Statement of Work Biosafety Cabinet Hood Certification.docx

STATEMENT OF WORK

Inspection & Certification of Biological Safety Cabinets, Laboratory Hoods & Pharmacy Clean/Ante Rooms, and Specialized Room Ventilation Systems Rocky Mountain Regional VA Medical Center Aurora, Colorado 80045

1. PURPOSE

1.1 This requirement is for procuring services for testing and certification of fume hoods, biological safety cabinets, specialized room ventilation systems, and laminar flow units to provide a safe environment for laboratory personnel within multiple areas of the medical center. Contractor shall test and certify laboratory hoods/cabinets, sterile processing areas, and pharmacy clean/ante rooms. Location includes Rocky Mountain Regional VA Medical Center (RMRVAMC), 1700 N. Wheeling Street, Aurora, Colorado, 80045.

2. SCOPE

2.1 Contractor shall furnish service as specified below to ensure that the equipment functions in accordance with:

2.1.1. ANSI-ASHRAE 110 (current version)

2.1.2. Testing and Certification for conformance with applicable standards in accordance with specified VA engineering design criteria (such as, but not limited to, ASHRAE, CDC (NIOSH), and OSHA) for the Hazardous Waste and Material Storage Areas and engineering control's adequacy for employee protection.

2.1.3. BSL 3 Commissioning in accordance with most current edition of "Biosafety in Microbiological and Biomedical Laboratories".

2.1.4. Ensure chemotherapy compounding labs are tested in accordance with most current Controlled Environment Testing Association (CETA) Standards

2.1.5. National Sanitation Foundation-Class II, (Laminar Flow) Biohazard Cabinetry-Standard Number 49 [NSF 49].

2.1.6. SAMA Standard LF10-1980 Laboratory Fume Hoods and USP 797/USP 800

2.1.7. USP General Chapter 800 Hazardous Drugs-Handling in Healthcare Settings 2017

2.1.8. CAG-002-2006

2.1.9. CAG-003-2006

2.1.10. CAG-007-2010

2.1.11. CAG-008-2010

2.1.12. IEST RP-CC-034

2.2 Furnish all labor, equipment, tools, materials, and travel necessary to test, certify and measure Government – owned biological safety cabinets, laminar flow units, hoods, pharmacy clean rooms and others as specified. Equipment and area details are provided below:

LABS

Dec

RESEARCH

2.3 Vendor to provide and changeout all filters for items listed above as required per manufacturer recommendations and end user preferences. Vendor is expected to have filters on hand for changing at each visit as needed. Starting within 3 months of award, vendor to change filters on Fume Absorber Cabinets in Laboratory area every 6 months due to odors.

2.4 The annual/semi-annual certifications shall be performed in sufficient time to ensure that none shall lapse. Contractor will submit a schedule that builds in time for repairs should that be necessary to ensure certifications never lapse. Contractor will work directly with POC to schedule all testing and certification based on areas and needs.

2.5 The Contractor shall provide certification reports upon completion of semi-annual and annual testing/certification. Report will include training/certifications of technicians performing the work and calibration certificates of the equipment used during the testing/certification.

2.6 Contractor will immediately notify POC in writing (letter) or by email, in the event any/all regulatory guidance governing the certifications of any subject equipment changes. Written advisement will include any issues which will impact testing/certification. Contractor will also advise Rocky Mountain Regional VA Medical Center of recommendations to resolve any issues related to the regulatory changes.

2.7 When testing/servicing/certifying equipment, the Contractor will provide on-site consultation to RMRVAMC VA staff (answer questions, make recommendations to maintain at optimum level) that use the Pharmacy cleanroom, the biosafety cabinets, and the laminar flow workstations. Technicians knowledgeable about certification requirements will converse with staff/POC to inform them of recommended adjustments to behaviors used in daily use, cleaning of area, maintenance of equipment, and any structural/HVAC/electrical/engineering issues related to the equipment or rooms encompassing equipment. Technicians will in-brief at each visit and provide an out-brief to POC if any issues/questions arise during inspection.

2.8 Contractor shall have the capability to respond within 24 hours of contact for emergency repair. Contractor shall furnish the POC with written estimate of cost to make necessary repairs and receive Contracting Officer (CO) approval prior to initiating repairs.

2.9 All the following information should be included in the report for clean room certification. Room number and/or location, Room type (e.g., oncology prep room), Date of testing, Date of next required certification, Standards used to test room, Room sketch, Total room area and volume, Room humidity and temperature, Air changes per hour, Pressure differential, non-viable particle counts, and viable particle count analysis. Pass/Fail notifications should be included on a per test basis where applicable.

3. CERTIFICATION AND TESTING REQUIREMENTS

3.1.3 Airflow smoke pattern test

3.1.11 A decal or label affixed to the cabinet in a visible location that indicates the results and date of the certification

3.2.6 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).

3.3 Pharmacy Testing and Certification: Testing and certification (under CAG-003-2006-11 and to USP 797 Pharmaceutical Compounding – Sterile Preparations and USP 800 Hazardous Drugs—Handling in Healthcare Settings Standards.) of the Pharmacy: Ante Room, Hazardous Buffer Room and Non-Hazardous Buffer Room as well as viable air and surface sampling for Fungus and bacteria will be semi-annually. Certification and testing shall consist of the following:

3.3.1 Test and validate the number of air changes per hour (ACPH) through the rooms Heating Ventilation and Air Conditioning (HVAC) equipment and Primary Engineering Control(s) (PECs).

3.3.3 Non-viable Particle Testing: The contractor shall perform environmental nonviable particle testing semiannually

3.3.4 Test and validate that the hood and room exhaust provide a unidirectional/laminar flow of air.

3.3.7 Take viable air samples for fungus and bacteria (1 location in each PEC: LFWs, BSC, Pass Thru, and 1 location in the room Ante, and 2 locations Chemo and IV Room. Colony forming units (CFU) results from the cultures shall be calculated in cfu per cubic meter (m3) of air.

3.3.8 Take viable surface samples for fungus and bacteria (1 each in laminar flow units, BSC, Pass Thru, Ante, Chemo and IV Room.

3.3.9 Specifics from VHA Directive 1108.12:

(2) Ensuring that PECs and SECs are installed and maintained in compliance with USP compounding chapters and VA design standards including third party testing and certification. NOTE: VA uses the CETA CAGs to define certification procedures for assessing if the Primary and Secondary Engineering Controls are operating as designed to maintain a sterile environment for the preparation of CSPs.

(3) Ensuring all vendors conducting primary and secondary engineering control certifications:

(a) Employ at least one CETA National Board Testing (CNBT) Registered Certified Professional (RCP) for Sterile Compounding Facility (SCF) individual on staff who will review and sign the final certification report.

(b) Have required CETA competencies and training related to the certification of primary and secondary engineering controls. NOTE: it is preferred that the on-site certification individuals have received NSF accreditation for the field certification of Class II Biosafety Cabinets and are accredited through CNBT as a registered certification professional in the sterile compounding facility (RCP-SCF).

“Certification procedures defined in applicable CETA Application Guides must be performed by a CETA National Board Testing (CNBT) Registered Certified Professional (RCP) for Sterile Compounding Facility (SCF) individual or a vendor that employs at least one of these individuals initially and no less than every 6 months. Areas additionally, must be recertified if there are any changes to the area such as redesign, construction, replacement or relocation of any PEC, or alteration in the configuration of the room that could affect airflow or air quality.”

“Contracts with CETA certified individuals or vendors must require that viable and non-viable testing results be provided to the Chief of Pharmacy Service and other designated VA medical facility staff (as indicated by the medical facility) no later than 2 weeks after the testing is performed. Certification must also include video of the airflow smoke pattern test documenting unidirectional flow at critical sites in the PEC.”

4. PERSONNEL ACCREDITATION REQUIREMENTS

4.1 Contractor services personnel must be NSF and CETA accredited and submit their NSF and CETA accreditation certificates with their bid proposal.

5. PERIOD OF PERFORMANCE AND WORK HOURS

5.1 The period of performance shall be for one base year and four one-year options periods.

5.2 The Contractor (or Representative) shall contact the POC to schedule work and prior to the beginning of work. Contractor to notify POC of upcoming test 5 business days in advance.

5.3 Services are to be performed during our business hours between 7:30 a.m. and 4:00 p.m. central time, excluding federal holidays. Because of the workload of the pharmacy during business hours, the contractor may need to work after 4:00 p.m. to accommodate the compounding schedule at the pharmacy. Contractors that are willing to perform after-hours work should include this information in their bid documentation. If a contractor is willing to perform services after 4:00 p.m. this service must be included within the bid pricing as no extra charge will be allowed. The ability to perform work after hours is not required; however, preference will be given to contractors that offer flexible work hours.

6. INSPECTION AND ACCEPTANCE

6.1 The Contractor shall conduct a joint inspection with the POC upon certification and testing of equipment.

7. DELIVERABLES

7.1 After work is completed, the contractor is to submit in writing, a complete report of services performed for each item of equipment and must include a listing of replacement parts, when applicable. Within one week of obtaining sampling results, the vendor will electronically report ventilation and sampling data semiannually to RMRVAMC Facilities Management has a means of evaluating the overall control of the compounding environment. The report should have guidance on interpreting results, possible contamination pathways and proper corrective actions to remediate contamination. All reports shall be provided to POC within 14 days of work being completed.

7.2 The contractor shall supply every unit that passes required certification specifications with a certification sticker.