HospitalInspections.org

Based on staff interviews and a lack of documentation, the pharmacy department failed to establish a policy to repeat the personnel competency evaluation for compounding patient medication, after a 90 day absence, as required. This failed practice had the potential to affect all patients receiving compounded medications at this hospital. The hospital reported an average daily census of 25 according to the most recent Database worksheet submitted February 2019.

Finding:

1. A review of the training policies for pharmacy personnel who compound medications was reviewed. No mention was made of repeating any competencies skills after an employee had been absent for 90 days, as required.

2. Interviews conducted with the Pharmacy Supervisor and the Director of Pharmacy Services on 2-13-19 revealed the facility did not have a policy to repeat competencies after an employee had been away for 90 days.

(Compounding medications is the act of combining different solutions, chemicals or substances, under sterile conditions, in a specially designed room, under a cabinet with a built-in hood with special ventilation, while wearing special garb to protect the employee from encountering dangerous substances and ensuring the medications is prepared under sterile conditions.)

(The donning and doffing of the attire required for compounding medications must be conducted in a very specific order, both when dressing and undressing, so as to prevent cross contamination and protect both the employee and the patient and is part of the competency testing.)

Based on staff interview, record review and direct observation, the pharmaceutical services failed to: 1) establish personnel policies according to current standards of practice; 2) ensure testing of the laminar air flow hood included all the required function tests; and 3) Pharmacy Supervisory Personnel failed to review the reports for completeness and failed to ensure the hood was functioning optimally prior to compounding patient medications inside the hood. This failed practice had the potential to affect all patients receiving compounded medications from the pharmacy. The hospital reported an average daily census of 25 patients, according to the Database worksheet, updated 2-11-2019.

( USP 624-626 (USP-797 United States Pharmacopoeia, an independent organization that establishes pharmaceutical standards for the preparation of patient medications.)
("A Laminar Air Flow Hood is a type of hood, equipped with a high efficiency particulate filter (HEPA) including a unidirectional air flow, that provides a sterile environment in which to prepare patient medications and to prevent contamination.

Findings:

1. Interviews conducted with the Director of Pharmacy Services and the Supervisor of Pharmacy on 2-13-2019 at 3:30 P.M. revealed the pharmacy was equipped with an ISO-5 laminar air flow hood (ISO=International Organization for Standards)

A review of the personnel policy governing competency evaluations of personnel who compound medications was reviewed. The policy lacked the requirement for personnel with a 3 month absence, to receive a competency evaluation, when returning to work. (USP 260-263)

2. A review of the last two inspections of the laminar air flow hood, (conducted 4-18 and 11-18), used to prepare compounded medications, was reviewed. Both hood tests failed to include microbial growth results and failed to include the required smoke test to determine adequate, unidirectionally correct air flow. ( USP 624-626 (USP-797 United States Pharmacopoeia, an independent organization that establishes pharmaceutical standards for the preparation of patient medications.)

3. These same interviews confirmed the hood tests lacked all the essential required elements of microbial testing and smoke test air flow.

4. Interviews conducted with the Director of Pharmacy Services and the Supervisor of Pharmacy on 2-13-2019 at 3:00 P.M. confirmed that neither of these individuals had reviewed the reports, nor were they aware that the above mentioned required function tests were missing.

USP 797 4.5 Certification and Refortification of Facilities at 607 -639 states, " Before a facility is used to compound either category 1 or 2 Compounding Sterile Products (CSP)s, it must be certified. The certification must include:
-Airflow- volume and velocity
-HEPA(High Efficiency Particle Air) filter test- particle size allowance
-Total Particle count viable and non-viable particles
-Smoke studies

Both reports lacked evidence of microbial testing or smoke testing, as required.

USP 797 also states at 635-639, "All certification records must be reviewed by supervising personnel ... to ensure controlled environments comply with the proper standards..."