S02 RFQ 36C24524Q0119 Revised.docx

36C24524Q0119

RFQ 36C24524Q0119

Pharmacy Sterile Clean Certification VA Capitol Health Care Network

VISN 5

849 International Drive Suite 275 Linthicum, MD 21090

This solicitation is intended to procure pharmacy sterile clean certification in accordance with the statement of work.

NAICS: 333413

TYPE OF CONTRACT: This will be a Firm-Fixed-Price Contract

This is a small business set-aside. Please see section E for Instructions to Offerors.

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C24524Q0119 -2023 Mark Smith 410-642-2411 12-1 -2023 13:00

EST

Department of Veterans Affairs Network Contracting Office 5 (NCO 5) 90C

NCO 5

510 Butler Ave Martinsburg WV 25405 X X 333413 500 Employees N/A X VA Capitol Health Care Network

VISN 5

849 International Drive, Suite 275 Linthicum MD 21090 Department of Veterans Affairs Network Contracting Office 5 (NCO 5) Satelite Office 510 Butler Ave Martinsburg WV 25405

PAYMENT WILL BE MADE BY

FSC e-Invoice Payment Invoice must be submitted electronically http://www.fsc.va.gov/einvoice.asp Invoice Setup Information 1-877-489-6135 See CONTINUATION Page Contractor shall provide sterile clean room certification in accordance with the statement of work.

This Indefinite Delivery Indefinite Quantity (IDIQ) contract shall be for a five-year period, which includes one-year ordering periods as noted in the price schedule.

Period of Performance: 04/01/2024 - 03/31/2029 Funding will be obligated on each individual task order.

POC: tracy.dotson@va.gov See CONTINUATION Page X X X Mark Smith Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

Department of Veterans Affairs Network Contracting Office 5 (NCO 5) 90C

NCO 5

510 Butler Ave Martinsburg WV 25405

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

B.2 SINGLE AWARD TASK ORDER CONTRACTS (SATOC)

Quantities listed are estimated only and are not guarantees.

This is a Fixed Price 5-year Indefinite Delivery Indefinite Quantity (IDIQ) Contract. Accordingly, funds are not obligated on this contract at award; rather, funds are obligated via task orders issued against the contract. Task orders shall only be issued by a warranted VA Contracting Officer (CO). VA CO will issue task orders to the contractor authorizing services via Standard Form 1449. Each task order shall clearly identify the dollar amount authorized under the individual task order and the period of performance of the individual task order. When a task order period of performance is completed, additional services shall not be provided unless a new task order is issued in accordance with this IDIQ.

The minimum dollar amount guaranteed under this contract for the performance period of five years is $2,500.00. The maximum dollar amount or contract ceiling for this contract is $4,250,000.00. The maximum amount is not guaranteed. The combined total of all orders placed against this contract cannot exceed the maximum amount/ceiling of this contract.

(End of Clause)

B.3 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 <797> 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 <797> and Chapter <800> 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 <797>. 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<797> 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 <797> standards as well as those referenced VHA HVAC Design Manual, which are more stringent than USP <797>.

In the event that a room does not meet USP<797> 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<797>. 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 <797> 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 <797> (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 <797> (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 <797> (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 <797> (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 <797> 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<797> 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.

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 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:

Specific PEC and Clean Room Information Per Site:

Baltimore VAMC:

Hood

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:

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

· 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)

· 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

· 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

· 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

· 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

· 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

Clean Benches EdgeGARD® HF Clean Benches

· 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<797> 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

B.4 PRICE/COST SCHEDULE

*NOTE: 0 quantities are for pricing only*

ITEM INFORMATION

Test and Certify Class II A2 Biological Safety Cabinet to NSF-49 Protocol Ordering Period 1 POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Test and Certify Class II B2 Biological Safety Cabinet to NSF-49 Protocol

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Test and Certify Compounding Aseptic Isolator to CAG-002-2006 Protocol

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Test and Certify Compounding Aseptic Containment Isolator to CAG-002-2006 Protocol

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Test and Certify Laminar Airflow Workstation

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Test and Certify PCR Workstation or Class I BSC

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

HEPA Filter Leak Test

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

HEPA-filtered Pass Through Leak Test

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Filter replacement consumables kit (filter grease, etc.)

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Viable air sample for bacteria

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Viable air sample for fungi

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Viable surface sample for bacteria - contractor captured

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Viable surface sample for bacteria - facility captured

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Viable surface sample for fungi - contractor captured

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Viable surface sample for fungi - facility captured

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Positive and Negative Control Plate (Set of 2)

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Room Nonviable Particle Count (up to 10 data points)

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Equipment Nonviable Particle Count (up to 5 data points)

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

USP Room Performance Testing (air changes per hour & static pressure)

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Development of final USP report

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Room smoke visualization testing with video documentation

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

PEC (BSC, Hood, etc.) smoke visualization testing with video documentation

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Chemo Wipe Sample - 1 sample location with analysis for 5-Fluorouracil, Cyclophosphamide, Ifosfamide, Methotrexate and Platinum.

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Gowning and Garbing Observation/Evaluation (Optional)

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Gloved Finger Tip Test (both hands) - contractor captured

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Gloved Finger Tip Test (both hands) - facility captured

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Medium-risk Media-fill Test (includes test kit) - contractor captured

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Medium-risk Media-fill Test (includes test kit) - facility captured

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Post-test Surface Sample - contractor captured

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Post-test Surface Sample - facility captured

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Travel charge for 1 technician, 1 site visit (Baltimore City and Loch Raven)

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies

Travel charge for 1 technician, 1 site visit (Perry Point)

POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 333413 - Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing PRODUCT/SERVICE CODE: L065 - Technical Representative - Medical, Dental, and Veterinary Equipment and Supplies