6515--PR Needed NEW Request / Tyroid Molecular Tests - THYROSEQ 5 year contract

Statement of Work/ Performance Work Statement

1. Contract Title.

Thyroid Molecular Testing

2. Background.

Thyroid nodules are common and require biopsy for diagnosis of a benign vs malignant

process. Fine needle aspiration cytology (FNA) is the biopsy method most frequently used to determine if a thyroid nodule is benign or malignant. Once assigned to the correct diagnostic category, a treatment plan can be prepared. If malignant, the treatment shall include a surgical procedure. Approximately 10% of the time the FNA diagnosis for a thyroid nodule shall be indeterminate for malignancy. These lesions are diagnosed: Follicular Lesion of Uncertain Significance (FLUS) or Follicular Neoplasm (FN). Thyroid nodules diagnosed on FNA as FLUS or FN may go on to surgery to determine the true nature of the nodule. Most thyroid nodules diagnosed FLUS or FN on FNA biopsy shall be found to be benign when the nodule is surgically removed. Therefore, many surgeries for thyroid nodules may not be necessary. Molecular testing of thyroid nodule FNA specimens was developed to aid in the diagnosis of indeterminate thyroid nodules. Molecular testing can detect hundreds of genes expressed in thyroid tissues. Reviewing thyroid-specific gene profiles can stratify thyroid nodule FNA specimens into those at low-risk (benign) and those at high-risk for malignancy.

3. Scope.

Molecular testing of thyroid nodule FNA specimens has been found to assist in the assessment of indeterminate thyroid nodules. Molecular testing can detect genetic alterations associated with thyroid malignancy. Molecular testing of an indeterminate thyroid nodule can stratify patients into those who may or may not need a surgical procedure. The Government has a requirement for molecular testing of indeterminate thyroid nodules at VA Puget Sound Health Care System (VAPSHCS) Seattle. This testing shall be performed at an outside laboratory. An FNA specimen from a thyroid nodule is placed into transport media provided by the contractor and shipped to the laboratory using their shipping materials. The volume of tests performed annually at VAPSHCS shall be approximately 120 molecular tests per year at the present biopsy rate and present rate of indeterminate nodules.

4. Specific Tasks.

a. The molecular test used for evaluating indeterminate thyroid nodules shall have high

specificity and sensitivity for malignancy, high predictive value, and shall employ an

extensive panel of thyroid-related gene mutations for detection to include at a minimum:

BRAF, RAS, TERT, RET, NTRK, and ALK. The test shall be able to use samples from fine needle aspirations and must accept frozen samples. A report shall be provided with each sample that shall include detected mutations/alterations with interpretation (including percentage/possibility of malignancy).

b. The Contractor shall provide the VAPSHCS with transport media for the FNA thyroid

specimen and must provide packaging and postage label for overnight shipment. The (TAT) turnaround time must be within seven (7) business days.

c. The Contractor facility shall be a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory, undergoing regular proficiency surveys of their testing. The

Contractor shall provide customer service that includes expertise in thyroid testing

panels, who shall be available Monday Friday between the hours of 8am 4:30pm,

MST. The laboratory shall have an established and reputable history of performing

thyroid molecular testing for other VA laboratories.

5. Performance Monitoring

VAPSHCS Medical Center will follow patients whose thyroid nodules have undergone molecular testing to ascertain whether the nodules were assigned to the correct diagnostic category of benign vs malignant.

6. Security Requirements

The C&A requirements do not apply, and a Security Accreditation Package is not required. Specimens will be labeled with patient s full name and SSN and be shipped according to Contractor instructions.

Results are Faxed to VAPSHCS using a secure FAX.

7. Privacy/Custody of VA Information

a. Information made available to the contractor or subcontractor by VA for the performance or administration of the contract shall be used only for the purposes and shall not be used in any other way without the written agreement of VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights of Data General, FAR 52.227-14(d)(1).

b. VA information should not be co-mingled, if possible, with any other data on the

contractor/subcontractor's information systems or media storage systems to ensure VA

requirements related to data protection and media sanitization can be met. If comingling

must be allowed to meet the requirements of the business need, the contractor

must ensure that VA's information is returned to the VA or destroyed in accordance with

VA's sanitization requirements. VA reserves the right to conduct onsite inspections of

contractor and subcontractor IT resources to ensure data security controls, separation of

data and job duties, and destruction/media sanitization procedures are in compliance

with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not

destroy information received from VA, or gathered / created by the contractor while

performing the contract without prior written approval by the VA. Any data destruction

done on behalf of VA by a contractor/subcontractor must be done in accordance with VA

Directive 6300, Records and Information Management and its Handbook 6300.1,

Electronic Media Sanitization. Self0-certification by the contractor that the data

destruction requirements above have been met must be sent to the VA Contracting

Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use,

disclose and dispose of VA information only in compliance with the terms of the contract

and applicable Federal and VA information confidentiality and security laws, regulations,

and policies. If Federal or VA information confidentiality and security laws, regulations

and policies become applicable to the VA information or information systems after

execution of the contract, or if NIST issues or updates applicable to FIPS or Special

Publications (SP) after execution of this contract, the parties agree to negotiate in good

faith to implement the information confidentiality and security laws, regulations, and

policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as

authorized and necessary to perform the terms of the agreement or to preserve

electronic information stored on contractor/subcontractor electronic storage media for

restoration in case any electronic equipment or date used by the contractor/subcontractor needs to be restored in an operating state. If copies are made

for restoration purposes, after the restoration is complete, the copies must be

appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality,

privacy, and security provisions of the contract, it shall be sufficient grounds for VA to

withhold payment to the contractor or third party or terminate the contract for default or

terminate for cause under FAR Part 12.

g. This contract will require a Business Associate Agreement between the Government and the contractor. If a VHA contract is terminated for cause, the associated BAA must also be terminated an appropriate action taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for

performance of the contract, the contractor/subcontractor may use and disclose VA

information only in two other situations: (i) in response to a qualifying order of a court of

competent jurisdiction, or (ii) with VA's prior written approval. The

contractor/subcontractor must refer to all requests for, demands for production of, or

inquiries about VA information and information systems to the VA contracting officer for

response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism, or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, the contractor/subcontractor shall immediately refer to such court orders or other requests to the VA Contracting Officer for response.

l. For service that involves storage, generating, transmitting, or exchanging of VA

sensitive information but does not require C&A or an MOU-ISA for system

interconnection, the contractor/subcontractor must complete a Contractor Security

Control Assessment (CSCA) on a yearly basis and provide it to the COTR. The

Reference Laboratory shall provide in accordance with all applicable federal, state, and

local regulations, laws, and ordinances, and in accordance with the specifications

outlined for accreditation certification if applicable, patient specimen testing for the

specific range of referral testing within their capability.

m. Services shall include the performance of analytical testing as defined by the

Laboratory's reference test manual, the reporting of analytical test results and

consultative services as required.

8. Liquidated Damages for Data Breach

a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to

sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under the contract.

b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in

the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity of the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the date breach for the potential misuse of any sensitive personal information involved in the data breach. The term "data breach" means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis.

Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

1. Nature of event (loss, theft, unauthorized access);

2. Description of the event, including:

a. Date of occurrence.

b. Date elements involved, including any PII, such as full name, social security

number, date of birth, home address, account number, disability code:

3. Number of individuals affected or potentially affected;

4. Names of individuals or groups affected or potentially affected;

5. Ease of logical date access to the lost, stolen, or improperly accessed data in light of

the degree of protection for the data, e.g. unencrypted, plain text;

6. Amount of time the data has been out of VA control;

7. The likelihood that the sensitive personal information will or has been compromised

(made accessible to and usable by unauthorized persons);

8. Known misuses of date containing sensitive personal information, if any;

9. Assessment of the potential harm to the affected individuals;

10. Data breach analysis as outlined in 6500.2 Handbook, Management of Security and

Privacy Incidents, as appropriate; and

11. Whether credit protection services may assist record subjects in avoiding or

mitigating the results of identity theft based on the sensitive personal information that

may have been compromised.

9. Place of Performance

The work will be performed at the Contractor s facility.

10. Period of Performance

10/1/2026 to 8/31/2027 Base Year

9/1/2027 to 8/31/2028 Option Period 1

9/1/2028 to 8/31/2029 Option Period 2

9/1/2029 to 8/31/2030 Option Period 3

9/1/2030 to 8/31/2031 Option Period 4