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SOURCES SOUGHT NOTICE

This is a Sources Sought Synopsis (SSS) ONLY. The U.S. Government is conducting market research only to determine the availability of qualified sources capable of providing Thyroid Molecular Testing services. Potential Contractors are invited to provide a response via e-mail to Contracting Officer Ross Byrne at ross.byrne@va.gov by Oct 13, 2023 1:00 pm (PT). Responses will be used to determine the appropriate strategy for a potential acquisition. Please clearly identify any information your company considers sensitive or proprietary. This notice is issued solely for information and planning purposes - it does not constitute a Request for Quotation (RFQ), or a promise to issue an RFQ in the future. This notice does not commit the U.S. Government to contract for any supply or service. Further, the U.S. Government is not seeking quotes, or proposals at this time and will not accept unsolicited quotes in response to this sources sought synopsis. The U.S. Government will not pay for any information or administrative costs incurred in response to this notice. Submittals will not be returned to the responder. Not responding to this notice does not preclude participation in any future RFQ, if any is issued.

BACKGROUND: The Boise VA Medical Center, has a requirement for a Contractor to provide Thyroid Molecular Testing services. Please see draft Statement of Work for requirements.

NAICS: 621511 (Medical Laboratories)

Interested potential Contractors please provide the following.

1) Company Name, address, point of contact, phone number, email address, and DUNS

Please indicate business size:
Small Disadvantage Business (SDB)____
8(a)____
Historically Underutilized Business Zone (HUBZone)____
Service-Disabled Veteran-Owned Small Business (SDVOSB)____
Veteran-Owned Small Business (VOSB)_____
Economically Disadvantaged Women-Owned Small Business (EDWOSB)_____
Women-Owned Small Business concerns (WOSB)_____
Small Business_____
Large Business_____

Federal Supply Schedule______

2) Please submit a brief capability statement (maximum two pages) with enough information to demonstrate to the Veterans Affairs that you have the capabilities and qualifications such as providing high specificity, sensitivity for malignancy, high predictive value, and a list of thyroid-related gene mutations for which your company can detect, ensuring transport media is available for all types of samples, to include frozen samples and provide delivery of a specimen report to the Boise VA Medical Center Point of Contact, within a seven (7) day turn-around as required in the Statement of Work.
**DRAFT STATEMENT OF WORK**
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. Review of 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 Boise VA. This testing shall be performed at an outside laboratory. An FNA specimen from a thyroid nodule is placed into transport media provided by contractor and shipped to the laboratory using their shipping materials. The volume of tests performed annually at Boise VA shall be approximately 10 molecular tests per year at the present biopsy rate and present rate of indeterminate nodules.
4. Specific Tasks.
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 small biopsy samples 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).
The contractor shall provide the Boise VA with transport media for the FNA thyroid specimen and must provide packaging and postage label for overnight shipment. Turnaround time must be within seven (7) business days.
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 an expertise in thyroid testing panels, who shall be available Monday Friday between the hours of 8am 4:30pm, MST.
5. Performance Monitoring
Boise VA shall 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 vendor instructions.
Results are Faxed to Boise VAMC using a secure FAX.
7. Privacy/Custody of VA Information
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 the 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).
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 co-mingling 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.
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.
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.
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.
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.
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.
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.
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.
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 all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.
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 such court orders or other requests to the VA Contracting Officer for response.
For service that involves the 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.
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

8.0 Liquidated Damages for Data Breach
a. Consistent with the requirements of 38U.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.
8. Place of Performance.
The work will be performed at the Contractor s facility.
9.0 Government Invoicing Instructions.
Invoicing shall be in accordance with the requirements of The Department of Veterans Affairs (VA) Financial Services Center (VAFSC). The latest information shall be used for invoicing and payments and may change during the Period of Performance of this acquisition. Invoice requirements are currently as follows: Invoice Number, Invoice Date, Purchase Order Number, Unit Price, Quantity and Unit of Measure, Total Invoice Price, Ship-To Location Name and/or code, Receipt of Goods/ Services, Invoice Payment Terms.Â
Current Invoicing information is located at http://www.fsc.va.gov/einvoice.asp. It states:
FSC Mandatory Electronic Invoice Submission:Â The Department of Veterans Affairs published a final rule in the Federal Register on November 27, 2012 to require contractors to submit payment requests in electronic form in order to enhance customer service, departmental productivity, and adoption of innovative information technology, including the appropriate use of commercial best practices. The rule is effective December 27, 2012.
Vendor Electronic Invoice Submission Methods
Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:
VA s Electronic Invoice Presentment and Payment System The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.
System that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI).
The X12 EDI Web site (http://www.x12.org).
The Department of Veterans Affairs Tungsten Number is: AAA544240062
Vendor e-Invoice Set-Up Information:
Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:
Tungsten e-Invoice Setup Information: 1-877-489-6135
Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com
FSC e-Invoice Contact Information: 1-877-353-9791
FSC e-invoice email: vafsccshd@va.gov

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