S02 - RFQ 36C26226Q0675 Ref Lab.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

644-26-3-5837-0030

36C26226Q0675 04-30-2026

Diaz, Marcos 858 228-0081 05-25-2026

07:00 PDT

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

X

621511

$41.5 Million

N/A

X

36C262

Department of Veterans Affairs Phoenix Veterans Affairs HCS 650 E. Indian School Road

Phoenix AZ 85012

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

Financial Services Center Submit Invoices electronically to:

https://authentication.tungsten-network.

com/login

(877) 489-6135

See CONTINUATION Page

STAT Reference Lab for Send Out Testing for Phoenix VAHCS testing services in accordance with schedule herein.

1) See Section E -SOLICITATION PROVISIONS, 52.212-1 on page 45 for instructions on submitting quotes/proposals.

2) See SOW in Section B.2. Offers must meet requirements set forth in this section.

3) This will be a firm-fixed-Price contract.

4) This is an unrestricted open-market solicitation.

5) The period of performance will begin on 06/23/2026, with 4 One-year Option periods.

6) Services to be ordered/used as needed.

See CONTINUATION Page

X 1

36C26226Q0675

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 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

C2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

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

C.4 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.5 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

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 (OCT 2025) (DEVIATION FEB 2025)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

E.2 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.4 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

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

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

1998)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION

FEB 2025)

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 36C262 Diaz, Marcos at Marcos.Diaz@va.gov.

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

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

[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] Monthly, as needed

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

The purpose of this PWS is to procure clinical and anatomic pathology diagnostic testing services from a qualified Reference Laboratory (hereafter Contractor) for the Phoenix Veterans Affairs Heath Care System (hereafter Phoenix VAHCS) on an as-needed basis, for laboratory testing protocols not performed by the in-house laboratory.

See Section SPECIAL CONTRACT REQUIREMENTS, Part VIII for information of items / tests currently being used. Any equal to substitutions shall be of equal quality and cover the same scope of testing.

Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide reference laboratory services to the Phoenix VAHCS described herein. Reference laboratory services include but are not limited to specimen preparation and storage; transportation of clinical laboratory specimens, microbiology cultures, and stocks; performance of analytical testing; reporting of analytical test results; and consultative services.

The Contractor must be CLIA certified and confirm that they are a covered entity. No Business Associate Agreement is required. This will be a base year plus four option years contract.

In accordance with Appendix A, Handbook 6500.6 Checklist blocks 6 and 7, the C&A requirements do not apply to this requirement, and that a Security Accreditation Package is not required since the Contractor is a covered entity and therefore protects all sensitive patient information.

I. Specimen Preparation and Storage for Reference Testing Specimens

A. Contractor shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor’s requirements.

B. Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory.

C. Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen.

II. Transportation Services for Reference Testing Specimens

A. Contractor shall provide and is responsible for transportation of primarily biomedical materials that include patient specimens and microbiology cultures and stocks, originating from Government facilities and destined to the contracted commercial reference laboratory. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part

173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in accordance with 49 CFR Part 173.199 to ensure the safety and integrity of the biomedical material is maintained.

B. COURIER SERVICE - shall be provided at no extra cost as needed and specimen pick up must be performed within two (2) hrs. from time of call initiated by client (Phoenix VA laboratory)

C. Routine transportation services shall occur once per day from the Phoenix VAHCS, Main Inpatient Laboratory. Specimen pick-up times will be negotiated after contract award.

D. Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor’s laboratory. These supplies shall include, but may not be limited to:

1) Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory.

2) Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.

3) Test request forms for specialized testing (i.e. Immunohistochemical (IHC) / In Situ Hybridization (ISH) Stains Request).

E. Contractor or designee shall be responsible for reconciliation of transportation fees.

III. Specimen Testing

A. The Contractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute all required testing. Contractor shall make available the following test information:

1) Access to manual requisition forms

2) Alphabetized test name list

3) Test order code

4) Specimen collection and preservation requirements

5) Test method employed (indicate if testing performed in duplicate) and interpretations.

6) Test reference intervals adjusted for age, sex or race, when required.

7) Test specific sensitivity, specificity and interferences, when required.

8) Result code

9) Test critical values if any

10) Policy for critical value notification

11) CPT coding

12) Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the Contractor and receipt of results by a government facility.

13) Schedule of test performance (specific days of week indicated)

14) Location of test performance by test name (i.e. name of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory must be cited)

Contractor shall notify the Contracting Officer and the Phoenix VAHCS Pathology and Laboratory Medicine Service of any test information modifications no later than two weeks prior to the implementation date of the test change.

Any new test(s) must be added to the contract through modification by the Contracting Officer (CORs and Government facility representatives do not have this authority) prior to specimen being tested.

B. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the VA Point of Contact or designee.

C. The Contractor shall ensure the accurate and timely performance of laboratory testing services on the biomedical materials.

IV. Specimen Retention

A. Clinical specimens, such as serum, whole blood and raw bone marrow, will be retained by the Reference Lab for a period that they deem necessary.

B. All anatomic pathology materials (e.g., histology blocks, slides or other diagnostic material) generated by the VA shall be returned within 7 days after final diagnosis is reported.

V. Reporting of Results

A. The results of testing shall be reported within the prescribed turnaround times provided by the Contractor as part of the test information.

B. Tests ordered STAT, results shall be available within 4 hours from time of specimen pick

up. Routine testing times will be in accordance with times published by the reference lab

C. A report of laboratory testing results must be issued either as a printed final copy or through electronic delivery by contractor secure date management system (website). However, in unusual circumstances where electronic delivery by contractor secure website is not possible, the Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing and/or transportation services by hand within 24 hours, or by telephone facsimile to a protected machine identified to the Contractor by the VA. Delivery by electronic mail i.e. MS Outlook, etc. is prohibited.

D. Each test report shall, at minimum, include the following information:

1) Patient's full name

2) Patient’s identification number, e.g., social security number (SSN)

3) Physician’s name (if supplied)

4) Government laboratory accession number (if supplied)

5) Submitting facility name

6) Submitting facility account number

7) Patient's location (clinic/ward) (if supplied)

8) Test(s) ordered.

9) Date/time of specimen collection (when available)

10) Date/time test completed.

11) Test result

12) Reference intervals (adjusted for age, sex or race, when appropriate)

13) Toxic and therapeutic ranges, if applicable

14) Flagged abnormal results.

15) Reference laboratory accession number

16) Name and address of testing laboratory

17) Any other information the laboratory has that may indicate a questionable validity of test results.

18) Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing.

E. Test results determined by the contractor to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission.

VI. Customer Service

A. Contractor shall provide customer service that is accessible by telephone service 24 hours per day, 7 days per week to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

B. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period:

1. Telephone Inquiries – Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government’s minimum time expectation for meeting this service.

a. Specimen Collection

1. Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call.

2. Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within ½ hour of the initial call.

b. Testing

1. Inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

2. Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call.

c. Technical Expertise

1. Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call.

2. Result interpretation inquiries shall be addressed within four business hours of initial call.

3. Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call.

d. Account follow-up

1. Information general in nature yet specific to the account, e.g. test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call.

C. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, lack of electronic order etc.

VII. Consultative Services/Utilization Reports

A. Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

B. Contractor shall provide a statistical analysis of the Government facilities’ workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities on mechanisms to reduce their costs.

C. Contractor shall provide a cumulative workload summary report of tests performed. The summary must include the test name/description, monthly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to date test expenditures.

1. A copy of the report shall be delivered electronically to the Contracting Officer, VA Point of Contact by the 10th of the month following the close of the reporting month.

2. All reports shall be submitted in electronic spreadsheet format and have the capability to sort by three (3) different methods:

a. Test names listed alphabetically.

b. Test names listed in order of year-to-date test frequency (highest to lowest)

c. Test names listed in order of year-to-date total test cost (highest to lowest)

VIII. Data Management System

A. Contractor shall provide to the Phoenix VAHCS all necessary laboratory test parameters (parameters are required for each test contained in a panel) to insure accurate test result transmission between the Phoenix VAHCS and the Contractor’s database. Required test parameters include:

1) Ordering code

2) LOINC code

3) CPT code

4) Interface code

5) Test cost

6) Reference ranges

7) Units of measurement

8) Test result interpretation or interpretive remarks, if appropriate

9) Testing site (if not performed at the vendor’s main laboratory facility

10) Test methodology

11) Specimen types

12) Specimen collection and handling requirements

13) Indication whether test is a panel/profile test, list of tests included.

The parameters for all tests in the Contractor’s database shall be kept current and be available to the Phoenix VAHCS throughout the performance period of the contract. Updates to the test parameter information must be provided to the Phoenix VAHCS no less than 2 weeks prior to the implementation of any changes. The Contractor shall provide telephone access to a Contractor’s technical representative to respond to any question(s) regarding the laboratory test parameter information.

B. The Contractor shall provide a data management system that meets the following requirements:

1) Test definition, test information and test requirements must be complete, available and easily accessible.

2) Shipping manifest must be generated that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered.

3) The status and the results of testing must be available within published timeframes and easily retrievable using varying options. At a minimum the options must include Sort by patient name; sort by date; sort by test; sort by incomplete test. Incomplete tests must have an indication of the pending time until completion. Alert messages, or other notification, must be generated when testing is delayed beyond published timeframes.

4) Reports of test results must be immediately available upon verification of the test result.

Contractor’s computer located at the Phoenix VAHCS must be able to print test results upon request and reprint retrospective test results.

SPECIAL CONTRACT REQUIREMENTS

I. Services

A. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Phoenix VAHCS and the contractor or the contractor’s employee(s). Contractor personnel are not subject to the supervision and control of a Phoenix VAHCS officer or employee. Rather, contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Phoenix VAHCS. The healthcare provider who furnishes services under this contract is subject to Phoenix VAHCS technical oversight of the services. The Phoenix VAHCS retains the right to reject services for contractual non-performance.

B. The Phoenix VAHCS may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

C. Contractor is required to maintain medical liability insurance for the duration of this contract.

Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider. Contractor must indemnify the Phoenix VAHCS for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance.

D. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.

II. Term of Contract

The period of performance for this contract is:

Base Year: 06/23/2026 – 06/22/2027 Option 1: 06/23/2027 – 06/22/2028 Option 2: 06/23/2028 – 06/22/2029 Option 3: 06/23/2029 – 06/22/2030 Option 4: 06/23/2030 – 06/22/2031

III. Federal Holidays

Contractor is not required to provide transportation of specimens on federal holidays, except in STAT situations. The 11 holidays observed by the Federal Government are:

1: New Year’s Day (Jan in 1st) 2: Martin Luther King’s Birthday (3rd Monday in Jan) 3: Presidents’ Day (3rd Monday in Feb) 4: Memorial Day (last Monday in May) 5: Juneteenth (June 19th) 6: Independence Day (July 4th) 7: Labor Day (1st Monday in Sept) 8: Columbus Day (2nd Monday in Oct) 9: Veterans Day (Nov 11) 10: Thanksgiving Day (4th Thursday in Nov) 11: Christmas Day (Dec 25th)

And any other day specifically declared by the President of the United States to be a national holiday.

When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.

IV. Qualifications/Requirements of Laboratory & Contractor Personnel

A. Laboratory

1. The Contractor must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments (CLIA) of 1988 or must demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The Contractor must maintain valid certifications during the entire performance period of this contract.

2. Reference laboratory shall provide CLIA license of the testing facility where testing is/was/will be performed.

3. Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this solicitation. In addition, as these documents are reissued or re-awarded, the awarded Contractor must supply a copy to the VA Point of Contact assigned to the Government facility.

4. Contractor must immediately notify the VA Point of Contact at the Government facility in writing, upon its loss of any required certification, accreditation or licensure.

5. Contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

B. Personnel

1. Contractor shall ensure all testing and supervisory personnel at the reference laboratory assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations and State standards.

Contractor shall be required to provide current unexpired documentation for this.

2. Contractor shall ensure its employees can perform the applicable duties consistent with their license and certification.

3. Any new requirements for mandatory education and/or competency reassessment, which occur during the contract period, must be completed by the individual contractor employee(s) within VA established timeframes.

4. Contractor couriers entering any Government facility shall prominently display a contractor-issued identification badge.

V. HIPAA Compliance

Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health, and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). The Contractor shall prove to the Phoenix VAHCS that they are identified as healthcare providers and that the PHI is being disclosed and/or used for treatment.

Therefore, no BAA is required for Contractor Services.

VI. Contract Performance Monitoring

A. Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. The VA Point of Contact will be responsible for verifying contract compliance. The VA Point of Contact will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms:

1. Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

2. Documentation of services performed will be reviewed prior to certifying payment. The VA Point of Contactwill perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually provided.

Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

3. Departments being served, through the VA Point of Contact, will provide a written statement annually to the Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted 45 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable).

VII. Quality Assurance Monitoring

A. Contractor shall maintain a Quality Assurance Program related to Reference Laboratory services covered under this contract.

B. Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the Phoenix VAHCS. This program must minimally address the quality aspects representative to the testing process, i.e. pre-analytical, analytical and post-analytical variables and include a description of monitoring and evaluation activities. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the Phoenix VAHCS staff for process review and improvement of contract performance on an as needed basis.

C. Copies of licensure/certifications are also required to be submitted upon request by the

VA.

D. If the contractor believes there are excusable circumstances, the contractor shall inform the Contracting Officer and the VA Point of Contact. Excusable circumstances may result in adjustment of the disincentives established in the Performance Matrix based upon the Contracting Officer’s Determination and Findings.

E. These monitoring procedures and disincentives for contractor’s failure in meeting these tasks are further illustrated in the following Performance Requirements Summary Matrix:

VIII. List Of Required Tests

Ensure offers provide pricing that covers the entire Base year + 4 One-Year Options. Use either the attached spreadsheet “S02 - RFQ Attachment A RefLab” or proprietary letterhead to provide pricing information.

Brand Name Brand Name Nomenclature Part #

Annual Qty

Sonora Cyclosporine A (Parent) (ROUTINE) 2638 120

Sonora Sirolimus (Rapamycin) (ROUTINE) 91071 64

Sonora Ethylene Glycol (STAT) 2180 72

Sonora Volatiles, Quantitative (STAT) 702139 28

Sonora Leukemia Lymphoma Panel 662 20

Sonora Gentamicin, Trough (ROUTINE) 10 16

Sonora C. difficile Toxin A and B, EIA (ROUTINE) 9171 16

Sonora FAXUS NGS HEME (ROUTINE) 907297 16

Sonora Chromosome Analysis: Bone Marrow (ROUTINE) 88858 12

Sonora FISH: AML Panel (ROUTINE) 788807 12

Sonora FISH: Low-Grade Lymphoma Panel (ROUTINE) 906762 8

Sonora Protein, Body Fluid (ROUTINE) 1047 240

Sonora Lipid Panel (ROUTINE) 1877 4

Sonora Lactate Dehydrogenase, Body Fluid (ROUTINE) 2033 240

Sonora Amylase, Body Fluid (ROUTINE) 2060 240

Sonora Methanol, Quantitative (STAT) 2145 4

Sonora Glucose, Body Fluid (ROUTINE) 2487 240

Sonora Gentamicin, Peak (ROUTINE) 3042 4

Sonora Urogram (ROUTINE) 3305 4

Sonora Hemoglobin A1c w cAG (ROUTINE) 9230 4

Sonora Urine Albumin, Random (ROUTINE) 9929 4

Sonora FISH: CLL Panel (ROUTINE) 88915 4

Sonora Tobramycin, Random (ROUTINE) 102073 4

Sonora Albumin, Body Fluid (ROUTINE) 102179 240

Sonora Testosterone, Free (Dialysis) and Total, MS (ROUTINE) 702723 4

Sonora Comprehensive Metabolic Panel (ROUTINE) 900323 4

Sonora Triglycerides, Pleural Fluid (ROUTINE) 901178 240

Sonora Cholesterol, Pleural Fluid (ROUTINE) 902042 240

Sonora Vitamin D, 25-Hydroxy, Total (ROUTINE) 904059 4

Sonora Bronchoalveolar Lavage CD4/CD8 (ROUTINE) 907275 4

Sonora FAXUS NGS AML (ROUTINE) 907296 4

Sonora Monkeypox Virus DNA, Qualitative Real-Time PCR

(ROUTINE) 907340 4

Sonora CBC w/ Differental, w/ Platelet (ROUTINE) 3000 4

Sonora TSH w/ Reflex free T4 (ROUTINE) 38055 4

Sonora Kidney Biopsy (ROUTINE) 100

Sonora T Spot (ROUTINE) 906927 24

Sonora Phenobarbital (ROUTINE) 702121 24

Sonora Blood Parasite Screen (ROUTINE) 8167 12

Sonora Stat Code 2051 480

Sonora Creatinine, Body Fluid (ROUTINE) 3481 240

Sonora Lipase, Body Fluid (ROUTINE) 2051 240

Sonora AFB Blood Culture and Smear (ROUTINE) 907199 4

Sonora AFB Culture and Smear (ROUTINE) 907201 4

Sonora Neutrophil Gelatinase-Associated Lipocalin (ROUTINE) 907193 6

Sonora BCR/ABL (ROUTINE) 905842 12

Sonora NGS MPN (ROUTINE) 907298 12

Sonora NGS Hematology panel (ROUTINE) 907297 4

Sonora FISH: Lymphoma Panel, High Grade (ROUTINE) 906763 4

Sonora NGS AML Molecular Panel (ROUTINE) 907296 4

Sonora Targeted Gene Panel with Fusions, Lung Cancer

(ROUTINE) 906807 4

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(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 unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

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

(i) Payment.—

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

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

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

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

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

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

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

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

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

(D) Contractor point of contact.

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

(6) Interest.

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

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

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

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

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

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

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

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

(A) The date fixed under this contract.

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

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

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

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

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

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

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

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

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

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

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

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

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

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

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

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

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

(1) The schedule of supplies/services.

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

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

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

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

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

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

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

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

(End of Clause)

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

PRODUCTS AND COMMERCIAL SERVICES

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

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

C2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

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

(End of Clause)

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

2000)

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

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

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

(End of Clause)

C.4 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

(a) Definitions. As used in this clause—

American Security Drone Act-covered foreign entity means an entity included on a list that the Federal Acquisition Security Council (FASC) develops and maintains and publishes in the System for Award Management (SAM) at https://www.sam.gov (section 1822 of Pub. L. 118-31, 41 U.S.C. 3901 note prec.).

Backhaul means intermediate links between the core network, or backbone network, and the small subnetworks at the edge of the network (e.g., connecting cell phones/towers to the core telephone network). Backhaul can be wireless (e.g., microwave) or wired (e.g., fiber optic, coaxial cable, Ethernet).

Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Covered article, as defined in 41 U.S.C. 4713(k), means:

(1) Information technology, as defined in 40 U.S.C. 11101, including cloud computing services of all types;

(2)…