SVS: Personnel and Environmental Monitoring Certification for VISN 8 Pharmacies
Performance Work Statement
Personnel and Environmental Monitoring Certifications for VISN 8 Pharmacies
1.0. Introduction
1.1. The Government requires personnel certification testing of gloved fingertip and thumb testing, media fill testing, facility compounding area surface monitoring, and air viable and non-viable testing in accordance with USP , USP , CETA and FDA guidelines in support of the VISN 8 Sunshine Healthcare Network pharmacies that compound sterile preparations (CSP).
2.0. Description / Scope / Objective
2.1. The Contractor must provide all labor, equipment, tools, materials including sampling supplies, supervision and other items and services necessary to perform the work as defined in this Performance Work Statement.
3.0. Applicable Documents
3.1. The following laws, regulations, policies, and procedures in effect on date of contract issuance and all subsequent changes or updates apply:
USP
United States Pharmacopeia
http://www.usp.org/
CETA
Controlled Environment Testing Association https://www.cetainternational.org/
FDA
U.S. Food and Drug Administration https://www.fda.gov/
4.0. Performance Requirements
4.1: The vendor shall refer to the most current versions of standards including but not limited to USP, FDA and CETA when conducting the requested monitoring and reporting. The frequencies of testing and specific procedure should be determined by the most updated version of CETA, USP and , and per specific facility requirements and/or requests. The vendor shall be responsible for complying with the most updated versions of this guidance and will conduct all sampling per the procedures outlined within the official chapters.
4.1.1 Gowning and Garbing Evaluation: The Vendor shall perform a gowning and garbing evaluation for each employee in conjunction with the gloved fingertip and thumb sampling and media-fill test. The vendor shall use the facility s standard operating procedure as guidance for their evaluation.
4.1.2. Gloved fingertip and thumb sampling: The Vendor shall perform the gloved fingertip and thumb sampling for the expected number of employees from each facility as listed in appendix A. This should be done in conjunction with media-fill testing. The results should be reported by number of colony-forming units (CFU) per hand (left hand, right hand). If any agar plates demonstrate growth, the preliminary results will be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact (contracting officer representative {COR}, etc.) as soon as the initial result is known. Final results will be expeditiously reported after further antimicrobial testing is complete.
4.1.3. Media-Fill Testing: The Vendor shall perform media-fill testing for the expected number of employees from each facility as listed in appendix A. This should be done in conjunction with gloved fingertip and thumb sampling. The results should include the name of the employee evaluated, the evaluation date/time, media and components used to include the expiration date and lot number, the results, and the signatures of the person evaluated and the observer. Failure of the test in indicated by visible turbidity or other visual manifestations of growth in the medium in one or more container-closer units on or before the end of the incubation period. If any container-closer units demonstrate growth, the preliminary results will be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact (COR, etc.) as soon as the initial result is known and final results will be expeditiously reported after further antimicrobial testing is complete.
4.1.4 Compounding area certification: The vendor shall provide certification of classified areas using procedures in the current Controlled Environment Testing Association (CETA) application guides. Certification must be performed at least every 6 months and as needed depending on facility requirements or requests. Certification must include the following:
4.1.4.1 Airflow testing: The air changes per hour (ACPH) from the HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report.
4.1.4.2 HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification.
4.1.4.3 Total particle count testing: Must be performed under dynamic operating conditions using current, state-of-the-art electronic equipment. Air sampling sites must be selected in all classified areas. Measurements must be taken in each PEC at locations where there is greatest risk to the exposed CSPs, containers, and closures. Measurements of nonviable airborne particles in other classified areas including the buffer room(s) and ante-room(s), should be taken at representative locations that reflect the quality of air in the room(s).
4.1.4.4. Smoke visualization studies: Must be performed for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation (s). Additional smoke tests will need to be performed in rooms without low air returns. A video of the smoke test must accompany the report. Any media files must be provided in DVD format to comply with VHA guidance for media. No .zip files, usb storage, flash drives, or downloadable files from vendor web sites.
4.1.4.5. Primary engineering control (PEC) certification (laminar flow hoods, biological safety cabinets, compounding aseptic isolators, compounding aseptic containment isolators, pass through chambers etc.). The PEC must be certified to meet ISO class 5 at 0.5 m and larger particles during dynamic operating conditions. PEC certification must include all specifications as outlined per CETA application guides and pertinent USP chapters. This must be performed at least every 6 months and as needed depending on facility requirements.
4.1.4.6. Differential pressure certification: Must be performed at least every 6 months and as needed depending on facility requirements for ante rooms and buffer rooms. Cleanrooms used for non-hazardous compounding must be positive pressure relative to the adjacent spaces. USP chapter requires a minimum pressure differential of 0.020 w.c. relative to adjacent spaces. Cleanrooms used for hazardous applications should be a minimum 0.010 w.c. negative relative to adjacent spaces.
4.1.5 Viable Air Sampling: Each classified area and pass through shall have volumetric active air sampling using an impaction device during dynamic operating conditions at least every 6 months and as needed depending on facility requirements. At least 1 cubic meter or 1000 liters of air should be sampled at each designated location. The media should be examined and the report should detail the total number of discrete colonies of microorganisms on each plate as CFU per cubic meter of air based on the sample type, sample location and sample date. The genus of any microorganism recovered must be identified with the assistance of a microbiologist if the CFU count exceeds the following: greater than 1 for ISO Class 5, greater than 10 for ISO class 7, and greater than 100 for ISO class 8. If any container demonstrates the presence of CFU that exceed the actionable levels, the preliminary results will be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact as soon as the initial result is known and final results will be expeditiously reported after further antimicrobial testing is complete.
4.1.6. Viable Surface Monitoring: Each classified area including the interior of the PEC (including equipment contained in it), staging or work areas near the PEC, frequently touched surfaces and pass through chambers must be sampled at least monthly. Sampling should be performed at the end of the compounding activities, but before the area has been cleaned and disinfected. The media should be examined and the report should detail the total number of discrete colonies of microorganisms on each device as CFU per sample based on the sample type, sample location and sample date. The genus of any microorganism recovered must be identified with the assistance of a microbiologist if the CFU count exceeds the following: greater than 3 for ISO Class 5, greater than 5 for ISO class 7, and greater than 50 for ISO class 8. If any device demonstrates the presence of CFU that exceed the actionable levels, the preliminary results will be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact (COR, etc.) as soon as the initial result is known and final results will be expeditiously reported after further antimicrobial testing is complete.
4.1.7 Environmental wipe sampling for hazardous drug (HD) surface residue should be performed routinely as outlined by USP for those facilities listed in appendix A. Results will be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact (COR, etc.) as soon as results are available.
4.1.8. The contracting officer representative will schedule testing with the vendor. The vendor shall provide the corresponding Pharmacy Service with all service reports and certification of the job performed. After completion of work, the vendor shall notify the contracting officer representative for signature and verification of work performed.
4.1.9. All equipment shall be maintained in proper operating condition as specified by the Manufacturer, USP, CETA and FDA standards. The vendor is to have required supplies, manuals, and schematics, which must be available on site to perform the services. All work is to be performed in accordance with the guidelines established by state and local ordinances with manufacturer s manual and quality control manual, and with all terms, conditions, provisions, schedules and specifications provided herein.
4.2. In the event that the facility or personnel require recertification or testing due to actionable results, the vendor must be able to provide retesting within 7 calendar days of the request. If vendor is not able to provide services within the required timeframe, the vendor shall propose a reasonable alternative response time.
4.3. In the event that the samples obtained during testing are damaged during transport or processing, the vendor shall annotate the damage in the report and provide retesting within 7 calendar days of the request at no additional cost to the facility. If the vendor is not able to provide services within the required timeframe, the vendor shall propose a reasonable alternative response time.
Paul Jarrett
Contracting Officer
813-972-2000 ext. 3107
Paul.Jarrett@va.gov
