D.4_Appendix C_Competency Assessment_Hazardous Drug Manipulation Technique.pdf
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- Attached to
- Sterile Compounding Services
- Solicitation number
- 36C25727Q0032
About this file
This is a competency assessment template for evaluating pharmacy staff on hazardous drug (HD) manipulation techniques and conduct within a hazardous buffer room or Compounded Sterile Preparation (CSP) area with a Biological Safety Cabinet (BSC).
The assessment is designed to be completed by qualified pharmacy staff and documents either initial or ongoing competency evaluation. The document contains approximately 30 specific skill criteria that evaluators must assess, with space for initials and comments next to each criterion. Key competency areas include: BSC operation and decontamination procedures using Peridox and sterile 70% isopropyl alcohol; proper medication and supply inspection and preparation; correct placement and handling of items to maintain air flow; appropriate use of the safety shield and transfer devices; vial swabbing and reconstitution techniques; minimization of positive pressure; solution inspection for contamination; labeling and sealing procedures; waste disposal protocols; protective equipment removal and hand hygiene; and knowledge of spill reporting and cleanup procedures. The assessment requires documentation of the employee name, position, evaluator name, evaluation date, and type of competency being assessed. An additional comments section is included for evaluator notes. This template does not address specific contract deliverables, timelines, pricing, or procurement details but serves as an internal quality assurance and training verification document for pharmacy operations.
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?.## APPENDIX C_COMPETENCY ASSESSMENT_HAZARDOUS DRUG MANIPULATION
TECHNIQUE
Appendix C
Competency Assessment: HD manipulation technique and conduct in the hazardous buffer room/C-SCA
Employee: ___________________________ Position: ____________________ Evaluator: ________________________________ Initials: ______ Date of Evaluation: ________ Type: ___ Initial Competency ___ Ongoing Competency
Observations and subsequent evaluation must be made by qualified pharmacy staff. Using the space designated next to each criterion, the evaluator will initial to signify that the criterion has been satisfied.
Skill Initials Comments
Demonstrates understanding that hazardous medications should be prepared in a Biological Safety Cabinet (BSC).
Demonstrates understanding that if the exhaust fan on a BSC is turned off, the cabinet must be decontaminated before reuse.
Cleans/decontaminates the BSC with Peridox followed by sterile 70% IPA appropriately during the following times:
- When there are spills
- Before and after certification
- Any time voluntary interruption occurs
- If the ventilation tool is moved
- At the end of the work shift
Once weekly, decontaminates the area underneath the work surface of the BSC
Collects correct medications, solutions, and supplies.
Inspects vials, ampules, IV bags for damage/contamination and expiration date before compounding.
Wipes appropriate medications and supplies with sterile 70% IPA before placing them in the BSC.
Demonstrates proper placement of items in the BSC to prevent blocking air flow. Keeps nonessential items outside BSC.
Checks labels both prior to and after compounding to ensure medications and solutions being used agree.
Lowers glass safety shield to no more than an 8-inch opening during admixture operations.
Demonstrates understanding of air flow in BSC, maintains flow of clean air over objects in BSC, does not interrupt air flow. Places only hands and arms in
BSC.
Does not utilize outer 6 inches of BSC opening, work too close to the sides of BSC, or block air intake grills during admixture preparation.
Does not take hands out of BSC or leave the BSC during admixture preparation.
Does not touch or contaminate any component that must remain sterile during admixture preparation.
Performs all work on plastic-backed paper mat placed on the work surface.
Demonstrates proper swabbing and entering of vials, ampules, and bags.
Correctly uses appropriate transfer devices (closed-system transfer devices, Luer-Lok syringes, filter needles, vented needles, dispensing pins, etc.).
Reconstitutes powders using proper technique.
Minimizes positive pressure in vials during reconstitution and withdrawal of medication.
After preparation, inspects solution for cores, precipitates, particulate matter, etc.
After finishing a patient’s batch, personnel decontaminate the deck and finished CSP with Peridox. The deck of the BSC must be decontaminated between compounding of different HDs.
Removes outer gloves, then affixes appropriate labels to admixture container including auxiliary and hazardous labels. Seals container in a zip-lock bag prior to removal from the BSC.
After waiting the appropriate dwell time of 3 minutes for Peridox and having put on a new pair of outer gloves, personnel wipe the deck with sterile 70% IPA before beginning the next hazardous CSP.
Disposes of all used equipment and waste in appropriate hazardous waste disposal containers.
Seals and wipes waste containers prior to removal from the BSC.
After completion of operations in the BSC, removes protective equipment (i.e. hair cover, gown, shoe covers, gloves) and places in appropriate waste container. Washes hands after completion of compounding activities.
Demonstrates knowledge of proper procedure for reporting and cleaning up hazardous medication spills both within and outside the BSC. Correctly verbalizes location of materials used to clean up spills (i.e. SPILL kit).
Additional Comments:
File details come from the government source that posted it. Updated .