STATEMENT OF WORK:
Fume Hood/Biosafety Cabinet/Isolation Room Testing, Certification, and Repair Service
The Department of Veterans Affairs, Veterans Integrated Service Network (VISN 2), New York Harbor Healthcare System anticipates the award of a Firm Fixed-Price service contract for chemical fume hood and biological safety cabinet decontamination, repair, testing, and certification; respiratory isolation room testing; pharmacy fume hood USP797 viable testing and certification; and pharmacy cleanroom certification. The contractor shall provide these services, inclusive of all labor, equipment, supplies, transportation, laboratory analyses and incidentals.
Projects will be assigned at:
- Brooklyn VA Medical Center, 800 Poly Place, Brooklyn, NY 11209
- Margaret Cochran Corbin (Manhattan) VA Medical Center, 423 East 23rd Street, New York, NY 10010
This is an emergency requirement that is required to commence immediately upon award. Awarded Contractor must coordinate with the facility POCs.
I. Requirements
The work to be performed under this Firm Fixed-Price service contract and in accordance with these contract documents includes furnishing all necessary labor, materials, and incidental related work described under the contract. The contractor must be a licensed scientific equipment product servicing contractor with documented capability to perform USP797 Viables Testing and Certification successfully and safely. The work will include:
- Fume hood and/or biosafety cabinet complete chlorine dioxide decontamination, replacement of HEPA filters, reassembly of fume hood and/or cabinet, and certification.
- Fume hoods and/or biological safety cabinets are to be tested in accordance with OSHA, AIHA/ANSI standards. Primary tests to be performed are inflow velocity profiling as per ANSI/AIHA Z9.5-2003 American National Standards for Laboratory Ventilation 6.3.3 Face Velocity Tests. The average face velocity shall be determined by the method described in the ANSI/ASHRAE 110-1995 Method of Testing Performance of Laboratory Fume Hoods. Face velocity measurements shall be made by dividing the hood opening into equal area grids with sides measuring no more than 12 in. (30.5 cm). The tip of the probe shall be positioned in the plane of the sash opening and fixed (not handheld) at the approximate center of each grid. Grid measurements around the perimeter of the hood opening shall be made at approximately 6 in. (15.2 cm) from the top, bottom, and sides of the opening enclosure. The average face velocity shall be the average of the grid velocity measurements. Each grid velocity shall be the average of at least 10 measurements made over at least 10 seconds. The plane of the sash shall be located at the midpoint of the sash frame depth. A hood that is found to be operating with an average face velocity more than 10% below the manufacturer’s designated average face velocity shall be labeled “OUT OF SERVICE” by the contractor and the COR shall be notified immediately.
- Testing of respiratory isolation rooms (including all anterooms associated with the isolation rooms). The locations of the isolation rooms are listed in the table shown in the Scope of Work. Testing must be performed in accordance with the following procedures:
- Routine pressure differential test between rooms: The pressure differential (door closed) between corridor and anteroom, and corridor and patient room should be checked using acceptable instrumentation as approved by COR. The reading and function of the permanently installed pressure monitors should also be checked and the results documented. If there appears to be a problem with the function of the permanent monitors, notify COR immediately. Report results in writing to COR, including pressure differential data and a clear determination of whether the rooms can be safely used.
- Perform the following additional tests as Unscheduled Maintenance as directed by the COR:
- HEPA filter pressure drop on exhaust side: HEPA filter pressure drop on the exhaust side of the ventilation system should be measured as directed by COR.
- Air exchange rate: The total air exchange rate shall be measured in the patient room as directed by the COR.
- Airflow direction between rooms and within-room airflow patterns: Perform airflow visualization testing as directed.
- Perform testing services and certifications in pharmacies at Manhattan VAMC to comply with the U.S. Pharmacopeia (USP) 797 and 800 standards. A technician certified by the Controlled Environment Testing Association (CETA) shall perform certification of the Compounding Aseptic and Containment Isolators (CACIs) and Biological Safety Cabinets (BSCs) listed in the table below, in accordance with the following standards and per manufacturer specifications:
- NSF / ANSI 49 (Biological Safety Cabinets)
- IEST-RP-CC034.3 (HEPA Filter Leak Testing)
- Dynamic smoke testing per USP 800 guidelines (see general notes)
- VHA Directive 1108.12, "Management and Monitoring of Pharmaceutical Compounded Sterile Preparations" issued in November 2018
The contractor must evaluate Containment Segregated Compounding Area (C-SCA); measure and document airflow volumes in the room; measure and document space pressurization in relationship to adjacent room(s); perform room calculations to determine air changes per hour in each room; perform and document by video smoke visualization study at doorway. Refer to USP standards for further requirements.
Perform Viable Environmental Sampling for microorganisms (Bacterial/Fungal counts with ID’s). All environmental testing to be performed by an accredited laboratory as approved by the COR: for each CACI, BSC and C-SCA area, collect and analyze the following: one (1) air bacterial, one (1) air fungal, one (1) surface bacterial and one (1) surface fungal.
Conduct Dynamic smoke testing in Containment Primary Engineering Control (C-PEC) Equipment to include smoke testing within the equipment while pharmacy personnel simulate processes within the equipment. Smoke testing shall be documented by recording a video.
Provide a comprehensive certification report containing summary of results, measured/calculated data, and recommendations.
II. Scope of Work
Table 1: Chemical (Non-Pharmacy) Fume Hood/Biological Safety Cabinet Decontamination, Repair, Testing, and Certification
Equipment
Campus / Location
Job Description
Quantity
ThermoFisher, Model # 1375, Serial # 300308858
Manhattan / 18th Floor, North Wing
- Perform complete chlorine dioxide decontamination on BSC, replace supply HEPA filter, replace exhaust HEPA filter, reassemble cabinet.
1
Table 2: Pharmacy Fume Hood/Biological Safety Cabinet USP797 Viables Testing and Certification
Equipment
Campus / Location
Job Description
Quantity
Baker, Model # SS500, Serial # 122603
Manhattan / Rm. 1141A North
- USP797-Viable Testing
- Certification
1
Baker, Model # SS500, Serial # 139067
Brooklyn / 12th Floor Pharmacy
- USP797-Viable Testing
- Certification
1
Germfree LFGI-4USP, Serial # 4S-15-LGU-20718
Manhattan / Bldg. 1, 12091S
1
Germfree LFGI-4USP, Serial # 4S-15-LGU-20719
Manhattan / Bldg. 1, 12091S
1
Germfree LFGI-4USP, Serial # 4S-15-LGU-20720
Manhattan / Bldg. 1, 12091S
1
Cleanroom in 12091S
Manhattan / Bldg. 1, 12091S
1
Germfree LFGI-4USP, Serial # 4S-15-LGU1-20387
Brooklyn / 8th Floor East
1
Germfree LFGI-4USP, Serial # 4S-15-LGU1-20388
Brooklyn / 8th Floor East
1
Germfree LFGI-4USP, Serial # 4S-15-LGU1-20389
Brooklyn / 8th Floor East
1
Cleanroom on 8th Floor East (Chemo Pharmacy)
Brooklyn / 8th Floor East
1
Table 3: Brooklyn VAMC Respiratory Isolation Room Testing
Room No.
Use
Job Description
Quantity
13-304W
Negative
- Pressure differential test
1
13-305W
Negative
- Pressure differential test
1
12-307W
Negative
- Pressure differential test
1
12-308W
Negative
- Pressure differential test
1
11-225E (ICU #9)
Negative
- Pressure differential test
1
11-227E (ICU #10)
Negative
- Pressure differential test
1
11-228E (ICU #11)
Positive
- Pressure differential test
1
11-302W
Negative
- Pressure differential test
1
11-303W
Negative
- Pressure differential test
1
8-302W
Negative
- Pressure differential test
1
8-303W
Negative
- Pressure differential test
1
6-312W (Dialysis)
Negative
- Pressure differential test
1
4-301W (GI)
Negative
- Pressure differential test
1
G-512 (ER)
Negative
- Pressure differential test
1
G-513 (ER)
Negative
- Pressure differential test
1
Table 4: Manhattan VAMC Respiratory Isolation Room Testing
Room No.
Job Description
Quantity
Room 1550 (Emergency Department)
Negative
- Pressure differential test
1
Room 4034W (Bed 7)
Negative
- Pressure differential test
1
Room 4063-1S
Negative
- Pressure differential test
1
Room 4073-1S
Negative
- Pressure differential test
1
Room 4553 (SICU Bed 10)
Negative
- Pressure differential test
1
Room 4555 (SICU Bed 11)
Negative
- Pressure differential test
1
Room 4557 (SICU Bed 12)
Negative
- Pressure differential test
1
Room 5117N (Hemodialysis Bed 10)
Negative
- Pressure differential test
1
Room 6574C (Procedure Room)
Positive
- Pressure differential test
1
Room 6594C (Interventional Radiology)
Positive
- Pressure differential test
1
Room 10137N (Bed 14)
Negative
- Pressure differential test
1
Room 10142N (Bed 13)
Negative
- Pressure differential test
1
Room 11019W (CCU/MICU Bed 14)
Negative
- Pressure differential test
1
Room 11024W (CCU/MICU Bed 12)
Negative
- Pressure differential test
1
Room 11031W (CCU/MICU Bed 11)
Negative
- Pressure differential test
1
Room 11118N
Negative
- Pressure differential test
1
Room 11119N
Negative
- Pressure differential test
1
Room 11140N
Negative
- Pressure differential test
1
Room 13072S
Negative
- Pressure differential test
1
Room 13074S
Negative
- Pressure differential test
1
Room 13081S
Negative
- Pressure differential test
1
Room 13139N (Bed 15)
Negative
- Pressure differential test
1
Room 13141N (Bed 14)
Negative
- Pressure differential test
1
Room 13143N (Bed 13)
Negative
- Pressure differential test
1
Room 13145N (Bed 12)
Negative
- Pressure differential test
1
Room 13148N (Bed 11)
Negative
- Pressure differential test
1
Room 13157N (Bed 2)
Negative
- Pressure differential test
1
Room 13163N (Bed 1)
Negative
- Pressure differential test
1
