L065--"NEW REQUIREMENT" V5 Pharmacy Sterile Clean Certification

Page 16 of 16

RFI SOURCES SOUGHT

DISCLAIMER: This Sources Sought is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this Sources Sought. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Sources Sought. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the Sources Sought will not be returned. At this time, questions concerning the composition and requirements for a future Request for Quote will not be entertained. The Department of Veterans Affairs is conducting market research in order to provide Testing and Certifications VISN 5. The Government anticipates awarding a Firm Fixed Price type contract that will provide the Testing and Certifications listed within the below Draft Statement of Work.

OBJECTIVE: See Draft SOW.

RESPONSE INSTRUCTIONS:

Name and Address of Company

Any small business designation as certified by the Small Business Administration

A through description of experience in managing support requirements of this nature.

CONTACT INFORMATION: Any questions related to this Sources Sought shall be directed to Mark Smith at Mark.Smith25@va.gov. All information regarding Capabilities Statements or any other proprietary information relative to this Sources Sought shall be submitted via email to Mark.Smith25@va.gov no later than 3:00 PM EST on 05/17/2023.

DESCRIPTION / SPECIFICATION / WORK STATEMENT

STATEMENT OF WORK PART A GENERAL INFORMATION

A.1 INTRODUCTION: This requirement is for testing and certification of all the VISN 5 facility s primary engineering controls (PECs), and sterile clean rooms used for preparation of Compounded Sterile Preparations (CSPs). PECs include biological safety cabinets (BSCs), laminar airflow workstations (LAFWs) hoods, compounding aseptic containment isolators (CACI), and compounding aseptic isolators (CAI). Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter 2022 (or most recent) guidelines and Controlled Environment Testing Association (CETA) Certification Guide for Sterile Compounding Facilities for USP Compliance (CAG-003).

A.2 BACKGROUND: VISN 5 is pursuing VISN-wide contract for standardizing testing criteria appropriate for all PECs used pursuant to USP Chapter and Chapter standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals/companies to establish consistent PEC certification procedures using the CETA Certification Guide for Sterile Compounding Facilities for USP Compliance (CAG-003) 2022 (or current) version).

The USP establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care, effective January 13, 2018, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities under the FD&C Act and applying the Insanitary Conditions at Compounding Facilities Guidance for Industry, November 2020 (or current version).

Certification procedures defined in CETA CAG including, but not limited to, 003 (CETA Certification Guide for Sterile Compounding Facilities for USP Compliance), 014 (Airflow Visualization Study), and 009 (Viable Environmental Monitoring for Sterile Compounding Facilities) shall be performed by a CETA National Board of Testing (CNBT) certified testing individual/company no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

A.3 SCOPE OF WORK:

A.3.1 NSF 49 Field Testing Requirements for Biological Safety Cabinets

The contractor shall certify all Class II biosafety cabinets to the current version of NSF/ANSI 49-2020 (or higher) specifications as well as CETA CAG 003. All equipment used to certify biological safety cabinets shall have ISO/IEC 17025 accredited calibration certification. Any unit that fails to meet specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified point(s) of contact (POC) as soon as practicable.

For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

Company name and address

Unit make, model and serial number

Report number

Location (room number)

Certification date

Recertification date

Technician signature

A.3.2 Fume Hood/Testing and Certification

The contractor shall test and certify each fume hood to the manufacturer s specifications. Tests shall include: face velocity test, airflow smoke pattern test and low flow alarm test. In the event that the fume hood has an air flow monitor (AFM) or controller (AFC), the contractor shall confirm the unit is calibrated and operating within +/-10% of actual velocity. If it is not calibrated appropriately the contractor shall calibrate the AFM or AFC. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to calculate the face velocity. The contractor shall report each individual face velocity reading and the average of those readings, a pass/fail grade for the airflow smoke pattern test and a pass/fail grade for the low flow alarm test. Any failures shall be reported directly to the POC(s) as soon as practicable.

For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

Company name and address

Certification date

Recertification date

Average face velocity

Sash height (only for fume hoods)

Technician name and signature

A.3.3 PEC Testing and Certification

The contractor shall test and certify each PEC to the most current version of The Institute of Environmental Sciences (IEST) RP CC002 (Unidirectional-flow, clean-air devices), CETA CAG -003, and to the manufacturer s specifications. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to perform all testing. The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and backstreaming test. Any failures shall be reported directly to the identified site point of contact(s) as soon as practicable.

Horizontal laminar flow cabinets shall be certified according to IEST RP-CC-002 Testing Laminar Air Flow Devices and in accordance with CETA CAG -003. All annual and semi-annual on-site certifications for Biological Safety Cabinets (BSCs) must be accomplished in accordance with the most current National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II (laminar flow) Biosafety Cabinetry. The list of tests includes, but is not limited to:

HEPA filter leak test

Cabinet leak test

Inflow velocity test to include exhaust airflow volume rate

Airflow Smoke pattern test

Electrical leakage and ground circuit resistance and polarity tests

Lighting intensity test

Vibration test

Noise level test

Ultraviolet (UV) lamp test

Laminar Flow Hoods certifications must be accomplished in accordance with the most current version of the National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II Biosafety Cabinetry, Annex F, test method A-D, 1992 or most current issue.

Fume hoods certifications must be accomplished in accordance with the most current version of the ANSI/ASHRAE 110-2016.

For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

Company name and address

Unit make, model and serial number

Report number

Location (room number)

Certification date

Recertification date

Technician name and signature

A.3.4 Viable and Non-viable Particle Counts

For the PECs, viable and non-viable particle counts samples will be collected. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP . Refer to the description of these tests in the section A.3.5.3 and A.3.5.4 for details.

A.3.5 USP Testing for Pharmacy Clean Rooms

The contractor will provide comprehensive cleanroom testing and certification services every 6 months for required semi-annual certifications to include:

HEPA filter integrity testing

Airflow testing: Airflow testing is performed to determine acceptability of the air velocity, the room air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions.

Total particle count testing

Room pressurization monitoring

Temperature and Humidity monitoring

Air pattern analysis

Microbiological air and surface monitoring

Dynamic airflow smoke pattern test for each PEC (contractor to leave video of smoke test on site prior to completion of certification process).

Written Report

Based upon findings noted in semi-annual certifications, or as necessary after an environmental excursion or physical change to the spaces or PECs occurs, additional applicable re-certification tests will be completed to reassess applicable areas and are included within this contract.

A.3.5.1 Air Changes per Hour

The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hour (ACPH) for each buffer and ante room and include their findings in the report. Comparison of ACPH will be completed both for USP standards as well as those referenced VHA HVAC Design Manual, which are more stringent than USP .

In the event that a room does not meet USP or VHA HVAC Design Manual requirements for ACPH the identified site POC(s) shall be informed immediately.

A.3.5.2 Pressure Requirements

The contractor shall include in their report differential pressure readings from each buffer/ante room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP. All readings and acceptance criteria shall be documented to at least one thousandths of an inch water column (e.g., 0.020 w.g. and not 0.02 w.g.) or one tenth of a pascal (e.g., 2.5 Pa). Pressure differentials will be reflected on a report showing the sketch of the room(s).

A.3.5.3 Viable Environmental Sampling

The contractor shall perform viable environmental (air and surface) sampling every 3 months for fungi and bacteria using high volume impaction samplers to conduct the sampling. While it is acceptable per USP standards to utilize Tryptic Soy Agar (TSA) media for bacteria, and another media specific to fungal VISN 5 requires all air samples to utilize TSA media which supports growth of both bacteria and fungi.

Air sampling: A sufficient volume of air (1000 liters) shall be tested at each location to maximize sensitivity. Samples of less than 1000 liters will not be acceptable.

Surface Sampling: Surface samples will be collected in each room, the interior of each ISO Class 5 PEC, pass through chambers connecting to classified areas, and frequently touched surfaces. Surface sampling will be performed at the end of the largest CSP batch of the day.

Any laboratory results equal to or greater than the action level will require notification of the POC(s) immediately upon receipt of results.

Reports to include at a minimum:

Date and time sampling was taken.

All Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the species grown to the genus level.

Medial lots used for samples

Comments indicating when dynamic conditions were used

Certificates of analysis of media used

Sketch identifying location of each sample obtained

A.3.5.4 Monthly Surface Sampling, Personnel Competency Assessment, and Gloved Fingertip (GFT) and Media Fill Test (MFT)

Monthly Surface Sampling:

For those months without a scheduled semi-annual certification or quarterly environmental sampling collection, the contractor shall collect surface samples for the assessment of ongoing compliance.

Surface samples will be taken from each of the following classified areas:

Class 5 PEC

Pass through chambers connecting to classified areas.

Equipment contained within PEC

Staging or work area(s) near the PEC

Frequently touched surfaces

Surface sample locations and quantity will be reviewed with and verified by local points of contact for each location by contractor.

Surface samples will be collected, sent through the same laboratory used for viable environmental sampling, incubated with appropriate temperature and storage time, and analyzed all in accordance with 2022 USP (or more recent) requirements.

Personnel Competency Assessment

Contractor shall offer service to complete and document assessment of competency of compounding personnel including gowning/garbing observation, GFT and MFT, and post-test surface sample. Facilities will have the option to utilize contractor to complete competency assessment during scheduled monthly contractor onsite visits. If facilities elect to utilize this service, they will clearly communicate with the contractor at the time of visit scheduling of this need, as well as the number of staff requiring competency assessment.

Gloved Fingertip (GFT) and Media Fill Test (MFT)

If facility elects for contractor to complete competency assessment, contractor will include materials and assessment of GFT/MFT results in accordance with 2022 USP (or more recent) requirements.

If facility elects to complete competency assessment internally, facility will capture GFT/MFT samples. Facility collected samples will be sent through contractor to same laboratory used for environmental sampling for consistency. Contractor and laboratory will ensure incubation temperatures, and storage times comply with 2022 USP (or more recent) requirements:

Report:

Through either contractor or facility captured GFT/MFT, contractor will utilize the same laboratory used for viable environmental sampling to incubate and analyze samples.

results will be reported as number of cfu per hand with notation of whether cfu action level is exceeded through reporting total number of cfu from both hands.

Competency assessment and documentation will be in accordance with 2022 USP (or more recent) requirements.

A.3.5.5 Environmental Wipe Sampling for Hazardous Drug Residue

The contractor will perform environmental wipe sampling for hazardous drug surface residue semiannually (e.g., every 6 months), or more frequently as needed to verify containment. The kits used to complete wipe sampling must be verified prior to use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs.

The drugs required for testing include:

Cyclophosphamide

Ifosfamide

Methotrexate

Fluorouracil

Platinum-containing drugs

Additional Drugs

Additional drugs may be requested based upon identified need per site.

Upon identified need, the applicable site will work directly with the contractor where additional cost will be clarified and agreed upon by both parties prior to testing.

A minimum of 6 surface samples will be completed per certification. Facilities can elect to work with contractor to expand beyond the minimum as they see fit but will be coordinated and communicated with contractor prior to certification visit. Surface sampling will include the following minimum areas:

Interior of PEC and equipment contained in it.

Pass-through chambers

Surfaces in staging or work areas near PEC

Areas adjacent to PECs (e.g., floors directly under C-PEC, staging, and dispensing area)

Areas immediately outside the hazardous drug buffer room or C-SCA

Patient administration areas

A.3.5.6 Nonviable Particle Testing

The contractor shall perform environmental nonviable particle testing semiannually (e.g., every 6 months). The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

ISO Class 5: not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any area primary engineering control (BSC or LAFW).

ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per cubic meter of air for any buffer area or hazardous compounding ante room.

ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any non-hazardous compounding ante room.

A.3.5.7 HEPA Filter Replacement and Minor Repairs

The contractor shall complete any identified HEPA filter replacement during certification visit in instances where a need is identified, and replacement is available on site. If HEPA filter changes must be postponed until a filter can be supplied, the contractor will install the new HEPA filter and conduct leak testing at an agreed upon time with the facility.

The contractor shall complete additional minor repairs associated with clean room certification and operations that are identified during certification visit, and within contractor ability to resolve which may include, but are not limited to:

PEC Chemo Decontamination

LAFW filter or blower replacement

BSC filter or blower replacement

Repairs may include parts if agreed upon by facility prior to installation.

A.3.5.8 Report Requirements

All of the following information should be included in the report for clean room certification. Pass/Fail notifications (in addition to actual findings) should be included on a per-test basis where applicable.

Executive summary or summary of findings

Recommendations to resolve any identified discrepancies

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

Notes

Room sketch (location of supply/exhaust diffusers, equipment, room dimensions)

Total room area and volume

Humidity and Temperature of each room assessed for certification

Air changes per hour with assessment based both from USP standards as well as those referenced within the VHA HVAC Design Manual

Pressure differential

Particle Count Tests

Nonviable particle counts

Viable particle count analysis

Picture of viable particle test location in room

Number of personnel present in each PEC and SEC during total particle-count tests

Environmental viable sample results

Environmental Wipe Sampling for Hazardous Drug Residue results

Dynamic Airflow Smoke-Pattern Test Results

Smoke test video (either embedded in report, or a link to the video)

Number of personnel present in each PEC and SEC

Confirm/distinguish dynamic and static conditions if applicable

Note: All PECs shall follow report requirements for a non-USP units but shall include viable and nonviable particle sampling.

A.3.5.9 Report Distribution

The contractor will immediately notify identified points of contact with any results indicating failure. A formalized written report including all required aspects specified in this Statement of Work will be provided in a timely manner with receipt by identified points of contact no more than 14 days from certification evaluation.

All completed reports will be provided via email tovisn5cspadvisorycommittee@va.gov. In addition, facility specific reports will be provided to the following points of contact:

Baltimore VAMC:

Christopher Maltese (Christopher.Maltese@va.gov)

Shawnol Jemison (Shawnol.Jemison@va.gov)

Eugene DeLara (Eugene.DeLara@va.gov)

Ron Lilly (Ronald.Lilly@va.gov)

Robert Johnson (Robert.Johnson5@va.gov)

Bill Mytsak (Vasyl.Mytsak@va.gov)

Perry Point VAMC:

Christopher Maltese (Christopher.Maltese@va.gov)

Eugene DeLara (Eugene.DeLara@va.gov)

Ifeanyi Anadu (Ifeanyi.Anadu@va.gov)

Robert Johnson (Robert.Johnson5@va.gov)

Bill Mytsak (Vasyl.Mytsak@va.gov)

Loch Raven VAMC:

Christopher Maltese (Christopher.Maltese@va.gov)

Eugene DeLara (Eugene.DeLara@va.gov)

Frederick Soetje (Frederick.Soetje@va.gov)

Robert Johnson (Robert.Johnson5@va.gov)

Beckley VAMC:

Jack Wright (Jack.Wright2@va.gov)

Brianne Fairchild (Brianne.Fairchild@va.gov)

Austin Lilly (Austin.Lilly@va.gov)

Lawrence Woods (Lawrence.Woods@va.gov)

Justin Greene (justin.greene@va.gov)

John Montgomery (John.Montgomery3@va.gov)

Louis A. Johnson (Clarksburg) VAMC:

Carissa Bartlett (Carissa.Bartlett@va.gov)

Angela Dawkins (Angela.Dawkins@va.gov)

Barbie Covelli (Barbara.Covelli@va.gov)

Dan Young (Daniel.Young@va.gov)

Amy Gay (Amy.Gay@va.gov)

Alyssa Green (Alyssa.Green@va.gov)

Huntington VAMC:

Joey Nash (William.Nash4@va.gov)

Chris Waugh (Chris.Waugh@va.gov)

Charles Alex Noble (Charles.Noble@va.gov)

Dan Nicholson (Daniel.Nicholson@va.gov)

Eli Gillespie (Eli.Gillispie@va.gov)

Jamie Farley (Jamie.Farley@va.gov)

John Klim (John.Klim2@va.gov)

Martinsburg VAMC:

David Everhart (David.Everhart@va.gov)

Denise Canby (Denise.Canby@va.gov)

Sarah Mickanis (Sarah.Mickanis@va.gov)

Krista Bowen (Krista.Bowen@va.gov)

Jeff Miller (Jeffrey.Miller6@va.gov)

Andrew Faust (Andrew.Faust@va.gov)

Washington DC VAMC:

Isaac Buabeng (Isaac.Buabeng@va.gov)

Ivan Cephas (Ivan.Cephas@va.gov)

Mitiku Berhanu (Mitiku.Berhanu@va.gov)

Berook Addisu (Berook.Addisu@va.gov)

William T. Hagen (William.Hagen@va.gov)

Contractor will be notified by facility of any updates to identified points of contact list on an as needed basis.

Within the first 10 calendar days of each quarter, the contractor will provide via email to visn5cspadvisorycommittee@va.gov a schedule of pending visits for the quarter per site including scheduled dates and planned tests (i.e. semi-annual certification, re-certification, viable sampling, etc.)

Testing Frequency:

Certification procedures defined in CETA CAG-003 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual/company no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

Environmental sampling (air and surface) will be completed quarterly (every 3 months), or more frequently if required to assess corrective actions associated with prior negative results. Government captured surface samples will be completed each month between contractor captured results.

Recertification procedures may be required in between scheduled semi-annual certifications based upon certification findings which may include any applicable certification test or environmental sampling. Recertification visits will be scheduled and completed within 2 weeks of request from the facility.

Environmental wipe sampling for hazardous drug residue will be performed every 6 months, or more frequently if required to verify containment.

STATEMENT OF WORK PART C SUPPORTING INFORMATION

C.1 Place of Performance:

Facility Name

Address

Baltimore VAMC

10 North Greene Street, Baltimore, MD 21201

Perry Point VAMC

VA Medical Center, Perry Point, MD 21902

Loch Raven VAMC

3900 Loch Raven Blvd, Baltimore, MD 21218

Beckley VAMC

200 Veterans Avenue, Beckley, WV 25801

Louis A. Johnson (Clarksburg) VAMC

1 Medical Center Drive, Clarksburg, WV 26301

Hershel Woody Williams (Huntington) VAMC

1540 Spring Valley Dr., Huntington, WV 25704

Martinsburg VAMC

510 Butler Avenue, Martinsburg, WV 25405

Washington DC VAMC

50 Irving St. NW Washington DC 20422

Specific PEC and Clean Room Information Per Site:

Baltimore VAMC:

Hood

Baltimore VAMC

1

2

3

Physical Location (Building #)

BA121K

BA121KÂ

BA121LÂ

Manufacturer

BakerÂ

 NuAire

 Baker

Model Number

 EG-6252

 NU-407-400

 SG400

Serial Number

 90751

68736ADUÂ

 60541

Make

 LFU

 Class II Type A/B3

 Class II Type A/B3Â

EE#

 EE81086

EE41397Â

EE46875Â

Clean Rooms:

Cleanroom Suite:

Anteroom (ISO 7)

Non-Hazardous IV Prep (Buffer) Room (ISO 7)

Hazardous IV Prep (Buffer) Room (ISO 7)

HEPA Filter Information:

Quantity:

8 Total HEPA Filters (7 Supply and 1 exhaust)

Location(s)

7 Ceiling Supply Diffusers

1 Above Ceiling not in interstitial space

Test Port Status:

installed by Winergy circa 2018/2019 and are functional.

Perry Point VAMC:

Hood

New hood purchased and enroute to site

Perry Point VAMC

CAI

Physical Location (Building 361)

GC108B

Manufacturer

Baker

Model Number

SS500

Serial Number

Unknown currently

Make

Class 5 CAI

EE#

Not onsite yet

Clean Rooms:

Segregated Compounding Area CAI certification only.

HEPA Filter Information:

Quantity:

N/A - SCA

Location(s)

N/A - SCA

Test Port Status:

N/A - SCA

Loch Raven VAMC: (under construction with completion tentative for April 2023)

Hood

Hood

Loch Raven VAMC

CAI

CACI

Physical Location (Loch Raven Campus)

TBD

TBD

Manufacturer

Baker

Baker

Model Number

SS500

CS600

Serial Number

TBD

TBD

Make

class 5 CAI

Class 5 CAI

EE#

Not onsite yet

Not onsite yet

Clean Rooms:

Segregated Compounding Area CAI certification only.

Containment Segregated Compounding Area CACI certification only.

HEPA Filter Information:

Quantity:

N/A - SCA

Location(s)

N/A - SCA

Test Port Status:

N/A - SCA

Beckley VAMC

Hood

Beckley VAMC

IVPB

CHEMO

LAFW

BSC

Cleanroom Pass Through

Physical Location (Building #)

1AB-108B-B

1AB-108B-C

Manufacturer

LABCONO

NUAIRE

BAKER

NuAire

Terra Universal

Model Number

36100000

NU-430-600

EG4320-19930

NU-543-410UB00

2634-80A

Serial Number

08283192 P

123452052208

140856

212883040722

2634-80A-P173983

Make

Class II Type A2

Class II Type A2

EE#

EE13673

EE13921

Clean Rooms:

Cleanroom Suite:

Anteroom (ISO 8)

Non-Hazardous IV Prep (Buffer) Room (ISO 7)

Hazardous IV Prep (Buffer) Room (ISO 7)

HEPA Filter Information:

Quantity:

Nine (9) 2x4 filters

Location(s)

3 Diffusers in Room 4AB-110 Anteroom; 3 Diffusers in Room 4AB-110B IV Compounding; 3 Diffusers in Room 4AB-110C Chemo Compounding

Test Port Status:

Available

Louis A. Johnson (Clarksburg) VAMC

Hood

Louis A. Johnson (Clarksburg) VAMC

Chemo

BSC 1

BSC 2

Physical Location (Building #)

Clinical Addition B215G-1

Clinical Addition B215F-1

Clinical Addition B215F-1

Manufacturer

LabConco

LabConco

LabConco

Model Number

3441000

346100

346100

Serial Number

091118151B

091118140B

091118141B

Make

4' purifier biosafety cabinet Class II Type B2

6' purifier biosafety cabinet Class II Type B2

6' purifier biosafety cabinet Class II Type B2

EE#

EE17187

EE17188

EE17189

Clean Rooms:

Cleanroom Suite:

Non-Hazardous Anteroom (ISO 8)

Non-Hazardous IV Prep (Buffer) Room (ISO 7)

Hazardous Anteroom (ISO 7)

Hazardous IV Prep (Buffer) Room (ISO 7)

Hazardous Drug Storage

HEPA Filter Information:

Quantity:

13 HEPA Filters (ceiling supply)

Location(s)

3 Anteroom

8 Non-HD Buffer Room

2 HD Buffer Room

Test Port Status:

Unknown

Huntington VAMC

Hood

Huntington VAMC

LAFW

LAFW

BSC

CACI

Physical Location (Building #)

1B101a

1B101a

1B101b

Research Building Room 101

Manufacturer

Baker

Baker

Nu-Aire

Nu-Aire

Model Number

EG-4252

EG-6252

NU-430-600

NU-NR800-400

Serial Number

109952

107979

153119100912

206990071221

Make

EdgeGARD

EdgeGARD

LabGard ES

FlowGard

EE#

37066

35809

35769

59777

Clean Rooms:

Cleanroom Suite: (Pending Construction Completion-TBD)

Non-Hazardous Anteroom (ISO 8)

Non-Hazardous IV Prep (Buffer) Room (ISO 7)

Hazardous Anteroom (ISO 7)

Hazardous IV Prep (Buffer) Room (ISO 7)

SCA

Hazardous IV SCA Room

HEPA Filter Information:

Quantity:

3 HEPA Filters

Location(s)

2 located in air handling above ceiling in ante room

1 filter located in air handler above break room table

Test Port Status:

Unknown

Martinsburg VAMC

Clean Rooms:

Cleanroom Suite:

Non-Hazardous Anteroom (ISO 8)

Non-Hazardous IV Prep (Buffer) Room (ISO 7)

Hazardous Anteroom (ISO 7)

Hazardous IV Prep (Buffer) Room (ISO 7)

HEPA Filter Information:

Washington DC VAMC

WASHINGTON DC VAMC HOOD INVENTORY

LAFT

LAFT

BSC

BSC

IVPB ISOLATOR

CHEMO ISOLATOR

Physical Location

1E-141

1E-141

1E-144

1E-144

4E-122

4E-124

Manufacturer

BAKER

BAKER

BAKER

BAKER

NUAIRE

NUAIRE

Model Number

EG-6252

EG-6252

SG604

SG604

NU-PR797-600

NU-NR797-600

Serial Number

131988

131987

131989

131990

1.43161E+11

1.42613E+11

Make

EdgeGARD® HF

Clean Benches

EdgeGARD® HF

Clean Benches

Class II, Type A2

Class II, Type A2

 CAI

 CACI

EE#

NA

NA

NA

NA

EE1288022

EE1292025

Clean Rooms:

Cleanroom Suite:

Anteroom: ISO 7

Non-Hazardous IV Prep (Buffer) Room (ISO 7)

Hazardous IV Prep (Buffer) Room (ISO 7)

Segregated Compounding Area

IVPB Isolator (CAI)

Chemo Isolator (CACI)

HEPA Filter Information:

Quantity:

5 Total HEPA Filters

Location(s)

5 filters within ceiling supply diffuser

Test Port Status:

5 test ports

Changes to facility PEC will be communicated in a timely manner to contractor and facility costs will be adjusted accordingly based on these changes. Contractor to provide unit-based costs for services to allow for adjustments in equipment.

C.2 Period of Performance: Contract period is from date of award for five (5) years. Performance is to begin 15 calendar days from date of award.

C.3 Special Considerations:

C.3.1 Contractor Furnished Materials:

All materials and tools to complete the work identified.

Contractor to ensure all staff that perform on-site testing arrive wearing non-shedding clothing.

C.3.2 Government Furnished Materials and Services:

The Government will provide all necessary personnel protective equipment (PPE) required for contractors on site.

The Government will provide oversight and verification of contractor personnel completion of donning of PPE and hand hygiene prior to testing/sampling.

The Government will, on rare occasion, provide office or meeting space to discuss test results, projects, or plans.

The Government will provide replacement HEPA filters, when applicable.

May also provide desk phone service as needed.

C.3.3 Qualifications of Key Personnel: VISN 5 is seeking a qualified contractor that meets the following specifications:

Provide three references showing the completion of at least 3 jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center.

All certifications must be signed by an NSF 49 certified technician. A copy of NSF 49 certifications must be attached to the bid documentation for any technicians that will be performing work at the facility.

All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility.

Provide AIHA accredited laboratory certification for all USP viable sampling analysis. Certification must be attached with bid documentation.

Provide copy of clean room certification report for evaluation.

C.3.4 Security Requirements: There are no security requirements required for this work, as samples are retrieved by the vendor and a test report is received in return.

C.3.5 Additional Considerations

The contractor (or Representative) shall contact the facility identified POC(s) to schedule work and prior to the beginning of work. Scheduling of work will be at the direction of facility identified POC(s) to ensure services are incorporated into current facility certification cycles.

Local facility POC(s) will provide the contractor with additional facility specific procedures which include: check in and check out procedures; contractor badging requirements; parking procedures; and any additional facility specific procedures. The contractor will be expected to adhere to those procedures. Services are to be performed during the hours between 8:00 AM and 4:00 PM Eastern Standard Time (EST), excluding federal holidays. Due to the workload of the pharmacy during business hours, the contractor may need to work after 4:00 PM EST 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 4:00pm EST this service must be included within the bid pricing as no extra charge. The ability to perform work after hours is not required; however, preferences will be given to contractors that offer flexible work hours.

C3.6 Invoicing

Payment will be made monthly in arrears, invoices will be prepared by the Contractor, and submitted through Tungsten Network (formerly known as OB10) http://www.tungstennetwork.com/us/en/. A properly prepared invoice shall contain:

Invoice Number and Date

Contractor s Name and Address

Accurate Purchase Order Number

Itemized service(s) and applicable cost:

Supply or Service provided (i.e., PEC certification, travel costs, etc.)

Period Supply or Service Provided

Total Amount Due

Contractor questions about the e-invoicing program (Tungsten Network), contact information is as follows:

Tungsten e-Invoice Setup Information: 1-877-489-6135

Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

FSC e-Invoice Contact Information: 1-877-353-9791

FSC e-invoice email: vafsccshd@va.gov

Web Address: HTTP://WWW.FSC.VA.GOV/EINVOICE.ASP

The contractor will provide an electronic copy of each invoice to the identified POC(s) referenced in A.3.5.6

C.3.7 Liable Insurance Requirements