By Stephen Novak, RPh, MPA, FASHP

WATAUGA MEDICAL CENTER, LOcated in Boone, North Carolina, is a 117bed acute care hospital and outpatient cancer center in the Appalachian Regional Health Care Services system. Of the 3,000 chemotherapies we compound per year, approximately 95% are administered on an outpatient basis.

For the past four years, we have been using Lab Safety Corporation’s Valiteq aseptic technique validation system as part of our compounding training processes. The Valiteq program is comprehensive and includes audiovisual, observational, and validation testing components. Our technicians are also able to receive ACPE continuing education credits by completing the Valiteq program.

When Lab Safety Corporation released their Chemoteq kit for hazardous substances compounding technique validation, we thought it a natural fit for our facility, given our high-volume chemotherapy compounding operation. Chemoteq allows us to simultaneously validate both the aseptic and containment techniques of our chemotherapy compounding personnel. Sterile tryptic soy broth (TSB) is substituted for actual drugs during the validation exercise to promote the growth of microorganisms in the compounded preparation. The growth medium also contains a non-inhibitory colorimetric tracer to help the pharmacist supervising the evaluation to visualize and recover any leakage that occurs during the compounding process. Each Chemoteq kit includes materials to perform two validation exercises, as well as easy-to-follow directions for qualitative residue recovery and manipulated product sterility tests, and a practical skills evaluation form and grading system.
We use Chemoteq as part of our annual compounding training procedures. Once our technicians have completed the written test and observational component of the Chemoteq program, they conduct the hands-on validation procedure. Working in a biological safety cabinet (BSC), the technician completes the following procedures:

1. Transfers 50 mL from a 100-mL saline bag to a 150-mL empty evacuated container
2. Attaches the administration set to the bag, primes the tubing, and secures the set to prevent leakage
3. Transfers 50 mL of TSB from a Chemoteq VM-50 vial to the bag using a dispensing pin
4. Transfers 50 mL of media from a second VM-50 vial to the evacuated container without a dispensing pin
5. Transfers 10 mL from a VM-10AC ampoule to the bag, making final adjustments into an empty vial
6. Transfers 10 mL from a second VM-10AC ampoule to the evacuated container, making adjustments in an empty vial
7. Adds 25 mL of sterile water for injection (SWFI) to a VM-25 vial without using a dispensing pin
8. Adds 25 mL of SWFI to a second VM-25 vial using a dispensing pin
9. Prepares three 10-mL syringes from the vial diluted in step #7 without using a dispensing pin
10. Prepares three 10-mL syringes from the vial diluted in step #8 using a dispensing pin
11. Labels the vials diluted in steps #7 and #8 for storage

The supervising pharmacist then begins incubating the syringes and vials, and performs the color tracer detection exercise before the technician has performed any cleaning or degowning. The pharmacist thoroughly swabs the BSC work surface, the product surfaces, the technician’s sleeves and gloves (particularly the fingertips), the front and lower lip of the BSC, the floor in front of and below the BSC, the surface upon which the product was placed after being removed from the BSC, and the outside of the chemo waste container. The swabs are then laid against a white background. Any pink or red coloration indicates leakage during the validation test, and necessitates additional training of the technician.

Chemoteq is an excellent system to both validate our compounding personnel’s aseptic technique and determine the leakage of hazardous drugs during the compounding process. The kit provides us with the standardized training method we previously lacked. Our future plans for Chemoteq include using the kit’s color tracer to demonstrate the risk of hazardous drug exposure to our nurses who administer chemotherapy to our patients. Our nurses have become more aware of the threats associated with exposure to these agents and should now become more aware of how their administration techniques are promoting or preventing leakage. Chemoteq’s ability to visualize such leakage will be invaluable in our efforts to reduce personnel exposure to chemotherapy agents.

Stephen Novak, RPh, MPA, FASHP, is the director of pharmacy at Watauga Medical Center in Boone, North Carolina. He earned his BS in pharmacy from Ferris State University in Big Rapids, Michigan, and his master’s degree in public administration from the University of Michigan.