This is a SOURCES SOUGHT NOTICE only. Responses to this notice will be used for information and planning purposes. No quotes are being requested or accepted at this time with this notice. The Department of Veterans Affairs has a request for information for GFT Medi Testing for the Wilkes Barre VA Medical Center Responses to this sources sought shall be submitted via email to christa.stine@va.gov by 13:00 EST. on November 13th, 2024. Suggested NAICS: 621511 Medical Laboratories Suggested Product Service Code (PSC): Q301 Drugs and Biologicals Open to suggestions from the market as to a more proper NAICS and or PSC. Below is a draft copy of the Statement of Work (SOW). Responses to this notice should include the following: Company Name Company UEI Number Data Universal Numbering System (DUNS) Number Company s address Point of Contact information (i.e., title, phone number and email address) Company s capability to meet this requirement and any pertinent information which demonstrates the company s ability to meet the above requirements. GSA Federal Supply Schedule contract number, if within scope of this effort (if applicable- Identify and report if ALL tests in SOW are on your schedule OR if only a portion of them). Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? Yes ___No ___ If yes, please identify which companies are considering a Joint Venture and the ownership of each company All responses to the sources sought shall reflect the below subject line for the email. SUBJECT LINE: GFT Medi Testing Company Name All Service-Disabled Veteran-Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) firms that respond shall include proof of their Vets First Verification via https://vetbiz.va.gov/ . All small business firms that respond shall include proof of small business status via their Representations and Certifications in accordance with FAR 4.1102 Policy.  While SDVOSB/VOSB contractors are preferred, all capable contractors are welcome to respond to this sources sought notice for market research purposes. All respondents shall be registered and active in https://sam.gov/content/home . The results of this market research will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., socioeconomic set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses. Statement of Work for Environmental Microbiology Laboratory Analytical Services General Requirements: Brand name or Equal ISO/TEC 17025 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 samples (GFT) and Media Fill Testing (MFT) samples obtained and submitted by Wilkes-Barre Veterans Medical Center (WBVAMC). Samples will be processed according to the most current version of CAG-009-2011 (or its successor) and results will be compared to recommendations provided in USP <797>. MUST BE FDA REGISTERED. Base plus 4 option years. Base Year: 01/01/2025 to 12/31/2025 Option Year 1: 01/01/2026 to 12/31/2026 Option Year 2: 01/01/2027 to 12/31/2027 Option Year 3: 01/01/2028 to 12/31/2028 Option Year 4: 01/01/2029 to 12/31/2029 All sampling supplies, plates and media fill will be provided by the laboratory pursuant to this contract. Certificate of analysis from the manufacturer will be provided for each lot of growth media to verify that the media meet the expected growth promotion, pH, and sterilization requirements. The contractor will assist in conducting gloved fingertip and thumb testing, media fill testing and surface sampling according to USP <797> guidelines and pharmacy needs. The Contractor shall assist with the collection, labeling and preparation of all samples. Days of sampling will be coordinated so delivery occurs according to contractor s normal hours. The majority of testing will be conducted bi-annually (approximately 35 employees) over two days of testing (on site assistance of approximately 16 hours twice a year). Any additional staff needed outside of the scheduled testing week will be conducted by pharmacy designee and shipped directly to the contractor for analysis. The contractor shall process personnel related assessment testing GFT samples according to CAG-009-2011 (or its successor), and 2022 USP <797> standards (or newest version). GFT results will be reported for each plate, with the amount of colony forming units (cfu) present on each plate reported. If there is no growth present that shall be indicated on the report (0 CFU or < 1 CFU). The contractor shall process MFT samples according to CAG-009-2011 (or its successor) and 2022 USP <797> standards (or newest version). 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 process viable surface samples according to the most current version of CAG-009-2011 and USP <797> standards. 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, in addition to the sample name and the number of CFU. If there is no growth present that shall be indicated on the report (0 CFU or < 1 CFU). Scope: The contractor shall perform routine work detailed in this Statement of Work (SOW) on a regular schedule, mutually agreed upon by the Contractor and Contracting Officer Representave (COR). The majority of the staff will be tested for GFT and Media fill on a twice yearly basis. Any newly hired staff will need to be tested on an adhoc basis according to the start date in the service. The number of surface sampling, gloved fingertip testing (GFT) and media fill testing (MFT) may change throughout the contract period. This is WBVAMC s best estimate of the number and type expected to be tested and sampled by the contract. WBVAMC reserves the right to delete or add units as required. If the numbers of listed items will be exceeded, no work is authorized without the prior written approval of the Contracting Officer (CO) to account for it. Work items or services not already included in this SOW, 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 SOW. 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. Task: Bacteria and Fungi surface incubation and sample analysis Gloved Fingertip and Thumb Sample incubation and sample analysis Media Fill Testing sample incubation and sample analysis The Contractor will assist with onsite support hours in conducting gloved fingertip and thumb testing, media fill testing and surface sampling according to USP <797> guidelines and pharmacy needs. The Contractor shall assist with the collection, labeling and preparation of all samples. Days of sampling will be coordinated so delivery occurs according to contractor s normal hours. The majority of testing will be conducted bi-annually (approximately 35 employees). Any additional staff needed outside of the scheduled testing week will be conducted by pharmacy designee and shipped directly to the contractor for analysis. Gloved Fingertip and Thumb Sampling Plates: Pharmacy compounding staff must be evaluated in Gloved Fingertip and Thumb Sampling (GFT) to demonstrate competency in garbing and hand hygiene, as set forth in USP <797>. The Contractor will perform GFT on site, 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. Contractor will incubate fingertip 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. 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, 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. Failure is if total cfu for both hands is greater than the action level for the type sampling (i.e., initial or bi-annual). The contractor will notify the USP Program Manager, or if unavailable, the 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. Surface Sample Plates: Surface sampling plates are preferred over paddles or slides. One plate of general microbial growth agar [e.g. typticase soy agar (TSA)] supplemented with neutralizing additives (e.g. lecithin & polysorbate 80). Microbiological surface monitoring will be performed after bi-annual media fill test is conducted by each employee as well as monthly in the IV room Suite and Segregated Compounding Contingency Area for both hazardous and non-hazardous compounding and all classified areas including: the interior of the Primary Engineering Controls (PECs) and any equipment contained within staging or work area(s) near the PEC Frequently touched surfaces * 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. Contractor will incubate media device(s) immediately upon receipt at a temperature of 30-35° C for no less than 48 hours. Sampling plates will be stored during incubation to prevent condensation from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates). Contractor will report the total number of discrete colonies of microorganisms on each plate as cfu per sample, with sample location, and sample date. If levels measured during surface sampling exceed the levels in USP <797> Table 6, an attempt must be made to identify any microorganism recovered to the genus level, and when possible, to species of the microorganism recovered. Contractor will incubate media device(s) at a temperature of 20-25° C for no less than 5 additional days. Sampling plates will be stored during incubation to prevent condensation from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates). Contractor will report the total number of discrete colonies of microorganisms on each plate as cfu per sample, with sample location, and sample date. If levels measured during surface sampling exceed the levels in USP <797> Table 6, an attempt must be made to identify any microorganism recovered to the genus level, and when possible, to species of the microorganism recovered. Contractor will identify which surface sampling method is included with bid. 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. Failure is if cfu of any plate is greater than the action level for the classified area. The contractor will notify the Pharmacy Inpatient/USP 797/800 Program Manager and the Chief of 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 6. Action Levels for Surface Sampling ISO Class Surface Sampling Action Levels (cfu/device or swab) 5 >3 7 >5 8 >50 Media Fill Samples: Media fill tests will be designed and developed by the Pharmacy Inpatient/USP 797/800 Program Manager to reflect the most complicated manipulations performed at WBVAMC. The contractor will be provided with the final Media Fill Testing sample (one sample) 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 licensed and qualified environmental microbiologist and 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 Pharmacy Inpatient/USP 797/800 Program Manager and the Chief of Pharmacy Services, within 1 (one) business day of any failure by utilizing a designated email group as provided by the facility. All results will be transmitted to the facility within one business day of final analysis. Environmental Wipe Sampling for Hazardous Drug Surface residue: Environmental HD (hazardous drug) surface sampling should be performed routinely, at least every 6 months. The test will be designed and developed by the Pharmacy Inpatient/USP 797/800 Program Manager to reflect the most commonly used HD medication at WBVAMC at 5 different locations within the facility each time. Contractor will perform the test and report any measurable contamination (with a limit of quantitation/limit of detection). The contractor will report results to the Pharmacy Inpatient/USP 797/800 Program Manager and the Chief of Pharmacy Services within one business day of final analysis. Place of Performance: Wilkes-Barre VA Medical Center 1111 East End Blvd Wilkes-Barre, PA 18711 570-824-3521 x24135 Contractor Qualifications: An ISO/TEC 17025 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP). Copies of pertinent certifications, licenses and EMLAP accreditation will be required. Performance requirement summary: Facility surface sampling analysis for viable particles from samples taken in the Segregated Compounding Area (SCA), Chemo Ante Room, Chemo Buffer Room, IV Ante Room, IV Buffer, and associated Primary Engineering Controls (PECs) Viable Surface Sampling analysis Identification to at least genus for any growth that exceed the levels in USP <797> Table 6, and when possible, to species of the microorganism recovered. Personnel related assessments include the following: Gloved Fingertip and Thumb Sample incubation and sample analysis Media Fill Testing incubation and sample analysis Surface sample post media fill test incubation and analysis 10. Number of samples: 8 newly hired staff for initial gloved fingertip and thumb sampling, post media-fill testing and surface sampling per year, to include failures if necessary (72 samples). 35 staff bi-annual fingertip and thumb samples (280 samples) 35 media-fill tests bi-annually (70 samples) 35 staff bi-annual surface samplings conducted post media-fill (70 samples) 13 total surface samplings monthly for IV compounding areas, sample locations to be determined by WBVAMC (130 samples) 2 additional surface samplings in the event of a failure to include STAT reporting of result 7 additional bi-annual fingertip and thumb samples in the event of a failure (56 samples) 7 additional media-fill tests bi-annually in the event of a failure (14 samples) 7 additional bi-annual surface samples conducted post media-fill in the event of a failure (14 samples) 5 locations of a hazardous medications bi-annually (10 locations total with 2 medications) Sampling Reports: Results of viable samples and/or surface sampling must be submitted to the Pharmacy Inpatient/USP 797/800 Program Manager and the Chief of Pharmacy within one (1) business day of the receipt of the results. Each employee will have their own individual results reported by the contractor to the site. Multiple employees should not be included on the same report. Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable. Each sampling reports shall contain, at a minimum, the following information: An SOP or protocol that describes the process for the handling, incubation and analysis for each sampling plate or MFT. Growth and Sterility Control Reports (where applicable) Signed lab personnel conducting the test results
