L066--Hood Testing & Certification Saginaw VA - Source Sought Notice

This is a Sources Sought Notice for biological, chemical and pharmacy hood testing and certification, including testing of room and equipment as identified in the Statement of Work (SOW) for the Aleda E. Lutz VA Medical Center in Saginaw, Michigan. The contractor shall furnish all necessary labor, supplies, materials, equipment, instrumentation, supervision, management, management support, and transportation necessary to furnish the following services. The services required are provided and are subject to changes. A draft SOW is attached to this notice and is subject to change should a solicitation be issued as a result of this notice. Please respond if you have the ability and actual intention to complete this requirement. Include the following information in your response: DUNS NUMBER Capabilities Statement Company name and address Point of contact information (name, phone, email) Socioeconomic size status (example: large, small, WOSB, SDVOSB, etc.) Whether a site visit will be requested; FSS or GSA contract number, if applicable. This Sources Sought Notice is intended to locate any business capable of performance. The anticipated NAICS Code for this requirement is 541380. This is not a Request for Quotation and quotes shall not be reviewed at this time. The Government shall not be responsible for any costs incurred by the contractor because of this Sources Sought Notice. This notice shall not be construed as a commitment by the Government to ultimately award a contract, nor does it restrict the Government to any particular acquisition approach. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. All responses shall be submitted via email by Thursday, April 7, 2022, at 10:00 AM Eastern Standard Time (EST). Responses shall be submitted to Jeanne Ortiz at contact@example.gov. PHONE CALLS SHALL NOT BE ACCEPTED FOR THIS NOTICE. DRAFT STATEMENT OF WORK The Aleda E Lutz Veteran Affairs Medical Center has a requirement for certification of laboratory biological safety hoods and sterile compounding facilities including testing of room and equipment on a semi-annual basis. All testing is to be performed by personnel accredited by NSF or CNBT for certification of sterile compounding facilities. Contractor personnel will follow VAMC protocols for use of personal protective equipment in sterile compounding areas. PERFORMANCE PLACE: Aleda E. Lutz VA Medical Center, 1500 Weiss Street, Saginaw, Michigan 48602. SCOPE OF WORK: The contractor shall provide all resources necessary to accomplish the deliverables described in this Statement of Work (SOW). The contractor shall provide all labor, materials, instrumentation, supervision, certification showing passing functions, and all other resources required to perform semi-annual and annual testing certification on all laboratory biological and safety hoods and sterile compound facilities within Aleda E. Lutz VAMC. Recertification shall be performed no less than every six months, or sooner if equipment is relocated or altered or major service is performed. EQUIPMENT LOCATIONS: Item Hood Type Quantity EE # Serial # Location Room # LABCONCO Logic Type 2 Biosafety Hood Biological Hood 1 29418 120659758 Main Medical Center Laboratory 2100 AirClean 600 Chemical Safety Hood Chemical Fume Hood 1 None AC632TA-5226 Main Medical Center Laboratory 2100c GermFree Vertical Laminar Flow Workstation Pharmacy Hood 1 159670 BV-4SS Main Medical Center Pharmacy 22-b715 WORK PERFORMANCE & PERIOD: The contractor shall complete the work required under this SOW in September and again in March, of the contract award term. Some critical areas may require testing to be scheduled in advance in order to gain access, which shall be scheduled through the Contracting Officer s Representative (COR). The contractor shall complete all testing within five (5) business days from the start date of the initial work. Certification of facilities will be conducted from cleanest to dirtiest area LAFW, then general pharmacy area. The contractor shall perform the designated testing and sampling in accordance with the most recent version of the identified standards and testing methods (or those referenced therein). Procedures described in this document are a general description; the designated methods shall be referenced for detailed guidance of testing and sampling procedures. All particle counts will measure particles of 0.5 microns and larger. Where instruments are used for testing, they shall be calibrated in accordance with current industry practice or as designated, no less frequently than every 12 months. Inspection, testing, certification, and acceptance criteria shall be in accordance with the most recent version of the following recognized standards, as applicable: United States Pharmacopeia, Chapter 797 United States Pharmacopeia, Chapter 1116 CAG-002-2006 CAG-003-2006 CAG-008-2010 CAG-009-2011 ISO 14644-1 IEST RP CC-006 IEST RP CC-034 Manufacturer Recommendations Upon recertification, viable sampling will occur prior to facility and equipment certification. Sampling will be conducted from cleanest to dirtiest area LAFW, then general pharmacy area. Contractor will provide agar plates for viable samples, which will be double or triple wrapped and certificate of quality for each lot will be provided. Aseptic technique per CAG-009-2011 will be followed and care will be taken by certification personnel to not contaminate agar plates or surfaces to be tested. Agar plates will be stored and transported inverted and cool, but not frozen. All viable samples must be sent same day or overnight to an appropriately credentialed laboratory for analysis. In addition to samples, two unopened agar plates of each media type will be sent for negative and positive controls. Chain of custody must be maintained. Reported results will include all data designated in CAG-009-2011, including colony counts and genus determination. Staphylococci will be designated as coagulase-positive or coagulase-negative. The results of each sampling and testing shall be recorded and submitted as a comprehensive report, along with a statement of compliance or non-compliance with the specified tests. A written report of certification for all primary engineering controls, with statement of Pass/Fail, will be furnished to the COR on the day of certification. Full report will be furnished to the COR, timely, upon completion of all analyses, including identification of viables, not to exceed 10 calendar days from certification date. The report shall be informative and comprehensive, including the following at minimum: Name, address, and contact information of the testing organization; Written and signed names of certification personnel, with appropriate accreditations; Date on which the certification was performed; Reference to appropriate standards (CAG or other, most recent version) and testing/sampling method(s); Explanation of test procedures, or referral to SOP, and justification for any deviations from established industry practices; Clear identification of the physical location of the areas tested (in relation to the physical layout of the compounding facilities, including equipment) and specific designations for coordinates and nomenclature of all sampling locations, via diagram; All reported values designated in CAG-008-2010 for the specified tests; Specified designation criteria for the areas, including the ISO classification and considered particle size(s), relevant occupancy state(s), airflow volume or velocity, and pressure differential; Instruments and equipment used for data collection, including make, model, serial number, documentation of most recent calibration with date performed and date calibration due; Test results, including particle concentration data for all sampling location coordinates and aggregates, as applicable, and laboratory reports; A clear indication of Pass or Fail for each test or sample conducted, as indicated by the included criteria; An overall indication of Pass or Fail for each sterile compounding area and primary engineering control. DESIGNATED TESTING AND SAMPLING Primary Engineering Controls Airflow Test Citations: USP <797>, CAG-001-2005, CAG-002-2006, Manufacturer Specifications Methods: CAG-002-2006 Locations: LAFW Procedure: Appropriate airflow parameters will be measured using a validated method which will be kept on file. Air velocity will be measured by thermal anemometer using equally spaced readings across a horizontal plane producing the most repeatable readings. The locations within the plane, and the level of the plane in relationship to the filter diffuser will be documented. Reported in feet per minute with % uniformity. Pass/Fail Criteria: PASS Average velocity and uniformity within manufacturer specifications FAIL Average velocity and uniformity outside manufacturer specifications HEPA Filter Integrity Test Citations: USP <797>, CAG-002-2006 Methods: CAG-002-2006, IEST-RP-CC034.2 Section 6.2.1 for filters that can be scan tested IEST-RP-CC034.2 Section 6.2.3 for filters that cannot be scan tested Locations: LAFW Procedure: HEPA filters will be leak tested using a validated method which will be kept on file. An aerosol challenge of 10-90 micrograms per liter of polydispersed dioctylphthalate, polyalphaolefin, or equivalent will be introduced upstream and filter efficacy verified by aerosol photometer scan. Certifier shall have capability to patch and repair HEPA filter up to 3% of the face area per side and not to exceed 1.5 inches in width or provide replacement HEPA filter with filter of like size and construction (Type C or K) on same day. Pass/Fail Criteria: PASS leakage of less than or equal to 0.01% of upstream concentration for filters that can be scanned, or 0.005% for filters that cannot be scanned FAIL leakage of greater than 0.01% or patch size exceeds IEST-RP-CC034 (current version) limit Airflow Smoke Pattern Test Citations: USP <797>, CAG-001-2005, CAG-002-2006 Methods: CAG-002-2006 Locations: LAFW Procedure: Visual observation of airflow patterns, under dynamic operating conditions, demonstrating first-air flow through critical sites within the DCA. Minimal dead spots or reflux away from critical sites is allowable. Methods will be kept on file. Delivery velocity of smoke generator shall not overcome isolator airflow patterns. Results to be video recorded and provided to Facility Program Manager for IV/Sterile Preparations. Pass/Fail Criteria: PASS Airflow demonstrates smooth downflow with no dead spots or refluxing across critical sites. FAIL Airflow does not meet direction or turbulence standards Particle Count Survey Citations: USP <797>, CAG-001-2005, CAG-002-2006 Methods: CAG-002-2006, ISO 14644-1 Locations: LAFW Procedure: Air particle counts will be measured using a validated method which will be kept on file. The pass-through will be tested under static (at-rest) condition and the main chamber under both static and dynamic operating conditions. A discrete particle counter capable of detecting particles of 0.5 micron and larger shall be used. Sampling probe is to be oriented upward and located no more than 12 above the work surface (static test) and 12 away from the critical site (dynamic test). A minimum sample of two liters of air over one minute will be taken for each testing location. Three particle counts will be taken from the geometric center of the pass-through and five particle counts each will be taken in the main chamber under static and dynamic conditions one near each corner, and one in the geometric center. Particle counts will be reported individually for each sampling location and designated by location and testing condition. Pass/Fail Criteria (each PEC): PASS ISO Class 5 or better for all samples: less than or equal to 3,520 particles (0.5 micron and larger) per cubic meter FAIL greater than 3,520 particles (0.5 micron and larger) per cubic meter for any sample Viable Air Sampling Citations: USP <797>, USP <1116>, CAG-009-2011 Methods: CAG-009-2011 Locations: One of each bacterial and fungal near the geometric center of the work surface in the LAFW and outside the LAFW. Procedure: All samples shall be collected under dynamic operating conditions by volumetric impaction. Bacterial samples will be collected using 55mm plates containing TSA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated inverted at 30-35° C for 48-72 hours. Fungal samples will be collected using 55mm plates containing MEA or SDA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated at 26-30° C for 5-7 days. Colony forming units will be assessed daily and counts will be adjusted per manufacturer MPN calculation or statistical correction factor and reported as CFU per cubic meter. Pass/Fail Criteria: PASS 1CFU per plate and no highly pathogenic organisms FAIL >1 CFU per plate or 1 CFU of highly pathogenic organisms Highly pathogenic organisms defined as gram-negative rods, coagulase-positive staphylococci, molds and yeasts Pass/Fail Criteria (Outside CAI): PASS 100 CFU per plate FAIL >100 CFU per plate Viable Surface Sampling Citations: USP <797>, USP <1116>, CAG-009-2011 Locations: One of each bacterial and fungal near the geometric center of the work surface in the LAFW, and outside the LAFW. Methods: CAG-009-2011 Procedure: All samples shall be collected under dynamic operating conditions using convex agar plates by gently rolling across the surface once in a single direction. Surface to be disinfected by wiping with non-shedding wipe saturated with sterile 70% isopropyl alcohol (provided by facility) immediately after each sample is collected. Bacterial samples will be collected using 55mm plates containing TSA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated inverted at 30-35° C for 48-72 hours. Fungal samples will be collected using 55mm plates containing MEA or SDA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated at 26-30° C for 5-7 days. Colony forming units will be assessed daily and reported as CFU per plate. Pass/Fail Criteria (CAI): PASS 3 CFU per plate and no highly pathogenic organisms FAIL >3 CFU per plate or 1 CFU of highly pathogenic organisms Highly pathogenic organisms defined as gram-negative rods, coagulase-positive staphylococci, molds and yeasts Pass/Fail Criteria (Outside CAI): PASS 100 CFU per plate FAIL >100 CFU per plate CONFORMANCE STANDARDS: All testing of equipment, hoods, and areas shall meet any VHA standards, Joint Commission for Accreditation of Hospital Organization (JCAHO) or National Codes, Controlled Environment Testing Association (CETA) Sterile Compounding Facilities (or equivalent) guidelines, and USP 797/800 standards.