Q301--Pharmacy Lab Analysis

Environmental Microbiology Laboratory Analytical Services IMPORTANTR NOTE: This RFI (Request for Information) is for information only. No award will be made from this RFI. PURPOSE: Oklahoma City VA Health Care System pharmacy has a requirement for 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 Oklahoma City VA Health Care System (OKCVAHCS). Samples will be processed by the laboratory immediately according to the general requirements outlined by ISO/IEC 17025:2017 and 2023 USP <797>, 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, its employees, agents and subcontractors 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: 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 2023 USP <797>. The contractor shall incubate and process personnel related assessment GFT samples according to 2023 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 2023 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 2023 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. SPECIFICATIONS: OKCVAHCS Pharmacy IV personnel will conduct gloved fingertip and thumb testing, media-fill testing, and surface sampling according to 2023 USP <797> guidelines and pharmacy needs. The Facility Program Manager or their designee shall collect, label, and prepare all samples for shipping pursuant to instructions provided by the contractor ensuring viability of samples during shipping. Every effort will be made to ship samples the same day as sampled and will be shipped for next day delivery to the contractor according to instructions. If samples are not able to be shipped the same day as sampled, they will be shipped no later than the day after sampling takes place. Days of sampling will be coordinated so delivery occurs according to contractor s normal hours. 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, as set forth in 2023 USP <797>. OKCVAHCS 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. 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, counting cfu, and performing identification of recovered microorganisms will be a licensed and qualified environmental microbiologist or technician. Failure is if total cfu for both hands is greater than the action level for the type of sampling (i.e., initial or biannual) listed in Table 1. The contractor will notify the Facility Program Manager, or if unavailable, the Inpatient Pharmacy Supervisor or Associate Chief Pharmacy Services, within 1 (one) business day of any failure. All results will be transmitted to the facility within one business day of final analysis. Table 1. Action Level for Gloved Fingertip Sampling and Thumb Sampling Gloved Fingertip & Thumb Sampling Action Level* Initial sampling after garbing >0 Subsequent sampling after media-fill testing (every 6 months) >3 *Action levels are based on the total cfu count from both hands. Media-Fill Testing Samples: Media-fill tests will be designed and developed by the Facility Program Manager to reflect the most complicated manipulations performed at OKCVAHCS. The contractor will be provided with the final MFT sample (one sample is composed of 6 vials) per staff member tested. Contractor will incubate MFT samples immediately upon receipt at a temperature of 20° 25°C for 7 (seven) days followed by 7 (seven) days at 30° 35°C to detect a broad spectrum of microorganisms. Contractor will report pass/fail results, 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 media fill including reading results are a licensed and qualified environmental microbiologist or technician. 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 will notify the Facility Program Manager and the Inpatient Pharmacy Supervisor, within 1 (one) business day of any failure. All results will be transmitted the facility within one business day of final analysis. Surface Sample Plates: Microbiological surface sampling will be performed by OKCVAHCS monthly in each classified area, at minimum in each room, the interior of each ISO Class 5 Primary Engineering Control (PEC), and pass-through chambers connecting to classified areas. Surface sampling in the direct compounding area must also be conducted in conjunction with media-fill testing to assess aseptic manipulation competency. Additional surface sampling may be performed during certification of new facilities and equipment, after servicing facilities or equipment, in response to identified problems, in response to identified trends, or in response to changes that could impact the sterile compounding environment. One sample of TSA will be obtained per sample location. Contractor will incubate surface 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 additional days. Each media device will be labeled with the sample location, as well as personnel identifier if applicable. Alternate procedure: Two surface sampling devices may be collected for each sample location and incubated concurrently. Both media devices could be TSA, or one TSA and one fungal media [e.g., malt extract agar (MEA) or Sabouraud dextrose agar (SDA)]. Contractor would incubate the surface sampling plates immediately upon receipt. Incubate each media device in a separate incubator. Incubate one media device at 30° 35° for no less than 48 hours and incubate the other media device at 20° 25° for no less than 5 (five) days. If fungal media are used, incubate the fungal media device at 20° 25° for no less than 5 (five) days. 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 report the number of cfu per plate 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, counting cfu, and performing identification of recovered microorganisms will be a licensed and qualified environmental microbiologist. If levels measured during surface sampling exceed the levels listed in Table 2, an attempt must be made to identify any microorganism recovered to the genus level, at minimum. Failure is if cfu of any plate is greater than the action level for the classified area. The contractor will notify the Facility Program Manager, Inpatient Pharmacy Supervisor, and the Associate Chief of Pharmacy, within 1 (one) business day of any failure. All results will be transmitted the facility within one business day of final analysis. Table 2. Action Levels for Surface Sampling ISO Class Surface Sampling Action Levels (cfu/device or swab) 5 >3 7 >5 8 >50 An ISO/IEC 17025:2017 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP). Copies of pertinent certifications, licenses, and EMLAP accreditation will be required. Performance Requirement Summary: Monthly surface sampling analysis of viable samples taken from the Segregated Compounding Areas (SCA), Chemo Ante Room, Chemo Buffer Room, IV Ante Room, IV Buffer, and associated Primary Engineering Controls (PECs). Personnel related sampling analysis of the following: Gloved Fingertip and Thumb Sample incubation and sample analysis Media Fill Testing incubation and sample analysis Surface sample of the direct compounding area (DCA) Identification of any surface sample to at least genus for any growth that exceed the levels in Table 2, and when possible, to species of the microorganism recovered. Sampling Reports: Results of viable samples and/or surface sampling must be submitted to the Facility Program Manager, Inpatient Pharmacy Supervisor, and the Associate Chief of Pharmacy within one (1) business days of the receipt of the results. Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable. Please communicate via e-mail to contact@example.gov by COB September 12, 2023, as to your company s ability to perform service per this brief Scope of Work. If interested, please provide the following: 1. Please state your company s business size as related to NAICS code 541380 2. As per the Limitations of Subcontracting: (see FAR 19.505) a. As Primary Contractor: what % of Total Contract Value will you retain? b. If using a Subcontractor: what % of Total Contract Value will go to them? 3. Please provide SAMs Unique Entity Identifier number. 4. If you have an FSS/GSA contract that includes this service. 5. Provide FSS/GSA contract number if applicable. In order for you company s information to be counted in relation to this Market Research all above questions must be answered.