S02_36C26123Q0559 draftv2.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

662-23-2-146-0016

36C26123Q0559 05-19-2023

Addlene Williams addlene.williams@va.gov 702-791-9000 ext. 15864 05-29-2023 4:00pm EDT

00261 Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

X

Y

541380

$16.5 Million

N/A

See Delivery Schedule

00261

Department of Veterans Affairs Network Contracting Office 21 Southern Nevada Healthcare System 6900 N. Pecos Road North Las Vegas NV 89086

Financial Services Center P.O. Box 149971

Austin TX 78714-9971

See CONTINUATION Page

Contractor shall provide Clinical Molecular Thyroseq Testing services to eligible veterans of the VA San Francisco Health Care System (VASFHC).

VASFHC will periodically send specimens for abnormal thyroid nodules which determines if surgery is appropriate for low risk malignancy.

Period of Performance: 06/15/2023 - 06/14/2028 Ordering Period 1: 06/15/2023 - 06/14/2024 Ordering Period 2: 06/15/2024 - 06/14/2025 Ordering Period 3: 06/15/2025 - 06/14/2026 Ordering Period 4: 06/15/2026 - 06/14/2027 Ordering Period 5: 06/15/2027 - 06/14/2028

See CONTINUATION Page

X 1

Joleo B. Dianala Contracting Officer

36C26123Q0559

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 PERFORMANCE WORK STATEMENT FOR ANATOMIC PATHOLOGY SERVICE

LAB TESTING

SECTION C - CONTRACT CLAUSES

C.1 52.216-18 ORDERING (AUG 2020)

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

C.3 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.5 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.6 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.7 VAAR 852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL (MAY 2020)

C.8 VAAR 852.211-76 LIQUIDATED DAMAGES - REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023)

C.9 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (OCT 2019)

C.10 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.11 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.12 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(OCT 2019)

C.13 VAAR 852.237-74 NON-DISCRIMINATION IN SERVICE DELIVERY (OCT 2019)

C.14 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.15 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 21

C.16 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.17 52.204-15 SERVICE CONTRACT REPORTING REQUIREMENTS FOR

INDEFINITE-DELIVERY CONTRACTS (OCT 2016)

C.18 52.219-4 NOTICE OF PRICE EVALUATION PREFERENCE FOR HUBZONE

SMALL BUSINESS CONCERNS (OCT 2022)

C.19 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.20 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JUL 2021)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 VAAR 852.273-70 LATE OFFERS (NOV 2021)

E.10 VAAR 852.273-74 AWARD WITHOUT EXCHANGES (NOV 2021)

E.11 VAAR 852.273-73 EVALUATION - HEALTH-CARE RESOURCES (NOV 2021) 412

E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

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: TBD

b. GOVERNMENT: Contracting Officer 36C261 Joleo B. Dianala

Network Contracting Office 21

VA Southern Nevada Healthcare System

6900 N. Pecos Road, Building 6

North Las Vegas NV 89086

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

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

The guaranteed minimum award amount for this contract is $1,000.00. The maximum aggregate value of orders that can be placed under this contract is $500,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

36.00 EA __________________ __________________

Clinical Molecular Thyroseq Testing

Contract Period: Ordering Period 1 POP Begin: 06-15-2023 POP End: 06-14-2024 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing

MANUFACTURER PART NUMBER (MPN): NA

Contract Period: Ordering Period 2 POP Begin: 06-15-2024 POP End: 06-14-2025 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Ordering Period 3 POP Begin: 06-15-2025 POP End: 06-14-2026 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Ordering Period 4 POP Begin: 06-15-2026 POP End: 06-14-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Ordering Period 5 POP Begin: 06-15-2027 POP End: 06-14-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

GRAND TOTAL __________________

B.3 PERFORMANCE WORK STATEMENT FOR ANATOMIC PATHOLOGY

SERVICE LAB TESTING

SCHEDULE OF SERVICES

Thyroseq testing profiles unique genetic alterations in patient thyroid nodules to determine malignant potential and whether surgery is appropriate or our SFVAMC patients.

Contractor shall provide laboratory services to include specimen packaging and transport of specimens to its laboratories; pre-analytic processing as defined in its Laboratory Testing Manual; performing test for Thyroseq testing for indeterminate thyroid nodule cases.

After the sample is collected, received in the Anatomic pathology laboratory, the container is labeled with patient name, accession number along with the completed requisition form with patient information and type of test and it has the correct patient name, accession number and proper tests for each request.

Fresh tissue in preservative media, thyroid tissue/formalin fixed paraffin embedded block, unstained formalin fixed sections on glass slides of for Thyroseq molecular testing.

Place of Performance: Services shall be provided at the outside laboratory.

Pricing Instructions:

The total cost shall base on number of tests submit to outside laboratories for processing including the courier service cost provides by Contractor. There is an increase of specimens received in Pathology laboratory for processing from other clinical services within the SFVAMC. The tests are submitted to be performed by outside laboratory and accurate results mean increased satisfaction which is more effective for our veterans care.

There is an increase of specimens received in the anatomic laboratory and these tests are more important for our veterans care. The SFVAMC pathologists evaluate the tissue and determine the best type of testing depending on the amount of tissue available for processing and testing. The total monthly cost depends on number of thyroid cases received within the pathology laboratory which is approximately 1-3 tests in a month.

The Contractor shall propose tests for Thyroseq testing on Thyroid Biopsy cases.

It is difficult to estimate the exact number of tests required because this depends on the number SFVAMC patients diagnosed with abnormali of thyroid nodules.

1. SCOPE OF WORK

1. 1 Contractor shall provide laboratory shipping materials to FedEx specimens to its laboratory; preanalytic processing as defined in its laboratory user’s manual; analysis, reporting of analytic results, and consultation regarding selection, collection, shipping and result interpretation.

The contractor shall provide the following services:

1.1.2. Provide all necessary shipping requirements, not limited to the following:

Requisition/order forms

Specimen/slide holders

Special instructions if any to transport paraffin blocks/slides safely

Current list of tests with reference ranges and specimen requirements

FedEx clinical lab packs

All forms, including Chain of Custody forms

1.1.3 Provide specimen shipping material as defined in the contract.

1.1.4 Transport samples in such a manner as to ensure the integrity of the specimen.

1.1.5 Contractor shall supply any special preservatives required for specimen preservation if required.

1.1.6 Analyze samples to perform Thyroseq testing. Thyroseq test looks for unique genetic alterations in patient thyroid nodules to determine malignant potential and whether surgery is appropriate.

1.1.7 Routine test results shall be faxed and reported within 2 to 3 weeks.

1.1.9 Consult with Laboratory on test results by telephone as needed.

1.1.10 Provide SFVAMC Laboratories with a means of communication to permit immediate inquiry regarding the status of pending tests.

1.1.11 Billing and test report summaries shall begin the first day of the month and include the last day of the month.

2. LICENSING AND ACCREDITATION.

2.1. Contractor shall have all licenses, permits, accreditation and certificates required by law.

2.1.1. All testing facilities providing laboratory services under the contract must possess a valid state license, CLIA license and full accreditation from the College of American Pathologists (CAP). Contractor shall provide evidence of such accreditation upon receipt of a written request.

2.1.2 Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst.

3. CHANGES.

3.1. Contractor shall be responsible for assuring all subcontractors have appropriate licensure and accreditation to perform tests that the contractor cannot perform. Contractor shall notify the CO and the COR of any change of subcontract laboratory. Any change shall be submitted to the CO for review and approval.

3.2. If it is deemed that the removal of the test from the test menu is required, due to any changes by the contractor, then it will be communicated by the CO, COR or designee.

3.3. The VA may need to add test to the test list during the contract term without contract modification. This may be due to a change or discontinued test previously done by another laboratory. Requests may be made for pricing, specimen requirements and methodology. The CO, COR or designee will make the final decision on the appropriateness of moving the test to the contractor.

4. PROCEDURE GUIDANCE

4.1. The Contractor shall not introduce new medical procedures and services for specimens provided by VA without prior recommendation to, and approval of, the COR, or authorized laboratory representative.

4.1.1. The Contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy (per all applicable regulatory agency [RA] guidelines). The standard deviation and daily control records are to be available for review upon request by the Contracting Officer or contracting officer’s representative.

4.1.2. The Contractor shall perform repeat tests at no charge to the government if the results do not, in the government requesting physician's opinion; fit the clinical picture of the patient.

When requesting these tests, the government requesting physician or representative will explain the conditions of the patient or any discrepancies observed. Repeat tests shall be the same test originally ordered.

4.1.3. The Contractor shall notify the SFVAMC COR or designee of instances in which, in the professional judgment of the Contractor, the patient requires services or tests, which were not originally requested.

4.1.4. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government.

4.1.5. The Contractor shall contact the SFVAMC COR to coordinate the furnishing and delivery of specimen collection and shipping materials to Fed-Ex tissue blocks and slides.

5. TRANSPORTING SPECIMENS.

5.1. The Contractor shall provide all necessary shipping material to transport specimens/paraffin blocks/glass slides.

6. TEST RESULTS.

6.1. The Contractor shall provide routine test results to the ordering SFVAMC facility within 2 to 3 weeks.

6.2. Telephone Consultation. The Contractor shall consult with the SFVAMC COR, requesting Clinician or designee at the VAMC by telephone as needed.

6.3. The Contractor shall immediately telephone the respective SFVAMC COR; requesting Clinician or designee to report Critical Values or test result that may indicate a life-threatening condition.

7. SLIDES.

7.1 The Contractor shall return all blocks and slides to SFVAMC for quality control review when requested. Quality control slides shall represent duplicate copies original slides prepared by the Contractor from permanent tissue blocks. The Contractor shall provide quality control slides to

SFVAMC.

8. STORAGE OF SPECIMENS.

8.1 The Contractor shall store all specimens as required by regulatory agencies (RA)

8.1.1 Upon request by the SFVAMC COR or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA.

8.1.2. In the absence of RA requirements, the Contractor shall store specimens, after all testing has been completed: clinical specimens seven (7) days, surgical specimens six (6) months, cytology and histopathology slides indefinitely; and paraffin blocks for five (5) years.

9. MONTHLY TESTS SUMMARY.

9.1 The Contractor shall provide to SFVAMC a cumulative (year-to-date) and monthly report of all tests received during the month and for all outstanding results. The report will also include turn around statistics, cost per test (including any additional charges) and specimen or testing issues.

10. SERVICE.

10.1 The contractor shall provide telephone number(s) and contact person to be used by the VA facilities to make specimen problem inquiries and problem solving at all times excluding weekends and holidays.

10.2 The contractor shall include names and telephone numbers of technical Directors available for consultation.

10.3 Contractor shall assign a specific local account representative to each VA facility.

10.4 Contractor shall advise facility of any changes in methodology, procedure, reference ranges, delays in testing, and any new tests introduced within a timely manner and prior to changes are made.

10.5 In the event that the contractor changes the assay procedure of a critically important component of an assay the contractor shall notify the SFVAMC COR prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged or be improved when desirable for all tests. All new tests shall have CPT codes.

Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the

CO/COR.

10.5.1. If it is deemed that the removal of the test from the test menu is required, due to any changes by the contractor, then it will be communicated by the CO, COR or designee.

11.1 PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY

IMPROVEMENT (QI).

11.1.1 To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of contract:

11.1.2 Indication of average monthly volume of specified tests in the Schedule that the laboratory performs.

11.1.3 For quality purposes routinely performed in duplicate should be indicated.

TAT and accurate in test results. Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs.

11.1.4 Proficiency testing data shall include a list of tests outside of the acceptable range for past 2 years. The contractor(s) facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the government upon prior written notice and during normal business hours during the life of the contract.

11.1.5 Maintains licensing and registration information kept current.

11.1.6 Privacy, Confidentiality and HIPAA. Contractor technician and pathologists comply with all laws, regulation, policies and procedures relating to Privacy, Confidentiality and HIPPA.

12. HOURS OF OPERATION.

12.1. Normal Hours of Operation. The Contractor shall perform the services required under this contract 8 to 10 hours a day, 5 days a week, 12 months of the year. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA COR.

13. RECORDS.

13.1. If requested by the VA COR, the Contractor shall provide the original record, or a reproducible copy of any such record, promptly of receipt of the written request.

14. RELEASE OF MEDICAL INFORMATION.

14.1 The Contractor shall not release any medical information obtained during the course of this contract to anyone outside the SFVAMC, unless authorized in writing by the SFVAMC COR and the patient, as required by applicable law.

15. SAFETY.

15.1 The Contractor shall comply with all applicable OSHA, Federal, State, laws, and regulations as required for performing the type of services required.

16. END OF CONTRACT PERFORMANCE.

16.1 At the end of the period of contract performance, the participating medical treatment facility will notify the Contractor of the quantity of unused supplies and arrange a pick-up time. All Contractor provided equipment shall be disconnected by the Contractor from the VAMC, upon contract expiration and removed within five working days.

17. GENERAL DEFINITIONS.

Critical Value. A test result that requires evaluation by a physician or other health care provider as soon as verified. Failure to take appropriate action as a result of a critical value might cause harm or undue suffering for a patient. A list of critical values is to be made available to each VA facility upon request.

Frozen Section. A biopsy specimen that is immediately frozen and cut with cryostat; then mounted on a slide, stained, and examined by a pathologist. Frozen sections provide a rapid diagnosis to the physician during surgery.

Paraffin Block. A tissue specimen that has been embedded in paraffin wax that the sections can be cut for histologic examination.

Reference or Referral Laboratory. The contract laboratory that provides testing, and examination of specimens provided by the medical treatment facility.

Reference Value. A range of test values expected for a designated population of individuals.

Slides. Glass surface containing biological material to be analyzed.

Specimen. A body fluid or tissue sample removed for medical examination and analytical testing.

Surgical Specimen. A sample or part of an organ or tissue removed during surgery for medical examination and analytical testing.

Tests. Diagnostic assays to evaluate patients with history of abnormal thyroid nodules.

Special handling - Unusual circumstances may dictate the need for a specimen to be picked up, run out of sequence at a special time, or reported within a shorter than usual time.

Proficiency Testing - An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by a large number of other labs. The proficiency survey is conducted by an organization or agency authorized by the Department of Health and Human Services to do so.

18. SAMPLE PREPARATION.

18.1 Each VA facility will provide laboratory specimens prepared according to the contractor's laboratory specimens according to industry standards. Contractor shall supply the transportation kits and any special preservatives required for specimen preservation and transport when necessary. All the blocks should be returned to SFVAMC after testing is complete.

18.2 SFVAMC is responsible for packaging the specimens and transport specimens between SFVMC Pathology laboratory at 4150 Clement Street, San Francisco and contractor.

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 first day of the ordering period through the last day of the ordering period.

(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 contract.

(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 the cost of one room, one veteran, one day, 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 $400,000.00;

(2) Any order for a combination of items in excess of $500,000.00; or

(3) A series of orders from the same ordering office within 120-days 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 30-days 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 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period;

provided, that the Contractor shall not be required to make any deliveries under this contract after the end of the ordering period.

(End of Clause)

C.4 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 before contract expiration.

(End of Clause)

C.5 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR

(APR 1984)

Funds are not presently available for performance under this contract beyond 09/30/2028. The Government's obligation for performance of this contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made.

No legal liability on the part of the Government for any payment may arise for performance under this contract beyond 09/30/2028, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the Contracting Officer.

(End of Clause)

C.6 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC

2022)

The Contracting Officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee’s authority. A copy of the designation letter shall be furnished to the Contractor.

(End of Clause)

C.7 VAAR 852.204-70 PERSONAL IDENTITY VERIFICATION OF

CONTRACTOR PERSONNEL (MAY 2020)

(a) The Contractor shall comply with current Department of Veterans Affairs policy for personal identity verification of all employees performing under this contract when frequent and continuing access to VA facilities or information systems is required.

(b) The Contractor shall insert this clause in all subcontracts when the subcontractor’s employees will require frequent and continuing access to VA facilities or information systems.

(End of Clause)

C.8 VAAR 852.211-76 LIQUIDATED DAMAGES - REIMBURSEMENT FOR

DATA BREACH COSTS (FEB 2023)

(a) Definition. As used in this clause, ‘‘contract’’ means any contract, agreement, order or other instrument and encompasses the definition set forth in FAR 2.101.

(b) Non-disclosure requirements. As a condition of performance under a contract, order, agreement, or other instrument that requires access to sensitive personal information as defined in VAAR 802.101, the following is expressly required—

(1) The Contractor, subcontractor, their employees or business associates shall not, directly or through an affiliate or employee of the Contractor, subcontractor, or business associate, disclose sensitive personal information to any other person unless the disclosure is lawful and is expressly permitted under the contract; and

(2) The Contractor, subcontractor, their employees or business associates shall immediately notify the Contracting Officer and the Contracting Officer’s Representative (COR) of any security incident that occurs involving sensitive personal information.

(c) Liquidated damages. If the Contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach, the Contractor shall, in place of actual damages, pay to the Government liquidated damages of $37.50 per affected individual in order to cover costs related to the notification, data breach analysis and credit monitoring. In the event the Contractor provides payment of actual damages in an amount determined to be adequate by the Contracting Officer, the Contracting Officer may forgo collection of liquidated damages.

(d) Purpose of liquidated damages. Based on the results from VA’s determination that there was a data breach caused by Contractor’s or any of its agents’ failure to protect or otherwise engaging in conduct to cause a data breach of VA sensitive personal information, and as directed by the Contracting Officer, the Contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of the following:

(1) Notification related costs.

(2) Credit monitoring reports.

(3) Data breach analysis and impact.

(4) Fraud alerts.

(5) Identity theft insurance.

(e) Relationship to termination clause, if applicable. If the Government terminates this contract, purchase order, or agreement, in whole or in part under clause 52.249–8, Default—Fixed-Price Supply and Service, or any other related FAR or VAAR clause included in the contract, in addition to the required liquidated damages for data breach related expenses specified in paragraph (c) above, the Contractor is liable for excess costs for those supplies and services for repurchase as may be required under the Termination clause.

C.9 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND

VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (OCT 2019)

(a) In an effort to achieve socioeconomic small business goals, VA shall evaluate offerors based on their service-disabled veteran-owned or veteran-owned small business status and their proposed use of eligible service-disabled veteran-owned small businesses (SDVOSBs) and veteran-owned small businesses (VOSBs) as subcontractors.

(b) Eligible service-disabled veteran-owned small businesses offerors will receive full credit, and offerors qualifying as veteran-owned small businesses will receive partial credit for the Service-Disabled Veteran-Owned and Veteran-Owned Small Business Status evaluation factor.

To receive credit, an offeror must be registered and verified in the Vendor Information Pages (VIP) database.

(c) Non-Veteran offerors proposing to use SDVOSBs or VOSBs as subcontractors will receive some consideration under this evaluation factor. Offerors must state in their proposals the names of the SDVOSBs and VOSBs with whom they intend to subcontract and provide a brief description of the proposed subcontracts and the approximate dollar values of the proposed subcontracts. In addition, the proposed subcontractors must be registered and verified in the VIP database.

(d) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

C.10 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

(a) The offeror agrees, if awarded a contract, to use the service-disabled veteran-owned small businesses (SDVOSBs) or veteran-owned small businesses (VOSBs) proposed as subcontractors in accordance with 852.215–70, Service-Disabled Veteran-Owned and Veteran- Owned Small Business Evaluation Factors, or to substitute one or more SDVOSBs or VOSBs for subcontract work of the same or similar value.

(b) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

C.11 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.12 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY

INSURANCE (OCT 2019)

(a) It is expressly agreed and understood that this is a non-personal services contract, as defined in Federal Acquisition Regulation (FAR) 37.101, under which the professional services rendered by the Contractor or its health-care providers are rendered in its capacity as an independent contractor. The Government may evaluate the quality of professional and administrative services provided but retains no control over professional aspects of the services rendered including, by example, the Contractor’s or its health-care providers’ professional medical judgment, diagnosis, or specific medical treatments. The Contractor and its healthcare providers shall be liable for their liability-producing acts or omissions. The Contractor shall maintain or require all health-care providers performing under this contract to maintain, during the term of this contract, professional liability insurance issued by a responsible insurance carrier of not less than the following amount(s) per specialty per occurrence:

*__________________. However, if the Contractor is an entity or a subdivision of a State that either provides for self-insurance or limits the liability or the amount of insurance purchased by State entities, then the insurance requirement of this contract shall be fulfilled by incorporating the provisions of the applicable State law.

* Amounts are listed below:

(b) An apparently successful offeror, upon request of the Contracting Officer, shall, prior to contract award, furnish evidence of the insurability of the offeror and/or of all healthcare providers who will perform under this contract. The submission shall provide evidence of insurability concerning the medical liability insurance required by paragraph (a) of this clause or the provisions of State law as to self-insurance, or limitations on liability or insurance.

(c) The Contractor shall, prior to commencement of services under the contract, provide to the Contracting Officer Certificates of Insurance or insurance policies evidencing the required insurance coverage and an endorsement stating that any cancellation or material change adversely affecting the Government’s interest shall not be effective until 30 days after the insurer or the Contractor gives written notice to the Contracting Officer. Certificates or policies shall be provided for the Contractor and/or each health-care provider who will perform under this contract.

(d) The Contractor shall notify the Contracting Officer within 5 days of becoming aware of a change in insurance providers during the performance period of this contract for all health-care providers performing under this contract. The notification shall provide evidence that the Contractor and/or health-care providers will meet all the requirements of this clause, including those concerning liability insurance and endorsements. These requirements may be met either under the new policy, or a combination of old and new policies, if applicable.

(e) The Contractor shall insert the substance of this clause, including this paragraph (e), in all subcontracts for healthcare services under this contract. The Contractor shall be responsible for compliance by any subcontractor or lowertier subcontractor with the provisions set forth in paragraph (a) of this clause. At least 5 days before the commencement of work by any subcontractor, the Contractor shall furnish to the Contracting Officer evidence of such insurance.

$1,000,000.00 per occurrence/ $3,000,000.00 aggregate

C.13 VAAR 852.237-74 NON-DISCRIMINATION IN SERVICE DELIVERY

(OCT 2019)

It is the policy of the Department of Veterans Affairs that no person otherwise eligible will be excluded from participation in, denied the benefits of, or subjected to discrimination in the administration of VA programs and services based on non-merit factors such as race, color, national origin, religion, sex, gender identity, sexual orientation, or disability (physical or mental).

By acceptance of this contract, the Contractor agrees to comply with this policy in supporting the program and in performing the services called for under this contract. The Contractor shall include this clause in all subcontracts awarded under this contract for supporting or performing the specified program and services. Accordingly, the Contractor shall ensure that each of its employees, and any subcontractor staff, is made aware of, understands, and complies with this policy.

(End of Clause)

C.14 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.15 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.

C.16 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):

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS

AND REQUIREMENT TO INFORM EMPLOYEES OF

WHISTLEBLOWER RIGHTS

JUN 2020

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

MAY 2011

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.224-1 PRIVACY ACT NOTIFICATION APR 1984

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

DEC 2022

52.224-2 PRIVACY ACT APR 1984

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

MAR 2023

52.237-3 CONTINUITY OF SERVICES JAN 1991

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

C.17 52.204-15 SERVICE CONTRACT REPORTING REQUIREMENTS FOR

INDEFINITE-DELIVERY CONTRACTS (OCT 2016)

(a) Definition.

First-tier subcontract means a subcontract awarded directly by the Contractor for the purpose of acquiring supplies or services (including construction) for performance of a prime contract. It does not include the Contractor's supplier agreements with vendors, such as long-term arrangements for materials or supplies that benefit multiple contracts and/or the costs of which are normally applied to a Contractor's general and administrative expenses or indirect costs.

(b) The Contractor shall report, in accordance with paragraphs (c) and (d) of this clause, annually by October 31, for services performed during the preceding Government fiscal year (October 1-September 30) under this contract for orders that exceed the thresholds established in 4.1703(a)(2).

(c) The Contractor shall report the following information:

(1) Contract number and order number.

(2) The total dollar amount invoiced for services performed during the previous Government fiscal year under the order.

(3) The number of Contractor direct labor hours expended on the services performed during the previous Government fiscal year.

(4) Data reported by subcontractors under paragraph (f) of this clause.

(d) The information required in paragraph (c) of this clause shall be submitted via the internet at www.sam.gov. (See SAM User Guide). If the Contractor fails to submit the report in a timely manner, the Contracting Officer will exercise appropriate contractual remedies. In addition, the Contracting Officer will make the Contractor's failure to comply with the reporting requirements a part of the Contractor's performance information under FAR subpart 42.15.

(e) Agencies will review Contractor reported information for reasonableness and consistency with available contract information. In the event the agency believes that revisions to the Contractor reported information are warranted, the agency will notify the Contractor no later than November 15. By November 30, the Contractor shall revise the report, or document its rationale for the agency.

(f)(1) The Contractor shall require each first-tier subcontractor providing services under this contract, with subcontract(s) each valued at or above the thresholds set forth in 4.1703(a)(2), to provide the following detailed information to the Contractor in sufficient time to submit the report:

(i) Subcontract number (including subcontractor name and unique entity identifier), and

(ii) The number of first-tier subcontractor direct-labor hours expended on the services performed during the previous Government fiscal year.

(2) The Contractor shall advise the subcontractor that the information will be made available to the public as required by section 743 of Division C of the Consolidated Appropriations Act, 2010.

(End of Clause)

C.18 52.219-4 NOTICE OF PRICE EVALUATION PREFERENCE FOR

HUBZONE SMALL BUSINESS CONCERNS (OCT 2022)

(a) Evaluation preference.

(1) Offers will be evaluated by adding a factor of 10 percent to the price of all offers, except—

(i) Offers from HUBZone small business concerns that have not waived the evaluation preference; and

(ii) Otherwise successful offers from small business concerns.

(2) The factor of 10 percent shall be applied on a line item basis or to any group of items on which award may be made. Other evaluation factors described in the solicitation shall be applied before application of the factor.

(3) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce (i.e., nonmanufacturer), is 500 employees if the acquisition—

(i) Is set aside for small business and has a value above the simplified acquisition threshold;

(ii) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(iii) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) Waiver of evaluation preference. A HUBZone small business concern may elect to waive the evaluation preference, in which case the factor will be added to its offer for evaluation purposes.

[ ] Offeror elects to waive the evaluation preference.

(c) Joint venture. A HUBZone joint venture agrees that, in the performance of the contract, at…