65--Blood & Blood Products

This is a Sources Sought (SS) Notice only, not a solicitation announcement and should not be considered as such. There is no solicitation available at this time. The Government will not pay for any information received in response to this SS, nor will the Government compensate any respondent for any cost incurred in developing the information provided to the Government. This SS 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 SS is to conduct Market Research to gain knowledge of potential qualified sources and their size classification (hub zone, 8(a), small, small disadvantage, service disabled veteran owned small business or large business) relative to NAICS Code 621991. The Department of Veterans Affairs, Network Contracting Office 10, is conducting market research to determine if there is a sufficient number of certified Service Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Hub zone Small Businesses, Woman Owned Small Businesses or 8(a) firms capable of performing the requirements to warrant a set-aside. Carefully consider the Statement of Work (SOW) prior to submitting your interest in this contract. Statement of Work (SOW) 1. BACKGROUND : The Chalmers P. Wylie VA ACC patients require blood products on an as needed basis and when their provider determines the need. The products are supplied by donors and an outside entity collects and processes the products following FDA and AABB standards. 2. SCOPE: Contractor shall furnish blood, blood products, and procedures to the VA ACC, Columbus, 420 North James Road, Columbus, Ohio, in such quantities and at such times as may be required and in accordance with the specification, terms, provisions, conditions and the schedule herein. 3. SPECIFIC TASKS Collection of Products: 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. Processing Blood Products: Blood will be typed for ABO & Rh antigens in accordance with methods recommended in the current editions of Standards for Blood Banks and Transfusion Services and the Technical Manual of the American Association of Blood Banks. Samples from all donors will be tested for all infectious diseases as required by the FDA. All products containing red blood cells and/or platelets may undergo an FDA-approved leuko reduction process. STORAGE AND PACKAGING: Immediately after donor phlebotomy, the blood product will be stored at the AABB standards. The products will be shipped to Columbus VA ACC according to AABB standards. DELIVERABLES: SOW Task# Deliverable Title Format Number Calendar Days After CO Start 1 Packed Red Cells Unit 125/year 0 2 Platelet Apheresis Unit 75/year 0 3 Platelet single unit Single unit 10/year 0 4 Fresh Frozen Plasma Unit 4/year 0 5 Irradiated Packed Red Blood Cells Unit 10/year 0 6 Irradiated Apheresis Platelets Unit 5/year 0 7 Cryo precipitate Unit 40/year 0 4. PERFORMANCE MONITORING Normal blood requests will be delivered as specified within twenty-four (24) hours following notification of need, during regular administrative hours. Emergency requirements are to be processed immediately and made available for pickup by delivery personnel within sixty (60) minutes of notification of need during facility operating hours currently Monday Friday 7a.m. 7 p .m. Empty containers, blood, and equipment being returned for credit will be returned at contractor s expense. Contractor will provide the VA with 100% volunteer donor blood in accordance with FDA rules and regulations effective May 15, 1978 or later revision. Definition of a Volunteer Donor is as follows: 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 cancellations of non-replacement fees that are not readily convertible to cash, do not constitute monetary payment. Contractor must maintain readily available blood donor lists including names, addresses and unique identification numbers. Such lists should indicate whether and on what date blood of a particular donor was furnished to the Department of Veterans Affairs under this contract. Donor selection must be in accordance with criteria established by the FDA and/or the AABB. Contractor will promptly notify VA ACC Columbus when information indicates that blood may deleteriously affect a transfusion recipient; provided, however, that ARC will not reveal the identity of any blood donor 5. SECURITY REQUIREMENTS Memorandum of Understanding. Including the individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information(PHI). VHA is a covered entity under the HIPPA Privacy Rule (Privacy Rule). HIPPA regulations require VHA to execute HIPAA-compliant MOU with certain entities that receives uses or discloses VAH PHI in order to perform some activity for VHA. These BAAs obligate the VHA business associates to provide the same protections and safeguards to PHI that required of VHA under the Privacy Rule. ( HIPAA Privacy Regulations ). Any obligation pursuant to HIPAA s Privacy Regulations to protect and safeguard individually identifiable health information will survive the termination or expiration of the Agreement. Contractors, contractor personnel, subcontractors and subcontractor personnel shall be subject to the same Federal Laws, regulations and standards a VHA regarding information an information system security. The term security incident means an event that has, could have, and resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security /privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. 1. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to the VA shall identity the information involved, the circumstances surrounding the incident (including to whom, how, when and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. 2. With respect to unsecured protected health information, the contractor is deemed to have discovered a data breach when the contractor knew or should have known of a breach of such information. Upon discovery, the contractor must notify the VHA of the breach. 3. All contractor employees will be provided information Security Awareness as well as HIPAA/Privacy Awareness training in accordance with HIPPA Privacy Rule. Proof of training and/or the training materials used to be provided to the CO/COR upon request. 6. GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI) Patient medical records shall be exchanged as needed by both facilities and remain confidential. VA ACC will provide patient information to help with patient. VA ACC requires receipt of findings to help ensure the appropriate care will be given in the future. Clinical or other medical records of VA beneficiaries treated by the Contractor will be forwarded to ARC Reference Lab if required Medical records of VA beneficiaries requested by the contractor are required to complete appropriate testing. The contractor determines appropriate testing that will help to determine appropriate blood products. VA ACC beneficiaries medical records from the contractor will be provided to medical records to scan into the VA ACC medical record system. 7. OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS ACCREDITATION: Accreditation by the American Association of Blood Banks (AABB) is required of the Contractor. Contractor and any subcontractors must have all licenses, permits, accreditation, and certificates required by law. HOURS OF SERVICE: Contractor shall provide services covered by this contract during their regular business work hours, except in case of emergency, to furnish such services on a national holiday or after normal work hours as described below. The following terms have the following meanings: Work hours: VA ACC Monday through Friday, 7 a.m. through 8 p.m.; Non-Work hours: VA ACC Monday through Friday, 8:01 p.m. through 6:59 a.m.; Weekends and holiday. National Holidays: The holidays observed by the VA ACC are: New Year's Day, Martin Luther King's Birthday, Washington's Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, Christmas, or any other day specifically declared by the President of the United States to be a national holiday Upon discovery, the VA ACC Columbus agrees to provide written documents indicating the name of blood component recipients, date of infusion, and other information as required by ARC, and to report particular information regarding patients who may have contracted a disease which may be attributable to a transfusion or to a transfusion-related practice, or to a reaction. The VA ACC Columbus agrees to cooperate with the ARC s investigation of any Adverse Event related to a transfusion of blood products. The VA ACC Columbus agrees to complete and return ARC s Recall of Blood Components Form within two weeks of receipt. The VA ACC Columbus and ARC agree to comply with all Look back Requirements from the Food and Drug Administration and Centers for Medicare and Medicaid Services. 8. INVENTORY MANAGEMENT AND REGULATORY CONTROL The VA ACC Columbus agrees to comply with the regulations of the Center for Biologics Evaluation and Research, Office of Blood Research and Review, of the Food and Drug Administration (21 Code of Federal Regulations), ARC, standards of the Joint Commission and in accordance with the American Association of Blood Banks standards or generally accepted blood banking practice where regulations have not been promulgated. The VA ACC Columbus agrees to report information for effective inventory management and information regarding projected component utilization, ARC agrees to report inventory levels to The VA ACC Columbus. The VA ACC Columbus agrees to batch order blood components to economize the use of ARC transportation services. IDENTIFICATION OF NON-DISCLOSURE REQUIREMENTS Patient medical Records will be available with this contract, a non-disclosure agreement will need to be signed at time of award. PACKAGING, PACKING AND SHIPPING INSTRUCTIONS All blood deliveries under this contract will be delivered to the VA ACC Columbus, 420 North James Road, Columbus, Ohio, and shall be properly packed and insulated in such a way to insure a temperature of 1-10 degrees Celsius during a normal automobile trip between the Contractor s place of business and the Department of Veterans Affairs Ambulatory Care Center is maintained. INSPECTION AND ACCEPTANCE CRITERIA The VA reserves the right to thoroughly inspect and investigate the establishment and facilities and other qualifications and performance of the contractor at any time during the term of this contract. The Laboratory Manager, Pathology and Transfusion Service Lead Technologist shall be responsible for monitoring performance and verifying contract compliance in accordance with the specifications. In the event that VA determines that the contractor is not meeting the requirements, VA may terminate the contract for cause in accordance with the applicable clauses listed in the contract. RISK CONTROL The contractor must be currently registered and/or licensed with the Food and Drug Administration (FDA), Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. Section 260. Prior to award, Contractor must submit proof that he/she holds an unrevoked U.S. Licenses which is issued by the Director, Bureau of Biologics, FDA under Section 351 of the Public Health Service Act, as amended, 42 U.S.C. Section 262, as a source of supply for whole blood. Contractor will provide the VA with 100% volunteer donor blood in accordance with FDA rules and regulations effective May 15, 1978 or later revision. Definition of a Volunteer Donor is as follows: 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 cancellations of non-replacement fees that are not readily convertible to cash, do not constitute monetary payment. Responses to this notice shall be e-mailed to Ronetta Sweeney at contact@example.gov. Please provide your Dun and Bradstreet number and socio-economic status if you are interested in this contract. Telephone responses will not be accepted. Responses must be received in writing no later than 12:00 p.m., Friday, October 28, 2016. This notice is to assist the VA in determining sources only. A solicitation is not currently available. THE VA IS NOT SEEKING PRICING OR OFFERS OF ANY KIND. There is no guarantee, expressed or implicit, that the market research for this acquisition will result in a particular set-aside or sole source award, or any other guarantee of award strategy. All information is to be provided on a voluntary basis at no charge to the Government.