36C25226Q0608 Pharmacy Compounding Cert.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

607-26-4-6022-0066

36C25226Q0608 07-31-2026

Anthony Hughes (414) 844-4800 08-21-2026

12:00 PM

36C252

Department of Veterans Affairs

Great Lakes Acquisition Center

115 South 84th Street, Suite 101

Milwaukee WI 53214-1476

X 100

X

541380

$19 Million

N/A

N/A

36C607

Department of Veterans Affairs

William S. Middleton Memorial Veterans Hospital

2500 Overlook Terrace

Madison WI 53705-2254

36C252

Department of Veterans Affairs

Great Lakes Acquisition Center

115 South 84th Street, Suite 101

Milwaukee WI 53214-1476

Department of Veterans Affairs

Financial Services Center

PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

Pharmacy Compounding Area Semi-Annual Certification and

Monthly Environmental Sampling Services for the William S.

Middleton Memorial Veterans Hospital, Madison, Wisconsin.

The Service Contract Labor Standards statute applies to the services being provided under this Contract. See Section D for the current Department of Labor Wage Determination for

Dane County, Wisconsin.

See CONTINUATION Page

607-3660162-6022-850300-2543 010050100

X 1

Ashley Johnson

36C25226Q0608

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA (continuation from Standard Form 1449)

OFFERORS MUST COMPLETE AND RETURN ALL INFORMATION DESIGNATED HEREIN

PRIOR TO THE TIME SPECIFIED IN BLOCK 8 OF SF 1449 IN ORDER TO BE CONSIDERED

FOR AWARD.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

1. CONTRACT ADMINISTRATION: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

CONTRACTOR NAME _____________________________________

ADDRESS ________________________________________________

CITY-STATE-ZIP __________________________________________

POINT OF CONTACT/TITLE ________________________________

PHONE NUMBER ______________________________________

FAX NUMBER ______________________________________

E-MAIL ADDRESS ______________________________________

SAM UEI NO. ____________________________________________

CAGE CODE _____________________________________________

b. GOVERNMENT: CONTRACTING OFFICE CODE: 36C252

DEPARTMENT OF VETERANS AFFAIRS

GREAT LAKES ACQUISITION CENTER

115 S. 84TH ST., STE 100

MILWAUKEE WI 53214-1476

2. FAR OVERHAUL (RFO): The Federal Acquisition Regulations (FAR) are undergoing the most thorough revision in their history, known as the Revolutionary FAR Overhaul (RFO). Accordingly, references to the updated regulations will be cited as RFO, rather than FAR, e.g., RFO 52.212-4 instead of FAR 52.212-4. The RFO may be found at RFO.

3. ACQUISITION OF COMMERCIAL ITEMS: This Request for Quote (RFQ) solicitation is issued under the authority of Revolutionary FAR Overhaul Part 12 - Acquisition of Commercial Products and Commercial Services. FAR Part RFO 14 and RFO 15 will not be used. From this RFQ, the

Government intends to award a firm fixed price contract where the contractor provides a price that is not subject to any adjustment on the basis of the contractor’s cost experience in performing the contract.

https://www.acquisition.gov/far-overhaul/far-part-deviation-guide

(Note: The terms “offeror” and “quoter” are both used in this Solicitation. For the purposes of this

Solicitation, these terms are interchangeable; there is no difference in meaning between the two.)

4. SET-ASIDE (If any): See box 10 of STANDARD FORM 1449.

5. SOLICITATION TIMELINE SUMMARY:

A. RFQ QUESTIONS:

In order to maintain integrity of this solicitation and subsequent award date, all offerors are advised that any question and answer requests must be submitted in a written form via e-mail to Contract Specialist

Anthony.Hughes2@va.gov no later than THURSDAY AUGUST 13, 2026, AT NOON LOCAL TIME.

Contracting will issue a consolidated response via solicitation amendment to https://sam.gov Contract

Opportunities within 2 business days to all parties.

B. SOLICITATION CLOSES/QUOTES DUE:

See box 8 of STANDARD FORM 1449 or most recent Amendment.

C. SUBMISSION OF QUOTE:

See 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services and addendum for specific instructions to offerors.

6. INVOICES: Use of the invoicing procedures set forth in this Contract are mandatory and supersede any other invoicing procedures otherwise used by the contractor. The contractor is responsible for the proper, timely submission of all invoices for work that has been completed under this Contract and accepted by the Government. Invoice payment, including the calculation of late fees when applicable, shall be conducted in accordance with current Department of Veterans Affairs policies and procedures at the time an invoice is submitted. Under no circumstances will a late payment be grounds for termination of this Contract.

a. Electronic Submission of Invoices: Invoices must be submitted after all work is completed for stand-alone Contracts or monthly in arrears for long-term Contracts, in accordance with: VAAR

852.232-72 Electronic Submission of Payment Requests. Invoices shall not be submitted for work not yet performed.

b. Payment in Arrears: Payment will be made in arrears upon receipt of a properly prepared invoice.

Advance payment for work not yet performed is not authorized under this Contract.

c. Electronic Accounts: Before an invoice can be submitted or payment rendered, all contractors must establish a payment account with the Department of Veteran Affairs Financial Services

Center (VAFSC) and register with the Tungsten Network for free electronic submission of invoices.

1. VAFSC Payment Account: A VAFSC payment account is established via the VAFSC

Customer Engagement Portal at VAFSC Customer Engagement Portal. For assistance, VAFSC customer service is available at (877) 353-9791, option 2, or e-mail at vafsccshd@mail.va.gov.

mailto:Anthony.Hughes2@va.gov https://sam.gov/ https://www.cep.fsc.va.gov/ mailto:vafsccshd@mail.va.gov

2. Tungsten Network: Registration with the Tungsten Network may be accomplished at

Tungsten Network Registration. Additional information and assistance may be found at

Introduction - Simplified Invoicing with the Tungsten Network. Tungsten Network support is available at (877) 489-6135 or e-mail at VA.Registration@Tungsten-Network.com.

Contractors shall submit an electronic invoice by the tenth (10th) of the following month services were performed or goods delivered via the Tungsten Network through the website at

Tungsten Network Portal.

d. Invoice Contents: All invoices must reference the contractor’s name and address, customer name, Contract number, appropriate obligation/funding order number, description of services or supplies provided, quantity, unit price, and total invoice amount (any additional info). Invoices must also include any payment discount terms.

e. Electronic Payment: All payments by the Government to the contractor will be made in accordance with FAR 52.232-33 Payment by Electronic Funds Transfer-System for Award

Management

7. NONPERSONAL SERVICES CONTRACT: This Contract is a nonpersonal services contract, as defined in FAR 37.101. VA personnel will not exercise any supervision or control over Contractor personnel performing work under this Contract. Such personnel shall be accountable solely to the

Contractor, which in turn is responsible to the Government for execution of the services under this

Contract.

8. CONTRACTING OFFICER AUTHORITY: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the

Contracting Officer is authorized to make commitment or issue changes that will affect price, quantity or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority, and no adjustment will be made in the contract price to cover any increase in cost incurred thereof.

9. FACILITY REQUIREMENTS: In addition to any other requirements set forth in this Contract, the Contractor, including its employees, agents, and subcontractors (collectively “the Contractor”), shall comply with the following facility requirements. Failure to comply with these requirements shall be considered a material breach of this Contract and may be a violation of Federal law resulting in charges answerable in the United States District Court.

a. The Contractor is responsible for following all on-site facility policies.

b. All VA property is considered Federal property, and all Federal laws are applicable.

c. It is the responsibility of the Contractor to park in the appropriate designated parking areas.

Information on parking is available from the VA Police Section. The VA will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

d. All VA facilities are drug free. Possession of drugs, to include marijuana and all marijuana byproducts are prohibited.

https://registration.tungsten-network.com/start https://us.tungsten-network.com/customer-campaigns/veteransaffairs/ mailto:VA.Registration@Tungsten-Network.com https://portal.tungsten-network.com/Login.aspx

e. All contractor personnel are required to adhere to all VA rules and regulations.

f. Smoking, including vaping products, is prohibited on the entire campus, both inside and outside the VA Facility.

g. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search.

h. VHA DIRECTIVE 1192: This Veterans Health Administration (VHA) directive establishes policy and provides guidance for the prevention of seasonal influenza in VHA facilities through the vaccination or masking of health care personnel (HCP). AUTHORITY: Title 38

United States Code (U.S.C.) 7301(b), 7318(b). Contractor is responsible in ensuring that all aspects of this directive are implemented, including providing face masks and influenza vaccines for all employees working at a VA facility.

10. SECURITY & PRIVACY CONTROL: Contractors shall coordinate all badging, background checks, and fingerprinting with the COR or otherwise designated facility point of contact. Reference VA Handbook 0710, VA Handbook 0735, VA Directive 0735.

11. RECORDS MANAGEMENT OBLIGATIONS:

a. Applicability: This section applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

b. Definitions: “Federal Record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal Record:

1. includes VA records;

2. does not include personal materials;

3. applies to records created, received, or maintained by Contractors pursuant to their VA contract; and

4. may include deliverables and documentation associated with deliverables.

c. Requirements:

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36

CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA)

(5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for

Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. The facility and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of the facility or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting

Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to the facility. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in this Contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the

Government’s behalf, without the express written permission of the Head of the Contracting

Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to the facility’s control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in this Contract. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and the facility’s guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with the facility’s policy.

8. The Contractor shall not create or maintain any records containing any non-public facility information that are not specifically tied to or authorized by the Contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The facility owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which the facility shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training.

The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. The facility, in coordination with the COR/POC, will provide any required training under this subparagraph.

d. Flow-down of requirements to Subcontractors:

1. The Contractor shall incorporate the substance of this section, its terms and requirements including this paragraph, in all subcontracts under this Contract and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the

Contractor.

[Remainder of Page Intentionally Left Blank – End of Section B.1]

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

2.00 JB __________________ __________________

Semi-Annual Pharmacy Compounding Area Certification

Contract Period: Base Year

POP Begin: 09-01-2026

POP End: 08-31-2027

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

PRODUCT/SERVICE CODE: H241 - Equipment and Materials Testing-

Refrigeration, Air Conditioning, and Air Circulating Equipment

10.00 JB __________________ __________________

Monthly Environmental Sampling (2 months included in certifications)

Contract Period: Base Year

POP Begin: 09-01-2026

POP End: 08-31-2027

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option Year 1

POP Begin: 09-01-2027

POP End: 08-31-2028

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option Year 1

POP Begin: 09-01-2027

POP End: 08-31-2028

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option Year 2

POP Begin: 09-01-2028

POP End: 08-31-2029

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option Year 2

POP Begin: 09-01-2028

POP End: 08-31-2029

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option Year 3

POP Begin: 09-01-2029

POP End: 08-31-2030

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option Year 3

POP Begin: 09-01-2029

POP End: 08-31-2030

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option Year 4

POP Begin: 09-01-2030

POP End: 08-31-2031

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option Year 4

POP Begin: 09-01-2030

POP End: 08-31-2031

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

GRAND TOTAL __________________

[End of Section B.2]

B.3 PERFORMANCE WORK STATEMENT

Pharmacy Compounding Area Certification and Environmental Sampling for the

William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin

A. Overview: This Performance Work Statement establishes the requirements for semi-annual pharmacy compounding area certifications and monthly environmental sampling services at the William S.

Middleton Memorial Veterans Hospital.

1. Description of Services: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, travel, tools, materials, supervision, and other items and non-personal services necessary to perform semi-annual pharmacy compounding area certifications and monthly environmental sampling.

2. Place of Performance: William S. Middleton Memorial Veterans Hospital

2500 Overlook Terrace

Madison, Wisconsin 53705-2254

3. Primary Work Location: The majority of the work for this contract will be completed in Building

1, 1st Floor, C-Wing, Rooms C1142, 1142A, & 1142B (Pharmacy Compounding Area) of the

Inpatient Pharmacy.

4. Government Furnished Equipment: The Government will not provide any Government Furnished

Equipment (GFE) for performance of the services under this Contract.

B. Scope of Work: The Contractor shall test and inspect the hospital’s pharmacy compounding area to provide certification of the space in accordance with USP 797, USP 800, and CAG-003-2022.

1. Semi-Annual Certification Inspections: Semi-annual certification inspections shall occur in the months of September and March for the base and each option year.

2. Monthly Environmental Sampling: Monthly environmental sampling shall occur during each calendar month and be included with the semi-annual certification inspection during September and March. For all other months, the environmental sampling shall be completed individually.

Monthly environmental sampling shall consist of Surface Viable Environmental Sampling only, as marked with an asterisk for each area to be inspected, as follows: * (Also complete during the monthly environmental sampling.)

3. Areas to be Inspected: For each area and equipment noted below, complete the certification tests and inspection per the standards and guidelines of USP 797, USP 800, and CAG-003-2022.

a. Ante Room (Room #C1142): Complete the following items during the semi-annual certifications.

(1) Airflow Test – ACPH

(2) Room Segregation Test

(3) Room Pressurization Test

(4) HEPA Filter Integrity Test

(5) Airborne Non-Viable Environmental Sampling

(6) Airborne Viable Environmental Sampling

(7) Surface Viable Environmental Sampling* (Also complete during the monthly environmental sampling.)

b. IV Prep Room/Non-Hazardous Drug Buffer Room (Room #C1142A): Complete the following items during the semi-annual certifications.

(1) Airflow Test – ACPH

(2) Room Segregation Test

(3) Room Pressurization Test

(4) HEPA Filter Integrity Test

(5) Airborne Non-Viable Environmental Sampling

(6) Airborne Viable Environmental Sampling

(7) Surface Viable Environmental Sampling* (Also complete during the monthly environmental sampling.)

c. Laminar Airflow Workstation Certification (Model EG-6252, SN 141662) located in Room

#C1142A: Complete the following items during the semi-annual certifications.

(1) Airflow Velocity Test

(2) HEPA Filter Leak Test

(3) Induction Leak Test

(4) Backstreaming Test

(5) Airflow Smoke Pattern Test

(6) Airborne Non-Viable Environmental Sampling

(7) Airborne Viable Environmental Sampling

(8) Surface Viable Environmental Sampling* (Also complete during the monthly environmental sampling.)

(9) Dynamic Visual Smoke Test

d. Laminar Airflow Workstation Certification (Model EG-4252, SN 141664) located in Room

#C1142A: Complete the following items during the semi-annual certifications.

(1) Airflow Velocity Test

(2) HEPA Filter Leak Test

(3) Induction Leak Test

(4) Backstreaming Test

(5) Airflow Smoke Pattern Test

(6) Airborne Non-Viable Environmental Sampling

(7) Airborne Viable Environmental Sampling

(8) Surface Viable Environmental Sampling* (Also complete during the monthly environmental sampling.)

(9) Dynamic Visual Smoke Test

e. Chemo Prep Room/Hazardous Drug Buffer Room (Room #C1142B): Complete the following items during the semi-annual certifications.

(1) Airflow Test – ACPH

(2) Room Segregation Test

(3) Room Pressurization Test

(4) HEPA Filter Integrity Test

(5) Airborne Non-Viable Environmental Sampling

(6) Airborne Viable Environmental Sampling

(7) Surface Viable Environmental Sampling* (Also complete during the monthly environmental sampling.)

f. Biological Safety Cabinet Certification (Model SG-404M, SN 141665) located in Room

#C1142B: Complete the following items during the semi-annual certifications.

(1) Airflow Velocity Test

(2) HEPA Filter Leak Test

(3) NSF Airflow Smoke Pattern Test

(4) Airborne Non-Viable Environmental Sampling

(5) Airborne Viable Environmental Sampling

(6) Surface Viable Environmental Sampling* (Also complete during the monthly environmental sampling.)

(7) Dynamic Visual Smoke Test

g. Biological Safety Cabinet Certification (Model SG-404M, SN 141663) located in Room

#C1142B: Complete the following items during the semi-annual certifications.

(1) Airflow Velocity Test

(2) HEPA Filter Leak Test

(3) NSF Airflow Smoke Pattern Test

(4) Airborne Non-Viable Environmental Sampling

(5) Airborne Viable Environmental Sampling

(6) Surface Viable Environmental Sampling* (Also complete during the monthly environmental sampling.)

(7) Dynamic Visual Smoke Test

h. HD Non-HEPA Pass Through: Complete Surface Viable Environmental Sampling during the semi-annual certifications and monthly environmental sampling.

i. IV Non-HEPA Pass Through: Complete Surface Viable Environmental Sampling during the semi-annual certifications and monthly environmental sampling.

j. Air Handling Unit: Complete air handling unit prefilter inspections during the semi-annual certifications.

C. Documentation/Reports/Deliverables: After completion of work, the Contractor shall provide, at the minimum, the following deliverables:

1. Semi-Annual Certification Reports: These reports shall be provided within 15 calendar days following the date of each semi-annual test/inspection (2 reports per year). The following sub-reports and documentation shall be included with the report.

a. USP 797/800 Compliance Checklist

b. Compounding Area Drawing indicating rooms, hoods, HEPA locations, particle count locations, and pressure gradients

c. Air Changes Per Hour Test Reports

d. Pressure Gradient, Temperature, and Humidity Reports

e. HEPA Filter Test Report

f. ISO Class Determination Reports with particle counts included

g. Laminar Flow Hood Test Reports

h. Biological Safety Cabinet Test Reports

i. Compounding Area Drawing indicating rooms and microbial sample locations

j. Environmental Sampling Results Report

k. Technician Certifications

l. Test Equipment Calibrations (shall be completed within the last year)

2. Monthly Environmental Sampling Results Reports: These reports shall be provided within 10 calendar days following the date of the monthly environmental sampling (10 individual reports per year; the other 2 reports shall be included in the semi-annual certification reports). These reports shall include, without limitation:

a. The findings from the monthly environmental sampling;

b. Recommended follow-on actions, if required;

c. The date and time the environmental sampling occurred; and

d. The name of the technician that performed the environmental sampling.

3. Report Submission: The Contractor shall provide electronic copies of the reports in pdf format to the designated VA staff emails for the COR, ACOR, Chief Engineer, Maintenance & Operations

Supervisor, Pharmacy Compounding and Operations Support Supervisor, and Associate Chief of

Pharmacy.

D. Scheduling: The Contractor shall comply with the following scheduling requirements when performing the services under this Contract.

1. Work Scheduled in Advance: As this work will be disruptive to pharmacy compounding processes, all work shall be coordinated and scheduled a minimum of one week prior to the desired start date with the COR and designated Pharmacy staff.

2. Business Hours: Unless otherwise indicated or coordinated in advance with the COR, the

Contractor shall perform the services under this Contract during normal business hours, defined as Monday through Friday, 7:00 a.m. to 5:00 p.m. local time, excluding Federal Holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government-directed facility closings.

3. Federal Holidays: The precise day a Federal Holiday is observed is available at U.S. Office of

Personnel Management: Federal Holidays. Federal Holidays include:

1. New Year’s Day;

2. Birthday of Martin Luther King, Jr.;

3. Washington’s Birthday;

4. Memorial Day;

5. Juneteenth National Independence Day;

6. Independence Day;

https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/#url=Overview https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/#url=Overview

7. Labor Day;

8. Columbus Day;

9. Veterans Day;

10. Thanksgiving Day;

11. Christmas Day; and

12. Any other day declared a Federal Holiday by Presidential Proclamation.

E. Contractor Qualifications: Contractor personnel performing work under this contract shall be trained and certified to test, inspect, and provide certification for Pharmacy Compounding areas in accordance with USP 797, USP 800, and CAG-003-2022 (current editions). Technician certifications shall be maintained and remain current during the contract period of performance. Technician certifications shall include:

1. CETA National Board of Testing Registered Certification Professional for Sterile Compounding

Facilities; and

2. NSF Certificate of Accreditation for Biosafety Cabinet Field Certifier or equivalent.

F. Additional Services or Supplies: The Contractor shall provide a quote to the COR for repair of any deficiencies found during any of the services being performed under this Contract within one (1) week of identifying such deficiency. The Contracting Officer, in the Contracting Officer’s sole discretion, may award a bilateral contract modification for such additional services or supplies in accordance with RFO 52.212-4(d). Any modifications that authorize such additional services or supplies under this paragraph shall be considered within the scope of the Contract.

G. Facility Security, Safety, and Privacy Requirements: The following requirements apply to the

Contractor, its employees, and any subcontractors that may be performing work on behalf of the

Contractor, including the subcontractor’s employees (collectively, the Contractor).

1. Check-in/Check-out Requirements: Contractor personnel performing work under this contract must check in with the VA Contracting Officer Representative (COR) or designee in the

Engineering area, Building 1, Ground Floor, B-Wing, Room B74 in addition to any other facility check-in/check-out requirements.

2. Badging: Prior to commencing work, all contractor personnel shall complete the VA’s badging process. Contractor employee shall not start working at any government facility until his/her fingerprints have been cleared through the suitability section of HR. The Contractor shall contact the COR at the VA facility to set up a date and time for its employees to get sponsored. Once clearance has been verified, the Contractor employees shall be sponsored and issued a Contractor identification badge from the facility Personal Identity Verification (PIV) security section. All

Contractor personnel are required to wear the identification badge the entire time they are on VA facility grounds. All personnel shall wear their identification badge so that it is clearly visible from the front, above the waist and below the face.

3. Physical Security: Any interior or exterior doors that shall be unlocked to gain access shall be kept locked during the performance of work unless it results in the creation of a safety hazard. In those instances, the Contractor is responsible to take necessary actions to maintain the same level of security prior to gaining access/performing work. Should any other devices need to be unlocked like an entry gate, those devices shall be locked immediately upon entry or exit. At no time shall the Contractor allow any person into a locked area or loan keys/access cards to another person. The Contractor may be held in default for failure to comply with this requirement and subject the Contractor and employees to contract and other legal remedies.

4. Information Security: The Contractor agrees that none of its officers or employees shall use or reveal any research, statistical, medical, or security information that may be obtained during the performance of the work or as a result their presence on Government premises without the written consent of the Government.

5. Building Security and Keys: The Government may provide the Contractor with keys to access the required rooms for services provided under this Contract, as applicable. The Contractor shall not lend keys or open locked rooms or areas to permit entrance by persons other than the Contractor’s assigned staff. The Contractor shall be responsible for securing areas upon completion of duties.

Keys must not be duplicated. Any keys lost by the Contractor will be replaced by the

Government, and the Contractor will be charged the replacement value of the lost key and for any expenses incurred for rekeying caused by the lost key. The Contractor must notify the COR/POC of any lost or suspected lost key as soon as possible.

6. Noninterference with Facility Functions: The Contractor must perform its services under this

Contract in a manner that does not interfere with the facility’s functions, including maintaining all tools and equipment in an orderly fashion and cleaning the work area at the conclusion of a service visit, as applicable.

7. Network/Data Security: Contractor personnel shall not be granted logical access to any VA network, VA information system, or VA-sensitive information, and no Contractor-owned equipment shall be connected to the VA network unless separately authorized in writing by the

Contracting Officer and VA IT Security. The Contractor shall ensure that all devices, materials, and media brought onto VA property are free of malicious code and do not contain or store VA-sensitive information.

8. Safety – Infection Control Risk Assessment (ICRA) Requirements: During the performance of this Contract, the Contractor must follow all ICRA requirements, as set forth by the infection control staff.

9. Safety – OSHA and CDC Requirements: The Contractor must comply with all OSHA and CDC requirements while performing work under this Contract, including without limitation: use of personal protective equipment; proper placement of caution signs; and providing the COR/POC with all Material Safety Data Sheets, as applicable, prior to beginning any work under this

Contract.

10. Patient Privacy Requirements: Due to the possibility that medical information may be accessible and/or visible to Contractor employees while performing work under this Contract, the Contractor shall ensure that no patient information is divulged.

11. Fire Safety: The Contractor shall comply with all facility fire safety requirements, to include maintaining a clear means of egress while performing work under this Contract.

12. Photography: Photographs may be taken on facility grounds only during the performance of the services provided under this Contract; photographs shall not be taken for any other reason.

Photographs must not contain any images or other personal information of patients, Government personnel, or other contractor personnel. Any violation of this policy is grounds for immediate revocation of that person’s access to the facility.

13. Legal/Professional Standards Compliance. All work performed under this Contract must comply with all applicable laws, regulations, ordinances, rules, and professional standards, specifically including without limitation: the Centers for Disease Control and Prevention (CDC); the

Occupational Safety and Health Administration (OSHA); the Environmental Protection Agency

(EPA); the National Fire Protection Association (NFPA); the Food and Drug Administration

(FDA); and The Joint Commission.

14. Jobsite Cleanliness: The Contractor shall remove and dispose of all debris, packaging, and waste created during performance of this Contract and otherwise keep the work area clean at all times, including the proper disposal of all personal trash (e.g., food packaging). The following specific requirements apply to all work performed under this Contract:

a. The Contractor shall provide its own off-site trash containers.

b. Waste disposal, particularly hazardous waste, must be coordinated with the facility via the

COR/POC.

c. Recyclable materials shall be disposed of according to applicable regulations.

d. Packing materials shall not be stored inside VA buildings for more than 24 hours.

e. Contractor personnel shall eat and drink only in designated areas.

15. Injuries and/or Property Damage: The Contractor must take care to protect persons and personal/Government property and shall be liable for any injuries and/or damage caused by the

Contractor, including its personnel and agents (including any subcontractors), to include all reasonable costs for medical treatment and/or damage repair. The Contractor must take all reasonable steps to mitigate all injuries and/or damage, with a report to the COR/POC to be submitted as soon as all injuries and damage have been mitigated to the maximum extent possible. The Contractor shall follow the COR’s/POC’s guidance for documenting any incident(s) and must cooperate with any investigation of such incident(s).

H. Personnel Requirements: The following requirements apply to all Contractor personnel, including subcontractor personnel, performing services at a VA facility, including the surrounding campus.

1. Proper Training: All personnel must be fully trained, thoroughly competent, and otherwise meet all legal requirements for performing services at a Federal Government facility, including all training recommended or mandated by the Centers for Disease Control and Prevention (CDC), the Occupational Safety and Health Administration (OSHA), The Joint Commission, and the

Veterans Health Administration prior to beginning any work onsite.

2. Physically Capable: All personnel shall be physically and medically able to perform the services under this Contract.

3. Legally Capable: All personnel shall be legally capable of working in the United States. Anyone found to be undocumented or otherwise working illegally will be remanded to the proper authorities.

4. Behavior Standards: While onsite, all personnel shall behave appropriately. Contractor personnel shall not be rude, argumentative, or confrontational with anyone. Any violation of this policy is grounds for immediate revocation of that person’s access badge and a permanent ban from the premises.

5. Clear Criminal Record: All personnel shall have a clear criminal record, which means no felony convictions or misdemeanor convictions for assaultive behavior or crimes of moral turpitude, nor any active criminal warrants.

6. Communicating in English: All personnel shall be able to effectively communicate in English— speaking, reading, and writing. The purpose of this requirement is to ensure that all personnel are able to understand any alerts or warnings, oral and written, issued by the facility.

7. Healthy at Work: All personnel shall be healthy when performing services under this Contract;

sick personnel must not report to work or shall depart the facility if becoming sick at work.

8. Appropriate Clothing: All personnel shall wear clothing appropriate for the services being performed and that clearly distinguishes them as Contractor personnel. Clothing shall present a neat appearance, be clean and maintained in good repair, and be worn as designed by the manufacturer. Contractor personnel shall not wear scrubs.

9. Identification Badge: All personnel shall wear their Government-issued identification badge, if issued, so that it is clearly visible from the front, above the waist and below the face.

I. Acronyms: The following acronyms are used and/or referenced throughout this Performance Work

Statement.

1. ACOR – Alternate Contracting Officer’s Representative

2. ACPH – Air Changes Per Hour

3. CAG – CETA Application Guide

4. CETA – Controlled Environment Testing Association

5. COR – Contracting Officer’s Representative

6. HD – Hazardous Drug

7. HEPA – High-Efficiency Particulate Air

8. ISO – International Organization for Standardization

9. IV – Intravenous

10. NSF – National Sanitation Foundation

11. USP – United States Pharmacopeia

12. VA – Veterans Affairs

13. VAH – Veterans Affairs Hospital

[Remainder of Page Intentionally Left Blank – End of Section B.3]

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…