hospital's P&P. Cross reference to A500.

3. Failure to ensure the preparation of all intravenous (IV - into the patient's vein) compounding (mixing medications) sterile (germ-free) preparations (CSPs) were consistent with federal regulatory requirements and/or accepted standards of practice. Cross reference to A501.

4. Failure to ensure the medications were stored securely in a manner to prevent unmonitored access by the unauthorized individuals. Cross reference to A502.

5. Failure to ensure the outdated or otherwise unusable medications were not available for patient use. Cross reference to A505.

6. Failure to implement their automatic stop order P&P for the safe use of Kayexalate (used to treat high blood potassium [an electrolyte]), Lovenox (used to prevent and treat harmful blood clots), and morphine (pain medication to treat moderate to severe pain). Cross reference to A507.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide pharmaceutical services in a safe and effective manner in accordance with the statutory-mandated Conditions of Participation for Pharmaceutical Services.

Based on interview and record review, the hospital failed to ensure the accurate reconciliation and accountability of all controlled substances (CS, medications that have a high potential for abuse and misuse) as evidenced by:

1. The hospital did not have an approved policy on reconciliation of CS medications used by the anesthesiologists from the Pyxis Anesthesia machines (A-Machines) or Main OR Pyxis, and the resolution of CS discrepancies, in Anesthesia Department. This failure resulted in unresolved CS discrepancies and CS medication diversion by an anesthesiologist.

2. For the hospital's Campus A, the hospital failed to follow up and resolve the identified CS discrepancies for 21 of 24 sampled patients (Patients 1, 3, 5, 6, 7, 8, 9, 10, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24) from January to April 2021.

3. For the hospital's Campus A, the hospital failed to contact the anesthesiologists to reconcile the identified CS discrepancies on 6/18/21, and failed to follow up and resolve the identified CS discrepancy on 6/15/21, for Patient 38.

4. The random review of CS use by MD 2 at the hospital's Campus A showed discrepancies for two of two sampled patients (Patients 25 and 26) who were not selected for audit by the hospital's pharmacy.

5. For the hospital's Campus B, from January to May 2021, the hospital did not have documentation to show the pharmacy staff compared the amount dispensed from the anesthesia box with the amount documented on the patients' CS administration records to ensure accurate reconciliation for 387 of 435 Anesthesia Controlled Substance Records (ACSRs).

6. For the hospital's Campus B, from January to May 2021, the hospital failed to clarify with the anesthesiologists and accurately reconcile the CS discrepancies for nine of 66 sampled patients (Patients 27, 28, 29, 30, 31, 32, 33, 34, and 35). In addition, the hospital failed to clarify with the nursing staff accurately reconcile CS discrepancies for four patients of 66 sampled patients (Patients 49, 50, 65, and 66).

7. For the hospital's Campus A, the nursing staff did not resolve and report the discrepancy of ketamine (a CS medication) in a timely manner.

8. For the hospital's Campus A, the hospital's pharmacist did not accurately remove ketamine from the Pyxis, and the nursing staff did not document its waste in the Pyxis.

9. For the hospital's Campus A, the hospital failed to accurately account for one missing capsule of Adderall (a CS medication).

10. For the hospital's Campus A, the Inpatient Endoscopy staff did not perform the CS inventory at the beginning and end of each shift as per the hospital's P&P.

11. The administration and wasted of CS were not accurate for Patients 49, 50, 65, and 66.

12. For the hospital's Campus B, the paper Anesthesia Controlled Substance Record (ASCR) forms for the anesthesia boxes (A-boxes, which contain a number of controlled substances) were not filled out in accordance with hospital's P&P for eleven of twelve patients (Patients 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, and 63). This failure had the potential to result in unknown information about the amount of controlled substances wasted and amount of controlled substances returned to the pharmacy as well as increased risk of drug diversion (illegal use) due to the inability to trace the use of the controlled substances.

13. For the hospital's Campus B, cumulative (amount) data was not tabulated on all discrepancies for the anesthesia boxes (A-boxes) and reviewed on a quarterly basis in accordance with the hospital's P&P. The failure had the potential to result in lack of administrative oversight, an increased risk of drug diversion, and/or increased risk of an impaired clinician providing patient care.

14. For Hospital Campus B, the hospital could not demonstrate accurate controlled substance accountability (tracing) when remifentanil (controlled substance schedule II - high potential for abuse) was withdrawn from the automated drug delivery systems for Patient 64. This failure had the potential to result the potential for the patient to be under-dosed or over-dosed on the controlled substance medication, ineffective pain management, and/or in inaccurate medical record.

These failures resulted in CS discrepancies in the two campuses; and had the potential for the diversion of CS medications, which may negatively impact the patients' health and safety.

Findings:

During the QAPI meeting on 6/24/21 at 1630 hours, the Regional Executive Director of Pharmacy (REDP) stated the hospital followed the ASHP (a nationally recognized professional standard of practice) guidelines.

During a review of the ASHP Guidelines on Perioperative Pharmacy Services, copyright © 2019, in the section of Controlled Substance Management and Surveillance, the guidelines indicated, "As with all controlled substances, anesthesia controlled substances must be: ...Accountable from the time the controlled substance is dispensed to (received by) the ACP [anesthesia care provider] to its final disposition (i.e. administration to patient, returned, or wasted), with amounts documented. The total amount administered, returned, and wasted must equal the total amount dispensed to (received by) the ACP ... Pharmacy should reconcile all anesthesia controlled substances. Reconciliation should be timely, with prompt notification to the ACP if a discrepancy is discovered. Resolution should occur within 24 hr [hours]. When circumstances do not allow for resolution within 24 hr, the time period for resolution should not exceed 72 hr. If a discrepancy cannot be resolved, it is reported to the drug diversion compliance officer or team as well as appropriate internal anesthesia team member(s) ...Pharmacy reconciliation of all anesthesia controlled substances and records ..."

During a review of the ASHP Guidelines on Preventing Diversion of Controlled Substances, copyright © 2017, in the section of Monitoring and Surveillance, the guidelines showed, "A process is in place to resolve CS discrepancies and specify the time in which discrepancies must be resolved ...Pharmacy is immediately notified of and supports the reconciliation investigation when an unresolvable discrepancy is discovered, and a pharmacist is responsible for overseeing the investigation of the discrepancy ...A trend of poor documentation practices by HCWs is reviewed for possible diversion ...Pharmacy reconciles CS in high-risk areas, such as surgery and anesthesia areas, by comparing the amount dispensed with the amount documented on the CS administration record and the amount documented as wasted ...The organization should identify high-risk areas (e.g., surgery, anesthesia, ...) and include an assessment of risk for diversion ...ease to detection ...and probability of harm ...The pharmacist should be responsible for all drugs and CS dispensed and distributed in the setting."

During a review of the hospital's P&P titled Controlled Substances Distribution for Anesthesiologists dated 6/22/17, the P&P showed, "It is the anesthesiologist's responsibility to obtain their controlled substance box from the Pyxis system in the OR Pyxis room ... The anesthesiologist then removes the box from its locked storage plate. The box may now be used during his/her cases. The Anesthesia Controlled Substance Record, used to document the amount of every controlled used in each case, is inside the box along with the corresponding supply of controlled substances ... If additional controlled substances are needed during a case, the anesthesiologist may also remove controlled substances from another A-machine or from the Main OR Pyxis machine and add them to the ACSR (Anesthesia Controlled Substance Record) inventory sheet ...Inventory Discrepancies ...The pharmacist will review the contents of all returned controlled substances boxes. If the content of the box does not reconcile with the stated inventory, a Report of Operating Room Controlled Substance Discrepancy ...must be completed. The pharmacist will contact the responsible anesthesiologist, immediately if possible, to reconcile the discrepancy ...If the discrepancy cannot be immediately accounted for, or the Anesthesiologist cannot be reached, the pharmacist will place a copy of the Anesthesia Controlled Substance Record and the Report of Operating Room Controlled Substance Discrepancy in the Anesthesiologist OR mailbox. This will be accomplished on the day the discrepancy is discovered. Within 24 hours of this, the Anesthesiologist again will be paged or called to inform him/her of the discrepancy ...If there is no resolution within twenty-four hours, the Anesthesiologist will be called or paged to inform him/her that the discrepancy must be resolved within the next forty-eight hours or a report of the discrepancy will be forwarded to the Anesthesia Sub-Section Chairperson ...Cumulative data will be tabulated on all discrepancies and reviewed by the Anesthesia Committee on a quarterly basis. Discrepancies that cannot be reconciled after review by the anesthesiologist and dialog with the Sub-section chairperson will be reported as required by law ..."

1. During an interview with the DOP, POM, and CPM on 5/24/21 at 0945 hours, the POM stated for the hospital's Campus A, the anesthesiologists would remove the CS from the anesthesia machine (A-machine) or from the main OR Pyxis to use during their cases and would use the anesthesia boxes (or controlled substance boxes) as their back-up. The POM further stated at the hospital's Campus A, the anesthesiologists were not expected to use the anesthesia boxes. The DOP stated the anesthesia boxes would be used only during downtime (when the A-machine was not working). The DOP stated the CPDA would audit the use of CS by comparing the amount of CS that had been removed or wasted from the A-machines or the main OR Pyxis to the amount of CS that had been administered and documented in the patients' medical records weekly and would report the audit to the DOP and POM monthly.

During a concurrent record review and interview with the CPDA, POM, CPM, and DOP on 5/24/21 at 1030 hours, the CPDA stated she audited the use of CS for 10 anesthesiologists per week by comparing the amount removed from their Pyxis activity reports with the amount documented in the patients' CS administration records. The CPDA further stated she filled out the anesthesiologist audit reports and reported the CS discrepancies to the DOP and POM. The POM stated he e-mailed and talked to MD 1 who was not the Director of Perioperative Service (DPS) about the Anesthesiologist Audit Reports. While the Anesthesiologist Audit Report was reviewed, the DOP and POM stated they did not know if the CS discrepancies were resolved or not because they did not receive any records to show the CS discrepancies had been resolved. The DOP stated all CS discrepancies should be resolved and the anesthesiologist should document all of the CS amount that were administered and wasted. The DOP stated their system to reconcile and account for the CS were insufficient and the review and audit for the use of CS had not been done for all anesthesiologists. Review the list of anesthesiologists showed there were 38 anesthesiologists in the hospital.

During a concurrent record review and interview with the DOP and POM on 5/26/21 at 0900 hours, the DOP stated the hospital's Controlled Substances Distribution for Anesthesiologists P&P was out of date, and it did not reflect the practice of the hospital's Campus A regarding the use of the A-machines and inventory discrepancies.

During a follow-up interview with the DOP on 5/27/21 at 1345 hours, the DOP stated the process for auditing the use of CS for 10 anesthesiologists per week had been in place and that was not enough audit.

During a concurrent record review and interview with the REDP, ADP, POM, and CPM on 6/21/21 at 1045 and 1130 hours, they provided two documents: the Inpatient Controlled Substance Management and the Controlled Substances, RX-411. The Controlled Substances, RX-411 document did not have an effective date. The REDP stated the hospital's policy related to the controlled substance management and controlled substances were not approved by the hospital's GB (or Board of Trustees). These hospital's policies were not officially approved.

During a review of the hospital's P&P titled Policy, Procedure, Protocol and Clinical Guidelines Management dated 10/29/20, the P&P showed, "Order of approval is as follows: responsible Director (or above), Policy and Procedure Committee, MedStaff committees and subcommittees, Nursing committees and subcommittees, Medical Executive Committee and the Board of Trustees."

2. Review the Anesthesiologist Audit Report for the month from January to March 2021 for the hospital's Campus A showed the following:

* For the month of January 2021, the monthly total numbers of errors (CS discrepancies) were 31.

* For the month of February 2021, the monthly total numbers of errors were 45.

* For the month of March 2021, the monthly total numbers of errors were 66.

An interview and concurrent record review were conducted with the CPDA and DOP on 5/26/21 at 1400 hours. The anesthesiologist audit reports from the CPDA from January to April 2021 were reviewed. 24 anesthesiologists' CS discrepancies were randomly selected for review. 21 of 24 anesthesiologists' CS discrepancies were identified as follows:

* On 1/4/21 at 0913, 1022, and 1110 hours, MD 2 removed three vials of fentanyl (a CS medication) 100 mcg (total of 300 mcg) from the A-machine. On 1/4/21 at 1147 hours, MD 2 returned one vial of fentanyl 100 mcg to the A-machine. Fentanyl 100 mcg was documented as administered to Patient 22. The administration or waste of the remaining 100 mcg of fentanyl was not recorded in Patient 22's medical record or the A-machine.

* On 1/4/21 at 1701 hours, MD 2 removed one vial of meperidine (a CS medication) 25 mg from the A-machine, but the administration or waste of meperidine 25 mg was not recorded in Patient 23's medical record or the A-machine.

* On 1/11/21 at 0800, 1141, and 1257 hours, MD 7 removed a total of three vials of fentanyl 100 mcg (total of 300 mcg) from the A-machine. Fentanyl 100 mcg was documented as administered to Patient 24. The administration or waste of two vials of fentanyl 100 mcg was not recorded in Patient 24's medical record or the A-machine.

* On 2/3/21 at 0351 hours, MD 6 removed one vial of fentanyl 250 mcg from the A-machine and fentanyl 150 mcg was documented as administered to Patient 20. The administration or waste of the remaining 100 mcg of fentanyl was not recorded in Patient 20's medical record or the A-machine.

* On 2/3/21 at 1510 hours, MD 2 removed three vials of meperidine 25 mg (total of 75 mg) from the A-machine, but the administration or waste of these three vials of meperidine 25 mg was not recorded in Patient 18's medical record or the A-machine.

* On 2/4/21 at 1312 hours, MD 2 removed four vials of meperidine 25 mg (total of 100 mg) from the A-machine, but the administration or waste of these four vials of meperidine 25 mg was not recorded in Patient 17's medical record or the A-machine.

* On 2/4/21 at 1416 and 1418 hours, MD 2 removed two vials of meperidine 25 mg (total of 50 mg) from two different Pyxis machines, but the administration or waste of these two vials of meperidine 25 mg was not recorded in Patient 19's medical record or the Pyxis machines.

* On 2/16/21 at 2008 hours, MD 2 removed three vials of meperidine 25 mg (total of 75 mg) from the A-machine, but the administration or waste of these three vials of meperidine 25 mg was not recorded in Patient 21's medical record or the A-machine.

* On 3/1/21 at 1326 hours, MD 5 removed one vial of fentanyl 100 mcg/2 ml from the A-machine and only fentanyl 50 mcg was documented as administered to Patient 5. The administration or waste of the other 50 mcg of fentanyl was not recorded in Patient 5's medical record or the A-machine.

* On 3/2/21 at 1230, 1307, 1333, 1449, 1547, and 1709 hours, MD 2 removed 14 vials of meperidine 25 mg (total of 350 mg) from different Pyxis machines, but only 11 vials of meperidine 25 mg (total of 275 mg) were documented as administered to Patient 7. The administration or waste of the other three vials of meperidine 25 mg was not recorded in Patient 7's medical record or the Pyxis machines.

* On 3/3/21 at 0734 hours, MD 5 removed one vial of fentanyl 100 mcg/2ml from the A-machine, but the administration or waste of this fentanyl 100 mcg was not recorded in Patient 3's medical record or the A-machine.

* On 3/3/21 at 1017 hours, MD 2 removed two vials of meperidine 25 mg (total of 50 mg) from the A-machine, but the administration or waste of these two vials of meperidine 25 mg was not recorded in Patient 8's medical record or the A-machine.

* On 3/3/21 at 1055, 1347, 1418, and 1733 hours, MD 2 removed 11 vials of meperidine 25 mg (total of 275 mg) from different Pyxis machines, but only eight vials of meperidine 25 mg (total of 200 mg) were documented as administered to Patient 6. The administration or waste of the other three vials of meperidine 25 mg was not recorded in Patient 6's medical record or the Pyxis machines.

* On 3/14/21 at 1503 and 1533 hours, MD 2 removed eight vials of meperidine 25 mg (total of 200 mg) from different A-machines, but the administration or waste of these eight vials of meperidine 25 mg was not recorded in Patient 9's medical record or the A-machine.

* On 3/15/21 at 1326 hours, MD 2 removed four vials of meperidine 25 mg (total of 100 mg) from the Pyxis machine, but the administration or waste of these four vials of meperidine 25 mg was not recorded in Patient 10's medical record or the Pyxis machine.

* On 3/19/21 at 1650 hours, MD 2 removed three vials of meperidine 25 mg (total of 75 mg) from the Pyxis machine,but the administration or waste of these three vials of meperidine 25 mg (three vials) was not recorded in Patient 12's medical record or the Pyxis machine.

* On 3/29/21 at 0754 and 0805 hours, MD 2 removed eight vials of meperidine 25 mg (total of 200 mg) from the A-machine, but 12 vials of meperidine 25 mg (total of 300 mcg) were documented as administered to Patient 13. There was no record of additional four vials of meperidine 25 mg removed from the Pyxis machine for Patient 13.

* On 3/29/21 at 1748 hours, MD 2 removed three vials of meperidine 25 mg (total of 75 mg) from the A-machine, but the administration or waste of these three vials of meperidine 25 mg was not recorded in Patient 15's medical record or the A-machine.

* On 3/29/21 at 1802 hours, MD 2 removed three vials of meperidine 25 mg (total of 75 mg) from the A-machine, but the administration or waste of these three vials of meperidine 25 mg was not recorded in Patient 16's medical record or the A-machine.

* On 3/31/21 at 2103 hours, MD 2 removed three vials of meperidine 25 mg (total of 75 mg) from the A-machine, but the administration or waste of these three vials of meperidine 25 mg was not recorded in Patient 14's medical record or the A-machine.

* On 4/28/21 at 1252 and 1527 hours, MD 3 removed two vials of fentanyl 100 mcg/2 ml and one vial of morphine (a CS medication) 10 mg/ml from the A-machine, but the administration or waste of these controlled drugs was not recorded in Patient 1's medical record or the A-machine.

The DOP and CPDA verified and confirmed the above discrepancies. The DOP stated they did not know if the CS discrepancies were resolved or not because they did not receive any records to show the CS discrepancies had been resolved.

During a concurrent record review and interview with the CPDA, POM, CPM, and DOP on 5/24/21 at 1030 hours, the CPDA stated she audited the use of CS for 10 anesthesiologists per week by comparing the removed amount on their Pyxis activity reports with the amount documented in the patients' CS administration records. The CPDA further stated she filled out the anesthesiologist audit report and reported the CS discrepancies to the DOP and POM. While reviewing the Anesthesiologist Audit Report, the CPDA stated she had not completed the Anesthesiologist Audit Report for the month of April 2021. The DOP stated all CS discrepancies should be resolved and the anesthesiologist should document all of the CS amounts that were administered and wasted. The DOP stated their system to reconcile and account for the CS was insufficient and the review and audit for the use of CS had not been done for all anesthesiologists.

During a concurrent record review and interview with the CMO, DPS, CQRC, DMSS who was on the phone, ADP, and DOP on 5/26/21 at 1010 hours, the DPS stated he had not received the anesthesiologist audit report and this report was new to him. The DPS further stated if he was aware of the spreadsheet of discrepancies (Anesthesiologist Audit Report), he would address and correct the discrepancies with the anesthesiologists.

During a follow-up interview and record review with the DOP and POM on 5/26/21 at 1300 hours, the POM confirmed from January to May 2021, he sent only one Anesthesiologist Audit Report for January 2021 to MD 1 on 2/24/21 at 1533 hours. The POM stated he should send the monthly reports. The DOP stated that was insufficient and their system was broken and lacked of formalized process.

During a follow-up interview and concurrent record review with the CPM on 6/22/21 at 0925 hours, Patient 1's medical record was reviewed. The record showed MD 3 removed two vials of fentanyl 100 mcg/2 ml and one vial of morphine 10 mg/ml from the A-machine on 4/28/21 at 1252 and 1527 hours, but the administration or waste of these controlled drugs were not recorded. The CPM confirmed the discrepancy was not resolved.

3. During a concurrent interview and record review with the REDP, ADP, POM and CPM on 6/21/21 at 1120, 1130, and 1140 hours, the REDP stated there was a department procedure Standard Work Sheet to perform daily reconciliation of CS removal and administration by the anesthesiologist.

Review of the procedure Standard Work Sheet for the hospital's Campus A showed the following:

* There was no approval date.

* "Discrepancy Resolution ...Contact the anesthesiologist directly to reconcile the discrepancy ASAP. The anesthesiologist involved should respond within 24-hours to resolve the discrepancy. After 24 hours, the pharmacist notifies the Leadership Team (Chief of Anesthesiology and Pharmacist in Charge (PIC) for follow-up ...When there is NO resolution of the discrepancy AFTER a total of 48 hours, the pharmacist will perform the following: ...Report the discrepancy of the controlled drug as an unresolved discrepancy in the Medication Event Reporting System (RL) ...Initiate the Controlled Substance Discrepancy Report form ..."

The CPM confirmed there was no approval date and stated the approval date should be the same date as the hospital's Campus B, or 6/14/21. The REDP stated the expectation was for the pharmacist to audit all anesthesiologists for the use of CS daily.

Review of the anesthesiologist audit report for the hospital's Campus A dated 6/18/21, showed there were seven errors (anesthesiologists' CS discrepancies). There was a handwritten note "Still need to call." The POM stated he did not call the anesthesiologists regarding the CS discrepancies identified on 6/18/21 (three days ago); those CS discrepancies were not resolved; and he should call the anesthesiologists. The POM further stated he called the anesthesiologist for other days but he did not follow up, and he did not know if the CS discrepancies had been resolved.

Review of the anesthesiologist audit report dated 6/15/21, showed on 6/15/21 at 0744 hours, MD 10 removed one vial of fentanyl 100 mcg/2 ml from the A-machine. Only fentanyl 75 mcg was documented as administered to Patient 38. The administration or the waste of the remaining fentanyl 25 mcg was not recorded in Patient 38's medical record or the A-machine. The record showed the pharmacy called the anesthesiologist on 6/16/21. The CPM stated there were no records of wasted fentanyl 25 mcg. The REDP stated it was for the pharmacy to follow up; if not, the CS discrepancies were still there. The REDP further stated the pharmacist should follow up on the discrepancies until it was resolved, and the pharmacy did not track the movement of CS in the anesthesia department.

During a follow-up interview with the ADP and CPM on 6/21/21 at 1315 hours, the CPM stated the CS discrepancies should be resolved.

During a concurrent interview and record review with the ADP, CPM and CPDA on 6/22/21 at 0830 hours, the CPDA stated she had not seen the Standard Work Sheet. The CPM stated the procedure Standard Work Sheet was a new process and the pharmacy staff's training for this process was in the progress.

4. A concurrent interview and record review was conducted with the CPDA and DOP on 5/26/21 at 1430 hours. MD 2's Pyxis activity report for March 2021 for the hospital's Campus A was randomly selected for review. The Pyxis report and CS administration records for two patients (Patients 25 and 26) were reviewed. The following was identified:

* On 3/8/21 at 0712, 0758, 0833, 0937, 0938, 1026, 1132, and 1236 hours, MD 2 removed 22 vials of meperidine 25 mg (total of 550 mg) from different A-machines, but only 20 vials of meperidine 25 mg (total of 500 mg) were documented as administered to Patient 25. The administration or the waste of two vials of meperidine 25 mg was not recorded in Patient 25's medical record or the A-machines.

* On 3/8/21 at 1501, 1602, and 1758 hours, MD 2 removed 12 vials of meperidine 25 mg (total of 300 mg) from different A-machines, but only 10 vials of meperidine 25 mg were documented administered to Patient 26. The administration or the waste of the other two vials of meperidine 25 mg was not recorded in Patient 26' medical record or the A-machines.

Review of the Anesthesiologist Audit Report for March 2021 did not show MD 2's Pyxis activity reports for Patients 25 and 26 were selected and audited by the hospital's pharmacy.

The DOP and CPDA verified and confirmed the CS used by MD 2 for Patients 25 and 26 were not audited and reviewed. They confirmed the above CS discrepancies.

5. During a concurrent record review and interview with the ADP, DOP, POM, RPH 1 and the Director, Risk management Regulatory Readiness, Pt (patient) Safety & Peer Review (DRPP) at the hospital's Campus B on 5/27/21 at 0910 and 1200 hours, the POM stated the hospital's Campus B did not have the A-machines. The anesthesiologists removed the anesthesia CS boxes from the Pyxis, and the pharmacist reconciled the anesthesia CS boxes every day. The POM further stated there was no unresolved discrepancies.

Review of 380 Anesthesia Controlled Substance Records (ACSRs) from January to April 2021, showed 358 ACSRs did not have the patients' CS administration records.

Review of 55 ACSRs for May 2021 showed 29 ACSRs did not have the patients' CS administration records.

RPH 1 stated the pharmacist should match the amounts of CS medications that the anesthesiologists documented on the ACSRs with the amounts documented on the patients' CS administration records, and that process had not been happened for these ACSRs. The DOP stated there was no documentation that the reconciliations happened for these records.

6. During a concurrent record review and interview with the ADP, DOP, POM, DRPP, and RPH 1 on 5/27/21 at 0910 and 1200 hours, the following CS discrepancies remained unresolved for the hospital's Campus B:

* The ACSR dated 4/8/21, showed MD 8 removed two vials of fentanyl 100 mcg/2 ml (total of 200 mcg) from the anesthesia box for Patient 27, but the Perioperative Clinical Record (PCR) showed total of 400 mcg of fentanyl were administered to Patient 27. The Pharmacist restocked with three vials of fentanyl 100 mcg/2ml (total of 300 mcg). There was no record showing the pharmacist contacted MD 8. RPH 1 stated there was no follow-up with MD 8. The DOP stated the pharmacist should clarify with MD 8.

* The ACSR dated 4/13/21, showed MD 3 removed one vial of fentanyl 100 mcg/2 ml from the anesthesia box for Patients 28 and 29 and the PCR showed fentanyl 50 mcg was administered to Patient 28. There was no record of administration or waste of the remaining 50 mcg of fentanyl in Patients 28 and 29's medical records. RPH 1 and the DOP stated the reconciliation did not happen.

* The ACSR dated 4/28/21, showed there was four vials of midazolam (a CS medication) 2 mg/2 ml in the anesthesia box. MD 9 removed two vials of midazolam 2mg/2 ml from the anesthesia box for Patients 30 and 31. The PCR showed one vial of midazolam 2mg/2 ml was administered to Patient 30 and one vial of midazolam 2mg/2 ml was administered to Patient 31. However, there was a note showing "Found 3 vials returned in box." There was no record showing the pharmacist contacted MD 9. The DOP and RPH 1 stated the pharmacist should contact MD 9 to clarify.

* The ACSR dated 4/29/21, showed MD 5 (anesthesiologist) removed two vials of fentanyl 100 mcg/2 ml (total of 200 mcg) from the anesthesia box for Patient 32, but the PCR showed 250 mcg was administered to Patient 32. There was a note "+1" (added one ml) to four ml on the ACSR for Patient 32. The DOP stated the note was not the same handwriting as the anesthesiologist, and that was not right for the pharmacist to correct the ACSR. The DOP further stated the pharmacist should not change the record and should contact the anesthesiologist to correct the discrepancy.

* The ACSR dated 5/20/21, showed MD 5 removed one vial of fentanyl 100 mcg/2 ml from the anesthesia box for Patient 33, but the administration or waste of this fentanyl 100 mcg was not recorded in Patient 33's medical record. RPH 1 confirmed the finding. The DOP stated there was no documentation to show the pharmacist reconciled the record. The DOP further stated that was insufficient.

During a concurrent record review and interview with the ADP, DOP, and DRPP on 5/27/21 at 1530 hours, the following controlled drug discrepancies remained unresolved:

* On 3/5/21 at 1037, 1227, 1311, 1311, 1408, and 1543 hours, MD 2 removed seven vials of meperidine 50 mg and four vials of meperidine 25 mg (total of 450 mg) from the Pyxis machine, but only meperidine 437.5 mg was documented as administered to Patient 34. The administration or waste of meperidine 12.5 mg was not recorded in Patient 34's medical record.

* On 3/25/21 at 1638 hours, MD 2 removed one vial of meperidine 50 mg and one vial of meperidine 25 mg (total of 75 mg) from the Pyxis machine, but the administration or waste of these meperidine vials (total of 75 mg) was not recorded in Patient 35's medical record.

The DOP confirmed the above discrepancies.

7. During a review of the hospital's P&P titled Controlled Substances Management dated 1/3/17, the P&P showed, "When a controlled substance discrepancy is discovered, the nurse who noted the discrepancy is responsible for reporting the discrepancy by: ...Printing a "Discrepancy Report" ...Reporting the discrepancy to the charge nurse ...Investigate the discrepancy with the charge nurse ...Charge Nurse Responsibility ...The charge nurse will notify the Department Director or designee, and the Administrative Supervisor. A Controlled Substance Discrepancy Report will be completed and submitted to the Department Director who will forward to the Director of Pharmacy ...The pharmacy reviews all narcotic discrepancies daily ...AT THE END OF EACH SHIFT THE CHARGE NURSE WILL VERIFY THAT ALL DISCREPANCY REPORTING HAS BEEN COMPLETED by running a Discrepancy Report. Information regarding any discrepancies that have not been resolved shall be forwarded to the Nurse Manager ...The Pharmacy does not allow unresolved shortages of controlled substances."

During a review of the hospital's P&P titled Medication: Pyxis Medstation dated 1/12/17, the P&P showed, "Pharmacy Procedures...Unresolved Controlled Substance Discrepancy Report (auto-prints daily): This report is used to follow up any unresolved controlled substance discrepancies."

A tour to the satellite pharmacy at the hospital's Campus A was conducted with the ADP and CPM on 5/24/21 at 1635 hours. There was an unresolved discrepancy of one ketamine 500 mg/10 ml vial from the Pyxis of the trauma unit. Review the Pyxis activity report for the discrepancies showed RN 1 removed ketamine on 5/22/21 at 1704 hours, with the information showing "Expec

Based on observation, interview, and record review, the hospital failed to ensure the drugs were controlled and distributed in accordance with the standards of practice and hospital's P&P as evidence by:

1. Failure to ensure the safe and effective control and distribution of controlled substances (CS, medications that have a high potential for abuse and misuse). The hospital pharmacy did not monitor the use of CS in the Anesthesia Department, including the high dose of meperidine used by MD 2 to identify the potential of CS diversion. This resulted in the ineffective control of CS and diversion of meperidine from MD 2.

2. Failure to ensure the safe and effective dispensing of fentanyl patch (a CS medication used for the management of persistent, moderate to severe chronic pain) was consistent with the hospital's P&P and in accordance with accepted standards of practice for one of 66 sampled patients (Patient 39) when the pharmacist did not document the patient met the criteria for the use of fentanyl patch before dispensing the first dose of fentanyl transdermal patch. This failure had the potential to cause serious, life threatening side effects (undesirable effects) to Patient 39.

3. Failure to ensure the discharged patients' medications were destroyed in accordance with the hospital's P&P for two of 66 sampled patients (Patients 36 and 37). This failure had the potential to create the risk of misuse of the medications.

Findings:

1. During the QAPI meeting on 6/24/21 at 1630 hours, the REDP stated the hospital followed the ASHP (American Society of Health-System Pharmacy, a nationally recognized professional standard of practice) guidelines.

During a review of the ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, copyright ©2013, the guidelines showed, "There shall be policies and procedures to ensure control of the distribution and use of controlled substances and other medications with a potential for abuse. These policies and procedures shall be consistent with applicable laws and regulations and shall include methods for preventing and detecting diversion."

During a review of the ASHP Guidelines on Perioperative Pharmacy Services, copyright © 2019, the guidelines showed, "Essential roles of the perioperative pharmacist or pharmacy team include the following: ...Medication procurement, preparation, distribution, and flow ...Promotion of safe medication use according to regulations and institutional policies ...Controlled substance management and surveillance ...a comprehensive and interdisciplinary approach to diversion surveillance for anesthesia is necessary and should include the following strategies: ...Regular review of atypical usage reports. Atypical usage, such as escalating activity and excessive waste, should be regularly reviewed. Reports should compare the amount of drug (e.g., fentanyl) removed overtime (per case, month, or quarter) by individual ACPs (anesthesia care providers) with peers for similar types of cases ..."

During a review of the hospital's P&P titled Controlled Substances Management dated 1/3/17, the P&P showed, "Purpose ...to provide for security controls and procedures to guard against theft and diversion of controlled substances ...Responsibility ...Director of Pharmacy Services and Pharmacist-In-Charge...Scope ...Covers the handling, storage, administration, documentation of waste and destruction of controlled substances by healthcare providers as outlined by their scope of practice."

a. Based on various interviews and record reviews on 5/24 and 5/26/21, at the hospital's Campus A, the following was identified:

- The hospital did not have an approved policy addressing the reconciliation of CS medications used by the anesthesiologists from the Pyxis Anesthesia machines (A-Machines) or Main OR Pyxis, and the resolution of CS discrepancies in Anesthesia Department. Cross reference to A494, example #1.

- The hospital failed to follow up and resolve the identified CS discrepancies for 21 of 24 sampled patients (Patients 1, 3, 5, 6, 7, 8, 9, 10, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24) from January to April 2021. Cross reference to A494, example #2.

- A random review of CS used by MD 2 showed discrepancies for two patients (Patients 25 and 26) who were not selected for audit by the hospital's pharmacy. Cross reference to A494, example #4.

During an interview with the POM, CPM, and DOP at hospital's Campus A on 5/24/21 at 0900 and 1030 hours, the CPM and POM stated the pharmacy did a limited random audit for the use of CS by the anesthesiologists, but the pharmacy did not oversee the use of CS by the anesthesiologists.

b. Based on interview and record review on 5/27/21, at the hospital's Campus B, the following was identified:

- From January to May 2021, the hospital did not have documentation to show the pharmacy staff compared the amount dispensed from the anesthesia box with the amount documented on the patients' CS administration records to ensure accurate reconciliation for 387 of 435 ACSRs. Cross reference to A494, example #5.

- From January to May 2021, the hospital failed to clarify with the physicians and accurately reconcile the CS discrepancies for nine of 66 sampled patients (Patients 27, 28, 29, 30, 31, 32, 33, 34, and 35). Cross reference to A494, example #6a.

During an interview with the Area Director of Pharmacy (ADP), DOP, POM and CPM on 5/24/21 at 0945, 1130, 1200, and 1330 hours, the DOP stated there was a case in April 2021 that MD 2 had diverted the meperidine medication from the hospital. MD 2 removed larger quantities of meperidine than usual and documented the medications were administered to the patients. The DOP further stated in some cases, MD 2 documented the administration amount more than the amount of meperidine that he removed from the Pyxis, and these indicators caused the red flag to the organization (hospital). The POM stated the Chair of the Quality Review Committee (CQRC) informed the pharmacy about MD 2 and asked for additional data of CS usage by MD 2. The ADP stated the pharmacy provided MD 2's Pyxis activity report and data of meperidine usage to the head of anesthesiologist and medical staff who conducted the interview with MD 2. The DOP further stated the Chief of Medical Officer (CMO) contacted the pharmacy to remove MD 2's access to the Pyxis machines. The DOP stated the pharmacy had the RxAuditor (CS screening tool) but did not use the RxAuditor or any other tools to detect and identify the potential CS diversion. The DOP stated this was a poor oversight by the pharmacy. The DOP further stated the pharmacy did not monitor the use of CS medications including meperidine in the Anesthesia Department. The pharmacy was purely reactive, not proactive. The ADP and DOP stated the pharmacy should oversee the movement of CS medications but the pharmacy was not a part of the investigation of MD 2 on the CS diversion. The ADP stated the identification of potential CS diversion and the monitoring of narcotic use in the Anesthesia Department should be a part of pharmacy oversight. The DOP provided the pivot tables (CS analysis tool) of MD 2's CS activities, and stated the pharmacy had used the pivot table to analyze the data from the Pyxis activity reports since April 2021, after MD 2's CS diversion.

During a concurrent interview and record review with the DOP on 5/24/21 at 1200 and 1350 hours, the DOP stated the identification and monitoring of potential CS diversion did not happen until the case of MD 2 was made known in April 2021. The DOP stated the hospital's P&P did not outline a process to help staff to detect and identify the potential CS diversion. The DOP further stated the RxAuditor and pivot table were not included in the hospital's P&P and the lack of hospital's P&P created inconsistency in the identification and monitoring of CS use in the hospital.

Review the pivot table of MD 2's CS activities from 2017 to 2021 showed the dose of meperidine (mg) (removal from the Pyxis) and the number of patients:

* In 2017, 16,500 mg of meperidine for 328 patients.
* In 2018, 23,950 mg of meperidine for 260 patients.
* In 2019, 22,050 mg of meperidine for 438 patients.
* In 2020, 22,275 mg of meperidine for 494 patients.
* In 2021, 24,950 mg of meperidine for 346 patients.
* 2021 annualized, 74,850 mg of meperidine for 1038 patients.
"2021 YTD (Year-to-date) as outlier, 2018 looks questionable as well ...2021 annualized projects to 3.5 x (time) higher mep (meperidine) use relative to previous years and 5-fold higher than 2017 (Mep dose)."

Review the pivot table of MD 2's monthly trending of meperidine activity showed the following:

* In January 2021, 143 vials (or 3,650 mg) of meperidine was removed for 59 patients.

* In February 2021, 270 vials (or 6,750 mg) of meperidine was removed for 96 patients.

* In March 2021, 565 vials (or 14,125 mg) of meperidine was removed for 183 patients.

The DOP stated the pharmacy should have monitored the use of meperidine for these patients.

During a review of the e-mailed report from the DOP to California Board of Pharmacy dated 4/16/21, the report showed, "Number of doses diverted is unclear, but removals increased significantly in 2021. Allowing for this increase in removals as indication of diversion, this suggests diversion of upwards of 3700 mg of meperidine in 2021 relative to baseline prescribing patterns in previous years."

During an interview with the CMO, Director of Perioperative Service (DPS), CQRC, Medical Director of Medical Staff Service (DMSS) who was on the phone, ADP, and DOP on 5/26/21 at 1010 hours, the DPS stated there was a gap in communication between the pharmacy and Anesthesia Department regarding fixing the CS discrepancies, identifying of the potential CS diversion, and the CS diversion of MD 2, and there was no systemic communication. The DPS further stated the Anesthesia Department identified the clinical concerns about the documentation of the use of meperidine from MD 2, raised the concerns to the medical staff, and requested the data analysis from the pharmacy. The DPS further stated the pharmacy should be a part of the MD 2's investigation on the CS diversion. The CQRC stated the change in meperidine usage by MD 2 was the big red flag as far as diversion concern and the data from the pharmacy was reviewed. Both medical staff and pharmacy were responsible for the use of CS in the Anesthesia Department. The CQRC further stated MD 2 confirmed some of the meperidine medications were administered to the patients but MD 2 would not answer the question where the rest of meperidine medications were.

During a concurrent interview and record review with the DOP on 5/26/21 at 1300 and 1400 hours, the DOP stated their system was broken, lacked of formalized process, and insufficient. The DOP further stated the pharmacy did not identify and monitor MD 2 who used the high dose of meperidine, and there was no oversight from the pharmacy.

During an interview with the REDP, ADP, POM and CPM on 6/21/21 at 1045 hours, the REDP and ADP stated there were no system to track the movement of CS in the Anesthesia Department. The POM stated no hospital's P&P was developed to specify the CS diversion. They acknowledged that patients' health and safety could be affected by MD 2's CS diversion.

During an interview with the Director of Perioperative Service (DPS) on 6/23/21 at 1210 hours, the DPS stated the hospital did not have a system for CS surveillance, there was no P&P, and that was a work in progress. The DPS further stated he used the pivot table and received the RxAuditor about one month ago.

During an interview with the POM on 6/24/21 at 1745 hours, the POM stated he sent the RxAuditor monthly reports for April and May 2021 to the nursing. The POM further stated the hospital needed to develop a system to monitor CS in the hospital.

During an interview and record review with the REDP, ADP, POM, and CPM on 6/28/21 at 0905 and 1430 hours, the CPM stated the first Carefusion knowledge portal (Pyxis) data analysis was sent to the DPS on 6/22/21, and he had not reviewed the pivot table with the DPS prior to 6/22/21. The POM stated he sent the RxAuditor monthly reports for April and May 2021 on 6/10 and 6/16/21, but he had not received the feedback. The CPM stated the hospital did not have a standard procedure to monitor CS diversion, but that was a work in progress. The ADP stated the hospital had no system to do CS diversion surveillance.

2. During a review of the hospital's P&P titled Medications: Fentanyl Patch Administration and Monitoring dated 5/1/20, the P&P showed, "The FDA Black Box Warning (the strongest warning that the FDA requires) for the fentanyl (transdermal) patch stipulates that it is to be used in opioid-tolerant patients (who has been taking another opioid at a dose comparable to a fentanyl [transdermal] patch) only ...Because serious or life-threatening hypoventilation could occur, fentanyl (transdermal) patches are contraindicated in ...Patients who are not opioid-tolerant ...The management of acute pain ...The management of post-operative pain ...The management of mild pain ...The management of intermittent pain ...All orders will be reviewed by a pharmacist prior to profiling and dispensing to assess eligibility for treatment ...For all new orders for fentanyl (transdermal), the pharmacist shall verify and document that the patient meets at least one of the following acceptable criteria for use of fentanyl (transdermal) while hospitalized ...Continuation of fentanyl patch regimen from home ...History of opioid use ..."

During the QAPI meeting on 6/24/21 at 1630 hours, the REDP stated the hospital followed the ASHP guidelines.

During a review of the ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, copyright © 2013, the guidelines showed, "Review of Medication Orders. All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered ...Medication therapy monitoring shall be conducted by pharmacist ...The therapeutic appropriateness of the patient's medication regimen ...The appropriate of the dose of the medication ..."

An interview and concurrent record review were conducted on 6/22/21 at 1555 hours, with the ADP and CPM in the Cardiac Telemetry unit.

Patient 39's medical record was reviewed. Patient 39 was admitted to the hospital's Campus A on 6/16/21.

Review of the fentanyl order details showed fentanyl 25 mcg/hr transdermal patch every 72 hours was ordered on 6/17/21, and RPH 5 verified the order.

When asked, the CPM stated the pharmacist should review the fentanyl patch order for the appropriateness before dispensing the fentanyl patch, and the pharmacist should document in the intervention before the first dose of fentanyl patch was dispensed. The CPM confirmed there was no document in the intervention before the first dose of fentanyl patch was dispensed. The CPM stated that was in the hospital's policy and the pharmacist should remember to do that.

3. During a review of the hospital's P&P titled Medication, Disposition of Patient's Own Medication" dated 1/2009, the P&P showed, "Patient's own medications...Those unclaimed which remain in the pharmacy department 3 months after discharge shall be destroyed in the following manner: ...Non-controlled substances shall be placed in the vendor supplied pharmaceutical waste box for incineration."

During a tour of the hospital's pharmacy with the ADP and CPM on 6/21/21 at 1500 hours, the patients' own medications were inspected. One bottle of Synthroid [used to treat an underactive thyroid (hypothyroidism)], one bottle of pravastatin (used to lower lipid levels in the blood), one bottle of telmisartan (blood pressure medication), one bottle of nifedipine (blood pressure medication), and one bottle of amoxicillin (used to treat infections) belonged to Patient 36; and one bottle of cephalexin (used to treat infections) belonged to Patient 37 were stored in the file cabinet of the medication room.

Review the Patient Medication Log showed Patient 36's medications were received by the pharmacy on 2/6/21, and Patient 37's medication was received by the pharmacy on 2/24/21. The CPM stated those medications were not picked up. After the CPM reviewed the hospital's P&P, he stated those medications should be discarded.

During a concurrent interview and record review with the CPM on 6/22/21 at 1545 hours, Patient 36 was discharged from the hospital on 2/18/21 (more than 4 months ago) and Patient 37 was discharged from the hospital on 2/24/21 (more than 3 months ago). The CPM stated these medications should be destroyed.

Based on observation, interview, and record review, the hospital failed to ensure the preparation of all IV compounding sterile preparations were consistent with federal regulatory requirements and/or accepted standards of practice as evidenced by:

1. The hospital failed to ensure the cleaning of the sterile compounding area (where the IV medications were prepared) was performed in accordance with the accepted professional standards of practice. The surface behind the IV hoods, wall, bar supporting the work surface, and anchor of one of the two IV hoods were not cleaned for the pharmacy at the hospital's Campus A.

2. The hospital failed to ensure the competency assessment of EVS personnel. Two of seven EVS personnel (EVSs 3 and 4) did not have competency assessment for the hospital's Campus A. In addition, the hospital's P&P did not address the training and competency assessments for the EVS personnel.

3. The hospital failed to ensure the pharmacy personnel at the hospital's Campus A and hospital's Cancer Center performed a proper hand washing technique before entering the compounding area in accordance with the hospital's P&P.

4. The hospital failed to develop the written environmental sampling plans based on the risk assessment of compounding activities performed at the hospital's Campus A, Campus B, and Cancer Center pharmacy compounding areas.

5. The infection control professional was not consulted for the immediate remediation (correction) for highly pathogenic (disease-causing) organisms detected in the hospital's Cancer Center pharmacy compounding area.

These failures had the potential for a lack of administrative oversight, inadequate risk assessments regarding the quality of the pharmacy compounding environments, unsafe compounding, and/or patients being administered potentially contaminated IV medications which could increase the patient's risk of adverse health outcomes, such as preventable infections, for the patients in the hospital.

Findings:

During an interview with the ADP and CPM on 6/21/21 at 1520 hours, the ADP stated the hospital followed the USP Chapter <797> as the hospital's standards for the compounding of CSPs.

1. During a review of the hospital's P&P titled Sterile Products - Compounding and General Guidelines dated 11/12/20, the P&P showed, "The Ante room ...and clean room floors are cleaned and disinfected daily and walls, ceiling, counter, chair/stool are cleaned/disinfected monthly by EVS personnel using Oxycide (sporicidal agent ...) ...The cleaning of the Direct Compounding Area (DCA) is the responsibility of Pharmacy personnel only and shall be completed at the beginning of each shift ...after spills ...or when known or suspected contamination has been introduced ...On a monthly basis, decontaminate all surfaces using a multi-purpose disinfectant/decontaminant cleaner with fungicidal activity ..." USP Chapter <797> is one of the references of this hospital's P&P.

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations dated June 2017, in the section Cleaning and Disinfecting the Compounding Area showed, "Environmental contact is a major source of microbial contamination of CSPs. Consequently, scrupulous attention to cleaning and disinfecting the sterile compounding areas is required to minimize this as a source of CSP contamination ...Work surfaces ...shall be cleaned and disinfected at least daily ...In the buffer or clean area, ante-area, ...walls, ceilings, and shelving shall be cleaned and disinfected monthly..."

During an observation and concurrent interview with RPH 3 and RXT 1 in the clean room of the hospital's Campus A on 6/21/21 from 1540 to 1640 hours, there were two Laminar Airflow Workbench (LAFW, an IV hood) in the clean room. When entered the clean room, LAFW 1 on the right side was observed bolted to the floor preventing it from moving. There were walls on the right side and back of LAFW 1. The gap between LAFW 1 and the right sidewalls and the gap between LAFW 1 and the back wall were about one to two inches. When asked about the area behind LAFW 1, RPH 3 stated there was not enough room for the EVS staff to clean the area behind LAFW 1 and the wall. When the surveyor used the sterile wipe to wipe the back of LAFW 1, a layer of dust was observed on the wipe. RPH 3 confirmed and stated the back of LAFW 1 should be clean. In addition, LAFW 1 was observed with the following:

- There were rusty materials on the bar that supported the work surface of the hood. RPH 3 used the Q-tip to wipe the bar and there was dust observed on the cotton of the Q-tip.

- There were rusty materials on the side of the anchor and floor.

RPH 3 and RXT 1 confirmed the above observations.

During a follow-up interview with the ADP and RPH 3 on 6/21/21 at 1650 hours, the ADP saw the sterile wipe and Q-tip and stated the area behind LAFW 1 and the wall, bar, anchor should be clean.

During an interview with the CPM, EVS Supervisor, EVS 1, EVS 2 on 6/22/21 at 1445 hours, the EVS Supervisor stated they could not make sure the area behind LAFW 1 and the wall were clean because of the narrow gap between LAFW 1 and the wall.

2. During a review of the hospital's P&P titled Sterile Products - Compounding and General Guidelines dated 11/12/20, the P&P showed, "EVS personnel will record cleaning activities on the Cleaning Log."

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations dated June 2017, in the section Cleaning and Disinfecting the Compounding Area showed, "Floors in the ...clean area ...are cleaned by mopping with a cleaning and disinfecting agent ...Mopping shall be performed by trained personnel using approved agents and procedures ...". Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations in the section Personnel Training and Competency Evaluation of Garbing, Aseptic Work Practices, and Cleaning/Disinfection Procedures showed, "In the event that cleaning and disinfecting procedures are also performed by other support personnel (e.g., institutional environmental services, housekeeping), thorough training of proper hand hygiene, garbing, and cleaning and disinfection procedures shall be done by a qualified aseptic compounding expert. After completion of training, support personnel shall routinely undergo performance evaluation of proper hand hygiene, garbing, and all applicable cleaning and disinfecting procedures conducted by a qualified aseptic compounding expert."

During a concurrent interview and record review on 6/22/21 at 1455 hours, with RPH 4 and the CPM, RPH 4 stated the training and competency assessments of EVS personnel were not addressed in the hospital's P&P Sterile Products - Compounding and General Guidelines and the training and competency assessment of EVS personnel should be added to the hospital's P&P. She further stated the clean room should be clean and the EVS personnel should be trained and reassessed yearly. The CPM acknowledged the training and competency assessments of EVS personnel were not addressed in the hospital's P&P.

During a concurrent interview and record review on 6/23/21 at 0920 hours, with RPH 4 and the CPM, the EVS Main Pharmacy Cleaning Record of April, May, and June 2021 were reviewed. There were seven EVS personnel cleaned the clean room. Two of seven EVS personnel (EVSs 3 and 4) did not have competency assessment. The CPM stated he did not have the record of competency assessments for those EVS personnel. RPH 4 stated the EVS personnel should be trained and reassessed for the competency annually, but that was not happened.

3. During a review of the hospital's P&P titled Sterile Products - Compounding and General Guidelines dated 11/12/20, the P&P showed, "Antiseptic Hand Cleansing Procedure ...Initial hand-cleansing - At the beginning of the shift, after exposure to contaminated substances or when deemed necessary: ...Use a nail cleaner under running warm water to remove debris underneath fingernails, followed by vigorous hand-washing. Hands & forearms should be washed to the elbows for at least 30 seconds with water and soap or hospital approved hand-washing agent."

a. During an observation and concurrent interview with RPH 3 and RXT 1 in the pharmacy clean room of the hospital's Campus A on 6/21/21 from 1540 to 1640 hours, RPH 3 was observed performing hand washing before entering the compounding area. RPH 3 did not use the nail cleaner to remove debris from underneath her fingernails. When asked, RPH 3 stated she should use the nail cleaner to remove debris from underneath her fingernails.

During an interview with RPH 4 and the CPM on 6/22/21 at 1455 hours, RPH 4 stated the pharmacy staff should use the nail cleaner to clean their fingernails before entering the compounding area.

b. During an observation and concurrent interview with RXT 2 in the pharmacy clean room of the hospital's Cancer Center on 6/24/21 from 1420 to 1445 hours, RXT 2 was observed performing hand washing before entering the compounding area. RXT 2 did not use the nail cleaner to remove debris from underneath his fingernails. RXT 2 did not scrub his hands and forearms up to his elbows when he washed his hands. When asked, RXT 2 stated he should use the nail cleaner to remove debris from underneath his fingernails and wash his hand up to his elbows.


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4. During a review of the hospital's P&P titled "Sterile Products - Compounding and General Guidelines" dated 11/12/20, the policy indicated, "References...USP [abbreviation for the United States Pharmacopeial Convention - an accepted standard of practice for sterile compounding] Chapter 797 Pharmaceutical Compounding".

During a review of the USP <797> dated 2008 in the section titled "INTRODUCTION", USP <797> indicated "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients...The standards in this chapter are intended to apply to all persons who prepare CSPs [compounded sterile preparations] and all places where CSPs are prepared (e.g., hospitals ...)."

During a review of the USP <797> dated 2008 in the section titled "ENVIRONMENTAL VIABLE AIRBORNE PARTICLE TESTING PROGRAM", USP <797> indicated "Sampling Plan...An appropriate environmental sampling plan shall be developed for airborne viable [capable of living] particles based on a risk assessment of compounding activities performed ... Selected sampling sites shall include locations...in the segregated [designated space] compounding areas at greatest risk of contamination (e.g., work areas near the ISO [abbreviation for International Organization for Standardization - a standard setting body] Class 5 [category of air cleanliness and quality]...environments, counters nears doors, pass-through boxes). The plan shall include sample location, method of collection, frequency of sampling, volume of air sampled, and time of day as related to activity in the compounding area and action levels...Viable Air Sampling...For low-, medium-, high-risk [risk categories] level compounding, air sampling shall be performed at locations that are prone to contamination during compounding activities and during other activities such as staging, labeling, gowning, and cleaning."

During a review of the USP <797> dated 2008 in the section titled "QUALITY ASSURANCE (QA) PROGRAM", USP <797> indicated "A provider of CSPs shall have in place a formal QA program intended to provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes described in this chapter ...Emphasis in the QA Program is placed on maintaining and improving the quality of systems and the provision of patient care. In addition, the QA program ensures that any plan aimed at correcting identified problems also includes the appropriate follow-up to make certain that effective corrective actions were performed. Characteristics of a QA program include the following...Formalization in writing...In developing a specific plan, focus is on establishing objective, measurable indicators for monitoring activities and processes that are deemed high risk, high volume, or problem prone."

During an interview with the POM on 6/24/21 at 1235 hours, the POM stated the hospital followed the USP <797> standards of practice for sterile compounding.

During a concurrent interview and record review with the POM on 6/24/21 at 1312 hours, the hospital's P&P titled "Sterile Products - Compounding and General Guidelines" dated 11/12/20, was reviewed with the POM. The POM acknowledged the policy and the hospital could not demonstrate the written environmental sampling plans for airborne viable particles based on the risk assessment of compounding activities performed as described in USP <797> for the hospital's Campus A, Campus B, and Cancer Center pharmacies.

5. During a review of the hospital's P&P titled "Sterile Products - Compounding and General Guidelines", dated 11/12/20, indicated, "References ...USP Chapter 797 Pharmaceutical Compounding".

During a review of the 2008 USP <797> in the section titled "INTRODUCTION", USP <797> indicated "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients...The standards in this chapter are intended to apply to all persons who prepare CSPs and all places where CSPs are prepared (e.g., hospitals ...)."

Review of the USP <797> dated 2008 in the section titled "Viable and Nonviable Environmental Sampling (ES) Testing" indicated "Environmental sampling shall occur as part a comprehensive quality management program and shall occur minimally under any of the following conditions...as part of the re-certification of facilities and equipment (i.e., every 6 months)..."

A review of USP <797> dated 2008 in the section titled "ENVIRONMENTAL VIABLE AIRBORNE PARTICLE TESTING PROGRAM...Action Levels, Documentation, and Data Evaluation", indicated "The value of viable microbial sampling of the air in the compounding environment is realized when the data are used to identify and correct an unacceptable situation. Sampling data shall be collected and reviewed on a periodic basis as a means of evaluating the overall control of the compounding environment. If an activity consistently shows elevated levels of microbial growth, competent microbiology personnel shall be consulted...Regardless of the number of cfu [abbreviation for colony forming units - a unit of measurement] identified in the pharmacy, further corrective actions will be dictated by the identification of microorganisms recovered...Highly pathogenic microorganisms (e.g. ...Gram-negative rods...molds and yeast) can be potentially fatal to patients receiving CSPs and must be immediately remedied regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist."

A review of USP <797> dated 2008 in the section titled "SURFACE CLEANING AND DISINFECTION SAMPLING AND ASSESSMENT" indicated "Surface sampling is an important component of the maintenance of a suitable microbially controlled environment for compounding CSPs, especially since transfer of microbial contamination from improperly disinfected work surfaces via inadvertent touch contact by compounding personnel can be a potential source of contamination into CSPs"...the section titled "Action Levels, Documentation, and Data Evaluation", indicated "The value of viable microbial sampling of gloved fingertips and surfaces of components and the compounding environment are realized when the data are used to identify and correct an unacceptable situation. Sampling data shall be collected and reviewed on a periodic basis as a means of evaluating the overall control of the compounding environment. If an activity consistently shows elevated levels of microbial growth, competent microbiology personnel shall be consulted...Regardless of the number of cfu identified in the pharmacy, further corrective actions will be dictated by the identification of microorganisms recovered...Highly pathogenic microorganisms (e.g....Gram-negative rods...molds and yeast) can be potentially fatal to patients receiving CSPs and must be immediately remedied regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist."

During a review of the hospital's document titled "Recurring Patient Audit Report" dated 6/28/21, showed 420 patients had the potential to receive care at the hospital's Cancer Center from 1/19/21 to 2/15/21.

During an interview with the POM on 6/24/21 at 1235 hours, the POM stated the hospital followed the USP <797> standards of practice for sterile compounding.

During a concurrent interview and record review with the POM on 6/24/21 at 1242 hours, the hospital's Cancer Center environmental viable testing report collected 1/19/21, was reviewed with the POM. The report showed the gram-negative rod was detected in the air of the ante-room and fungus was detected on the surface of the ante-room rack. The POM acknowledged the above documentation and there was no documentation to demonstrate that the infection control profession was involved to assist with the immediate remediation of the highly pathogenic organisms detected in the Cancer Center pharmacy compounding area.

During an interview with the Cancer Center Pharmacy Supervisor (RXS) on 6/28/21 at 1323 hours, the RXS stated the majority of patients were the patients with oncology (immunocompromised cancer) conditions. She stated there was no documentation to demonstrate the infection control professional was involved to assist with the immediate remediation of the highly pathogenic organisms detected in the Cancer Center pharmacy compounding area for the 1/19/21, environmental viable testing report.

Based on observation, interview, and record review, the hospital failed to ensure the medications were securely stored as evidenced by:

1. The crash cart container (stock emergency medications for use by medical personnel during medical emergencies) in the Outpatient Endoscopy space was stored in the unlocked cabinet.

2. The IV solutions were stored in the unlocked supply cart at the ED South nursing station and at the fourth bay of the Inpatient Endoscopy space.

These failures had the potential for the medications to be accessible to the unauthorized persons and possible misuse of the medications.

Findings:

During a review of the hospital's P&P titled Medication Labeling and Storage dated 12/14/16, the P&P showed, "Drugs shall be accessible only to authorized personnel designated by the hospital, in accordance with state and federal regulations."

1. During a review of the hospital's P&P titled Emergency Drugs dated 4/20/20, the P&P showed, "All emergency medications will be placed in emergency drug supply containers ...An emergency drug container is stocked inside each locked crash cart."

During an observation and concurrent interview with the DOE, CNC 2, and CPM at the hospital's Campus A Outpatient Endoscopy on 6/24/21 at 1500 hours, the crash cart container that contained emergency medications was observed in the unlocked cabinet above the crash cart. CNC 2 stated the cabinet was not locked. The CPM stated he was not sure why the crash cart container was in the unlocked cabinet and the crash cart container should be locked inside the locked crash cart.

2.a. During a tour of the ED with the DET, ADP, and CPM on 6/22/21 at 1030 hours, the unattended supply cart at the South ED nursing station was observed unlocked. There were more than 10 bags of 1000 ml 0.9% sodium chloride (a fluid used for intravenous hydration) injection in the unlocked drawer of the supply cart. A scribe (a personal assistant to the physician) was in a room in front of the supply cart. The DET stated the supply cart should be locked.

During a follow-up interview with the ADP and CPM on 6/23/21 at 0820 hours, the CPM stated the scribe was not an authorized personnel; he should not have access to the IV solutions; and the supply cart should be locked.

b. During a tour of the Inpatient Endoscopy with CNC 1, RN 5, and CPM on 6/23/21 at 1010 hours, the unattended supply cart in the fourth bay was observed to be unlocked. RN 5 stated they would have patient to come to this bay. Four 500 ml bags of 0.9% sodium chloride, one 1000 ml bag of 0.9% sodium chloride, and one 500 ml bag of Lactated Ringer's (medication to replace fluids and electrolytes) in the unlocked drawer of the supply cart. CNC 1 stated the supply cart should be locked.

During a follow-up interview with the CPM on 6/23/21 at 1445 hours, the CPM acknowledged the patient and family members could access to the IV solutions and the supply cart should be locked.

Based on observation, interview, and record review, the hospital failed to ensure the outdated or otherwise unusable medications were not available for patient use. Two 500 ml bags of 0.9% sodium chloride (a fluid used for intravenous hydration) with the expiration date of 12/2019 were found in Procedure Room 2 of Inpatient Endoscopy. This failure had the potential of exposing the patients to the expired or deteriorated medications that could lead to ineffective treatment (such as longer hospitalization or condition deterioration) for the patients.

Findings:

During a review of the hospital's P&P titled Medication Labeling and Storage dated 12/14/16, the P&P showed, "Drugs shall not be kept in stock after the expiration date on the label ...No contaminated, deteriorated or outdated drugs shall be available for use."

During an observation and concurrent interview with the DPS, CPM and RN 5 in Procedure Room 2 of Inpatient Endoscopy at the hospital's Campus A on 6/23/21 at 1100 hours, two 500 ml bags of 0.9% sodium chloride with the expiration date of 12/2019 were observed in the medication cart. The DPS stated the bags of sodium chloride should be discarded. The CPM acknowledged the expired sodium chloride bags.

Based on interview and record review, the hospital failed to implement their automatic stop order P&P for the safe use of Kayexalate, Lovenox, and morphine when these medications were not automatically stopped in accordance with the hospital's P&P. This failure had the potential to increase the adverse effects for the patients with prolonged use of these medications.

Findings:

During a review of the hospital's P&P titled Medication, Automatic Stop Orders dated 8/9/16, the P&P showed, "Purpose: To define medication stop orders ...Procedure: This policy applies to the following medication orders unless the physician specifies the duration of therapy or the total number of doses to be given ...1. The following medications have automatic stop orders: ...24 hours (renewal required every 24 hours) ...Sodium Polystyrene Sulfonate (Kayexalate) ...All other drug classes and/or individual drug entities not listed above shall have automatic stop dates of 30 days (renewal required) unless the physician has specified the duration of therapy or the total number of doses to be given."

During a concurrent interview and record review with the ADP and CPM on 6/23/21 at 1525 hours, the CPM was asked to enter the order of Lovenox and morphine in the pharmacy computer system. The CPM stated there were no hard stop for Lovenox and morphine unless the physician specify the duration of therapy. When asked, the CPM acknowledged the order would be continued without the duration of therapy. The ADP and CPM stated the order should have an automatic stop date.

During a follow-up interview and record review with the REDP, ADP, and CPM on 6/24/21 at 1010 hours, the CPM was asked to enter the order of Kayexalate in the pharmacy computer system. The CPM acknowledged there was no stop date for Kayexalate, Lovenox, and morphine; and the hospital's P&P specified 24 hours automatic stop orders for Kayexalate, 30 days automatic stop orders for all other drug classes. The CPM stated the policy need to be updated, modified to reflect the new pharmacy computer system; and there was a soft stop at 25 days with the new pharmacy computer system. The CPM further stated the soft stop gave an alert to the provider but would not stop the order in the pharmacy computer system. The REDP stated these orders were not automatically stopped in the new computer system and these orders should have the automatic stop date.