IDIQ Blood Products

THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). No solicitation document is available at this time; this notice is to acquire information only. PLEASE PROVIDE ALL RESPONSE TO THE CONTRACT SPECIALIST NO LATER THAN CLOSE OF BUSINESS 12 JANUARY 2021 52.215-3 -- Request for Information or Solicitation for Planning Purposes (Oct 1997) (a) The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation. (b) Although proposal and offeror are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal. (c) This sources sought is issued for the purpose of conducting market research to identify vendors that are capable and qualified to provide blood and testing products. If your firm is a Service-Disabled Veteran Owned or Veteran Owned Small Business, you must be CERTIFIED in VetBiz (see internet site: http://vip.vetbiz.gov). Mark your responses as - Proprietary Information if the information is considered business sensitive. Prospective Contractors are reminded that in accordance with FAR Subpart 4.11 they shall be registered in the System for Award Management (SAM) database and shall complete electronic annual representations and certifications in SAM prior to award of a contract. SAM is located at http://www.sam.gov and consolidated the capabilities of CCR/FedReg, ORCA, and EPLS. There is NO cost to use SAM. The intended contract period is a five-year IDIQ contract with a one-year base period plus (4) four one-year ordering periods. Anticipated North American Industry Classification System (NAICS) code is 621991, small business size standard $32.5 Million. The contractor shall provide Blood Products/Testing Items to eligible veterans. Please see the attached Statement of Work for full and complete details. Responses to this notice must include the following information: Company Name: Company Address: Company DUNS: Company NAICS Code(s): Point of Contact Name: Point of Contact Phone Number: Point of Contact Email Address: Company Website (if available): Business Size/Type: (Large; Small; Service-Disabled Veteran-Owned Small Business (SDVOSB); or Veteran Owned Small Business (VOSB) only) If your company has worked with the VA or any other Federal Government agency A description of your company's experience with providing prescription eyeglasses. Any questions should be addressed to the Contract Specialist, in writing, at the email address provided. This is a request for information only, answers to questions will not be posted. If your organization has the capability to provide these items and is interested, please respond to Timothy Kimmel, Contract Specialist, Network 23 Contracting Office (NCO23), via e-mail at contact@example.gov. B.5 STATEMENT OF WORK SPECIFICATIONS/STATEMENT OF WORK Blood Products The cost of all testing for infectious diseases and tests that are required by state or federal agencies [(i.e. Food and Drug Administration (FDA), American Association of Blood Banks (AABB), Code of Federal Regulations ( CFR), and College of American Pathologists (CAP) ]etc.) shall be included in the offered prices. No additional fees will be paid for blood testing. Blood will be typed and labeled for ABO and Rh antigens in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and the Technical Manual of the American Association of Blood Banks. A sample of blood from each donation will be tested for infectious diseases and all testing shall comply with American Association of Blood Banks (AABB ) standards and the Code of Federal Regulations, 21 CFR Parts 606,607,610,630,640,660, governing blood products. Products must be non-reactive for infectious disease markers prior to shipment, except with the express written authorization of the Veterans Administration (VA) Blood Bank Medical Director or his/her designee. All blood is to be collected by the closed system under aseptic conditions and shall be processed in appropriate solutions and the container so labeled. The label shall also bear the expiration date of the contents. All blood supplied will be grossly free of hemolysis, excessive chyle, and clots. Contractor must maintain registration and/or licensure with the Food and Drug Administration (FDA), Department of Health and Human Services pursuant to Section 5l0 of the Federal Food, Drug and Cosmetic Act as amended, 2l USC Section 260. Contractor must also maintain U.S. License as issued by the Director, Bureau of Biologics, FDA under section 35l of the Public Health Act, as amended, 42 USC Section 262, as a source to supply whole blood. Copies of these will be provided to the Contracting Officer prior to award. Contractor must provide the VA with l00% "volunteer donor" blood in accordance with FDA rules and regulations effective May l5, l978 or later revisions. Definition of a "volunteer donor" - A volunteer donor is a person who does not receive monetary payment for blood donation. Benefits, such as monetary time off from work, membership in blood assurance programs and cancellation on non-replacement fees that are not readily convertible to cash, do not constitute monetary payment." Donor Requirements: Contractor must maintain readily available blood donor lists including names, addresses and Social Security numbers. Such lists should indicate whether, and on what date, blood of a particular donor was furnished to VA under this contract. Donor selection must be in accordance with criteria established by the FDA and/or the AABB. Blood from VA patients may require typing, antibody detection, direct antiglobulin test (DAT) testing and cross matches. Cross matches may be on a STAT basis and require blood delivered to the VA within 3 hours of receipt of the blood sample . The VA will be responsible for delivering samples to the contractor for the required testing. Ordering/Shipping Requirements: Non-emergency delivery schedules may be altered by contractor during holiday weeks (normal business hours are 7:00am to 3:30pm CST M-F)). VA shall be informed in advance of any delivery schedule changes. Contractor must take telephone blood orders twenty-four (24) hours each day. The VA will pick up the orders. The VA will set up the pick- up schedule in coordination with vendor. Oral orders for the delivery of requirements for the Blood Bank will be placed by authorized Blood Bank/Laboratory personnel on an "as needed" basis by calling vendor at ___________(605) 333-7081. The blood shall be available for pick-up delivered as specified within twenty-four (24) hours following request therefore. Emergency requirements are to be available for pickup by station personnel within 60 minutes of request. Empty containers, blood, and equipment being returned for credit shall be returned at contractor's expense. All blood products picked up by VA under this contract shall be properly packed and insulated in such a way as to ensure that appropriate temperature for the products is maintained during a normal automobile trip between contractor's place of business and VA Medical Center. Shipping containers are supplied by the contractor. Blood products shall be supplied as fresh as possible to minimize losses due to outdating. Red blood cells shall be returned to the offeror's facility for credit when the units are within 7 calendar days of expiration date. Fresh frozen plasma shall be returned for credit when units are within two months of expiration date. Blood shall be shipped in clean Office of Biologics approved containers in accordance with all Federal and State Department of Transportation (DOT) requirements for the transportation of human blood and blood products. Red blood cells shall be transported in a manner to maintain a temperature of l-l0 degree C. Pooled cryoprecipitate, pooled platelets and individual platelets shall be transported at 20-24 degrees C. Fresh frozen plasma and individual units of cryoprecipitate shall be transported in a manner to maintain them frozen. Products received which do not meet these criteria shall be rejected and returned for full credit. Units of fresh frozen plasma which are received with broken bags shall be rejected and returned for full credit. Each shipment shall be accompanied by an itemized invoice including product description, ABO/Rh, unit number and expiration date. 7. Blood/Component Returns: VA shall be given full credit for any blood/components rejected and returned if it is mutually determined they are unsuitable for transfusion. Credit as indicated in Cost Schedule shall be given for all units rejected and units returned for credit that meet described expiration dates. and Red blood cells returned at least 7 calendar days prior to expiration date if the following conditions are met: ai. The original blood/component label must not be obliterated or defaced with any non-removable markings or stickers. b. ii At least two (2) segments for further test must remain attached to the original container of red blood cells. iiic. The original tamperproof seal must not have been broken. ivd. There must be recorded evidence of continuous storage at the proper temperature. Code of Federal Regulations (CFR) 606.l60 requires documentation of continuous storage of blood/components. The recorded evidence must be validated by authorized personnel's signature. b. Fresh frozen plasma shall be returned for credit when units are within two months of expiration date. ai.. The original blood/component label must not be obliterated or defaced with any non-removable markings or stickers iib. The original tamperproof seal must not have been broken. iic. There must be recorded evidence of continuous storage at the proper temperature. CFR 606.l60 requires documentation of continuous storage of blood/components. The recorded evidence must be validated by authorized personnel's signature. 8. Records of Adverse Reactions: In accordance with CFR 21:606.170, VA agrees to maintain records of any suspected adverse reactions to blood/components supplied by the contractor by a recipient of the blood/component. If VA determines that the blood/component caused a serious adverse reaction, a written report shall be forwarded to the contractor within one calendar week (7 calendar days) of the reaction. A serious reaction is defined as being life-threatening, permanently disabling, or fatal. Furthermore, VA agrees to report all cases of post-transfusion hepatitis, transfusion-associated Human Immunodeficiency Virus (HIV), and transfusion-associated fatalities to the contractor Medical Director where such cases are due to blood/components supplied by the contractor. Reports of transfusion-associated fatalities shall be made by telephone as soon as possible following the occurrence, and in no case more than 24 hours following the fatality. Other reports shall be made by telephone or letter within one calendar week (7 calendar days) after VA's notice of such post-transfusion illness. 9. Blood shall be furnished labeled as to A, B, O, and Rh type. Type A Rh negative and O Rh negative must have been drawn from donor, not more than 5 calendar days before date that purchase order is issued. Types such as AB Rh positive, B Rh negative, and AB Rh negative shall be supplied as fresh as possible, but not over 15 calendar days old. These time limits may be adjusted, if a system for exchange on credit is provided which minimizes or precludes losses due to outdating. All units shall be in accordance with International Society of Blood Transfusion ( ISBT) labeling. 10. Cryoprecipitate and platelets shall be pooled prior to shipment. No individual units shall be accepted unless specifically requested. 11. Contractor shall be paid, upon submission of monthly statement, in arrears, for all blood products furnished during the previous month, less any applicable credits. 12. Tests and products required with annual estimate: TEST NAME CPT ESTIMATED ANNUAL VOLUME Red blood cells P9016 450680 Platelet concentrate P9019 120150 Cryoprecipitate or platelet pooling 86965 330 Single donor plasma, fresh, frozen P9017 75100 Cryoprecipitate P9012 245 Compatibility test (crossmatch) 86920 4040 Antibody identification 86870 5050 Antigen typing 86902 5050 Autologous donation processing 86890 1010 Direct antiglobulin test (DAT) 86880 4035 Pooling charge 86965 3030 Irradiation charge 86945 1010 Rh 86901 4040 ABO 86900 4040 Antibody screen 86850 3020 13. Contractor shall follow AABB, FDA, CAP and Joint Commission guidelines when performing tests listed below. The following tests should be completed within the designated turn-around-times on a 24/7 hour basis. TEST NAME REQUIRED TURN-AROUND-TIME (from time of receipt to completion of the test) Compatibility test (crossmatch) 2 hours Antibody identification 2 hours Antigen typing 2 hours Direct antiglobulin test (DAT) 4 hours Rh 1 hours ABO 1 hours Antibody screen 1 hours Type and screen 1 hours Type and crossmatch 2 hours Products must be labeled with ISBT 128 barcode labels. 14. Draw and preparation of blood donated by relatives, friends, and members of service organizations, etc., for the specific use of the Department of Veterans Affairs patients shall be made available. The contractor shall cooperate in scheduling and accepting these donors. 15. CONTRACTOR RESPONSIBILITIES The contractor shall obtain all necessary licenses and/or permits required to perform this work. He/she shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. He/she shall be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employee's fault or negligence, and shall maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of South Dakota. Further, it is agreed that to the extent applicable to a Federal Employee's actions, the Federal Tort Claims Act describes VA liability. 16. INSURANCE REQUIREMENTS: In accordance with VAAR 852.237-7 Indemnification and Medical Liability Insurance the following minimum liability insurance coverage levels shall apply to this contract: General Liability of not less than: $1,000,000.00 per occurrence. The Contractor must present to the Contracting Officer, prior to award, evidence of general liability insurance without any exclusionary clauses that would void the general liability coverage. 17. ORDERING PROCEDURES: Delivery orders will be placed by telephone or fax, on an as needed basis, by VA Medical Center (VAMC) Laboratory personnel twenty-four hours a day seven days per week. Names of Lab personnel authorized to place, accept, or reject orders shall be provided to the Contractor upon request. In accordance with the Invoices Procedures listed on page 4 the contractor shall submit invoices on a monthly basis listing all orders placed over the course of the month. Lab personnel authorized to place, accept or reject orders: The names of the authorized personnel allowed to place orders will be named after award is made. The titles will be following however:, Medical Laboratory Technologist, Medical Laboratory Technicians 18. RESULTING PROCEDURES: Contractor must deliver results in a standardized, legible manner in which there would be no question for interpretation. (See attachment for example of standardization of resulting.) Each report shall at a minimum indicate the following information: (a) Patient's full name and Social Security number (b) Physician's name (if supplied) (c) VA Medical Center name (d) Patient's location, e.g. clinic, ward (if supplied) (e) Test ordered (f) Date/time of specimen collection (when available) (g) Date/time specimen received in Reference Lab (h) Date test completed (i) Test result (j) Name of testing laboratory (contractor and/or subcontractor) (k) Testing laboratory specimen number (l) Type of specimen (m) Comments related to the test provided by the submitting lab (n) Information that may indicate a questionable validity of test results (o) Unsatisfactory specimen shall be reported with reason as to its unsuitability for testing Quality Control To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of the contract: (a) Annual summary. (b) Proficiency testing data. (c) The contractor(s) facilities, methodologies (defined as the principal of the method and references), and quality control procedures may be examined by representatives of the VA at any time during the life of the contract. (d) Contractor agrees to maintain the minimum acceptable service, reporting systems and quality controls as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency. Testing Changes The Contractor shall advise the VA of any changes in assay methodology, procedures, and any new tests introduced. In the event the contractor changes the assay procedures or a critically important component of an assay the contractor shall notify the VA Contracting Office and the VA Laboratory Director prior to the intended change. They shall provide documentation that the quality and efficacy of the test will remain unchanged or be improved. Changes in the assay material, testing procedures or methodology that have not been reviewed and pre-approved by VA Laboratory Director and mutually agreed upon in writing between the contractor and the VA Contracting Officer, may be sufficient cause for the VA to use an alternate contractor for that specific test for the duration of the contract. .