Q301--Molecular Thyroid Mutation Reference Testing for Rocky Mountain Regional VA Medical Center, Aurora, CO. Amendment 0003.

36C25921Q0622

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36C25921Q0517, 0002 Combined Synopsis/Solicitation Amendment for Molecular Thyroid Reference Testing

Amendment 0002 Re-Solicitation and Request for Proposal after Revision of Statement of Work

The Statement of Work, Evaluation Factors and the Instructions to Offerors have been amended for this solicitation and Blanket Purchase Agreement terms have been added to this amendment. See below for the revised Statement of Work, Evaluation Factors, and Instructions to Offerors, in addition to the CLIN/Schedule, Proposal Deadline and BPA terms.

This solicitation 36C25921Q0517 is issued as a request for quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-05 (effective 03/10/2021) and VAAR 2008-28 (effective 01/27/2021). No telephone requests will be accepted. Only written requests received directly from the offeror are acceptable. The associated North American Industry Classification System (NAICS) code for this procurement is 621511 (Medical Laboratories), with a small business size standard of $11.0 million. This solicitation is unrestricted with no set-asides. IF OFFEROR IS A GSA SCHEDULE HOLDER, ALL INFORMATION REQUESTED IN THIS NOTICE MUST BE PROVIDED, NOT JUST THE OFFEROR S SCHEDULE NUMBER

The following is a list of the contract line item numbers, quantities and units of measure for years one (1) through five (5). Pricing shall be Firm Fixed Price and include any discount being offered. Shipping Terms: FOB (Free on Board) is Destination. All shipping, packaging and delivery costs for all tests and supplies must be included in the per case/test price. No separate line item for shipping/freight/packaging/delivery shall be accepted.

CLIN

TEST

Estimated Annual Cases

Price per Case/Test

Total Annual Price

0001

Mutation Detection in Thyroid Samples

40

1001

Mutation Detection in Thyroid Samples

40

2001

Mutation Detection in Thyroid Samples

40

3001

Mutation Detection in Thyroid Samples

40

4001

Mutation Detection in Thyroid Samples

40

Estimated TOTAL (Total Annual x 5 years): _______________________

STATEMENT OF WORK (SOW) MOLECULAR THYROID REFERENCE TESTING:

1. Scope

The Contractor shall provide testing for the detection of unique genetic alterations (including mutations, insertions, deletions, fusion and gene expression) to help determine if a thyroid nodule is benign or malignant in fine needle aspirates (FNAs) that are read as indeterminate (Bethesda III and IV) by a Rocky Mountain Regional VA Medical Center pathologist. Samples will be sent from the Rocky Mountain Regional VA Medical Center (RMRVAMC), located at 1700 North Wheeling Street, Aurora, CO, 80045.

2. Purpose

The RMRVAMC requires access to a molecular assay which analyzes thyroid fine needle aspiration specimens from patients who have had a previous diagnosis of atypical cells of undetermined significance . The purpose of the test is to detect mutations which would predispose a patient to increased risk of thyroid carcinoma. This test would decrease the need for repeat biopsies from the patient, which, in turn, would reduce the risk of procedure-related complications and optimize patient follow-up. An ideal molecular test to evaluate thyroid nodules with indeterminate cytology should have a combination of high negative and positive predictive value (NPV must be >95% for Bethesda III and IV cytology when evaluated separately) and have sufficient confirmation of analytical validation, clinical validation and clinical utility by non-institution-based data demonstrating the same. Thus, a negative test could allow for thyroid surgery to be safely avoided.

3. Conformance Standards

The contractor shall meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Amendments (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). The contractor shall also provide any valid, in-date CLIA and College of American Pathologists (CAP) certifications, showing the address and CLIA or CAP number of the testing laboratory. The contractor shall be HIPAA-compliant. The contractor shall be approved to provide clinical diagnostic laboratory testing under both Medicare and Medicaid regulations and all applicable federal and state laws.

4. Testing to be Performed

Targeted mutation detection for thyroid samples may include BRAF testing from:

Fine needle aspiration (FNA)

Stained slides/smears

Formalin fixed paraffin-embedded cell blocks

Any other acceptable sample types

Specimen Preparation and Transportation

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

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

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

Transportation Services for Reference Testing Specimens:

Contractor shall provide transportation of primarily biomedical materials that include patient specimens.

Transportation shall be done in such a manner that maintains the safety and integrity of the biomedical material.

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

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

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

Test request forms preprinted with the appropriate Shipping Section details and account information.

Test request forms for specialized testing (i.e., cytogenetics, tissue, etc.).

Testing Requirements

Contractor shall provide testing using tissue extracted during a fine needle aspiration. Contractor shall provide genomic sequencing to determine the expression profile of the mRNA. This test shall use the expression profile to determine a benign or suspicious for malignancy interpretation for the submitted tissue. The Contractor shall offer BRAF and RET/PTC mutation testing in addition to the genomic sequencing classification to help determine the extent of surgery.

Contractor shall make available the following test information:

Requisition form requirements

Specimen collection and preservation requirements

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

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

Test-specific analytic and clinical sensitivity, specificity, and interferences

Test critical values, if any

Policy for critical value notification

Report turn-around time will be within 14 days from the date on which the Contractor receives the specimen

Testing shall be performed Monday-Saturday

Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change.

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

Reporting

Results may be called to the VA Anatomic Pathology Department at 720-723-6821 or faxed to 720-723-6037. Alternative methods of contact can be provided, if needed. Vendor shall comply with posted turn-around times to ensure no delay in care or, in appropriate circumstances, notify RMRVAMC when a delay in turnaround time is anticipated.

Invoice requirements and supporting documentation:

The supporting documentation and invoice shall be submitted within 30 days of the end of each month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a proper invoice in accordance with FAR 52.212-4 (g), all invoices must include:

Name and Address of Contractor

Contractor s ID Number (Tax ID number)

Specimen ID (Patient name, patient ID number, order number)

Invoice Date and Invoice Number

Contract Number and Purchase/Task Order Number

Date of Service

Line Item Pricing, including test name

Total Price

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 per the accepted electronic data transmission methods below. Reference VAAR Clause 852.232-72: The contractor shall submit electronic payment requests through Tungsten.

Customer Service

Contractor shall provide customer service that is accessible during Contractor s business hours Monday-Friday 7:00am-5:00pm to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

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

Consultative Services/Utilization Reports

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

Confidentiality of Patient Records

The Contractor is a VA contractor and shall assist in the provision of health care to patients seeking such from or through VA. As such, the Contractor is considered as being part of the Department healthcare activity. Contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Furthermore, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7332. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

The records referred to above shall be, and remain the property of, VA and shall not be removed or transferred from VA except in accordance with U.S.C. 551 (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (Freedom of Information Act), 38 U.S. C. 5705 (Confidentiality of Medical Quality Assurance Records), 38 U.S.C. 7332 (Confidentiality of certain medical records), and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA s records at VA s place of business on request during normal business hours, to inspect and review and make copies of such records.

HIPAA Compliance

Contractor shall adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability ACT (HIPAA) or 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). The VA has recognized Diagnostic Laboratory Facilities as healthcare providers and that the PHI is being disclosed and/or used for treatment. Therefore, no BAA is required for Reference Laboratory Services.

BPA TERMS

INTRODUCTION

In the spirit of the Federal Acquisition Streamlining Act, the Department of Veterans Affairs (DVA) and (Contractor) hereby enter into a cooperative agreement, otherwise referred to as a Blanket Purchase Agreement (BPA), to further reduce the administrative costs of acquiring supplies/services.

The agreement details all supplies with accompanying prices and descriptions, which may be ordered under this BPA.

All orders placed against this BPA are subject to the terms and conditions of all the clauses and provisions in full text or incorporated by reference in this document.

TERMS AND CONDITIONS

The Contractor agrees to the following terms of a Blanket Purchase Agreement (BPA) EXCLUSIVELY WITH the Department of Veterans Affairs.

ADMINISTRATIVE DATA

A Blanket Purchase Agreement (BPA) is hereby established between (Contractor) and the Department of Veterans Affairs under the following terms and conditions incorporated in this BPA:

Contractor

Primary Point of Contact:

Alternate Point of Contact:

DUNS NUMBER:

Cognizant Office (Include complete address):

Department of Veterans Affairs

Network Contracting Office 19

NCO 19

6162 South Willow Drive, Suite 300

Greenwood Village CO 80111

PRICING DATA

1. The prices included on the BPA list (or applicable "discounted" rates submitted in a proposal response to an RFQ resulting in award) that are in effect on the effective date of an order shall govern that order's basic performance period. With regard to any option years, which are later exercised, the proposed option year rates as incorporated into the order award are in effect until such time, if applicable, that the contractor has been authorized a rate increase culminating from a negotiation with the Contracting Officer.

2. The BPA holder can voluntarily reduce offered prices at any time by giving 24-hour advance notice (by facsimile or electronic-mail) to the Department of Veterans Affairs/Contracting Officer. This BPA also allows for additional discounts if a "large order" is placed at one time. An advanced notice is not required for discounts offered for only an individual order. Whether an order is large enough to warrant such a discount is subject to the discretion of the BPA holder.

3. The BPA holder may also increase BPA prices at any time. Any BPA price increase shall not take effect until the Department of Veterans Affairs Contracting Officer receives written notification (U.S. mail, facsimile, or electronic-mail). Any order already issued shall not be affected by any change to BPA pricing. The prices offered under this BPA will undergo annual review by the Department of Veterans Affairs Contracting Officer.

OPTION TO EXTEND THE TERM OF THE BPA

a. The Government may extend the term of this BPA by written notice to the Contractor at any time prior to the expiration of the BPA, provided that the Government shall give the Contractor a preliminary written notice of its intent to extend at least days before the BPA expires. The preliminary notice does not commit the Government to an extension.

b. If the Government exercises this option, the extended BPA shall be considered to include this option provision.

c. The total duration of this BPA, including the exercise of any options under this clause, shall not exceed the performance period.

AUTHORIZED LIMITS

The Government estimates, but does not guarantee, that individual BPA Orders placed against this Agreement may reach $100,000.00/per Order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the Agreement is set at $500,000.00 over the period covered by the Agreement; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary. Authorization for individual Task Orders above the stated Task Order and/or Ceiling Limits must be coordinated through the Contracting Officer before larger valued orders can be issued and prior to commencement of work. All unauthorized work, regardless of amount, will be processed through the ratification process.

OBLIGATION OF FUNDS

This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by the Contracting Officer.

PERIOD OF PERFORMANCE

Year One: September 20, 2021 September 19, 2022

Year Two: September 20, 2022 September 19, 2023

Year Three: September 20, 2023 September 19, 2024

Year Four: September 20, 2024 September 19, 2025

Year Five: September 20, 2025 September 19, 2026

AUTHORIZED INDIVIDUALS

Individuals Authorized to Place Orders:

DVA authorizes the following entities to place orders:

ORDER FORMAT

Orders will be placed against this BPA via e-mail, Electronic Data Interchange (EDI), FAX, or in hardcopy format. Each individual BPA Task Order will describe the tasks, services and deliverables required.

AUTHORIZED REPRESENTATIVES

The primary Contracting Officer (CO) for this Agreement is:

Department of Veterans Affairs

Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300

Greenwood Village, CO 80111

Ronnie Jones

(303) 712-5721

Ronnie.Jones@va.gov

Juanita Street

303-712-5736

Juanita.Street@va.gov

The Primary and/or Secondary COR will be responsible for technical monitoring of the contractor's performance and deliveries. The COR and the Contractor's Representative shall work together to ensure that all contractual requirements are being met. The COR will interpret specifications or technical portions of the work. The COR is not authorized to perform, formally or informally, any of the following actions:

(1) Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change this contract;

(2) Waive or agree to modification of the delivery schedule;

(3) Make any final decision on any contract matter subject to the Disputes Clause;

(4) Terminate, for any reason, the contractor's right to proceed;

(5) Obligate in any way, the payment of money by the Government. Only a warranted Contracting Officer is authorized to obligate funds on this or any other contract action.

The contractor shall immediately notify the Contracting Officer in writing if the COR has taken an action (or fails to take action) or issues directions (written or oral) that the contractor considers to exceed the above limitations.

The contractor shall provide the Contracting Officer information copies of all correspondence to the COR.

FEDERAL HOLIDAYS

Unless specifically authorized in writing by the Contracting Officer, no services will be provided and no charges will be incurred and/or billed to any order on this contract on any of the Federal Holidays listed below.

New Year s Day

Labor Day

Birthday of Martin Luther King, Jr.

Columbus Day

Washington s Birthday

Veterans' Day

Memorial Day

Thanksgiving Day

Independence Day

Christmas Day

INVOICES

a. Inspection and acceptance shall be accomplished as follows: The Government, for all services furnished under any resulting order, hereby designates the COR in the program office as the point of final inspection and acceptance. The BPA holder will submit each invoice, including all back-up data, to the Contracting Officer (CO) for review and signature. When the CO receives an accurate and complete invoice, he/she will return a signed copy to the BPA holder within five (5) working days. If the invoice is incomplete or inaccurate, the CO will return the unsigned invoice to the BPA holder for correction. The Contracting Officer will then forward the signed invoice to the Chief Financial Officer (CFO) for payment. Final payment for each order will be accomplished by final invoice accompanied by a receiving report.

b. An itemized invoice shall be submitted to the CO at least monthly or upon expiration of this BPA, whichever occurs first, for all deliveries made during a billing period and for which payment has not been received. Copies of delivery tickets shall support these invoices. "Approved-for-payment" invoices will be submitted to the payment address specified on each individual order issued under this BPA.

PRECEDENCE

The Terms and conditions included in this BPA apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this BPA and the Contractor's invoice, the provisions of this BPA will take precedence.

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS

The Contracting Officer (CO) is the only point of contact for this acquisition. Proposals shall be submitted electronically via email to Juanita.Street@va.gov and NCO19Services2@va.gov by 10 AM MT on Wednesday, September 8th, 2021.

The appearance of the proposal will not be rated; however, if the reviewers cannot locate information required by the solicitation, the proposal may be determined not responsive and will be eliminated from further consideration.

Offeror shall make pricing and terms valid for a minimum of 120 calendar days from the solicitation closing date appearing in block 8 of the SF1449.

Proposal shall include the solicitation number (36C25921Q0517), the proposed unit price, any prompt payment discount terms, company name, the company point of contact, address, phone number, fax number, e-mail address, Tax Identification Number, DUNS number, and business size status.

Offeror shall complete the proposal in accordance with FAR provision 52.212-1, INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS, which is part of this solicitation, and the following additional instructions.

The information listed below shall be included in each proposal, or the proposal may be determined not responsive and eliminated from further consideration.

(1) One completed SF1449 with original signature, including acknowledgement of any solicitation amendments issued by the Government. The acknowledgement of amendments may be accomplished by signing the front page of each amendment (SF30) and including the signed SF30(s) together with the SF1449. Amendments may also be acknowledged by a signed statement identifying each amendment by number and acknowledging they were included in the preparation of the proposal.

(2) One completed Schedule of Supplies/Services and Prices/Costs (Continuation of SF1449) including proposed prices for each contract line item as appropriate. Any apparent discrepancies in extended amounts will be clarified.

(3) One completed copy of FAR provision 52.212-3, OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS, which is part of this solicitation, and any other provisions or clauses required in the solicitation.

(4) One (1) copy of the offeror s exception(s) to any terms, conditions, or requirements of the intended contract as presented in the solicitation. Include the exception(s) taken and the offeror s proposed resolution. If no exceptions are taken, include a signed statement to that effect.

(6) The Offeror shall provide information to demonstrate that they can provide the services and any additional peripherals and/or supplies to comply with the requirements shown in the SOW. The Offeror shall provide all other information, data, and written responses to all paragraphs and sections contained within the SOW.

(7) List of references. References must be provided for three (3) relevant contracts that are/were active within the last three years, similar in complexity and magnitude to this solicitation and that demonstrate the ability of the offeror s current organization to perform the required services. These may include contracts with the Federal government, State and local government agencies, and commercial customers.

End of Addendum 52.212-1

52.212-2 EVALUATION COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

1) Technical

2) Past Performance

3) Price

Technical and past performance, when combined, are more significant than price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)

ADDENDUM to FAR 52.212-2 EVALUATION COMMERCIAL ITEMS (OCT 2014)

(a) Contract award will be made based on the solicitation response that represents the best value to the Government using a Contracting Officer s Comparative Analysis. Since the Contracting Officer is considering price and other factors, the CO may award to other than the lowest-priced offer. The information below explains the evaluation approach:

The following factors will be considered by the Government to decide which offer represents the best value to the Government and is in compliance with the Statement of Work.

Factor 1: Technical Data - Contractor shall address how they plan to meet the requirements of the statement of work by addressing all paragraphs and sections contained within the SOW.

Factor 2: Past Performance

Contractor shall provide three references of past performance of the same or similar type of service within the last 3 years from date of solicitation (references shall be submitted with proposal).

Past performance will be assessed through checks in CPARS and PPIRS as well as reviewing provided references. Lack of recent and relevant past performance that is similar in complexity and magnitude to this solicitation will be evaluated as neutral.

Factor 3: Price

The Price Proposal will be evaluated using Price Schedule submitted by offerors. Price shall be evaluated for reasonableness.

Comparative Analysis Process will consist of a direct comparison of all quotes received against each other for each of the above Factors.

(End of Document)

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36C25921Q0517, 0001 Combined Synopsis/Solicitation Amendment for Molecular Thyroid Reference Testing

Amendment 0001 Questions and Answers to Combined Synopsis/Solicitation

Question 1: The bid for the following opportunity has a table which asks for each price for molecular testing. However, pricing for testing can vary based upon the extent of testing requested by the physician and the diagnosis. My question is how best to present detail in this situation. Is it best to provide a weighted average for each price, or create a new scale incorporating the various possibilities and providing an estimate of how often each would be billed?

Answer 1: In order to compare pricing amongst vendors, it is important to provide pricing based on the price table listed in the combined synopsis/solicitation. Therefore, a weighted average which includes all tests, additional fees, any shipping costs, etc. must be included in a single price per case/test format.

Another option is to provide two pricing options. One can be the weighted average (single price per case/test). The second pricing option can have a weighted average for the main test cost and then a separate table for any additional tests that may be required/requested. Out of the two pricing options, one will be chosen by the Government for the contract.

Question 2: Is it correct to send the response in the attached format? (Wherein the proposal/quote information is added directly onto the combined synopsis/solicitation including any additional fee information)?

Answer 2: The quote/proposal should be in a separate document except for the price quote. The price quote can be added to the table in the combined synopsis/solicitation OR it can be provided in a separate document. If the price quote is provided in a separate document, make sure to follow the table format listed in the combined synopsis/solicitation.

Page 15 of 15

MOLECULAR THYROID REFERENCE TESTING for

Rocky Mountain Regional VA Medical Center, Aurora, CO

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will also be attached.

This solicitation 36C25921Q0517 is issued as a request for quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-05 (effective 03/10/2021) and VAAR 2008-28 (effective 01/27/2021). No telephone requests will be accepted. Only written requests received directly from the offeror are acceptable. The associated North American Industry Classification System (NAICS) code for this procurement is 621511 (Medical Laboratories), with a small business size standard of $11.0 million. This solicitation is unrestricted with no set-asides. IF OFFEROR IS A GSA SCHEDULE HOLDER, ALL INFORMATION REQUESTED IN THIS NOTICE MUST BE PROVIDED, NOT JUST THE OFFEROR S SCHEDULE NUMBER

The following is a list of the contract line item numbers, quantities and units of measure for years one (1) through five (5). Pricing shall be Firm Fixed Price and include any discount being offered. Shipping Terms: FOB (Free on Board) is Destination. All shipping, packaging and delivery costs for all tests and supplies must be included in the per case/test price. No separate line item for shipping/freight/packaging/delivery shall be accepted.

CLIN

TEST

Estimated Annual Cases

Price per Case/Test

Total Annual Price

0001

Mutation Detection in Thyroid Samples

40

1001

Mutation Detection in Thyroid Samples

40

2001

Mutation Detection in Thyroid Samples

40

3001

Mutation Detection in Thyroid Samples

40

4001

Mutation Detection in Thyroid Samples

40

Estimated TOTAL (Total Annual x 5 years): _______________________

MOLECULAR THYROID REFERENCE TESTING DESCRIPTION:

1. Scope

Contractor shall provide testing for the detection of unique genetic alterations (to include mutations, insertions, deletions, fusion and gene expression) to help determine if a thyroid nodule is benign or malignant in fine needle aspirates (FNAs) that are read indeterminate (Bethesda III and IV) by a Rocky Mountain Regional VA Medical Center provider. Samples will be sent from the Rocky Mountain Regional VA Medical Center (RMRVAMC), located at 1700 North Wheeling Street, Aurora, CO, 80045.

2. Purpose

The RMRVAMC requires access to a molecular assay which analyzes thyroid fine needle aspiration specimens from patients who have had a previous diagnosis of atypical cells of undetermined significance . The purpose of the test is to detect mutations which would predispose a patient to increased risk of thyroid carcinoma. This test would decrease the need for repeat biopsies from the patient, which, in turn, reduces the risk of procedure-related complications and optimize patient follow-up. An ideal molecular test to evaluate thyroid nodules with indeterminate cytology should have a negative predictive value that is comparable to that of benign thyroid cytology (< 3%). Thus, a negative test could allow for thyroid surgery to be safely avoided.

3. Conformance Standards

The contractor shall meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). The contract shall also provide any valid, in-date CLIA and College of American Pathologist (CAP) certifications, showing the address and CLIA or CAP number of the testing laboratory. The contractor shall be HIPAA compliant. The contractor shall be approved to provide clinical diagnostic laboratory testing under both Medicare and Medicaid regulations and all applicable federal and state laws.

4. Testing to be Performed

Targeted mutation detection for thyroid samples may include BRAF testing

Fine Needle Aspiration (FNA)

Cytology slide smears

FNA Cell Block

Resected Tissue (tumors)

Any other acceptable sample types

Specimen Preparation and Transportation

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

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

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

Transportation Services for Reference Testing Specimen:

Contractor shall provide transportation of primarily biomedical materials that include patient specimens.

Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained.

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

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

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

Test request forms preprinted with the appropriate Shipping Section details and account information.

Test request forms for specialized testing (i.e., cytogenetics, tissue, etc.).

Testing Requirements

Contractor shall provide testing using tissue extracted during a fine needle aspiration. Contractor is requested to provide genomic sequencing to determine the expression profile of the mRNA. This test must use the expression profile to determine a benign or suspicious for malignancy interpretation for the submitted tissue. The Contractor is requested to offer BRAF and RET/PTC mutation testing in addition to the genomic sequencing classification to help determine the extent of surgery.

Contractor shall make available the following test information:

Requisition form requirements

Specimen collection and preservation requirements

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

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

Test-specific sensitivity, specificity and interferences, when required

Test critical values, if any

Policy for critical value notification

Report turn-around time will be within 14 days from the date on which the Contractor receives the specimen

Testing shall be performed Monday-Saturday

Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change.

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

Reporting

Results may be called to the VA Anatomic Pathology Department at 720-723-6821 or faxed to 720-723-6037. Alternative methods of contact can be provided, if needed. Vendor must comply with posted turn-around times to ensure no delay in care.

Invoice requirements and supporting documentation:

Supporting documentation and invoice must be submitted within 30 days of the end of each month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a proper invoice in accordance with FAR 52.212-4 (g), all invoices must include:

Name and Address of Contractor

Contractor s ID Number (Tax ID number)

Specimen ID (Patient name, patient ID number, order number)

Invoice Date and Invoice Number

Contract Number and Purchase/Task Order Number

Date of Service

Line Item Pricing, including test name

Total Price

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 per the accepted electronic data transmission methods below. Reference VAAR Clause 852.232-72: The contractor shall submit electronic payment requests through Tungsten.

Customer Service

Contractor shall provide customer service that is accessible during Contractor s business hours Monday-Friday 7:00am-5:00pm to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

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

Consultative Services/Utilization Reports

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

Confidentiality of Patient Records

The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such from or through VA. As such, the Contractor is considered as being part of the Department healthcare activity. Contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Furthermore, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7332. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

The records referred to above shall be, and remain the property of, VA and shall not be removed or transferred from VA except in accordance with U.S.C. 551 (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (Freedom of Information Act), 38 U.S. C. 5705 (Confidentiality of Medical Quality Assurance Records), 38 U.S.C. 7332 (Confidentiality of certain medical records), and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA s records, at VA s place of business on request during normal business hours, to inspect and review and make copies of such records.

HIPPA Compliance

Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability ACT (HIPAA) or 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). The VA has recognized Diagnostic Laboratory Facilities as healthcare providers and that the PHI is being disclosed and/or used for treatment. Therefore, no BAA is required for Reference Laboratory Services.

CONTRACT PROVISIONS

The provision at FAR 52.212-1, Instructions to Offerors Commercial Items (JAN 2020), applies to this acquisition with the following addenda:

The following FAR and VAAR Provisions are Incorporated into Reference per 52.252-1 Provisions Incorporated by Reference (FEB 1998). Provisions may be obtained via the internet at: http://www.acquisition.gov/far/index.html (FAR) and

http://www.va.gov/oal/library/vaar/index.asp (VAAR)

Provision

Description

Date

52.204-7

System for Award Management

OCT 2018

52.204-16

Commercial and Government Entity Code Reporting

AUG 2020

52.216-1

Type of Contract

(See Attachment section for specifics)

APR 1984

52.233-2

Service of Protest

SEPT 2006

852.215-72

Notice of Intent to Re-Solicit

OCT 2019

FAR 52.216-1 Type of Contract (APR 1984) The Government contemplates award of a FIRM-FIXED PRICE Blanket Purchase Agreement resulting from this solicitation.

FAR 52.233-2 Service of Protest (SEPT 2006)

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from

Ronnie R. Jones, Contracting Officer, Network Contracting Office 19 (NCO 19), Rocky Mountain Acquisition Center, 6162 South Willow Drive, Suite 300, Greenwood Village, Colorado 80111

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO. (End of Provision)

VAAR 852.233-70 Protest Content/Alternative Dispute Resolution (JAN 2008)

VAAR 852.233-71 Alternate Protest Procedure (JAN 1998)

Ronnie R. Jones, Contracting Officer, Network Contracting Office 19 (NCO 19), Rocky Mountain Acquisition Center, 6162 South Willow Drive, Suite 300, Greenwood Village, Colorado 80111

(End of Addendum to Provision 52.212-1)

The provision at FAR 52.212-2, EVALUATION -- COMMERCIAL ITEMS (OCT 2014), applies to this acquisition. (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Technical: The offer shall be evaluated on the conformance to the requirements listed in the Statement of Work.

Price: Offeror s price shall be evaluated to determine its fair and reasonableness.

Technical is more significant than price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of Provision)

A completed copy of the provision at FAR 52.212-3, OFFEROR REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL ITEMS (OCT 2018) shall be submitted with the offer.

CONTRACT CLAUSES

The clause at FAR 52.212-4 CONTRACT TERMS AND CONDITIONS -- COMMERCIAL ITEMS (OCT 2018), applies to this acquisition, with the following addenda:

The following FAR and VAAR clauses are Incorporated into Reference per 52.252-2 Clauses Incorporated by Reference (FEB 1998). Clauses may be obtained via the internet at: http://www.acquisition.gov/far/index.html (FAR) and

http://www.va.gov/oal/library/vaar/index.asp (VAAR)

Clause

Description

Date

52.203-16

Preventing Personal Conflicts of Interest

JUN 2020

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

52.204-13

System for Award Management Maintenance

OCT 2018

52.204-18

Commercial and Government Entity Code Maintenance

AUG 2020

52.222-19

Child Labor

JUL 2020

52.224-1

Privacy Act Notification

APR 1984

52.224-2

Privacy Act

APR 1984

52.232-40

Providing Accelerated Payments to Small Business Subcontractors

DEC 2013

52.237-3

Continuity of Services

JAN 1991

852.212-70

Provisions and Clauses Applicable to VA Acquisition of Commercial Items

852.203-70, Commercial Advertising

852.232-72, Electronic Submission of Payment Requests

852.233-70, Protest Content/Alternative Dispute Resolution

852.233-71, Alternate Protest Procedure

852.237-70, Indemnification and Medical Liability Insurance

852.273-70, Late Offers

852.273-74, Award without Exchanges

APR 2020

852.242-71

Administrative Contracting Officer

OCT 2020

FAR 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 6Â months. The Contracting Officer may exercise the option by written notice to the Contractor within sixty (30) days of the expiration date of the current contract period.

For the purposes of the award of this Contract, the Government intends to evaluate the option to extend services under FAR 52.217-8 as follows:

The evaluation will consider the possibility that the option can be exercised at any time, and can be exercised in increments of one to six months, but not for more than a total of six months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be at the same rates as those in effect under the contract at the time the option is exercised. The evaluation will therefore assume that the addition of the price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement and the total price for the priced options has the same effect on the total price of all proposals relative to each other, and will not affect the ranking of proposals based on price, unless, after reviewing the proposals, the Government determines that there is a basis for finding otherwise. This evaluation will not obligate the Government to exercise any option under FAR 52.217-8. The `specified' rates under this clause will be those rates in effect under the contract each time an option is exercised under this clause. (End of clause)

52.232-19 Availability of Funds for The Next Fiscal Year (Apr 1984) Funds are not presently available for performance under this contract beyond SEPTEMBER 30TH OF ANY FISCAL YEAR. 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 SEPTEMBER 30TH OF ANY FISCAL YEAR, 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)

(End of Addendum to 52.212-4)

(17) Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (JAN 2021) applies to this acquisition. Addendum to FAR 52.212-1 applies to this solicitation. In addition, the following FAR/VAAR clauses/provisions, either by reference or full text, apply (clauses may be obtained via the internet at:

http://www.acquisition.gov/far/index.html (FAR) and

http://www.va.gov/oal/library/vaar/index.asp (VAAR)

Clause

Description

Date

52.203-6

Restrictions on Subcontracting Sales to the Government

JUN 2020

52.204-10

Reporting Executive Compensation & First Tier Subcontract Awards

JUN 2020

52.209-6

Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

JUN 2020

52.219-8

Utilization of Small Business Concerns

OCT 2018

52.219-28

Post Award Small Business Program Representation

NOV 2020

52.222-3

Convict Labor

JUNE 2003

52.222-19

Child Labor-Cooperation with Authorities and Remedies

JAN 2020

52.222-21

Prohibition of Segregated Facilities

APR 2015

52.222-26

Equal Opportunity

SEP 2016

52.222-35

Equal Opportunity for Veterans

JUN 2020

52.222-36

Equal Opportunity for Workers with Disabilities

JUN 2020

52.222-37

Employment Reports on Veterans

JUN 2020

52.222-40

Notification of Employee Rights Under the National Labor Relations Act

DEC 2010

52.222-50

Combating Trafficking in Persons

OCT 2020

52.223-18

Encouraging Contractor Policies to Ban Text Messaging While Driving

JUN 2020

52.224-3

Privacy Training

JAN 2017

52.225-13

Restrictions on Certain Foreign Purchases

JUN 2008

52.232-33

Payment by Electronic Funds Transfer System for Award Management

OCT 2018

Quotes shall include the solicitation number (36C25921Q0517), the proposed unit price, any prompt payment discount terms, company name, the company point of contact, address, phone number, fax number, e-mail address, Tax Identification Number, DUNS number, and business size status.

The Government will evaluate quotes on the basis of the material presented in the quote. The Offeror s quote shall contain: 1) Documents/Literature/Publications showing that the offeror can meet the requirements in the Statement of Work and 2) Completion of Price Table with per case/test prices.

All information has been posted and there are no other documents available. Offers are to be sent via email to Contracting Officer Juanita Street at Juanita.Street@va.gov and NCO19Services2@va.gov no later than 10:00 A.M. Mountain Time on Friday, July 23rd, 2021.

Any questions regarding this solicitation must be submitted in writing to Juanita.Street@va.gov and NCO19Services2@va.gov no later than 10:00 a.m. MT, Friday, July 16th, 2021.

(End of Document)