Attach A - PWS (SPA-CC) - 6.13.22 - Amend0001.pdf

SPA-CC

Attach A – PWS (SPA-CC) – 6.13.22

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Attachment A

Performance Work Statement (PWS)

Single Point of Access-Coordinating Center

(SPA-CC)

June 13, 2022

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Table of Contents

I. BACKGROUND

II. GENERAL DESCRIPTION

III. PERIOD OF PERFORMANCE

IV. TASKS

Task 1 – Fulfill Contract Administration Requirements

Task 2 – Coordinate Transplantation Network

Task 3 – Facilitate Searches for CBU and Adult Bone Marrow Donors

Task 4 – Facilitate and Enhance Cord Blood Expansion and Utilization

Task 5 – Facilitate Adult Donor Recruitment and Retention Activities

Task 6 – Provide Adult Volunteer Donor Advocacy and Cord Blood Donor Support

Task 7 – Provide Support to and in Collaboration with HRSA

Task 8 – Submit Reports

Optional Tasks that may be exercised up to 5 times

V. HHS Policy for Information Technology Procurements - Security and Privacy Language

A. Procurements Requiring Information Security and/or Physical Access Security

B. Requirements for Procurements Involving Privacy Act Records

C. Procurements Involving Government Information Processed on GOCO or COCO Systems

D. Contracts Involving Cloud Services

E. Other IT Procurements

Appendix A .......................................................................... Error! Bookmark not defined.

VI. SCHEDULE OF DELIVERABLES

VII. PAYMENT SCHEDULE

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Performance Work Statement (PWS) June 2, 2022

Single Point of Access-Coordinating Center (SPA-CC)

I. BACKGROUND

In 1987, the National Bone Marrow Donor Registry (NBMDR) was initiated through a congressionally directed grant from the United States (U.S.) Department of the Navy and formally established in 1990 as a responsibility of the U.S. Department of Health and Human Services (HHS). The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute initially provided oversight, but, the Health Resources and Services Administration (HRSA) has provided oversight since 1994. The activities of the NBMDR included increasing the number of transplants for recipients suitably matched to biologically unrelated donors of cord blood and adult volunteer donors of bone marrow. Activities also included ensuring health care professionals and patients were able to search electronically for cells from bone marrow donors and cord blood units (CBUs) through a single point of access. Additional activities involved providing patient advocacy and case management support from diagnosis through survivorship, and collecting stem cell transplant outcomes data in a standardized, electronic format.

In 2005, the Stem Cell Therapeutic and Research Act (Public Law 109-129)1 amended the Public Health Service Act (Act) to require the HHS Secretary (Secretary), acting through HRSA, to rewrite provisions that required the Secretary to establish and maintain the C.W. Bill Young Cell Transplantation Program (CWBYCTP), the successor to the NBMDR. The goal of the CWBYCTP is to increase the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow and cord blood. The Act also requires the Secretary to enter into contracts with qualified cord blood banks to assist in the collection and maintenance of at least 150,000 new, high quality CBUs, which are to be available for transplantation through the CWBYCTP.

The SPA-CC is comprised of the Single Point of Access, Bone Marrow Coordinating Center, and Cord Blood Coordinating Center, three of the federally legislated functions within the CWBYCTP. The SPA-CC is authorized by section 379 of the Public Health Service Act [42 U.S.C. § 274k(d)], as amended. The Act requires the operation of 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 derived from adult bone marrow donors and CBUs through a single point of access.

1 As amended by P.L. 111-264, and reauthorized by P.L. 114-104 and P.L. 1174-15 (‘‘Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act of 2021’’ or the ‘‘TRANSPLANT Act of 2021’’).

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Every year, approximately 18,000 patients are diagnosed with life-threatening blood cancers or other diseases for which a blood stem cell transplant may be their best or only hope for a cure. Often, the ideal donor is a suitably matched family member, but only 30 percent of people have a fully matched relative. The other 70 percent, or approximately 12,600 people, often search for a matched unrelated adult donor or umbilical CBU. This is especially true for those from under-represented racial and ethnic diverse populations, mainly because they possess more complex tissue types. Blood stem cells from cord blood can result in successful transplants with a less perfect match in tissue type between the donor and recipient than is needed with adult donors.

As such, adding high-quality, diverse CBUs and volunteer adult bone marrow registrants to the CWBYCTP helps individuals without a matched family member identify other potential matched blood stem cell sources. The CWBYCTP serves individuals in need of unrelated blood stem cell transplantation and works to ensure that members of medically underrepresented racially and ethnically diverse populations have the same probability of finding a suitable unrelated donor as an individual who is not a member of an underrepresented population.

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II. GENERAL DESCRIPTION

The HRSA, Health Systems Bureau, Division of Transplantation, CWBYCTP requires that the SPA-CC Contractor establish and maintain a system for health care professionals and physicians searching on behalf of patients to search electronically for cells derived from adult bone marrow donors and CBUs through a single point of access and support coordination activities for bone marrow and cord blood donation and transplantation.

The Contractor shall also:

1. establish a system for identifying, matching, ranking, 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;

2. establish a mechanism to ensure volunteer adult bone marrow donors are consented, using an HRSA- approved consent form, to join the CWBYCTP donor registry;

3. 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;

4. provide a mechanism to receive and display information on tissue typing and infectious disease marker testing of adult volunteer donors and CBUs;

5. 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 physician searches and other health care professionals working on behalf of patients;

6. support and expand new and existing studies, demonstration, and outreach projects for the purpose of increasing bone marrow and CBU donation,and collection.;

7. provide information to physicians, other health care professionals, and the public regarding bone marrow and cord blood transplants from donors as a treatment option;

8. assess the impact of new policies or proposed changes to existing policies in an effort to ensure that such policies do not conflict with other policies established for other components of the CWBYCTP; and

9. certify that National Cord Blood Inventory (NCBI) CBUs meet eligibility criteria for listing on the donor registry.

In the performance of this contract, the SPA-CC Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities as needed to perform its tasks as listed below in the Performance Work Statement. The Government shall monitor the Contractor’s performance under this contract in accordance with the contractor’s proposed and accepted Quality Assurance Surveillance Plan (QASP) (Attachment B).

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III. PERIOD OF PERFORMANCE

The period of performance shall be a base period of twelve months and four (4) twelve-month option periods. The option periods under this contract may be exercised in accordance with Federal Acquisition Regulation (FAR) clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000). The period of performance under this contract shall commence with the effective date of the contract. The work will be performed off site, primarily at the location of the Contractor’s site.

IV. TASKS

Task 1 – Fulfill Contract Administration Requirements

1.1 Attend Initial/Kick-off Meeting – The Contractor shall meet with the COR and other Government staff to review the requirements, QASP (Attachment B), and deliverable schedule for the contract. The Contractor shall meet with HRSA either in person in Rockville, Maryland or via video conference/teleconference.

The COR shall provide the meeting agenda and meeting access information prior to the meeting, and the Contractor shall submit the meeting minutes after the kick-off meeting.

1.2 Attend Quarterly COR Meetings – The Contractor shall attend quarterly meetings, via remote conference, with the COR to discuss milestones, discuss progress and challenges related to the SPA-CC contract, and provide recommendations on improvements to the SPA-CC structure and processes to increase efficiency and effectiveness of the SPA-CC functions. The Contractor shall schedule the meetings (this includes sending the meeting invitations), provide the meeting agenda prior to each meeting, and submit the meeting minutes after each quarterly COR meeting.

1.3 Attend Special COR Meetings – The Contractor shall convene via remote conference, no more than 12 times per year, for special or emergency situations that arise. The Contractor or HRSA may request the Special COR meeting. The Contractor shall schedule the meetings (this includes sending the meeting invitations) and, after each special COR meeting, submit the meeting minutes. If the Contractor is the requester of the meeting, the Contractor shall provide the meeting agenda prior to each meeting.

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1.4 Establish Policy and Technical Direction of the SPA-CC – The Contractor shall submit a plan that outlines the technical direction of and policies that impact the SPA-CC. This shall include policies that cover the following:

search, distribution, and reservation; donor recruitment and retention;

informed consent of adult donors; donor suitability for donation; donor safety and confidentiality; donor advocacy; confidentiality of data; selection criteria for blood stem cell products; criteria for network participation; and non-compliance for network participants.

The Contractor shall consult with the COR and obtain the COR’s approval, prior to implementation of new policies or proposed policy changes that have an impact beyond day-to-day operations of the SPA-CC. The Contractor shall also ensure that such key 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. At the direction of the COR, the Contractor shall also provide an opportunity for public comment by posting proposed changes on the CWBYCTP website (https://bloodstemcell.hrsa.gov).

The Contractor shall include key stakeholders in the structure used to establish the policy and technical direction and provide a copy of the Contractor’s conflict of interest (COI) policy and a blank copy of any document(s) required to assess COI of the stakeholders. The Contractor shall also provide written certification that its COI policy is in place and being followed. Updates on this task shall be provided in the progress report. (Task 8.1).

1.5 Records and Information Regulation – 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.

The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

https://bloodstemcell.hrsa.gov/

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1.6 Records Management Training – The contractor (and/or subcontractor) shall ensure that all employees having access to (1) Federal information or a Federal information system, or (2) personally identifiable information (PII), complete the HHS Records Management Training before performing work under this contract, and thereafter completing the annual refresher course during the life of the contract. The training is located at https://humancapital.learning.hhs.gov/courses/2021recordsmanagement/01_index.ht

ml. At the end of the Records Management training, the “Congratulations" slide is considered your certificate of completion. Please send the completion certificates to the Contracting Officer Representative (COR) of the contract. The listing of completed training shall be included in the first progress report. Any revisions to this listing as a result of staffing changes shall be submitted with next required progress report.

1.7 System Of Records Notice – Managing the records includes, maintaining records to retain functionality and integrity throughout the records’ full lifecycle including: (1) maintenance of links between records and metadata, and (2) categorization of records to manage retention and disposal, either through transfer of permanent records to NARA or deletion of temporary records in accordance with NARA-approved retention schedules.

For the records identified in the System of Records Notice (SORN) the Contractor shall follow the NARA-approved retention period. If there is no NARA- approved disposition schedule, the Contractor shall retain the records permanently during the duration of the contract, until Contracting Officer Representative (COR) notifies the contractor that NARA has approved an HRSA Records Schedule and HRSA provides approval for disposal of records.

Task 2 – Coordinate Transplantation Network

2.1 Coordinate Network to Facilitate Access to Donors and CBUs – The

Contractor shall prepare a plan for coordinating a network of organizations to facilitate the identification and recruitment of volunteer adult donors to serve as bone marrow donors and donor mothers of CBUs; facilitate the selection and distribution of CBUs; increase access to blood stem cell transplantation; and increase the efficiency of operations of that network. The plan shall also detail plans, subject to COR approval, for the Contractor to require a written participation agreement specific to the functions of each type of organization, foreign or domestic, as a condition of participation in the SPA-CC network.

Written agreements from foreign organizations shall be submitted to the COR for approval and not made effective until U.S. Department of State approval has been received. The Contractor shall consult with the COR regarding any proposed changes to the participation agreements or criteria having an impact beyond day-to-day operations.

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fhumancapital.learning.hhs.gov%2Fcourses%2F2021recordsmanagement%2F01_index.html&data=05%7C01%7CNShawir%40hrsa.gov%7C8dc54780f1664f9e26f508da43cb53a3%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C637896837800496732%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=sU9pjlvFS3gh3R1etiy3HehuVMvf%2BNB5Sy2vaN2Wyj0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fhumancapital.learning.hhs.gov%2Fcourses%2F2021recordsmanagement%2F01_index.html&data=05%7C01%7CNShawir%40hrsa.gov%7C8dc54780f1664f9e26f508da43cb53a3%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C637896837800496732%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=sU9pjlvFS3gh3R1etiy3HehuVMvf%2BNB5Sy2vaN2Wyj0%3D&reserved=0

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The Contractor shall ensure participating organizations comply with the U.S.

Food and Drug Administration (FDA) requirements for Investigational New Drug (IND) and Biologics License Applications (BLA), whether through participation agreements or other means. The Contractor will apply FAR clauses (and DHHS FAR Supplement clauses) in its agreements with third parties to the extent that the activities under such agreements are funded directly by HRSA.

Organizations outside of the U.S. appropriately may participate in the SPA-CC to increase patient access to cord blood stem cells and bone marrow transplants and to facilitate the collection of data regarding patients who reside outside the U.S. Types of organizations in the network shall include, at a minimum, the following: transplant centers; cooperative stem cell registries; cord blood banks;

donor centers; recruitment organizations; cooperative donor registries; marrow and peripheral blood stem cell collection centers; histocompatibility and infectious disease testing laboratories; and tissue repositories.

The plan shall also include access procedures by which non-network transplant centers may also access potential adult volunteer donors that may donate blood stem cells for transplant. The procedures shall include obtaining written assurance from the non-network transplant center that it will submit the required outcomes data.

The Contractor shall also notify the COR when network participants are determined to no longer be in compliance with the SPA-CC’s standards or requirements, as outlined in the participation agreements. The Contractor shall develop a corrective action plan for non-compliant network participant(s) and submit it to the COR for review. Additionally, the COR shall be notified when exemptions or deviations to specific standards or requirements are granted to participant(s). Updates on this task shall be provided in the progress report.

(Task 8.1).

2.2 Support Network Participants – The Contractor shall provide a plan for supporting a network of organizations aimed at facilitating access to volunteer adult donors and to donor mothers of CBUs. Support shall include providing training and technical assistance to participants of the SPA-CC network and developing a process to receive feedback from the network. In completing this task, the Contractor may convene meetings of the entire network or specific types of network participants (e.g., transplant physicians, recruitment organizations, donor center coordinators, transplant center coordinators, donor contact and work-up specialists).

In developing a process to receive feedback from its network, the Contractor shall determine the extent to which the SPA-CC is meeting the needs of the

SPA-CC - Page 10 of 49 participating organizations; identify whether additional services are needed; and identify ways in which the system can be improved to best meet the needs of the network, patients, donors, and the CWBYCTP. The Contractor shall ensure the network can provide such feedback anonymously and that the feedback will not influence the network’s relationship with the SPA-CC.

2.3 Facilitate Sharing of Best Practices – The Contractor shall develop and implement a process through which participating organizations, such as donor recruitment centers, cord blood banks, and apheresis centers can, with their respective networks, share best practices and learn about ways they might improve efficiencies (e.g., transplant outcomes) and programmatic goals.

2.4 Engage in Contingency Planning – The Contractor shall establish a plan for assistance in coping with disasters and other events that could result in suppression of hematopoietic function. The plan should also address coping with public health emergencies that could impact facilitating unrelated hematopoietic blood stem cell transplants. Revisions to the plan shall be submitted to the COR for approval. Updates on this task shall be provided in the progress report. (Task

Task 3 – Facilitate Searches for CBU and Adult Bone Marrow Donors

3.1 Establish Search, Distribution and Reservation Plan and Procedures – The Contractor shall develop a plan to establish and review the policies and procedures around search, distribution, and reservation. The Contractor shall develop a process for facilitating the distribution of stem cell products for transplantation. The Contractor shall submit to the COR for approval, prior to its implementation, a description of this facilitation process, including the roles and responsibilities of each party and the chain of custody from the collection hospital, apheresis center, or cord blood bank to the transplant center. The plan shall also outline procedures through which a transplant center can request further testing and/or make an exclusive and firm reservation of a donor product or CBU (including multiple CBUs) for transplantation, for a maximum time determined by the cord blood community. The Contractor must work with transplant centers and cord blood banks to accomplish this task. Updates on this task shall be provided in the progress report. (Task 8.1).

3.2 Specify Content and Format of Search Data – The Contractor shall submit a written report that: 1) specifies the content and format of the data required for running searches and interpreting search results; 2) specifies the content and format of the data needed for each potential volunteer donor and for each CBU to be made available for transplantation; 3) details the use of an automated process that uses a single algorithm for human leukocyte antigen (HLA) matching to display the suitable adult volunteer donors and CBUs in rank order and according to established criteria; and 4) details a plan for rank-ordering potential matches in

SPA-CC - Page 11 of 49 an unbiased fashion, consolidating search results into reports, and providing those reports to health care providers, including non-transplant physicians, and others who may be working on behalf of patients. The Contractor shall also offer transplant centers expert histocompatibility/search consultation, including recommendations regarding the strategy for evaluating and selecting potential adult bone marrow donors and CBUs. The Contractor must work with transplant centers, cord blood banks, histocompatibility experts, and other identified stakeholders to accomplish this task. Updates on this task shall be provided in the progress report. (Task 8.1).

3.3 Develop Quality Control Plan regarding Search Reports – The Contractor shall develop and implement, a quality control plan regarding search reports and other information provided to patients and physicians electronically. The quality control plan shall address the utility and accuracy of information, including updating CBU documentation and adult donor status and correcting discrepancies or inaccuracies (may include removing unavailable adult donors and CBUs). The quality control plan shall also address the removing listed units or adults that are no longer acceptable or medically eligible for transplant.

Additionally, the quality control plan shall describe any special studies conducted to determine the quality of the information available and/or to analyze quality control alternatives, and describe how “real-time” information (e.g., search outcomes) will be made available to patients and physicians searching on behalf of patients. Updates on this task shall be provided in the progress report. (Task

3.4 Audit the Search Process and Search Process Results – The Contractor shall submit a plan regarding their audit and review of how adult bone marrow donors and CBUs were ranked for a sample of patients. The Contractor shall ensure that the reports are organized in a manner that allows the transplant centers to select the best donors from a rank-order list and allow cord blood banks and adult donor centers to assess how and where their units are displayed on the list. The Contractor shall provide the COR and participating donor centers, cord blood banks, and transplant centers with a report detailing the auditing procedures used as well as the findings from each of these reviews. Updates on this task shall be provided in the progress report. (Task 8.1).

Task 4 – Facilitate and Enhance Cord Blood Expansion and Utilization

4.1 Collaborate with the Cord Blood Community – The Contractor shall collaborate with the cord blood community to obtain feedback to identify priority areas for special projects, for approval by the COR. The Contractor shall identify and prioritize at least one special project or study to be conducted per year.

Examples of possible projects or areas of studies include: an international comparison of how public cord blood banking is financed; ways of assessing the financial health of the public cord blood banking industry; and ways in which

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NCBI banks can reduce their reliance on HRSA funds while continuing to build a diverse inventory. The Contractor shall submit a plan to identify, prioritize, implement, and evaluate special projects and studies. Updates on this task shall be provided in the progress report. (Task 8.1).

4.2 Leverage Outreach Platforms to Support Cord Blood Banks – The

Contractor shall develop a plan to leverage outreach platforms that support cord blood banks and the cord blood community (e.g., the Cord Blood Advisory Group) with providing education and outreach activities to expectant mothers.

These new outreach platforms will assist expectant mothers in making informed decisions regarding the use of CBUs: family banking, public donation, research, or disposal as medical waste. The Contractor must work with the cord blood banks (public and private) to accomplish this task.

Contractor shall develop a process to ensure that the intent outlined in the signed consent form by the donor mother, is communicated and implemented throughout the CWBYCTP. The Contractor shall communicate with cord blood banks to ensure that CBUs of donor mothers, who opt out of research, are not used for research purposes (including the research repository). The Contractor must work with transplant centers and cord blood banks to accomplish this task.

The informed consent requirements shall not conflict with those established by cord blood banks. Updates on this task shall be provided in the progress report.

(Task 8.1).

4.3 Facilitate the Expansion of Cord Blood Collections – The Contractor shall implement a process for supporting the opening of new collection sites or for increasing collections at existing collection sites (birthing centers). The Contractor shall provide data on birthing centers with high rates of ethnically- and racially-diverse populations, to cord blood banks. The Contractor shall also provide support to NCBI contractors with existing HRSA agreements in collecting CBUs among underrepresented racial and ethnic populations.

Updates on this task shall be provided in the progress report. (Task 8.1).

Task 5 – Facilitate Adult Donor Recruitment and Retention Activities

5.1 Submit Annual Recruitment and Retention Plan – The Contractor shall submit to the COR, for approval and prior to implementation, an annual recruitment and retention plan (including goals in absolute numbers) for broad population groups.

The Contractor shall support efforts to add 10,000 supported recruits from underrepresented racial and ethnic populations, who are recruited and added to the C.W. Bill Young Cell Transplantation Program each funding year.

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The Contractor shall provide the COR with a plan for achieving those goals and the goals shall be set so as to increase minority volunteers, add unique phenotypes and replace volunteers lost through attrition, consistent with the contract funds available. The Contractor shall negotiate annual recruitment goals with each recruitment organization.

The Contractor shall establish and maintain one or more recruitment repositories of adult volunteer donors. The recruitment repositories will store samples from adult volunteer donors for future testing. The Contractor shall ensure that the repositories keep identifying information about donors confidential and do not release identifying information about potential donors to transplant centers.

5.2 Perform HLA Typing – The Contractor shall develop a plan for performing HLA typing of potential donors. The Contractor shall ensure that the HLA typing plan reflects the current best practices in the blood stem cell transplantation.

The Contractor shall support efforts to add 10, 000 HLA typing tests conducted on volunteer adult donors from underrepresented racial and ethnic populations, who are recruited and added to the C.W. Bill Young Cell Transplantation Program each funding year. The Contractor shall develop a plan, subject to COR approval, for performing HLA typing of 10,000 potential donors per year.

Task 6 – Provide Adult Volunteer Donor Advocacy and Cord Blood Donor Support

6.1 Provide Donor Advocacy and Case Management Support for Adult Donors

– The Contractor shall provide a plan for donor advocacy and case management services for volunteer adult donors who have been identified as a possible match for physicians searching on behalf of patients. The plan shall address how the Contractor shall ensure that the donors are both physically and mentally suitable to donate. The Contractor shall determine from actual donors and potential donors the extent of satisfaction with the donor advocacy and case management services provided by the SPA-CC. Updates on this task shall be provided in the progress report. (Task 8.1).

Task 7 – Provide Support to and in Collaboration with HRSA

7.1 Provide Analytic Support to HRSA – The Contractor shall provide analytic support to HRSA specific to the CWBYCTP. This shall include support to other CWBYCTP contracts, the Advisory Council, the provision of information used in preparation of the Annual Report to the Congress, the preparation of international reports, and the preparation and submission of Office of Management and Budget (OMB) Clearance Packages and Federal Register Notices (FRN). For the OMB package, specifically, the Contractor shall prepare and submit draft 60-day and 30-day FRNs, and a draft information collection request clearance package, in accordance

SPA-CC - Page 14 of 49 with OMB's clearance process under the Paperwork Reduction Act. The Contractor shall make necessary changes to these documents, as requested by the COR, and respond in writing within 10 days of request (or as otherwise specified); within 48 hours for urgent requests, revisions, or for questions; and within 48 hours if data cannot be released, is not available, or is not collected.

This support must include working with the Stem Cell Therapeutic Outcomes

Database (SCTOD) to ensure that transplant centers submit complete, timely and accurate data on the outcomes of related and unrelated-donor hematopoietic transplants and data on emerging therapeutic applications of cells from cord blood. Additionally, support must include working with the SCTOD to establish and maintain one or more research repositories containing donor-recipient paired samples to be used in the ongoing examination of tissue matching factors affecting transplant outcomes and facilitate research to determine the degree of HLA match required for successful transplants.

This support must include working with the OPA to:

1. Develop a plan to increase the awareness of referring physicians, transplant physicians, primary care physicians, and obstetricians (for CBUs) regarding the availability of adult volunteer donors and CBU donors, the outcomes of unrelated blood stem cell transplants, and the need for early patient referral and for a larger, more diverse registry of volunteer adult donors and inventory of CBUs,

2. Analyze data on the number and percentage of patients who are unable to complete the search process, and the underlying reasons,

3. Develop initiatives to reduce barriers (e.g., financial, adequate stem cell source, access to health care) to bone marrow and cord blood transplantation,

4. Develop website content and supporting maintenance of the CWBYCTP website, and

5. Prepare a draft and final comprehensive plan that: (1) estimates, to the extent feasible, the annual need for unrelated blood stem cell transplants for each major population group within the United States and the extent to which the CWBYCTP is meeting that need; and, (2) presents a strategy for increasing the number of successful transplants facilitated by the SPA-CC.

7.2 Provide grant funding to up to 2,000 blood stem cell candidates, including those who could benefit from cord blood transplantation, with an emphasis on serving patients from underrepresented racial and ethnic groups, to help overcome barriers before and after transplant.

7.3 Verify the Funding Eligibility of NCBI CBUs – The Contractor shall collaborate with the NCBI cord blood banks and HRSA to establish a process for verifying CBUs are eligible for HRSA reimbursement. The process shall account for the

SPA-CC - Page 15 of 49 funded targets established by HRSA as well as the specific requirements set forth in the NCBI contracts. The process shall generate verification reports for HRSA and the NCBI banks. The Contractor shall submit, to the COR for approval and prior to implementation, the plan to verify the funding eligibility of NCBI CBUs.

Task 8 – Submit Reports

8.1 Submit Quarterly Progress Reports – The Contractor shall submit quarterly progress reports to the COR. The progress report includes implementation status updates, progress and challenges, and recommendations for improvement for the deliverables of the following tasks:

1. Task 1.4 – Establish Policy and Technical Direction of the SPA-CC

2. Task 2.1 – Coordinate Network to Facilitate Access to Donors and

CBUs

3. Task 2.4 – Engage in Contingency Planning

4. Task 3.1 – Establish Search, Distribution and Reservation Plan and

Procedures

5. Task 3.2 – Specify Content and Format of Search Data

6. Task 3.3 – Develop Quality Control Plan regarding Search Reports

7. Task 3.4 – Audit the Search Process and Search Process Results

8. Task 4.1 – Collaborate with the Cord Blood Community

9. Task 4.2 – Leverage Outreach Platforms to Support Cord Blood Banks

10. Task 4.3 – Facilitate the Expansion of Cord Blood Collection and

Utilization

11. Task 5.1 – Submit Annual Recruitment and Retention Plan

12. Task 5.2 – Perform HLA Typing

13. Task 6.1 – Provide Donor Advocacy and Case Management Support for

Adult Donors

14. Task 8.3 – Promote Donor Safety and Donation

15. Optional Tasks

8.2 Submit Statistical Reports for Network Participants – The Contractor shall prepare and provide to the network, including participating cord blood banks and the COR, quarterly statistical reports for the SPA-CC. The reports shall include data that uses the racial and ethnic categories established by the CWBYCTP, which is based upon OMB race and ethnicity classification. The reports shall also include data on the size and composition of the donor files of each participating donor center and cooperative registry, both cumulative numbers and additions in the preceding twelve months and by donor race and ethnicity. The reports shall also include data on the size and composition of the National Cord Blood Inventory, as well as other units available through the CWBYCTP (in terms of race/ethnicity and age of CBUs collected using HRSA funds), and the number of CBUs available at each participating cord blood bank and cooperative registry.

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The reports should also include data on non-NCBI units, cord blood transplants, adverse events, and search requests through the SPA-CC.

8.3 Promote Donor Safety and Donation – The Contractor shall establish a system for recording, tracking and reporting any complications or adverse events associated with donations, donation recovery, and cord blood collections and infusions. The report shall describe the process for notifying HRSA on all donor (including marrow) and recipient safety and adverse events correspondence at the same level reportable to the FDA. In addition, the Contractor shall develop a mechanism to share donor and patient safety information with an independent body for assessment and feedback, and share that feedback from the independent body with the COR. The Contractor shall also provide long-term follow-up of donors, assess possible consequences of donation, and evaluate ways to improve donor safety. Updates on this task shall be provided in the progress report. (Task 8.1).

Optional Tasks

Optional Task 1: Submit Transition Plan – The Contractor shall submit a draft written transition plan that includes the transition completion timeline for receiving materials from the predecessor contractor (if applicable) and for notifying affected parties of the transition, or for transitioning materials to the successor contractor (if applicable). If transitioning from a predecessor contractor, the transition plan shall address scheduling of a meeting with the predecessor contractor to discuss the receipt and transfer of data and documentation and continuity of services during the transition period. The transition plan shall also address the description and receipt of contract materials from the predecessor contractor.

During this period, the Contractor shall cooperate with the successor contractor(s) to maintain parallel systems, continue backup of data, and compare results of searches.

Optional Task 2: Facilitate the Expansion of Cord Blood Collections (may be exercised 5 times per the entire contract life)– The Contractor shall implement a process for supporting the opening of new collection sites or for increasing collections at existing collection sites (birthing centers). The Contractor shall provide data, on birthing centers with high rates of ethnically- and racially-diverse populations, to cord blood banks.

Optional Task 2.1 (may be exercised 5 times per the entire contract life) - The Contractor shall provide support to NCBI contractors with existing agreements in collecting up to 3,000 cord blood units from underrepresented racial and ethnic populations.

Optional Task 3: Collaborate with the SCTOD Contractor to Make available a Cord Blood Dataset (may be exercised 5 times per the

SPA-CC - Page 17 of 49 entire contract life) – The Contractor shall develop a cord blood dataset as determined valuable from the cord blood community.

Optional Task 4: Provide Search Strategy Advice and Cord Consultation Services to Transplant Centers (may be exercised 5 times per the entire contract life) - The Contractor shall offer transplant centers expert histocompatibility/search consultation, including experts in selecting CBUs, to offer recommendations on potential CBUs that may best meet the needs of patients. The Contractor must work with transplant centers, cord blood physicians, histocompatibility experts, and other identified stakeholders to accomplish this task.

Optional Task 5: Supplemental Engagement with the Cord Blood Community (may be exercised 5 times per period of performance/25 times per the entire contract life)- The Contractor shall schedule supplementary engagements with the cord blood community to develop process improvements and to further enhance cord related searches, procurement, and delivery.

Optional Task 6: Perform High Resolution HLA Typing of NCBI CBUs (may be exercised 5 times per period of performance/25 times per the entire contract life) - The Contractor shall develop a plan, subject to COR approval, and perform high resolution HLA typing (which includes confirmatory typing) on NCBI CBUs collected and banked by NCBI contractors.

Optional Task 6.1 – Perform high resolution HLA Typing (which includes confirmatory testing) on up to 1,000 NCBI CBUs (may be exercised 5 times per period of performance/25 times per the entire contract life)

Optional Task 7: Perform Genetic Testing of NCBI CBUs (may be exercised 5 times per period of performance/25 times per the entire contract life) - The Contractor shall develop a plan, subject to COR approval, and perform genetic tests on NCBI CBUs collected and banked by NCBI contractors.

Optional Task 7.1 – Perform Genetic testing on up to 15,000 NCBI CBUs. An example of a potential allowable use of funding includes but is not limited to CC chemokine receptor 5 (CCR5) genotype testing of CBUs for the CCR5-delta 32 polymorphism. The CCR5-delta 32 homozygous genotype may provide resistance to Human Immunodeficiency Virus-1 (HIV-1 infection). The Contractor shall ensure that the genetic testing plan reflects the current best practices in blood stem cell transplantation. Updates on this task shall be provided in the progress report. (May be exercised 5 times per period of performance/25 times per the entire contract life)

Optional Task 8 - Assess Feasibility of a Flat Fee for Searching and Procuring Hematopoietic Blood Stem Cells (may be exercised 2 times per the entire contract life) – The Contractor shall assess the feasibility and desirability of a flat fee for each physician searching on behalf of a patient (with and without procurement costs). The Contractor must work with the Office of Patient Advocacy (OPA) and transplant centers

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(large and small) to accomplish this task. The Contractor shall submit to the COR a detailed report describing findings. The report shall be prepared in a format for possible sharing with the Advisory Council.

The Contractor shall assess the feasibility and desirability of a flat fee for donor search and/or procurement of stem cell sources, including bone marrow, peripheral blood, and cord blood, to permit transplant physicians the ability to select the most desirable grafts for transplant candidates without financial considerations.

V. HHS Policy for Information Technology Procurements - Security and Privacy

Language

A. Procurements Requiring Information Security and/or Physical Access Security

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

i. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

ii. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/HRSA policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

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Availability, which means ensuring timely and reliable access to and use of information.

Note to the Requiring Activity Representative: Complete the following section using the information obtained from the Information Security and Privacy Certification Checklist.

ii. Categorize all information owned and/or collected/managed on behalf of HHS/HRSA and information systems that store, process, and/or transmit HHS information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories. Based on information provided by the ISSO, CISO, HRSA Senior Official for Privacy (SOP), or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Confidentiality: [ ] Low [ X ] Moderate [ ] High Integrity: [ ] Low [ X ] Moderate [ ] High Availability: [ X ] Low [ ] Moderate [ ] High Overall Impact Level: [ X ] Low [ ] Moderate [ ] High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of HHS/HRSA regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the HHS/HRSA Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain all applicable security and privacy policies by contacting the CO/COR or HHS/HRSA security and/or privacy officials.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

d. Privacy Compliance. Comply with the E-Government Act of 2002, http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

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NIST SP 800-53, and applicable HHS/OpDiv privacy policies, and complete all the requirements below:

Note to the Requiring Activity Representative: This information may be included after award in the event it is not yet available at the time of acquisition. Section d must be included in all contracts regardless of whether or not personally identifiable information (PII) is involved.

i. Per the Office of Management and Budget (OMB) Circular A- 130, Personally Identifiable Information (PII), is "information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother's maiden name, biometric records, etc.

ii. To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, HHS uses a privacy analysis process to assess the risks associated with HHS's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how HHS collects, disseminates, maintains, or disposes of the public's PII.

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if a full Privacy Impact Assessment (PIA) needs to be completed.

If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information within 60 days after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

The Contractor must support the agency in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or

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e. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR,…