Q301 - Incubation/Speciation of Viable Samples for – Media-Fill, Gloved Fingertip and Thumb Sampling, Viable Surface Sampling

Statement of Work Incubation/Speciation of Viable Samples for – Media-Fill, Gloved Fingertip and Thumb Sampling, Viable Surface Sampling The VA Southern Nevada Healthcare System (VASNHCS) Pharmacy has a requirement for Environmental Microbiology Lab Accreditation Program (EMLAP) to process (incubate, analyze, record and report results) microbiological surface samples, Gloved Fingertip and Thumb (GFT) samples and Media-Fill Testing (MFT) samples conducted in accordance with this PWS, in an efficient and cost-effective manner, supporting the VA mission. This is a non-personal services contract. The Contractor shall not be considered VA employees for any purpose of fulfilling the PWS and shall be considered employees of the Contractor. Contractor shall furnish all labor, materials, parts, equipment, tools, shipping, transportation, insurances, licenses, certifications, and supervision necessary to provide services in accordance with this Performance Work Statement (PWS). TASKS and REQUIREMENTS: An ISO/IEC 17025:2017 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP) will process (incubate, analyze, record and report results) microbiological surface samples, Gloved Fingertip and Thumb (GFT) samples and Media-Fill Testing (MFT) samples conducted and submitted by VASNHCS Pharmacy. Samples will be processed by the laboratory immediately upon receipt according to the general requirements outlined by ISO/IEC 17025:2017 and current version of USP <797>. The contractor shall incubate and process personnel related assessment GFT samples according to current version of USP <797> standards. GFT results will be reported for each plate, with the amount of colony forming units (cfu) present on each plate reported. No growth present shall be indicated on the report as 0 (zero) cfu or < 1 cfu. The contractor shall incubate and process personnel related assessment MFT samples according to current version of USP <797> standards. MFT results will be reported as negative (pass) or positive (fail); failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container–closure unit(s) on or before 14 days. The contractor shall incubate and process viable surface samples according to current version of USP <797> standards. Surface sample results will be reported in number of cfu. If cfu measured during viable sampling exceed USP <797> threshold levels, the report will at minimum identify genus and, when possible, species of any microorganism recovered on the report. No growth present shall be indicated on the report as 0 (zero) cfu or < 1 cfu. Shipping the collected samples to the Contractor will be done by VASNHCS Pharmacy. The Contractor shall report the receipt of samples via email within two days of receipt. This report shall include the number of samples and their condition. The media-fill test kits will be provided by VASNHCS. The samples will be collected by qualified VASNHCS staff and will be shipped to the Contractor at the cost of the facility. SCOPE: The contractor shall perform routine work detailed in this Performance Work Statement (PWS) on a schedule that is mutually agreed upon by the Contractor and Contracting Officer Representive (COR). Work items or services not already included in this PWS, but relevant to it, may be ordered by the CO without further competition. Only the CO has the right to obligate funding or order work not expressly detailed in this PWS. The Government shall not be held responsible for payment for any work performed by the Contractor that is outside the scope of this contract or without the prior approval of the CO. Fixed pricing for microbial identification shall include all isolates identified on one sample (e.g., per sample plate, per both sides of media paddle). TASKS: Upon request from the VA Southern Nevada Healthcare System Pharmacy: Gloved fingertip and thumb sample incubation and sample analysis. Media-fill testing sample incubation and sample analysis. Bacteria and fungi surface sample incubation and sample analysis. Microbial identification to at least the genus level of viable surface samples exceeding the cfu limits listed in current version of USP <797> standards. Gloved Fingertip and Thumb Sampling: Pharmacy compounding staff must be evaluated in Gloved Fingertip and Thumb (GFT) sampling to demonstrate competency in garbing and hand hygiene and assess aseptic technique and related practices as set forth in current version of USP <797>. This sampling is done upon hire and then at a minimum of every 6 months thereafter. VASNHCS Pharmacy staff will perform GFT onsite, using one sampling device per hand (e.g., plates, paddles, or slides) containing general microbial growth agar {e.g., trypticase soy agar (TSA)} supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) as this agar supports both bacterial and fungal growth. Each media device will be labeled with a personnel identifier, right or left hand, and the date and time of sampling. The plates/paddles will be provided by the facility. The samples will be shipped to the Contractor at the cost of the facilities. Contractor will incubate GFT sampling plates immediately upon receipt at a temperature of 30-35° C for no less than 48 hours and then at 20°–25° C for no less than 5 (five) additional days. Samples must be incubated in an incubator. Sampling plates will be stored during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates). Contractor will record and report the number of cfu per hand (left hand and right hand), as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. Contractor personnel who analyze sampling plates including reading of plates, …