Q301--Storage of cryopreserved cellular products

THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The purpose of this Sources Sought Notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. The responses received from interested contractors will assist the Government in determining the appropriate acquisition method. The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 20, is conducting market research to identify potential sources which can provide the following in support of the VA Puget Sound Health Care System (VAPSHCS): VAPSHCS has a need for storage of cryopreserved cellular products for individual patients. Statement of Work (SOW): Fred Hutch Cancer Center (FHCC) Cellular Therapy Laboratory (CTL) Hematopoietic Stem Cell Transplant (HSCT)/Cellular Products Cryopreservation and Storage Service. Background Hematopoietic stem cell transplantation (HSCT) is the process by which hematopoietic stem cells (HSCs)/cellular products are propagated and collected from a donor, stored, and reinfused into a recipient as a method to treat hematological malignancies (i.e., blood cancers). The VA Puget Sound Health Care System Seattle Division, provides hematopoietic stem cell transplantation services to Veterans and is one of only two VA HSCT centers in the United States and accept referrals from all VA facilities. There are two types of HSCTs performed at VA Puget Sound, autologous (self) and allogeneic (non-self; donated by a relative or unrelated donor). Since its inception in the 1980 s, the VA Puget Sound Marrow Transplant Program has been utilizing the FHCC to provide services for collection of stem cells (i.e., apheresis), laboratory processing and testing, and cryopreservation & storage at CTL. The VA Puget Sound Marrow Transplant Program currently does not have the laboratory resources nor equipment, expertise, or personnel, to collect, process, and store HSCs/cellular products for short- or long-term storage and use for transplantation. The Fred Hutch Cancer Center (FHCC) and Cellular Therapy Laboratory is a laboratory who provides Hematopoietic Stem Cell (HSC)/cellular product cryopreservation and storage services. Cryopreserved hematopoietic stem cells/cellular products are collected and assigned to a unique individual, and are required to be stored indefinitely, once collected to be available for potential future use for that individuals hematopoietic stem cell transplant(s) (HSCT s). These HSCs/cellular products in short- or long-term storage will be destroyed upon the assigned individuals death. Description of Work This statement of work will address a specific portion of the HSCT process for VA Puget Sound Health Care System Seattle Division. We will be addressing specifically the FHCC CTL HSCs/cellular products cryopreservation annual storage fee per individual patient. The remainder of the HSCT process for HSCs collection (apheresis) and laboratory testing & processing is currently covered and paid for under the VA Community Care Program Authorization (Triwest). The VA Community Care Program has determined that the HSCs/cellular products cryopreservation annual storage fee is not a valid use of the program funds and are not billable under an appropriate CPT code as it is not a patient care service. Therefore, these annual storage costs will need to be the obligation of the VA Puget Sound Health Care System Seattle Division under a unique contract for FHCC CTL services. The cryopreservation of HSCs/cellular products is important for all types of transplants and has become a standard care procedure. In some situations, fresh stem cells can be employed in the setting of autologous or allogeneic transplants, but cryopreservation became employed more frequently following the COVID-19 pandemic. For any transplant recipient, if there is a portion of HSCs/cellular products that will not be transplanted/infused into the assigned individual, the remainder of the HSCs/cellular products will be cryopreserved and stored indefinitely for the assigned individual for potential future use for that individuals hematopoietic stem cell transplant(s) (HSCT s). These HSCs/cellular products in short- or long-term storage will be destroyed upon the assigned individuals death. The cryopreservation process includes the following general components: Harvesting of the donor cells, which entails the actual collection of the HSCs and the reduction of bulk. Addition of cryopreservatives to the donor cells. The actual freezing procedure. Assessment of the viability of the frozen unit after about 72 hr. The thawing procedure. The washing and conditioning of the donor unit prior to transplant. HSCs/cellular products must have a cryopreservative added to it to protect the cells from freezing damage. Dimethyl sulfoxide (DMSO) at a concentration of 5-10% with normal saline and serum albumin is used as the cryopreservative. HSCs/cellular products are initially frozen at -4°C for up to 72 hours, and then frozen down to a target temperature of either -80°C, or -156°C (when stored in vapor nitrogen phase), or -196°C (when stored in liquid nitrogen phase) or in mechanical freezers. Prior to the actual HSCT, the sample is rapidly thawed in a 37°C water bath. Timetable and Deliverables VA Puget Sound averages about 60-80 new HSCTs per year, and as of May 25, 2023 we currently have 284 Veterans HSCs/cellular products cryopreserved and in storage at FHCC CTL. In addition, about 5-10 HSCs/cellular products are removed from storage each year due to usage or Veteran death. Quarterly, during the fiscal year, FHCC CTL will provide to the VA Puget Sound Marrow Transplant Program a report listing the Veterans with HSCs/cellular products that need renewal of annual storage. This report will be reviewed and updated by the Marrow Transplant Program Administrative staff, and a notation will be made to document confirmation of continued storage or termination of storage, for each Veteran on the report. The report will be returned to FHCC CTL, who will generate invoices by Veteran for the annual cryopreservation storage fee (storage is for one year (i.e., 365days) from the date the HSCs/cellular products were put into storage or the date of the last renewal of the annual storage period) and these invoices will be provided to VA Puget Sound Health Care System Seattle Division for payment. Quarterly this report and invoices will be audited to ensure proper invoicing has been received and payment completed. If there are any discrepancies discovered or delinquencies of payment, these will be addressed and resolved within an appropriate timeframe. Privacy and Information Security Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS 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. VAINFORMATION CUSTODIAL LANGUAGE 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). VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. 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. 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. 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. 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. 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. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. 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. 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. SECURITY INCIDENT INVESTIGATION 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. LIQUIDATED DAMAGES FOR 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: Nature of the event (loss, theft, unauthorized access); Description of the event, including: date of occurrence; data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected; 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; Amount of time the data has been out of VA control; The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); Known misuses of data containing sensitive personal information, if any; Assessment of the potential harm to the affected individuals; Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and 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: Notification; One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. SECURITY CONTROLS COMPLIANCE TESTING On aperiodic 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. Potential candidates having the capabilities necessary to provide the above stated supplies at a fair and reasonable price are invited to respond to this Sources Sought Notice via e-mail to Nazanin Kreiner at contact@example.gov no later than December 11, 2023, 5:00PM MDT. No telephone inquiries will be accepted. RESPONSES SHOULD INCLUDE THE FOLLOWING INFORMATION: Company name, address, SAM UEI and business size; point of contact name, phone number, and e-mail address; whether services are presently offered on a current GSA Federal Supply Schedule contract. NAICS Code 541380 Size Standard: $19 Million is applicable to determine business size standard. Any questions or concerns may also be directed via email to Nazanin Kreiner at contact@example.gov. Disclaimer and Important Notes: This Sources Sought Notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. The Government will treat any information received as proprietary and will not share such information with other companies. Any organization responding to this Sources Sought Notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government may or may not issue a solicitation as a result of this announcement. There is no solicitation available at this time.