Q--586-20-1-143-0003 MICROBIOLOGY LAB TESTING
2 SOURCES SOUGHT SYNOPSIS DESCRIPTION: This Sources Sought Synopsis shall be used to determine the availability of potential sources having the skills and capabilities necessary to perform/provide ISO... 2 SOURCES SOUGHT SYNOPSIS DESCRIPTION: This Sources Sought Synopsis shall be used to determine the availability of potential sources having the skills and capabilities necessary to perform/provide ISO/TEC 17025 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP) to analyze microbiological surface samples, Gloved Fingertip and Thumb Testing (GFT) samples and Media Fill Testing (MFT) samples obtained by G.V. (Sonny) Montgomery Department of Veterans Affairs, Jackson, MS. Sampling results will be processed and analyzed according to USP <797> standards for sterile compounding. All interested vendors are invited to provide information to contribute to this market survey/sources sought synopsis including, commercial market information. This is not a solicitation announcement. This is a source s sought synopsis only. Questions should be submitted by email to anthony.mitchell4@va.gov. Provide only the requested information below. The purpose of this synopsis is to gain knowledge of potential qualified sources. Socio-economic status, size classification, relative to NAICS 621511, Medical Laboratory Testing Services is needed. The size standard for the NAICS code is 32.5 million. Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought synopsis, a solicitation announcement may be published on the FBO website. Responses to this sources sought synopsis are not considered adequate responses to the solicitation announcement. All interested offerors must respond to the solicitation announcement in addition to responding to this sources sought announcement. Please demonstrate the contractor's ability to perform services of this nature as the course of its daily business operations. Services shall be performed in accordance with industry standards and practices by qualified personnel. Responses must be emailed to anthony.mitchell4@va.gov no later than NOON CST, August 13, 2019. Your response should include both the STATEMENT OF CABABILITY, BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained below. Please place Attention: Microbiology Laboratory Testing , in the subject line of your email. This notice is to assist the VA in determining sources only. A solicitation is not currently available; therefore, DO NOT REQUEST A COPY OF A SOLICITATION THAT DOES NOT EXISTS. If a solicitation is issued it will be announced at a later date, and all interested parties shall respond to that solicitation announcement separately from the responses to this announcement. REQUESTED INFORMATION: (1) STATEMENT OF CABABILITY: (1) Submit a brief [five (5) pages or less] capability statement explaining your capability to perform commercial residential substance abuse treatment program services. Include the number of qualified personnel need to accomplish this service. Include past experience in performing these services for the VA, other Government (Federal or State) agency, or for a private medical facility. Please specify your maximum capacity and your availability to start. (2) BUSINESS SIZE AND SOCIO-ECONOMIC STATUS: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at http://www.sam.gov and/or the VetBiz Registry at http://vip.vetbiz.gov/. If not, please NOTE: any future solicitation could only be awarded to a contractor who is registered in the System for Award Management (SAM). To receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry. SPECIFIED REQUIREMENT: The contractor shall communicate its capabilities to accomplish the following: (See next page) 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 analyze microbiological surface samples, Gloved Fingertip and Thumb Testing (GFT) samples and Media Fill Testing (MFT) samples obtained by G.V. (Sonny) Montgomery Department of Veterans Affairs, Jackson, MS. Sampling results will be processed and analyzed according to USP <797> standards for sterile compounding. 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. Samples must be incubated in a calibrated incubator at temperatures that will promote growth of bacteria and fungi. The incubator temperature must be monitored during incubation, either manually or by a continuous recording device. The contractor shall process personnel aseptic competency (GFT and MFT) testing samples according to the most current version of CETA CAG-009, and 2019 USP <797> standards to ensure that sterile compounding personnel are properly trained and competent to aseptically compound sterile products within the sterile compounding facility. The contractor shall process viable surface samples according to the most current version of CAG-009, and 2019 USP <797> standards to assess the cleaning procedures and processes for the sterile compounding areas. If CFU levels measured during viable surface sampling exceed USP <797> threshold levels, the report will at minimum identify genus and, when possible, species of any microorganism recovered on report, in addition to the location of the CFU and specific recommendations for remediation. If CFU levels measured during GFT or MFT testing 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 identifying information for the sample. 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 Representative (COR). The number of surface sampling, gloved fingertip and thumb testing (GFT) and media fill testing (MFT) may change throughout the contract period. This is the Government's best estimate of the number and type expected to be tested and sampled by the contract. The Government 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 sample analysis Bacterial and fungal glove fingertip and thumb sample analysis Media Fill 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. Pharmacy IV personnel shall collect, label and prepare all samples for shipping pursuant to instructions provided by the contractor to ensure viability of samples during shipping. All samples will be shipped the same day as sampled and will be shipped for next day delivery to the contractor according to instructions. If there is a concern for the integrity of any samples received, the contractor will notify the IV Program Manager, or if unavailable, the Associate Chief Pharmacy Services upon receipt of the samples and make arrangements to repeat the affected sampling process. Days of sampling will be coordinated according to contractor s normal business hours. Fingertip Sampling Plates: Gloved fingertip and thumb sampling plates are preferred over paddles or slides. One sampling plate will be used for each hand. Each plate will consist of general microbial growth agar [e.g. typticase soy agar (TSA)] supplemented with neutralizing additives (e.g. lecithin & polysorbate 80) as this agar supports both bacterial and fungal growth. Plates must allow for labeling by the facility with a personnel identifier, which hand was sampled (right or left) and the date and time of sampling. Contractor will incubate fingertip sampling plates immediately upon receipt at a temperature of 30 degrees to 35 degrees for no less than 48 hours and then at 20 degrees to 25 degrees 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). All microorganisms will be identified to at least genus, and when possible, to species of the microorganism recovered. Contractor will 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 IV Program Manager, or if unavailable, the Associate Chief 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 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) per sampling site. Microbiological surface monitoring will be performed monthly in all classified areas and pass-through chambers connected to classified areas during dynamic operating conditions. 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 degrees to 35 degrees 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, sample location, and sample date. All microorganisms will be identified to at least genus, and when possible, to species of the microorganism recovered and specific recommendations for remediation. Contractor will incubate fungal media surface sampling plates immediately upon receipt at a temperature of 20 degrees to 25 degrees 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, sample location, and sample date. All microorganisms will be identified to at least genus, and when possible, to species of the microorganism recovered. 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 IV Program Manager, or if unavailable, the Associate Chief 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 2. Action Levels for Viable 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 IV Program Manager to reflect the most complicated manipulations performed at this facility. Tests may use a combination of bags, vials of soybean-casein digest media and empty sterile vials/bags for assessing competency of compounding staff. Tests may consist of not more than 10-vials total and 2-100ml bags of testing media per test which may include 4-6 sterile empty vials. Individually ordered testing supplies will be preferred over Media Fill Test Kits. Contractor will incubate MFT samples immediately upon receipt at a temperature of 20 degrees to 25 degrees for 7 (seven) days followed by 7 (seven) days at 30 degrees to 35 degrees 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 and performing identification of recovered microorganisms will be a 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 IV Program Manager, or if unavailable, the Associate Chief Pharmacy Services, 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: G.V. (Sonny) Montgomery Department of Veteran Affairs 1500 E. Woodrow Wilson Drive Jackson, MS. 39216-5199 601-364-1555 Period of Performance: Table 3. Performance Years 2020(Base year) 1 October 2019 30 September 2020 2021 (Option year 1) 1 October 2020- 30 September 2021 2022 (Option year 2) 1 October 2021- 30 September 2022 2023 (Option year 3) 1 October 2022- 30 September 2023 2024 (Option year 4) 1 October 2023- 30 September 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 related environmental sampling for the CAI, CACI, LAFW, and BSC include the following: Surface sampling plates: Tryptic soy agar (TSA)- 1 per sample Surface sampling plates: Malt Extract Agar (MEA or SDA)**- 1 per sample Viable Surface Sampling analysis Identification to at least genus for any growth Personnel related assessments and tests (GFT and MFT) include the following: Fingertip sampling plates: TSA w/Lecithin and Tween 80- 1 plate per hand Media fill TSB bags, TSB vials, and sterile empty vials- dependent upon test Gloved Fingertip and thumb Sampling analysis Media-Fill Testing analysis Identification to at least genus for any growth Table 4. Overview of Sampling Facility-related cleanroom certification and samplings Performance Objective Standard Performance Threshold Method of Surveillance Viable Surface Sampling FDA CAG-009 USP <797> USP <800> One TSA Sample and one MEA (or SDA) sample from each Horizontal Flow Clean Bench and/or Biological Safety Cabinet or one TSA sample and one MEA sample from the main chamber of each CAI and/or CACI and from each pass-through chamber. 8 samples of each TSA and MEA per month. Contractor provided reports Personnel-related Tests Performance Objective Standard Performance Threshold Method of Surveillance CAG-009-v3 USP <797> USP <800> 100% of personnel responsible for sterile compounding every 6 months or as established standards dictate. 28 personnel total every 6 month review. One sampling device per hand (plates) containing general microbial growth agar [e.g. trypticase soy agar (TSA)] supplemented with neutralizing additives (e.g. lecithin & polysorbate 80) as this agar supports both bacterial and fungal growth. 56 media fill tests per year consisting of soybean-casein digest media. Contractor provided reports Gloved Fingertip and Thumb Sampling Media-Fill Testing Tests: 28 personnel garbing and gloving assessments are required every 6 months to validate personnel according to the following criteria: Initial assessment must be completed three times successfully before compounding All assessments after the initial assessment must be completed one time every 6 months successfully to continue compounding 28 gloved fingertip samplings are required every 6 months to validate personnel according to the following criteria: All tests after the initial sampling must be completed one time with no growth to continue compounding 28 media-fill tests are required every 6 months to validate personnel. 16** total surface samplings for each ISO class 5 environment in the segregated compounding area. One bacterial and one fungal surface sample in the direct compounding area for the 2-Horizontal Laminar Clean Bench and the 2-Biological Safety Cabinets, if applicable. One bacterial and one fungal surface sample for each location of the main chamber of the 2-CAIs and 2-CACIs if applicable and one bacterial and one fungal sample in the ante-chamber of each of the 2-CAIs and 2-CACIs. Assessment Reports: Pass/Fail notifications should be included along with recommendation for remediation where applicable. Sampling Reports: Results of viable samples and/or surface sampling must be submitted to the IV Program Manager 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) Certificate of incubator calibration Price Schedule: The contract rate is an all-inclusive rate. No separate fees will be allowed. Contracting with Parties Listed on the OIG List of Excluded Individuals/Entities: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Office of Inspector General has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal payments due to fraud and/or abuse of the Medicare and Medicaid programs. The list of excluded individuals/entities can be found on the OIG web site at www.hhs.gov/oig. With submittal of proposal, the contractor shall provide evidence than none of the contractor s employees are on the Excluded Parties list. Invoices/Payments: This provision shall survive the termination or ending of the contract. Payment for services rendered by the Contractor under the terms of this contract will be made upon receipt of a properly executed invoice. Invoice to be submitted within fourteen (14) workdays following completion of the Contractors rendered services. VA will verify services performed and certify invoice for payment within thirty (30) days following date of receipt of sampling reports. Any identified discrepancy(s) in billings shall be cause for extending provisions of this paragraph until the discrepancy or other identified problem with the billing invoice has been resolved. Invoices shall: Be electronically prepared and submitted in accordance with FAR 52.212-4(g) Clearly state the terms of any discounts offered Include the current fiscal year and purchase order number Include the period of performance covered by the invoice Accept payment for services rendered under this contract as payment in full. This provision shall survive the termination or ending of the contract. Information Security Officer, Information Protection: The contractor will not have access to VA Desktop computers nor online resources belonging to the government while conducting services. Privacy Officer: The contractor will not have access to Patient Health Information (PHI) nor have the capability of accessing patient information during the services provided to the VA. Records Manager: The contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chapters 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. *Surface sampling may be performed on Horizontal Laminar Clean Benches, Biological Safety Cabinets, CAIs, or CACIs dependent upon equipment. Four class 5 environments total will be subject to required surface sampling each month.
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