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The Department of Veterans Affairs, Network Contracting Office 10, 24 Frank Lloyd Wright Drive, Lobby M, Suite 2200, Ann Arbor, MI 48105, intends to solicit offers for REFERENCE LAB TESTING with all l... The Department of Veterans Affairs, Network Contracting Office 10, 24 Frank Lloyd Wright Drive, Lobby M, Suite 2200, Ann Arbor, MI 48105, intends to solicit offers for REFERENCE LAB TESTING with all labor, materials, equipment, supervision, and all necessary resources to meet the requirements below. The REFERENCE LAB TESTING shall be performed for the VA Ann Arbor Healthcare System, 2215 Fuller Rd, Ann Arbor, MI 48105 Contractors that can provide this requirement and meets the requirements below are requested to send their 1. Company Name, 2. DUNS number, 3. Business size under NAICS 621511 and 4. If the item(s) are available on an FSS contract or not and the FSS contract number if it is available on contract, 5. Notification if they are a VETBIZ registered VOSB/SDVOSB, SMALL BUSINESS, WOMEN OWNED SMALL BUSINESS, COMPETETIVE 8 (a), or not. 52.219-14 Limitations on Subcontracting. Services, At least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern. This is not a solicitation. This is a Request for Information, Sources Sought. This Sources Sought will close on 8/15/2019 at 1:00 PM EST. Please e-mail all responses to Thomas.Auten@va.gov. INTERESTED CONTRACTORS SHALL SUBMIT WRITTEN DOCUMENTATION SHOWING THEIR ABILITY TO COMPLETE THE REQUIRED TESTS AND AUTHORIZATION AGREEMENT TO USE PATENTED PROMETHEUS OR EQUIVALENT TESTS. STATEMENT OF WORK C.0 SCOPE: C.0.1 VA ANN ARBOR HEALTHCARE SYSTEM AND COMMUNITY BASED OUTPATIENT CLINICS (CBOCS): The Contractor shall provide reference laboratory testing for the patients of the VA Ann Arbor Healthcare System, 2215 Fuller Rd., Ann Arbor, MI 48105. C.1 DEFINITION OF NEED: C.1.1 VA ANN ARBOR HEALTHCARE SYSTEM: The VAAAHS requests a base year contract for the VAAAHS that includes 2 additional option years. The test menu provided to the VAAAHS and CBOCs will be varied and based on the patient test orders placed by the clinicians. These laboratory tests are not performed in-house for various reasons such as low testing volume or specialized equipment requirements that are not available at the VAAAHS. C.2 DUTIES OF CONTRACTOR: C.2.1 VA ANN ARBOR HEALTHCARE SYSTEM AND COMMUNITY BASED OUTPATIENT CLINICS: Vendor shall provide Federal Express courier service pick-up at the VAAAHS, 2215 Fuller Rd., Ann Arbor, MI 48105, Room E333 (Central Receiving), to collect packaged laboratory specimens that are ready for transport. The courier will transport the sample to the respective vendor facility for patient testing. C.2.2 Once patient testing is completed; the laboratory results shall be faxed to the VAAAHS or a printed copy of laboratory results will be mailed to the Central Receiving Office. C.2.3 The Contractor shall provide the specialized tubes and shipping kits required for select patient testing, specimen transport request forms, reference laboratory testing and reporting, and maintain a customer support telephone service. Vendor shall provide electronic and paper test menu and pricing schedule. C.3 CONFORMANCE STANDARDS: C.3.1 VAAAHS AND THE TOLEDO CBOC: Vendor must maintain full compliance with applicable Federal and State regulations. All services provided under this contract must be performed in conformance with the Nation Fire Protection Agency (NFPA), Occupational Safety and Health Administration and other applicable national, state and local regulatory agencies. Vendor must maintain a CLIA certificate of accreditation, and The Joint Commission, and/or the College of American Pathologists. C.4 HOURS OF WORK: C.4.1 VAAAHS: Federal Express pick-up of patient samples shall be provided Monday through Friday, business hours. Patient testing shall be done a minimum of Monday through Friday but may include weekends if the reference site chooses to perform weekend testing. C.4.2 The ten holidays observed by the Federal Government are New Years Day, Martin Luther King Day, President s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Thanksgiving Day, and Christmas Day. Also, any other day declared by the President of the United States to be a national holiday. C.5 MEDICAL LIABILITY INSURANCE LIMITS: C.5.1 VAAAHS AND THE TOLEDO CBOC: In accordance with VAAR 852.237-7, Indemnification and Medical Liability Insurance, the contractor shall maintain liability insurance or self-insurance of not less than $1,000,000.00 per specialty per occurrence. C.6 PAYMENT: C.6.1 VAAAHS: Payment for services satisfactorily performed will be made quarterly in arrears upon receipt of a proper invoice at the designated office. Payment will be made by certified invoice and money will be distributed from the appropriate VAAAHS to pay the obligations. C.6.2 The Supervisory Medical Technologist (Laboratory Manager) will make certification for Pathology and Laboratory Medicine Service for the VAAAHS. All invoices will be processed in accordance with the Prompt Payment Act. Any discrepancy between the terms of the contract and the amount of the invoice will be promptly referred to the VA Contracting Officer for resolution. Invoices for contract services for the VAAAHS should be mailed to: Resource Office (20V) VA Ann Arbor Healthcare System 2215 Fuller Road Ann Arbor, MI 48105 C.7 TERM OF CONTRACT FOR VAAAHS AND THE TOLEDO CBOC: The contract will be effective for one year from the date of the contract award, with four additional contract option years. The contract is subject to the availability of appropriated funds. C.8 MISSION, VISION AND VALUES STATEMENT-VAAAHS AND THE TOLEDO CBOC: C.8.1 Mission: The mission of the VA Ann Arbor Healthcare System, including Community Based Out-patient Clinics is to provide high quality primary and tertiary care to eligible veterans through highly qualified staff, mutual beneficial educational affiliations and strong research programs. C.8.2 Vision: To function as a member of a fully integrated health services network that coordinates all processes for the benefit of the patient. C.8.3 Values: Patient Satisfaction, Accountability, Compassion, Excellence, Teamwork, and Collaboration, Effective Communication, Adaptability, Mutual Respect, Diversity, Integrity and Innovation. C.9 THE JOINT COMMISSION COMPLIANCE STANDARDS: C.9.1 GENERAL: All applicable VA and VHA policies, procedures and directives shall be followed by the contractor. The contractor shall continuously meet or exceed all Joint Commission Hospital standards. The patient population treated at the VA Ann Arbor Health Care System, located in Ann Arbor, Michigan, consists of veterans with varying physical, psychiatric, and psychological needs. Care delivered will reflect the VA Medical Centers mission, vision and values. C.9.2 PATIENT RIGHTS: Protection of all patients rights is of highest priority. Patient privacy and confidentiality shall be maintained at all times. Computer access will be granted on a need-to-know basis, and security of computerized information will be maintained at all times .No patients shall be subject to any research activity without his fully informed consent, subject to study approval by the Investigational Research Board (IRB). The contractor shall abide by the VAMC Code of Ethics, which addresses marketing, admission/transfer/referral/discharge processes, and billing issues C.9.3 PATIENT SAFETY: The VAMC shall inform the contractor of all applicable Sentinel Event or other Patient Safety Alerts received by the VAMC. For every applicable alert, the contractor shall take the necessary steps to redesign processes to prevent occurrence and provide written feedback to the COTR describing prevention actions taken. All events related to patient injury, medication errors, and other breeches of patient safety will be documented utilizing the contractor s format and reported to the COTR utilizing the VAMC Incident Report. The VAMC shall provide the contractor with VAMC Sentinel Event definitions in the start-up phase. The contractor shall verbally notify the VAMC COTR immediately when a Sentinel Event has occurred, which is to be followed by written notification within one (1) business day or sooner if requested by the medical center. The VAMC shall determine when a Root Cause Analysis (RCA) is required of the contractor. The contractor shall conduct all Root Cause Analysis according to VAMC policy and within established time frames (45 days). Completed RCAs shall be provided to the VAMC COTR. C.9.4 PERFORMANCE IMPROVEMENT: The contractor shall comply with the VAMC Performance Improvement (PI) program as applicable to the Pathology and Laboratory Medicine Service. Pathology and Laboratory Medicine Service will monitor the vendor s Test Assay Turn Around Times (TATs) on a quarterly basis. Vendor shall provide a quarterly TAT report for all patient testing requests sent for analysis. Quality Assurance Technologist will provide a quarterly report to VAAHS management team for review. Contractor PI activities may be directed by the VAMC, VISN or VHA, as well as accreditation or licensing bodies. The contractor shall abstract, compile and report PI data as requested by the VAMC. VA Data collection methodology, report format, and reporting deadlines will be defined by the VAMC. Examples of required PI activities include the VHA Performance Measures/Clinical Practice Guidelines program, and the Joint Commission ORYX or Core Measurement program. It is noted that PI activities are dynamic and subject to change, as driven by current priorities and resources. In all cases, the contractor shall continually assess for, and act upon, clinical and administrative improvement opportunities. High priority shall be given by the contractor to the prevention of risk for the patient. The contractor shall implement process-related internal controls to prevent risk to the veteran. VA monitoring for continuous compliance with Joint Commission standards shall be directed by VAMC staff and communicated to the contractor through the COTR. VA aggregate and/or practitioner-specific data collected by the VAMC will be provided to the contractor in accordance with established reporting schedules. VA measures related to contract compliance will be identified by the COTR. C.9.5 LEADERSHIP: The contractor shall effectively manage daily operations, information and support systems, and conserve physical and financial assets while meeting the mission of the VAMC. C.9.6 ENVIRONMENT OF CARE: All significant problems identified shall be reported verbally to the COTR within 24 hours. A written corrective plan of action shall be submitted to the COTR within 5 working days. VA timeframes and priorities for completion of action plan items will be mutually agreed upon by the contractor and the VAMC Safety Officer. C.9.7 INFORMATION MANAGEMENT: The VAMC Information Management plan shall be followed by the contractor. Documentation and record keeping shall be in accordance with VAMC policies and procedures. VAAR-852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (Interim Oct 2008) must be included in contract. C.9.8 CONFLICT OF INTEREST: Conflict of Interest acknowledgement document(s) must be signed by all procurement officials and copies filed in the OPF in accordance with VHA Handbook 1660.3. Contracting Officials, COTRs, selection officials, and others involved in the contracting processes are free from any actual or perceived conflicts of interest. The Contracting Officer will monitor compliance and will review the selection board for conflicts. C.10 TEST MENU REQUIREMENTS FOR THE VAAAHS: QUANTITY AS REQUIRED -Prometheus TPMT Genetics; CPT code81335 - Prometheus TPMT Enzyme; phenotype patients for individualized starting dose of thiopurines, CPT code 82657, 82542 - Prometheus Thiopurine Metabolites (6-TGN, 6-MMPM), CPT code 82542. - Prometheus ® Celiac PLUS - Other clinical diagnostics testing for IBD/CELIAC/CROHN S e.g ANSER, IBD-sgi, MONITR.