S02 36C24424Q0551 Hematology Philadelphia 4 11 24.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

36C24424Q0551 04-11-2024

Amanda Saunders 412-503-3555 04-22-2024

10:00 AM EDT

36C244 Department of Veterans Affairs Network Contracting Office 4 Services 5 1010 Delafield Road Pittsburgh PA 15215 Amanda Saunders

X

1000 Employees

N/A

X

36C642

Michael J. Crescenz VAMC

36C244

Department of Veterans Affairs Network Contracting Office 4 Services 5 1010 Delafield Road Pittsburgh PA 15215

TBD

Austin Payment Center Department of Veterans Affairs

PO Box 149971 Austin TX 78714-9971

(877) 353-9791 (512) 460-5429

See CONTINUATION Page

Award is intended to be FAR Part 13, Single Firm Fixed BPA for Clinical Laboratory Chemistry, Immunochemistry, Chemilumines and Hematology Testing IAW the PWS for Michael J. Crescenz VAMC.

Period of performance is five (5) years from the effective date.

Period of Performance: 09/01/2024 - 08/31/2028 Unilateral Task orders will be issued for a 12-month period fPeriod at a time, contingent upon .

availability of VA Funds.

Exemption from Application of the Service Contract Labor Labor Standards to Contracts IAW FAR 52.222-52.

See CONTINUATION Page

Determined at Task Order Level

X X

X 1

Amanda Saunders Contracting Officer

36C24424Q0378

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

A.2 PRICE SCHEDULE

ITEM INFORMATION

A.3 DELIVERY SCHEDULE

SECTION B ‐ CONTINUATION OF SF 1449 BLOCKS

B.1 BPA TERMS AND CONDITIONS

B.2 AUTHORIZED REPRESENTATIVES

B.3 PERIOD OF PERFORMANCE

B.4 PRICING

B.5 INVOICES

B.6 OBLIGATION OF FUNDS

B.7 AUTHORIZED INDIVIDUALS

B.8 ADMINISTRATIVE DATA

B.9 PRECEDENCE

SECTION C ‐ CONTRACT CLAUSES

C.1 52.216-18 ORDERING (AUG 2020)

C.2 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.3 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.7 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES

OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC

2023)

SECTION D ‐ CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 PERFORMANCE WORK STATEMENT

D.2 ATTACHMENT A TEST LIST & ANNUAL HISTORICAL VOLUMES

SECTION E ‐ SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

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

(NOV 2021)

E.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND

VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.5 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—

REPRESENTATION AND DISCLOSURES (DEC 2023)

E.6 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.7 52.216-1 TYPE OF CONTRACT (APR 1984)

E.8 52.233-2 SERVICE OF PROTEST (SEP 2006)

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

E.10 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

A.2 PRICE SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

48.00 MO $________________ $_________________

Clinical Laboratory Chemistry, Immunochemistry, Chemiluminescent and Hematology Testing in accordance with the terms of the PWS (to include instrumentation, reagents, supplies and services). Reference Attachment A Annual Historical Volumes.

Contract Period: Base POP Begin: 09-01-2024 POP End: 08-31-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing MANUFACTURER PART NUMBER (MPN): Various LOCAL STOCK NUMBER: Various

GRAND TOTAL $_________________

A.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY DELIVERY DATE

IAW the PWS 48.00 09/01/2024 – 08/31/2028

SECTION B ‐ CONTINUATION OF SF 1449 BLOCKS

B.1 BPA TERMS AND CONDITIONS

This order is subject to the terms referenced in BPA .

B.2 AUTHORIZED REPRESENTATIVES

The primary Contracting Officer (CO) for this Agreement is:

Amanda Saunders

Department of Veterans Affairs Network Contracting Office 4

Services 5 1010 Delafield Road

Pittsburgh, PA 15215 amanda.saunders@va.gov

The Primary Contracting Officer's Representative (COR) for projects under this Agreement is:

None

The Primary and/or Secondary COR will be responsible for technical monitoring of the contractor's performance and deliveries. The COR and the Contractor's Representative shall work together to ensure that all contractual requirements are being met. The COR will interpret specifications or technical portions of the work. The COR is not authorized to perform, formally or informally, any of the following actions:

(1) Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change this contract;

(2) Waive or agree to modification of the delivery schedule;

(3) Make any final decision on any contract matter subject to the Disputes Clause;

(4) Terminate, for any reason, the contractor's right to proceed;

(5) Obligate in any way, the payment of money by the Government. Only a warranted Contracting

Officer is authorized to obligate funds on this or any other contract action.

The contractor shall immediately notify the Contracting Officer in writing if the COR has taken an action (or fails to take action) or issues directions (written or oral) that the contractor considers to exceed the above limitations.

The contractor shall provide the Contracting Officer information copies of all correspondence to the COR.

B.3 PERIOD OF PERFORMANCE

This BPA expires on 08-31-2028 or such later ending date as determined by the exercise of any option.

B.4 PRICING

Contract 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 a Firm-Fixed-Price 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.5 INVOICES

a. Inspection and acceptance shall be accomplished as follows: The Government, for all services furnished under any resulting order, hereby designates the COR in the program office as the point of final inspection and acceptance. The BPA holder will submit each invoice, including all back-up data, to the Contracting Officer (CO) for review and signature. When the CO receives an accurate and complete invoice, he/she will return a signed copy to the BPA holder within five (5) working days. If the invoice is incomplete or inaccurate, the CO will return the unsigned invoice to the BPA holder for correction. The Contracting Officer will then forward the signed invoice to the Chief Financial Officer (CFO) for payment. Final payment for each order will be accomplished by final invoice accompanied by a receiving report.

b. An itemized invoice shall be submitted to the CO at least monthly or upon expiration of this BPA, whichever occurs first, for all deliveries made during a billing period and for which payment has not been received. Copies of delivery tickets shall support these invoices. "Approved-for-payment" invoices will be submitted to the payment address specified on each individual order issued under this BPA.

B.6 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.7 AUTHORIZED INDIVIDUALS

Individuals Authorized to Place Orders:

DVA authorizes the following entities to place orders:

Contracting Officer: Amanda Saunders | amanda.saunders@va

B.8 ADMINISTRATIVE DATA

A Blanket Purchase Agreement (BPA) is hereby established between and the Department of Veterans Affairs under the following terms and conditions incorporated in this BPA:

Primary Point of Contact: Contracting Officer Amanda Saunders amanda.saunders@va.gov

DUNS NUMBER:

Cognizant Office (Include complete address):

Department of Veterans Affairs Network Contracting Office 4 Services 5 1010 Delafield Road Pittsburgh PA 15215

B.9 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.

SECTION C ‐ CONTRACT CLAUSES

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.1 52.216‐18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from effective date of BPA through expiration date of BPA.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the BPA

(End of Clause)

C.2 52.216‐19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $100.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $1,000,000.00;

(2) Any order for a combination of items in excess of $6,999,999.00; or

(3) A series of orders from the same ordering office within 1 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216- 21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 1 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.3 SUPPLEMENTAL INSURANCE REQUIREMENTS

In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:

(a) Workers' compensation and employers liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

(b) General Liability: $500,000.00 per occurrences.

(c) Automobile liability: $200,000.00 per person; $500,000.00 per occurrence and $20,000.00 property damage.

(d) The successful bidder must present to the Contracting Officer, prior to award, evidence of general liability insurance without any exclusionary clauses for asbestos that would void the general liability coverage.

(End of Clause)

C.4 VAAR 852.232‐72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute

(ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.5 VAAR 852.242‐71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

C.6 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/

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

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

52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION JAN 1997

852.203-70 COMMERCIAL ADVERTISING MAY 2018

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

NOV 2023

852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS

(DEVIATION)

JAN 2023

(End of Addendum to 52.212-4)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (DEC 2023) (Section 1634 of Pub. L. 115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.232–40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[X] (1) 52.203–6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

[X] (2) 52.203–13, Contractor Code of Business Ethics and Conduct (NOV 2021) (41 U.S.C. 3509).

[] (3) 52.203–15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[] (4) 52.203–17, Contractor Employee Whistleblower Rights (NOV 2023) (41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

[X] (5) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (6) [Reserved]

[] (7) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (8) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (9) 52.204–27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117–328).

[] (10) 52.204–28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (DEC 2023) (Pub.

L. 115–390, title II).

[] (11)(i) 52.204–30, Federal Acquisition Supply Chain Security Act Orders— Prohibition. (DEC 2023) (Pub. L. 115–390, title II).

[] (ii) Alternate I (DEC 2023) of 52.204–30.

[X] (12) 52.209–6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) (31 U.S.C. 6101 note).

[X] (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(OCT 2018) (41 U.S.C. 2313).

[] (14) [Reserved]

[] (15) 52.219–3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) (15 U.S.C.

657a).

[] (16) 52.219–4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C.

657a).

[] (17) [Reserved]

[] (18)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-6.

[] (19)(i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-7.

[] (20) 52.219-8, Utilization of Small Business Concerns (SEP 2023) (15 U.S.C. 637(d)(2) and (3)).

[] (21)(i) 52.219–9, Small Business Subcontracting Plan (SEP 2023) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (JUN 2020) of 52.219–9.

[] (v) Alternate IV (SEP 2023) of 52.219–9.

[] (22)(i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

[] (ii) Alternate I (MAR 2020) of 52.219-13.

[] (23) 52.219–14, Limitations on Subcontracting (OCT 2022) (15 U.S.C. 657s).

[] (24) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) (15 U.S.C.

637(d)(4)(F)(i)).

[] (25) 52.219–27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (OCT 2022) (15 U.S.C. 657f).

[] (26) (i) 52.219–28, Post-Award Small Business Program Rerepresentation (SEP 2023) (15 U.S.C. 632(a)(2)).

[] (ii) Alternate I (MAR 2020) of 52.219–28.

[] (27) 52.219–29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (OCT 2022) (15 U.S.C. 637(m)).

[] (28) 52.219–30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (OCT 2022) (15 U.S.C. 637(m)).

[] (29) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C.

644(r)).

[] (30) l(26) 52.219–33, Nonmanufacturer Rule (SEP 2021) (15 U.S.C. 657s).

[X] (31) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).

[] (32) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (NOV 2023) (E.O.

13126).

[X] (33) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (34)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (ii) Alternate I (FEB 1999) of 52.222-26.

[X] (35)(i) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

[] (ii) Alternate I (JUL 2014) of 52.222-35.

[X] (36)(i) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C.

793).

[] (ii) Alternate I (JUL 2014) of 52.222-36.

[X] (37) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

[X] (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[X] (39)(i) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627).

[] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

[X] (40) 52.222-54, Employment Eligibility Verification (MAY 2022). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

[] (41)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (MAY 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (42) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

[] (43) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

[] (44)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (OCT 2015) of 52.223-13.

[] (45)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-14.

[] (46) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C.

8259b).

[] (47)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-16.

[X] (48) 52.223–18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

[] (49) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

[] (50) 52.223-21, Foams (JUN 2016) (E.O. 13693).

[] (51)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

[] (ii) Alternate I (JAN 2017) of 52.224-3.

[] (52)(i) 52.225-1, Buy American—Supplies (OCT 2022) (41 U.S.C. chapter 83).

[] (ii) Alternate I (OCT 2022) of 52.225–1.

[] (53)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (NOV 2023) (19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

[] (ii) Alternate I [Reserved].

[] (iii) Alternate II (DEC 2022) of 52.225-3.

[] (iv) Alternate III (NOV 2023) of 52.225-3.

[] (v) Alternate IV (OCT 2022) of 52.225-3.

[] (54) 52.225–5, Trade Agreements (NOV 2023) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[X] (55) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

[] (56) 52.225–26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

[] (57) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (NOV 2007) (42 U.S.C. 5150).

[] (58) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (NOV 2007) (42 U.S.C. 5150).

[X] (59) 52.229–12, Tax on Certain Foreign Procurements (FEB 2021).

[] (60) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (NOV 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

[] (61) 52.232-30, Installment Payments for Commercial Products and Commercial Services

(NOV 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

[X] (62) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management

(OCT 2018) (31 U.S.C. 3332).

[] (63) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (JUL 2013) (31 U.S.C. 3332).

[] (64) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

[] (65) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

[] (66) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

[] (67)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) (46 U.S.C. 55305 and 10 U.S.C. 2631).

[] (ii) Alternate I (APR 2003) of 52.247-64.

[] (iii) Alternate II (NOV 2021) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[] (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

[] (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (MAY 2014) (29 U.S.C 206 and 41 U.S.C. chapter 67).

[X] (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[] (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[X] (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022).

[X] (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706).

[] (9) 52.226–6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(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 Subpart 4.7, Contractor Records Retention, of the 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 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.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203–13, Contractor Code of Business Ethics and Conduct (NOV 2021) (41 U.S.C. 3509).

(ii) 52.203–17, Contractor Employee Whistleblower Rights (NOV 2023) (41 U.S.C. 4712).

(iii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iv) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (DEC 2023) (Section 1634 of Pub. L. 115–91).

(v) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115–232).

(vi) 52.204–27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117–328).

(vii) (A) 52.204–30, Federal Acquisition Supply Chain Security Act Orders— Prohibition. (DEC 2023) (Pub. L. 115–390, title II).

(B) Alternate I (DEC 2023) of 52.204–30.

(viii) 52.219–8, Utilization of Small Business Concerns (SEP 2023) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219–8 in lower tier subcontracts that offer subcontracting opportunities.

(ix) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(x) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

(xi) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

(xii) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

(xiii) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

(xiv) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xv) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

(xvi)(A) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O.

13627).

(B) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xvii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xviii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xix) 52.222-54, Employment Eligibility Verification (MAY 2022) (E. O. 12989).

(xx) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022).

(xxi) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706).

(xxii)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

(B) Alternate I (JAN 2017) of 52.224-3.

(xxiii) 52.225–26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

(xxiv) 52.226–6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxv) 52.232–40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph (c) of 52.232–40.

(xxvi) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) (46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

SECTION D ‐ CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 PERFORMANCE WORK STATEMENT

Clinical Laboratory Chemistry, Immunochemistry, Chemiluminescent and Hematology

Instrumentation with Automation Line and Auto-verification

The instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) and be able to 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) and the Clinical and Laboratory Standards Institute

(CLSI). This request is for the instrumentation, reagents supplies and services to perform Clinical

Laboratory Chemistry, Immunochemistry, Chemiluminescent and Hematology Testing on an automation line with auto-verification.

1. ORDERING METHOD: The participating facility may order products via Electronic Data

Interchange (EDI), telephone, Electronic mail or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

1.1.1. Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory.

1.1.2. If Contractor offers a family of analyzers, Michael J. Crescenz VAMC technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

1.1.1. Equipment shall be acquired for Michael J. Crescenz VAMC. Equipment must meet the volume and turnaround time requirements of Michael J. Crescenz VAMC Lab.

STATs are 60 minutes from receipt in lab to verification in lab computer.

1.1.2. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform 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. Sigma performance may be included to

36C24424Q0551 support test quality. 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. The

Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America.

1.1.3. 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.

2. GENERAL REQUIREMENTS:

2.1. Automation Line/Middleware

2.1.1. Automation line must support all instruments provided by the vendor.

2.1.2. Must connect to and support the instrumentation, hardware and software of Stago

Coagulation instruments. Vendor will make all connections.

2.1.3. Must connect to and support the instrumentation, hardware and software of the

Diasorin. Vendor will make all connections.

2.1.4. Must be able to connect instrumentation to an automated line. The automated line must be able to accept all size tubes, all types of caps, with minimal bar-code readers.

It must contain an automated refrigerated stockyard that holds at least 10000 samples.

2.1.5. Automation line must have large input module for volume and have automated specimen retrieval capabilities.

2.1.6. Must have middleware to control all instrumentation, track all specimens on the system, and be programmable for automatic reflex testing and automatic rerun.

2.1.7. 8. Automatic calculations performed by the instrument or middleware

2.1.8. Specimen archival through mapping of specimens to racks; for easy retrieval once moved off-line.

2.1.9. Must support the current auto verification software in use at the CMCVAMC which requires maintaining and adding rules for both the Remisol Advance software and

Data Innovations Instrument Manager wrapper rules for the current instruments and new instruments added to the automation line. There must be Data Innovations support included to assist in writing new rules for newly added instrumentation and for troubleshooting any issues that may occur that could break current rules.

2.2. Chemistry and Immunochemistry

2.2.1. Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Multiple analyzers are required to meet the productivity specifications defined herein. Therefore additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. (2 primary analyzers for Chemistry and 2 primary analyzers for Immunochemistry).

2.2.2. Operational Features‐ The instrumentation offered shall have the following:

2.2.2.1. The capability of performing analysis on 100% of the tests listed in

Attachment A Test List.

2.2.2.2. Sufficient capacity and throughput to meet the volume/ service demands as defined in Attachment A Test List.

2.2.2.3. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. Contractor must provide a mechanism for the Clinical Laboratory to meet local discharge requirements (i.e. mercury and formaldehyde SDS sheets must be provided in advance for review).

2.2.2.4. A bi-directional, bar-coded computer interface compatible with the current

VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the

VA computerized hospital information system.

2.2.2.4.1. The accuracy of the barcode reading must have less than a 1% failure rate.

2.2.2.4.2. Equipment must be able to support multiple barcode formats (Code

39, Code 128) that may be enabled concurrently.

2.2.2.4.3. Equipment must accept, at a minimum, BCBC characters in specimen identifier that is all alpha.

2.2.2.5. Ability to prioritize STAT testing without compromising existing programmed testing.

2.2.2.6. Menu flexibility to accommodate batch testing.

2.2.2.7. Minimal daily, monthly, and periodic maintenance.

2.2.2.8. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

2.2.2.9. On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least six (6) months for reagents when available.

2.2.2.10. Ready to use reagents to ensure less test downtime.

2.2.2.11. Ability to accept serum/plasma, CSF, urine, body fluids, supernatants and whole blood

2.2.2.12. No requirements for sample pre-treatment for most assays.

2.2.2.13. 6 point calibrators for immune assays preferred.

2.2.2.14. Capability to detect out of range quality control and ensure ceasing of patient testing until resolution if the quality control is out of range.

2.2.2.15. Ability to accept various types of sample containers.

2.2.2.16. Specimen indices (hemolysis, icteric, and lipemia) are required to be determined for each specimen at no additional charge.

2.2.2.17. On board dilution capability (desired).

2.2.2.18. Must have accurate metering capability for monitoring reagent usage or accept CMCVAMC’s monthly LMIP statistics generated from VistA computer system.

2.2.2.19. Instruments should have the ability to perform infectious disease testing.

2.2.3. Technical Features‐ The instrumentation must be approved by the Food and Drug

Administration (FDA) and shall have the following:

2.2.3.1. On-board QC data management system with a storage capacity for QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.

2.2.3.2. Ability to monitor instrument performance, preferably using a secure, direct data connection to a technical support center so instrument performance can be managed in real time.

2.2.3.3. On board reagent inventory system.

2.2.3.4. Minimal carryover, no carryover preferred.

2.2.3.5. Minimal reagent preparation, preferably no reconstitution required.

2.2.3.6. Antigen excess checks (immunochemistry).

2.2.3.7. Ability to run replicate testing with one sample.

2.2.3.8. Testing for adulteration of urine samples for DAU.

2.2.3.9. Ability to change reagents while instrument is in operation.

2.2.3.10. Onboard calibration and lot (calibrator and reagent) tracking.

2.2.3.11. Long calibration stability.

2.2.3.12. Minimal specimen volume.

2.2.3.13. Adequacy of sample detection.

2.2.3.14. Equipment performance evaluations will be based on at least the following:

2.4.4.15.1 Quality and accuracy of testing,

2.4.4.15.2 Amount of downtime of each analyzer,

2.4.4.15.3 Competence of service personnel, and

2.4.4.15.4 Number of times the service engineer has to return to fix the same instrument issue

Other performance categories can be added or removed as needed.

2.2.4. Hardware Features‐ The instrumentation shall have the following:

2.2.4.1. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

2.2.4.2. Total equipment footprint cannot require major construction projects.

2.2.4.3. An on-board monitor/screen that is easily readable.

2.2.4.4. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID).

2.2.4.5. An uninterruptible power supply with line conditioner for each instrument provided.

2.2.4.6. An auto sampling system that includes cap piercing closed tube aspiration, auto-loader, and auto-mixing.

2.2.4.7. Primary tube sampling.

2.2.4.8. Clot detection.

2.2.4.9. Manual sampling mode that reads barcode label; ideally both closed and open manual sampling modes is desirable.

2.2.4.10. Connection to technical support to monitor instrument/QC performance.

2.2.4.11. A quality control user group comparison program.

2.2.4.12. The Contractor shall be able to provide any incremental support equipment, e.g. water system, ultracentrifuge, for their systems.

Method Performance/Validation Requirements

1. Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and…