Lab Developed Testing

NOTICE INFORMATION Agency/Office: Defense Health Agency Location: Contracting Office- Falls Church Title: Laboratory Developed Testing Description(s): Request for Information Title: Laboratory Developed Testing Introduction: 1. This announcement constitutes a Request for Information (RFI). This announcement does not constitute a commitment, implied or otherwise that a solicitation will be issued. This is not a Request For Proposal (RFP) or an Invitation For Bid (IFB). 2. Please note that the collection of this requested information does not obligate the U.S. Government to incorporate any solicited comments nor does it obligate the Government to procure services. Proprietary information should not be included in the RFI response. Responses to this RFI will not be returned. The Government is not liable to pay any costs associated with companies responding to this RFI. 3. All information received resulting from this RFI will be used by the Defense Health Agency (DHA) for acquisition planning and market research purposes only. However, your response may be releasable to the public under the Freedom of Information Act (FOIA). If you wish the DHA to consider any portion of your response as "confidential commercial information", you should clearly mark the portion as "confidential commercial information". 4. The Defense Health Agency (DHA), at its discretion, may request respondents to this RFI to elaborate on information in their written response. Respondents to this RFI will not be notified of any results derived from a review of the information provided. 5. The DHA invites all interested parties to submit a written response to this Request for Information (RFI). This RFI is issued for the sole purpose of conducting market research in accordance with the Federal Acquisition Regulation (FAR) Part 10. Background The DHA is the DoD organization responsible for managing the TRICARE health care benefits. This includes integrating state of the art technologies to enhance patient safety, efficiency, and cost effectiveness. Under DHA, the Enterprise Support Activities initiative was established with the goal to consolidate resources, standardization, and reengineer processes. These are essential elements in order to improve performance, decrease costs, and enable the Military Health System (MHS) to operate more efficiently as an integrated health system. As part of this goal, DHA is seeking information from industry to assist in the implementation and deployment of a comprehensive and commercially available Laboratory Developed Test Solution for the Military Health System (MHS). The Center for Laboratory Medicine Services office ensures regulatory compliance across the MHS Laboratories. They also advise, evaluate, establish policy involving laboratory standards and approve laboratory developed tests. The Defense Health Agency's Clinical Laboratory Medicine Services will hold an Industry Day on December 4, 2019. This will be a virtual meeting. The purpose of Industry Day is to gather information from vendors that perform Laboratory Developed Testing (LDT). Tests presented during this event may be included in the battery of tests being evaluated during the next Defense Health Agency's Laboratory Joint Working Group. Information Submission Instructions: There will be 10 presentations and each presenter will have 40 minutes. The 40 minutes includes 5 minutes for preparation, 25 minutes for presentations, and 10 minutes for panel questions. Each individual vendor will be allocated one 40 minute time slot. A vendor may register for only one time slot. Time slots will be organized by similar test types. Registration will be available to the first 10 vendors. Additional industry days will be added to allow all vendors who register a chance to present their LDT. Vendors should submit a summary of their submission in the format provided (see attachment) no later than (NLT) COB November 22, 2019. A summary should accompany each test presented. Vendors may submit a directory of laboratory tests their laboratory performs. All submissions and presentation information should be submitted to: Linda.M.Walker38.civ@mail.mil and Tatanya.L.Cooper.mil@mail.mil. Registration requests/and or questions concerning this event should also be directed to Tatanya Cooper, Tatanya.L.Cooper.mil@mail.mil or at: 703-681-7317. Primary Point of Contact: Linda Walker Contracting Officer Linda.m.walker38.civ@mail.mil Phone: 7036816571 Contracting Office Address: 7700 Arlington Blvd. Suite 1M413 Falls Church, Virginia 22042 United States Place of Contract Performance: This solution is to be deployed enterprise-wide across all Military Treatment Facilities (MTFs) within the Department of Defense (DoD). United States OFFICE OF THE ASSISTANT SECRETARY OF DEFENSE HEALTH AFFAIRS 7700 ARLINGTON BOULEVARD, SUITE 5101 FALLS CHURCH, VIRGINIA 22042-5101 MEMORANDUM FOR LABORATORY JOINT WORKING GROUP LAB DEVELOPED TEST (LDT) REVIEW PANEL FROM: Company Name Address Point of contact Phone Number/E-mail SUBJECT: Name of LDT being presented (one summary per test) 1. Company/Business Description: 2. Lab Developed Test (LDT) description: 3. Current Procedural Terminology (CPT) codes: 4. Have other governmental and/or commercial enterprises approved this test: 5. Clinical indications/Associated disease states/Conditions: 6. Current clinical research evidence: May be included as an attachment. 7. Support clinical validity of the test: May be included as an attachment. A. Trials published in referred medical literature B. Formal technology assessments C. National medical policy organization positions D. National professional associations E. National expert opinion organizations SIGNATURE BLOCK OF PREPARER/PRESENTER