Inactive Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)

1 STATEMENT OF WORK INSPECT/CERTIFY EQUIP/PHARMACY CLEANROOMS 1. INTRODUCTION AND SCOPE OF WORK: Contractor shall furnish service as specified to ensure that the equipment functions in accordance with... 1 STATEMENT OF WORK INSPECT/CERTIFY EQUIP/PHARMACY CLEANROOMS 1. INTRODUCTION AND SCOPE OF WORK: Contractor shall furnish service as specified to ensure that the equipment functions in accordance with NCI Specification General Purpose, Clean Air, Biological Safety Cabinet, revised August 19, 1975 , NIH specification NIH-03-11ZC dated Sept 17, 1974; National Sanitation Foundation-Class II, (Laminar Flow) Biohazard Cabinetry-Standard Number 49 [NSF 49]; Federal Standard No. 209E-April 24, 1973, Clean Room And Work Station Requirements, Controlled Environment ; SAMA Standard LF10-1980 Laboratory Fume Hoods, USP 797 and 800. Furnished all labor, equipment, tools, materials and travel necessary to test, certify and measure Government owned Biological Safety Cabinets (BSCs), Laminar Flow Hoods (LFHs), and Pharmacy clean rooms. 2. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT: Each respondent must have an established business, with an office and full-time staff. The contractor must meet Joint Commission requirements by providing competency of the service technician. All certifying technicians who perform work under this contract will have a current Controlled Environment Testing Association (CETA) certification. Contractor will provide a copy of CETA certification to COR. If subcontractor(s) are under consideration for use, they must be approved by the COR and meet the CETA certification requirements noted in 2.b. Prior to each certification event/visit, the Contractor shall provide the BVAHCS with the current calibration of all test equipment which is used on BVAHCS s equipment. This certification shall also be provided on a periodic basis when requested by the BVAHCS. Test equipment calibration shall be traceable to the national standard. 3. REFERENCES: Contract service shall ensure that the equipment functions in accordance with the following standards/guidelines: National Safety Foundation (NSF) 49-2019: Biosafety Cabinetry: Design, Construction, Performance and Field Certification. American Society of Heating, Refrigeration and Air Conditioning Engineers (ASHRAE) 110-2016: Method of Testing Performance of Laboratory Fume Hoods. International Organization for Standardization (ISO), 14644-1 Part 1: Classification of air cleanliness. The Science Equipment and Furniture Association (SEFA) 1.2-1996: Laboratory Fume Hoods Recommended Practices. American Conference of Governmental Industrial Hygienist (ACGIH). The United States Pharmacopeial Convention (USP) 2020, Chapters 797 (USP 42 NF 37) and 800 (USP 40 NF 35). American Society Health-System Pharmacists (ASHP) Minimum Standards for Pharmacies in Hospitals (2013). CETA Certification Guide for Sterile Compounding Facilities (CAG-003-2012). The most recent revision of each standard takes precedence. 4. REPORTING REQUIREMENTS: The Contractor shall be required to check in by calling (see below) the Contracting Officer s Representative (COR) prior to entering the facility. This check in is mandatory. When the service is completed, the Field Service Representative (FSR) shall document services rendered on a legible Engineering Service Reports (ESRs). The FSR shall be required to log out with the COR. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature". If the COR is unavailable, a signed copy of the ESR will be sent to the COR after the work is performed. VA Contact Person(s): Safety Manager/COR Location (Building/Room Number): BVAHCS 2706-D & 2710 Telephone Number & Extension(s): (205) 933-8101, extension 8063/5795 5. Biosafety Cabinet Certification The Pharmacy BSCs shall be certified twice per year (see ATTACHMENT 1). All other BSCs will be certified once per year (see ATTACHMENT 2). Certification shall consist of the following: Down flow velocity test Direct inflow method velocity test Airflow smoke pattern test HEPA filter leak test Alarm function test Blower interlock test (Class II, type B cabinets) Electrical leakage on the main cabinet (those that are not UL listed) Ground Fault Circuit Interrupter (GFCI) outlet trip test. A visual inspection to identify defects, damage, misuse, or missing parts Documentation of the certification and inspection results A decal or label affixed to the cabinet in a visible location that indicates the results and date of the certification Posting an Out of Service sign on cabinets that fail certification. Notifying the cabinet user and the COR of cabinets that fail certification. 6. Laminar Flow Hood Certification Laminar Flow Hoods (LFHs) shall be certified twice per year (see ATTACHMENT 1). Certification shall consist of the following: Measurement of sash face velocity according to the current version of ASHRAE 110. Comparison of the sash face velocity to the current ACGIH recommendation. Airflow smoke pattern test. HEPA filter leak test. GFCI outlet trip test. A visual inspection to identify defects, damage, misuse or missing parts. Documentation of the certification and inspection results (e.g., a decal or label affixed in a visible location that indicates the sash certification height, the face velocity and the date of certification). Posting an Out of Service sign hoods that fail certification. Notifying the hood user and the COR of hoods that fail certification. 7. Pharmacy Testing and Certification Testing and certification (under CAG-003-2006-11 and to USP 797 and 800 Standards) of the Pharmacy Ante Room(s), Buffer (IV) Room and Chemo Buffer Room as well as viable air sampling for mold and bacteria will be twice per year (see ATTACHMENTS 3 & 4). Certification and testing shall consist of the following: Smoke Pattern Test (with Digital Recording) USP 797, First Air Direct Compounding Area. Dynamic airflow smoke pattern test conducted in situ to ensue unidirectional air flow and sweeping action over and away from product. All air flow visualization testing will be performed using simulations that mimic the most complex processes performed. Simulated dynamic smoke pattern test in the Primary Engineering Controls (PEC) and BSCs as required by USP 797. Smoke testing will be video recorded & provided on a USB drive of the date of service. USP 797 Air Viable Sampling per location dual analysis. Air samples shall be taken in: the IV (non-hazard) buffer room, two (2) each; the chemo (hazardous drug) buffer room, two (2) each; the airlock leading to the chemo (HD) room, one (1) each; the anteroom, one (1) each; the LFHs, two (2) each; the BSCs, two (2) each; Colony forming units (CFU) results from the cultures shall be calculated in CFU per cubic meter (m3) of air. USP 797 surface viable sampling per location dual analysis. Surface samples shall be taken in: the IV (non-hazard) buffer room, one (1) each; the chemo (HD) buffer room, one (1) each; the airlock leading to the chemo (HD) buffer room, one (1) each; the anteroom, one (1) each; the LFHs, two (2) each; the BSCs, two (2) each; the passthrough boxes, three (3) each. Colony forming units (CFU) results from the cultures shall be calculated in CFU per device or swab). Cleanroom certification per room will include: Room air change calculations (air changes per hour). Room-to-room differential pressures/room pressurization (this includes the and Chemo Storage Room) Airborne particle count survey. Work height velocity (unidirectional). Airflow parallelism. Airflow uniformity Airflow smoke pattern tests. Room recovery. Enclosure integrity leak test. Temperature and humidity (this includes the Chemo Storage Room). Particle count statistical analysis. Lighting and noise level test. Test and validate that the hood and room exhaust provide a unidirectional/laminar flow of air. Inspect HVAC filter assembly for air bypass issues. Test and calibrate the existing air balancing monitors (Chemo and Ante Rooms). 8. Re-testing Testing and certification will include up to two (2) additional air samples and two (2) additional surface samples (i.e.., re-testing) if any sample results are out of compliance (OOC) for the base year and any subsequent option years. Re-testing will be included in the contract as a separate line item (CLIN) and travel cost should be included in the cost. 9. Maintenance and Repair: The main purpose of this Contract is to eliminate unscheduled shutdowns and contribute significantly to the continuous operating economy and integrity of the system. All work is to follow NSF-49 and ASHRAE 110. The following items shall be provided as part service to the BVAHCS: Biological safety cabinet and laminar flow hood filters shall be replaced when they fail a leak test and cannot be repaired. This should be a separate line item (CLIN). When applicable, cabinets will be marked inside to indicate the safe capture air zone to prevent contamination of the outside work area. Cabinet dampers shall be adjusted to provide required flow and marked to indicate correct position. The Contractor s equipment shall be calibrated according to the manufacturer s specifications. Consult with end user and COR regarding unit performance. 10. DOCUMENTATION/REPORTS: At the conclusion of each certification visit, documentation shall be submitted and include detailed descriptions of the scheduled certifications required to maintain the equipment in accordance with the manufacturer s specifications. Such documentation shall meet the guidelines as set forth in paragraph 3, References. In addition, each FSR must, at a minimum, document the following data legibly and in complete detail: a. Name of contractor. b. Name of FSR who performed services. Contractor service FSR number/log number. Date, time (starting and ending), equipment downtime, and hours on-site for the service call. BVAHCS purchase order numbers(s) covering the call if outside normal working hours. Description of problem reported by COR (If applicable). Identification of the equipment to be serviced: Inventory ID number Manufacturer s name Device name Model number Serial Number Any other manufacturer s identification numbers Itemized Description of Service Performed (including Costs associated with after normal working hour services) including: Materials and Circuit Location of problem/corrective action. Total Cost to be billed for service(s) rendered. Signatures: FSE performing services described. VA Employee who witnessed service described. NOTE: Failure to provide this information in the service report may result in non-payment of invoice. 11. NOTES AND OTHER INFORMATION: ADDITIONAL CHARGES: There will be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE. Security Issues: There are security issues associated with this Statement of Work Both the Pharmacy and Medical Research are controlled access areas and a VA employee escort is required to enter these areas. 12. DEFINITIONS: Acceptance Signature - VA employee who indicates FSE demonstrated service conclusion/status and User has accepted work as complete/pending as stated in ESR Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR. PARKING: Contractors are responsible for finding their own parking. 14. ARRIVAL AT THE BVAHCS Contractors are required to report their arrival to the Safety Office, room 2710, 700 19th Street South, Birmingham, AL 35233. While on BVAHCS property, contractors will be escorted by the COR, a Safety Office employee, or the Service they are certifying (e.g., Path & Lab, Medical Research, Or Pharmacy). Records Management (NARA) Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. b. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. ATTACHMENT 1 - PHARMACY EQUIPMENT Pharmacy Equipment Make Model Serial No. Location Work Performed LFH NuAire 301-530 165343092514 1101D, IV Buffer Rm Annual Certification/Inspection LFH NuAire 301-530 165342092514 1101D, IV Buffer Rm Annual Certification/Inspection BSC NuAire 540-300 203893020121 1101D, Chemo Buffer Rm Annual Certification/Inspection BSC NuAire 540-300 198819052720 1101D, Chemo Buffer Rm Annual Certification/Inspection ATTACHMENT 2 PATHOLOGY & LABORATORY AND RESEARCH EQUIPMENT Medical Research Equipment Equip. Make Model Serial No. Location Work Performed BSC NuAire 425-400 165290092414 5713 Annual Certification/Inspection BSC NuAire 425-400 165289092414 5718 Annual Certification/Inspection BSC NuAire 425-400 165288092414 5708 Annual Certification/Inspection BSC NuAire 425-400 165282092314 5720 Annual Certification/Inspection BSC NuAire 425-400 165280092314 5714 Annual Certification/Inspection BSC ThermoFisher TSF 1377 1540488-1046 5715 Annual Certification/Inspection Pathology and Laboratory Equipment Equip. Make Model Serial No. Location Work Performed BSC NuAire 425-400 165285092414 3428 Annual Certification/Inspection BSC NuAire 425-600 165287092414 3428 Annual Certification/Inspection BSC NuAire 543-300 203540011821 3427F Annual Certification/Inspection BSC NuAire 543-300 203541011821 Annex, 1A165 Annual Certification/Inspection ATTACHMENT 3 PHARMACY CLEANROOMS Cleanrooms Room Approximate Square Footage Location Ante 83 1101D Chemo 120 1101D Buffer (IV) 113 1101D Air lock 45 1101D Chemo Storage 54 1101D ATTACHMENT 4 - PHARMACY LAYOUT