Q508--BLOOD AND BLOOD PRODUCTS AMERICAN RED CROSS RALPH H. JOHNSON VA MEDICAL CENTER CHARLESTON, SOUTH CAROLINA

The Department of Veterans Affairs, VISN 7, intends to award a sole source contract to The American Red Cross, 8085 Rivers Ave Suite D, North Charleston, SC 29406. Requirement is to provide an alternative source for procurement of blood and blood products by Blood Bank, Pathology & Laboratory Medicine Service, Ralph H. Johnson VA Medical Center, Charleston, SC. This is an Indefinite Delivery, Indefinite Quantity (IDIQ) contract with Firm-Fixed Pricing. Contract will include a base period and four (4) additional option years, for a total of five (5) years. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals or a solicitation for offers. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product to Joseph M. Locke, Contracting Officer at contact@example.gov NLT August 20, 2021 at 10am EST. All capability statements received by the closing date of this notification of this synopsis will be considered by the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This acquisition is being conducted under FAR Part 12 commercial procedures. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 621991- Blood and Organ Banks. This is for informational purposes only and not to be considered as a commitment by the Government. Any information submitted to this notice of intent is voluntary. BLOOD AND BLOOD PRODUCTS DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK Contractor Requirements: Contractor must be eligible to enter contracts with the Department of Veterans Affairs and the United States Government. Performance Period: Base Period: October 1, 2021 to May 31, 2022 Option Year 1: June 1, 2022 to May 31, 2023 Option Year 2: June 1, 2023 to May 31, 2024 Option Year 3: June 1, 2024 to May 31, 2025 Scope: TYPE OF CONTRACT An indefinite delivery with indefinite quantity contract with firm-fixed price delivery orders placed against it will be awarded for the solicitation of blood, plasma, cryoprecipitate, platelets, transfusion related reference laboratory testing, and onsite hospital plasmapheresis services. The contractor shall notify the VA 30 days in advance of any price increases due to requirements mandated by state or federal agencies. The contract will be modified to include mandated price increases subject ft availability of funds. Approximation of products/services to be provided annually; ABO/Rh will vary depending on product and needs. 1500 units of Leukoreduced Packed Red Blood Cells(LPRBCs) 375 units of Fresh Frozen Plasma 300 Leukoreduced Plateletpheresis Pathogen Reduced 75 units of Pooled Cryoprecipitate 20 onsite hospital patient plasmapheresis services. 75 blood unit negative antigen typing 400 patient testing services (ABO/Rh, Ab Screen, Ab ID, DAT, phenotype, special processing) 10 blood product irradiation services. 100 STAT processing/non-routine delivery services NOTICE The VA Medical Center Transfusion Service will not receive or store units found reactive for infectious disease testing (See b, ii.) Infectious Disease Testing Blood establishments must test each donation of human blood or blood components intended for allogeneic use or intended for use as a component of a medical device for the following, unless otherwise excluded under 21 CFR 610.40(c): Human Immunodeficiency Virus, types 1 & 2 (anti-HIV and HIV-1 Antigen (HIV-1 Ag)) Hepatitis B Virus (HBsAg and anti-HBc) Hepatitis C Virus (anti-HCV) Human T-Cell Lymphotropic Virus, types I and II (anti-HTLV-I/II) Syphilis [required under 21 CFR 640.5(a)] These testing requirements are also applicable to autologous donations that may be used for allogeneic transfusion. Blood establishments may also test for other infectious agents, for example, antibody to Cytomegalovirus (anti-CMV). A blood establishment must do further testing on each reactive donation using supplemental tests approved for such use unless otherwise excluded under 21 CFR 610.40(e). The blood establishment may do its own testing or may contract part or all of the testing. Only a testing laboratory that registers with FDA and that is certified by the Centers for Medicare and Medicare Services for infectious disease testing may perform testing on blood donations. The laboratory testing must comply with 21 CFR 610.40 (a), (b), (e) and (f). 21 CFR 610.40(c) identifies exceptions to required testing. Testing must be performed using licensed test kits, with the exception of the serological test for syphilis. Although not licensed, the serological test for syphilis must be labeled for use in donor screening. A manufacturer that contracts infectious disease testing must ensure the contract laboratory is registered with FDA. SPECIFICATIONS All blood shall be tested as required by the Food and Drug Administration (FDA) and the American Association of Blood Banks (AABB). All blood shall be collected by the close system under aseptic conditions and shall be stored in currently approved, appropriate solutions and the container shall be correctly labeled. The label shall also bear the expiration date of the contents, not to exceed the established AABB guidelines for: ACD/CPD/CP2D of 21 days, CPDA-1 of 35 days, AS-1/AS-3/AS-5 of 42 days. All blood supplied shall be free of hemolysis, clots, and excessive chyle. Offers shall be considered only from offerors whose blood bank is currently registered and/or licensed with the Food and Drug Adminsitration (FDA), in accordance with the 21 USC Section 360. Prior to award the offeror must submit proof that he holds an unrevoked US license which is issued by the Director, Bureau of Biologics, FDA under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262. If interstate shipment of blood or blood component is involved, the offeror must submit with the offer a statement that such approval has been authorized as indicated under section 42 USC 262. The offeror shall certify that he will comply with the requirements outlined below with respect to donors, containers, delivery, etc. Offers will be considered only from blood banks who are able to provide the VA with 100% volunteer donors blood in accordance with the latest FDA rules and regulations. Definition of 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 cancellations on non-replacement fees that are not readily convertible to cash, do not constitute monetary payment. Donor Requirements: The offeror shall maintain readily available blood donor listing which include names, addresses and social security numbers of the donors; along with the date the donor(s) blood or blood components is furnished to the medical center under this contract. All donor information, including without limitation, information in the donor database, is confidential and proprietary to the contractor. Donor selection shall be in accordance with criteria established by FDA and/or the AABB. The contractor shall make every reasonable effort to confirm consultation results within twenty-four (24) hours of sample shipment. Subject to availability, voluntary blood donations and absence of force majeure events, emergency shipments shall be delivered within two (2) hours. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE Packaging and Marking Blood components shall be labeled in accordance with all FDA requirements, including: kind of component, blood group and type (ABO/Rh), expiration date, unique donor unit identification, and storage and handling. Blood components shall be packaged for shipping and transport to ensure the FDA required temperature ranges are maintained: red cell components(1-10 degrees Celsius), frozen plasma components (below minus 20 degrees Celsius), and platelet components (20-24 degrees Celsius). Invoices Payment: Payment will be monthly, in arrears, upon receipt of a properly prepared invoice. The contractor shall submit invoices to each deliveries address or as shown on individual purchase order. Return Policy: Return of blood products will be in accordance with the contractor s return policy for each region. Credits: Credit will be issued for blood units returned with 14 or more days of shelf life; plateletpheresis will be credited when accepted for transfer by the offeror and the product is utilized. Notification of Product Recalls The Contractor will notify the VA of any possible infectious disease associated with distributed blood products, when subsequent information or suspicion regarding the safety and/or regulatory compliance of distributed blood/blood products becomes available. The VA will notify the Contractor of any possible infectious disease or other serious complication associated with transfusion that may have resulted from any of the blood, including suspected post-transfusion hepatitis, transfusion-associated HIV or HTLV infection, and any other transfusion associated infections (malaria, babesiosis, bacterial contamination or infection) and death. VA will cooperate with the Contractor s investigation of any and all such diseases or complication and supply to the contractor in confidence information concerning the recipient of the blood, to the extent permissible under the laws applicable to patient confidentiality. VA will make available to the contractor information concerning transfusions to include product names, lot identifications and quantities, any therapeutic adverse effects, complaints or other pertinent information relating to the blood. 852.246-73 - Noncompliance with packaging, packing, and/or marking requirements. As prescribed in 846.302 73, insert the following clause: Noncompliance With Packaging, Packing and/or Marking Requirements (JAN 2008) Failure to comply with the packaging, packing and/or marking requirements indicated herein, or incorporated herein by reference, may result in rejection of the merchandise and request for replacement or repackaging, repacking, and/or marking. The Government reserves the right, without obtaining authority from the contractor, to perform the required repackaging, repacking, and/or marking services and charge the contractor at the actual cost to the Government for the same or have the required repackaging, repacking, and/or marking services performed commercially under Government order and charge the contractor at the invoice rate. In connection with any discount offered, time will be computed from the date of completion of such repackaging, repacking and/or marking services. (End of clause) 852.246-71 - Inspection. Alternate I (JAN 2008). As provided in 846.302 71(b), insert the following clause: Inspection (JAN 2008) The contractor shall remove rejected supplies within 48 hours after notice of rejection. Supplies determined to be unfit for human consumption will not be removed without permission of the local health authorities. Supplies not removed within the allowed time may be destroyed. The Department of Veterans Affairs will not be responsible for nor pay for products rejected. The contractor will be liable for costs incident to examination of rejected products. (End of clause) 852.270-1 - Representatives of contracting officers. As prescribed in 801.603 70(d), insert the following provision: Representatives of Contracting Officers (JAN 2008) The contracting officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee's authority. A copy of the designation shall be furnished to the contractor. (End of provision) 52.247-35 - F.o.b. Destination, Within Consignee s Premises. (a) The term f.o.b. destination, within consignee s premises, as used in this clause, means free of expense to the Government delivered and laid down within the doors of the consignee s premises, including delivery to specific rooms within a building if so specified. (b) The Contractor shall (1)(i) Pack and mark the shipment to comply with contract specifications; or (ii) In the absence of specifications, prepare the shipment in conformance with carrier requirements; (2) Prepare and distribute commercial bills of lading; (3) Deliver the shipment in good order and condition to the point of delivery specified in the contract; (4) Be responsible for any loss of and/or damage to the goods occurring before receipt of the shipment by the consignee at the delivery point specified in the contract; (5) Furnish a delivery schedule and designate the mode of delivering carrier; and (6) Pay and bear all charges to the specified point of delivery. (End of clause) Quality Oversight and Monitoring: The COTR for Pathology and Laboratory Service, in consultation with the Blood Bank Technical Specialist and Laboratory Manager, will be responsible for oversight of quality and performance of this contract. Contractor Security Requirements 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. c. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 3. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). b. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. c. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. d. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. e. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. f. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. g. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. h. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. i. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. 4. SECURITY INCIDENT INVESTIGATION a. The term security incident means an event that has, or could have, 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 COTR 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. b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify 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. c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 5. LIQUIDATED DAMAGES FOR DATA BREACH a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 6. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day s notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. 7. TRAINING a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. RECORDS MANAGEMENT OBLIGATIONS A. - Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists. - B. - Definitions Federal Record as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. - The term Federal record: 1. includes [Agency] records. 2. does not include personal materials. 3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract. 4. may include deliverables and documentation associated with deliverables. C. - Requirements 1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. 3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. 4. RHJ VAMC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of RHJ VAMC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to RHJ VAMC. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to RHJ VAMC control or the Contractor must hold it until otherwise directed. Ite...