Department of Veterans Affairs Veterans Health Administration Sources Sought Notice - Specialized Laboratory Testing Services and Autopsy Services for VA CT This is a Sources Sought notice and not a request for quote. This request is solely for the purpose of conducting market research to enhance VHA's understanding of potential sources and their capabilities to provide these services. The Government will not pay any costs for responses submitted in response to this Sources Sought Notice. This Sources Sought notice provides an opportunity for respondents to submit their notice of ability, and their available products in response to the requirement described below. Vendors are invited to submit information relative to their potential of fulfilling the requirement below, in the form of a capability response that addresses the specific requirement identified in this Sources Sought. The Veterans Health Administration (VHA) is seeking a vendor to provide specialized laboratory testing services and autopsy services for the VA Connecticut Healthcare System as further described below. Services are required to perform off-site consultative dermatopathology, chromosome analysis, and consultative surgical pathology services to include both technical and professional components, pathology professional services for flow cytometry testing, and special coagulation testing, autopsy services and other selected clinical pathology tests for the Department of Veterans Affairs Medical Center, VA Connecticut Healthcare System (herein referred to as VAMC). See specific Test Schedule contained in Attachment A below. Refer to the General Requirements section below for the requested service description. This Sources Sought is to facilitate the Contracting Officer's review of the market base, for acquisition planning, size determination, and procurement strategy. General Requirements: The Contractor Laboratory shall provide the following services: 1. Perform testing services entirely upon their premises. 2. Accept VA generated manifests for patient test requisitions. 3. Perform analytical testing for VAMC patients for the tests defined in the test menu included as Attachment A. The Contractor shall bill only for the tests specified in the request sent by the VAMC Laboratory service and that are contained in the test menu. 4. Provide a reference test manual, and report of analytical test results and consultative services as required assimilating the full scope of its laboratory operations. 5. Provide VAMC with appropriate laboratory supplies not customarily utilized by the VAMC. These supplies are to be used by the VAMC only in connection with specimens being sent for testing to the contractor. 6. Carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations. 7. Provide all test result reports/consults immediately by fax to the send-out office of the VA Connecticut Healthcare System's Clinical Laboratory for entry into the VA electronic medical record. FAX# to be provided with the Award. 8. Refer to the following list to communicate abnormal test results and uncommon malignancy results within 24 hours of detection and verification of these results. Critical Test results will be communicated within 2 hours of detection and verification. a. Flow Cytometry Results: Monday - Friday (8-5p): POC and Phone# to be provided in Award b. Flow Cytometry Professional Services: Monday - Friday (8-5p): POC and Phone# to be provided in Award c. Flow Cytometry Professional Services: Saturday - Sunday: Pathologist on call. A VAMC contact list will be provided upon award. d. Special Coagulation Testing: Monday -Friday (8-5p) - A VAMC contact list will be provided upon award. e. Surgical Pathology: Monday- Friday: Phone# to be provided in Award f. All other 24X7: Phone# to be provided in Award 9. Provide a consultation/laboratory result report and at a minimum will contain the following information: o Patient's full name o Patient's date of birth o Patient's full social security number or unique hospital identification number o Ordering Physician's name o Date/time of specimen collection, when available o Date/time test completed o Test(s) ordered o Test result(s) o Flagged abnormal results o Type of specimen/source o Any additional comments related to test provided by ordering physician, if applicable o Unsatisfactory specimen shall be reported with regard to its unsuitability for testing " VAMC Lab accession number, if supplied " VAMC submitting facility name " Patient location if supplied " Date/time specimen receipt " Abnormal intervals/Toxic & therapeutic ranges, if applicable " Any other information the laboratory has that may indicate a questionable validity of test results. " VAMC facility account number " Contractor accession number " Contractor address " Contractor CLIA number " Reference intervals " Testing laboratory name 10. Consult with VAMC on test results by telephone as needed. 11. Provide a printed or electronic Laboratory Manual containing the following information: o Testing methodology for a test must be defined in the laboratory user's manual o Department hours of operation o Accreditation o Technical Staff o Service Departments (Method of contacting, phone numbers, hours of availability) o Quality Assurance Information o Billing Procedures & fee schedules for services provided o Procedures and criteria for phoning reports and other important information o Report forms 12. Provide telephone number(s) and contact person(s) to be used by the VA Medical Center to make specimen problem inquiries and problem solving at all times including weekends and holidays. *NOTE: Also include names and telephone number(s) of Technical Directors and Pathologists available for consultation. 13. Maintain the minimum acceptable service, reporting systems, and quality control as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency. 14. Assign a specific local account representative. 15. Advise VAMC facility of any planned changes in methodology, procedure or reference ranges at least 14 days prior to changes. In the event that two week notification is not possible due to emergency, contractor shall notify VAMC as soon as possible. 16. Not release patient's records that include test results to any person other than the ordering healthcare provider or VA Pathology and Laboratory Medicine staff member. All member records shall be treated as confidential so as to comply with all state and federal laws regarding the confidentiality of patient's records. This provision shall survive termination of the resulting contract award. 17. Certify and ensure that all employees, officers, or agents do not use Protected Health Information received from any VAMC site that would constitute a violation of any applicable provision in standards set forth in the Health Insurance Portability and Accountability Act (HIPAA). 18. Provide 4 quarterly (Oct- December, January- March, April-June, July- September) utilization/cost reports and an annual report (for contract performance period) to the sending VA site laboratory administration and to the VISN1 Network Consolidated Laboratory office (NCL). The reports shall be in Microsoft excel format and include at a minimum the following column headers: patient name, date of service, CPT code, test name/procedure, volume, cost per test, total cost. The data will be in the rows. These reports shall be forwarded to the sending VA site and NCL within 30 days of the end of the quarter. Licensing and accreditation - Contractor Laboratory: 1. Shall have all licenses, permits, accreditation certificates required by Federal law and State law. 2. Shall be accredited by the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA) or the College of American Pathologists (CAP). Copies of all professional certifications, licensures and renewal certifications shall be provided and updated as needed to the Contracting Officer to include the contractor laboratory's Laboratory Director(s) and/or Medical Director(s). 3. Medical Director(s) must have suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP standards. 4. Personnel assigned to perform the services covered by this contract shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board. 5. Shall comply with the regulatory requirements of Health and Human Services Health Care Financing Administration, Centers for Medicare and Medicaid (CMS). 6. Shall notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure. 7. Shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention. Contract Performance Monitoring: Quality Control: The contractor must operate a successful quality assurance program as required by CAP/CLIA. Services are to be performed in accordance with this Performance Work Statement (PWS). The quality control program shall include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor's quality control program is the means by which the contractor laboratory assures that work complies with the requirement of the contract. o The VA Medical Center will maintain an Internal Quality Control Program to monitor the quality of test results received from the contractor. The method used for monitoring is at the discretion of the VA Medical Center and may include, but is not limited to, unidentified split specimens sent periodically to the contractor for testing, split specimen sent to another reference laboratory for comparison, or monitoring of turn-around-time. o The contractor's facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the VAMC during the life of the contract. Quality Assurance: The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint commission and regulations required for performing the type of services described herein. The government shall evaluate the contractor's performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is describes how the Government will evaluate the contractor's performance. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s). Federal Holidays: (The contractor does not have to perform on these holidays with the exception of STAT testing which is required 365 days per year.) New Year's Day Labor Day Martin Luther King Jr.'s Birthday Columbus Day President's Day Veteran's Day Memorial Day Thanksgiving Day Independence Day Christmas Day Hours of Operation: The contractor is responsible for providing services 24 hours per day/ 7 days per week for Stat testing. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. All certifications must be kept current with any change of personnel assigned to this contract. Contractor Program Manager: The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the Contracting Officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 4:30p.m EST/EDT, Monday thru Friday, except Federal holidays or when the government facility is closed for administrative reasons. Identification of Contractor Employees: All contract personnel attending meetings, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. RESPONSE COMMITMENT I. NOTES: A. All questions, comments or concerns shall be directed to [email protected]. B. Submittals furnished will not be returned to the sender. No debriefs will be conducted. Eligibility to participate in a future acquisition does not depend upon a response to this notice. C. Proprietary information is neither requested nor desired. If such information is submitted, it must clearly be marked "proprietary" on every sheet containing such information, and the proprietary information must be segregated to the maximum extent practicable from other portions of the response (e.g., use an attachment or exhibit). II. TIMELINE: A. This request will close on stated date within the FBO site. III. Requested information: Interested parties shall provide the following information in addition to your capability response: A. Format: 1. MS Word or pdf format (please ensure email is under 5 mb) 2. Page limit - 2-4 pages (please make the response as brief and concise as possible) 3. Company name and Sources Sought number listed on each page B. Specifics: 1. In your response, please provide the following information based on the requirement. a. Your company's capability of fulfilling this requirement as it is described. 2. Please also provide name of company, company address, a contact person's name, telephone number, fax number and email address. 3. DUNS number, and indicate if actively registered on System for award management (SAM) 4. Contractual vehicles the company holds, such as NAC or GSA schedules. 5. Socio-economic Status & NAICS Code: State the size of your company [e.g., 8(a) (including graduation date), HUBZone-certified small business, Service- Disabled Veteran-Owned small business, small business, large business, etc.]. ? Attachment A - Test Schedule Description/Part Number Estimated Quantity Cytogenetics Lymph node culture 88239 0-1 Leukocytes Unstimulated culture 88237 20 Bone Marrow Analysis 88264 20 Interphase 100-300 88275 40 Cytogenetics and molex 88291 2 Chromosome Analysis 88237,88262,88291 0-1 FISH Nucleic Acid 88271 200 Pathology Immunoperoxidase 88342 200 Immunoperoxidase 88342-tc 304 Immunoperoxidase 88344 4 Tissue Exam 88302 -tc 0-1 Consult 88321 100 FISH 88365 10 MGMT genex 81479 3 Laser Micro disection 88380 0-1 Microdisection 88381 0-1 Molecular DNA Probe 88271 106 Molecular Interphase 88274 40 Special Stains 88312 5 Special Stains II 88313 135 Professional Interpret G0452 60 Gene Rearrangement 81261 20 Surg Path Level IV 88305 28 Immuno Studies 88346 150 Tissue Exam 88304 2 Electon Mic 88348 20 Surg Path Level V 88307 0-1 Tissue Exam 88309 0-1 Consult 88323 1 Consult 88325 12 Molecular Isolation/Extraction 83890 0-1 Bone Marrow Smear interp 85097 0-1 Histochem/FS 88314 20 Cytogenetics and molex 88291 45 IHC additional AB 88341 100 Morphomet Analysis 88360 41 Decalcification 88311 0-1 Cytopath Fluid 88112 0-1 Interpretation and report 83912 15 MSI PCR 81301 2 Autopsy Services Autopsy Services complete without brain 88020 3 Autopsy Services complete with brain 88025 3 Autopsy Services limited 88036 3 Autopsy Services limited to single organ 88037 3 Autopsy Services complete with brain and spinal cord 883027 3 Dermpath Immuno Studies 88346 70 Surg Path Level IV 88305 10 Stains 88342 (G0461) 5 IHC single AB 88342 26 Dermpath Consult 88321 30 Special Stains, group 1 88312 5 Special Stains group2 88313 1 Consult with slide 88323 3 Surg Path 88304 1 Immuno Studies, each additional 88350 40 Immuno Studies, each additional 88341 25 Specialized Testing Special Coag Interpretation 85390-26 3 Interpretation Flow Marker 2-8 88187 10 Interpretation Flow Marker 88188 2 Interpretation Flow Marker 16 or more 88189 10 BCR/ABL Screen Bone Marrow G0452 -26 2 CYCLIN D1, interpretation G0452 -26 6 T-Cell Re-arrangement G0452 -26 2 B-Cell Re-arrangement G0452-26 2 Special Stains Interpretation 88104-26 2 Acute Myelocytic Leukemia P G0452 2 Molecular Interpretation G0452-26 0-1 Igh gene rearrange amp meth 81261 0-1 Flow Professional 88180 0-1 PTH BR 83970 1 Mycobacterium (PCR) 87556 1 Special Stains interpretation 88104-26 2 Mutation Scan 83903 1 BRAF PCR 81210 1 Ki-RAS (PCR) 81275 1 FLT3-IDT AND FLT-D835 BONE G0452 1 SPEP 84165 1 Immunofix Electroph 86334 1 JAK2 MUTATION BONE MARROW G0452 1 Human Identity Testing (DNA matching) Y4412 4 Amplification 83898 0-1 Archival Retrieval 88363 0-1

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