Hood Testing & Certification - Detroit VA

SEE ATTACHED SOURCES SOUGHT NOTICE FOR FULL DETAILS DRAFT STATEMENT OF WORK GENERAL INFORMATION The Detroit VA Medical Center at 4646 John R. Street, Detroit, Michigan 48201, requires a firm, fixed-price contract for Hood Testing and Certification services for one (1) 12-month base year, and three (3) 6-month option periods. SCOPE OF WORK Semi-Annual: The contractor shall provide all resources necessary to perform and complete the tasks described in this statement of work (SOW), except as may otherwise be specified. The contractor shall provide all labor, materials, instrumentation, supervision, and all other resources required to perform semi-annual testing and certifications on the following hoods: These rooms are in PALMS, Pharmacy, and Nuclear Medicine. Annual: The contractor shall provide all resources necessary to perform and complete the tasks described in this statement of work (SOW), except as may otherwise be specified. The contractor shall provide all labor, materials, instrumentation, supervision, and all other resources required to perform annual testing and certifications on: Background Semi-Annual: Semi-Annual hoods and the IV Clean room are to be tested and certified for proper airflows on an annual and semi-annual basis. The contractor shall test and certify all hoods and the IV Clean room within the John D. Dingell VAMC. The contractor shall perform these tests in November and May for the semi-annual testing and certifications. The contractor will schedule the work to ensure there is not more than a 6-month overlap of inspections under the contract period of performance. Background Annual: Annual hoods are to be tested and certified for proper airflows on an annual basis. The contractor shall test and certify all hoods within the John D. Dingell VAMC. The contractor shall perform these tests in November testing and certifications. Performance Period: The contractor shall complete the work required under this SOW within the month of November and again in the month of May under the contract period of performance. The work shall take place between the hours of 6:00 am to 4:30 pm, Monday through Friday. Some critical areas may require testing to be scheduled a day ahead of time in order to gain access. This will be scheduled through the COR. The contractor shall complete all testing within five business days from the start date of the initial work. SPECIFIC MANDATORY TASK AND ASSOCIATED DELIVERABLES The contractor shall provide the specific deliverables below within the performance period stated in Section B-5 of this SOW. The contractor shall begin the first semi-annual testing/certification of all the hoods and IV clean room in the month of November of the contract period of performance and complete the work within five business days from when the work was started. The contractor shall begin the second semi-annual testing/certification of all the hoods and IV clean room in the month of May of the contract period of performance and complete the work within five business days from when the work was started. The contractor must provide the Contracting Officer Representative (COR) at least one week notice before starting any testing. The contractor shall communicate with the COR daily during the inspections to inform of any issues with hoods tested that day. The contractor shall notify the COR of any hoods that do not meet certification criteria and supply the COR with a quote for repairs needed to make the hood compliant, prior to leaving the facility. Testing of the Pharmacy IV clean room shall be done on a semi-annual schedule to coincide with the hood testing. The following testing and sampling is required: 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 Temperature and Humidity Tests: Ante Room, I.V. Room, Air Lock, and Chemo Room Purpose: The purpose of these tests is to demonstrate the capability of the system to control temperature uniformity and humidity within buyer-specified limits. Sound Level Tests: Ante Room, I.V. Room, Air Lock, and Chemo Room Purpose: The purpose of this test is to establish the airborne sound pressure levels produced by the basic Cleanroom mechanical and electrical systems as experienced within the room and in adjacent external occupied areas, and to verify that performance meets the Buyer's specifications. Light Level Tests: Ante Room, I.V. Room, Air Lock, and Chemo Room Purpose: The purpose of this test is to verify that the specified lighting levels and uniformity of lighting within the Cleanroom has been met. Room Pressurized Tests: Ante Room, I.V. Room, Air Lock, and Chemo Room Purpose: To verify the capability of the Cleanroom system to maintain the specified pressure differential in the Cleanroom. Locations of all areas and test locations will be required for each individual test. 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. HOURS OF WORK The Hood testing and Pharmacy IV clean-room testing will be performed Monday through Friday between the hours of 6:00 am to 4:30pm. Any time changes must be cleared thru the acting COR of the contract. All Federal Holidays are observed Detroit VA Medical Center, and any proposed work during these days must be cleared through the COR or Facilities Maintenance Service Chief. F. GOVERNMENT RESPONSIBILITIES The Government will provide access to rooms where hoods are located so contractor can perform testing/certifications. The Government will supply room maps for all areas of work. The COR will provide an escort for Contractor, if needed, to find rooms and locations. G. SAFETY The contractor shall provide all personal protective equipment (PPE) needed for their employees such as safety glasses, hearing protection, safety shoes, gloves and any other PPE. H. REPORTS The contractor shall be responsible for submitting detailed reports within 14 days of completion of each semi-annual inspection, for each type of hood. The report must include the type of hood, ID number, EE number, room number, air flow data and hood pass/fail