Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JULY 10, 2022 SAM #7527
SOURCES SOUGHT

Q -- Prolaris Testing

Notice Date

7/8/2022 11:14:47 AM
 

Notice Type

Sources Sought
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

262-NETWORK CONTRACT OFFICE 22 (36C262) Gilbert AZ 85297 USA
 

ZIP Code

85297
 

Solicitation Number

36C26222Q1238
 

Response Due

7/15/2022 1:00:00 PM
 

Archive Date

09/13/2022
 

Point of Contact

Domen, Clift, Contract Specialist, Phone: 562-766-2241
 

E-Mail Address

Clift.Domen@va.gov
(Clift.Domen@va.gov)
 

Awardee

null
 

Description

THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a sources sought/RFI only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 621511 (size standard of $35.0 Million). Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, is seeking sources that can provide Prolaris Testing that at a minimum meets the following Statement of Work for the VA Long Beach Healthcare System (VALBHCS): Estimated Period of performance: 09/01/2022 08/31/2023 (on an as needed basis) STATEMENT OF WORK (SOW) Background The VA Long Beach Healthcare System (VALBHCS) providers preferred the VA Long Beach Pathology & Laboratory Medicine Service (PALMS) to use Prolaris to test for patient with cancer diagnostics. Prolaris is a molecular diagnostic test that measures the expression level of genes involved with tumor proliferation to predict disease outcome. Prolaris can be used in conjunction with other clinical parameters to determine prostate cancer aggressiveness. Scope The contractor shall perform services for the VALBHCS PALMS. The contracted reference laboratory (Contractor) shall process the slides and/or perform analytical testing as defined by the Contractor's reference test manual, report analytical test results, and provide consultation services as required. All terms, conditions and requirements defined herein shall apply to any laboratory (i.e., branch, division, sub-contractor, etc.) performing reference testing on behalf of the Contractor. The Prolaris® test combines existing clinicopathologic features (Gleason, PSA, Stage, % Positive, age) with a quantitative PCR analysis to measure the mRNA expression levels of 31 cell cycle progression genes and 15 control genes to measure tumor aggressiveness independent of but in addition to pathologic characteristics at the fixed time of biopsy. The VALBHCS is located at: VA Long Beach Healthcare System (VALBHS) Pathology & Laboratory Medicine Service 5901 E. 7th Street Long Beach, CA 90822 Specific Test Requirements qRT-PCR technology Gold Standard Assay TaqMan Cared using Applied Biosystems 7900HT Fast Real-Time 46 Gene RNA-expression tests (31 CCP Gene Expression measured against 15 normal genes) Sample Requirements Sample: Prostate Needle Biopsy Deliverables Shipping: Prefilled FedEx Priority label affixed to Packaging required for sample transportation Turnaround Time: 7 14 days Delivery of clinical grade patient reports and data return to the VA in structured formats via secure file transfer mechanisms. Patient Facing Visual Diagram with QR Code for interactive report tutorial Provider Facing Risk stratification diagrams included comparison to NCCN groups and validated treatment thresholds. Provider QR code for interpretation of clinical diagrams and details included Disease Specific Mortality when untreated and Risk of Metastasis when treated calculation from Prolaris Cell-cycle Risk score CCR algorithm Separation of clinical and pathologic indications from Prolaris Cell Cycle Proliferation score CCP Additional Options: Faxed, Mailed, Sent to Secure Portal and other custom options based on preference in any data type. Standard Delivery Time: Estimated at 14 days from each Order Date Licensures Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor shall be licensed/accredited by the College of American Pathologists (CAP), the Nuclear Regulatory Commission, Center for Disease Control, Medicare and other state regulatory agencies as mandated by Federal and State statutes. In addition, the laboratory shall be certified as meeting the requirements of the Clinical Laboratory Improvement Act (CLIA) of 1988 and shall comply with the National Standards to Protect the Privacy of Personal Health Information in accordance with Health Insurance Portability and Accountability Account of 1996 (HIPAA). Contractor copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America are located at the link provided below. In addition, as these documents are reissued or reworded, the awarded Contractor shall supply a copy to the Contracting Officer. This documentation shall also be supplied for each reference laboratory that is a subcontractor of the primary Contractor. The Contractor shall ensure that each facility is in compliance with the College of American Pathologists (CAP) standards, Clinical Laboratory Improvement Amendments (CLIA) standards, and VHA Directive 1106 and VHA Handbook 1106.01, Attachments B and C respectively. Additional Requirement Specifications Performance Monitoring The Contractor shall furnish a monthly exception report and turn-around-times will be monitored as part of VA quality assurance plan. Security Requirements The Contractor shall be responsible for the security and integrity of specimens and for compliance with all Health Insurance Portability and Accountability Act (HIPAA) requirements. The Contractor shall also be responsible for ensuring the proper credentialing of its employees who interact with personnel. Additionally, the Contractor shall adhere to all Information Technology Security requirements as set forth in VA Handbook 6500.6, Attachment D, and shall adhere to Appendix C and Appendix D and submit proper documentation as required. The reference laboratory shall assume full liability for the samples and data at the time of receipt. The Contractor shall use reasonable and appropriate safeguards to prevent use or disclosure of protected health information (PHI) not provided for by this solicitation. Within 24 hours of the Contractor becoming aware of a HIPAA violation involving electronic transactions, paper labels and code sets, privacy, security or standard identifier, or disclosure of PHI not provided for by this solicitation, the Contractor shall report violations to the proper authorities identified in VA Handbook 6500.6. The C&A requirements do not apply and that a Security Accreditation Package is not required. Third Party contract terms and provisions The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. All VA policies shall be followed and the contractor shall not copy, expose, and share information of Protected Health Information documents. Hours of Operation Normal tour-of-duty hours at VA Healthcare Centers is 7:30 am to 5:00 pm, Monday through Friday, excluding Federal holidays. However, the service is operating 24/7 and as such there may be instances in which the vendor s workday may be outside of this period. The vendor is required to coordinate these times with the designated Program Manager. In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as Legal Federal official holidays New Year s Day January 1st Martin Luther King s Birthday Third Monday in January President s Day Last Monday in January Memorial Day Last Monday in January Juneteenth Third Monday in June Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veteran s Day November 11th Thanksgiving Day Fourth Thursday in November When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies. Invoicing. The Contractor shall submit a monthly invoice for services rendered no later than 21 days following the close of the month in which the test result was reported. The invoice shall be checked for accuracy and shall display chronologically by date of Contractor receipt the name of the patient, the date of specimen collection by the Contractor, details of the test performed on each patient, and the unit and total testing costs. The Contractor shall not charge for repetitive testing performed on a specimen to verify questionable initial results. Use obligation number for payment processing. All invoices must be submitted via Tungsten at: https://portal.tungsten-network.com/Login.aspx?ReturnUrl=%2f The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. If you are interested, and are capable of providing the sought out services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc.) (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer or distributor of the items being referenced above (or equivalent product/solution)? What is the manufacturing country of origin of these items? (4) If you re a small business and you are an authorized distributor/reseller for the items identified above (or equivalent product/solution), do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (5) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract type and number. (6) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (7) Please provide general pricing for your products/solutions for market research purposes. (8) Please state your company s DUNS number. (9) Please submit your capabilities in regard to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? *** Submissions addressing Section (9) should show clear, compelling and convincing*** evidence that all equal to items"" meet all required salient characteristics. Responses to this notice shall be submitted via email to Clift.Domen@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Friday, July 15th, 2022 at 1:00 p.m. PDT. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/3d295c05bfc54b25aa986024a9127847/view)
 

Place of Performance

Address: VA Long Beach Healthcare System 5901 E. 7th Street, Long Beach 90822, USA

Zip Code: 90822

Country: USA
 

Record

SN06383271-F 20220710/220708230109 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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