H265--Blood and Organ Banks

This Sources Sought Notice is for planning and market research purposes only. Response(s) to this Sources Sought Notice will be treated as information only. A solicitation does not exist at this time. The Department of Veterans Affairs (VA) Veteran Health Administration (VHA) Network Contracting Office 7 (NCO7) is conducting market research to determine industry capabilities to provide multi-disciplined services to support the Columbia VA Healthcare System which encompasses the Atlanta VA Health Care System (ATLVAHCS) and its surrounding Community-Based Outpatient Clinics (CBOCs). The contractor shall be responsible for providing Atlanta VA Health Care System (ATLVAHCS) and its surrounding Community-Based Outpatient Clinics (CBOCs) program management support as well as technical and reporting deliverables to help ensure VHA projects are accomplished efficiently and effectively for pre-execution/feasibility support. Specific expertise needed include but are not limited to: 1. GENERAL: The Contractor shall provide the Transfusion Service of the Charlie Norwood VA Medical Center, Augusta, Georgia, Homologous Blood and Blood Products and Autologous Red Blood Cells in accordance with the pricing, terms and conditions contained herein for the base period of October 1, 2022 through September 30, 2023 with four option years. Red Blood Cells (LR, IRR) approximately 400 Units Cryoprecipitate- approximately 10 units Platelet Pheresis (LR, IRR) approximately 40 units Plasma Frozen- approximately 60 units Autologous- approximately 4 each HLA Platelets- approximately 5 each Platelet Pheresis Cross Match- approximately 5 each Stat Fee- approximately 25 each Autologous Fee- approximately 4 each Misc. Blood products otherwise not previously listed, as needed for patient treatment- 50 each 2. BACKGROUND: Charlie Norwood VA Medical Center (CNVAMC) in Augusta, Georgia must maintain an inventory of blood products and components that will sustain the transfusion needs of all patients within the facility. It is the mission of the Transfusion Medicine Service to provide cellular hemotherapy treatment for urgent care, surgical care, and medical care to patients in maintaining their homeostasis levels with a positive outcome. 3. PERIOD OF PERFORMANCE: Base plus four option years. PERIOD DATES Base Year October 1, 2022 September 30, 2023 Option One (1) October1, 2023 September 30, 2024 Option Two (2) October 1, 2024 September 30, 2025 Option Three (3) October 1, 2025 September 30, 2026 Option Four (4) October 1, 2026 September 30, 2027 4. PLACE OF PERFORMANCE: Charlie Norwood VA Medical Center, Pathology and Laboratory Medicine Service, Augusta, Georgia. 5. HOURS OF OPERATION: The normal business hours are 8:00a.m. to 4:30p.m. 6. PERFORMANCE REQUIREMENTS: A. Contractors responsibilities: A. Quality of the Product 1. All blood and blood components provided to patients in the VA medical center must meet the requirements of the American Association of Blood Banks (AABB) and/or the Food and Drug Administration (FDA), Department of Health and Human Services. 2. Allogeneic blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies and must be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB. a. All blood must be collected by the closed system under aseptic conditions, processed in appropriate solutions and the container so labeled. The label must also bear the expiration date of the contents, which must not exceed the Food and Drug Administration (FDA) allowable limit for the type of anticoagulant in which the blood component is drawn. b. All blood supplied must be free of hemolysis, clots, and excessive chyle. c. All blood supplied must have at least 3 segments attached to the RBC unit at the time of delivery. 3. Autologous blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies and must be tested for all transfusion transmitted disease markers currently required by the FDA. 4. The Contractor shall supply 100% volunteer donor blood as defined in 21CFR606.121(c)(5)(ii). All blood/blood components must be collected from donors in accordance with the requirements of the AABB and the FDA. 5. In the event of a recall or market withdrawal, the Contractor shall promptly send copies of the recall or market withdrawal request to the Blood Bank Medical Director at the VA medical center where the blood product was issued. 6. The Contractor awarded to this contract shall be the primary source for blood and blood components to maintain maximum stock inventories, rare donor requests, and the secondary source to complete urgent requests and autologous donor blood. The Facilities shall obtain blood and blood components from a provider other than the awarded Contractor when: (i) There is an emergent circumstance (as defined in the Facilities reasonable discretion, with an explanation to be provided to the Contractor if requested); or (ii) There is a Force Majeure Event (as provided herein); or (iii) The Contractor is unable to provide blood or blood components within a reasonable time of an order being placed; or (iv) The Contractor refuses to provide blood or blood components; or (v) At the request or direction of a patient or a patient s physician, the facility is directed to use autologous blood or homologous blood and type specific components which is available through a provider other than the awarded contractor B. Changes in Testing Requirements for Transfusion Transmitted Diseases In the event that additional testing for transfusion transmitted diseases is nationally mandated by the FDA during the contract period, specific price adjustments may be requested by the supplier to address the cost for the additional testing. In the event that this should occur, a letter detailing the rationale for the price increase must be submitted to the Contracting Officer at least 30 days before the intended implementation date. C. Donor Requirements 1. Offeror s donor identification numbers must be unique to the donor unit and must have a FDA-approved numbering schematic. 2. Donor selection must be in accordance with criteria established by the FDA and/or the AABB. 3. Each unit of blood collected through voluntary donation must minimally be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB. 4. Each platelet component must be tested for bacterial contamination (sterility) in accordance with current AABB standards. 5. Donors who have a positive antibody screen or positive direct antiglobulin test will not be accepted for transfusion of their red blood cells. The Unit will be returned to the contractor for credit and a replacement unit will be requested. 6. Red Blood Cells with less than 14 days and Frozen plasma and Cryoprecipitate with less than six months of viability/expiration will be credited if not transfused due to the component s shortened shelf life unless it has been agreed upon by the VA transfusion service supervisor to accept them. B. Supplies: Orders/Deliveries Contractor is to deliver all Routine and Stat orders accordingly as follows: -Routine shipments of blood products are to arrive on the same day before 2 pm for orders entered electronically before 10 AM. After 10 AM, all orders entered electronically are to be shipped within six hours. All autologous shipments are to arrive before 2 PM the day preceding the patient s surgery date. -Stat shipments of blood products are to arrive within 90 minutes of the time that the online order was placed. The Contractor must contact the Blood Bank Technologist or Supervisor by phone when the orders will not arrive on time or when the products are unavailable. c. The Contractor shall make delivery services for blood and blood components available 24 hours per day, seven days a week, 365 days a year, subject to blood product availability and a lack of force majeure events as set forth in 48CFR52.212-4(f). d. Routinely ordered products will include but not be limited to Leukoreduced, irradiated, or antigen negative red blood cells, frozen plasma, platelet pheresis, irradiated platelet pheresis, autologous red blood cells, cryoprecipitate (cryo) and specialized products including crossmatched platelet pheresis, HLA platelet pheresis, and rare donor typed units. C. VA responsibilities: a. Blood Bank Technologist will be subject to and comply with all requirements and regulations associated with the recall and withdrawal of blood and blood components from its inventory due to health and safety risks. b. Blood Bank Technologist will assist the contractor and other facilities in meeting patient transfusion needs by transferring blood products from the VA inventory to the contractor and receiving credit for each product transferred. c. Charlie Norwood VA Transfusion Service personnel are the only authorized staff to place orders and receive shipments from the Contractor. 6. CONTRACT PERFORMANCE MONITORING: The government reserves the right to monitor services in accordance with Performance Based Matrix. Performance Indicators PWS Ref Performance Measure Acceptable Level of Quality Method of Assessment Incentive Dis-incentive Delivers all supplies timely and in accordance with delivery schedule Para 6(B) Timeliness 95% Direct Observation and Periodic Inspection/audit Positive Past Performance ____ Integrity of Products delivered to Medical center. Para 6 (A,B,C) Quality 100% Direct Observation and Periodic Inspection Positive Past Performance ____ Delivers quantity of Products requested Para 6(B)(b) Quantity 95% Direct Observation and Periodic Inspection Positive Past Performance _____ Submit accurate and timely (within 30 days of delivery) invoices Para 7 Accuracy 95% Review of invoices in OB10/ Audit of all invoices submitted Positive Past Performance _____ 7. INVOICES: a. Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor, clerk reviewed and approved by the Contracting Officer s Representative (COR) for certification by designated VA official, and submitted electronically through OB-10 to the VA central accounting office. b. A properly prepared invoice will contain: Invoice Number and Date Contractor s Name and Address Accurate/Current Purchase Order Number Description of Blood products or Services Date products or services were completed Total amount due c. Contractor shall submit all pending invoices to OB-10 (IPPS) within 30 days after the expiration of the contract. The Government intends to close out this contract/Purchase Order within 45 days after the expiration of the contract. Late invoices are not acceptable and may not be paid. All discrepancies are encouraged to be resolved within 45 days of the expiration of the contract in order to close out all obligations. Notifications of discrepancies will be completed by written documentation from the COR. 8. 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. PER REVIEW OF VA HANDBOOK 6500.6, CONTRACT SECURITY, APPENDIX A- INFORMATION SECURITY AND PRIVACY CHECKLIST: The C&A requirements do not apply, and a Security Accreditation Package is not required. Acquisition of this service does not involve the storage, generating, transmitting, or exchanging of VA sensitive information to the vendor There may exist exposure to VA sensitive information, in particular to sensitive personal information (SPI) while implementing contractual services Minimum Statutory Requirements Prohibition on unauthorized disclosure: 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). See VA Handbook 6500.6, Appendix C, paragraph 3.a. Requirement for data breach notification: Upon discovery 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, the contractor/subcontractor shall immediately and simultaneously notify the COR, the designated ISO, and Privacy Officer for the contract. 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. See VA Handbook 6500.6, Appendix C, paragraph 6.a Requirement to pay liquidated damages in the event of a data breach: 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. 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. 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. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual 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 (see VA handbook 6500.6, appendix c, paragraph 7.a, 7.d) 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. (END of PWS) The planned procurement is a base plus four contract which will be procured under FAR Part 13 Simplified Acquisition Procedures. The primary North American Industrial Classification System (NAICS) code applicable is 621991 Blood and Organ Banks which has a size standard of $35 million dollars. The information received will be used by Veterans Health Administration contracting office to facilitate the decision-making process. This Sources Sought Notice is one facet in the Governments overall market research in regard to whether the proposed solicitation will be issued as a competitive set-aside or as full and open (unrestricted). The procurement strategy will not be determined based solely on the information received in response to this Sources Sought Synopsis. No reimbursement will be made for any costs associated with providing information in response to this announcement or any follow-up information requests. This notice does not constitute a Request for Proposal and is not to be construed as a commitment by the Government for any purpose other than market research. Respondents will not be notified of the results of this market research. Interested parties are advised that in accordance with the Veterans First Contracting program under 38 U.S.C. 8127-8128, as implemented under VA Acquisition Regulation (VAAR) subpart 819.70 and VA Procurement Policy Memorandum 2016-05 Implementation of the Veterans First Contracting Program, if the Contracting Officer has a reasonable expectation that two or more small business concerns owned and controlled by Service-disabled veteran-owned small business (SDVOSB) concerns will submit responses to the solicitation and that award can be made at a fair and reasonable price that offers the best value to the United States, the requirement will be set-aside for SDVOSB concerns. If an SDVOSB set-aside is not appropriate, the requirement will be evaluated to determine whether a Veteran Owned Small Business (VOSB) set-aside is appropriate. The term SDVOSB / VOSB under the Veterans First Contracting program has the same meaning as defined in FAR subpart 2.101, except for acquisitions authorized by 38 U.S.C. 8127 and 8128 for the Veterans First Contracting Program SDVOSB and VOSB concerns must be listed as verified in the Vendor Information Pages (VIP) database at https://www.vip.vetbiz.gov in addition to meeting the NAICS code small business size standard to be eligible for award under Veterans First Contracting Program set-asides. Interested sources are invited to respond to this sources sought notice in writing by providing a capabilities statement which reflects the interested source s ability to provide the services listed, relevant prior/current experience providing the same/similar service and DUNS number. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements. At minimum submission of capability statement strongly encouraged. Respond to this Sources Sought Notice by July 5, 2022 at 2:00 pm EST. All responses under this Sources Sought Notice must be emailed to contact@example.gov.