Volume 2024 | No. 2
SURVEYOR
PCAB COMPOUNDING
Examples of surveyor findings:
n During the observation of compounding, the technician used a stock solution and entered an incorrect lot number on the compounding record. After using the vial, it was discarded in the trash. It was stated that there is no “in-process” check currently being performed. No volumes were being double-checked. n During the observation of the media fill the following was noted: A rubber stopper was dropped on the deck very near the front opening of the vertical flow hood and was used. Rubber stoppers were opened from autoclave bags and poured out in a pile on the deck and not laid out appropriately for first air. ٝ A preparation was not sterilized in the final dispensing container, and the tip of the tubing used to fill the dispensing containers was not kept sterile and in direct first air. Gowns were not fully zipped and closed. Sterile gloves were not regularly disinfected with sIPA during the compounding process. n Handwashing technique: Nails were not cleaned using a nail pick/cleaner under warm running water. Upon rinsing, water drained from the elbows back down to the hands, potentially contaminating the hands with contaminated water from the upper forearms. n The compounder was observed removing their hands from inside the PEC (LAFW) to remove waste and bring in supplies. The hands were not re-sanitized with sterile isopropyl alcohol (sIPA) 70% before returning to work inside the PEC. The moving of hands from outside and inside the PEC was not kept to a minimum. n The technician’s head entered the hood during compounding and cleaning. During Category 3, compounding skin was showing, and a nonsterile respirator was worn. n The particulate matter inspection was not performed using a black/white background box prior to labeling. n An appropriate smoke test was not performed to determine if there was any ingress of air from the HD buffer room to the pre-sterilization area. There is a large pass-through and it does not have its own source of HEPA-filtered air. n The pharmacy lacks a process to validate that bulk bottles of medications are reconstituted appropriately before they are used to make CSPs. n First air principles: First air was blocked in the vertical and horizontal laminar hoods during the filling of vials. ٝ When disinfecting gloves or filling vials, the placement of supplies caused the technician to block first air to the tops of vials and the critical site on syringes.
n Implement policies and procedures regarding measuring, weighing, and mixing loose powders. Develop a process for powder containment. Keep supplies such as weigh boats and spatulas outside of the powder hood due to the potential for cross-contamination. n Create a thorough training and competency process for all compounders and pharmacists who oversee the compounders and provide final checks of the compounded preparations. n Educate technicians that compounding directions should be followed as described, including order and method of mixing components. Direct staff that any deviations should be documented. Review common deviations to determine if compounding records and master formulation records should be adjusted. The compounding record should be a complete and reproducible record of the compounding process. n Ensure that all personnel remain uninterrupted while performing critical tasks Verify cleaning and sanitizing processes comply with USP standards. Appropriately clean compounding work surfaces and equipment after use. Change to all disposable equipment if cleaning procedures are not able to effectively remove all drug residue. Examine each piece of equipment prior to use for any wear and tear or damage that requires repair prior to use.
Conduct an annual observation competency assessment of compounders to ensure they comply with the compounding process as stated in the MFR and CR.
TCRX6-L Overview of the requirement:
Note: This standard applies to sterile compounding only. Policies and procedures define techniques for how sterile compounding is performed. Compliance is assessed through review of policies and procedures, direct observation of compounding and response to interviews. Most deficiencies cited errors in hand hygiene and garbing, aseptic technique, and principles of first air.
Comment on deficiencies:
Frequency of citation:
33%
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