36C25625Q0440_RFQ.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* RFQ: Physician Authorized Genetics Testing for MEDVAMC

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056-5643

SOLICITATION NUMBER* 36C25625Q0440

QUESTIONS DATE/TIME/ZONE 03-20-2025 16:00 CENTRAL TIME, CHICAGO, USA

RESPONSE DATE/TIME/ZONE 03-27-2025 16:00 CENTRAL TIME, CHICAGO, USA

ARCHIVE 1 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE SBA

PRODUCT SERVICE CODE* Q301

NAICS CODE* 621511

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 16 Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston TX 77056-5643

POINT OF CONTACT*

Contract Specialist Shasta Britt Shasta.Britt@va.gov

PLACE OF PERFORMANCE

ADDRESS Department of Veterans Affairs Michael E. DeBakey VA Medical Center

MEDVAMC

2002 Holcombe Blvd.

Houston Texas

POSTAL CODE 77030

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov URL DESCRIPTION Department of Veterans Affairs AGENCY CONTACT’S EMAIL ADDRESS Shasta.Britt@va.gov EMAIL DESCRIPTION 36C25625Q0440-RFQ Response-Vendors Name mailto:Shasta.Britt@va.gov mailto:Shasta.Britt@va.gov

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for

Evaluation and Solicitation for Commercial Items,” in conjunction with FAR Part 13.5 for Certain

Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written

SF1449 solicitation document will not be issued.

This solicitation is issued as a Combined Synopsis Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular: 2025-03 01/17/2025. This competitive solicitation is being issued as Small Business Set-Aside.

The associated North American Industrial Classification System (NAICS) code for this procurement is 621511, with a size standard of $41.5 Million.

The FSC/PSC is Q301

Contractor is required to be actively in the System for Award Management (SAM). Contractor quote may be considered non-compliant and rejected if the Contracting Officer is unable to verify active registration status. The Department of Veterans Affairs (VA), Michael E. DeBakey

VA Medical Center (MEDVAMC), Pathology & Laboratory Medicine Service department is requesting to establish a Single Awarded Indefinite Delivery, Indefinite Quantity (IDIQ) for

Genetic Testing.

See Attached RFQ on next page…

36C25625Q0440

Table of Contents

SECTION B - CONTINUATION CONTRACT OPPORTUNITIES COMBINED SYNOPSIS

SOLICITATION

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

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

C.2 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.3 52.216-18 ORDERING (AUG 2020)

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

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

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

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

C.8 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023) (DEVIATION)

C.9 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ..14

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 STATEMENT OF WORK

D.2 IT CONTRACT SECURITY

D.3 PRICE LIST

D.4 WAGE DETERMINATIONS No.: 2015-5233 REV. 29 (DEC2024)

SECTION E - SOLICITATION PROVISIONS

E.1 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

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

E.5 52.233-2 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 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

E.10 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

SECTION B - CONTINUATION CONTRACT OPPORTUNITIES

COMBINED SYNOPSIS SOLICITATION

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR: Company Name:

ATTN/POC Name:

Address:

Phone:

Email:

UEI:

GSA/FSS, NAC, Contract# (if applicable):

b. GOVERNMENT: Contracting Officer 36C256

Department of Veterans Affairs Network Contracting Office 16 Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston TX 77056-5643

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

a. 52.232-33 Payment by Electronic Funds Transfer - System for Award

Management through TUNGSTEN

3. INVOICES: Invoices shall be submitted in arrears:

a. Other: Upon receipt and acceptance by the Government

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.

5. Offeror shall complete the following located in Sections B thru E of this solicitation to be deemed eligible:

a. Section B- CONTRACT ADMINISTRATION DATA, CONTRACTOR contact information.

b. Section B- PRICE/COST SCHEDULE, unit price, amount, and grand total.

c. Section E- 52.204-24 and 52.209-7.

d. Section E- 52.212-3 (if not current in SAM.gov).

e. Submission of manufacturer’s authorized distributor letter, cut-sheets, and specifications.

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

AMENDMENT NO DATE

(End of Contract Administration Data)

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

DESCRIPTION

OF SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 YR __________________ __________________

Contractor shall provide all labor, services, shipping and deliver all items as listed in Section D: Price List for Genetic Testing and adhere to the terms and conditions as listed herein and the SOW.

Contract Period: Order Year One (1) POP Begin: 04-01-2025 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

LOCAL STOCK NUMBER: N/A

deliver all items as listed in Section D: Price List for Genetic Testing and adhere to the terms and conditions as listed herein and the SOW.

Contract Period: Order Year Two (2) POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference deliver all items as listed in Section D: Price List for Genetic Testing and adhere to the terms and conditions as listed herein and the SOW.

Contract Period: Order Year Three (3) POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference deliver all items as listed in Section D: Price List for Genetic Testing and adhere to the terms and conditions as listed herein and the SOW.

Contract Period: Order Year Four (4) POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

PRODUCT/SERVICE CODE: Q301 - Medical - Reference deliver all items as listed in Section D: Price List for Genetic Testing and adhere to the terms and conditions as listed herein and the SOW.

Contract Period: Order Year Five (5) POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference

GRAND TOTAL VALUE

Estimated quantities listed for each Contract Item numbers are estimates of the total requirement for the described product. The Government may place orders at quantities less than the estimated total quantity as stated in the schedule of items. There is no express or implied guarantee that the quantities will be ordered regularly.

This is a five (5) year firm fixed price IDIQ and list overall 5-year period of performance. The

Government anticipates issuing a single order covering each ordering period below. However, the possibility exist the Government may issue multiple orders during each ordering period at the rates established for a period. Each order or combination of order “may” exceed the ordering period grand total; however, all orders shall not exceed the stated IDIQ maximum.

***Note*** (Period of Performance for Ordering periods are based on a twelve (12) month period, with the Order Year One (1) being short to the end of the FISCAL year, effective date and end date may change depending on when an award will be made but will be based on a twelve (12) month period).

Evaluation of options under FAR 52.217-8 will be accomplished by using the prices offered for the last order year period to determine the price for a 6-month order period, which will be added to the base and other order years to arrive at the total price. Evaluation of options will not obligate the Government to exercise the order(s).”

i. Prior to exercising any option, the Contracting Officer will ensure that it is still in the government’s best interest, with price and other factors considered.

ii. Any extension, in accordance with FAR 52.217-8 shall utilize Order Year Five (5) pricing. Thus, the offeror’s total price for the purpose of evaluation will include the Order Years

1, 2, 3, 4, and 5, and ½ of the fifth order period. As indicated in FAR 52.217- 8, the government will have the option clause to extend the performance of the contract up to an additional 6 (six) months, when the contractor is provided written notice. Thus, providing separate pricing for the optional six-month extension period is not required.

Pricing shall be firm fixed price and may not be changed, but quantities are estimated, and actual quantities ordered may fluctuate. Total ordering cannot exceed the total obligation amount for performance period unless first approved in writing by the contracting officer.

B.3 DELIVERY SCHEDULE

ITEM # SHIPPING INFORMATION QUANTITY DELIVERY DATE

0001 SHIP TO: IAW SOW

1.00 04/01/2025-09/30/2025

FOB: DESTINATION

0002 SHIP TO: IAW SOW

1.00 10/01/2025-09/30/2026

0003 SHIP TO: IAW SOW

1.00 10/01/2026-09/30/2027

0004 SHIP TO: IAW SOW

1.00 10/01/2027-09/30/2028

0005 SHIP TO: IAW SOW

1.00 10/01/2028-09/30/2029

[End of Section B]

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 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

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

FAR

Number

Title Date

52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST JUN 2020

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

NOV 2023

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

JAN 2025

52.217-6 OPTION FOR INCREASED QUANTITY MAR 1989

52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY

PRICED LINE ITEM

MAR 1989

52.217-8 OPTION TO EXTEND SERVICES NOV 1999

52.228-5 INSURANCE—WORK ON A GOVERNMENT

INSTALLATION

JAN 1997

52.247-34 F.O.B. DESTINATION NOV 1991

52.249-8 DEFAULT (FIXED-PRICE SUPPLY AND SERVICE) APR 1984

(End of Clause)

C.2 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 https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/ 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.3 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 executed award date through Not To Exceed (NTE) five (5) years.

(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.4 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 $1,800,000.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

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

(1) Any order for a single item in excess of $50.00;

(2) Any order for a combination of items in excess of $360,000.00; or

(3) A series of orders from the same ordering office within 7 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 7 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.5 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 .

(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 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of

Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.8 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND

VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023)

(DEVIATION)

(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 certification status and their proposed use of eligible certified service-disabled veteran-owned small businesses (SDVOSBs) and certified veteran-owned small businesses (VOSBs) as subcontractors.

(b) Eligible and certified 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 certified Service-Disabled Veteran-Owned and Veteran-Owned Small Business Status evaluation factor. To receive credit, an offeror must be listed at the time of submission of offers and at time of award, as a certified SDVOSB/VOSB in the SBA certification database on the

SBA Veteran Small Business Certification Program portal at https://veterans.certify.sba.gov/

(see 13 CFR 128) and be otherwise eligible in accordance with SBA size standards for the acquisition and limitations on subcontracting requirements set forth in SBA regulations (see 13

CFR 121, 125 and 128.).

(c) Non-Veteran offerors proposing to use certified SDVOSBs or VOSBs as subcontractors will receive some consideration under this evaluation factor. Offerors must state in their proposals the names of the certified 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 listed at the time of submission of offers and at time of award, as a certified SDVOSB/VOSB in the SBA certification 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 https://veterans.certify.sba.gov/ debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

C.9 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.10 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.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT

2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer

(ACO) for the purpose of performing certain tasks/duties in the administration of the contract.

Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

(End of Addendum to 52.212-4)

[End of Section C]

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR

ATTACHMENTS

D.1 STATEMENT OF WORK

GENERAL: The Michael E. DeBakey VA Medical Center (MEDVAMC) is pursuing a contract with a base year ordering period from date of award to the end of the first FISCAL year with additional four ordering years (12-months) for genetic testing.

BACKGROUND: The genetic test will be prescribed by the Veterans' attending Physician who has the authority to prescribe the method of treatment for best optimal medical care of his/her patient. The physician has determined that the requested Genetic Tests are medically necessary to diagnose the Veteran’s medical condition. These genetic tests are critical for making a diagnosis for the patient which in turn will help focus their management and initiate surveillance.

Making a diagnosis is crucial for the patient as it removes uncertainty, determines further management including treatment and surveillance and prevents further intensive workup and expensive investigations. It improves patient outcomes as management can be based on anticipatory guidance and prognosis, thus optimizing long-term care. This will help us to achieve the best possible outcomes for our Veteran patients needing genetic and genomic care.

Genetics testing that also offer supplementary RNA analysis for specific oncology panels which is very helpful for interpreting variants of uncertain significance and determining further management for our Veteran patients. Management decisions are based on genetic testing results, particularly in oncology and having access to RNA sequencing is essential for determining the clinical significance of variants in genes associated with hereditary cancer. We have had many young male and female Veteran patients ask for carrier screening to help determine their future reproductive planning.

SCOPE: The MEDVAMC is requesting referral genetic testing for the below CPT Code and respective Manufacture Catalog # of variants. A detailed list of tests is included with the contracting packet and is titled “VA Test Panel List” SEE ATTACHED. They should be able to perform sample intake, processing, analysis, interpretation, and reporting for germline genetic testing. These will include single gene testing, as well as panels, including whole exome and whole genome sequencing curated by the laboratory in accordance with national guidelines.

TASK: The Contractor shall notify the Contracting Officer Representative (COR) or authorized

MEDVAMC Lab Tech representative when test results will not be available for greater than 21 days at 713-794-7332.

Test Contractor Point of Contact. The Contractor shall assign a specific account representative to

MEDVAMC. The Contractor shall provide the following point(s) of contact when immediate inquiry regarding the status of a pending test(s) is required:

a. Person(s) name(s): TBD

b. Telephone number: TBD

c. Fax number: TBD

The Contractor laboratory shall provide and ensure safe, secure, and careful handling of the patient samples and the reporting of results in accordance with established guidelines from the

Department of Veterans Affairs Handbook 6500, the College of American Pathologists (CAP), the Joint Commission on Accreditation of Health Care Organizations (JCAHO), guidelines established by VA Laboratory Service or as required to follow the Health Insurance Portability and Accountability Act of 1996 (HIPAA) during transportation. The contractor must be approved by the College of American Pathologists (“CAP”) and the Clinical Laboratory

Improvement Amendments (“CLIA”).

The Contractor shall maintain current licenses and certificates and provide copies of such to VA within 30 days of written request. The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. Technologist, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical

Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology acceptable to the United States Surgeons General and must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction; and shall have provided pathology services for a minimum of 24 months within the past 36 months and pathology consultation services at a minimum of 36 months within the past 48 months. The

Contractor shall include names and telephone numbers of technical Directors and Pathologists available for consultation.

The Contractor shall advise the MEDVAMC of any changes in methodology, procedure, reference ranges delays in testing, and any new tests introduced.

They will provide a list of tests available as well as a secure online ordering and reporting portal.

Invitae will maintain the minimum acceptable service, reporting system, and quality control.

The VA send out laboratory will be responsible to provide laboratory specimens to be prepared in accordance with the contractor laboratory specifications. All specimens will be labelled with at least two patient identifiers (e.g., name, DOB, medical record number).

INVOICING:

The contractor shall bill only for the tests sent by the VISN16 telegenomics program run through the Michael E DeBakey VA Medical Center and ordered by authorized providers. The contractor laboratory shall provide up-to-date point of contact information for all correspondence related to genetic testing and billing from the VA.

HOURS OF OPERATION:

The contractor laboratory is responsible for providing services Monday through Friday 8:00 AM

– 4:30 PM Central Standard Time (CST), except Federal Holidays and the contractor shall always maintain an adequate workforce to ensure provision of genetic testing services.

PERIOD OF PERFORMANCE:

Order Year 1: From Date of Award to end of FISCAL year 09/30/2025.

Order Year 2: 12 months – 10/01/2025-09/30/2026

Order Year 3: 12 months - 10/01/2026-09/30/2027

Order Year 4: 12 months - 10/01/2027-09/30/2028

Order Year 5: 12 months - 10/01/2028-09/30/2029

GOVERNMENT FURNISHED: The MEDVAMC is responsible for collecting, packaging, and mailing the specimens.

The MEDVAMC Send-Out laboratory personnel will affix a label containing the patient’s full name and full social security number to the specimen’s container to ensure integrity of the information, place the specimen (that is being sent for processing) in a sealed tamper evident container and ship via UPS.

The Genetics Counselor have access to the portal and will post results on the share point. Then

MEDVAMC laboratory personnel will scan the result report to CPRS.

FEDERAL HOLIDAYS: The Contractor is not required to perform services on the following

Federal holidays:

New Year’s Day January 1st

Birthday of Martin Luther King Jr. 3rd Monday in January

Washington’s Birthday 3rd Monday in February

Memorial Day Last Monday in May

Juneteenth National Independence Day June 19th

Independence Day July 4th

Labor Day 1st Monday in September

Columbus Day 2nd Monday in October

Veterans Day November 11th

Thanksgiving Day 4th Thursday in November

Christmas Day December 25th

In addition to the days designated as holidays, the Government observes the following days: Any other day designated by Federal Statute. Any other day designated by Executive Order. Any other day designated by the President’s Proclamation.

The Government anticipates award of a Firm Fixed Price type.

SECURITY REQUIREMENTS: VA Protected Health Information is provided to the vendor under this contract. This contract is to enable a HIPAA Covered Entity to provide clinical services on behalf of VA. A patient’s consent is not required (1605.1P24). The vendor is required to secure the PHI as required by HIPAA.

INFORMATION SYSTEMS OFFICER, INFORMATION PROTECTION: The Contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

PRIVACY OFFICER: The Contractor will not have access to protected Patient Health

Information (PHI), nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for

Contractor analyses is de-identified.

VA-SPECIFIC/PRIVACY TRAINING. The Contractor shall complete the VA Privacy and

Information Security Awareness and Rules of Behavior (VA10176) training and Privacy and

HIPAA Focused training (VA10203) in the Talent Management System (TMS) annually, as well as, any other mandated training, at their own cost before access is given, at no cost to the government.

INFORMATION SYSTEM SECURITY: For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system.

The contractor’s security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

Adequate security controls for collecting, processing, transmitting, and storing of

Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a

Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor’s systems in accordance with VA

Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program

Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

The contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the

ISO for entry into VA’s POA&M management process. The contractor/subcontractor must use

VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities.

Security deficiencies must be corrected within the timeframes approved by the government. The

Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the

C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook

6500.3. This may require reviewing and updating all of the documentation (PIA, System Security

Plan, and Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

VA prohibits the installation and use of personally owned or contractor / subcontractor owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal

(host-based or enclave based) firewall that is configured with a VA approved configuration.

Software must be kept current, including all critical updates and patches. Owners of approved

OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook

6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

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

Vendor must accept the system without the drive;

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

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

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

The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

RECORDS MANAGER: Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of

44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for

Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law.

Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

Michael E. DeBakey Veterans Affairs Medical Center system and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Michael E. DeBakey

Veterans Affairs Medical Center system or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the

Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to

Michael E. DeBakey Veterans Affairs Medical Center system. The agency must report promptly to NARA in accordance with 36 CFR 1230.

The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from

Government facilities or systems, or facilities or systems operated or maintained on the

Government's behalf, without the express written permission of the Head of the Contracting

Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Michael E. DeBakey Veterans Affairs Medical Center system control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting

Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY

PROHIBITED unless in accordance with Paragraph (4).

The Contractor is required to obtain the Contracting Officer’s approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to contracts. The

Contractor (and any sub-contractor) is required to abide by Government and Michael E.

DeBakey Veterans Affairs Medical Center system guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Michael E. DeBakey Veterans Affairs Medical

Center system policy.

The Contractor shall not create or maintain any records containing any non-public Michael E.

DeBakey Veterans Affairs Medical Center system information that are not specifically tied to or authorized by the contract.

The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of information Act.

Michael E. DeBakey Veterans Affairs Medical Center system owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Michael E. DeBakey Veterans Affairs Medical Center system shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

TRAINING: All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take Michael E. DeBakey Veterans Affairs Medical

Center system provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

(End of SOW)

D.2 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY LANGUAGE

1. GENERAL. This entire section applies to all acquisitions requiring any Information

Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter

“contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR

52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA

Contracting Officer (CO). The primary clause used to define Government and

Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support

(including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government

Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies.