Biological Safety Cabinets/Lab Hoods Inspect/Test Base Plus Four Opt Years VA Medical Center Oklahoma City OK 73104
Inspection & Certification of Biological Safety Cabinets,
Laboratory Hoods & Pharmacy Clean/Aute Rooms and
Specialized Room Ventilation Systems
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma
BRIEF SCOPE OF WORK
(This is for information only)
PURPOSE
This requirement is for procuring services for testing and certification of specialized room ventilation systems, chemical hoods, Laminar Flow Workstations (LFWs) and Biological Safety Cabinets (BSCs) to provide a safe environment for laboratory personnel at multiple locations. Contractor shall test and certify laboratory equipment, sterile processing areas, and pharmacy clean/ante rooms. Location includes: Oklahoma City VA Medical Center, 921 NE 13th St., Oklahoma City, Oklahoma 73104.
SCOPE
Contractor shall furnish service as specified below 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 and USP 797
USP General Chapter Hazardous Drugs-Handling in Healthcare Settings 2017
CAG-002-2006
CAG-003-2006
CAG-007-2010
CAG-008-2010
IEST RP-CC-034
CETA Compounding Testing Guide 2006
FDA Insanitary conditions for Compounding
CETA Viable Sampling SOP
CETA Certification Guide May 2015
Furnish all labor, equipment, tools, materials, and travel necessary to test, certify and measure Government owned Biological Safety Cabinets (BSCs), Laminar Flow Work Stations (LFWs), and Pharmacy clean rooms.
Equipment and locations are identified on the Schedule of Items.
The annual/semi-annual certifications shall be performed in sufficient time to ensure that none shall lapse (contractor will schedule testing that builds in time for repairs should that be necessary to insure certifications never lapse). With two lab hoods in Chemo and two hoods in IV mixing areas. Lab hoods are to be staggered for certification with two hoods certified in the months of December/June and the other two hoods certified during the months of March and September each year. Research provides backup bariatric hoods for mixing chemo and IV s and these hoods are certified during the months of March/September.
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.
Contractor will immediately notify COR 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 Oklahoma City VA Medical Center of recommendations to resolve any issues related to the regulatory changes.
When testing/servicing/certifying equipment, the Contractor will provide on-site consultation to Oklahoma City 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/COR 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 brief COR of any issues/questions raised by staff upon checking out post-certification.
Contractor shall have the capability to respond within 24 hours of contact for emergency repair. Contractor shall furnish the Contracting Officer Representative (COR) with written estimate of cost to make necessary repairs and receive COR approval prior to initiating repairs.
All of 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. Biological Safety Cabinets (BSC): The Pharmacy biosafety cabinet shall be certified semi-annually. All other Biosafety cabinets will be certified annually. Certification shall consist of the following:
Down flow velocity test
Inflow velocity test
Airflow smoke pattern test (videotaping must be included for Pharmacy hoods only)
HEPA filter leak test
Alarm function test
Blower interlock test (Class II, type B cabinets)
Electrical leakage on the main cabinet (those that aren t 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.
3.2 Laminar Airflow Workstations (LAFW): All LAFWs will be certified annually. 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.
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 on lab fume hoods that fail certification.
Notifying the lab fume hood user and the COR of lab fume hoods that fail certification.
3.3 Pharmacy Cleanroom(s) Testing and Certification:
Testing and certification (under CAG-003-2006-11 and to USP797 Standards and 800 Hazardous Drugs Handling in Healthcare Settings.) of the Pharmacy: Ante Room, Hazardous Buffer (IV) Room and Non-Hazardous Buffer (Chemo) Room as well as viable air and surface sampling for mold and bacteria will be semi-annually. Certification and testing shall consist of the following:
Test and validate the number of air changes per hour (ACH) through the rooms Heating Ventilation and Air Conditioning (HVAC) equipment and exhaust hood.
Pressure Requirements: The contractor shall include in their report differential pressure reading from each buffer/ante room to all surrounding areas
Non-viable Particle Testing: The contractor shall perform environmental nonviable particle testing semiannually
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).
Take viable air samples for mold 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.
Take viable surface samples for bacteria (1 each in LFWs, BSC, Pass Thru, Ante, Chemo and IV Room.
4. PERSONNEL ACCREDITATION REQUIREMENTS
4.1 Contractor services personnel must be NSF accredited and submit their NSF accreditation certificates with their
bid proposal.
4.2 Technician performing on-site testing for Pharmacy must be CETA certified.
5. PERIOD OF PERFORMANCE AND WORK HOURS
5.1 The period of performance shall be for one base year with four possible one-year option periods (as outlined with the schedule / line items).
5.2 The Contractor (or Representative) shall contact the COR, Contracting Officer s Representative, to schedule work and prior to the beginning of work.
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. in order 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. DELIVERY
6.1 No delivery of items
7. INSPECTION AND ACCEPTANCE:
7.1 The Contractor shall conduct a joint inspection with the COR upon certification and testing of equipment.
8. DELIVERABLES
8.1 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 Oklahoma City VA Medical Center Safety 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.
8.2 The contractor shall supply every unit that passes required certification specifications with a certification sticker.
9. TRAINING
9.1 No training is required from the contractor.
10. Transportation Visits = 6 visits a year (4 required and 2 additional trips for troubleshooting/retesting etc.)
11. WARRANTY:
11.1 NA
12. Facility Information Security Officer (FISO) SECURITY LANGUAGE:
12.1 GENERAL
Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.
12.2 SECURITY CLAUSE:
Authorization and Assessment (A&A) and/or Security Package is not required.
13. See below spreadsheet for Testing and Certification Descriptions:
ITEM#
DESCRIPTION/PART # (BASE YEAR)
LOCATION
MFG/MODEL
Serial #
QUANTITY OF CERTIFICATION
NUMBER OF HOODS
STANDARD
1
BIOSAFETY CABINET (MICROBIOLOGY LAB)
4F115
NUAIRE Labgard ES
159780102513
ANNUAL *
1
NSF49/MFG RECOMMENDATIONS
2
BIOSAFETY CABINET (BSL3 LAB)
4F115-C1
NUAIRE Labgard ES
ANNUAL *
1
NSF49/MFG RECOMMENDATIONS
3
BIOSAFETY CABINET (CYTOLOGY)
4F133
NUAIRE Labgard ES
159781102513
ANNUAL *
1
NSF49/MFG RECOMMENDATIONS
4
BIOSAFETY CABINET (MOLECULAR)
4F137
NUAIRE Labgard ES
159779102513
ANNUAL *
1
NSF49/MFG RECOMMENDATIONS
5
BIOSAFETY CABINET (LAB)
4F105
NUAIRE Labgard ES
164095070314
ANNUAL *
1
NSF49/MFG RECOMMENDATIONS
6
PHARMACY CHEMO (COMPOUNDING) AND ROOM
GA142A1
Laminar Air Flow/Baker Edgard
120719/91623
SEMI-ANNUAL *
2
NSF49/USP797-USP800
7
PHARMACY IV HOODS AND ROOM
GA142B1
Baker SterilchemGard III Advance
92560/92561
SEMI-ANNUAL*
2
NSF49/USP797-USP800
8
PHARMACY IV ANTEROOM
GA142A
N/A
N/A
SEMI-ANNUAL*
1
USP 797/USP800
9
PHARMACY CHEMO ANTEROOM
GA142B
N/A
N/A
SEMI-ANNUAL*
1
USP 797/USP800
10
RESEARCH PHARMACY CHEMO/IV HOODS
GR-102
Baker chemoshield
118544
SEMI-ANNUAL*
2
CAG-002-2006, USP & MFG RECOMMENDATIONS
11
RESEARCH PHARMACY CHEMO/IV HOODS ROOM
GR-102
Baker chemoshield
118545
SEMI-ANNUAL*
1
CAG-002-2006, USP & MFG RECOMMENDATIONS
12
SPUTUM INDUCTION CHAMBER
5F-130
AEROMED SPUTUM INDUCTION BOOTH
18099
ANNUAL*
1
MFG RECOMMENDATIONS
13
ISOLATION ROOM (HEPA)
5F-116
FILTER
N/A
ANNUAL*
1
IEST RP-CC-034
14
ISOLATION ROOM (HEPA)
5F-144
FILTER
N/A
ANNUAL*
1
IEST RP-CC-034
15
ISOLATION ROOM (HEPA)
BF-132/133
FILTER
N/A
ANNUAL*
1
IEST RP-CC-034
* 2.1 Contractor shall furnish service as specified below 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 and USP 797
USP General Chapter Hazardous Drugs-Handling in Healthcare Settings 2017
14. Pharmacy IV Room Agar Plate Sample Log: sample collection (30 samples) for the following areas in Pharmacy on a Semi-annual basis.
Additional 5 samples for re-testing for any positive test results.
Pharmacy (119) IV Room Agar Plate Sample Log
Attn: Matt Clark Date/Time: ______________
Sample
Date Prepared
Date of Results
Negative for Growth
Positive for Growth
CFU per Plate
Comments
Agar Contact Plates
ISO-5 Environment
IV Hood #1 (left)
IV Hood #1 (right)
IV Hood #2 (left)
IV Hood #2 (right)
IV Hood #3 (Chemo) (left)
IV Hood #3 (Chemo) (right)
IV Hood #4 (Chemo) (left)
IV Hood #4 (Chemo) (right)
Chemo Barrier Isolator (left)
Chemo Barrier Isolator (right)
Non-Hazardous Barrier Isolator (left)
Non-Hazardous Barrier Isolator (right)
ISO-7 Environment
IV room Counter-top
IV room clean-cart
IV room Storage cart
IV room Supply cart
IV room floor
IV room wall
Chemo room counter-top
Chemo room supply cart
Chemo room chemo storage cart
Chemo room floor
Chemo room wall
Chemo ante-room cart
Chemo ante-room supply cart
Chemo ante-room wall
Chemo ante-room floor
ISO-8 Environment
IV Ante-room cart
IV Ante-room wall
IV Ante-room floor
Location of performance
VA Medical Center
921 NE 13th St
Oklahoma City, OK 74103
IMPORTANTR NOTE: This RFI (Request for Information) is for information only; no award will be made from this RFI.
Please communicate via e-mail to Lance.Davis2@va.gov by COB November 6, 2018 as to your company s ability to perform service per this brief Scope of Work.
If interested please provide the following:
Please state your company s business size
Please provide DUNS number
If you have a FSS/GSA contract that includes this service
Provide FSS/GSA contract number if applicable
Lance Davis
Lance.Davis2@va.gov
Lance.Davis2@va.gov
