H299 - MICROBIOLOGICAL LABORATORY TESTING

STATEMENT OF WORK (SOW) as of 05/12/2026 1. Contracting Officer’s Representative (COR). Name: TBD Section: Pharmacy Service Address: 10701 East Boulevard Cleveland, OH 44106-1702 2. Contract Title. VANEOHS Compounded Sterile Preparations Program – Environmental and Personnel Sampling 3. Background. Pharmacy staff must undergo regular assessments, and sterile compounding areas must be sampled to ensure compliance with regulatory standards, including U.S. Pharmacopeia (USP) General Chapters <797> and <800>. These assessments are integral to a comprehensive quality assurance program that prioritizes patient safety, staff competency, and the maintenance of a controlled environment within sterile compounding spaces. Although trained pharmacy staff are responsible for conducting these tests, it is crucial that viable samples are incubated and analyzed by an independent third party to guarantee unbiased results. Consequently, it is essential to identify an appropriately accredited microbiological laboratory contractor that specializes in USP General Chapter <797> environmental and personnel sampling. 4. Scope. VA Northeast Ohio Healthcare System (VANEOHS) is looking to identify an appropriately accredited microbiological laboratory contractor that specializes in USP General Chapter <797> environmental and personnel sampling. The contractor shall be capable of supplying necessary testing and competency materials, performing the required analyses, and delivering results that comply with USP standards and the specific requirements of VANEOHS. 5. Specific Tasks. 5.1 Task 1 – Supply Testing Materials and Equipment The contractor must provide the following testing materials and equipment as requested by the facility. Materials and equipment must be orderable through an online portal. Microbial Growth Media Plates Must include Certificates of Analysis from the manufacturer verifying that the sampling media meet expected growth promotion, pH, and sterilization requirements consistent with USP General Chapter <797>. Must contain TSA general microbial growth media supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) to neutralize the effects of any residual disinfecting agents. Plates used for surface sampling must have a raised convex surface. Must support both bacterial and fungal growth on the same plate. Microbial growth media plates used for monthly surface sampling must be provided as a monthly surface sampling kit to include materials, analysis, positive and negative controls, and shipping. Plates are overnight mailed the same day if ordered prior to a contractor specified time except in extenuating circumstances. Enverify™ Surface Sampling Competency Kits or the equivalent SAS Air Sampler or equivalent available Media Fill Materials Components must be available to demonstrate low, medium, or high complexity compounding. Components must be available to purchase as kits or individually. Chain of Custody forms to be completed by pharmacy personnel and sent to the contractor along with samples for testing. Deliverables: Microbial Growth Media Plates Enverify Surface Sampling Competency Kits or equivalent SAS Air Sampler or equivalent Media Fill Materials 5.2 Task 2 – Sample Incubation and Analysis The contractor must provide sample incubation and analysis as requested by the facility. Incubation must start within 48 hours of sample receipt. Samples sent to the laboratory must be incubated and tested in accordance with the current official USP General Chapter <797>. Surface sample, gloved fingertip sample, and viable air sample analysis must include counts of discrete colony forming units. Surface sample, gloved fingertip sample, and viable air sample analysis must include identification of recovered organisms to at least the genus level when required by USP General Chapter <797>. Monthly surface sampling must be provided as a monthly surface sampling kit to include materials, analysis, positive and negative controls, and shipping. Cost of microbial identification does not need to be included in this kit. Media Fill Sample analysis must include visual appearance of the media product, including any indications of microbial growth including but not limited to turbidity. 5.3 Task 3 – Reporting. The contractor must provide a final report electronically (via e-mail to facility specified e-mail address and be available on an online portal with individual user access) within 48 hours of completion of their assessment of results and no later than 72 hours after the incubation periods have completed. Preliminary failing results should be reported to the facility as soon as identified. The final report must include: Signature indicating testing and reporting was completed accurately and in compliance with USP and applicable accreditation standards. Contractor name and contact information. Accreditation and testing methodology. Facility name, contact information, and project name as specified by facility personnel on chain of custody form. Documentation of the media received and tested, to include the type of media, manufacturer, lot number, and expiration date. Date of collection, as specified by facility personnel on chain of custody form, and the date samples were received by contractor. Incubation parameters including incubation temperatures, dates and times of incubation, and incubation procedures. Must indicate a statement of compliance or non-compliance with USP General Chapter <797> based on results of testing (e.g., Pass or Fail). Action levels used to determine a pass or fail result must be defined in the final report. For Surface Samples, Viable Air Samples, and Gloved Fingertip Samples: Sample ID, description, and ISO classification (if applicable) as specified by facility personnel on chain of custody form. Total number of discrete colonies of microorganisms for each sample (as CFU per…