ATTACHMENT A.doc

10-250-SOL-00079DM

ATTACHMENT A—Description and Statement of Work

CONTENTS (SOW PARTS A THROUGH F):

A. Background

B. Tasks

C. HRSA Cord Blood Accreditation Requirements

D. HRSA Informed Consent Requirements

E. Processing and Storage Requirements for HRSA Reimbursable Cord Blood Units

F. Specifications for HRSA Reimbursable Cord Blood Units

A.

BACKGROUND

Authorizing Law The Stem Cell Therapeutic and Research Act of 2005 (Public Law 109-129) requires the Secretary to enter into contracts with qualified cord blood banks (CBB) to assist in the collection and maintenance of 150,000 new units of high-quality cord blood to be made available for transplantation through the C.W. Bill Young Cell Transplantation Program (Program). Qualified CBB are defined as those banks that have: (1) obtained all applicable Federal and State licenses, certifications, registrations (including pursuant to the regulations of the FDA), and other authorizations required to operate a CBB; (2) implemented donor screening, cord blood collection practices, and processing methods intended to protect the health and safety of donors and transplant recipients to improve transplant outcomes, including with respect to the transmission of potentially harmful infections and other diseases; (3) been accredited by an accrediting organization recognized by the Secretary; (4) established a system of strict confidentiality to protect the identity and privacy of patients and donors in accordance with existing Federal and State law; (5) established a system for encouraging donation from a genetically diverse group of donors; and, (6) established a system to confidentially maintain a linkage between a cord blood unit (CBU) and a donor mother.

The Act requires recipients of contracts to: acquire, tissue-type, test, cryopreserve, and store donated CBU obtained with the informed consent of the donor, as described in the law, and as determined by the Secretary; encourage donations from a genetically diverse population; and, make CBU collected, that are not appropriate for clinical use, available for peer-reviewed research. The law requires CBB receiving contracts to make data available in a standardized electronic format to the Program and to submit data in a standardized format for inclusion in the Stem Cell Therapeutic Outcomes Database maintained under section 379A of the Public Health Service Act. The law also authorizes a 3-year related donor demonstration project, which is not included in this request for proposals.

On October 20, 2009, the Food and Drug Administration (FDA) published guidance related to a path to licensure for establishments that manufacture cord blood intended for unrelated-donor transplantation for certain medical conditions. On the same day the FDA published draft guidance related to distribution of cord blood units under Investigational New Drug Applications (IND).

Legislative History Enactment of P.L. 109-129 was preceded by the introduction of bills to authorize Federal support for collecting high quality, diverse CBU for a national cord blood inventory, and bills to reauthorize the National Bone Marrow Donor Registry. While the authorizing process continued, the U.S. Department of Health and Human Services (HHS) Appropriations Act for FY 2004 provided nearly $10 million for a National Cord Blood Stem Cell Bank Program within the Health Resources and Services Administration (HRSA). The Conference Report stated that the purposes were to provide funds to a network of cord blood banks to: (1) build an inventory of the highest quality CBU for transplantation; and, (2) ensure an integrated system through which physicians and patients are able to locate a suitably matched cord blood unit or adult volunteer marrow donor via a single, electronic access point. The units were to be made available for blood stem cell transplants, and a portion of the units were to be made available for pre-clinical and clinical research focusing on cord blood stem cell biology and the use of cord blood stem cells for human transplantation and cellular therapies.

The Conference Report did not specify the structure for the program. Noting that this is a new and developing field, the Report directed HRSA to initiate an Institute of Medicine (IOM) study to “recommend an optimal structure and address pertinent issues to maximize the potential of cord blood technology.” The HHS appropriations for FY 2005 provided additional funds for the program, with no further direction. The report of the IOM study was published on April 14, 2005. The IOM Report recommended a program structure similar to that subsequently authorized in P.L. 109-129. The IOM report stated that expansion of the cord blood inventory should be the highest priority in the near future.

Overview of Blood Stem Cell Transplantation Bone marrow and peripheral blood have been the predominant sources of blood stem cells for patients in need of transplantation to treat various life-threatening disorders. Initially, transplants were performed between identical twins. Later, transplants were performed with cells from genetically matched siblings. Advances in medicine and immunology permitted transplants with cells from donors closely matched in tissue type but not related to the patients. This was critical because only about 25% of patients needing transplant have a suitably matched related donor. The National Bone Marrow Donor Registry (Registry) was created to recruit adult volunteer donors and to facilitate unrelated donor transplants. Even with over nine million adults on the registries worldwide, the close tissue matching required with adult donors has left many patients without a suitable unrelated adult donor. This is especially true for racial or ethnic minorities, mainly because they possess more diverse tissue types.

Umbilical cord blood has been shown to contain a high concentration of blood stem cells and thus offers another source of blood stem cells for hematopoietic reconstitution. Importantly, research indicates that 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. An adequate cell dose relative to the patient’s weight is critical for cord blood transplants, and research is ongoing to further define the role of cord blood in transplanting larger patients.

Prior Related Federal Programs The National Bone Marrow Donor Registry was begun in 1987 through a Congressionally-directed grant from the Navy and formally established in 1990 as a responsibility of the Department of Health and Human Services, with oversight initially by the National Heart, Lung, and Blood Institute and from 1994 to 2007 by HRSA. The National Bone Marrow Donor Registry has been succeeded by the new structure of the C.W. Bill Young Cell Transplantation Program. The current contracts for the C.W. Bill Young Cell Transplantation Program encompass, among other activities, recruitment and tissue typing of adult volunteer donors; facilitating selection of donors for particular patients and distribution of blood stem cells to transplant centers; providing case management and advocacy services for patients; coordinating an international network of over 400 organizations including transplant centers, donor recruitment organizations, blood stem cell collection centers, and cord blood banks; collecting data on transplant outcomes; and, developing contingency plans to deal with events that could cause marrow toxic injuries.

The first contracts (first cohort) for National Cord Blood Inventory collections were awarded to six banks on November 2, 2006. Awards were made to the following cord blood banks: the New York Blood Center’s, National Cord Blood Program; the Cord Blood Bank at the University of Texas, M.D. Anderson Cancer Center; the Carolinas Cord Blood Bank at Duke University Medical Center and Health System; the University of Colorado Cord Blood Bank; the Puget Sound Blood Center; and StemCyte Inc.

The second contracts (second cohort) for National Cord Blood Inventory collections were awarded to two banks on September, 2007. Awards were made to the Saint Louis Cord Blood Bank at SSM Cardinal Glennon Children’s Hospital and the Texas Cord Blood Bank at the South Texas Blood and Tissue Center. The third competition (third cohort) for National Cord Blood Inventory collections resulted in one award in September, 2008, to Life South Community Blood Centers (LifeCord). In 2009 three new awards were made (fourth cohort) to New Jersey Cord Blood Bank (Bergen), the Cleveland Cord Blood Center, and CORD:USE Cord Blood Bank (Orlando, Florida).

The Act established an Advisory Council to advise the Secretary of the Department of Health and Human Services and HRSA on matters related to the C.W. Bill Young Cell Transplantation Program and National Cord Blood Inventory. The first meeting of the Secretary’s Advisory Council on Blood Stem Cell Transplantation was held in Rockville, Maryland on January 28-29, 2008. Information about the Advisory Council, including minutes of meetings, is available on the Program website (bloodcell.transplant.hrsa.gov).

B.

TASKS

In performance of this contract, the Contractor must furnish all the necessary services, qualified personnel, material, equipment, and facilities to perform the tasks listed below.

Task 1: Meet with the Project Officer

1.a.

Initial Meeting The Contractor must meet with the Project Officer to review the requirements and schedule for the contract within the timeframe specified in the Schedule of Deliverables. The meeting location will be either at the Contractor’s cord blood bank facility or Rockville, MD; location to be determined by the Project Officer.

1.b.

Annual Meeting The Contractor must meet with the Project Officer at least annually as specified in the Schedule of Deliverables. The annual meeting, at the determination of the Project Officer, may include other cord blood banks collecting units for the National Cord Blood Inventory (NCBI) and cord blood banks (CBB) participating in the C.W. Bill Young Cell Transplantation Program (Program). The date and location of the meeting will be determined by the Project Officer.

1.c.

Additional Program Meetings The Contractor must budget for and participate in any additional meetings and conference calls for the Program (including meetings and conference calls sponsored by other Program contractors) as determined by the Project Officer. The Contractor must budget for a minimum of two additional in-person meetings beyond the annual meeting with the location to be determined by the Project Officer.

Task 2: Operational Quality Management

2.a.

Regulations, Certifications, Licenses, Accreditations, Insurance, and CBU Replacement The Contractor must have and maintain all Federal and State licenses, certifications, registrations and other authorizations required to collect unrelated donor cord blood for transplantation and to operate and maintain a public cord blood stem cell bank. The Contractor must have and maintain any licenses and investigational new drug applications required by the Food and Drug Administration for collecting, processing, storing and distributing cord blood products intended for unrelated donor transplantation.

The Contractor must have and maintain CBB accreditation from an accrediting organization recognized by HRSA. The Contractor must comply with all HRSA requirements for accreditation. Additional requirements for accreditation are described in Part C: HRSA Cord Blood Accreditation Requirements.

The Contractor must meet HRSA requirements for operating and maintaining CBB. The Contractor must submit to the Project Officer within 30-days upon receipt, any copies of Form FD-483, List of Inspectional Observations, issued by the Food and Drug Administration as the result of an FDA inspection.

The Contractor must ensure that information shared for the purposes of the collection, storage, and distribution of CBU for the NCBI complies with Program requirements and the following: (1) confidentiality provisions of Section 379 of the Public Health Service Act; (2) The Privacy Act (PL 93-579); (3) any other applicable Federal requirements, including requirements for compliance with the Health Insurance Portability and Accountability Act (HIPAA).

The Contractor must have liability insurance and any other relevant insurance including coverage for loss of NCBI CBU. The liability insurance must cover NCBI tasks or services provided by the Contractor or on behalf of the Contractor.

In the event of NCBI CBU loss or removal (including distribution outside of the CBCC) from the NCBI inventory, the Contractor must replace NCBI units with an equivalent (race/ethnicity) unit at no cost to the Government within 30-days of loss or removal or a date thereafter approved by the Project Officer. Replacement units must have been collected on the same date or more recently than the CBU that is being replaced. The Project Officer must be notified in writing of NCBI CBU loss or removal and the circumstances surrounding the loss or removal within 5-days of the Contractor’s discovery of the loss or removal.

2.b.

Standard Operating Procedures, Quality Assurance, and Proficiency Testing The Contractor must have and maintain, at a minimum, the standard operating procedures (SOP) required for operation of a high quality CBB. The Contractor must ensure ongoing training and competency evaluation of personnel involved in all aspects of CBB operations including donor screening and consent and the collection, processing, and storage of CBU. Training attendance and evaluation results must be documented. The Contractor must have a system to track and verify which staff is involved in each step of donor screening, CBU collection and processing, and testing of cord blood units and donor samples.

The Contractor must have and maintain a quality management/assurance program that includes a site-specific quality assessment program (i.e., encompassing all CBB activities from recruitment through banking and final release of CBU).

The Contractor must have an internal proficiency-testing program to ensure consistency in quality of cord blood products and interpretation of laboratory assays. The Contractor must have an established program for proficiency testing to ensure at minimum the predefined processing endpoints for sterility, cell recovery, and cell viability/function (must include in the program the testing of post-processing, pre-freeze CFU-GM) are reached in a consistent manner. The Contractor must participate in any external proficiency programs established at HRSA’s direction or by the Cord Blood Coordinating Center (CBCC) for the Program. The Contractor must submit to HRSA a plan for its internal and external proficiency programs and must provide updates on these programs through the progress reports as specified in the Schedule of Deliverables.

2.c.

Maintenance of Electronic Records The Contractor must have written and validated SOP for creation and maintenance of all required electronic records to ensure that the CBU were collected, processed and stored according to the terms of this contract and to assure transplant physicians, the CBCC, and patients that the units are acceptable for release. Electronic records must include at a minimum the following documents: the donor mother’s signed informed consent form (electronic image of signed consent must be maintained) and medical history questionnaire; results of infectious disease marker (IDM) testing; results of human leukocyte antigen (HLA) testing; results of hemoglobinopathy screening; post-processing total nucleated cell (TNC) count, colony forming units (CFU), viability results; a copy of the freeze curve for the CBU; and, any other documents needed to verify the quality and eligibility of the unit. The Contractor must have a designated off-site location to store back-up copies of all essential records, including donor mother consent forms. The Contractor must maintain internal records of all modifications and upgrades to their electronic records management system. The Project Officer must be notified of significant modifications to the system. The Contractor must submit to the Project Officer a description of the electronic management system. The Contractor must have and maintain a fully operational electronic management system.

2.d.

Quality Assurance and Data on Product Quality and Transplant Outcomes

1.

Quality Assurance (QA) Plan The Contractor must have an established QA plan with validated procedures addressing the daily operations of the CBB, including all collection sites. The QA plan must address the long-term maintenance of the CBU, and the quality of cord blood products released for transplantation. The QA plan must provide for secure, off-site storage of copies of all records and software needed to continue CBB operations in the event of a loss of on-site records or temporary inability to access on-site records. The QA plan must include validation of the process for retrieving and restoring records and software.

2.

Data on Product Quality and Transplant Outcomes The Contractor must, directly or through the CBCC, provide to the Stem Cell Therapeutic Outcomes Database required data on the pre-freeze characteristics of CBU used in transplants. To the maximum extent feasible the Contractor must require that transplant centers, as a condition of obtaining a CBU, submit data required by the Stem Cell Therapeutic Outcomes Database regarding CBU characteristics upon receipt and after processing by the transplant center, and transplant outcomes. This requirement includes NCBI and non-NCBI CBU regardless of whether or not the CBU is distributed through the CBCC. The CBB must have procedures for receiving and analyzing transplant outcomes data, including it in the documentation for the CBU history, and taking appropriate action when the data so indicates. The Contractor must submit information to the Project Officer on all CBU released for transplant (HRSA reimbursed and CBU not reimbursed by HRSA in the Contractor’s public inventory) as specified in the Schedule of Deliverables and Task 7.

2.e.

Continuity of Operations Plan The Contractor must have an established plan to operate the CBB and maintain storage of the collected (cryopreserved) CBU under appropriate conditions in the event of equipment failures, natural disasters, or other emergency situations. The Contractor must have an emergency contingency plan for the continuity of CBB operations including transition plans to relocate the CBU and the CBB operations. The Contractor must ensure the CBB staff has had adequate training and practice to execute the plan if needed.

The Contractor must have sufficient emergency standby freezer space available in the event of mechanical failure of storage containers. The Contractor must have an electric backup capable of maintaining the CBU and associated samples for as long as necessary, in the event of power failure. The Contractor must have a documented plan for responding to freezer alarms or failures with adequate time to salvage CBU before they reach the specified long-term storage temperature (currently ≤-150(C). The Contractor must maintain access to and operations of the electronic records and other data systems required to sustain bank operations and maintain the inventory during emergency situations. Continuity of operations plans must include periodic testing and validation including the process for retrieval and restoration of records stored off-site.

2.f.

Medical Contingency Response Plan The Contractor must have a medical contingency response plan to respond to an emergency, such as a terrorist attack, that may require the use of cord blood for blood stem cell transplantation. The plan must demonstrate the Contractor’s capability to accelerate CBU collections and processing under this contract, if so directed by the Project Officer. The plan must include methods to accelerate collections to ensure that appropriate numbers of public units remain available using an approach commensurate with the demands of the situation. Additionally, the plan must provide for adequate logistical support including security and transportation for the collection and distribution of CBU and the ability to perform, or provide the data to the CBCC to perform, urgent, large-scale search requests. Depending on the event, HRSA may determine that the Contractor may use a portion of the funds already awarded to accelerate the pace of collections or respond to search requests, or may award additional funds, if available, for this purpose.

Task 3: Collection of CBU

HRSA reimbursable CBU are defined as those qualified units collected and stored under this contract for inclusion in the NCBI, which is the federally reimbursed cord blood collection component of the Program. The NCBI includes those CBU that are reimbursed by HRSA (HRSA reimbursed CBU), but may also include units transferred into the NCBI as a result of certain NCBI contract requirements (e.g., units transferred in from other NCBI CBB). These CBU are referred to as “HRSA reimbursed/reimbursable CBU” or “NCBI CBU”. The Contractor must collect and store CBU in accordance with the collection schedule set forth in Contract Section B.2.b. The following parts of this Statement of Work specify additional requirements for the collection of CBU: HRSA Cord Blood Bank Accreditation Requirements; HRSA Informed Consent Requirements; Processing and Storage Requirements for HRSA Reimbursable Cord Blood Units; and, Specifications for HRSA Reimbursable Cord Blood Units.

3.a.

Collection Site Agreements and Collection Schedule The Contractor must have written agreements with facilities in which the Contractor proposes to collect and store CBU for the NCBI. The agreements must clearly state that fees will not be charged to the donor mother or donor baby for the collection and storage of the CBU for the NCBI. The CBU storage schedule for the first year and subsequent options are set forth in Contract Section B.2.b. A monthly collection and storage schedule for each year in which HRSA CBU reimbursements occur, must be approved by the Project Officer and submitted as set forth in the Schedule of Deliverables. The schedules must include the number of NCBI CBU contracted to be collected and stored in the racial and ethnic categories as set forth in Contract Section B.2.b. The Contractor must submit an annual plan for the collection and storage of high-quality and genetically diverse CBU. The collection plan must include specific objectives with an implementation time line to achieve the donation, collection, and storage targets described in the plan.

3.b.

Donor Consent and Screening Additional detail regarding HRSA informed consent requirements is found in Part C: HRSA Cord Blood Accreditation Requirements. The Contractor must have formal review of investigational protocols and informed consent documents for cord blood collections by an institutional review board or another formal review process with similar structure and functions to ensure protection of human rights of donors and patients. At the time of donation, the Contractor must ensure the donor mother is at least 18-years old and eligible under State law or regulations to consent to cord blood donation. The Contractor must ensure the donor (donor mother and donor baby) screening process complies with all applicable Federal regulations including the donor eligibility and tissue regulations for the donation of unrelated donor cord blood for stem cell transplantation. The donor baby is defined as the baby from whom the CBU is obtained. The donor mother must be the biological and birth mother of the donor baby. The Contractor must follow donor screening and cord blood collection practices that protect the health and safety of donors (donor mother and donor baby) and transplant recipients, and prevent the transmission of potentially harmful infections and other diseases. Informed consent documents to be used for the collection of NCBI CBU must be submitted to and approved by the Project Officer prior to beginning NCBI collections.

3.c.

Revocation of Consent The Contractor must have established procedures regarding the possibility of donor mothers wishing to revoke consent to donate their baby’s CBU to the bank. If the Contractor’s procedures allow for revocation, the Contractor must replace any NCBI units removed from the inventory with an equivalent unit at no cost to the Government within 30-days of removal from inventory. Replacement units must have been collected on the same date or more recently than the CBU that is being replaced. The Project Officer must be notified of NCBI CBU donor revocation within 5-days of the occurrence.

3.d.

Staff Training and Assessments At least annually, the Contractor must ensure collections staff receives ongoing training and competency evaluation specific to the duties they perform in donor screening and cord blood collections. The Contractor must document the training and competency evaluation.

3.e.

Donor Confidentiality The Contractor must have established confidentiality policies adequate to protect the identity and privacy of donors and patients in accordance with all Federal and State laws and policies established by the CBCC. Ongoing staff training and competency evaluations must include confidentiality. The Contractor must have established procedures to confidentially maintain the linkage between the donated CBU and the donor mother. The Contractor’s confidentiality policies and procedures must ensure that the identifying information for the donor mother, donor baby and the linkage to the CBU are confidentially maintained during any transfer of CBU from one bank or facility to another.

3.f.

Donor Baby Follow-up The Contractor must have established policies for donor baby follow-up to assess the continued suitability of the CBU for public donation. The Contractor must have a procedure to document and review, to the extent practical, any changes identified in the donor baby’s health status and re-evaluate the CBU eligibility for public banking. The offeror must have a policy that addresses public donation of cord blood from babies that will be adopted. If the offeror proposes to accept donations from a donor-mother who is placing her infant up for adoption, its policy must encourage and enable adoptive parents to contact the bank if the adopted child is diagnosed with a serious illness after his/her unit has been publicly banked.

3.g.

Release of Information The Contractor must have established procedures for the release of donor mother and donor baby information and records, including information and records shared between entities (e.g., collection sites, cord blood bank, registries).

3.h.

Reporting of Race/Ethnic Information The Contractor must report to the Project Officer, through the CBU progress reports, the race (race categories identified below) and ethnicity (Hispanic or non-Hispanic) of each NCBI CBU. The Contractor must have a method to acquire the race and ethnicity information on the donated CBU directly from the donor mother. The donor mother must have an opportunity to identify the ethnicity of the donated CBU as Hispanic or non-Hispanic and the race as one or more of the following five broad race categories: American Indian or Alaska Native; Black or African-American; Asian; Native Hawaiian or Other Pacific Islander; and White. If a donor does not select one or more broad race categories, the unit is ineligible for HRSA reimbursement. If a donor does not select Hispanic ethnicity, the ethnicity must be reported as non-Hispanic.

Task 4: Processing, Cryopreservation, Storage, and Release of CBU

The following requirements pertain to the processing, storage and release of CBU:

1. The Contractor must comply with all Federal and State requirements applicable to cord blood banking for unrelated donor transplantation, including licensure and IND requirements.

2. The Contractor must assign each NCBI CBU a unique identifier and must be able to reliably identify the unit as a NCBI CBU.

3. The Contractor must complete cryopreservation of collected CBU within the time frame and manner specified in Part E, Processing and Storing Requirements for HRSA Reimbursable CBU.

4. The Contractor must establish and maintain procedures for the control of CBU storage areas to prevent cross contamination and improper release of CBU.

5. The Contractor must perform testing of the cord blood and the donor mother samples as specified by HRSA, the FDA, and the CBCC.

6. The Contractor must establish validated procedures for storing, selecting, retrieving and transporting CBU to transplant centers. The Contractor must have a system to document CBU requests, requests for reference samples, requests for and results of testing, and the transportation of units and samples between facilities.

7. The Contractor must ensure that the terms of the donor consent form are adhered to and that donor confidentiality is maintained.

8. The Contractor must provide transplant centers receiving CBU with adequate instruction (including validated SOPs) to ensure, to the maximum extent feasible, that CBU for transplant are stored, thawed, and processed by the center using procedures appropriate for the CBU being released. Prior to the release of a CBU for transplant, the Contractor must have a written request from the transplant center (physician) or CBCC for shipment of the CBU. Prior to releasing the CBU for transplant, the CBB medical director must review the CBU record, including the processing record, test results, donor medical history and screening records, and any donor follow-up information.

9. The Contractor must collaborate with the CBCC and the transplant centers to ensure a system is established defining the roles and responsibilities of each entity involved the CBU distribution process.

10. The Contractor must have an established system to track and document the chain of custody of each CBU from collection to disposition of the unit, including release to a transplant center.

Task 5: CBU for Research The Contractor must establish a system to make available for peer-reviewed research some CBU that do not meet NCBI reimbursement criteria. This system must include a method for tracking requests and their disposition. The Contractor must verify that the units released for clinical research are being utilized in an IRB approved protocol or that the recipient of the research unit has a documented exemption. The Contractor must ensure the necessary research consent was obtained from the donor for such units. If the unit is being used for a research protocol that receives Federal grant or contract funds, the Contractor must provide HRSA and the CBCC with the grant or contract number. At a minimum, the Contractor must submit the specified information in Task 7 as set forth in the Schedule of Deliverables and in the CBU Collection Progress Reports; additional required information may be defined by the CBCC, subject to HRSA approval.

Task 6: CBU Availability, Reservation, Distribution and Outcomes Data Collection

6.a.

CBU Data Available for Search

NCBI CBU: For all HRSA reimbursed CBU, the Contractor must provide to the CBCC the data needed for CBU listing and search activities, adhering to the content, format, and time frame specified by the CBCC (currently using the CordLink application). Distribution of these units must be performed as described in Task 6.c. If the Contractor elects to make NCBI CBU available for search directly or through organizations other than the CBCC, the Contractor must inform HRSA and the CBCC. If the Contractor makes NCBI CBU available through search systems other than the CBCC, the Contractor must include in the CBU progress reports a summary of which other search systems are used.

Other CBU (CBU not reimbursed by HRSA): For other CBU in the Contractor’s inventory that meet the CBCC requirements for listing as approved by HRSA, the Contractor must make available to the CBCC the data needed for listing and search activities adhering to the content, format, and time frame specified by the CBCC (currently using the CordLink application). Although these CBU are not part of the NCBI, information on them must be made available for CBU searches performed by or facilitated through the CBCC. The Contractor must notify HRSA through the CBU Collection progress reports per the Schedule of Deliverables as these units become available to the CBCC for search.

Multiple Search Systems: The Contractor must work with the CBCC and any other search systems utilized by the Contractor to make sure a CBU listed in multiple systems is easily identifiable as the same CBU in all systems. The Contractor must provide updates on the availability of CBU to all search systems as soon as practical.

Project Officer Access to CBU Data: The Contractor must work with the CBCC to grant the Project Officer and designated alternate with read-only access to the Contractor’s non-confidential data maintained in the CBCC’s automated system (currently CordLink). Infrequently, HRSA may need to access this data for reporting purposes or to address invoicing discrepancies.

6.b.

CBU Reservations The Contractor must follow reservation policies and procedures established by the CBCC subject to HRSA approval to enable transplant physicians to make exclusive, time limited reservations of units.

6.c.

Distribution of CBU The Contractor must distribute CBU reimbursed under this contract exclusively through the CBCC. However, the Contractor may distribute the HRSA reimbursed CBU directly or through other organizations in any rare instances in which the best interest of the patient cannot be served by distribution through the CBCC (as described below). CBU distributed outside of the CBCC are subject to the replacement requirement as described in task 2.a.

Patient’s Best Interest If it is in the patient’s best interest to distribute a unit from the Contractor directly to a transplant center or through an organization other than the CBCC, the Contractor may distribute the unit for transplant in that manner. In these instances, the Contractor still must submit data as specified in task 2.d. The Contractor must notify the Project Officer within 5-days of each such distribution and the reason(s) it was necessary. HRSA expects that these instances will be rare; frequent use of this exception without a reason acceptable to the Project Officer will be considered a violation of contract requirements.

Summary of Requirements for NCBI Banks Regarding CBU Search and Distribution

*Exception: Patient’s best interest requires other means (expected to be rare)

Task 7: Timely Information on Contract Progress The Contractor must keep the Project Officer informed of contract progress. Progress reports must be submitted in accordance with the Schedule of Deliverables and the Collection Progress Reports. The content of the progress reports must be submitted in an organized, easily viewed electronic format that can be printed on letter or legal size paper with all information printable within the margins.

7.a.

Progress Reports The reports must describe the progress of the contract in relation to the approved collection schedule. The progress reports must include information on NCBI and non-NCBI CBU collected for inclusion in the Contractor’s public inventory. The information and format will be further specified by HRSA. At a minimum, the progress reports must include the following information:

1. NCBI CBU distributed through other search systems If the Contractor makes NCBI CBU available through search systems other than the CBCC, the Contractor must include in the progress reports a summary note on the other search systems used and the percent of NCBI units made available in each search system. The Contractor must clearly identify any CBU that were not distributed through the CBCC.

2. Peer-Reviewed Research The progress reports must include information on CBU not suitable for HPC transplantation made available for peer-reviewed research. The report must include a summary note on the number of CBU provided for peer-reviewed research, researchers and organization(s) receiving the CBU, the types of research, if the research is clinical or non-clinical, and if applicable, the amount charged to researchers.

3. CBU Released for Transplant The progress reports must include information on the characteristics of all NCBI and non-NCBI CBU released for transplant or other therapeutic use and the outcomes of patients receiving these units.

4. NCBI CBU Transfers The progress report must include a summary note on any NCBI CBU transferred from another bank into the Contractor’s inventory. A summary must be included in the progress report for the reporting period in which the units are transferred. The summary note must include the number of CBU, the CBU identifier(s) of the CBU transferred, the identity of the CBB from which the Contractor received the transferred units, and the reason for the transfer. CBU transferred into the Contractor’s inventory do not count towards the number of CBU the Contractor agreed to collect in the collection schedule for this contract.

5. Operational Changes The Contractor must include in the progress report a summary note on any changes that may potentially impact the progress of the contract (e.g., in key personnel, facilities, accreditation, significant equipment, and governing bodies).

6. Adverse Events The Contractor must promptly report any serious adverse events related to the CBU including events related to transplant outcomes and donors (donor mother or donor baby) to the Project Officer, CBCC, and to the appropriate Federal and State agencies as required. The Contractor must follow-up on each serious adverse event and continue to inform the Project Officer through progress reports until resolution of the event. The Contractor must inform HRSA of all other entities to which the adverse event has been reported.

Task 8: Annual and Final Report of Contract Activity

The Contractor must submit to the Project Officer an annual report and a final report of the contract. The reports must include the same types of information specified for the progress reports. This report must also include descriptive information on CBU collected for the NCBI, non-NCBI CBU, and CBU made available for peer-reviewed research. The report must include summaries in the following areas: CBU collections; data collection since the last report (type of data collected and the number of CBU with data reported); current list of the Contractor’s governing groups; changes in CBB key personnel, facilities, governing bodies, registry/search system(s); and fee structure for CBU testing and distribution of CBU since the last report. The report must cover all items identified in the Schedule of Deliverables. This data must be presented in summary form covering the period of performance from the effective date of the contract to report due date.

Task 9: Program Obligations

The Contractor must participate in the Program’s Cord Blood Coordinating Center for the performance period of the contract, including providing specimens to the donor-recipient repository as specified by the CBCC. Additionally, the Contractor must make CBU collected and stored pursuant to this contract available and obtainable through the CBCC for the Program in perpetuity, or for such time as they are determined viable by the Secretary.

C. HRSA CORD BLOOD ACCREDITATION REQUIREMENTS

HRSA may, in the future, modify accreditation requirements based on Recommendations of the Advisory Council on Blood Stem Cell Transplantation or for other reasons. HRSA will provide the Contractor with sufficient time to comply with any changes in these requirements.

1. The Contractor must have and maintain CBB accreditation from an accrediting organization recognized by HRSA (currently AABB or FACT). The Contractor must submit to HRSA documentation of new or renewed accrediting certifications and any changes in certification status. The Contractor must notify HRSA of any deficiencies or non-conformities identified during the accreditation process and the final resolution or corrective action required to resolve the deficiencies or non-conformities. The Contractor must provide HRSA with copies of the inspection reports. The Contractor must, as a matter of daily practice, comply with the requirements of the HRSA recognized accrediting organization(s). The Contractor must comply with any additional HRSA requirements that may be included as part of the accreditation process or as an addendum for HRSA contracted banks.

2. HRSA contract requirements may differ from the standards established by the accrediting organization(s) and the accrediting organization(s) may be asked to assess the Contractor’s facility against specific HRSA criteria. If an additional assessment of the Contractor’s facility is required to comply with NCBI contract requirements, it is the responsibility of the Contractor to make arrangements for this assessment. Any additional fees charged by the accrediting organization(s) for assessing HRSA specific criteria is the sole responsibility of the Contractor and will not be reimbursed by the Government.

D.

HRSA INFORMED CONSENT REQUIREMENTS

HRSA may modify these informed consent requirements based on any future recommendations made by the Advisory Council on Blood Stem Cell Transplantation or for other reasons. HRSA will provide the Contractor with sufficient time to comply with any changes in these requirements.

Informed Consent Procedures

1. Prior to the collection of any units for the NCBI, the Contractor’s informed consent form, and any changes made to an approved consent form, must be submitted to HRSA and any necessary institutional review boards for approval.

2. Policies and procedures for education and obtaining informed consent must address how the consent process will be implemented, the education provided to the donor mother, and the timing and content of the consent process.

3. The bank must have established policies for dealing with paternal objections to the cord blood donation.

4. At the time of consent, the cord blood bank must ensure the donor mother is at least 18-years old and of eligible age by State regulations to consent for cord blood donation. The education and consent process for cord blood donation should begin prior to the donor mother’s admission to the collection facility for delivery. Whenever feasible, cord blood banks must obtain written informed consent to donate from donor mothers prior to hospital admission and active labor. Banks always must obtain written informed consent to collect the CBU prior to the initiation of the collection process.

5. The Contractor’s informed consent process, at a minimum, must cover the following:

a. Ensure that the informed consent discussion with the donor mother is accurate, objective, non-coercive and culturally appropriate.

b. Ensure that the consent is understood by the donor mother and obtained in a language understood by the donor mother.

c. Ensure that the donor mother is actively involved and knowledgably informed in the choice of whether and how to donate cord blood. Ensure the donor mother demonstrates her active participation and consent by acknowledging in writing prior to the CBU collection that she fully understands all possible dispositions of her baby’s cord blood, the collection procedure, and her decision to donate the baby’s cord blood to a public cord blood bank.

d. Ensure the donor mother is not given the impression that the unit will be available to the family after donation if it is donated for inclusion in the NCBI. If applicable, inform the donor mother that the donor mother gives up all claims to the CBU, including rights to any commercial value derived from the CBU; that the CBU may or may not be used for transplantation; and that once her CBU is donated for possible inclusion in the NCBI, the CBU becomes the property of the CBB to which it is donated and may be transferred to another NCBI bank.

e. Inform the donor mother that there will be no charges incurred by the donor mother or donor baby for the public donation of cord blood to the NCBI.

f. Inform the donor mother if any donor information or records will be shared or stored with an entity other than the bank in which the unit was donated. Inform the donor mother how the bank maintains the confidential linkage between donated CBU and the donor mother including during the transfer of the donated unit or donor information from one facility to another.

g. Ensure the donor mother understands all the possible uses for the donor baby’s cord blood including, but not limited to, clinical, research and commercial use. The donor mother must be informed that the unit may be given or sold to investigators to be used in research and that the unit may be discarded without her approval or notification.

6. The informed consent document must, at a minimum, cover the following information:

a. Purpose of the consent document and cord blood collection.

b. Disclosure of potential risks/harm to donor mother and donor baby; donor safety concerns and that the procedure will not interfere with routine obstetrical practice.

c. If applicable, consent to review the donor mother and donor baby medical chart.

d. Where and how the unit and associated samples will be stored.

e. Donor mother and donor baby specimen collection, testing and storage (specify current and future testing of collected/stored maternal and cord blood samples).

f. Consent to draw blood from the donor mother to be tested for infectious disease markers.

g. Notification procedure for abnormal test results (donor notification and requirements to notify state health departments as applicable).

h. If applicable, consent to receive copies of state screening tests.

i. Risks associated with donating, including for research (e.g., violations/breaches of privacy and confidentiality even after the removal of personal identifiers).

j. Discovery/disclosure of health related information (negative information such as positive infectious disease or genetic test results) and potential impact that this may have on the donor mother and donor baby (e.g., future insurability).

k. Importance of the donor mother’s notification to the cord blood bank of changes in the donor baby’s health, which may affect the suitability of the unit for transplantation.

l. Possible dispositions of the donor baby’s cord blood and, at a minimum, include the following alternatives to public banking: private (family) storage; research; and discard.

m. Specify that the donor mother is consenting to donate the donor baby’s cord blood for potential inclusion in the NCBI, which is part of the C.W. Bill Young Cell Transplantation Program. The consent also must clarify that the CBU ultimately may not meet the criteria for the NCBI or for public banking and clarify what may happen to the unit in such cases.

n. Clearly state that the donor mother gives up all claims to the CBU, including rights to any commercial value derived from the CBU; that the CBU may or may not be used for transplantation; and that once her CBU is donated for inclusion into the NCBI, the CBU becomes the property of the CBB to which it is donated and may be transferred to another NCBI bank. The bank must ensure that the consent form (subsequent to any IRB-required changes) is consistent with this requirement or employ an alternative approach, approved by the project officer, to prevent depletion of the NCBI by revocations of donation. (See Task 3.c.).

o. If applicable, include discussion of any donor information or records that will be shared or stored with an entity other than the bank in which the unit was donated. The consent document must cover how the bank maintains the confidential linkage between donated CBU and the donor mother including during the transfer of the donated unit or donor information from one facility to another and how confidentiality is maintained.

p. All the possible uses for the donor baby’s cord blood including, but not limited to, clinical, research and commercial use; and if the unit may be given or sold to investigators to be used in research and that the unit may be discarded without donor mother’s approval or notification.

E.

PROCESSING AND STORAGE REQUIREMENTS FOR HRSA

REIMBURSABLE CBU

CBU Processing for HRSA Reimbursable CBU: HRSA, in consultation with the Advisory Council and other experts, will assess processing methods and revise requirements as necessary to best meet the needs of the National Cord Blood Inventory and the C.W. Bill Young Cell Transplantation Program. HRSA will provide the Contractor sufficient time to comply with any changes in these requirements.

Standard Operating Procedures (SOP) and Training Requirements: The Contractor must have scientifically sound, standardized, validated SOP for collecting, processing, cryopreserving, storing, shipping, testing, and releasing CBU. The Contractor must use methods intended to ensure cord blood product safety and efficacy in order to optimize clinical transplant outcomes and minimize the risk of transmission of disease.

CBU Processing, Cryopreservation, and Storage:

1. The Contractor must store cord blood in bags designed for the storage of human blood stem cells and validated to maintain integrity at temperatures of -196ºC. The storage bags used must be validated for the segments of the bags to maintain their integrity at a temperature of -196ºC.

2. The Contractor must over-wrap each CBU with plastic prior to the initial long-term storage of the unit.