36C25921Q0517.docx

SUBJECT*

Molecular Thyroid Mutation Reference Testing for Rocky Mountain Regional VA Medical Center

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

POINT OF CONTACT*

Contracting Officer Juanita Street Juanita.Street@va.gov

PLACE OF PERFORMANCE

Rocky Mountain Regional VA Medical Center

1700 North Wheeling Street

Attn: Pathology and Laboratory

Aurora CO

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

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.

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

a. 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

5. 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.

6. Transportation Services for Reference Testing Specimen:

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

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

c. 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:

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

2. 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.

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

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

7. 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:

a. Requisition form requirements

b. Specimen collection and preservation requirements

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

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

e. Test-specific sensitivity, specificity and interferences, when required

f. Test critical values, if any

g. Policy for critical value notification

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

i. 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.

8. 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.

9. 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:

a. Name and Address of Contractor

b. Contractor’s ID Number (Tax ID number)

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

d. Invoice Date and Invoice Number

e. Contract Number and Purchase/Task Order Number

f. Date of Service

g. Line Item Pricing, including test name

h. Total Price

10. 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.

11. 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.

12. 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.

13. 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.

14. 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)

(See Attachment section for specifics)

APR 1984

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)

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:

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

1. 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)

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

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 6 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)

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)