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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 17, 2019 FBO #6384
SOURCES SOUGHT

66 -- Prognostic Molecular Test

Notice Date

5/15/2019
 

Notice Type

Synopsis
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 22;4811 Airport Plaza Drive;Suite 600;Long Beach CA 90815
 

ZIP Code

90815
 

Solicitation Number

36C26219Q0720
 

Response Due

5/20/2019
 

Archive Date

6/19/2019
 

Point of Contact

won.chae@va.gov
 

Small Business Set-Aside

N/A
 

Description

664-19-3-196-0110 Myriad Genetic Laboratories, Inc 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 $32.5 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 Prognostic Molecular Test for the VA San Diego Healthcare System (VASDHS) meeting following Statement of Work: Statement of Work Background. The contracted reference laboratory (Contractor) shall process the specimens 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. Scope. The contractor shall perform services for VA San Diego Healthcare System, San Diego, California. This procurement is for Prolaris, a prognostic molecular test for prostate cancer. This test is critical to an existing VA San Diego patient s course of treatment. Specific Tasks. Sample Processing The VA Laboratories will provide specimens properly prepared, identified and labeled for testing. The Contractor shall provide at no additional charge an adequate supply of specimen collection materials dictated by the commercial reference laboratory's specimen collection requirements, for example, dry ice, stabilizing tablets, ice packets, etc. The Contractor shall process specimens a manner that ensures their integrity. Material Safety Data Sheets shall be provided as appropriate for supplies containing hazardous chemicals (e.g., boric acid tablets, acids). Transportation The VA Laboratories will transport specimens via UPS. The Contractor will provide shipping and transport instructions to maintain specimen integrity. Specimen Testing The Contractor shall provide timely and appropriate testing of patient specimens, as detailed in the Reporting Results section. Specimen Storage The Contractor shall store the specimens a minimum of seven days after the test is reported in the event that subsequent action is required (i.e., problem solving and/or repeat testing). Reporting Results A report, defined as a printed final copy of laboratory testing results, shall be transmitted to the ordering laboratory by faxing to a secure fax machine. Test report shall at minimum contain the following information: Patient's name and/or identification number VA accession number if provided by the laboratory Physician's name if supplied Medical record number or laboratory accession number if supplied Patient's location (clinic/ward) if supplied Test ordered Date/time of specimen collection when available Date/time test completed Test result Reference intervals Toxic and therapeutic ranges if applicable Flagged abnormal Critical value Reference laboratory specimen number Name and address of testing laboratory if other than Contractor Other information the laboratory has that may indicate questionable validity of test results Unsatisfactory specimens shall be reported with documentation supporting unsuitability for testing. Specifications 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). In response to this solicitation, the Contractor shall supply copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America. 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. General Test Information. The following general test information shall be provided with the Contractor's offer in hard copy test catalog format and available on CD-ROM format as requested: Requisition form requirements Alphabetized test name list Reference lab test number Specimen collection requirements Test method used (indicate if performed in duplicate) Test reference intervals Test critical values, if any Policy for critical value notification CPT coding LOINC codes Test turnaround times (minimum and maximum times), where the turnaround time is defined as the time between arrival of the specimen by the Contractor and receipt of results by the ordering VA facility. Frequency of test performance (specific days of the week) Location of test performance by test name, i.e., name and address of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub- contracted) lab if applicable The Contractor shall notify the Contracting Officer and the Contracting Officer Technical Representative (COTR) when any modifications to this information occur. Performance Monitoring The Contractor shall furnish a monthly exception report and turn-around-times will be monitored as part of VA San Diego 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 selected reference laboratory(ies) 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. 8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). N/A 9. Other Pertinent Information or Special Considerations. N/A 10. Period of Performance. One Year (on an as needed basis) 11. 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: http://www.tungsten-network.com/veterans Tungsten Phone: 1(877)353-9791. Item Information: Prolaris Testing-Prognostic Molecular Test for Prostate Cancer: Estimated Quantity-12 EA for one year. 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 supplies/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, distributor, or an equivalent solution to the items being referenced above? (4) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (5) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (6) 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 number. (7) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? (8) Please provide general pricing of your products/solution for market research purposes. (9) Please submit your capabilities in regards to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? (10) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. (11) Please provide your DUNS number. (12) Please provide a list of detail requirements and drawings. *** Submissions addressing Section (8) 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 won.chae@va.gov. Telephone responses shall not be accepted. Responses must be received no later than May 20, 2019 at 1:00 p.m. PST. 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. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (15-MAY-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
 

Web Link

Link To Document
(https://www.fbo.gov/spg/VA/LBVANBC/VAMD/36C26219Q0720/listing.html)
 

Place of Performance

Address: Department of Veterans Affairs;VA San Diego Healthcare System;3350 La Jolla Village Drive;San Diego, CA

Zip Code: 92161

Country: US
 

Record

SN05312199-F 20190517/190515230021 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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