36C25027Q0065.pdf

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

583-27-2-669-0011

36C25027Q0065 10-27-2026

Luke A. Turner 513-559-3702 11-10-2026

10:00 EST

36C250

Department of Veterans Affairs

Network Contracting Office 10

260 E University Avenue

Cincinnati OH 45219-2356

X 100

X

541620

$19 Million

N/A

X

Richard L. Roudebush VA Medical Center

1481 W. 10th Street

Indianapolis, IN 46202-2803

36C250

Department of Veterans Affairs

36C250

Financial Services Center

Invoices to be submitted electronically https://www.tungsten-network.com

877-489-6135

See CONTINUATION Page

Chemical Hoods & HEPA PM.

Contact Information: Luke A. Turner, Contracting Officer

513-559-3702, luke.turner@va.gov.

Deliver Services To: Reference Block 15

Please submit your quotation to luke.turner@va.gov, by the closing date/time of this solicitation. No physical quotes will be accepted.

As outlined in the SOW, a site visit is being offered for

11-03-2026, at 10:00 AM Local Time. Quotes from vendors who do not attend the site visit will not be accepted. All attendees must meet at the Building 6 conference room.

See CONTINUATION Page

583-3670162-669-854100-2543 010055590

X X

Luke A. Turner

VA-VHA-RPOC-2024-0076

36C25027Q0065

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PERFORMANCE WORK STATEMENT

B.2 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.4 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS

(DEVIATION APR 2026)

C.5 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.6 52.240-93 BASIC SAFEGAURDING OF COVERED CONTRACTOR INFORMATION

SYSTEMS (DEVIATION) (NOV 2025)

C.7 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE

OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (OCT 2026) (DEVIATION) ...44

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 ATTACHMENT I - SCA WD

D.2 ATTACHMENT II - VAAR 852.219-75

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (NOV 2025)

(DEVIATION)

E.3 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.4 52.233-2 SERVICE OF PROTEST (NOV 2025) (DEVIATION)

E.5 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

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:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C250 Luke A. Turner/CO

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

[] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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.

https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the

Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PERFORMANCE WORK STATEMENT

Testing, Certification, Environmental Monitoring, and HEPA Filtration Services

1.0 BACKGROUND

The Richard L. Roudebush VA Medical Center (RLRVAMC) requires recurring inspection, testing, certification, environmental monitoring, preventive service, and filter work for laboratory containment equipment, Pharmacy engineering controls and controlled environments, Research equipment, and selected Engineering HEPA filtration systems. The services support patient safety, employee safety, infection prevention, pharmaceutical compounding compliance, and reliable operation of critical ventilation and containment systems.

2.0 OBJECTIVE AND SCOPE

The Contractor shall furnish all qualified personnel, supervision, labor, test equipment, calibrated instruments, materials, consumables, transportation, reports, labels, videos, disposal services, and incidentals required for scheduled recurring work. Condition-based HEPA replacement filters and associated replacement services shall be furnished only when ordered under an applicable separately priced option contract line item. Pharmacy: certify five primary engineering controls (PECs) to ISO Class

5 specifications or better, certify three ISO Class 7 rooms, perform environmental monitoring, replace prefilters, service diffusers, and test 10 ceiling/pass-through HEPA filters.

Laboratory (P&LMS): service 18 active assets—13 Class II Type A2 BSCs, four chemical fume hoods, and one grossing station.

Research: service all 60 inventory entries—36 chemical fume hoods, 20 BSCs, two LFWS units, one hypoxia chamber, and one mini BSC/special containment device.

Engineering: annually inspect and test 24 HEPA filters in AHU 37A/37B, six HEPA filters in AHU 46, and two terminal HEPA filters in Operating Room 5 served by AHU 38; replace these filters only when failed, damaged, or otherwise unacceptable and authorized; and perform scheduled isolation-exhaust filter service.

The equipment inventories in Appendices A through D are part of the scope. The Contractor shall reconcile the physical inventory after award and shall not service or invoice unlisted equipment without written Government authorization.

2.1 Explicit Scope Boundaries

The AHU 37A/37B filters are the 24-filter bank serving the 9 operating rooms; they are not an additional set of 24 filters in each operating room.

The AHU 46 filters are the six 30-inch by 30-inch by 12-inch-deep HEPA filters serving the Cardiology procedure room.

Operating Room 5 is served by AHU 38. AHU 38 contains no central HEPA filters; the two HEPA filters in scope are terminal filters located in Operating Room 5 and are separate from the AHU 37A/37B filter bank.

Operating room and Cardiology room relationships are provided for system identification and outage coordination. Except for the terminal-filter and room-performance measurements expressly required for

Operating Room 5 in Section 8.5, general room certification, air-change verification, pressure testing, or cleanliness certification is excluded unless expressly stated elsewhere in this PWS.

Isolation-room listings identify systems served. Room-level pressure, ACPH, door/seal, or infection-control certification is excluded from the isolation-exhaust scope.

Repairs and replacement parts not expressly included are outside scope unless ordered under a funded line item or contract modification. Contractor-caused damage and retesting remain the Contractor's responsibility.

3.0 PERIOD AND PLACE OF PERFORMANCE

The anticipated period of performance is one 12-month base period and four 12-month option periods.

Each exercised period includes the service frequencies stated in this PWS.

Place of performance: Richard L. Roudebush VA Medical Center, 1481 West 10th Street, Indianapolis, Indiana 46202, including roofs, mechanical rooms, interstitial spaces, controlled Pharmacy areas, laboratories, Research spaces, and other listed locations.

4.0 APPLICABLE REQUIREMENTS AND ORDER OF PRECEDENCE

The following editions are the technical basis for this PWS. The edition is incorporated by solicitation or contract controls. A later revision does not change contract scope or price unless incorporated by the

Contracting Officer. The Contractor shall promptly notify the COR/COTR and Contracting Officer of conflicts before proceeding.

29 CFR 1910.1450, Occupational Exposure to Hazardous Chemicals in Laboratories, including the facility Chemical Hygiene Plan requirements applicable to hood operation and maintenance.

VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Sterile

Preparations, dated February 14, 2024.

USP General Chapter <797>, Pharmaceutical Compounding—Sterile Preparations, and USP General

Chapter <800>, Hazardous Drugs—Handling in Healthcare Settings, official versions in effect for the facility.

CETA CAG-002 (2026), CAG-003 (2022), CAG-005 (2025), CAG-006 (2023), CAG-008 (2022), CAG-

009 (2023), CAG-014 (2022), and CAG-015 (2025), as applicable to the specific equipment and service.

ISO 14644-1:2015, ISO 14644-2:2015, and ISO 14644-3:2019.

NSF/ANSI 49-2024, Biosafety Cabinetry: Design, Construction, Performance, and Field Certification.

ANSI/ASHRAE Standard 110-2016 (RA 2025), Methods of Testing Performance of Laboratory Fume

Hoods.

ANSI/ASHRAE Standard 111-2024, Measurement, Testing, Adjusting, and Balancing of Building

HVAC Systems, where airflow system measurement is required.

ANSI/ASHRAE/ASHE Standard 170-2021 and adopted addenda applicable to health care ventilation systems.

IEST-RP-CC034.5 (2022), HEPA and ULPA Filter Leak Tests, and the applicable current edition of

IEST-RP-CC001 for HEPA filter performance and construction.

NFPA 45-2024, Standard on Fire Protection for Laboratories Using Chemicals, where applicable to chemical hood installation and operation.

CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 6th edition, as advisory biosafety practice were incorporated by facility policy.

VA HVAC Design Manual, VA Pharmacy Service Design Guide, VHA technical guidance, facility policies, infection-control requirements, and manufacturer instructions furnished or identified by the

Government.

Where the PWS prescribes a more frequent service interval than a referenced minimum, the PWS frequency controls. An asset shall not be represented as certified as a standard that does not apply to its equipment type or listing.

5.0 CONTRACTOR QUALIFICATIONS

Pharmacy PEC/SEC certification shall be performed by a CNBT Registered Certification Professional for

Sterile Compounding Facilities (RCP-SCF), or by a firm employing an RCP-SCF who is responsible for the work, as required by VHA Directive 1108.12.

Class II BSC field certification shall be performed by personnel holding current NSF Enhanced BSC

Field Certifier accreditation or another qualification specifically accepted by the applicable standard and the Government.

The lead fume-hood tester shall hold a current CNBT fume-hood credential or demonstrate equivalent documented training and experience with ASHRAE 110 field testing acceptable to the Government.

The lead HEPA/cleanroom tester shall hold a current CNBT cleanroom-testing credential or demonstrate equivalent documented training and experience with in-place aerosol-photometer testing and the cited

IEST/CETA methods.

Personnel conducting viable environmental monitoring shall be trained in aseptic sampling, chain of custody, incubation/media controls, result interpretation, and applicable USP/CETA requirements.

Analysis shall be performed by a qualified microbiology laboratory using documented methods.

The Contractor shall submit technician names, roles, credentials, certificate numbers, expiration dates, relevant experience, and proposed assignments before work begins and whenever personnel change.

All measuring instruments shall be appropriate for the range and accuracy required, maintained in calibration at the manufacturer-prescribed interval, and traceable to recognized standards where applicable.

6.0 PRE-PERFORMANCE SUBMITTALS AND INVENTORY VERIFICATION

6.1 Mandatory Pre-Proposal Site Visit

Offerors shall attend the Government-scheduled site visit. Offerors shall inspect accessible equipment, housings, service clearances, filter banks, test ports, roof/interstitial access, shutdown constraints, and controlled-area entry requirements. Offerors shall verify conditions that materially affect labor, materials, access, safety, scheduling, and pricing.

AHU 37A/37B contains eighteen 24-inch by 24-inch by 11.5-inch deep and six 12-inch by 24-inch by

11.5-inch deep. Offerors shall field-verify dimensions, construction, efficiency, gasket orientation, and replacement requirements.

AHU 46 contains six nominal 30-inch by 30-inch by 12-inch-deep HEPA filters. Offerors shall verify actual dimensions, construction, efficiency, and gasket orientation.

Operating Room 5 contains two terminal HEPA filters served by AHU 38, which have no central HEPA filters. Offerors shall verify each terminal filter's location, dimensions, manufacturer, model, efficiency rating, housing and seal type, access method, test ports, upstream aerosol-injection access, downstream scan access, and replacement requirements.

Pharmacy contains 10 HEPA filters identified collectively as ceiling and pass-through HEPA filters. The

Government does not have the final filter-by-filter allocation; offerors shall verify the number, location, equipment association, access method, and filter identifiers.

Offers will not be accepted from companies that do not attend the site visit. Performance issues in the past made this a necessary restriction to apply to the procurement.

6.2 Post-Award Submittals

Within 10 business days after award: Quality Control Plan, safety plan, credential roster, instrument/calibration list, sample report forms, and proposed annual schedule.

Within 30 calendar days after award: reconciled electronic inventory identifying each asset, room, asset number, manufacturer, model, serial number, equipment classification, service frequency, filter quantity/size/efficiency, and discrepancies.

Before each controlled-area event: work plan, proposed tests, sampling map, shutdown/access needs, aerosol and containment method, and infection-control controls.

No newly discovered asset, repair, or replacement may be performed or invoiced without written authorization under the contract.

7.0 SCHEDULING, ACCESS, AND PROTECTION OF OPERATIONS

Normal performance hours are 0700 through 1800, Monday through Friday, excluding Federal holidays.

Early morning, evening, weekend, and shutdown work may be required to protect patient care and departmental operations. All work shall be scheduled through the COR.

Pharmacy semiannual certifications shall be scheduled so the interval does not exceed six months. Other semiannual events shall be approximately six months apart; annual events shall be completed within the applicable 12-month certification interval.

The Contractor shall not shut down an air handler, exhaust fan, PEC, or critical system without an approved outage and explicit authorization to proceed.

Work in sterile compounding, operating-room, procedural, laboratory, roof, or interstitial areas shall comply with facility infection-control, interim life-safety, fall-protection, lockout/tagout, and access requirements.

Aerosol challenge shall be planned and contained so challenge material is not introduced into occupied clinical spaces or other systems. The Contractor shall coordinate isolation, shutdown, purge, and return-to-service criteria with the COR/COTR and affected department.

Operating Room 5 testing shall be performed during an approved operating-room outage. The Contractor shall coordinate diffuser removal, aerosol challenge, purge or clearance, cleaning, reassembly, and return to service with the COR/COTR and affected operating-room personnel.

Photography and video are limited to required equipment documentation and smoke studies. Images must exclude patients, protected health information, computer screens, labels containing patient data, and unauthorized personnel.

8.0 TECHNICAL PERFORMANCE REQUIREMENTS

8.1 Pharmacy PECs, SECs, Environmental Monitoring, and HEPA Filters

The Contractor shall perform a complete semiannual certification event for all five Pharmacy PECs and all three ISO Class 7 rooms. The five PECs consist of two Class II Type A2 BSCs, two LAFWs, and one

CAI. Semiannual PEC testing shall include the applicable field-certification tests; it is not a limited visual inspection.

Perform nonviable particle counting and classification; measure and document supply and exhaust airflow; calculate and report total air changes per hour (ACPH) for each room; and verify pressure relationships and segregation, temperature, relative humidity, airflow visualization, HEPA filter integrity, and applicable alarms and monitors, as required by USP, CETA, VA, and the approved room design. For the non-HD classified room, the certification report shall separately state: (1) ACPH provided by HVAC supply air and (2) total ACPH, including the airflow contribution from the LAFWs located in that room.

The report shall identify the room volume and measured airflow values used in each calculation. BSCs:

inflow and downflow measurements, supply and exhaust HEPA leak testing, dynamic airflow smoke patterns with video, alarms/interlocks, site installation assessment, and other NSF/ANSI 49 and CETA tests applicable to the model and installation.

LAFWs: HEPA leak testing, airflow velocity and uniformity, nonviable particle count, induction-leak/back-streaming evaluation, dynamic airflow smoke visualization with video, alarms/controls, and diffuser inspection.

CAI: HEPA leak testing, airflow and particle performance, chamber and transfer-chamber pressure, ingress/egress or recovery testing, dynamic airflow smoke visualization with video, alarms/interlocks, and glove/sleeve integrity when required by the manufacturer or governing procedure.

Pass-through HEPA filter(s): test in accordance with CETA CAG-015, the manufacturer method, and the applicable room/containment requirements. Report each pass-through separately.

Perform 48 viable air and surface field samples of PECs, pass-throughs, and ISO Class 7 rooms at each semiannual event. Samples should be collected and incubated in accordance with the dual plate method, each site will have a separate bacterial and fungal sample. Required positive/negative media controls and blanks are additional and shall not be counted among the 48 field samples.

Provide complete laboratory analysis, colony counts, alert/action-level comparison, required organism identification, excursion assessment, and follow-up recommendations. Maintain chain of custody and media/incubation records.

Replace four LAFW prefilters (two per LAFW) semiannually and dispose of removed prefilters. Remove and clean five laminar-flow hood/PEC diffusers semiannually in accordance with manufacturer instructions.

Inspect and perform filter integrity-test for all 10 Pharmacy ceiling/pass-through HEPA filters semiannually. HEPA replacement is condition-based and requires written authorization; see Section 9.0.

Certification activities must be conducted during the hours of 8:00 to 17:00, Monday through Friday during standard business days. Certifications will not be conducted on weekends nor on Federal Holidays without express authorization of Compounded Sterile Preparations Pharmacy Program Manager and

COR.

Contractor shall send at least two personnel to perform certification activities due to the locations of ceiling HEPA filter test ports.

8.2 Laboratory (P&LMS)

The active Laboratory inventory is 13 Class II Type A2 BSCs, four chemical fume hoods, and one grossing station. Missing model, asset, or certification-history fields shall be verified during inventory reconciliation.

BSCs: certify annually using NSF/ANSI 49 field-certification tests applicable to each cabinet. Apply a certification label showing date, status, certifier, and next due date.

Chemical fume hoods: test annually at the designated operating sash position, including condition inspection, face-velocity traverse and uniformity, airflow visualization, sash operation, monitor/alarm verification, fan/exhaust response, and comparison with the facility/manufacturer design criterion.

ASHRAE 110 tracer-gas containment testing is required when the facility Chemical Hygiene Plan, manufacturer, prior certification basis, risk assessment, post-modification condition, failure investigation, or COR/COTR direction requires it. It shall not be substituted for routine measurements or billed without the applicable priced authorization.

Grossing station: annually verify exhaust capture using manufacturer criteria and applicable ventilation methods, including velocity/capture measurements, smoke visualization, controls/alarms, lighting and work-surface condition, and drainage/utility observations relevant to safe operation.

8.3 Research

The Research inventory contains 60 entries: 36 chemical fume hoods, 20 BSCs, two LFWS units, one hypoxia chamber, and one mini BSC/special containment device. All 60 entries are included. The hypoxia chamber is in room D3014.

Standard BSCs: certify annually using the applicable NSF/ANSI 49 field tests and manufacturer criteria.

Chemical fume hoods: test annually using the routine operational tests and tracer-gas conditions stated in

Section 8.2.

LFWS units: certify semiannually for HEPA integrity, airflow velocity/uniformity, particle performance, airflow visualization, alarms/controls, and applicable manufacturer criteria.

Mini BSC/special containment device: determine the actual equipment classification, listing, manufacturer, and intended function. Perform the applicable manufacturer and containment tests annually. Do not label the device NSF-certified unless it is eligible and all applicable criteria are met.

Hypoxia chamber: annually perform manufacturer-required preventive maintenance and functional certification, including oxygen/atmosphere sensor calibration, control and alarm verification, door/seal condition, purge and gas-supply safety functions, exhaust/containment observations, and documented setpoint accuracy. Do not represent this chamber as a BSC or fume hood.

Provide up to two BSC/biological containment decontamination events per contract year only when the

Contracting Officer exercises the applicable separately priced option contract line item. The COR/COTR may validate the need and coordinate scheduling and access.

8.4 AHU 37A/37B and AHU 46 HEPA Filter Banks

Annual service is inspection and applicable integrity/performance testing. Routine annual replacement is prohibited. Each filter and filter-bank position shall receive a unique durable identifier that is carried forward in reports.

Inspect filter media, frames, gaskets, seals, clamps, holding frames, housing surfaces, penetrations, access doors, test ports, and evidence of moisture, corrosion, bypass, damage, loading, or microbial contamination.

Record filter manufacturer, model, serial/lot if available, nominal/actual dimensions, efficiency/performance level, installation date if known, orientation, design airflow, measured differential pressure, and observed condition.

Perform in-place aerosol-photometer leak testing under operating conditions using IEST-RP-CC034.5.

Establish and document upstream challenge concentration and uniformity; scan the downstream filter face, perimeter, gasket, frame, and accessible penetrations; and apply the acceptance criterion for the installed filter's performance level and approved test method.

Measure/document airflow, face velocity, differential pressure, and other system performance needed to establish that testing occurred under representative conditions. Identify limitations that prevent a complete scan; a limited test shall not be reported as a full certification.

Permitted adjustment, reseating, or manufacturer-allowed repair shall be documented and require

COR/COTR coordination. Filters that remain unacceptable, are damaged, or exceed manufacturer/standard repair limits shall be recommended for replacement under Section 9.0.

Following test activity, restore the system, verify normal airflow and controls, remove challenge aerosol in accordance with the approved plan, and obtain authorization before returning the system to clinical service.

8.5 Operating Room 5 Terminal HEPA Filters

AHU 38 serves Operating Room 5 and contains no central HEPA filters. Operating Room 5 contains two terminal HEPA filters. The Contractor shall inspect and test each terminal filter annually and after installation, replacement, repair, reseating, terminal-housing work, or another significant disturbance that could affect integrity or performance.

Inspect the filter media, frame, terminal housing, gasket or gel seal, retaining devices, diffuser, ceiling interface, accessible penetrations, and evidence of damage, deterioration, moisture, loading, or bypass.

Assign a durable unique identifier to each terminal filter and record its location, manufacturer, model, serial or lot number when available, nominal and actual dimensions, efficiency rating, installation date if known, housing and seal type, and observed condition.

Perform an in-place aerosol-photometer integrity and leak test under representative operating airflow using IEST-RP-CC034.5. Establish and document a safe upstream challenge concentration and uniformity for each terminal; scan the entire accessible downstream filter face, perimeter, frame, seal, housing joints, and penetrations; and apply the acceptance criterion for the installed filter's performance level, approved method, manufacturer requirements, and facility design.

Measure and report terminal airflow volume or face velocity and uniformity, as applicable to the terminal design, and differential pressure when a manufacturer-provided test port, gauge, or approved measurement method is available.

Under the representative operating mode, document total supply airflow to Operating Room 5, the room dimensions and calculated volume, total air changes per hour, room pressure relationship and airflow direction relative to adjacent spaces, temperature, and relative humidity. Compare results with the facility-approved design criteria and the contract-adopted VA and ASHRAE/ASHE healthcare ventilation requirements.

Identify any surface or component that could not be accessed or scanned. A limited scan or incomplete room-performance test shall not be reported as a complete certification.

After testing, reinstall and clean diffusers and disturbed surfaces as required, remove challenge aerosol under the approved plan, verify normal airflow and controls, document final operating status, and obtain authorization before returning Operating Room 5 to service.

8.6 Isolation Exhaust Filter Systems

Provide and replace 23 isolation-exhaust prefilters quarterly and 23 HEPA filters annually using the bag-in/bag-out or other housing-specific safe-change method. Verify quantities, sizes, filter-bank relationships, and housing access during the site visit and initial inventory reconciliation.

Coordinate exhaust shutdowns and room impact before work; follow facility infection-control and respiratory-protection requirements.

Contain, label, transport, and dispose of removed filters in accordance with the facility waste determination and applicable regulations. Do not assume all filters have the same waste classification.

After HEPA replacement, verify seating and seals, perform an in-place integrity test where the housing permits and the system requirement call for it, document differential pressure and operation, and obtain release to service.

9.0 CONDITION-BASED HEPA REPLACEMENT

This section applies to the 24 filters in AHU 37A/37B, six filters in AHU 46, two terminal HEPA filters in Operating Room 5, and 10 Pharmacy ceiling/pass-through HEPA filters. It does not change scheduled prefilter replacement or the stated annual isolation-exhaust HEPA replacement.

A HEPA filter shall be replaced only when one or more of the following is documented: failure of the applicable integrity/performance acceptance criterion; physical or moisture damage; failed gasket/frame/seal that cannot be corrected within manufacturer limits; unacceptable loading or pressure drop; contamination or condition requiring replacement under facility policy; or another manufacturer/standard requirement.

The Contractor shall immediately identify the filter, measured failure, acceptance criterion, operational consequence, recommended replacement, and proposed replacement filter.

The Contractor shall notify the COR/COTR and provide documentation supporting the recommended replacement. The COR/COTR may validate the technical need and recommend replacement.

Replacement shall not begin until the Contracting Officer provides written authorization by exercising the applicable separately priced option contract line item or issuing another authorized contractual action.

The applicable firm-fixed unit price shall include the correctly rated replacement filter, freight, labor, outage coordination, removal, containment, disposal, cleaning, gasket/seal materials, installation, labeling, and post-replacement integrity/performance testing.

Replacement filters shall match the approved dimensions, efficiency/performance level, airflow capacity, pressure-drop characteristics, frame construction, fire classification, gasket/gel-seal arrangement, and environmental compatibility. Substitutions require Government approval.

After installation, repeat the failed test and all tests needed to establish acceptable final operation. Report the complete sequence: initial result, failure, authorization, replacement, post-test, and final status.

10.0 SERVICE SUMMARY AND FREQUENCIES

Area Quantity / Asset Service Frequency

Pharmacy 5 PECs (2 BSC, 2

LAFW, 1 CAI)

Complete certification including but not limited to: Dynamic smoke-pattern testing with video; non-viable particle count;

HEPA filter challenge/leak testing;

airflow testing; applicable certification testing; ISO Class 5 classification

Semiannual; interval not to exceed 6 months

Area Quantity / Asset Service Frequency

Pharmacy 3 ISO Class 7 rooms

Room/SEC certification including but not limited to: USP room performance testing; ISO 7 environmental classification/particle testing;

pressure/airflow/ACPH [VHA requires 35

ACPH for ISO Class 7 rooms]

Semiannual

Pharmacy 48 field samples per event

Viable bacterial/fungal air and surface sampling; positive/negative controls additional; laboratory analysis; action-level comparison

Semiannual

Pharmacy 10 HEPA filters

HEPA filter challenge/leak testing for ceiling and pass-through HEPA filters;

replace only if authorized/required

Semiannual

Pharmacy 4 LAFW prefilters Change prefilters; dispose of removed filters (2 prefilters per LAFW) Semiannual

Pharmacy 5 PEC diffusers Remove, clean, and reinstall Semiannual

Laboratory 13 BSCs NSF/ANSI 49 field certification Annual

Laboratory 4 fume hoods Operational certification/testing Annual

Laboratory 1 grossing station Capture/exhaust certification Annual

Research 20 BSCs NSF/ANSI 49 field certification Annual

Research 36 fume hoods Operational certification/testing Annual

Research 2 LFWS units HEPA/airflow certification Semiannual

Research 1 hypoxia chamber Manufacturer PM and functional certification Annual

Research 1 mini BSC/special device

Classification and applicable containment certification Annual

Engineering

24 AHU 37A/37B

HEPA filters Inspect and integrity/performance test

Annual; replacement condition-based

Engineering 6 AHU 46 HEPA filters Inspect and integrity/performance test Annual; replacement condition-based

Engineering 2 OR 5 terminal HEPA filters

Integrity/leak testing; terminal airflow and room-performance verification

Annual and after disturbance;

replacement condition-based

Engineering 23 isolation prefilters Provide, replace, dispose Quarterly

Area Quantity / Asset Service Frequency

Engineering 23 isolation HEPA filters

Provide, replace, dispose; post-test as applicable Annual

On call

Up to 2 decontamination events/year

BSC/biological containment decontamination

Up to two events per contract year;

Contracting Officer authorization required.

11.0 REPORTING AND DELIVERABLES

The Contractor shall provide preliminary pass/fail information before leaving the work area. Critical deficiencies shall be reported immediately to the COR/COTR and affected department, followed by written notice within 24 hours. Final routine reports other than Pharmacy reports shall be submitted electronically within five business days after service. Final Pharmacy reports, including completed incubation and laboratory results, shall be submitted within 10 calendar days after service and within the

VHA reporting limit incorporated into the contract.

One searchable PDF report package and one editable electronic inventory/report data file for each service event.

Asset/system identification, room, department, date/time, operating condition, technician, credentials, and work performed.

Applicable standard/method and edition, manufacturer criterion, instrument identification, calibration date/status, raw measurements, calculations, acceptance criteria, and pass/fail determination. The final report shall include a current calibration certificate for each test instrument used. The certificate shall match the instrument identified in the report, be valid on the testing date, and document traceability to

NIST or another recognized standard, as applicable.

For HEPA tests: filter-bank or terminal-filter map, unique filter ID and location, upstream concentration and uniformity, scan method, leakage or penetration results, accessible surfaces scanned, limitations, repairs or adjustments, and final result.

For fume hoods: sash test position, traverse points, individual and average velocities, variability, smoke result, monitor/alarm result, observed cross-drafts/room conditions, and certification status.

For Pharmacy: whether testing occurred under dynamic or static conditions; room diagrams showing viable and nonviable sampling locations; equipment and room dimensions; supply and exhaust filters;

pressure differentials; total ACPH for each classified room; for the non-hazardous-drug room, supply-air

ACPH and total ACPH including LAFW airflow; number of personnel present during certification;

viable-sample media, lot, expiration, certificates of analysis, and incubation conditions; bacterial and fungal colony-forming-unit counts; genus and species identification when an action level is exceeded and identification is practicable; alert and action-level comparisons; as-found and as-left conditions for adjusted equipment; PEC-specific reports that reference manufacturer-approved values; calibration documentation; and smoke-study videos in a VA-acceptable format using clearly visible, neutrally buoyant smoke.

For Operating Room 5: each terminal filter's identifier and location, challenge concentration and uniformity, complete scan results, terminal airflow, total room supply airflow, room volume, calculated total air changes per hour, pressure relationship and airflow direction, temperature, relative humidity, test operating mode, access limitations, acceptance criteria, and final pass/fail status.

For filter replacement: old/new filter data, reason, authorization reference, disposal/manifest information as applicable, installation details, post-test data, and final return-to-service status.

Certification labels shall not be applied to failed equipment. Restricted/conditional labels shall plainly state the limitation and refer to the report.

Incomplete or inaccurate reports shall be corrected and resubmitted within three business days after

Government notice. The Contractor shall retain service documentation for at least six years after final payment, or longer if the contract or law requires.

12.0 DEFICIENCIES, CORRECTIVE ACTION, AND RETESTING

Class Definition Notification

Critical Immediate or significant patient, personnel, infection-control, containment, or critical-system risk

Immediate verbal notice;

written within 24 hours

Major Failure of an applicable acceptance criterion or inability to complete a required certification

Prompt COR/COTR notice and written deficiency in final report

Minor Condition requiring correction or monitoring without failure of required performance Document in routine report

Document the failed parameter, measured result, acceptance criterion, likely impact, and recommended corrective action.

Minor adjustments customarily required to complete certification are included. Repairs, parts, and condition-based replacements require written Contracting Officer authorization under the applicable priced option contract line item or another authorized contractual action.

Retesting after Contractor error, damage, improper adjustment, incomplete work, or invalid test is at no additional cost.

Retesting after an authorized Government repair or condition-based replacement shall be performed under the applicable contract line item and documented to final status.

13.0 QUALITY CONTROL AND GOVERNMENT SURVEILLANCE

The Contractor is responsible for quality control. The Quality Control Plan shall address personnel qualification, method control, calibration, sampling controls, report review, data integrity, nonconforming work, corrective action, and document retention. The Government may observe work, review records, independently verify measurements, reject incomplete deliverables, and require correction of nonconforming work.

Government observation, review, or acceptance does not relieve the Contractor of responsibility for compliance. The COR/COTR may coordinate and inspect performance but may not change contract terms, price, quantity ceilings, or funding.

14.0 SECURITY, PIV, AND FACILITY ACCESS

Because performance requires routine and continuing access to VA facilities, Contractor and subcontractor personnel assigned to unescorted work shall be eligible for, promptly apply for, obtain, and maintain the credential determined by VA, including a PIV card when required. The Contractor shall comply with FAR 52.204-9, VAAR 852.204-70, VA Directive 0735, and current VA credentialing procedures incorporated into the contract.

Initiate sponsorship, identity proofing, fingerprinting, background investigation, training, enrollment, and issuance actions promptly after award.

Do not assign personnel who cannot obtain or maintain required eligibility to work requiring that access.

Display/carry credentials as directed, comply with check-in and escort rules, protect keys/badges, and return Government credentials when access ends.

PIV eligibility does not independently authorize entry into Pharmacy, Research, laboratories, roofs, interstitial spaces, mechanical rooms, or clinical areas; area-specific authorization remains required.

No access to VA information systems, patient records, or VA sensitive information is anticipated.

Immediately report inadvertent exposure to the COR/COTR and follow VA privacy/security direction.

The C&A requirements do not apply and a Security Accreditation Package is not required

15.0 GOVERNMENT-FURNISHED ACCESS AND INFORMATION

The Government will designate a COR; provide reasonable coordinated access to listed Government equipment and spaces; furnish available inventories, prior reports, and facility procedures; and coordinate required outages, escorts, and departmental contacts. Access remains subject to patient care, security, safety, infection control, and operational restrictions.

The Government does not furnish Contractor labor, tools, test instruments, calibration, transportation, PPE, routine consumables, replacement filters, sampling materials, laboratory analysis, or other resources required by this PWS.

16.0 PRICING AND AUTHORIZATION CONTROLS

Recurring scheduled services shall be priced under one or more firm-fixed-price contract line items for each contract period. Condition-based HEPA replacement and other variable work shall be separately priced as firm-fixed-price option contract line items. The Government is not obligated to purchase any optional quantity unless the Contracting Officer exercises the applicable option in writing. At a minimum, pricing shall distinguish:

Pricing element Required basis

Recurring services

One or more firm-fixed-price line items per contract period for all scheduled certifications, tests, monitoring, prefilter service, diffuser cleaning, routine isolation-filter service, and reporting.

AHU 37A/37B 24 × 24 ×

11.5-inch HEPA replacement

Fully burdened firm-fixed unit price per filter. Authorized quantity shall not exceed 18 per contract period without Contracting Officer action.

AHU 37A/37B 12 × 24 ×

11.5-inch HEPA replacement

Fully burdened firm-fixed unit price per filter. Authorized quantity shall not exceed six per contract period without Contracting Officer action.

AHU 46 30 × 30 × 12-inch

HEPA replacement

Fully burdened firm-fixed unit price per filter. Authorized quantity shall not exceed six per contract period without Contracting Officer action.

Operating Room 5 terminal HEPA replacement

Fully burdened firm-fixed unit price for each verified terminal-filter type or location. Authorized quantity shall not exceed two per contract period without Contracting Officer action.

Pharmacy HEPA replacement

Fully burdened firm-fixed unit price for each materially different filter type or location verified during the mandatory site visit. Authorized quantity shall not exceed 10 per contract period without Contracting Officer action.

Additional replacement mobilization

Firm-fixed price per return visit when an authorized replacement cannot be completed during scheduled testing. This line item shall not be charged when replacement occurs during a scheduled service event or mobilization is included elsewhere.

BSC decontamination Firm-fixed unit price per authorized event, not to exceed two events per contract period.

ASHRAE 110 tracer-gas testing Firm-fixed unit price per hood when separately required and authorized.

Each HEPA replacement unit price shall include the correctly rated replacement filter, freight, labor, outage coordination, removal, containment, disposal, cleaning, gasket and seal materials, installation, labeling, and required post-replacement integrity and performance testing.

When separately priced work may be required, the Contractor shall provide the COR/COTR with the applicable equipment identification, measured condition or failure, acceptance criterion, recommended action, proposed materials, and applicable contract line item. The COR/COTR may validate the technical need and coordinate scheduling and access.

The Contractor shall not proceed based on an oral request or COR/COTR direction alone. Only the

Contracting Officer may exercise an option contract line item, authorize a payable quantity, change a quantity ceiling, or obligate additional funding. Work performed without the required Contracting Officer authorization shall not be invoiced or paid.

17.0 INVOICING

Invoices shall be submitted in arrears through the VA-designated electronic invoicing process and shall identify the contract line item, service date, department/system, quantity, authorization reference for variable work, accepted report, and amount. Unauthorized, incomplete, failed, or unaccepted work shall not be invoiced as complete. The Contracting Officer will incorporate applicable FAR/VAAR invoicing clauses into the solicitation and award. For variable or optional work, the invoiced quantity shall not exceed the quantity authorized in writing by the Contracting Officer and accepted by the Government.

APPENDIX A — PHARMACY INVENTORY

Equipment / System Location. EE/MX Make/Model SN

ISO Class 5 PEC

Class II, Type A2

Biological Safety

Cabinet (BSC)

A-7086

Right side of room

X18262

Baker BSC

SG404

127090

ISO Class 5 PEC

Class II, Type A2

Biological Safety

Cabinet (BSC)

A-7086

Left side of room

MX1826

Baker BSC

SG404

127091

ISO Class 5 PEC

Horizontal Laminar

Airflow Workstation

(LAFW)

A-7086

Right Side of room

MX2493

NuAire-340-

199005060820

ISO Class 5 PEC

Horizontal Laminar

Airflow Workstation

(LAFW)

A-7086

Left side of room

MX2493

NuAire-340-

198953060420

ISO Class 5 PEC

Restricted Access

Barrier System –

Compounding

Aseptic Isolator

(CAI)

D-2035

MX2717

NuAire

NU-PR797-

209374111521

ISO Class 7

Positive Pressure

Cleanroom

A-7086

Equipment / System Location. EE/MX Make/Model SN

ISO Class 7

Negative Pressure

Cleanroom

A-7086

ISO Class 7

Anteroom A-7086

APPENDIX B — LABORATORY (P&LMS) INVENTORY

Location EE/MX Type Model Serial Number

Cytology A2064 MX3546715 Class II Type A2 NU-540-400 224778021324

Micro A2044 EE51772 Fume Hood 54L590P 54L590P

Micro A2044 MX3610896 Class II Type A2 NU-540-400 224971022624

Micro A2044 MX3610898 Class II Type A2 NU-540-300 225067022924

Histology A2067 MX1895323 Fume Hood EH6V 126690

Frozen Room

A2066 MX1630107 Class II Type A2 NU-540-300 182346100917

Frozen Room

A2066 MX1705534 Fume Hood FH5C 123429

Molecular A2042 MX3400517 Class II Type A2 NU-540-400 216884110822

Molecular A2042 MX3400516 Class II Type A2 NU-540-400 216882110822

Molecular A2042 MX3400474 Class II Type A2 NU-540-400 216887110822

Molecular A2043 MX3400462 Class II Type A2 NU-540-400 216883110822

Molecular A2043 MX3400519 Class II Type A2 NU-540-400 216886110822

Micro A2044 MX3688203 Class II Type A2 NU-540-300 228747111124

Histology A2067 MX1826106 Grossing Station Not provided MB670H15001

Micro A2049 EE4241 Class II Type A2 NU-425-600 22454WN

Processing A2132 EE46944 Class II Type A2 3620400 070874972

Mohs C-1094 MX1982304 Class II Type A2 Not provided N/A

Location EE/MX Type Model Serial Number

Cytology A2064 No EE

Assigned Fume Hood Not provided 231056295

APPENDIX C — RESEARCH INVENTORY

Line Room Inventory Description EE/MX / Identifier

1 D3014 1 Hypoxia Chamber EE82869/EE63841

2 C3077 1 Fume Hood EE24581

3 C3078 1 Fume Hood EE24583

4 C3078 1 BSC IU 000125

5 C3092 1 Fume Hood EE9351

6 C3111 1 Fume Hood EE9361

7 C3113 1 Fume Hood EE9362

8 C3113 1 Fume Hood EE67976

9 C3113 1 LFWS EE63937

10 C3113 1 LFWS EE67766

11 C3116 1 BSC EE79416

12 C3117 1 BSC EE65512

13 C6064 1 Fume Hood EE52550

14 C6071 1 BSC MX3644482

15 C6072 1 BSC EE69558

16 C6077 1 Fume Hood EE51336

17 C6078 1 Fume Hood EE51322

18 C6080 1 Fume Hood Not provided

19 C6082 1 Fume Hood Not provided

20 C6091 1 Fume Hood EE52364

21 C6114 1 Fume Hood EE59407

22 C6115 Mini BSC EE86988

23 C6115 1 Fume Hood EE52475

24 C6133 1 BSC EE34270

25 C6134 1 BSC EE4240

26 C6134 1 BSC EE34271

27 C6139 1 Fume Hood EE59204

28 C7093 1 Fume Hood EE28216

29 C7095 1 Fume Hood EE28215

30 C7098 1 BSC EE51409

31 C7106 1 BSC MX2054121

32 C7110 1 BSC MX2062903

33 D2004 1 BSC EE4544

34 D2005 1 BSC MX1944880

35 D2006 1 Fume Hood EE52041

36 D2007 1 Fume Hood EE51719

37 D2007 1 BSC MX1633251

38 D2010 1 BSC EE67995

39 D2012 1 Fume Hood No MX/EE# Vectaire

40 D3002 1 BSC EE26708

41 D3004 1 Fume Hood No MX/EE# Vectaire #26

42 D3005 1 Fume Hood No MX/EE# Vectaire #21

43 D3006 1 Fume Hood MX1633270

44 D3007 1 Fume Hood No MX/EE# Vectaire #23

45 D3008 1 Fume Hood No MX/EE# Vectaire #24

46 D3014 1 BSC MX1633240

47 D3015 1 BSC MX2031906

48 D3016 1 BSC EE51541

49 D3016 1 Fume Hood No MX/EE# Vectaire #25

50 C3102 1 Fume Hood EE67978

51 C3113 1 Fume Hood EE63937

52 C338A 1 Fume Hood EE73176

53 C340A 1 Fume Hood EE72534

54 C6082 1 Fume Hood EE51329

55 C6136 1 Fume Hood EE746

56 C6136 1 BSC MX2026750

57 D2001 1 Fume Hood EE21352

58 E220 1 Fume Hood EE37551

59 C2192 1 Fume Hood EE9353

60 AB007 1 Fume Hood MX3624750

APPENDIX D — ENGINEERING SYSTEM INVENTORY

System Access Served Area / Rooms Filter / Housing Frequency

AHU

37A/37B 5th Floor MER 9 Surgery operating rooms

24 HEPA filters total; (18) 24 x 24 x 11.5 in, (6) 12 x

24 x 11.5 in

Annual test;

condition-based replacement

AHU 46 6th Floor MER Cardiology procedure room

6 HEPA filters;

nominal 30 x 30 x

12 in

Annual test;

condition-based replacement

OR 5

terminal

HEPA

filters

OR 5 ceiling terminals; upstream challenge access to verify

Operating Room 5; served by

AHU 38

2 terminal HEPA filters; no central

HEPA…