HospitalInspections.org

Based on observation, interview, and record review, the hospital failed to:

1. Develop a policy in accordance with accepted pharmaceutical standards of practice and guidelines for safe administration of high-alert medications.

2. Ensure that antibiotic therapy had been overseen and reviewed for the patients who had been provided pharmaceutical services while in the hospital.

These failures had the potential for medication errors when failing to follow nationally recognized standards of practice when administering high-alert medications to patients and potential for patient harm and when being treated without antibiotic therapy reviews as outlined in the hospital's policy and procedures.

Findings:

**This is a repeat deficiency.**

1. The Institute for Safe Medication Practices (ISMP) is a national organization devoted entirely to preventing medication errors. The ISMP's List of High Alert Medication in Acute Care Setting indicates ...based on error reports submitted to the ISMP National Medication Error Reporting Program (ISMP MERP), reports of harmful errors in the literature, studies that identify the drugs most often involved in harmful errors, and input from practitioners and safety experts, ISMP created and periodically updates a list of potential high alert medications .... This list of medications included antithrombotic (reduces the formation of blood clots) agents including anticoagulants (blood thinners to prevent blood clots) warfarin, enoxaparin (Lovenox) etc. ...The ISMP further indicated using the list to determine which medications require special safeguards to reduce the risk of errors ...strategies such as standardizing the ordering, storage, preparation, and administration of these products, improving access to information about these drugs; limiting access to high-alert medications; using auxiliary labels; employing clinical decision support and automated alerts; and using redundancies such as automated or independent double checks when necessary.

During a concurrent observation and interview on 10/3/23, at 11:39 a.m., with the licensed nurse (LN 1) and the chief nursing officer (CNO), in the medication room on the medical surgical floor (on the surgical side of unit), the Omnicell (automated medication dispensing system) was observed. LN 1 was asked to pull out enoxaparin (Lovenox an anticoagulant) from the Omnicell. LN 1 located the Lovenox and retrieved the medication from the drawer. There were 10 prefilled syringes of Lovenox observed in the drawer. When observing the Lovenox there was no high-risk, high-alert medication label on the medication. When LN 1 retrieved the medication there were no high-risk medication alerts or nursing double check alerts in the Omnicell. LN 1 was asked if Lovenox was an anticoagulant and considered a high-alert medication, LN 1 acknowledged Lovenox was a high alert medication. When asked if this medication needed a double check with two nurses before administering the medication, LN 1 verbalized this is not our practice. On the wall, next to the Omnicell, there was a list of high alert medications that required double checks with specific requirements and additional considerations. When observing the high alert list, Lovenox did not appear on the list. When asked if this list was part of the hospitals policy and procedure for high alert medications the CNO stated, "Yes", this was the high-alert list. When asked if anticoagulants (i.e., Lovenox) should be on the high-alert list, the CNO verbalized the high-alert medication list was updated and further verbalized this list was the old version. Both the CNO and LN 1 acknowledged Lovenox was not on the high-alert medication list attached to the hospitals policy and procedure for high-alert medications.

During a concurrent interview and record review on 10/4/23, at 10:27 a.m. with the pharmacy operations manager (POM), the hospital's policy and procedure for high-alert medication administration was reviewed. The POM was asked if the hospital follows the ISMP recommendations and standards of practice for high alert medication administration, the POM verbalized the hospital is currently following the Tenet Corporation policy for High alert medication administration. When asked how the Tenet Corporation develops a policy and what standards of practice are they referencing, the POM verbalized policies are discussed during pharmacy and therapeutics committees (P&T). The POM verbalized the P&T committee held on 9/20/23 discussed the policy and procedure for high-alert medication administration. The POM verbalized the ISMP high alert medication list was discussed, and P&T committee took into consideration the ISMP recommendations, however, currently we are following the corporate policy. The POM verbalized thrombolytics were added to the hospital's policy high-alert medication list. When asked about anticoagulants (i.e., Lovenox) being added to the high-alert medication list per ISMP recommendations, POM verbalized as of now, anticoagulants have not been added to the high-alert medication policy. When further reviewing the hospital's policy and procedure for high-alert medications, the POM acknowledged there was no reference to a nationally recognized pharmaceutical standard of practice or guidelines for safe administration of high-alert medications on the hospitals policy. The POM was informed this is a CMS regulation when developing policy and procedures.







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2. Review of the hospital's Pharmacy policy and procedure entitled: "Antibiotic Stewardship Policy", dated 10/10/2018, reviewed on 10/4/2023 at 5:30 pm read: "Antimicrobial Stewardship implies that there will be ...interventional approach to optimizing the use of antimicrobial agents prescribed for patients admitted to facility "X X (name) Community Hospital" (TCCH) ...TCCH goals include: 4.2.1.1 Primary: Optimize outcomes for hospitalized patients with infections while minimizing such consequences of antimicrobial use as toxicity, selection of pathogenic and/or resistant organisms such as Clostridium difficile, Acinetobacter, and VRE ...purpose 1) to promote appropriate use of antimicrobials by selecting the appropriate agent, dose, duration, and route of administration with the objective of optimizing the utilization of antibiotics in order to minimize resistance, improve patient outcomes and reduce toxicity ... The morning pharmacist reviews infection Control Culture Report and Antibiotic List..Pharmacist compiles clinical data on each patient with current data collection rationale for the review...need for Pharmacokinetics (PK) monitoring by pharmacy from review of the report or via Consult request by prescribing physician....The development of an electronic data collection tool as a function of a database capable of being analyzed later on to measure success of the program...". All of which, the hospital's pharmacy staff failed to do for 230 patient care opportunities and the review of antibiotic usage/prescribing, during the month of 9/2023.

The policy and procedure from above continued to read: "pharmacy reviews all in house patients receiving antibiotic agents daily." Pharmacy had failed to review 230 patient's antibiotics for 25 days in the month of September 2023 alone. Further investigation of the pharmacists daily antibiotic usage/prescribing reviews revealed that during the month of September 2023, a total of 540 patient antibiotic usage/prescribing reviews, but 230 of these patients' antibiotic usage/prescribing reviews had not been completed on a daily basis, as outlined in the hospital's policy and procedure. Based on the data above, the Pharmacists collectively failed to complete 42% of the antibiotic daily usage/prescribing reviews (for the month of September 2023), which the pharmacy has been responsible for completing. Interview with one of the hospital's staff pharmacists on 10/4/2023, revealed that as a result of the hospital's pharmacists staffing issues, the pharmacists were not able to complete their daily patient antibiotic usage/prescribing reviews. The hospital's same antibiotic stewardship policy and procedure also goes on to read: "Pharmacist reviews ...Primary intervention targets are: 1) Drug bug mismatches, 2) De-escalation opportunities (the term de-escalation refers to the discontinuation or the switching of antibiotics for more effective treatment), 3) Intravenous (I.V.) to oral (P.O.) conversion as soon as possible and as appropriate." The hospital had failed to complete this review for 230 patient antibiotic reviews.

Further review of the hospital's Pharmacy policy and procedure entitled: "Antibiotic Stewardship Policy", dated 10/10/2018, read: "It is the responsibility of the Chief Nursing Officer (CNO) and Director of Pharmacy to insure compliance with this policy and procedure." During an interview with the hospital's CNO (also known as the Director of Nursing [DON]) on 10/4/2023 at 5:15 pm he stated: "all of the hospital's antibiotic stewardship data goes to the hospital's Pharmacy and Therapeutics Committee (P&T), yet a review of the hospital's P&T committee minutes for 8/2023 and 9/2023, revealed that no antibiotic stewardship data had been sent up to the P&T committee meetings during these meetings for the committee's review. The DON was asked if he could provide any evidence that any data from the antibiotic stewardship reviews had been taken up to the hospital's P&T Committee, yet he was unable to provide any evidence after reviewing the P&T meeting minutes for 8/2023 and 9/2023. Further interview with the DON revealed that one of the Pharmacists from their sister hospital, had been responsible for collecting their antibiotic stewardship data, yet the DON revealed that this Pharmacist, had been out on maternity leave since 6/2023 and that it appeared that no one else had been gathering this antibiotic stewardship data in her absence, so no antibiotic stewardship data was available for review by the P&T committee from 6/2023 on, which is why no data had been presented at the hospital's P&T meeting on 8/2023 and 9/2023.

Further review of the hospital's Pharmacy policy and procedure entitled: "Antibiotic Stewardship Policy", dated 10/10/2018, read: "The Core Members [of the Antibiotic Stewardship Committee], will meet monthly to: 1) review on-going therapy and Microbiological and Antibiotic Utilization Stewardship Reports." Yet the hospital was unable to provide any evidence of these monthly report reviews for 8/2023 and 9/2023. The hospital's policy went on to read: "2) Data will be reviewed, aggregated, and analyzed. 3) Any actionable issues will be reported to prescribers and to P&T Committee ..." Yet review of the P&T minutes from 8/2023 and 9/2023 revealed that none of these (Microbiological and Antibiotic Utilization Stewardship Reports, data review, aggregated, and analyzed data, no actionable issues which had been found, had not been provided in the hospital's P&T minutes for 8/2023 and 9/2023. The hospital was also unable to provide any of the information above to the survey team while the survey team was on-site at the hospital.