Inactive

Page 2 of 2 Synopsis: Please note that this is NOT a request for quotes or proposals, the Government is seeking information for market research purposes only. Network Contracting Office (NCO) 2 of the... Page 2 of 2 Synopsis: Please note that this is NOT a request for quotes or proposals, the Government is seeking information for market research purposes only. Network Contracting Office (NCO) 2 of the Department of Veterans Affairs is currently conducting a market survey for qualified firms capable of providing Environmental & Personnel Sampling & Reporting for the Stratton VA Medical Center. The North American Industry Classification Systems (NAICS) is 541380. Responses to this notice must be submitting in writing (email or fax) and must be received not later than April 7, 2020 at 10:00AM. Email: Janice.Brooks@va.gov and Fax: 718-741-4585. No telephone inquiries will be accepted. Interested parties MUST provide company/individual name, a capability statement, examples of same or similar work performed at other facilities, DUNS number and address, point of contact and social-economic. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women owned small business, HUB Zone, 8(a), small business or large business), relative to NAICS 541380. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on Federal Business opportunities website http://www.fbo.gov at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Statement of Work Environmental & Personnel Sampling & Reporting Stratton VA Medical Center Albany, NY 12208 GENERAL INFORMATION The United States Pharmacopeia (USP) Chapter 797 is an enforceable standard that requires environmental microbiological surface sampling for viable particles and personnel sampling to ensure aseptic gloving and technique. Environmental Surface Sampling: Is required monthly and whenever there is a change to the placement of equipment in the room or any other alteration within the cleanroom suite that affects the quality of the air Is required in response to identified problems and trends Is required in response to changes that could impact the sterile environment (changes in cleaning agents) Personnel Sampling: Media fill Is required for each inpatient pharmacy staff member initially in triplicate and every 6 months thereafter Personnel sampling: gloved fingertip test (GFT) Is required for each inpatient pharmacy staff member initially in triplicate and every 6 months thereafter USP 797 compliant media fill testing kits and growth media plates are required for testing. PERIOD OF PERFORMANCE May 1, 2020 March 31, 2021 SCOPE OF WORK To secure sufficiently accredited microbiological laboratory testing services and testing supplies for USP 797 compliance associated with environmental surface sampling, media fill testing and gloved fingertip testing with detailed report of testing results provided to the pharmacy by the laboratory via email. TEST SAMPLE TYPE COUNTS ONLY (NEGATIVE) GENUS ID (POSITIVE) TURN-AROUND TIME ESTIMATED QUANTITY (ANNUALLY) SINGLE PLANT METHOD (1 PLATE FOR BACTERIA & FUNGUS) CONTACT PLATE YES YES 8 DAYS 120-150 PLATES SINGLE PLANT METHOD (1 PLATE FOR BACTERIA & FUNGUS) FINGERTIP PLATE YES YES 8 DAYS 100-160 PLATES TEST SAMPLE TYPE COUNTS ONLY (NEGATIVE) SPECIES ID (POSITIVE) TURN-AROUND TIME ESTIMATED QUANTITY (ANNUALLY) MEDIA FILL (INCUBATED BY LAB - DUAL TEMPERATURE) MEDIA FILL UNITS (VIALS, BAGS) YES YES 14 DAYS 50-70 KITS PRODUCT TYPE DESCRIPTION ESTIMATED QUANTITY (ANNUALLY) USP AGAR MEDIA (GAMMA-IRRADIATED, ISOLATOR WRAP) TRYPIC SOY W/ LECITHIN AND POLYSORBATE 80 (TSA W/ LP) 55MM - 60MM AGAR PLATES WITH NEUTRALIZERS FOR CONTACT/SURFACE SAMPLES 12 15 PACKS (10/PK) USP AGAR MEDIA (GAMMA-IRRADIATED, ISOLATOR WRAP) TRYPIC SOY W/ LECITHIN AND POLYSORBATE 80 (TSA W/ LP) 90MM - 100MM AGAR PLATES WITH NEUTRALIZERS FOR FINGERTIP SAMPLES 10 16 PACKS (10/PK) MEDIA FILL KITS (HARDYVAL, RL2, OR EQUIVALENT) MEDIUM COMPLEXITY KIT - COMPREHENSIVE (OR EQUIVALENT) PER KIT INSTRUCTIONS 50 70 KITS Laboratory Service must be able to provide the following: American Industrial Hygiene Association (AIHA) accredited services, ISO/IEC 17025 accreditation Microbial growth media plates Must include: certificates of analysis from the manufacturer that verify the plates meet the expected growth promotion, pH and sterilization requirements consistent with USP 797 Must contain TSA supplemented with neutralizing additives (lecithin and polysorbate 80) Must have a raised convex surface Must support both bacterial and fungal growth on the same plate Must be USP 797 compliant Media fill testing kit designed to simulate medium complexity sterile IV compounding, must be USP 797 compliant Prepaid mailer for properly sending samples to the laboratory for testing Samples sent to the laboratory service must be incubated in accordance with current USP Chapter 797 requirements for duration and temperature A report of the total number of discrete colonies of microorganisms for each sample (as CFU per sample) along with sample type, location and date must be provided to the facility Any recovered organisms (bacterial and fungal) must be identified at least to the genus level Report must indicate a statement of compliance or non-compliance with USP 797 based on results of testing Results of all testing must be emailed to the specified email addresses or posted to an online account with facility access within 15 business days. Growth media plates, media fill testing kits and prepaid mailer must be sent upon request, based on facility needs as outlined in General Information above.