Inactive

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY (as defined in FAR 15.201(e)), this is not a solicitation. Solicitations are not available at this time. Requests for a solicitation will not receive a res... THIS IS A REQUEST FOR INFORMATION (RFI) ONLY (as defined in FAR 15.201(e)), this is not a solicitation. Solicitations are not available at this time. Requests for a solicitation will not receive a response. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received, provide feedback to respondents with respect to any information submitted, or respond to any questions or comments that may be submitted in response to this RFI. This notice does not constitute a commitment by the United States Government and does not obligate the Government to award a contract or otherwise pay for the information provided in response. Responders are solely responsible for all expenses associated with responding to this RFI. VHSO VA Medical Center Pharmacy Service 1100 North College Ave. Fayetteville, AR 72703 Statement of Work for Environmental Microbiology Laboratory Analytical Services GENERAL REQUIREMENTS: An 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 (GFS) and Media Fill Testing (MFT) samples obtained and submitted by Veterans Healthcare System of the Ozarks (VHSO). 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>. All sampling supplies, plates and media fill will be provided by the laboratory pursuant to this contract as available on as needed per order basis (indefinite need, indefinite quantity). 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 number of surface sampling, gloved fingertip testing (GFS) and media fill testing (MFT) may change throughout the contract period. This is VHSO's best estimate of the number and type expected to be tested and sampled by the contract. VHSO reserves the right to delete or add units as required. This requirement will represent an indefinite need and an indefinite quantity of testing supplies and analytical services. The contractor shall process personnel related assessment testing GFS samples according to CAG-009-2011 (or its successor), and 2019 USP <797> standards. GFS 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 testing samples according to CAG-009-2011 (or its successor) and 2019 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 process viable surface samples according to the most current version of CAG-009-2011 and 2019 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). 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 Pharmacy IV personnel will conduct gloved fingertip and thumb testing, media fill testing and surface sampling according to USP <797> guidelines and pharmacy needs. The Inpatient Pharmacy/USP 797/800 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 Plates: Pharmacy compounding staff must be evaluated in Gloved Fingertip and Thumb Sampling (GFS) to demonstrate competency in garbing and hand hygiene, as set forth in USP <797>. VHSO will perform GFS 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 site specified personnel, determined post award. All results will be transmitted 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 each of general microbial growth agar [e.g. typticase soy agar (TSA)] supplemented with neutralizing additives (e.g. lecithin & polysorbate 80) and one plate of fungal media (malt extract agar or sabouraud dextrose agar) will be used at each sampling site. Microbiological surface monitoring will be performed monthly in the Segregated Compounding Area and all classified areas including: pass-through chambers 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 TSA surface sampling plates 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 condensate 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 fungal media surface sampling plates immediately upon receipt at a temperature of 20-25° C for no less than 5 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 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. Alternate procedure: one sample of TSA may 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. 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). 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 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 VHSO. 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 teperature 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 site specified personnel, determined post award, within 1 (one) business day of any failure. All results will be transmitted the facility within one business day of final analysis. Place of Performance: Veterans Healthcare System of the Ozarks 1100 N College Avenue Fayetteville, AR 72703 479-587-5990 Period of Performance: Performance Years 2020(Base year) 1 December 2019 - 30 November 2020 2021 (Option year 1) 1 December 2020 - 30 November 2021 2022 (Option year 2) 1 December 2021 - 30 November 2022 2023 (Option year 3) 1 December 2022 - 30 November 2023 2024 (Option year 4) 1 December 2023 - 30 November 2024 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 Number of samples: Sampling services will be requested as an indefinite need, indefinite quantity basis. Services will be provided on a fee for service agreement. Baseline sampling is estimated to include (but not limited to): Initial gloved fingertip and thumb sampling-6 staff for initial testing per year (36 samples anually 6 plates per person) 25 staff bi-annual fingertip and thumb samples (100 samples anually 2 plates per sample) 25 media-fill tests bi-annually (50 samples anually) Up to 40 total surface samplings monthly for IV compounding areas, sample locations to be determined by VHSO (20 total sampling sites) 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 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. 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)