H236--Test and Certify Government Owned Labs in Green Bay VA HCC Contract

STATEMENT OF WORK GENERAL: Provide all labor, materials, equipment, tools and reports required to test and certify the Government owned laboratory hoods, biosafety cabinets and HEPA bank filters listed below, located at the Green Bay Health Care Center (HCC), 2851 University Ave Green Bay WI 5431 and the John H. Bradley Appleton VA Clinic Building 1, 10 Tri-Park Way Appleton WI 54914. SCOPE: Provide two-hour telephone response time for equipment related telephone inquiries and 24-hour on-site response time for emergency/issue verification. Testing of the biological safety cabinets shall follow current standards set by National Sanitation Foundation (NSF)/ America National Standard (ANS)/( NSF/ANSI-49), the NSF Certification policies for biosafety Cabinetry, and manufacturer specification. All biosafety cabinets shall be certified every 6 months or semi-annually. The operational integrity of the cabinet must be validated before being put into service or after being repaired, relocated or having filters replaced. Testing of all the hoods for Pharmacy Service shall include a semi-annual air quality evaluation (particle count) as outlined in the most recent edition of the United States Pharmacopeia 797 (USP) indicating the ISO classification for the environment within the hood. The testing of these hoods shall also include a semi-annual high-efficiency particulate air (HEPA) filter integrity/leakage test. The rooms in Pharmacy Service used for sterile preparations shall be tested for compliance as outlined in the most recent edition of USP 797. This shall include measurement of air changes per hour as well as a semi-annual air quality evaluation (particle count) as outlined in the most recent edition of USP 797 indicating the International Organization for Standardization (ISO) classification for the environment in the buffer and anteroom zones. Testing of all hoods/units in Pharmacy service, as well as associated rooms, shall include semi-annual microbial testing as outlined in the most recent edition of USP 797. The sterile preparation rooms in Pharmacy Service shall have an annual room pressurization test, in accordance with ANIS/ the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE)/ American Society of Heating and Air-Conditioning Engineers (ASHAE); ANSI/ASHRAE/ASHAE Standard 170-2008 or latest version - Ventilation of Health Care Facilities. The isolation rooms in Specialty Clinic and Primary Care Clinic 2 shall have an annual room pressurization test, in accordance with ANSI/ASHRAE/ASHAE Standard 170-2008 or latest version - Ventilation of Health Care Facilities. The rooms in Sterile Processing shall have an annual room pressurization test, in accordance with ANSI/ASHRAE/ASHE Standard 170-2008 or latest version - Ventilation of Health Care Facilities. The OR suites including Cystology shall have an annual room pressurization test, in accordance with ANSI/ASHRAE/ASHE Standard 170-2008 or latest version - Ventilation of Health Care Facilities. The biosafety cabinetry in Pharmacy Service shall include a semi-annual containment leakage test. This is the hood cabinetry used for preparation of cytotoxic or hazardous drugs. The contractor shall document all certifications performed by placing a certification sticker on the certified equipment immediately after certification. The contractor shall document all certifications by providing reports detailing each certification or test performed within 30 days. The contractor shall not be required to go on the roof of the building. The contractor is responsible for providing all contract employees with required personal protective equipment, respiratory protection and an occupational health program to ensure a safe work environment consistent with current Occupational Safety and Health Administration (OSHA) regulations. SERVICE: Service shall consist of one annual or two semi-annual inspections (see Attachment A) for frequency and month(s) required and certifications that the equipment is functioning properly according to manufacturer s specifications. The contractor shall provide all labor, materials, travel, supervision, tools and facilities required for testing and certification of all equipment listed in this contract (See Attachment A) located at the Medical Center. Contractor shall ensure that the equipment functions in conformance with the latest published edition of applicable standards, such as: NFPA 99, UL, NSF/ANSI 49, ASHRAE 110, SAFA, ANSI, OSHA, VA, IEST, ISO, USP, CDRH, etc. Scheduled Work: Scheduled work is required in the performance of this contact shall be performed during the facility regular hours of 8:00 a.m. and 4:30 p.m., excluding federal holidays. The contractor shall notify the COR at least 7 days prior to the normal testing/inspection cycle visit and 8 hours prior to any emergency activities. Federal Holidays observed by the VAMC(s) are: New Years Day Independence Day Thanksgiving Day Presidents Day Martin Luther King Day Labor Day Christmas Day Columbus Day Memorial Day Veterans Day REPORTING REQUIREMENTS: The contractor shall be required to report to the Contracting Officer Representative: Room - 1J009, to check in and verify identification is present and worn by contractor(s). REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE: The contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR of the existence of the development of any defects or repairs outside of the terms and conditions of this contract. The contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs within 7 working days. DOCUMENTATION/REPORTS: Certification reports shall include full documentation of service performed. Each report shall include a unique identification of equipment and all readings and measurements found. In addition, each report shall contain a written comment on the visual condition and use of each cabinet and hood. An identifying certification sticker shall be placed on each unit at the time of inspection indicating status of unit. All completed written reports are due within 30 days of final on-site inspection. All preventative maintenance and other repairs shall be done according to the manufacturer s recommendations. Any authorized repairs/maintenance activities mandate only new standard parts by the original equipment manufacture (OEM) to be furnished by the contractor. All parts shall be of current manufacture and shall have full compatibility with the equipment being repaired. PERFORMANCE STANDARDS: All work must be performed by competent technicians, experienced and qualified to work on the listed equipment. Service Technicians conducting inspection, testing and certification of equipment, must be currently certified as a Technical Certifier by the National Sanitation Foundation (NSF). All work must be performed in accordance with commercial practices. Documentation indicating qualifications (CV, certificates, etc.) must be submitted to the COR, prior to initiation of any work on station. APPROVAL OF CONTRACTOR PERSONNEL: The VA reserves the right to refuse employment under this contract or require dismissal from contract work of any contractor employee who, by reason of previous unsatisfactory performance at the VA or for any other circumstance, is considered by the Contracting Officer s Representative and Contracting Officer to be objectionable. TEST EQUIPMENT: Prior to commencement of work on this contract, the contractor shall make available to the COR a copy of the current calibration certification of all test equipment which is to be used by the contractor on the Milo C. Huempfner VA Medical Center and the John H. Bradley Appleton VA Clinic (GB HCC) s equipment. This certification shall also be provided on a periodic basis when requested by the COR. Test equipment calibration shall be traceable to a national standard. All testing and certification equipment must undergo annual calibration by a recognized testing entity (See Attachment A). PROCEDURES: When a deficiency per the requirements of the SOW exists, it shall be brought to the attention of the COR. The COR shall confirm the deficiency by inspection and record results, noting the date and time of inspection of the deficiencies for correction. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: The Contractor's employees shall wear visible identification at all times while on the premises of the VA facilities. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police. The facility will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited on VA property. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court. ATTACHMENT A Annual Services to be done in January Annual Hepa Bank # Hepa filter location Type Model ID Name (Room) HFB 1 2C246 OR 3 HFB 2 2C249 OR 2 HFB 3 2C243 OR 4 HFB 4 2C221 OR 1 HFB 5 2C239 OR 5 HFB 6 2C225 Cysto HFB 7 2C245 Clean Corridor HFB 8 2C233 Clean Core HFB 9 2C237 Clean Corridor HFB 10 1S020 Hood in IV prep HFB 11 1S020 EF-IL Hood in Chemo prep HFB 12 1E024 VAV IV Prep HFB 13 1E024 VAV Chemo Prep HFB 14 1E021 VAV Ante room HFB 15 1D113 Lab HFB 16 1C233 Isolation room HFB 17 2C229 Clean Corridor HFB 18 2C224.1 Clean vestibule HFB 19 1B029 Isolation room Bio Hood 1D113 Nuaire NU-477-400 EE# 77646 Lab Bio Hood 153E Appleton Lab Positive pressure rooms 1G008 Positive pressure SPS 1G011 Positive Pressure SPS 2C225 Positive Pressure Cysto 2C221 Positive Pressure OR #1 2C249 Positive Pressure OR # 2 2C246 Positive Pressure OR # 3 2C242 Positive Pressure OR # 4 2C239 Positive Pressure OR # 5 2C132 Positive Pressure PACU/Recovery Negative Pressure rooms 1B029 Specialty Clinic Neg. Pressure room(Isolation) Neg Pressure room (Isolation) Primary Care Clinic 2 1C233 Neg. Pressure room (Isolation) Neg. Pressure Room (Isolation) SPS 1G025 Neg Pressure (Decon cart washer) SPS Decon cart washer 1G025 SPS 1G020 Neg Pressure SPS Decon scope area 1G020 SPS 1G010 Neg. Pressure SPS Sterilizer Equipment 1G010 SPS 1G023 Neg Pressure SPS Decon SPS 1G006 Neg Pressure SPS Men s Toilet SPS 1G004 Neg Pressure SPS Women s Toilet SPS 1G019 Neg Pressure SPS Women s Toilet SPS 1G017 Neg Pressure SPS Men s Toilet Semi-Annual Services to be done in July Semi Annual Hoods Room Make Model ID Name (Room) IV Prep 1E023 Particle Count Room IV Prep IV Prep 1E021 Particle Count Ante Room Ante Room IV Prep Laminar Baker SG-400 IV Prep IV Prep Particle Count Baker SG-400 IV Prep IV Prep Microbial Air Plates 12 each IV Prep IV Prep Microbial Surface Plates 8 each IV Prep Oncology Hood Biohood Baker NCB-D4 Oncology Prep Particle Count Baker 1E022 Oncology Prep Particle Count Room 1E022 Oncology Prep Microbial Air Plates 12 each 1E022 Oncology Prep Microbial Surface Plates 8 each 1E022 Bio Hood 1D113 Nuaire NU-477-400 EE#77646 Lab Bio Hood 153E Appleton Lab Clean Storage room 150 Appleton ACH and Gradient Clean Storage HFB 12 1E024 VAV IV Prep HFB 13 1E024 VAV Chemo Prep HFB 14 1E031 VAV Ante room