Inactive Total Small Business Set-Aside (FAR 19.5)

VISN 19-Wide Pharmacy Lab Analysis and Clean Room Testing IMPORTANTR NOTE: This RFI (Request for Information) is for information only. No award will be made from this RFI. PURPOSE: The purpose of this... VISN 19-Wide Pharmacy Lab Analysis and Clean Room Testing IMPORTANTR NOTE: This RFI (Request for Information) is for information only. No award will be made from this RFI. PURPOSE: The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification relative to NAICS 541380. The Veteran Affairs Pharmacies has a requirement for Environmental Microbiology Lab Accreditation Program (EMLAP) will process (incubate, analyze, record and report results) microbiological surface samples, Gloved Fingertip 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, 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: VISN 19 wide 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 Veterans Affairs Pharmacies listed below. Samples will be processed by the laboratory immediately. The contractor shall incubate and process personnel related assessment GFT samples according to 2023 United States Pharmacopeia (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. Some VA pharmacies will not require incubation and will only submit surface samples for identification of microorganism(s). VA Pharmacy will de-identify any personal identifiable information (PII) such as employee names prior to sending samples to the vendor. VA Pharmacy will be the only agent able link a random identification number to a VA staff member per OMB M-07-16. 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 Tryptic Soy Agar (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. a. 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 International Standards Organization (ISO) Class Surface Sampling Action Levels (CFU/device or swab) 5 >3 7 >5 8 >5 Qualifications An International Standards Organization/International Electrotechnical Commission (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: a. 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). b. Personnel related sampling analysis of the following: 1. Gloved Fingertip and Thumb Sample incubation and sample analysis 2. Media Fill Testing incubation and sample analysis 3. Surface sample of the direct compounding area (DCA) c. 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. The service will be performed at 9 different locations within VISN 19. In response to this announcement, please provide the information below: Company Name: Address: Contact Name: Phone No: Email: Business size information Select all that applies: o Certified Service-Disabled Veteran Owned Small o Veteran Owned Small Business o Small Business FSS/ GSA Contract Holder Yes No FSS/ GSA Contract Number Effective Date / Expiration Date This notice is neither a request for competitive proposal nor solicitation of offerors. This notice is to assist the VA in determining sources only and a solicitation is not currently available. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from this response. Responses to this sources sought is not a request to be added to a prospective bidders list or to receive a copy of the solicitation. Information received as a result of this notice will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This notice does not represent a commitment by the Government to pay for costs incurred in the preparation and submission of information or any other costs incurred as a response to this announcement. Inquiries will only be accepted in writing via email David.glanton@va.gov on or before March 15, 2024, by 10:00 AM MST.