S02 - RFQ 36C26226Q1411.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

36C26226Q1411 08-26-2026

Diaz, Marcos 858 228-0081 09-08-2026

07:00 PDT

36C262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

X 100

X

621511

$41.5 Million

N/A

36C262

Participating VISN 22 sites listed in Statement Of Work

Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

Financial Services Center

See CONTINUATION Page

VISN 22 Semen & Vasectomy Test Kits

1) See Section B.7. STATEMETN OF WORK (SOW) for requirement details. Offers must conform with the SOW.

2) See Section E - SOLICITATION PROVISIONS, 52.212-1, Pg 37 for instructions on submitting quotes/proposals.

3) This will be Blanket Purchase Agreement (BPA) contract.

4) This is a Small Business set-aside solicitation.

5) Supplies to be ordered/used as needed.

Period of performance:

Base Year: 10/01/2026 – 09/30/2027 Option Year 1: 10/01/2027 – 09/30/2028 Option Year 2: 10/01/2028 – 09/30/2029 Option Year 3: 10/01/2029 – 09/30/2030 Option Year 4: 10/01/2030 – 09/30/2031

USE SOLICITATION # 36C26226Q1411 on all offer submissions and correspondence.

See CONTINUATION Page

36C26226Q1411

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B – GENERAL TERMS

B.1 BLANKET PURCHASE AGREEMENT (BPA) ADMINISTRATION DATA

B.2 DESCRIPTION OF AGREEMENT

B.3 PRICING

B.4 OBLIGATION OF FUNDS

B.5 FEDERAL HOLIDAYS

B.6 PRECEDENCE

B.7 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

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

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 17

C.4 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.5 52.219-14 LIMITATIONS ON SUBCONTRACTING (NOV 2025) (DEVIATION)

C.6 52.222-40 NOTIFICATION OF EMPLOYEE RIGHTS UNDER THE NATIONAL

LABOR RELATIONS ACT (NOV 2025) (DEVIATION)

C.7 52.223-23 SUSTAINABLE PRODUCTS (NOV 2025) (DEVIATION)

C.8 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.9 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

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

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.5 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

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

1998)

SECTION B – GENERAL TERMS

B.1 BLANKET PURCHASE AGREEMENT (BPA) ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C262

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

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

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

[X] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly as needed

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.

Submit Invoices electronically to:

https://authentication.tungsten-network.com/login

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

AMENDMENT NUMBER DATE

B.2 DESCRIPTION OF AGREEMENT

1. INTENT

In the spirit of the Federal Acquisition Streamlining Act and pursuant to Federal Acquisition Regulation (FAR) Part 12, the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 22 Healthcare Centers is establishing this single award Blanket Purchase Agreement (BPA) contract for Blood Bank Automation, Equipment Capital Purchase and CPT Solution as described within this solicitation. The Contractor shall make available for purchase all the necessary products and services commercially available by Contractor to meet VISN 22 Healthcare Center's needs as outlined within this BPA.

VISN 22 Healthcare Centers require the following:

1) A complete solutions from a single vendor/offeror as defined and detailed in the Statement Of Work (SOW)

2) Semen Analysis (SA) and Post Vasectomy Semen Analysis (PVSA) test kits to be purchase and delivered to the VA Healthcare Systems and then directly distributed to patients as needed.

2. TERM OF AGREEMENT:

This BPA shall be one (1) base year plus four (4) optional years which will be reviewed, at least, annually In Accordance With (IAW) RFO FAR Part 12 to ensure the BPA terms are met, to assess current market conditions and to determine price reasonableness. Additional discounts may be requested by VISN 22 at any time. If the Contractor fails to perform in a manner satisfactory to the Contracting Officer (CO), this BPA may be canceled with a thirty (30) day written notice to the Contractor by the CO.

3. BPA LIMITS:

The estimated BPA time is approximate One (1) Base year and four (4) option years from the effective date of the BPA. Pricing must be established based on the estimated user quantities listed in Attachment A; therefore, the overall BPA total estimate may be revised via supplemental agreement between the Contractor and the VA to accommodate the Government needs.

Estimated Period of Performance is listed in the SOW herein.

4. BPA ORDERS:

This BPA is a pricing agreement and does not obligate any funds. The Government is obligated only to the extent of authorized BPA Delivery Orders (DO) issued under the BPA by authorized individuals. DO’s shall be identified by the BPA Number (TBD) and DO Number (TBD). DO’s may include option years, if it is determined that option years would be in the best interest of the Government. Any DO issued during the effective term of this BPA shall be completed by the Contractor within the time specified in the DO, including all option years, which may extend beyond the BPA term. The Contractor shall accept the price, terms and conditions of an issued DO as long as they do not conflict with the terms set forth in the BPA. DO’s shall be limited to $(TBD) per order.

5. PARTICIPATING FACILITIES:

Future facilities that fall under the authority of this office, Network Contracting Office 22 (NCO 22), may be added or deleted to this agreement with an exercise of a supplemental agreement between the Government and the Contractor.

Participating facilities are listed in the SOW herein.

6. DELIVERY:

The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in the SOW herein as ordered by individual BPA DOs from the participating facilities.

The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The primary facility POC shall be required to notify the Contractor when delivery locations have been changed.

All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain:

Contractor name, BPA number, DO number, VA obligation number, date of order, date of delivery, itemized list of products furnished, including product description and quantity shipped.

All deliveries shall be made during normal working hours from 8:00a.m. to 4:30p.m, local time unless specified otherwise. Standard orders shall be delivered within no more than four (4) working days after receipt or placement of order. Emergency deliveries may be necessary on rare occasions and may occur outside of working hours from 4:00 p.m. to 8:00 a.m. Under emergency occurrences, the Contractor shall deliver to the Government site in the most expeditious manner possible. Without additional cost to the Government, unless expedited shipping/delivery is approved by the primary facility POC, CO or another authorized individual. The Contractor shall provide an emergency point of contact, if different from the standard points of contacts.

No product substitutions shall be made by Contractor without prior approval of the treating facility primary Point of Contact. However, if substitution would further obligate the government, the Contractor shall have approval of a warranted Contracting Officer.

7. PACKAGING:

All supplies shall be adequately packaged to prevent damage during shipping, handling and storage.

Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

B.3 PRICING

Contract Supplies as listed below, with associated pricing, can be ordered under this BPA. The Contractor shall be allowed to vary within the categories for successful and efficient task completion not to exceed funded values of each order awarded under this agreement. As proposed, the Contractor will apply applicable extended/tier pricing to all categories used in the performance of orders issued under this Agreement. Orders may be awarded on an as needed basis only. All Calls/Orders placed against this BPA are subject to the terms and conditions of the referenced BPA, the Contractor's proposal and this Agreement, except where noted below. Contractor's proposal dated is hereby referenced.

B.4 OBLIGATION OF FUNDS

This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by the Contracting Officer.

B.5 FEDERAL HOLIDAYS

Unless specifically authorized in writing by the Contracting Officer, the Contractor shall not provide services or incur and/or bill charges under any order issued pursuant to this contract on any Federal holiday, as defined by applicable law.

B.6 PRECEDENCE

The Terms and conditions included in this BPA apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this BPA and the Contractor's invoice, the provisions of this BPA will take precedence.

B.7 STATEMENT OF WORK

OBJECTIVE

The specific objective of this contract is to award a single Blanket Purchase Agreement (BPA) contract to provide Semen analysis and post vasectomy testing on samples provided by using a unique mail-in kit collection system. The Government intends to contract for a “one-Stop Shop” where the vendor/offeror provides the full service from start to finish. The laboratory testing will be for all facilities within VISN22.

SCOPE OF WORK

VISN22, comprising VA Medical Centers, VA Outpatient Clinics (OPCs), and VA Community- Based Outpatient Clinics (CBOCs), requires comprehensive laboratory support under the resultant Blanket Purchase Agreement (BPA). The government intends to procure Semen Analysis (SA) and Post Vasectomy Semen Analysis (PVSA) test kits to be distributed by the VISN22 Veterans Administration Healthcare System (VAHCS) sites directly to patients for home self-collection, with specimens shipped directly to the Contractor’s designated laboratory(ies).

Direct distribution to patients improves compliance and minimizes the potential for loss or disposal of test kits that can result from delivery through conventional carrier methods. The Contractor shall provide all necessary materials, logistics, and laboratory testing services as specified in this Statement of Work, in full support of VISN22 VAHCS operations.

All requirements and provisions specified herein apply to any laboratory, including branches, divisions, or subcontractors, performing testing on behalf of the Contractor.

It is possible that during the life of this contract that VISN22 might add additional facilities within the California, Arizona, or New Mexico geographic areas that will require the services specified in the Statement of Work. The Government shall have the right to unilaterally modify this contract to add any new facilities in those geographic areas during the period of performance and the Contractor shall provide the services described in the Statement of Work to those facilities. The prices charged for services provided to any new facilities shall adhere to the prices agreed upon should an award be made to an offeror after a valid solicitation. When additions occur, a modification to the BPA will be executed notifying the Contractor of the new facility to be serviced.

The VA will only buy the tests kits. The cost of the test kits must include all material, shipping, lab processing and reporting costs. The VA will provide the tests directly to the patient to take home, the patient will collect the sample and follow the procedures to ship the test to the laboratory. The sample must be Self-collected at home.

This is a new requirement, no pre-existing incumbent.

PERIOD OF PERFORMANCE

Base Year: 10/01/2026 – 09/30/2027 Option Year 1: 10/01/2027 – 09/30/2028 Option Year 2: 10/01/2028 – 09/30/2029 Option Year 3: 10/01/2029 – 09/30/2030 Option Year 4: 10/01/2030 – 09/30/2031

PARTICIPATING VISN22 HEALTHCARE SYSTEMS

VA LONG BEACH HEALTHCARE SYSTEM

5901 E. Seventh St Long Beach, CA 90822

VA LOMA LINDA HEALTHCARE SYSTEM

11201 Benton Street Loma Linda, CA 92357

VA SAN DIEGO HEALTHCARE SYSTEM

3350 La Jolla Village Drive San Diego, CA 92161

VA GREATER LOS ANGELES HEALTHCARE SYSTEM

11301 Wilshire Blvd.

Los Angeles, CA 90073

VA ALBUQUERQUE HEALTHCARE SYSTEM

1501 San Pedro Dr. SE Albuquerque, NM 87108

VA NORTH ARIZONA HEALTHCARE SYSTEM

500 AZ-89

Prescott, AZ 86301

VA PHOENIX HEALTHCARE SYSTEM

650 E Indian School Rd.

Phoenix, AZ 85012

VA SOUTHERN ARIZONA HEALTHCARE SYSTEM

3601 S 6th Ave.

Tucson, AZ 85723

REQUIREMENTS

A. VISN 22 requires the following test kits for patient specimen testing:

Product Description Unit of Issue Quantity

1. Test kit, Semen Analysis EA As needed

2. Test kit, Post Vasectomy Semen EA As needed

B. GENERAL

To procure semen analysis and post-vasectomy mail-in testing kits. The contractor will provide full test kits, logistical support for patients, and reporting tools for clinicians. The test kits will be purchased and delivered directly to the purchasing site, not to patients. This service includes:

1. Mail-in semen analysis kits validated for a minimum of 52 hours of room temperature stability hours.

2. Post-vasectomy testing kits validated for room temperature stability for up to 7 days, allowing unlimited retesting until azoospermia is confirmed.

A full semen analysis will be performed after the third attempt.

3. Full clinic portal access for reviewing and uploading results to EHR.

4. Replacement kits at no charge if test results are delayed or invalid or kits are expired.

C. DESCRIPTION OF SERVICES

The Contractor shall provide CLIA certified and FDA registered prepackaged mail-in kits for which Contractor provides laboratory services.

1. All report data the Contractor exports and submits to the facility shall be Health Information Portability and Accountability Act (HIPAA) compliant.

2. Gel packs included to stabilize and maintain temperature within the test kit. Summer and winter packs are used for seasonality.

3. Non-Toxic preservative used in transport kits.

4. Able to store kits at room temperature.

5. Reportable Parameters

a. Post-Vasectomy analysis

• Volume in mL

• Concentration of Azoospermia in cells/mL

• Count of Azoospermia in cells/ejaculate

• To include centrifuged specimen analysis in cases of cryptozoospermia.

b. Semen AnalysisTotal motility in millions/ejaculate

• Volume in mL

• Concentration in millions/mL

• Motility in %

• Morphology in %

• Total count in millions/ejaculate

D. SAMPLE PROCESSING:

Each facility will provide properly prepared laboratory specimens, identified and labeled for testing. The Contractor shall provide an adequate supply of specimen collection materials for such testing, including all materials required for specialized handling as dictated by the Contractor’s laboratory's specimen collection requirements, (e.g. dry ice, stabilizing tablets, ice packets, etc). The Contractor shall transport and store specimens in such a manner as to ensure the integrity of the specimen. The Contractor shall provide additives required for collection of specimens in unit packages to facilitate collection at Community Based Outpatient Clinic’s (CBOC) and Outpatient Clinics (OPC). Material Safety Data Sheets will be provided by the Contractor to sites as appropriate for supplies containing hazardous chemicals (e.g. boric acid tablets, acids, or other substances as required to comply).

PATIENT TEST REPORT

A patient test report is defined as a printed final copy of laboratory testing results or host-to-host VPN electronic transmission of test results. This report will be received by VPN computer interfaced to the VistA Laboratory Package. Contractor shall make all results retrievable via a Secure Web Portal; in addition to providing the Web Portal, Contractor also send results via fax to a secure facsimile.

A. PATIENT TEST REPORT: At a minimum, the Contractor shall provide the following information on each laboratory test report/result:

1. Patient's name

2. Date of Birth

3. Test ordered

4. Date/time of specimen collection

5. Date/time test completed

6. Test result

7. Reference intervals as appropriate

8. If applicable, toxic and therapeutic ranges

9. Flagged abnormal

10. Critical Value

11. laboratory specimen number

12. Name and address of testing laboratory

13. Any other information that may indicate questionable validity of test results

14. Unsatisfactory specimen shall be reported with documentation supporting its unsuitability for testing

The Contractor shall provide test results, either by hard copy or electronic report transmission via electronic portal or fax to each site.

B. CLIENT SERVICES: Contractor shall provide Client Services for at least 8 hours per day, Monday through Friday to address inquires such as test availability, specimen collection, storage, transport requirements, addition or cancellation of testing, and the ordering of supplies. During normal business hours, the Contractor shall provide access to medical experts to address laboratory test interpretation, testing recommendations, and education regarding testing options.

ADMINISTRATIVE REPORTS

MONTHLY REPORTS: The Contractor shall provide the reports listed below in a downloadable Excel format. Each healthcare system shall receive a facility specific report and VISN22 Leadership shall receive a single cumulative document to include all VISN22 healthcare system.

A. TEST UTILIZATION REPORT: Contractor shall provide a statistical analysis of the VISN22 facilities workload testing volumes to assist in monitoring of ordering trends and utilization patterns. The analysis shall include:

1. Tests performed

2. Test Order Code

3. Test volumes

4. Associated cost per test

ANNUAL BUSINESS REVIEW REPORT:

The Contractor shall provide an annual business review in downloadable MS Excel format. Each healthcare system shall receive a facility specific report and VISN22 Leadership shall receive a single cumulative document to include all VISN22 healthcare system.

REQUIREMENT FOR SHIPPING SERVICES

A. The Contractor shall provide safe transport of all biological substances. This shall include the proper receipt, distribution, storage and security of patient specimens in accordance with all federal regulations governing the safe transport of these materials including the following, which are incorporated herein by reference:

1. Department of Transportation 49 CFR Parts 171-180 – Hazardous Materials:

Infectious Substances; Harmonization with the United Nations Recommendations, Final Rule.

2. Department of Health and Human Services 42 CFR Parts 72 and 73 – Interstate Shipment of Etiologic Agents and Select Agents and Toxins

3. Department of Labor/OSHA 29 CFR, Section 1910.1030-Bloodborne Pathogens

4. HIPAA Privacy Rule 45 CFR Parts 160 and 164.

B. Contractor shall comply with all state and local regulations that are applicable to the services it provides.

C. The Contractor shall implement procedures that ensure the accountability and integrity of all biological substances from the point of possession to the point of delivery.

D. The Contractor shall ensure that all transport personnel are properly trained and that their competency is regularly assessed in the appropriate safety, packaging and environmental control procedures suitable to specimen type and distances transported.

E. The Contractor shall provide an adequate supply of materials necessary for the efficient, organized and coordinated receipt, transport, and delivery of specimens (e.g. bags, temperature condition stickers, transportation receipt forms, rigid-sided containers, dry ice, coolers, incubators, etc.). Upon request, the Contractor shall provide temperature integrity tracking data.

LICENSURES

A. Contractor shall perform specimen testing only in fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing described in this BPA contract. The laboratory must be licensed/accredited by the College of American Pathologists (CAP) as well as any other state regulatory agencies as mandated by federal and state law. In addition, the Laboratory must be certified as meeting the requirements of the Clinical Laboratory Improvement Act (CLIA) of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information in accordance with Health Insurance Portability and Accountability Account of 1996 (HIPAA) and VA Directives 1106, 1106.01 and 1106.2

B. Laboratory shall provide and maintain a CLIA license of the testing facility where testing is/was/will be performed during the life of the contract.

C. Offeror shall provide evidence that each laboratory used for this service holds a valid Clinical Laboratory Improvement Act (CLIA) certificate.

As these documents are reissued or re-awarded, the Contractor shall supply a copy to the Contracting Officer and each VISN22 facility. The above documents must also be supplied for each laboratory that is a subcontractor of the Contractor.

SPECIAL STANDARDS OF RESPONSIBILITY

To assist the contracting officer in determining if the special standards of responsibility applicable to this procurement are met, offerors are asked to provide the following information with their offer. Failure to include this information could result in a contracting officer’s determination that an otherwise successful offeror is not eligible for contract award. Offerors must meet the requirements set forth in this Statement of Work (SOW).

A The selected offeror must hold an active registration in the SYSTEM FOR AWARD MANAGEMENT website: WWW.SAM.GOV. if the offeror is not registered, the next lowest offeror conforming to the SOW will be selected.

(End Statement Of Work)

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 in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. The Government will send a cure notice to the Contractor, unless the reason for the termination is late delivery. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered under this contract are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C.

chapter 87, Kickbacks; 49 U.S.C. 40118, Government-financed air transportation; and 41 U.S.C.

chapter 21 relating to procurement integrity.

(r) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Disputes, Payments, Invoice, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) Other contract clauses incorporated in the solicitation or contract;

(4) Addenda to this solicitation or contract,

(5) Solicitation provisions incorporated in the solicitation.

(6) Other paragraphs of this clause.

(7) Other documents, exhibits, and attachments; and

(8) The specification.

(s) Unauthorized obligations.

(1) Except as stated in paragraph (s)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government-authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (s)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(t) Comptroller General examination of record. This paragraph applies if this contract was awarded using other than sealed bid procedures and is in excess of the simplified acquisition threshold on the date of award of this contract.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices, at all reasonable times, the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR part 4, longer period required by statute, or periods specified in other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This clause does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(u) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

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

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

(End of Clause)

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

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

C.4 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

C.5 52.219-14 LIMITATIONS ON SUBCONTRACTING (NOV 2025)

(DEVIATION)

(a) This clause does not apply to the unrestricted portion of a partial set-aside.

(b) Definition. Similarly situated entity, as used in this clause, means a first-tier subcontractor, including an independent contractor, that—

(1) Has the same small business program status as that which qualified the prime contractor for the award (e.g., for a small business set-aside contract, any small business concern, without regard to its socioeconomic status); and

(2) Is considered small for the size standard under the North American Industry Classification System (NAICS) code the prime contractor assigned to the subcontract.

(c) Applicability. This clause applies only to—

(1) Contracts that have been set aside for any of the small business concerns identified in 19.000(a)(3);

(2) Part or parts of a multiple-award contract that have been set aside for any of the small business concerns identified in 19.000(a)(3);

(3) Contracts that have been awarded on a sole-source basis in accordance with sections 19.105, 19.106, 19.107, and 19.108;

(4) Orders expected to exceed the simplified acquisition threshold and that are set aside for small business concerns under multiple-award contracts, as described in 8.4 and 16.5;

(5) Orders, regardless of dollar value, that are set aside in accordance with sections 19.105, 19.106, 19.107, and 19.108 under multiple-award contracts, as described in 8.4 and 16.5; and

(6) Contracts using the HUBZone price evaluation preference to award to a HUBZone small business concern unless the concern waived the evaluation preference.

(d) Independent contractors. An independent contractor shall be considered a subcontractor.

(e) By submission of an offer and execution of a contract, the Contractor agrees that in performance of a contract assigned a North American Industry Classification System (NAICS) code for—

(1) Services (except construction), it will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the prime contractor’s 50 percent subcontract amount that cannot be exceeded. When a contract includes both services and supplies, the 50 percent limitation shall apply only to the service portion of the contract;

(2) Supplies (other than procurement from a nonmanufacturer of such supplies), it will not pay more than 50 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the prime contractor’s 50 percent subcontract amount that cannot be exceeded. When a contract includes both supplies and services, the 50 percent limitation shall apply only to the supply portion of the contract;

(3) General construction, it will not pay more than 85 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the prime contractor’s 85 percent subcontract amount that cannot be exceeded; or

(4) Construction by special trade contractors, it will not pay more than 75 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the prime contractor’s 75 percent subcontract amount that cannot be exceeded.

(f) The Contractor shall comply with the limitations on subcontracting as follows:

(1) For contracts, in accordance with paragraphs (c)(1), (2), (3) and (6) of this clause—

[] By the end of the base term of the contract and then by the end of each subsequent option period; or

[] By the end of the performance period for each order issued under the contract.

(2) For orders, in accordance with paragraphs (c)(4) and (5) of this clause, by the end of the performance period for the order.

(g) A joint venture agrees that, in the performance of the contract, the applicable percentage specified in paragraph (e) of this clause will be performed by the aggregate of the joint venture participants.

(1) In a joint venture comprised of a small business protégé and its mentor approved by the Small Business Administration, the small business protégé shall perform at least 40 percent of the work performed by the joint venture. Work performed by the small business protégé in the joint venture must be more than administrative functions.

(2) In an 8(a) joint venture, the 8(a) participant(s) shall perform at least 40 percent of the work performed by the joint venture. Work performed by the 8(a) participants in the joint venture must be more than administrative functions.

(End of Clause)

C.6 52.222-40 NOTIFICATION OF EMPLOYEE RIGHTS UNDER THE

NATIONAL LABOR RELATIONS ACT (NOV 2025) (DEVIATION)

(a) During the term of this contract, the Contractor must post an employee notice, of such size and in such form, and containing such content as prescribed by the Secretary of Labor, in conspicuous places in and about its plants and offices where employees covered by the National Labor Relations Act engage in activities relating to the performance of the contract, including all places where notices to employees are customarily posted both physically and electronically, in the languages employees speak, in accordance with 29 CFR 471.2(d) and (f).

(1) Physical posting of the employee notice must be in conspicuous places in and about the Contractor's plants and offices so that the notice is prominent and readily seen by employees who are covered by the National Labor Relations Act and engage in activities related to the performance of the contract.

(2) If the Contractor customarily posts notices to employees electronically, then the Contractor must also post the required notice electronically by displaying prominently, on any Web site that is maintained by the Contractor and is customarily used for notices to employees about terms and conditions of employment, a link to the Department of Labor's Web site that contains the full text of the poster. The link to the Department's Web site, as referenced in (b)(3) of this section, must read, "Important Notice about Employee Rights to Organize and Bargain Collectively with Their Employers."

(b) This required employee notice, printed by the Department of Labor, may be—

(1) Obtained from the Division of Interpretations and Standards, Office of Labor-Management Standards, U.S. Department of Labor, 200 Constitution Avenue, NW., Room N-5609, Washington, DC 20210, (202) 693-0123, or from any field office of the Office of Labor- Management Standards or Office of Federal Contract Compliance Programs;

(2) Provided by the Federal contracting agency if requested;

(3) Downloaded from the Office of Labor-Management Standards Web site at http://www.dol.gov/olms/regs/compliance/EO13496.htm; or

(4) Reproduced and used as exact duplicate copies of the Department of Labor's official poster.

(c) The required text of the employee notice referred to in this clause is located at Appendix A, Subpart A, 29 CFR Part 471.

(d) The Contractor must comply with all provisions of the employee notice and related rules, regulations, and orders of the Secretary of Labor.

(e) In the event that the Contractor does not comply with the requirements set forth in paragraphs (a) through (d) of this clause, this contract may be terminated or suspended in whole or in part, and the Contractor may be suspended or debarred in accordance with 29 CFR

471.14 and subpart 9.4.