Inactive

This is a sources sought/market research synopsis. The Alexandria VA Health Care System (AVAHCS), Pineville, LA contracting office is performing market research to ascertain whether there are potentia... This is a sources sought/market research synopsis. The Alexandria VA Health Care System (AVAHCS), Pineville, LA contracting office is performing market research to ascertain whether there are potential sources and their business size classification: HUB-Zone, 8(a), Small Business, Small Disadvantage Business, Women Owned Business, Service Disabled Veteran Owned Business (SDVOSB), or Veteran Owned Small Business (VOSB). Preferably SDVOSB/small businesses. The NAICS Code is 541380/$16.5M. The Overton Brook VA Medical Center, Shreveport, LA requires the professional services of a contractor to perform the necessary testing for compliance of all regulatory requirements for the preparation of sterile compounded products. The contractor shall furnish all labor, equipment, tools, materials and travel necessary to test, inspect and certify equipment used for certification of the Containment Segregated Compounding Area (C-SCA) and all classified areas; Compounding Aseptic Containment Isolator (CACI), Compounding Aseptic Isolators (CAI), Laminar Air Flow Workbench (LAFW), Biological Safety Cabinet (BSC), three ISO classified 7 Rooms, two ISO classified 5 pass-throughs. Testing will address: Certification of Classified Areas Environmental Testing to include; Air Sampling and Surface Sampling Smoke Study Hazardous Drug Surface Wipe Sampling Contractor shall provide Controlled Environment Testing Association (CETA) certified technician to perform all testing, inspections and certifications in accordance with United States Pharmacopeia (USP) 797 and 800 and CETA-CAG guidelines. TESTING/ SAMPLING: CERTIFICATION OF CLASSIFIED AREAS: To be performed under dynamic conditions. C-SCA and classified areas to include CACI, CAI, LAFW, BSC, three ISO classified 7 Rooms, two ISO classified 5 pass-throughs. Certification to include: Airflow Testing HEPA filter integrity testing Airflow pattern smoke testing Total particle count testing Site installation assessment testing Certification of classified areas is required to be completed every six months per USP 797 and 800 and CETA-CAG guidelines. In the case of certification failure, contractor will have to recertify after corrective actions are completed. Retesting will be through a separate purchase order from the facility at the established contract unit rate. Due to operational requirements, the semi-annual certification of the CAI and CACI shall be on a different schedule than the semi-annual certification of the BSC and LAFW. ENVIRONMENTAL SAMPLING Air Sampling - Impaction volumetric air sampling under dynamic conditions with a sample size of at least 1000 liters in each location. Two (2) sample locations (to consist of one (1) fungal and one (1) bacterial for each location) in the direct compounding area (DCA) of the four (4) primary engineering controls (PEC). Total of sixteen (16) samples. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) on the cart directly outside of the two (2) PECs in the classified areas. Total of four (4) samples. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the two (2) antechambers. Total of four (4) samples. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the two (2) pass-through windows located in the secondary engineering controls (SEC). Total of four (4) samples. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the ante room on the clean side of the line of demarcation. Total of two (2) samples. Three (3) sample locations (to consist of one (1) fungal and one (1) bacterial) to be determined on work patterns and approved by the Contracting Officers Representative (COR) or their approved representative. Total of six (6) samples. Total of Thirty-six (36) samples for bacterial and/or fungal contaminates. Surface Sampling Contact plates with general growth media supplemented with neutralizing additives which neutralizes cleaning agents and prevents false negative. Sampling to take place at the end of the of the compounding activity prior to cleaning. Two (2) sample locations (to consist of one (1) fungal and one (1) bacterial for each location) in the direct compounding area (DCA) of the four (4) primary engineering controls (PEC). Total of sixteen (16) samples. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) on the cart directly outside of the two (2) PECs in the classified areas. Total of four (4) samples. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the two (2) antechambers. Total of four (4) samples. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the two (2) pass-through windows located in the secondary engineering controls (SEC). Total of four (4) samples. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the ante room on the clean side of the line of demarcation. Total of two (2) samples. Three (3) sample locations (to consist of one (1) fungal and one (1) bacterial) to be determined on work patterns and approved by the COR or their approved representative. Total of 6 samples. Total of thirty-six (36) samples for bacterial and/or fungal contaminates. In-house surface sampling(monthly) contractor to supply fifty (50) plates (for each month sampling is not completed by the contractor on-site). Contractor to provide incubation, reading and results from surface sampling collected by the VA. Total of four hundred (400) plates yearly. Environmental Sampling is to be performed quarterly. It is expected that two samplings will be performed at the areas identified above as part of this contract If a positive result is received, then retesting will be performed after the VA has taken remedial action. Within 72 hours of notification from the VA that the remediation has been completed, the contractor will be on site to perform the retest. Then testing will be performed monthly until three (3) consecutive negatives are obtained with no-actionable recommendations per USP 797 Guidelines. Any additional testing required due to a positive result will be covered by a separate purchase order at the approved unit price per test. SMOKE STUDY - Smoke study to be performed and videoed bi-annually. One (1) in each of the four (4) PEC s. Each study of adequate length for viewer to see the directional air flow completely. Video to be provided via Digital Versatile Disc (DVD). HAZARDOUS DRUG SURFACE WIPE SAMPLING Hazardous drug surface sampling to be performed bi-annually. Sampling to be performed on the cart outside of the BSC and CACI, in the bottom of the Chemo pass-through, ANTE chamber of the CACI, and on the floor below the BSC and CACI. Total of six (6) wipe samples. EQUIPMENT - Prior to any testing, the following information must be provided to the COR for all equipment used in the certification and sampling process: Manufacturer Model Serial Number Equipment calibration date Calibration Due Date Acceptance criteria for each test Pass/Fail statement for each test and for the unit overall Pass/Fail refer to any appropriate industry standards. Type of cabinet Name of certifier (signed) Venting criteria to room, to roof, exhaust fan, type of damper Type of agar use in sampling Lot and expiration date of all media used in sampling Certificate of analysis of media used in sampling to verify that the devices meet the expected growth promotion, pH and sterilization requirements. Any additional information as required per USP 797 and 800 and CETA-CAG Contractor shall provide written certification reports upon completion of testing to include the CETA certification certificate of the technician performing the test, inspection and certification. Written report will be provided within 15 work days of completion of sampling and/or testing. Written report must contain: Test results. Media lots utilized for samples. Comments indicating when dynamic conditions were used. Certificates of Analysis of media used. Room number of locations tested. Sketches depicting testing locations. All calculations. Number of staff (VA and contractor) present in each PEC and SEC during total particle count test and dynamic air flow smoke pattern test. Any additional information as required per USP 797 and 800 and CETA-CAG. The report should have guidance on interpreting results, possible contamination pathways and proper corrective actions to remediate contamination. A list of recommendations and discrepancies. Written advisement will include any issues which will impact testing/certification. Contractor will also advise COR of recommendations to resolve any issues related to regulatory changes. The contractor shall supply every unit that passes certification specifications with a certification sticker. SPECIAL PROPOSAL CONSIDERATIONS BY THE CONTRACTOR: None SAFETY CONSIDERATIONS: Contractor s workmen shall provide and utilize any items required to ensure safety requirements are in accordance with OSHA regulations during all phases of the work. PERIOD OF PERFORMANCE: A base year of 12 months plus 4 one year option periods: Base Year: 1 Oct 2020 30 Sep 2021 Option One 1 Oct 2021 30 Sep 2022 Option Two 1 Oct 2022 30 Sep 2023 Option Three 1 Oct 2023 30 Sep 2024 Option Four 1 Oct 2024 30 Sep 2025 HOURS OF PERFORMANCE: Work is to be performed during the duty hours of 7:30 AM and 4:30 PM, Monday through Friday, exclusive of Federal holidays. Contractor to schedule all testing and sample collection with the COR or their authorized representative. Any work required to be performed outside of normal working hours needs to be scheduled and approved by the COR or their authorized representative. This notice is to assist the VA in determining sources only. This is not a solicitation for proposals or quotes. A solicitation will be issued at a later date and time. All information submitted in response to this sources sought notice is considered voluntary. Interested and capable respondents are requested to provide: company name, address, point of contact, phone number, DUNS number, geographical location, business size and number of employees. Responses to this notice shall be e-mailed to Lonest Bonton, Contracting Officer at e-mail address: lonest.bonton@va.gov. Telephone responses will not be accepted. Reponses must be received by no later than COB (4:30pm CST), May 12, 2020.