36C26124Q0040 VISN 21 Urinalysis Testing.pdf

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VISN 21 Laboratories - Urinalysis Testing Federal contract opportunity
Solicitation number
36C26124Q0040
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 21

About this file

This solicitation requests offers for urinalysis testing services to support multiple Department of Veterans Affairs medical facilities in California. The contractor shall provide automated urinalysis instrumentation on a cost per test or cost per reportable result basis over five one-year ordering periods. Services include urine chemistry, flow cytometry, and microscopy analysis at various VA hospitals and clinics. Offerors must quote pricing for over 200,000 tests annually at locations in Northern California, Palo Alto, San Francisco, and Central California. Questions are due by October 23, 2023 and the government intends to make award by October 18, 2023. The contractor must maintain inventory of all required reagents, supplies, and materials to avoid service interruptions.

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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

36C261-23-AP-2830

36C261-24-AP-0007

36C26124Q0040 10-18-2023

David Alvarez 916-923-4564 11-01-2023

10:00 am PST

612MCP

Department of Veterans Affairs

VA Sierra Pacific Network (VISN 21)

Network Contracting Office (NCO) 21

3237 Peacekeeper Way, Bldg 200 Suite 204

McClellan Park CA 95652

X

334516

1000 Employees

N/A

See Statement of Work

612MCP

Department of Veterans Affairs

Network Contracting Office (NCO) 21

3237 Peacekeeper Way, Bldg 200 Suite 204

McClellan CA 95652

FMS VA-9(101) Financial Services Center

PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

The Contractor shall provide Automated Urinalysis

Instrumentation. The contract shall be Cost per Test (CPT)/

Cost per Reportable Result (CPRR), Clinical Laboratory

Analyzers supporting VISN 21 in accordance with the

Statement of Work.

Period of Performance:

Ordering Period 1: 4/1/2024 - 9/30/2024

Ordering Period 2: 10/1/2024 - 9/30/2025

Ordering Period 3: 10/1/2025 - 9/30/2026

Ordering Period 4: 10/1/2026 - 9/30/2027

Ordering Period 5: 10/1/2027 - 9/30/2028

Questions regarding this RFQ are due 10/23/2023 by 10:00am

PDT. Questions and quotes shall be submitted by email only to david.alvarez4@va.gov.

See CONTINUATION Page

X 1

David J. Alvarez

Contracting Officer

36C26124Q0040

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (DEC 2022)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.9 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 35

C.10 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

1998)

E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.8 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.10 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

E.11 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C261 David J. Alvarez

VA Sierra Pacific Network (VISN 21)

Network Contracting Office (NCO) 21

3237 Peacekeeper Way, Bldg 200 Suite 204

McClellan Park CA 95652

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Upon Delivery and Government Acceptance

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.

www.fsc.va.gov/einvoice.asp

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

The Contractor shall furnish a Cost per Test (CPT)/ Cost per Reportable Result (CPRR), Clinical

Laboratory Analyzers for Automated Urinalysis Instrumentation for the Department of Veterans

Affairs in accordance with the specifications listed herein.

The guaranteed minimum award amount for this contract is $10,000.00. The maximum aggregate value of orders that can be placed under this contract is $7,000,000.00. The

Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVI

CES

QUANTI

TY

UNI

T UNIT PRICE AMOUNT

12,958.0

EA _______________

Urinalysis Testing - Northern California HCS (Mather) Ordering Period: 1 POP Begin: 04-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Medical Laboratory Use

MANUFACTURER PART NUMBER (MPN): N/A

7,848.00 EA _______________

Urinalysis Testing - Northern California HCS (Martinez) Ordering Period: 1 POP Begin: 04-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Urinalysis Testing - Northern California HCS (Redding) Ordering Period: 1 POP Begin: 04-01-2024

POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Urinalysis Testing - Northern California HCS (Stockton) Ordering Period: 1 POP Begin: 04-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, 10,950.0

EA _______________

Urinalysis Testing - Palo Alto HCS (Palo Alto) Ordering Period: 1 POP Begin: 04-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, 2,920.00 EA _______________

Urinalysis Testing - Palo Alto HCS (Livermore) Ordering Period: 1 POP Begin: 04-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, 3,650.00 EA _______________

Urinalysis Testing - Palo Alto HCS (Monterey) Ordering Period: 1 POP Begin: 04-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Urinalysis Testing - San Francisco HCS (San Francisco) Ordering Period: 1 POP Begin: 04-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, 1,460.00 EA _______________

Urinalysis Testing - San Francisco HCS (Oakland) Ordering Period: 1 POP Begin: 04-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, 5,620.00 EA _______________

Urinalysis Testing - Central California HCS (Fresno) Ordering Period: 1 POP Begin: 04-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, 25,915.0

EA _______________

Urinalysis Testing - Northern California HCS (Mather) Ordering Period: 2 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, 15,695.0

EA _______________

Urinalysis Testing - Northern California HCS (Martinez) Ordering Period: 2

POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Redding) Ordering Period: 2 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Stockton) Ordering Period: 2 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, 21,900.0

EA _______________

Urinalysis Testing - Palo Alto HCS (Palo Alto) Ordering Period: 2 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, 5,840.00 EA _______________

Urinalysis Testing - Palo Alto HCS (Livermore) Ordering Period: 2 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

7,300.00 EA _______________

Urinalysis Testing - Palo Alto HCS (Monterey) Ordering Period: 2 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - San Francisco HCS (San Francisco) Ordering Period: 2 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Urinalysis Testing - San Francisco HCS (Oakland) Ordering Period: 2 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, 11,240.0

EA _______________

Urinalysis Testing - Central California HCS (Fresno) Ordering Period: 2 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Mather) Ordering Period: 3

POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Martinez) Ordering Period: 3 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Redding) Ordering Period: 3 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Stockton) Ordering Period: 3 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Palo Alto HCS (Palo Alto) Ordering Period: 3 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Urinalysis Testing - Palo Alto HCS (Livermore) Ordering Period: 3 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Urinalysis Testing - Palo Alto HCS (Monterey) Ordering Period: 3 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - San Francisco HCS (San Francisco) Ordering Period: 3 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Urinalysis Testing - San Francisco HCS (Oakland) Ordering Period: 3 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Central California HCS (Fresno) Ordering Period: 3

POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Mather) Ordering Period: 4 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Martinez) Ordering Period: 4 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Redding) Ordering Period: 4 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Stockton) Ordering Period: 4 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

EA _______________

Urinalysis Testing - Palo Alto HCS (Palo Alto) Ordering Period: 4 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Urinalysis Testing - Palo Alto HCS (Livermore) Ordering Period: 4 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Urinalysis Testing - Palo Alto HCS (Monterey) Ordering Period: 4 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - San Francisco HCS (San Francisco) Ordering Period: 4 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Urinalysis Testing - San Francisco HCS (Oakland) Ordering Period: 4

POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Central California HCS (Fresno) Ordering Period: 4 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Mather) Ordering Period: 5 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Martinez) Ordering Period: 5 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Northern California HCS (Redding) Ordering Period: 5 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

EA _______________

Urinalysis Testing - Northern California HCS (Stockton) Ordering Period: 5 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Palo Alto HCS (Palo Alto) Ordering Period: 5 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Urinalysis Testing - Palo Alto HCS (Livermore) Ordering Period: 5 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Urinalysis Testing - Palo Alto HCS (Monterey) Ordering Period: 5 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - San Francisco HCS (San Francisco) Ordering Period: 5

POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Urinalysis Testing - San Francisco HCS (Oakland) Ordering Period: 5 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, EA _______________

Urinalysis Testing - Central California HCS (Fresno) Ordering Period: 5 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, GRAND TOTAL _______________

B.3 STATEMENT OF WORK

1. LANGUAGE

1.1. INTENT: It is the intent of the Department of Veterans Affairs to establish a contract for

Automated Urinalysis Instrumentation. The contract shall be Cost per Test (CPT)/ Cost per Reportable Result (CPRR), Clinical Laboratory Analyzers.

1.2. DELIVERY LOCATIONS, VOLUME AND TERMS: Pricing is based on the AVERAGE monthly test volume. The Government requires the following equipment to complete testing at each site:

Location UA Chemistry, Flowcell, and Microscopy

Analyzer with additional Backup

Chemistry Analyzer

UA Chemistry and Flowcell

Analyzer

UA Chemistry Analyzer Only

STATION 612 NORTHERN

CALIFORNIA HEALTH CARE SYSTEM

VA Sacramento Medical Center 10535 Hospital Way Mather, Ca 95655 Point of contact: Martha A Goodwin –

(916) 843-7235 – (Martha.Goodwin@va.gov)

X

Martinez CBOC 150 Muir Road Martinez, CA 94553 Point of contact: Martha A Goodwin –

(916) 843-7235 – (Martha.Goodwin@va.gov)

X

Redding CBOC 3455 Knighton Road Redding, CA 96002 Point of contact: Martha A Goodwin –

(916) 843-7235 – (Martha.Goodwin@va.gov)

X

Stockton CBOC 7777 Freedom Rd, French Camp, CA 95231 Point of contact: Martha A Goodwin –

(916) 843-7235 – (Martha.Goodwin@va.gov)

X

STATION 640 VA PALO ALTO

HEALTHCARE SYSTEM

VA Palo Alto HCS Building 50 Warehouse 3801 Miranda Ave, Palo Alto, CA 94304

POC: Lana Hur – (650) 493-5000 ext 66722 - (lana.hur@va.gov)

Livermore VA CBOC Building 65 Warehouse 4951 Arroyo Road Livermore, CA 94550 POC: Lana Hur – (650) 493-5000 ext 66722 - (lana.hur@va.gov)

X

Monterey VA CBOC 209 9th st, Marina, CA 93933 (Lab:Room C160) POC: Lana Hur – (650) 493-5000 ext 66722 - (lana.hur@va.gov)

X

STATION 662 VA SAN FRANCISCO

VA Medical Center 4150 Clement Street San Francisco, CA 94121 Point of contact: Kristopher Taylor –

(415) 750-2276 – (kristopher.taylor@va.gov)

X

Oakland CBOC 2221 Martin Luther King Way Oakland, CA 94612 Point of contact: Kristopher Taylor –

(415) 750-2276 – (kristopher.taylor@va.gov)

X X

STATION 570 VA CENTRAL CA

HEALTHCARE SYSTEM

2615 E. Clinton Ave Fresno, CA 93703 Point of contact: Mike Newell 559-225-6100 x5719 michael.newell1@va.gov

X

STATION 593 VA SOUTHERN

NEVADA HCS

Allow to add later by means of contract modification, if needed

STATION 654 VA SIERRA NEVADA

HEALTH CARE SYSTEM

Allow to add later by means of contract modification, if needed

STATION 459 PACIFIC ISLANDS Allow to add later by means of contract modification, if needed

2. DESCRIPTION/SPECIFICATIONS

2.1. SCOPE OF PROCUREMENT:

2.1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in this Statement of Work. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA). The instrument also must be approved by The Food and Drugs Administration (FDA).

2.1.2. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform mailto:michael.newell1@va.gov tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy.

Expiration date must be clearly marked on reagent, standards and control containers.

Unexpected changes in methodology/technology shall be at the expense of the Contractor.

Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

2.1.3. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery with no shipping expenses.

2.2. DEFINITIONS:

2.2.1. Cost per Patient Reportable Result (CPRR)- The per patient reportable result price shall include costs covering: (1) 5-year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) all necessary maintenance to keep the equipment in good operating condition (his element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors shall provide delivery, installation, and removal of equipment at no additional charge.

2.2.2. Cost per Test (CPT) – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) five year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

2.2.3. Parameter definitions

2.2.3.1. Automated Urine Macroscopic – Direct loading of specimen and quality control for automated chemical analysis of urine to include color, clarity, specific gravity, pH and the presence/absence of leukocytes esterase, nitrites, total protein, glucose, blood/hemoglobin, ketone, ascorbic acid, urobilinogen and bilirubin. Providing complete hands-free walkaway testing. For all sites except for Oakland.

2.2.3.2. Automated Urine Microscopic- Provide automated analysis using flow cytometry to determine the presence/absence of sediment constituents, such as but not limited to red blood cells, epithelial, white blood cells, casts, crystals, bacteria, etc. providing a quantitative result of each constituent. Automated Urine Microscopic imaging to display particle microscope quality images to provide high confidence in the classification of such elements for the larger Medical Center Laboratories. System should be capable of reporting red blood cells, epithelial, white blood cells, casts, and bacteria without reviewing microscopy images.

2.3. GENERAL REQUIREMENTS:

2.3.1. Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation.

2.3.2. Contractor shall provide quality control material at a minimum of two levels: normal and elevated/abnormal levels.

2.3.3. Significant physical, functional and performance characteristics- The instrumentation offered shall have the following:

2.3.3.1. Technology that assays urine chemistry and urine microscopic testing with Fluorescent Flow cytometry technology and digital imaging and a reliable chemistry back up analyzer.

2.3.3.2. Bench top analyzer 110 volts /220 volts.

2.3.3.3. Urinalysis analyzer with alternate back up chemistry analyzer which ensures standardized test results and excellent correlation – Sacramento Medical Center only.

2.3.3.4 Backup instrument should be a walk-away with autosampler and high throughput.

2.3.3.5. Both primary and secondary (back-up) instrument should be validated to demonstrate that chlorhexidine present in our current BD VACUTAINER PLUS UA Preservative tubes will not have any adverse effect on the routine urinalysis parameters. Both instruments should have an excellent agreement.

2.3.3.6. UA analyzer with digital imaging which yields microscope- quality images with accurate sediment classification and cell identification for fewer screen review – Large Medical Centers only.

2.3.3.7. Decreased need to do manual microscopy for confirmation of formed elements. i.e., presence of bacteria, yeast cells and crystals.

2.3.3.8. Random access with walkaway shutdown, restart capabilities and continuous analyses.

The patient samples should be able to be used for repeats or reruns on the same or different instrumentation.

2.3.3.9. Utilize Fluorescent Flow Cytometry methodology in identifying and quantifying cells.

Utilizing side scatter detection technology to differentiate similarly sized crystals and RBC.

2.3.3.10. Reduced carryover with adjustable carryover rinse cycle settings to eliminate interference.

2.3.3.11. No dilution required. No special handling requirements for particle analysis.

2.3.3.12. ON Board Warmer that dissipates urates and phosphate material thus eliminating an additional step to reduce amorphous interference. This will help tremendously in analyzing samples from CBOCs.

2.3.3.13. Provide calibration and assisted calibration verification and set up reference ranges.

2.3.3.14. Ready to use reagents with good stability up to 14 days.

2.3.3.15. Easily standardized with accurate particle differentiation, bacteria quantification, and enhanced detection down to <0.5 um.

2.3.3.16. Minimal maintenance <30 minutes with walkaway capability and minimize staff hands-on and free technologists for more critical tasks.

2.3.3.17. Be able to print results and/or interface to Vista LIS system.

2.3.3.18. Data Innovations interface compatible.

2.3.3.19. Cost effective, Safe, Easy to use and labor saving.

2.3.3.20. Assays FDA approved.

2.3.3.21. Precision when compared with other laboratory performances on proficiency surveys.

2.3.3.22. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

2.3.3.23. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, offered according to the following terms:

2.3.3.24. Service Requirements

2.3.3.24.1. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within two weeks of the scheduled due date.

2.3.3.24.2. A technical assistance center shall be available by telephone 24 hours per day, seven days per week with a maximum call back response time of 0.5hour(s).

2.3.3.24.3. Equipment repair service shall be provided during core business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

2.3.3.24.4. Equipment repair response time shall be no more than one hour.

2.3.3.24.5. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

2.3.3.24.5.1. Date and Time Notified

2.3.3.24.5.2. Date and Time of Arrival

2.3.3.24.5.3. Serial Number, Type and Model Number of Equipment

2.3.3.24.5.4. Time spent for Repair, and

2.3.3.24.5.5. Proof of Repair that includes documentation of a sample run of quality control verifying acceptable performance.

2.3.3.24.6. Each notification for an emergency repair service call shall be treated as a separate and new service call.

2.3.3.25. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability.

2.3.3.26. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g.

starter kits, tables/stands, etc.

2.3.3.27. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g., Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software.

2.3.3.28. Characterization of waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements.

Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

2.3.3.28.1. The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements.

Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

2.3.3.28.2. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements.

2.3.3.29. The documentation the Contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

2.3.3.30. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 45 days after the award of the contract. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe.

Contractor shall not be penalized for implementation timelines that extend beyond the 45 day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government.

2.3.3.30.1. Upon award of contract, the transition period for the awarded contract to have all equipment and peripherals installed and operational shall be from date of award through 45 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

2.3.3.30.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 45 days for the transition of all services under the awarded contract including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations.

Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract.

2.3.3.30.3. At the end of 45 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services under the awarded contract.

2.3.4. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any contract at an effectiveness level of 90% or more.

2.3.4.1. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

2.3.4.2. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

2.3.4.3. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure.

Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

2.3.4.4. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

2.3.4.5. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

2.3.4.6. During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

2.3.5. Government’s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

2.3.6. Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

2.3.7. The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

2.3.8. Prior to termination or completion of this contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the contract.

2.3.9. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the contract or disposal or return of the IT equipment, whichever is earlier.

2.3.10. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

2.3.10.1. Contractor must accept the system without the drive.

2.3.10.2. VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or

2.3.10.3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

2.3.11. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then.

2.3.11.1. The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

2.3.11.2. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order.

2.3.11.3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS

AND REQUIREMENT TO INFORM EMPLOYEES OF

WHISTLEBLOWER RIGHTS

JUN 2020

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

MAY 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(a) 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.

(b) 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.

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

(d) 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 at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default…

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