USP <797> requires annual gloved fingertip testing prior to and after aseptic media fill tests. This requirement will soon increase to biannual for Category 2 compounding and more often for Category 3 once the new USP revisions are released and enforceable. This is an overdue and welcomed change since we should be assessing our sterile compounding personnel more frequently than once annually (especially those who are new to the facility). In this blog post we will introduce Random Fingertip Sampling as a quality assurance check, used in addition to the minimum standards of USP <797>, that provides analytical data to objectively evaluate staff adherence to technique and facility processes.
Random Fingertip Sampling is simply an unannounced sampling that can happen to anyone at any time. An employee is randomly and unexpectedly selected at the end of a compounding batch/session, prior to adhering any tamper-proof seals or cleaning the area, and asked to place fingertips to the agar. The employee must then immediately change gloves and finish the process for cleaning the area. Since the idea is for the employee to be unaware of what is about to take place, the person testing may not be able to fully observe technique and therefore, this test would not fulfill USP requirements for documented observation.
Addition of a surface sample can be added as well prior to gloves being changed (always remembering to clean the surface with the facility’s detergent/germicidal followed by sterile isopropyl alcohol 70%).
Fingertip testing stated in USP <797> is sufficient to demonstrate competency that staff can compound within safe standards. However, the downfall is that the employee is prepared. It’s like the announced exam in school where all the students are prepared for the challenge. Although competence is demonstrated, it fails to provide information on compliance with facility compounding processes on the day-to-day basis.
However, addition of the random fingertip sampling introduces the “pop” quiz to the equation. It’s designed to test the student’s technique and adherence to SOPs at any given time so that understanding, and compliance may be assessed more appropriately. Once this process is introduced into a quality assurance program, it often increases staff awareness by decreasing fatigue-related process breaks from repetitive tasks.
Ideally, employees should be randomly tested once a week. However, if this is not achievable, remember that the possibility alone of being selected for a random test increases awareness and compliance of compounding personnel. The inconsistency of testing can actually increase the effectiveness of this program.
Results from random fingertips sampling should be documented on a spreadsheet and trended as would any other samplings. Excursions of more than 3 CFU (as a total from both hands) should be worked up as any microbial excursion, including source identification. The extra time spent for this process is small in exchange for proof that personnel are compliant and strengthens any quality assurance program.
Random fingertip sampling is a reliable addition to any quality assurance program to verify compounding staff compliance more frequently during active compounding conditions and therefore provides a better depiction of an individual’s understanding, compliance with SOPs, regulations, and standards on a day-to-day basis.
Comments