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Subject: Request for Information (RFI/Sources Sought), for Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Pathology and Laboratory Services. This source sought RFI is being... Subject: Request for Information (RFI/Sources Sought), for Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Pathology and Laboratory Services. This source sought RFI is being published in accordance with Title 38 U.S.C. § 8127. VHA Pathology and Laboratory Services is gathering information for a new laboratory service contract. Currently, over 250 of the VA Laboratories are not contracted with any Accreditation Organization. This Request for Information (RFI) will be used to formulate a plan that best fits the VA requirements for laboratory accreditation and quality monitoring. We are exploring options with various levels of contracted service to fit this need including full accreditation, inspection service only, and waived site inspections. Your input is vital for a solicitation and contract to be created that ensures a good partnership and VA laboratory quality program success. The responses from this RFI may result in the issuance of a solicitation. This request for information/sources sought encourages potential contractors to submit a non-binding statement of interest and a response to the questions provided below. Further, it is intended to assess industry s capability to support and develop an adequate solution to the Governments continuing need(s). The Strategic Acquisition Center (SAC) is requesting responses from qualified business concerns; the qualifying NAICS code for this effort is 813920. This sources sought is to gain knowledge of our potential requirement for planning purposes as well as qualified sources and their size classifications (Service Disabled/Veteran-Owned Small Business (SDVOSB/VOSB), Hub Zone, 8(a), small disadvantaged, women-owned small business, or large business) relative to NAICS 813920. Responses to this notice will be used by the Government to make appropriate acquisition decisions. After review of the responses to this notice, a solicitation announcement may be published. Responses to this RFI or sources sought are not considered adequate responses to any corresponding solicitation announcement. All interested offerors will have to respond to any resulting solicitation announcement, in addition to responding to this RFI or sources sought. Please indicate whether you hold a GSA federal-supply schedule contract that covers these services and, if so, the contract number. Provide business size and socio-economic status; (a) Indicate whether your business is large or small (b) If small indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Service-Disabled Veteran-Owned Small Business (SDVOSB) or Veteran-Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at http://www.sam.gov and /or the VetBiz Registry (i) provide current commercial pricing for Audible Prescription Reading Devices (and applicable discounts or trade-in values for old equipment (j) link to the respondents General Services Administration (GSA) schedule, or attached file of same, if applicable (k) citation of any current or part customers (i.e., within the past (2) years) to include contract number, point of contact telephone number or e-mail address; and (I) other material relevant to establishing core competencies of the firm. (M) Company information on warranty and training packages for each material solution. Responses are due by 3pm EST, April 13, 2020. Please submit e-mail responses to Mr. Matthew Cron, Contracts Specialist, at email address: Matthew.Cron@va.gov. Your response should include the RESPONSE TO THE QUESTIONS BELOW, STATEMENT OF CAPABILITY, GSA SCHEDULE INFORMATION (if any), and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained above. Please place Attention: Lab Services, in the subject line of your email. Disclaimer: Issuance of this RFI/sources sought is to assist the VA in completing planning, market research, determining sources only and does not commit or bind the Government under any circumstances nor does it constitutes any obligation whatsoever on the part of the Government to procure these commodities/supplies or to issue a solicitation nor to notify respondents of the results of this notice. No solicitation documents exist at this time; The Department of Veterans Affairs is neither seeking proposals nor accepting unsolicited proposals, and responses to this RFI/sources sought cannot be accepted as offers. Any information the vendor considers proprietary should be clearly marked as such. The U.S. Government will not pay for any information or administrative cost incurred in response to this RFI/ sources sought. SEE NEXT PAGE LAB SURVEY SERVICES REQUIREMENTS QUESTIONS FOR BUSINESS CONCERNS: Is your organization a CMS deemed accreditation organization for inspection and accreditation of clinical laboratories? What other type of clinical laboratory inspection or accreditation credentials does your organization possess? _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ Does your organization allow for electronic updating of laboratory or organizational profiles through an online portal? _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ What accreditation activity or monitoring activity does your organization perform outside of on-site inspections or activity as part of your full accreditation service? Check or List Activities Yes No Self-inspection processes PT monitoring PT ordering checks Complaint triage Guideline interpretation resources Qualification verifications What resources does your organization provide as part of your full accreditation service? Check or List Resources Yes No Recorded Webinars Inspection tools Self-paced training Live teleconference training Printed materials Inspector Training Lab director Training Lab manger Training Supervisor training Specialty training Face to Face training Guideline interpretation resources provided by subject matter experts Continuing education programs The VA requires all clinical lab inspections to be minimally based off the CMS CFR 42 part 493 standards. What additional standards or inspection criteria is included in your organization s inspection process? Would your organization be willing to incorporate VA custom standards from VA P&LM handbook 1106.01 into your inspection process? _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ Does your organization provide custom laboratory section specific inspection or accreditation requirements based on the testing performed by individual CLIA laboratory? _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ Does your organization have guidelines for the following laboratory functions? Yes No Laboratory Developed Tests or Analyte Specific Reagents Telepathology Direct to Consumer Testing Laboratory Informatic Systems Auto verification Does your organization utilize trained subject matter experts such as Clinical Laboratory Scientists (Medical Laboratory Technologists), Laboratory Medical Technicians, Cytotechnologists, etc. as for on-site activity or inspections? _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ Do your on-site inspectors or activity staff have knowledge and experience with any of the clinical laboratory specialty/sub-specialties listed below? List any missing. Yes No Chemistry Hematology Immunology Special Chemistry Urinalysis Blood Gases Toxicology Body Fluid Analysis Coagulation Bacteriology Mycology Molecular Microbiology Histocompatibility Mycobacteriology Bioinformatics Quality Management CONTINUED Yes No Point of Care Testing - Non-Waived Point of Care Testing - Provider Performed Point of Care Testing Waived Flow Cytometry In Situ Hybridization Conventional Cytogenetics Hematopoietic Progenitor Cell Services Tissue Storage and Issue Donor Services Transfusion Services Immunohematology Parasitology Electron Microscopy Virology Patient Blood Management There are about 150 VA labs that have pathology service or are classified as a VA Medical Center. The VA requires board certified pathologists to serve as an on-site inspectors or activity staff, for these high complex VA labs or labs performing pathology services. How many pathologists do you have on staff/affiliated now that serve as on-site inspectors or activity staff for your organization? _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ SEE NEXT PAGE Indicate what anatomic pathology specialty/sub-specialties your organization personnel can inspect. List any missing. Yes No Anatomic Pathology Processing Autopsy Pathology Cytology Processing Cytology Screening Gynecologic Cytopathology Intraoperative Consultation/MOHS Non-Gynecologic Cytopathology Surgical Pathology Molecular Pathology Histology There are many VA laboratories that are AABB accredited. Does your inspection or on-site activity process allow for coordinated accreditation or inspection with AABB with your organization inspections or on-site activity? Has your organization worked with the AABB using this process in the past? _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ There are VA labs located in Hawaii, Alaska, Philippines and Puerto Rico. Is your organization able to offer on-site inspection or activity services to these remote location labs? _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ There are 264 VA moderate or high complex labs. Would your organization participate in a contract where multiple vendors may be awarded a variable number of lab inspections classified by complexity, location and/or affiliate group? _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ There are approximately 800 waived labs in the VA system. Would your organization be interested in performing on-site inspections for these waived testing labs? _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ Does your organization offer on-site inspections and issue inspection findings to laboratories that are not seeking full accreditation? If not, would your organization be open to performing on-site inspection activity only, without full traditional accreditation monitoring? _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ Does your organization require laboratories to keep an up to date analyzer specific laboratory testing menu used for proficiency testing ordering verification? _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________