Sources Sought Notice Contracting Office Address Health Resources and Services Administration (HRSA) Office of Acquisition Management and Policy 5600 Fishers Lane Rockville, MD 20857 Description The purpose of this Amendment is to extend the date for responses to this notice to not later than 10:00 AM Eastern Time on August 9, 2021 for consideration. Please submit responses via e-mail. This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small and large entities, including private nonprofit entities, to provide any or all of the functions as stated in the Stem Cell Therapeutic and Research Act. Functions include bone marrow functions, cord blood functions, Single Point of Access, Patient Advocacy and Case Management, and maintaining a Stem Cell Therapeutic Outcomes Database. Full functions authorized under the act can be found via web search. The Division of Transplantation (Program), Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA) is seeking a contractor or multiple contractors to fulfill the requirements of the following functions. Offerors can choose to respond to an individual function or more than one function. Stem Cell Therapeutic Outcomes Database (SCTOD) function Background The SCTOD is authorized by sec. 379A of the Public Health Service Act (Act) [42 U.S.C. 274l], as amended. The Act stipulates that the U.S. Department of Health and Human Secretary, through the Health Resources and Services Administration (HRSA), C.W. Bill Young Cell Transplantation Program (CWBYCTP) shall by contract establish and maintain a scientific database of information relating to patients who have been recipients of a stem cell therapeutics product (including bone marrow, cord blood, or other such product) from a donor. It also stipulates that the Secretary shall require the entity awarded a contract under this section to submit to the Secretary an annual report concerning patient outcomes with respect to each transplant center. Project Requirements For the SCTOD function, the contractor will be required to do the following: Collect data, using a standardized electronic system, on the outcomes of all recipients of allogeneic (related and unrelated) transplants for hematopoietic reconstitution (including multiple unit cord blood transplants), regardless of the source of funding for the transplant or the collection, processing, storage, or procurement of the stem cell product. Create Standard Analysis Files (without any individually identifiable information) that includes analyzable SCTOD data set with calculated analytical variables. Provide a repository that stores donor and recipient samples for research and for the collection and analysis of data on clinical outcomes of hematopoietic stem cell transplant (HSCT) recipients and of blood stem cell products. Provide statistical and other analytic support to the CWBYCTP on a broad range of issues, including in the preparation of recurring and special reports to Congress and the Advisory Council on Blood Stem Cell Transplantation, and the development of Office of Management and Budget clearance packages. Disseminate data sets and summaries to the public and organization-specific data to the organizations participating in the CWBYCTP. Prepare and submit an annual report on patient outcomes at each transplant center, and make scientific information available to the public. Collaborate with contractor(s) selected to carry out other functions (i.e., bone marrow, cord blood, Office of Patient Advocacy, single point of access) for the C.W. Bill Young Cell Transplantation Program. Assess the impact of proposed policies in an effort to ensure that such policies do not conflict with other policies established for other components of the CWBYCTP and, in the case of National Cord Blood Inventory (NCBI) cord blood units (CBUs), with HRSA requirements for such CBUs. Collaborate with existing stem cell database organizations, transplant centers, the suppliers of stem cell products, and other transplant and research registries to collect and maintain the necessary data. Capability Statements In response to the SCTOD function, capability statements must address the following: Describe your knowledge of the respective roles of HHS, CWBYCTP, SCTOD, and organizations that facilitate HSCT transplants, and demonstrate how your organization is able to collaborate with and support other CWBYCTP and National Cord Blood Inventory contractors. Describe your electronic system for collecting and sharing data and the process used to carry out system security controls and system validations. Describe your knowledge and experience creating and maintaining a large database in a health care environment with the capability of conducting analysis using complex algorithms including performing risk- adjusted survival analysis. Describe how your work can improve clinical practices regarding the utilization of cord blood and adult blood stem cells. Describe your knowledge and experience receiving and disseminating data and datasets to and from multiple organizations (including experience in establishing and maintaining the necessary relationships to ensure these data are obtained). Describe your qualified available personnel with a range of clinical expertise to meet the requirements of directing the project and supporting HSCT research-focused committees, as well as qualified personnel with at least master level degree in statistics or related quantitative research fields. Describe your ability to adapt to the rapid scientific changes in HSCT and other arising challenges such as COVID-19. Office of Patient Advocacy (OPA) function: Background The OPA is authorized by sec. 379 of the Public Health Service Act (Act) [42 U.S.C. 274k], as amended. The Act stipulates that the U.S. Department of Health and Human Services Secretary, through the Health Resources and Services Administration (HRSA), C.W. Bill Young Cell Transplantation Program (CWBYCTP) shall by contract establish and maintain an Office of Patient Advocacy, which shall be staffed with a director and individuals with expertise in cord blood and bone marrow therapy covered under the CWBYCTP. The OPA shall also serve as an advocate for the patient; provide individualized case management services to the patient (or family members, physicians, or other individuals acting on behalf of the patient); assist the patient in efficiently utilizing the system to search for a bone marrow donor or cord blood unit; and assist with information regarding third party payer matters. The OPA shall ensure that data are made available to patients and shall conduct surveys to determine the extent of satisfaction with the OPA and identify ways to improve it. Project Requirements For the OPA function, the contractor will be required to do the following: Establish and maintain a system for patient advocacy and case management, which shall serve patients (or family members, physicians, or other individuals acting on the patient’s behalf), searching for a bone marrow donor or CBU through the CWBYCTP. Head the OPA with a director and staff with individuals with expertise in cord blood and therapy bone marrow (including a physician with experience in cord blood transplantation) covered under the CWBYCTP. Provide histocompatibility/search expertise and guidance for patients and physicians searching for a bone marrow donor or CBU. Monitor the patient’s search process to determine the extent to which the patient’s needs are being met and resolve any problems in the search process, to the extent practicable. Make hematopoietic stem cell transplantation (HSCT) information and education available to patients, families, health care professionals, and to the public. This information and education should include the following: pre-transplant, transplant and post-transplant processes (diagnosis through survivorship); third party payer matters; and all treatment options (e.g., unrelated blood stem cell transplants, related blood stem cell transplants; haplo-identical transplants, cord blood transplants, other types of cellular therapy and clinical trials (clinicaltrials.gov). Provide maintenance of the CWBYCTP website. Collaborate with individuals within the blood stem cell community, including recipients of a CBU or bone marrow transplant, individuals who require a CBU or bone marrow transplant, family members of such persons, persons with expertise in cord blood and bone marrow therapy (including a physician with experience in cord blood transplantation) covered under the CWBYCTP, transplant physicians, cord blood banks, donor registries, persons with expertise in diversity and inclusion, and persons with expertise in outreach and other stakeholders. Assess the impact of proposed policies in an effort to ensure that such policies do not conflict with other policies established for other components of the CWBYCTP and, in the case of NCBI CBUs, with HRSA requirements for such CBUs. Capability Statements In response to the OPA function, capability statements must address the following: Describe your knowledge of the respective roles of HHS, CWBYCTP, OPA, and organizations that facilitate HSCT transplants, and demonstrate how your organization is able to collaborate with and support other CWBYCTP and National Cord Blood Inventory contractors. Describe your experience examining patient searches and providing access to timely information regarding viable treatment using various blood stem cell products. Describe your organization’s experience with conducting patient advocacy, conducting outreach and collaborating with HSCT stakeholders. Describe your organization’s experience with providing case management and patient services, including increasing access to HSCT and providing patient support before, during, and after HSCT. Describe your organization’s experience with data dissemination, including making data publicly available to the public. Describe your organization’s experience with developing and maintaining automated search systems and your organization’s experience with complying with patients’ privacy and information security guidelines. Describe your organization’s efforts in increasing access and reducing barriers (e.g., educational, financial, etc.) to HSCT. Describe your experience developing relationships and collaborating with stakeholders to address patient services, diversity and inclusion, and patient safety. Describe your ability to adapt to the rapid scientific changes in HSCT and arising challenges such as COVID-19. Single Point of Access-Coordinating Center function (SPA-CC): Background The SPA-CC function is comprised of three legislative functions: Bone Marrow Coordinating Center function, the Cord Blood Coordinating Center function, and Single Point of Access function. The SPA-CC is authorized by sec. 379 of the Public Health Service Act (Act) [42 U.S.C. 274k], as amended. This Act stipulates that the U.S. Department of Health and Human Services Secretary, through the Health Resources and Services Administration (HRSA), C.W. Bill Young Cell Transplantation Program (CWBYCTP) shall by contract operate a system for searching, identifying, matching, and facilitating the distribution of bone marrow and donated CBUs suitably matched to a patient. The Act also requires the allowance of health care professionals and physicians searching on behalf of patients to search electronically for cells (and reserve those cells) derived from volunteer adult marrow donors and CBUs through a single point of access. Project Requirements For the SPA-CC function, the contractor will be required to do the following: Establish a system for identifying, ranking, matching, and facilitating the distribution of donated CBUs and adult bone marrow that are suitably matched to candidate patients who need a potentially lifesaving bone marrow or cord blood transplant. Carry out informational and educational activities for the recruitment of volunteer adult bone marrow donors and mothers of donors of CBUs, giving priority to increasing underrepresented donor populations. Provide a mechanism to receive and display information on tissue typing and infectious disease marker testing of adult volunteer donors and CBUs. Facilitate the collection, verification, and analyses of human leukocyte antigen (HLA) data from unrelated bone marrow and CBUs and ensure such information is adequately displayed for searches by physicians and other healthcare professionals working on behalf of patients. Support and expand new and existing studies and demonstration and outreach projects for the purpose of increasing bone marrow and CBU donation and collection. Provide information to physicians, other health care professionals, and the public regarding bone marrow and cord blood transplants from donors as a treatment option. Assess the impact of proposed policies in an effort to ensure that such policies do not conflict with other policies established for other components of the CWBYCTP. Certify that National Cord Blood Inventory (NCBI) CBUs meet eligibility criteria for listing on the donor registry. Establish a mechanism to ensure volunteer adult bone marrow donors are consented, using an HRSA- approved consent form, to join the CWBYCTP donor registry. Capability Statements In response to the SPA-CC function, capability statements must address the following: Describe your knowledge of the respective roles of HHS, CWBYCTP, SPA-CC, and organizations that support and facilitate blood stem cell transplants. Demonstrate how your organization is able to collaborate with and support other CWBYCTP and National Cord Blood Inventory contractors to facilitate blood stem cell transplants. Describe your organization’s experience with operating and maintaining an electronic system for identifying, matching, and facilitating the distribution of hematopoietic stem cell products. Describe your organization’s experience with operating and maintaining an electronic system that allows health care professionals and physicians, working on behalf of patients, to search electronically, through a single point of access, for cells derived from volunteer adult marrow donors and cord blood units. Demonstrate your organization’s experience with establishing and coordinating a network of organizations (e.g., donor registries, cord blood centers, apheresis centers, coordinating centers, donor centers, transplant centers, etc.), including international organizations, to facilitate blood stem cell transplants. Demonstrate your experience with receiving information from various organizations (e.g., donor registries, cord blood centers, apheresis centers, coordinating centers, donor centers, transplant centers, etc.) to facilitate access to blood stem cell sources that will be used for transplantation. Describe your organization’s experience with adult volunteer bone marrow donor recruitment and retention. This includes increasing access and reducing barriers (e.g., educational, lost wages, etc.) to volunteer donors providing blood stem cells for transplantation. Describe your ability to work with cord blood banks to recruit and consent donor mothers of umbilical CBUs. This includes increasing access and reducing barriers (e.g., educational, language, etc.) for expectant mothers to donate umbilical CBUs. Describe your experience developing relationships and collaborating with stakeholders to address volunteer adult donor advocacy services. Describe whether your organization has physicians with clinical experience in bone marrow transplantation. Describe whether your organization has physicians with clinical experience in cord blood transplantation. Describe your ability to adapt to the rapid scientific changes in HSCT and arising challenges such as COVID-19. Interested contractors may select and choose any of the functions that they intend to submit a proposal for in the future. Interested contractors may select one, some, or all of the functions. If multiple functions are selected, then the interested contractor must address any potential organization conflict interest (OCI) in its response. For the Stem Cell Therapeutic Outcomes Database function, the NAICS code is 541990 and the PSC code is B506. For the Office of Patient Advocacy function, the NAICS code is 541611 and the PSC code is R408. For the Single Point of Access function, the NAICS code is 541611 and the PSC code is R408. Interested potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents’ capacity and capability to perform the specific work as required. Responses must directly demonstrate the company’s capability, experience, and/or ability to marshal resources to effectively and efficiently perform each of the tasks described above at a sufficient level of detail to allow definitive assessment and evidence that the contractor can satisfy the requirements. Failure to provide sufficient information related to these functions will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 25 pages, and must include: Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. Capability statements and experiences related to performing similar functions. Must demonstrate past work experience that is on a national level. Must indicate which of the functions the contractor is interested in and the potential OCI of performing the functions. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the System for Award Management (SAM) database (http://www.sam.gov) in order to be considered as potential sources. If the company has a Government approved accounting or purchase system, please identify the agency that approved the systems. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the services contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received by the Contract Specialist named below not later than 10:00 AM Eastern Time on August 2, 2021 for consideration. Please submit responses via e-mail. Responses to this announcement will not be returned, and there will not be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and HRSA may contact one or more respondents for clarifications or for information that will enhance the Government’s understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. POINTS OF CONTACT: Primary Point of Contact: Secondary Point of Contact: Veronica Dhaness Shirley Karver Contract Specialist Director/Contracting Officer E-mail:
[email protected] E-mail:
[email protected] Phone: (301) 443-5131 Phone: (301) 443-0136 PLACE OF PERFORMANCE United States of America