36C24226Q0808.docx

36C24226Q0808

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

36C24226Q0808 08-06-2026 Cara Grittner 585-201-6763 08-24-2026

10 AM

EDT

Department of Veterans Affairs 400 Fort Hill Ave.

Canandaigua NY 14424 X X 541380 $19 Million N/A X Department of Veterans Affairs Stratton VA Medical Center 113 Holland Avenue Albany NY 12208 Department of Veterans Affairs Network Contracting Activity 400 Fort Hill Ave.

Canandaigua NY 14424

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

See CONTINUATION Page This firm fixed-price requirement is for one base plus four 12 Month Option periods for the Stratton VA Medical Center in Albany NY a description is included in the SOW (Statement of Work) herewith.

Quotes shall be emailed to Cara.Grittner@va.gov and shall include the information required in Sections B.3 and E.1.

All questions must be submitted by 8/17/2026 by 10:00AM EST to the email address above.

D.2 Attachment must be filled out and signed if you are a Service Disabled Veteran Owned or Veteran Owned Small Business.

Site visit: Thursday, 8/12/2026 at 12:00 pm at the Albany VA Medical Center, 113 Holland Ave., Albany, NY 12208. RSVP to Cara.Grittner@va.gov by Tuesday 8/10/2026 at 2:00 pm to confirm attendance and receive location details.

See CONTINUATION Page X X X One(1) Lisa Harris Contract 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:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C242 Lisa Harris

Department of Veterans Affairs 400 Fort Hill Ave.

Canandaigua NY 14424

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.

Tungsten Network 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:

B.2 STATEMENT OF WORK

Stratton VA Medical Center Albany, New York

Request for Services - Statement of Work (SOW) USP Compliant Pharmacy Certification/& Lab BSC/Fume Hood Certification Services

1. Background Albany VA Medical Center (Albany VAMC) requires a contract to provide all labor, materials and travel to perform the United States Pharmacopeia (USP) 797/800, and VHA directive 1108.12 compliant certification of the pharmacy compounding areas and annual biological safety cabinet (BSC)/fume hood recertifications throughout the Medical Center. This is a Base plus four (4) year contract.

2. Scope (Pharmacy) A. All pharmacy-specific equipment will have Controlled Environment Testing Association (CETA) certification completed at least every six (6) calendar months from the date of the last certification/testing of biological safety cabinets, laminar flow hoods, ceiling mounted high-efficiency particulate air (HEPA) filters, and room spaces/environments in accordance with VHA Directive 1108.12, and USP 797 & 800. In addition, CETA certification of pharmacy sterile compounding areas or equipment must also be completed whenever it is required by USP 797 (e.g. after redesign, construction, replacement or relocation of any primary engineering controls, alteration in configuration of the room, or other event of significance). To ensure compliance with USP 800, certification of non-sterile compounding facilities and equipment will be completed semi-annually. Pharmacy specific spaces and equipment are as follows:

a. Sterile Compounding - 11A Pharmacy Space

i. A1106a ISO Class 7 Anteroom (shared), one (1) ceiling mounted HEPA filter.

ii. A1106b ISO Class 7 HD buffer room: one (1) biological safety cabinet and two (2) ceiling-mounted HEPA filters.

1. 4ft Baker SterilGard - EG404, SN: 137983

iii. A1106c ISO Class 7 non-HD buffer room: one (1) laminar airflow workstation (LAFW) and one (1) ceiling-mounted HEPA filter

1. 4ft Baker EdgeGard - EG4320, SN: 137953

b. Sterile Compounding - 9A Pharmacy Primary Spaces

i. A921- ISO Class 7 Anteroom, one (1) ceiling mounted HEPA filter.

ii. A923 - ISO Class 7 HD buffer room: two (2) biological safety cabinets and two (2) ceiling mounted HEPA filters.

1. 6ft Baker SterilGard - EG604, SN: 129000

2. 4ft Baker SterilGard - EG404, SN: 128979

c. Sterile Compounding: 1B Pharmacy Primary Spaces

i. B122a - Outer room of Segregated Compounding Area, SCA (former anteroom)

ii. B122b: Inner room of SCA, two (2) Laminar Airflow Workbenches, and one (1) ceiling mounted HEPA filter outside SCA.

1. 6ft Baker EdgeGard - EG6320, SN: 144455

2. 4ft Baker EdgeGard - EG4320, SN: 142230

d. Non-sterile Compounding: Negative Pressure 1B Pharmacy Space (testing for USP 800 only)

i. B126a: one (1) Ductless Double Filter Fume Hood, Containment Ventilated Enclosure

1. Test to manufacturer specifications

2. Perform smoke pattern testing with video recording

3. Check velocity

4. Check HEPA filter integrity

ii. Negative Pressure Receiving Area

1. Determine room differential pressures

2. Check functionality of pressure gauge

3. Determine air velocity and calculate air changes per hour

4. Conduct temperature and humidity testing with calibrated device B. The contractor shall:

a. CETA certify spaces listed in section 2A above using CETA application guide (CAG)-003 - current version, semi-annually (every 6 months)

i. Note: Secondary Engineering Controls (SECs) B122a and B122b are non-ISO classified spaces and will be tested to the cleanroom standards for information only.

b. Perform all required semi-annual testing of primary and secondary engineering controls to meet the compounding requirements set forth in USP 797 and USP 800.

c. Perform semi-annual air & surface viable environmental sampling (bacterial & fungal), reporting counts of recovered colony forming units (CFUs). All environmental microbiologic testing is to be performed by an accredited environmental testing laboratory (i.e. American Association for Laboratory Accreditation (A2LA)) and the laboratory report provided to the compounded sterile preparations (CSP) pharmacist. Samples must be labeled, and a diagram of sampling locations provided.

d. Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Albany VA Medical Center. Certification and testing shall conform to USP, CETA and OSHA standards.

i. Sampling shall include:

1. Viable surface sampling of all classified areas (primary and secondary engineering controls) including equipment contained within the primary engineering controls (PEC), and staging or work areas near the PEC that are frequently touched. Sampling for microbial contamination must be conducted semi-annually during certification.

2. Viable air sampling of all classified areas (primary and secondary engineering controls) conducted during semi-annual certification.

e. Perform semi-annual non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions to calculate room ISO rating. This must be completed for all primary and secondary engineering controls.

f. Measure and document HEPA filter(s) air volumes and velocities semi-annually

g. Perform room calculations to determine air changes per hour (ACPH) in each room.

h. For Primary Engineering Controls (BSCs and LAFWs)

i. Perform HEPA filter integrity testing and perform patching of leaks if necessary

ii. Perform prefilter check

iii. Perform viable air (impact volumetric airborne particulate sampling) and surface sampling

iv. Perform non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating

v. Perform dynamic smoke testing (video recorded and made available for download on a secure website) for all primary engineering controls; must have sufficient smoke and record from multiple angles to demonstrate unidirectional airflow and sweeping action over and away from any preparation

vi. Measure downflow air velocity (BSC)

vii. Check exhaust damper (BSC)

viii. Measure inflow velocity (BSC)

ix. Check function of any alarms (BSC)

x. The certification tag must be updated on each of the PECs that pass certification

i. For Secondary Engineering Controls

i. Perform HEPA filer leak testing (integrity testing) for all engineering controls listed in 2A above. If leak is found, patch as appropriate

ii. Perform viable air (impact volumetric airborne particulate sampling) and surface sampling

iii. Perform non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating

iv. Measure pressure differentials between each pair of SECs and between the anteroom and general pharmacy area.

v. Conduct smoke pattern testing between each pair of SECs and between anteroom and general pharmacy area to establish direction of airflow

vi. Test airflow directionality: at air returns and at doors

vii. Conduct temperature and humidity testing with calibrated device

viii. Perform calibration of room pressure differential gauges. Gauges will be affixed with calibration sticker.

ix. Measure and determine Air Changes Per Hour (ACPH) from HVAC, ACPH contributed from PEC, and the total ACPH.

j. Report results as follows (Pharmacy Results Only)

i. Contractor shall provide a written report of all testing and certification results, no later than seven (7) business days following completion of all work (except for viable sampling results). All reports must be sent via email or secure link/portal (due to email size constraints) directly to the COR and to the CSP pharmacist.

ii. At a minimum, this report must contain:

1. Name of CETA-certified technician performing the testing

2. A certificate indicating compliance with testing standards

3. List of equipment used for the testing: manufacturer, model, serial number and calibration due date

4. Number of personnel in the room

5. Type, make, model and serial number for each PEC

6. Each PEC and SEC nonviable particulate counts (including sample volume and time) and ISO classification.

7. Measured air velocity data for PEC, including CFM, average and standard deviation of air velocity measurements and acceptance criteria

8. PEC blower setting and pressure gauge reading (if any)

9. For BSCs: measured downflow air velocity data, acceptance criteria and pass/fail result

10. For BSCs: measured exhaust damper acceptance criteria and pass/fail result

11. For BSCs: inflow velocity test method, measurements and results

12. Air Changes Per Hour (ACPH) from HVAC, ACPH contributed from PEC, and the total ACPH.

13. Pressure differentials between each SEC and the anteroom/pharmacy

14. Results of HEPA leak tests for all filters tested, as well as the results of any patching that was performed

15. If leaks were detected and sealed, include a diagram showing approximate location of sealed leaks

16. Prefilter type, size and condition for each PEC

17. Viable testing results (once available). The microbiology report must include:

a. Sampling location and counts of any CFUs recovered (or as specified in USP 797)

b. Incubation temperature and duration

c. Manufacturer, lot number and expiration for each media lot

d. Positive and negative controls

e. Determination of whether findings are actionable (pass/fail)

f. Chain of custody for samples

18. SEC temperature and relative humidity

19. Video recording of all smoke pattern testing (airflow and dynamic)

20. Alarm test results (if any)

21. A diagram of the areas tested, noting the approximate location of surface, air and particle counts

22. Any recommendations for HEPA replacement/HEPA lifespan

23. Performance standard used for testing

24. The CSP pharmacist must be notified of any microbial growth immediately after it is identified (no later than 48 hours after the report is received by the contractor from the laboratory).

iii. For non-sterile compounding/receiving areas report must include:

1. For Containment Ventilated Enclosure

a. Video recording of smoke pattern testing of the containment ventilated enclosure. Video must be made available for download on a secure website.

b. Results of testing to manufacturer specifications

c. Inflow velocity testing results

d. Assessment of HEPA filters, including any leakage or patching that was needed

e. List of equipment used for the testing: manufacturer, model, serial number and calibration due date

2. For Receiving Area Spaces:

a. Diagram of airflow within the receiving area spaces

b. Report of temperature and humidity testing

c. Pressure gauge verification report with testing parameters and indication of pass/fail.

d. Room air volume and velocity report

e. Number of air changes per hour

f. Room pressure differentials for exterior hallway to receiving area and pharmacy hallway to receiving area

g. List of equipment used for the testing: manufacturer, model, serial number and calibration due date

C. Additional Requirements:

a. The individual performing the testing shall be CETA certified to perform this work. The technician/contractor shall provide a copy of the individuals CETA credentials at time of offer. If, during the contract, a different individual(s) is designated by the contractor, CETA certification of the individual(s) must be provided to the CO and COR and approved prior to the start of work.

b. The contractor shall comply with Federal, State, and Local Laws, and federal regulations as applicable to the performance of this contract; to include USP 797 and USP 800.

c. The contractor shall obtain all necessary licenses and/or permits required to perform the work herein.

d. Contractor will supply all necessary equipment for the certification and microbial testing of the sterile compounding area (cleanroom suite or SCA)

e. The contractor shall follow Albany VAMC protocols for use of personal protective equipment (PPE) in the classified spaces and understand the risks associated with facilities and equipment designed for storage and preparation of hazardous drugs.

f. Disinfect and sanitize all equipment brought into the cleanroom suite or segregated compounding area (SCA) prior to entry (with Caviwipe, followed by sterile 70% isopropyl alcohol or as per current standard operating procedure for the cleanroom suite).

g. The contractor shall ensure all equipment used in testing has been serviced and calibrated as recommended by the manufacturer.

h. Response Time in the Event of Urgent Need (Pharmacy Only): Contractor shall use commercially reasonable efforts to:

a. Respond by telephone to any report of a malfunction requiring repair within one hour of notification.

b. Provide on-site support within 24 hours of notification unless prevented by unforeseen circumstances

3. Scope Laboratory Equipment Certification:

A. Perform annual certification of five (5) Biological Safety Cabinets and six (6) Chemical Fume Hoods in accordance with the following standards and per manufacturer specifications:

B. National Sanitation Foundation (NSF) / American National Standards Institute (ANSI) 49 (Biological Safety Cabinets) C. IEST-RP-CC034.3 (HEPA Filter Leak Testing)

4. Scope Research Equipment A. Perform annual certification of nine (9) Fume Hoods in accordance with the following standards and per manufacturer specifications:

B. ANSI/ASHRAE STANDARD 110-2016 (excluding tracer gas testing)

5. Scope Dental/Prosthetics Equipment A. Perform annual certification of (2) Fume Hoods in accordance with the following standards and per manufacturer specifications:

B. ANSI/ASHRAE STANDARD 110-2016 (excluding tracer gas testing) C. Inventory.

6. Travel and Related Expenses Contractor shall be responsible for its service-related trip expenses including round trip travel, mileage, and overnight living expenses.

7. Title to Equipment Contractor shall not assume possession or control of any part of the equipment. The Government retains ownership to title thereof.

9. Utilities Contractor may use Government utilities, (e.g., electrical power, compressed air, and water) which are available and required for any service performed under this contract.

10. Access to Equipment Contractor shall be provided reasonable access to all equipment that is to be serviced and utility outlets required to do the service. The contractor shall be free to start and stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on duty personnel responsible for such equipment.

11. Technical Support Technical support shall be made available from the Contractor to Stratton VAMC 24/7, 365 days a year via telephone.

12. Parts and Materials All compensation for parts and materials is included in contract price.

13. Parts/Supplies Quality Parts and Supplies provided under this contract shall be new OEM parts.

14. Field Service Reports Contractor shall provide a written or electronic report of all testing and certification results, no later than seven (7) business days following completion of all work (except for viable sampling results). Contractor shall include Summary tables listing all rooms or areas tested and the acceptable limits, actual readings and indication of testing results (e.g. pass/fail) for the designated testing criteria for compliance.

15. Place of Performance.

Stratton VAMC 113 Holland Ave Albany, NY 12208

16. Period of Performance.

Attachments:

1A Layout 9A Layout 11A Layout

1A Layout

9A Layout

11A Layout

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

USP compliant certification for the Sterile Compounding Pharmacy suite, Laboratory equipment, Research equipment, and Dental/Prosthetics equipment Contract Period: Base POP Begin: 10-01-2026 POP End: 09-30-2027

0001AA

Bi-Annual ( Every 6 months) CETA certification for the Sterile Compounding Pharmacy suite

Using CETA application guide (CAG)-003 - current version

0001AB

Annual certification of five (5) Biological Safety Cabinets and six (6) Chemical Fume Hoods in accordance with manufacturer specifications and the following standards: NSF / ANSI 49 (Biological Safety Cabinets) and IEST-RP-CC034.3 (HEPA Filter Leak Testing)

0001AC

Annual certification of nine (9) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications (excluding tracer gas testing)

0001AD

Dental/Prosthetics Equipment : Annual certification of two (2) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications(excluding tracer gas testing)

Semi- Annual Environmental Sampling and Testing

0002AA

Primary Engineering Controls (PEC)- Biological Safety Cabinets (BSC) and Laminar Airflow Workbenches (LAFWs)

To include :HEPA filter integrity testing and perform patching of leaks if necessary Perform prefilter check, viable air (impact volumetric airborne particulate sampling) and surface sampling, non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating ,dynamic smoke testing (video recorded and made available for download on a secure website) for all primary engineering controls; must have sufficient smoke and record from multiple angles to demonstrate unidirectional airflow and sweeping action over and away from any preparation Measure downflow air velocity (BSC), Check exhaust damper (BSC) , Measure inflow velocity (BSC),Check function of any alarms (BSC), The certification tag must be updated on each of the PECs that pass certification

Contract Period: Base

0002AB

Secondary Engineering Controls (SECs)

To Include:

HEPA filer leak testing (integrity testing) for all engineering controls. If leak is found, patch as appropriate, viable air (impact volumetric airborne particulate sampling) and surface sampling non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating Measure pressure differentials between each pair of SECs and between the anteroom and general pharmacy area, smoke pattern testing between each pair of SECs and between anteroom and general pharmacy area to establish direction of airflow, Test airflow directionality: at air returns and at doors, Conduct temperature and humidity testing with calibrated device, Perform calibration of room pressure differential gauges. Gauges will be affixed with calibration sticker. Air Changes Per Hour (ACPH) from HVAC, ACPH contributed from PEC, and the total ACPH.

Contract Period: Base

Report (Pharmacy Results Only)

Contractor shall provide a written report of all testing and certification results (see SOW for details) Contract Period: Base

USP compliant certification for the Sterile Compounding Pharmacy suite, Laboratory equipment, Research equipment, and Dental/Prosthetics equipment Contract Period: Option 1 POP Begin: 10-01-2027 POP End: 09-30-2028

1001AA

Bi- Annual (Every 6 months) CETA certification for the Sterile Compounding Pharmacy suite

1001AB

Annual certification of five (5) Biological Safety Cabinets and six (6) Chemical Fume Hoods in accordance with manufacturer specifications and the following standards: NSF / ANSI 49 (Biological Safety Cabinets) and IEST-RP-CC034.3 (HEPA Filter Leak Testing)

1001AC

Annual certification of nine (9) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications (excluding tracer gas testing)

1001AD

Dental/Prosthetics Equipment : Annual certification of two (2) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications(excluding tracer gas testing)

Semi- Annual Environmental Sampling and Testing

1002AA

Primary Engineering Controls (PEC)- Biological Safety Cabinets (BSC) and Laminar Airflow Workbenches (LAFWs)

Perform prefilter check, viable air (impact volumetric airborne particulate sampling) and surface sampling, non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating ,dynamic smoke testing (video recorded and made available for download on a secure website) for all primary engineering controls; must have sufficient smoke and record from multiple angles to demonstrate unidirectional airflow and sweeping action over and away from any preparation Measure downflow air velocity (BSC), Check exhaust damper (BSC) , Measure inflow velocity (BSC),Check function of any alarms (BSC), The certification tag must be updated on each of the PECs that pass certification

Contract Period: Option 1

1002AB

Secondary Engineering Controls (SECs)

HEPA filer leak testing (integrity testing) for all engineering controls. If leak is found, patch as appropriate, viable air (impact volumetric airborne particulate sampling) and surface sampling non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating Measure pressure differentials between each pair of SECs and between the anteroom and general pharmacy area, smoke pattern testing between each pair of SECs and between anteroom and general pharmacy area to establish direction of airflow, Test airflow directionality: at air returns and at doors, Conduct temperature and humidity testing with calibrated device, Perform calibration of room pressure differential gauges. Gauges will be affixed with calibration sticker. Air Changes Per Hour (ACPH) from HVAC, ACPH contributed from PEC, and the total ACPH.

Contract Period: Option 1

Report (Pharmacy Results Only)

Contractor shall provide a written report of all testing and certification results (see SOW for details) Contract Period: Option 1

0.00

USP compliant certification for the Sterile Compounding Pharmacy suite, Laboratory equipment, Research equipment, and Dental/Prosthetics equipment Contract Period: Option 2 POP Begin: 10-01-2028 POP End: 09-30-2029

2001AA

Bi-Annual (Every 6 months) CETA certification for the Sterile Compounding Pharmacy suite

Contract Period: Option 2

2001AB

Annual certification of five (5) Biological Safety Cabinets and six (6) Chemical Fume Hoods in accordance with manufacturer specifications and the following standards: NSF / ANSI 49 (Biological Safety Cabinets) and IEST-RP-CC034.3 (HEPA Filter Leak Testing)

2001AC

Annual certification of nine (9) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications (excluding tracer gas testing)

2001AD

Dental/Prosthetics Equipment : Annual certification of two (2) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications(excluding tracer gas testing)

Semi- Annual Environmental Sampling and Testing

2002AA

Primary Engineering Controls (PEC)- Biological Safety Cabinets (BSC) and Laminar Airflow Workbenches (LAFWs)

Perform prefilter check, viable air (impact volumetric airborne particulate sampling) and surface sampling, non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating ,dynamic smoke testing (video recorded and made available for download on a secure website) for all primary engineering controls; must have sufficient smoke and record from multiple angles to demonstrate unidirectional airflow and sweeping action over and away from any preparation Measure downflow air velocity (BSC), Check exhaust damper (BSC) , Measure inflow velocity (BSC),Check function of any alarms (BSC), The certification tag must be updated on each of the PECs that pass certification

Contract Period: Option 2

2002AB

Secondary Engineering Controls (SECs)

HEPA filer leak testing (integrity testing) for all engineering controls. If leak is found, patch as appropriate, viable air (impact volumetric airborne particulate sampling) and surface sampling non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating Measure pressure differentials between each pair of SECs and between the anteroom and general pharmacy area, smoke pattern testing between each pair of SECs and between anteroom and general pharmacy area to establish direction of airflow, Test airflow directionality: at air returns and at doors, Conduct temperature and humidity testing with calibrated device, Perform calibration of room pressure differential gauges. Gauges will be affixed with calibration sticker. Air Changes Per Hour (ACPH) from HVAC, ACPH contributed from PEC, and the total ACPH.

Contract Period: Option 2

Report (Pharmacy Results Only)

Contractor shall provide a written report of all testing and certification results (see SOW for details) Contract Period: Option 2

USP compliant certification for the Sterile Compounding Pharmacy suite, Laboratory equipment, Research equipment, and Dental/Prosthetics equipment Contract Period: Option 3 POP Begin: 10-01-2029 POP End: 09-30-2030

3001AA

Bi-Annual ( Every 6 months) CETA certification for the Sterile Compounding Pharmacy suite

Contract Period: Option 3

3001AB

Annual certification of five (5) Biological Safety Cabinets and six (6) Chemical Fume Hoods in accordance with manufacturer specifications and the following standards: NSF / ANSI 49 (Biological Safety Cabinets) and IEST-RP-CC034.3 (HEPA Filter Leak Testing)

3001AC

Annual certification of nine (9) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications (excluding tracer gas testing)

3001AD

Dental/Prosthetics Equipment : Annual certification of two (2) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications(excluding tracer gas testing)

Semi- Annual Environmental Sampling and Testing

3002AA

Primary Engineering Controls (PEC)- Biological Safety Cabinets (BSC) and Laminar Airflow Workbenches (LAFWs)

Perform prefilter check, viable air (impact volumetric airborne particulate sampling) and surface sampling, non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating ,dynamic smoke testing (video recorded and made available for download on a secure website) for all primary engineering controls; must have sufficient smoke and record from multiple angles to demonstrate unidirectional airflow and sweeping action over and away from any preparation Measure downflow air velocity (BSC), Check exhaust damper (BSC) , Measure inflow velocity (BSC),Check function of any alarms (BSC), The certification tag must be updated on each of the PECs that pass certification

Contract Period: Option 3

3002AB

Secondary Engineering Controls (SECs)

HEPA filer leak testing (integrity testing) for all engineering controls. If leak is found, patch as appropriate, viable air (impact volumetric airborne particulate sampling) and surface sampling non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating Measure pressure differentials between each pair of SECs and between the anteroom and general pharmacy area, smoke pattern testing between each pair of SECs and between anteroom and general pharmacy area to establish direction of airflow, Test airflow directionality: at air returns and at doors, Conduct temperature and humidity testing with calibrated device, Perform calibration of room pressure differential gauges. Gauges will be affixed with calibration sticker. Air Changes Per Hour (ACPH) from HVAC, ACPH contributed from PEC, and the total ACPH.

Contract Period: Option 3

Report (Pharmacy Results Only)

Contractor shall provide a written report of all testing and certification results (see SOW for details) Contract Period: Option 3

USP compliant certification for the Sterile Compounding Pharmacy suite, Laboratory equipment, Research equipment, and Dental/Prosthetics equipment Contract Period: Option 4

4001AA

Bi-Annual (Every 6 months) CETA certification for the Sterile Compounding Pharmacy suite

4001AB

Annual certification of five (5) Biological Safety Cabinets and six (6) Chemical Fume Hoods in accordance with manufacturer specifications and the following standards: NSF / ANSI 49 (Biological Safety Cabinets) and IEST-RP-CC034.3 (HEPA Filter Leak Testing)

4001AC

Annual certification of nine (9) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications (excluding tracer gas testing)

4001AD

Dental/Prosthetics Equipment : Annual certification of two (2) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications(excluding tracer gas testing)

Semi- Annual Environmental Sampling and Testing

4002AA

Primary Engineering Controls (PEC)- Biological Safety Cabinets (BSC) and Laminar Airflow Workbenches (LAFWs)

Perform prefilter check, viable air (impact volumetric airborne particulate sampling) and surface sampling, non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating ,dynamic smoke testing (video recorded and made available for download on a secure website) for all primary engineering controls; must have sufficient smoke and record from multiple angles to demonstrate unidirectional airflow and sweeping action over and away from any preparation Measure downflow air velocity (BSC), Check exhaust damper (BSC) , Measure inflow velocity (BSC),Check function of any alarms (BSC), The certification tag must be updated on each of the PECs that pass certification

Contract Period: Option 4

4002AB

Secondary Engineering Controls (SECs)

HEPA filer leak testing (integrity testing) for all engineering controls. If leak is found, patch as appropriate, viable air (impact volumetric airborne particulate sampling) and surface sampling non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating Measure pressure differentials between each pair of SECs and between the anteroom and general pharmacy area, smoke pattern testing between each pair of SECs and between anteroom and general pharmacy area to establish direction of airflow, Test airflow directionality: at air returns and at doors, Conduct temperature and humidity testing with calibrated device, Perform calibration of room pressure differential gauges. Gauges will be affixed with calibration sticker. Air Changes Per Hour (ACPH) from HVAC, ACPH contributed from PEC, and the total ACPH.

Contract Period: Option 4

Report (Pharmacy Results Only)

Contractor shall provide a written report of all testing and certification results (see SOW for details) Contract Period: Option 4

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SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

(a) Definitions. The clause at Federal Acquisition Regulation (FAR) 52.202-1, Definitions, is incorporated by reference.

(b) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(c) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(d) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(e) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause FAR 52.233-1, Disputes, which is incorporated in this contract by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence. Examples of occurrences include acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. When an excusable delay occurs, the Contractor shall—

(1) Notify the Contracting Officer in writing as soon as possible;

(2) Remedy the delay as quickly as possible; and

(3) Notify the Contracting Officer when the occurrence is over.

(g) Invoice. The Government will handle invoices according to the Prompt Payment Act (31 U.S.C. 3903) and 5 CFR part 1315. The Contractor shall submit invoices to the address designated in the contract to receive invoices. An invoice must include the information required by 5 CFR part 1315.9(b).

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees, and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark, or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date that appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(4) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable;

(D) Contractor point of contact; and

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(5) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by FAR part 33 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see FAR part 32).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a termination for cause.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on-

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures for interest credits prescribed in FAR part 32 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon—

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause…