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Based on interview and record review, the hospital failed to provide an adequate number of personnel to ensure pharmaceutical services which meets patients' needs for three of three sampled patients (Patients 1, 2, and 3). The hospital failed to ensure that the pharmacist reviewed each medication ordered for appropriateness before the first dose was dispensed. New medication orders received after pharmacy hours, were not reviewed by a pharmacist prior to being administered to a patient. The hospital pharmacy hours were between 0600 and 2130 hours, Monday to Friday; 0600 and 2100 hours on Saturday and Sunday. All medication orders received between 2100 and 0600 hours were not reviewed by a pharmacist prior to administration when pharmacy was closed.

This failure has a potential to result in patients' medication errors and adverse events leading to poor health outcome.

Findings:

Review of the hospital's P&P titled Medication Procurement After Hours dated 9/23, showed the hospital has established a mechanism for providing medications for patient care in the absence of a pharmacist ... All emergency and physician written "Now" or "Stat" medications will be procured.

Review of the hospital's P&P titled Pharmacist Review of Medication Orders dated 11/22, showed each medication order is reviewed for appropriateness by a pharmacist prior to the dispensing and administration of the medication, unless specific conditions exist. Pharmacist review prior to the initiation of medication therapy has been shown to decrease medication errors and adverse events ...
Prospective review of medication orders by a pharmacist must take place prior to the administration of a medication with the following exceptions:
o The physician directly controls the ordering, preparation, and administration of the medication and is available to provide immediate intervention should a patient experience an adverse medication event, or
o Urgent situations when the resulting delay would harm the patient, including situations in which the patient experiences a sudden change in clinical status (e.g., new onset of nausea).

Review of the hospital's P&P titled Medication Administration (General) dated 3/23, showed the hospital pharmacy is open from 0600 to 2130 hours on weekdays and 0600 to 2100 hours on Saturday and Sunday.

Review of some medication orders administered while pharmacy was closed showed:

Patient 1, LORazepam (used to treat alcohol withdrawal) 1 milliGRAM intravenous every 4 hours as needed ordered on 8/11/2024 at 2131 hours, administered at 2145 hours and on 8/12/24 at 0310 hours while pharmacy was closed.

Patient 2's orders of 8/29/24 at 0251 hours, for lisinopril (used to treat high blood pressure) oral 20 milliGRAM(s) daily and hydralazine oral (used to treat high blood pressure) 50 milliGRAM(s) every 8 hours as needed for SBP > 160 or DBP >90.

Patient 3's acetaminophen 325 milliGRAM(s) tablet every 6 hours as needed for mild pain ordered on 9/6/2024 at 2252 hours and administered.

On 9/9/24 at 1505 hours, an interview and concurrent record review was conducted with the DOP in the presence of the Quality Manager and Chief Quality Officer.
The DOP verified above orders were maintenance and not emergency orders.
The DOP stated new medication orders received after pharmacy hours were not verified prior to administration to patients. The DOP also stated a pharmacist was on call for consultation when pharmacy was closed, and medication orders were reviewed when pharmacist came in at 0600 hours.

Based on interview and record review, the hospital failed to provide safe and effective pharmaceutical services to ensure patient safety as evidenced by:

Failure of the Pharmacy & Therapeutic (P&T) Committee to develop and implement P&P for nursing compounding of sterile products in emergency situations as specified in state law.

This failure created the potential of exposing patients to infections and medication related negative outcomes for the patients.

Findings:

Title 22, California Code of Regulations, Section 70263 (c)(1) requires the committee (P&T) to develop the written policies and procedures for the establishment of safe and effective systems for procurement, storage, distribution, dispensing and use of drugs and chemicals.

On 9/9/24 at 1045 hours, during an inspection of the medications in the ED, RN 1 stated they did not compound any medications in ED during the day shift, pharmacy was responsible for compounding their intravenous medications.

During an interview on 9/9/24 at 1100 hours by the ED medication room, the DOP stated nursing compounded some medication drips and intravenous fluids during the night when pharmacy was closed.

Review of the nursing staff compounded sterile medication competencies showed it did not include sanitizing the medication vial septum and the intravenous (IV) bag port prior to entry.

During an interview on 9/9/24 at 1200 hours, the ED/ICU Director verified above and stated there were no other handouts/in-services done for compounding sterile medications other than the competency test and the return demonstration at the time of orientation.

Review of the hospital's Compounded Sterile Products P&P showed it did not mention nursing compounding medications.

During an interview on 9/9/24 at 1330 hours with the DOP, in the presence of the Quality Manager and Chief Quality Officer. The DOP verified the hospital did not have a P&P for nursing compounding medications. The DOP also verified nursing sterile compounded medication competencies did not include sanitizing the medication vial septum and the bag port prior to entry.

During an interview on 9/9/24 at 1530 hours, the DOP stated the hospital do not have a record of medications compounded by nursing.

During a telephone interview on 9/12/24 at 1030 hours, RN 2 stated she worked night shifts in ED. RN 2 stated there was no training handout or manual. RN 2 signed off night shift RNs competencies. RN 2 stated they did not compound a lot of drips but commonly used premix pressor medications (used to increase blood pressure and constrict blood vessels). RN 2 stated they reviewed how to make common drips during competency. RN 2 went over the process of compounding intravenous medication but did not mention sanitizing the vial septum and the intravenous bag port prior to entry until prompted.

During a telephone interview on 9/12/24 at 1050 hours, RN 3 stated they did not use any training handout. RN 3 signed off staff for competency. RN 3 went over the process of compounding sterile products. She mentioned they used aseptic technique; they cleaned the compounding area with Sani wipes (a disinfectant) and wipe the intravenous fluid bag hub/port. RN 3 described how to transfer the medication from the vial to the bag but did not sanitize the medication vial septum until prompted.