Q301--Sources Sought - Reference Laboratory Testing Services - FHCC

THIS IS A SOURCES SOUGHT (SS) NOTICE ONLY, NOT A SOLICITATION ANNOUNCEMENT AND SHOULD NOT BE CONSIDERED AS SUCH. The Government will not pay for any information received in response to this notice, nor will the Government compensate any respondent for any cost incurred in developing the information provided to the Government. This notice does not constitute a commitment by the Government. Any information provided in response to this market survey will be used for informational purposes only and will not be released. Vendor participation is not a promise of future business with the Government. The purpose of this notice is to conduct market research and obtain information to identify possible businesses that are capable of providing medical laboratory testing, analysis, courier, and related services at the time of this posting. Adequate information shall be provided for the Government to determine Contractor s ability to provide the required services and meet test menu requirements at the time of Contractor s response to this notice. The J.A. Lovell Federal HealthCare Center (FHCC), to include the Main Campus Fisher Branch Clinic, and Red Rover Branch Clinic in VISN 12, will be pursuing a firm fixed price Indefinite Delivery Indefinite Quantity contract. The contract will be awarded to a single Contractor for a five-year ordering period for comprehensive commercial reference medical laboratory testing and analysis services. The required FHCC test menu is attached. Potential sources shall submit: Business name, address, point of contact and phone number. Business size, any applicable socio-economic category and SAM unique Entity Identifier (UEI) number. Copy of Contractor s current test menu. Information for recent/relevant Government projects similar in nature/size and complexity to include customer name(s), contract number(s), period of performance, testing performed and contract(s) value. If you have not performed any contract of a similar scope and size, please note that in your response. A list of Contractor s testing laboratory location(s). Include address, CLIA licensure number, Lab Certification Code(s), effective dates, and Lab Director for each testing site. Contractor s current laboratory accrediting agency for each testing site. College of American Pathology (CAP), The Joint Commission on Laboratory Accreditation (TJC), The Commission on Office Laboratory Accreditation (COLA), etc. A list of VHA laboratories with currently established and fully operational LEDI interconnections for automatic ordering and resulting of laboratory tests between Contractor s testing laboratory information system and the FHCC Oracle Health (Cerner) Electronic Record. Include the types of tests utilizing the LEDI interconnection at each VHA laboratory. Provide a list of all required tests (see attached test menu) that are not performed in-house. For tests not performed in-house by the Contractor, provide a list of external laboratories where testing is referred to include Laboratory name, address and CLIA number. Indicate for each respective laboratory whether or not a formal agreement and/or contract is in place to perform the testing. Confirmation that your CAP, TJC, or COLA test activity menu demonstrates accreditation for the complete FHCC test menu. Detailed documentation demonstrating the Contractor s ability to meet each of the requirements listed in the Requirements section below as well as test menu requirements. A report of your company s maximum capacity (number of tests capable of performing in one month). A report of your current monthly output (number of tests currently being performed by your company). Minimum Requirements: Contractor Laboratory (ies) shall be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA-88). Contractor Laboratory (ies) shall be fully licensed and accredited ensuring compliance with CLIA-88, The College of American Pathologists (CAP), The Joint Commission on Laboratory Accreditation, and/or other state regulatory agencies as mandated by federal and state statutes. Contractor shall accept a single purchase order from each Main Campus and Red Rover Branch Clinic laboratory for invoicing purposes. Contractor shall perform required testing listed on the FHCC test menu within awarded Contractor s laboratory(ies) with minimal referral to external/outside laboratories. For any testing not performed in-house at Contractor s lab, Contractor referred tests shall only be sent to a laboratory meeting all CLIA-88 regulatory requirements. Contractor must meet the required stricter turn-around time (TAT) timeframes for the tests listed below when sent from the Red Rover Clinic. Test Name Required Turnaround Time Hepatitis A Ab Total Next business day from collection date by 1330 Hepatitis B Surface Ab QN Next business day from collection date by 1330 Measles (Rubeola) IGG Next business day from collection date by 1330 Rubella IGG Next business day from collection date by 1330 Varicella IGG Next business day from collection date by 1330 Mumps IGG Next business day from collection date by 1330 Sickle Cell Screen Next business day from collection date by 1200 Hemoglobin & Hematocrit Next business day from collection date by 1300 G6PD Deficiency Screen Next business day from collection date by 1000 Fasting Glucose Next business day from collection date by 1330 B-HCG Quantitative Next business day from collection date by 1330 ABO and Rh Next business day from collection date by 1330 Hemoglobin A1C Next business day from collection date by 1330 Syphilis Antibody Cascading Reflex Two business days from collection date by 1330 Gonorrhea PCR Two business days from collection date by 1330 Chlamydia PCR Two business days from collection date by 1330 Urinalysis Two business days from collection date by 1330 Urinalysis Microscopic Two business days from collection date by 1330 Hemoglobinopathy Two business days from collection date by 1330 Tuberculosis Test (must be 1 tube method) Two business days from collection date by 1330 Contractor must meet the required stricter faster turn-around (TAT) timeframes for the tests listed below when sent from the FHCC Main Campus, Anatomic Pathology section. H/E slide preparation (to include tissue processing, embedding, sectioning, staining, and coverslipping). FHCC to submit grossed tissues that are ready for processing. H/E slides and paraffin blocks to be delivered back to FHCC by 9-10am next business day from pick-up date Immunohistochemistry and Special Stains (Anatomic pathology) Not to exceed 3 business days from pick-up date and delivery date. Must be notified of all delays. Paps and HPVs Not to exceed 5 business days from pick-up date. Must be notified of all delays. Urine Cultures Not to exceed 3 business days from pick-up date and delivery date. Must be notified of all delays. Contractor shall provide three (3) full-time equivalent Specimen Processing Technicians to the FHCC (two assigned to the Red Rover Branch Clinic and one assigned to the Main Campus) laboratories to assist with the processing of specimens, e.g. centrifuging, packaging, shipping, ordering, etc. The technicians will need access to Oracle Health (Cerner) for transfer specimen applications to build and send transfer lists for samples to the reference lab. The technician shall also be responsible for retrieving laboratory results, obtaining test information, contacting customer service to obtain results and resolve inquiries, running and reconciling incomplete test lists. The specimen processing technicians will work Monday through Friday, excluding federal holidays, from 6:00 a.m. 2:30 p.m. for the Red Rover Laboratory and 7:00 a.m. 3:30 p.m. for the Main Campus Laboratory. Lunch breaks will be a half-hour in duration. No overtime is anticipated or approved under this contract. Contractor shall provide a copy of their current VA-approved, national or local MOU/ISA demonstrating bi-directional computer-based interconnectivity capability between the awarded Contractor s testing laboratory(ies) lab information system (LIS) and the Main Campus and East Campus Red Rover Branch Clinic Oracle Health (Cerner) Electronic Record. If the Contractor does not currently have a VA-approved national or local MOU/ISA, identify what steps have been taken to obtain one. Contractor shall have a successfully established and fully operational bi-directional interconnection immediately available prior to contract performance at the Main Campus and East Campus Red Rover Branch Clinic FHCC laboratories. The interconnection shall include and/or support: electronic ordering between Contractor s LIS and FHCC Laboratories automatic population via HL7 messaging directly into the Oracle Health (Cerner) Electronic Record of qualitative and quantitative test results and other relevant information. generation of transfer lists from each FHCC laboratory for individual specimen tracking and order accuracy. Contractor shall meet VHA Directive and Handbook 6500 requirements that are applicable to the existing fully operational interconnection and sustain compliance as delineated in the Contractor s respective VA-approved MOU/ISA. Contractor shall perform specimen pick-up services (routine and stat) from FHCC Laboratories, the Red Rover Branch Clinic, Fisher Clinic, and the Main Campus. Contractor shall perform routine specimen pick-up from the Red Rover Branch Clinic and Fisher Branch Clinic once daily Monday through Friday and twice daily 7 days/week Monday through Sunday, including holidays and last minute declared holidays, from the Main Campus Laboratory. Pick up times shall be based upon each Laboratory s hours of operation and workflow. Contractor shall provide STAT specimen pick-up services within four hours of notification for the Main Campus and East Campus Clinic Laboratories. Pick-up services shall include packaging of specimens to maintain specimen integrity during transport while ensuring Department of Transportation (DOT), International Air Transport Association (IATA), and other applicable requirements for transportation are met. Contractor shall reconcile specimens for transport against the respective manifest prior to departing each FHCC laboratory pick up location. Contractor shall provide transportation/delivery/routing to the Contractor s respective testing laboratory location to perform testing. Contractor shall provide any special preservatives and/or collection containers required for specimen preservation. Contractor shall provide an on-line test inquiry system (website or SharePoint) for access to test information that includes test name, synonyms as applicable, ordering test code, CPT code, LOINC code, reference range, test methodology, specimen type(s), collection and handling requirements, clinical significance/test interpretation and test turn-around time. This should include any tests that are being subcontracted. Contractor shall provide automatic notification to each participating FHCC laboratory s point(s) of contact following required test order delays, changes, or cancellations. Test order delays, changes and test cancellation notifications shall be generated on date of occurrence. Contractor shall provide the capability for automatic printing/faxing of patient results/reports at each participating FHCC lab upon completion of testing by Contractor s laboratory. Contractor shall provide customer service representatives that are available for contact by phone 24 hours per day, 7 days per week. Contractor performing laboratory shall call critical test results to the respective FHCC Laboratory immediately following test completion, regardless of time of day. Contractor shall provide customer service and/or technical support staff to respond to routine inquiries regarding specimen collection requirements for any test under the contract including those tests that are performed by a sub-contractor. These inquiries shall be addressed at the time of the initial call. Inquiries for esoteric collection requirements shall be addressed within ½ hour of initial call. Contractor shall provide, within two (2) hours of initial call, technical expertise to address test utilization inquiries. Result interpretation inquiries shall be addressed within four (4) hours of initial call. Contractor shall provide customer service for calls related to account follow-up, supply ordering, test pricing, etc. These questions shall be addressed within four (4) hours of the initial call. Responses to this notice shall be emailed to Donald.st.onge@va.gov. Include the following in the email subject line: Reference Laboratory Testing Services . The associated North American Industrial Classification System (NAICS) code for this procurement is 621511, Medical Laboratories and the small business size standard of $41.5 million. Vague or incomplete submissions of capabilities will not be considered responsible sources. This notice is to assist in determining potential sources only. Adequate information shall be provided for the Government to determine Contractors ability to provide the required services and meet test menu requirements at the time of Contractor s response to this notice. There is no solicitation currently available. There is no guarantee, expressed or implicit, that the market research for this acquisition will result in a particular set-aside, sole source award or any other guarantee of award strategy. All information is to be provided on a voluntary basis and at no charge to the Government.