65--Blood Supply and Products

NOTICE OF INTENT TO SOLE SOURCE REQUIREMENT The Department of Veterans Affairs, VA Healthcare System, VISN 10, Contracting Activity intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR Part 6.302-1, Only One Responsible Source for the deliverables outlined below. The vendor will be CENTRAL INDIANA REGIONAL BLOOD CENTER, INC. The associated NAICS code is 621991. The business size is $32.5 million. The anticipated award date is 10/01/2018. A firm fixed price contract for a base year and four option years is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source. This notice of intent is not a request for competitive quotes or proposals. It is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses shall include: (1) Business Name and Address, (2) FSS Contract Number, (3) Point of Contact Name, Phone Number and E-mail Address (4) DUNS and NAICS code (5) Business Size (6) Type of Business SERVICE DISABLED VETERAN OWNED, VETERAN OWNED, 8A, HUBZone, WOMEN-OWNED etc. Responses shall be submitted to John Saunders, Contracting Officer, at contact@example.gov no-later-than Thursday, June 7, 2018 at 4:30pm EST. The Contractor shall provide the deliverables outlined within the Statement of Work below to the VAMC Indianapolis 1481 West 10th Street Indianapolis, IN 46202. SEE THE STATEMENT OF WORK BELOW FOR SPECIFICATIONS OF THIS REQUIRMENT Statement of Work (SOW) Blood Services for RLR VA Medical Center 1.1 Background: This acquisition seeks to provide a continued supply of blood necessary to ensure care for veterans located at the Richard L. Roudebush VA Medical Center (VAMC), 1481 West 10th Street, Indianapolis, IN 46202-2803. The VAMC must have a secure blood supplier that can procure, transfer, and make available blood/blood products and related services. These products and services are an integral part of the care of patients, and directly impact the VAMC and affiliated clinics ability to provide vital services. 2.1 Scope: The contractor shall provide all resources and products necessary to provide the deliverables described in this statement of work (SOW). The tasks in the SOW are required to continue the safe delivery and adequate supply of products to meet the patient care needs of the VAMC network. The contractor shall assume responsibility for the manufacture of the product; ensuring the safety, purity, and potency of the product; and ensuring that the contract manufacturer complies with all applicable product standards and regulations. The contractor shall be a specialist in providing blood products and laboratory services. Services shall include all necessary qualified personnel, laboratory services, transportation, materials, equipment, and supplies to perform and report accurate and timely results, products, and laboratory services. 3.1 Objectives: The goal of this contract is to ensure the blood bank of the VAMC Pathology & Laboratory Service can continue patient care at the current high level or better. The contract shall maximize the cost effectiveness realized by the government. The blood bank shall be able to provide quality and safety of all products for the veterans. The contractor shall be licensed at all times by the American Association of Blood Banks (AABB), College of American Pathologist, (CAP), Food and Drug Administration (FDA), Indiana State Department of Health (ISDH), American Society for Histocompatibility and Immunogenetics (ASHI), and registered as a compliant ISBT 128 facility. All services provided shall be in conformity with the standards of quality of the industry, as set forth by the FDA, AABB, ASHI, and the Clinical Laboratory Improvement Amendments (CLIA). The laboratory testing shall be performed in a laboratory certified by the Centers for Medicare and Medicaid Services (CMS). Tasks: The following tasks are a requirement of the SOW. Blood Banking services (to include autologous, directed, and homologous blood products and apheresis products). Laboratory testing services (to include donor testing, reference lab, HLA and paternity testing). The requisitions for products covered under this contract shall provide and include specimen requirements and special handling instructions. All results shall be provided with normal values and technical method analysis. The blood supplier shall make available all quality control information and proficiency testing results pertaining to any testing performed by the Contractor for the RLR VAMC. The Contractor shall provide transportation for specimens/products and delivery service for products, upon request. All appropriate specimen containers and transportation materials shall be provided by the contractor, including leak proof containers for routine shipping of blood/blood products or specimens. The Contractor shall also provide appropriate supplies for the transport of blood/blood products including, but not limited to, wet ice, dry ice, or room temperature monitoring containers. The packaging employed shall be capable of maintaining temperature requirements for blood/blood products and specimens. The contractor shall provide two free routine courier runs per weekday (M-F, non-holidays). The contractor shall also provide proof of Shipping Hazard materials training. All specimens picked up shall be processed and results returned on a routine or emergency basis as requested. Any critical values shall immediately be conveyed to the RLR VAMC blood bank by telephone (+1 (555) 000-0000) or by facsimile (+1 (555) 000-0000). The Contractor shall make available consultative services for all tests performed on blood products for the RLR VAMC. Consultations shall be performed upon the request of the VA pathologist, physician, nurse practitioner, or blood bank staff. The Contractor shall notify the RLR VAMC of any recalls/market withdrawals in a timely manner as deemed by regulatory agencies. The Contractor shall provide a copy of the process for notification regarding blood/blood products or testing which are found to be nonconforming with the response to this RFP. The blood supplier shall abide by all provisions of law relating to the licensing and regulation of health care organizations, blood services, and laboratory testing. The Contractor shall provide copies of all required licenses, permits, accreditations and certificates of the agencies stated in the objectives no-later-than September 1, 2018, the response deadline given in the RFP. Additionally, copies of renewed licenses and certificates shall be provided to the Contracting Officer before their expiration. Blood/Blood Product requirements: Red Blood Cells received by the VA shall have no less than twenty-one (21) days until the expiration date. Aseptic methods shall be employed to minimize the risk of microbial contamination of blood/blood products. Equipment and solutions that come into direct contact with blood/blood products shall be sterile and pyrogen-free. Single use equipment shall be used whenever possible. Additional requirements include: a) the ability to provide apheresis platelets and pooled cryoprecipitate, b) all blood products shall be free of hemolysis and clots, c) all donor blood shall be tested for ABO and Rh, d) detection of unexpected antibodies shall be performed, e) provide Leukoreduced blood, f) provide CMV negative blood/blood products, g) capable of performing irradiation of products at supplier location, h) capable of washing packed red blood cells at the supplier location, i) only allogeneic blood testing negative for all FDA mandated infectious disease tests (including HBsAg, anti-HBc, anti-HCV, HCV RNA, anti-HIV-1/2, HIV-1 RNA, anti-HTLV-I/II, a serologic test for syphilis and WNV RNA (seasonal criteria apply)) shall be supplied for transfusion, j) only autologous blood testing negative for all FDA mandated infectious disease tests (including HBsAg, anti-HBc, anti-HCV, HCV RNA, anti-HIV-1 /2, HIV-1 RNA, anti-HTLV-I/II, a serologic test for syphilis and WNV RNA (seasonal criteria apply)) shall be supplied for transfusion, k) any units deemed unacceptable by the RLR VAMC, shall be returned free of charge (this includes, but not limited to, clotted, hemolyzed, clerical errors, broken in water bath during thaw, and units with less than 2 segments). Labeling of blood/blood products containers shall be in conformation with the most recent version of the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components using ISBT 128. Per this standard, all provided blood shall be labeled with: 1) the ABO/Rh, 2) donation identification number, 3) product code, and 4) facility identification. All labeling information shall be in machine readable format. The contractor shall ensure the storage of blood/blood products is continuously monitored. The storage of documents and records shall be in accordance with AABB and CAP standards. The contractor shall provide a method of provision of blood/blood products and services in a disaster or time of emergency. A copy of a disaster plan shall be submitted with the proposal. This Procedure/Policy shall include: 1) notification procedures, 2) ongoing communication (i.e. command center), 3) evacuation or relocation, 4) isolation or containment, 5) personal safety and protection, and 6) provision of additional staffing. The Contractor shall provide data on all HLA/DNA and Reference Tests. This data shall state: 1) test description, 2) specimen and handling requirements, 3) testing schedule, and 4) turnaround time Technical staff performing tasks under this contract shall be certified by a national professional certification body appropriate for the specialty and complexity of the task being performed. The Supervisory personnel, including the Medical Director(s) shall maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the College of American Pathologist (CAP), and AABB accreditation standards. The Medical Director shall be a licensed physician with suitable qualifications and experience to direct a laboratory and blood bank facility. Copies of the professional certification and licensure of the Laboratory Director and Medical Director shall be provided with the Contractors response to this RFP. Service availability - The blood/blood products shall be available 24 hours per day, seven (7) days per week, including all holidays. STAT deliveries shall be completed within 1-hour, SPECIAL deliveries shall be completed within 90 minutes, and STANDARD deliveries shall be completed within 3 hours. The Reference Laboratory testing shall be available 24 hours per day, seven (7) days per week, including all holidays. The STAT shall be completed as urgent as possible. The ASAP shall be completed within 24 hours. The ROUTINE shall be completed within 1-5 days. The Reference Laboratory shall include the following services: Ability to obtain rare donor units for transfusion. Enzyme treatments of specimens Adsorptions Warm Autoantibody detection Antibody Detection Auto adsorptions Compatibility Screening Direct Antiglobulin Testing Donor and Patient Antigen Testing DTT Treatments Eluates Microhematocrit Cell Separation Titrations ABO/Rh Discrepancies HLA/DNA testing shall be available Monday Friday during the dayshift hours (8-4:30), excluding holidays. Available testing from HLA/DNA shall include: a) platelet support services, b) cardiac transplant services, c) renal transplant services, d) disease association services, e) bone marrow services, and f) TRALI investigation. Additionally, donor patient services shall be available by the contractor. Available services from donor patient services shall include: Cross matching of HLA platelets Autologous Donor Units Directed Donor Units (ensuring irradiation is performed if applicable) Directed Platelets Therapeutic Phlebotomy arrangements Multiple off-site draw facilities for easy patient access. The Contractor shall provide a contract service manager to address any satisfactory or unsatisfactory performance of required services. All situations shall be followed up with documentation when applicable. The manager shall meet, as necessary, to discuss immediate administrative or technical issues as they arise. The blood supplier shall be able to identify and trace all critical materials used in processing, as well as laboratory samples and donor and patient records of all blood/blood products donations. Contractor shall provide control materials if necessary and be able to perform any necessary look backs or reviews concerning donors or units as deemed necessary by the supplier or the RLR VA Medical Center. 5.1. Delivery: The adherence to established timeliness standards and accurate reporting of blood/blood products and laboratory testing is essential. With this contract, the contractor shall deliver products and services to the Blood Bank of the Pathology and Laboratory Department of the RLR VAMC. Additionally, the tracking of all deliveries, testing, blood/blood products, and laboratory test results shall be made available by the contractor as required by the appropriate regulatory agencies. 6.1 Government Furnished Equipment: N/A. There is no Government Owned equipment furnished for this acquisition. 7.1 Security: The contractor shall be responsible for the security and integrity of specimens/patient information/results and for the compliance of all Health Insurance Portability and Accountability Act (HIPAA) provisions. Additionally, Contractor staff shall comply with HIPAA. Neither the contractor or nor any of its employees shall disclose private medical information concerning patients to third parties other than those personnel designated by the Government to receive patient results. All medical results shall be handled as private medical records. 7.1 Place of Performance: All specimens for laboratory testing shall originate from the RLR VAMC. The results shall be redelivered to the RLR VAMC via fax or phone at the numbers given in paragraph 1.4 this SOW. The Contractor shall be responsible for the adherence to the STAT/non-STAT timing requirements. Furthermore, all blood/blood products shall originate from the contractor. The products shall not be obtained from donors being compensated for their donation. All donations shall be voluntary. 8.1. Period of Performance: The Period of Performance for this contract is anticipated to be one base year (10/01/2018 09/30/2019) and 4 option years.