SOLICITATION NOTICE
Q -- Molecular Thyroid Mutation Reference Testing for the Rocky Mountain Regional VA Medical Center
- Notice Date
- 9/1/2021 2:09:40 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- NETWORK CONTRACT OFFICE 19 (36C259) Greenwood Village CO 80111 USA
- ZIP Code
- 80111
- Solicitation Number
- 36C25921Q0517
- Response Due
- 9/8/2021 9:00:00 AM
- Archive Date
- 10/08/2021
- Point of Contact
- Juanita Street, Contracting Officer, Phone: 303-712-5736
- E-Mail Address
-
Juanita.Street@va.gov
(Juanita.Street@va.gov)
- Awardee
- null
- Description
- 36C25921Q0622 Page 1 of Page 1 of Page 19 of 69 Page 1 of Page 1 of Continuing Pages 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)
- Web Link
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- Place of Performance
- Address: Department of Veterans Affairs Rocky Mountain Regional VA Medical Center Attn: Pathology and Laboratory 1700 N Wheeling Street, Aurora 80045, USA
- Zip Code: 80045
- Country: USA
- Zip Code: 80045
- Record
- SN06119229-F 20210903/210901230121 (samdaily.us)
- Source
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