Breadcrumb

Combined Assessment Program Summary Report – Evaluation of Compounded Sterile Product Practices in Veterans Health Administration Facilities

Report Information

Issue Date
Report Number
16-03807-223
VA Office
Veterans Health Administration (VHA)
Report Author
Office of Healthcare Inspections
Report Type
Comprehensive Healthcare Inspection Program
Recommendations
5
Questioned Costs
$0
Better Use of Funds
$0
Congressionally Mandated
No

Summary

Summary
The VA Office of Inspector General completed a healthcare inspection of compounded sterile product (CSP) practices in Veterans Health Administration facilities. The purpose of the review was to determine whether facilities complied with selected requirements for the safe preparation of CSPs. CSPs are pharmaceutical preparations made or modified in a controlled sterile environment. We conducted this review at 25 Veterans Health Administration medical facilities during Combined Assessment Program reviews performed across the country from October 1, 2015, through March 31, 2016. We noted high compliance in several areas, including that facilities had adequate policies and provided safe conditions for CSP preparation; that staff documented sampling for contamination in required areas and took actions when they identified positive cultures; and that when facilities used non-VA sources for CSPs, the sources were appropriately registered. We made five recommendations.

Open Recommendation Image, SquareOpenClosed and Implemented Recommendation Image, CheckmarkClosed-ImplementedNot Implemented Recommendation Image, X character'Closed-Not Implemented
No. 1
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
We recommended that the Acting Under Secretary for Health, in conjunction with Veterans Integrated Service Network and facility senior managers, ensure that for employees who prepare compounded sterile products, facilities include in their competency assessment requirements gloved fingertip sampling and the required number of gloved fingertip samplings for initial competency assessment.
No. 2
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
We recommended that the Acting Under Secretary for Health, in conjunction with Veterans Integrated Service Network and facility senior managers, ensure that facilities include in the competency assessment checklists of employees who prepare compounded sterile products donning of personal protective equipment in the required order and performance of appropriate hand hygiene after personal protective equipment removal.
No. 3
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
We recommended that the Acting Under Secretary for Health, in conjunction with Veterans Integrated Service Network and facility senior managers, require that facility managers ensure competency assessments for employees who prepare compounded sterile products include gloved fingertip sampling, written tests, and visual observation or “hands-on” skill assessment of aseptic technique at the required risk level frequency.
No. 4
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
We recommended that the Acting Under Secretary for Health, in conjunction with Veterans Integrated Service Network and facility senior managers, require that facility managers ensure sterile chemotherapy-type gloves are available in areas where hazardous compounded sterile products are prepared.
No. 5
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
We recommended that the Acting Under Secretary for Health, in conjunction with Veterans Integrated Service Network and facility senior managers, require that facility managers ensure employees clean sterile compounding area floors daily and storage shelving monthly and document the cleaning.