Att_A_PWS_NCBI_07222019.pdf

Attachment A Performance Work Statement (PWS)

National Cord Blood Inventory (NCBI)

July 22, 2019

DEFINED TERMINOLOGY

A. INTRODUCTION

Mission Purpose Background on Federal Programs Related to Unrelated Blood Stem Cell Transplantation5 Overview of Blood Stem Cell Transplantation

B. GENERAL REQUIREMENTS

Contractor Personnel, Disciplines, and Specialties

C. PERFORMANCE REQUIREMENTS

Task 1 Federal Records Management Task 2 Federal Records Management Training Task 3 HRSA OIT Security Requirements

3.1 Baseline Security Requirements

3.2 Incident Response

3.3 Contract Initiation and Expiration

Task 4 Interrelated Contract Requirements

4.1 Comply with CWBYCTP and NCBI Requirements

4.2 Contract Administration Requirements

4.2.1 Attend Initial/Kick-off Meeting

4.2.2 Attend Annual Progress Meetings

4.2.3 Host Site Visits

4.3 Operational Requirements

4.3.1 Operate a Cord Blood Bank

4.3.2 Maintain Cord Blood Collection Sites

4.3.3 Expand Collections at Existing or New Sites

4.3.4 Maintain a CBU Collection Schedule

4.3.5 Maintain CBU Delivery Schedule

4.3.6 Specify NCBI CBU Characteristics and Specifications

4.3.7 Define and Report CBU Broad Race and Ethnicity

4.3.8 Maintain NCBI CBU Availability Status

4.3.9 Remove and Replace NCBI CBUs

4.3.10 Provide CBU for Peer-Reviewed Research

4.3.11 Maintain Contingency Plan

4.3.12 Achieve Self Sufficiency

4.4 Submit Reports

4.4.1 Verify Submissions to the Government for Accuracy

4.4.2 Submit Monthly Progress Reports

4.4.3 Submit Annual Progress Reports

4.4.4 Submit Final Progress Report

Defined Terminology

For purposes of ensuring all potential bidders have and understand common terminology used by the government within this performance work statement.

CBU: Cord Blood Unit CBB: Cord Blood Bank NCBI CBU: CBU added to the NCBI pursuant to this contract SPA-CC: CWBYCTP’s Single Point of Access-Cord Blood Coordinating Centers SPA-CC Contractors: Contractor(s) with HRSA Contracts for the Single Point of Access, Cord Blood Coordinating Center, Bone Marrow Coordinating Centers, or a bundled CWBYCTP component contracts.

Performance Work Statement (PWS) National Cord Blood Inventory (NCBI)

A. INTRODUCTION

The Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration (HRSA), is seeking to contract with cord blood banks (CBBs) to continue to build the National Cord Blood Inventory (NCBI) by adding new, high-quality, genetically diverse cord blood units (CBUs). CBUs added to the NCBI are available to patients through HRSA’s C.W. Bill Young Cell Transplantation Program (CWBYCTP). Some CBUs collected for the NCBI that are not suitable for clinical use are available to researchers for peer-reviewed research activities.

Mission

The NCBI supports HRSA's mission to improve access to quality healthcare and services by contracting services to achieve the statutory goal of adding at least 150,000 new, high-quality, genetically diverse CBUs to the NCBI and making these CBUs available through the

CWBYCTP.

Purpose

The purpose of this contract is to increase cord blood collections by public cord blood banks, add new, high-quality, genetically diverse CBUs to the NCBI and make these units available through the CWBYCTP, and make CBUs not suitable for clinical use available for peer-review research activities. In performing the activities of the NCBI, the Contractor shall:

1. Operate a public CBB that complies with the requirements of the CWBYCTP and its program contractors, NCBI, HRSA Recognized NCBI Cord Blood Bank Accrediting Organizations Standards (for accreditations it has achieved), and U.S. Food and Drug Administration (FDA) biologics license application (BLA), Section 351 of the Public Health Service Act, for the biological product, Hematopoietic Progenitor Cell (HPC), Cord Blood, for use in unrelated donor hematopoietic progenitor cell transplantation procedures.

2. Collect and store cord blood units from a genetically diverse group of donors;

3. Make CBUs available through the CWBYCTP;

4. Make some CBUs, not suitable for clinical transplantation available for peer-reviewed research;

5. Submit data in a standardized format to the Government and CWBYCTP contractors;

6. Maintain a contingency plan for transferring NCBI CBUs in the event that the Contractor can no longer meet contract requirements;

7. Maintain a contingency plan for receiving NCBI CBUs in the event that the CBB receives

NCBI CBUs from another CBB; Demonstrate self-sufficiency by financial and operational sustainability.

Background on Federal Programs Related to Unrelated Blood Stem Cell Transplantation

In 1987, the National Bone Marrow Donor Registry (NBMDR) was initiated through a congressionally-directed grant from the 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), with oversight initially by the National Institutes of Health (National Heart, Lung, and Blood Institute) and, since 1994, by HRSA. The NBMDR contract encompassed, among other activities, the recruitment and tissue typing of adult volunteer donors; the facilitation of the selection of donors for particular patients, the distribution of blood stem cells to transplant centers; the provision of case management and advocacy services for patients; the coordination of an international blood stem cell transplant; and the development of contingency plans to address events that may cause marrow toxic injuries.

In 2005, the Stem Cell Therapeutic and Research Act (Public Law (P.L.) 109-129), as amended by P.L. 111-264 (in 2010) and P.L. 114-104 (in 2015), amended the Public Health Service Act to require the HHS Secretary, acting through HRSA, to rewrite provisions that required the HHS Secretary to establish and maintain the NBMDR. The provisions of the Stem Cell Therapeutic and Research Act were rewritten to establish and maintain the CWBYCTP, the successor to the NBMDR, to increase the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow and cord blood.

The provisions also established the NCBI to contract with cord blood banks to meet the statutory goal of building a public inventory of at least 150,000 new, high-quality, genetically diverse CBUs, which are made available to individuals, through CWBYCTP, on the donor registry. The Act requires recipients of contracts for the NCBI to make CBUs that are not suitable for clinical transplantation available for peer-reviewed research.

In addition to the requirement for the Secretary to enter into contracts with qualified CBBs to assist in the collection and maintenance of at least 150,000 new units of high-quality cord blood, the Act requires recipients of contracts for the NCBI to submit data in a standardized electronic format for inclusion in the stem cell therapeutic outcomes database maintained under section 379A of the Public Health Service Act, as amended by the Stem Cell Therapeutic and Research Act of 2005 (Public Law 109-129, and as amended).

The Stem Cell Therapeutic and Research Act also requires the Secretary to establish an Advisory Council to advise, assist, consult with, and make recommendations to the Secretary of Health and Human Services and the Administrator of HRSA on matters carried out by both CWBYCTP and the NCBI Program.

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 each year nearly 18,000 people in the U.S. are diagnosed with life-threatening illnesses where blood stem cell transplantation from a matched donor is the best treatment option. 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 cord blood unit. Even with over 20 million adult donors and over 700,000 umbilical cord blood units listed on the registries worldwide, the close tissue matching required with adult donors has left many patients without a suitably matched unrelated adult donor. This is especially true for racial and ethnic minorities, mainly because they possess more diverse tissue types. Therefore, other sources of blood stem cells like umbilical cord blood has provided a potential cure for many patients.

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.

B. GENERAL REQUIREMENTS

This section describes the general requirements for this effort. The following sub-sections provide details of various considerations on this effort.

Contractor Personnel, Disciplines, and Specialties

The Contractor shall accomplish the assigned work by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. Pursuant to the Key Personnel clause (HHSAR 352.237-75), the following individual(s) is (are) designated as Key Personnel and considered to be essential to the work being performed under this contract:

Project Director and Coordinator.

C. PERFORMANCE REQUIREMENTS

The performance requirements include the tasks listed below.

Task 1 Federal Records Management

The contractor shall manage and maintain Federal records, including electronic records, ensuing from this contract in accordance with all applicable records management laws and regulations, including but not limited to the Federal Records Act (44 U.S.C. Chapters. 21, 29, 31, 33); 36 CFR § 1236.20 What are appropriate recordkeeping systems for electronic records? & 1236.22 What are the additional requirements for managing electronic mail records?

(http://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=36:3.0.10.2.25); NARA Bulletin 2013- 02, August 29, 2013, Guidance on a New Approach to Managing Email Records (https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html); and NARA Bulletin http://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=36:3.0.10.2.25 https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html

2010-05 September 08, 2010 (http://www.archives.gov/records-mgmt/bulletins/2010/2010- 05.html), Guidance on Managing Records in Cloud Computing Environments.

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.

Task 2 Federal Records Management Training

The contractor shall ensure that all employees having access to (1) Federal information or a Federal information system, or (2) personally identifiable information (PII), complete the HRSA Records Management Training before performing work under this contract, and thereafter completing the annual refresher course during the life of the contract. The training can be requested by emailing the records management team at recordsmanagement3@hrsa.gov. 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.

Task 3 HRSA OIT Security Requirements

The Contractor shall implement security and privacy protections for all systems directly used to fulfill this contract following industry best practices. Annual independent audits/testing shall be included in the implemented best practices.

3.1 Baseline Security Requirements

1) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

2) Confidentiality and Nondisclosure of Information. Any information provided to the contractor(and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor officer or employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such officer or employee can be used only for that purpose and to the extent authorized herein.

http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html mailto:recordsmanagement3@hrsa.gov

Unauthorized disclosure of information is governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

3) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the HRSA non-disclosure agreement (Attachment B). A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

3.2 Incident Response

1) Report all suspected and confirmed information security and privacy incidents and breaches to the HRSA Security Operations Center (SOC), COR, CO, HRSA SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable HRSA and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

b. not include any sensitive information in the subject or body of any reporting e-mail;

and

c. encrypt sensitive information in attachments to email, media, etc.

2) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally

Identifiable Information, HHS, and HRSA incident response policies when handling PII breaches.

3) Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents.

This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls.

3.3 Contract Initiation and Expiration

1) Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation to the CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

2) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within 10 days before an employee stops working under this contract.

Task 4 Interrelated Contract Requirements

4.1 Comply with CWBYCTP and NCBI Requirements

The Contractor shall:

• Comply with C.W. Bill Young Cell Transplantation Program (CWBYCTP) and NCBI Program requirements.

• Participate in the CWBYCTP Program through the period of performance of the contract.

The contract period of performance is, at least, 10 years from the last date Federal funds are obligated to the contract.

• Make data available in the standardized format required by SPA-CC contractors to make

NCBI CBU available through the CWBYCTP Program.

• Make NCBU CBUs available through the CWBYCTP SPA-CC contractors until the CBUs are released for therapy to a designated patient through an FDA BLA or IND, no longer eligible per contract requirements, or transferred to another NCBI CBB contract.

• Comply with the requirements of the CWBYCTP SPA-CC contractor to protect the rights and confidentiality of cord blood donors and CBU recipients, and maintain linkage between a CBU and maternal donor.

• Submit NCBI CBU pre-transplant data in compliance with the requirements of the

CWBYCTP’s Stem Cell Therapeutic Outcomes Data Base (SCTOD).

• Submit data for indications that are specified by the SCTOD.

• Submit the data in the standardized format per the SCTOD contractor.

• Provide a description of how it shall submit NCBI CBU pre-transplant data for CBU distributions facilitated by and not facilitated by CWBYCTP SPA-CC contractor.

• Report in contract progress reports if the data has been submitted to SCTOD.

4.2 Contract Administration Requirements

4.2.1 Attend Initial/Kick-off Meeting

• Meet with the Contracting Officer Representative (COR) to review the task requirements, Quality Assurance Surveillance Plan (Attachment C), and schedule for the contract. The meeting shall be by telephone. An agenda and a conference number will be provided to the Contractor.

• Submit meeting minutes to the COR within three (3) calendar days after the kick-off meeting.

The meeting minutes shall include:

1. Date of meeting;

2. Names of attendees;

3. A summary of all discussion topics in the order outlined in the agenda;

4. Action items to be addressed;

5. Individual(s) responsible for completing each action item;

6. Due dates for each action item;

7. Materials, if any, presented at the meeting; and

8. Date of follow-up meeting (if any).

4.2.2 Attend Annual Progress Meetings

• Meet with Government staff annually to review contract progress against contract plans, schedules, and requirements. The Project Director or Coordinator shall participate in the meeting. The meeting shall be by telephone. The COR will provide agenda and a conference number or call the Contractor directly.

• Submit meeting minutes to the COR within three (3) calendar days after the meeting.

3. A summary of all discussions;

4. Action items to be addressed;

5. Individual(s) responsible for completing each action item;

6. Due dates for each action item;

4.2.3 Host Site Visits

For the initial site visit, the Contractor shall:

• Meet with Government staff, prior to initiating NCBI CBU collections, to review progress report formats and expectations, progress of implementation of task requirements. The initial site visit shall be a CBB site visit.

For subsequent visits, the Contractor shall:

• Meet with Government staff for a site visit each year it has a delivery schedule for NCBI CBUs. The COR will schedule a site visit at the Contractor’s CBB or cord blood collection site(s).

• Provide a draft site visit agenda to the COR for approval no later than 10 calendar days prior to the visit. The meeting agenda shall cover the following:

1. Contract number and name;

2. Dates and times of agenda items;

3. Name of staff, by title, conducting contractor-led agenda items;

4. Meeting locations with street addresses for all activities;

5. Contractor’s meeting participants by name, title, and contract role; and

6. Contractor’s contact information during site visit: names and positions, phone numbers, and email addresses.

• Submit meeting minutes to the COR within three (3) calendar days after the site visit.

3. A summary of all discussion topics in the order outlined in the agenda;

4. Action items to be addressed;

5. Individual(s) responsible for completing each action item;

6. Due dates for each action item;

Cord Blood Bank Site Visit: The Contractor shall provide a tour of its CBB. The Contractor shall arrange for Government staff to observe cord blood processing in its laboratory.

Collection Site Visit: The COR will select the collection site location for visit(s). If the Contractor has more than one site within the site visit vicinity, the COR may visit an additional site. The Contractor shall provide a tour of the collection site(s). The tour shall include a description of the collection and administrative activities that occur at the site and the roles of personnel roles. If the site performs ex utero collections, the Contractor shall arrange for Government staff to observe an ex utero collection performed by its collection staff.

4.3 Operational Requirements

4.3.1 Operate a Cord Blood Bank

• Have and maintain its CBB in compliance with its U.S. FDA BLA, Section 351 of the Public Health Service Act, for the biological product, Hematopoietic Progenitor Cell (HPC), Cord Blood, for use in unrelated donor hematopoietic progenitor cell transplantation procedures.

• Have and maintain its CBB in compliance with accreditation Standards for all NCBI accrediting organizations that it has achieved accreditation.

• Have and maintain CBB accreditation from an NCBI Accrediting Organization. If the Contractor has accreditations by more than one (1) NCBI accrediting organization, the Contractor shall maintain all accreditations throughout the period of performance of the contract.

• Submit copies of its Federal BLAs, NCBI CBB accrediting organization accreditation certificates for the biological product, Hematopoietic Progenitor Cell (HPC), Cord Blood, for use in unrelated donor hematopoietic progenitor cell transplantation, to the COR within 15-calendar days after the initial/kick-off meeting, for review.

1. The Contractor shall in accordance with the Schedule of Deliverables, progress reports, and contract tasks:

a. Submit to the COR the most recent copy of the approval letter for the Contractor’s FDA BLA for HPC, Cord Blood.

b. Notify the COR, in writing, of any changes to the Contractor’s FDA BLA affecting the contract including previously delivered CBUs.

c. Notify the Contracting Officer (CO) and COR, in writing, of any changes to its FDA BLA that affects manufacturing CBUs in accordance with the technical requirements of the contract. The notification shall be received before requesting reimbursement of CBU affected by its FDA BLA changes.

d. Notify the COR, in writing, of any status changes to the Contractor’s Federal licenses, (including pursuant to the regulations of the U.S. FDA), for the collection, processing, storage, and distribution of unrelated donor CBUs for

HSCT.

2. The Contractor shall in accordance with the Schedule of Deliverables, progress reports, and contract tasks:

a. Submit to the COR the most recent copy of accreditation letter(s) and any accreditation renewals received from accrediting organization(s).

b. Notify the COR, in writing, of any changes to the Contractor’s accreditation(s) affecting the contract, including eligibility of previously delivered CBUs. The notification shall be received before requesting further reimbursement of CBUs.

4.3.2 Maintain Cord Blood Collection Sites

• Maintain cord blood collection sites for NCBI CBU collections to achieve NCBI CBU deliveries.

• Have and maintain signed agreements with collection sites for NCBI CBU collections.

The agreements shall describe the responsibilities of each party and authorize the Contractor to operate its cord blood collection activities at the collection site.

• Provide the COR with copies of agreements that have been executed between the

Contractor and the collection site prior to initiating collections for the contract.

• Provide the COR copies of revised or amended agreements, including renewals. CBUs are not eligible for reimbursement from collection sites with expired collection site agreements or agreements that were not submitted to the COR prior to collections. Copies of executed agreements shall be provided to the COR within 15-calendar days after the initial/kick-off meeting for review.

4.3.3 Expand Collections at Existing or New Sites

• Have and maintain a plan for expanding its cord blood collections at existing collection sites, assisting with the establishment of new collection sites, or contracting with new collection sites. The plan shall cover all contract years listed in B.2. Price.

The plan shall describe the Contractor’s strategy for adding CBUs, by collection site and by race and ethnicity, to its public inventory.

• Implement the plan per the Schedule of Deliverables.

• Demonstrate annually the progress against its approved plan. The results of the evaluation shall be against the plan’s objectives and timelines, highlighting accomplishments and delays. The annual evaluation shall be by fiscal year, October 1- September 30.

• Submit annual evaluations in accordance with the Schedule of Deliverables and progress reports.

The plan shall include the following:

1. Contract years listed in B.2. Price.

2. Specify CBU increase by collection site and by race and ethnicity.

3. Specific annual objectives for increasing the quantity of Black/African-American CBUs and Asian CBUs added to the Contractor’s public inventory.

4. Timelines with a completion date for achieving annual objectives.

5. Projections on the increase in quantity of CBU collections, by race and ethnicity, for each year of the contract.

The Contractor shall submit a revised plan to the COR within 15-calendar days after the initial/kick-off meeting for review. The Contractor shall evaluate the progress against the plan annually.

4.3.4 Maintain a CBU Collection Schedule

• Have and maintain an NCBI CBU Collection Schedule for the NCBI CBU quantities listed for each contract year in B.2 Price. The schedule shall support delivery of all contracted NCBI CBUs by the final CBU delivery dates for each contract year and contract line item number (CLIN). Collection dates outside of the timeframe specified for each contract year, as shown below shall not be accepted.

Contract Year CBU Collection

Start Date begins on or after the effective date of CLIN award for the contract year

CBU Collection End Date and not before the following:

Year 1 January 1, 2020 September 30, 2020 Subsequent years

July 1 September 30

For example, Year 2

July 1, 2020 September 30, 2021

In accordance with Schedule of Deliverables and progress report tasks, the Contractor shall:

• Submit a schedule with a monthly breakdown, by CLIN and race/ethnicity, for NCBI collections for the NCBI CBU quantities listed for each contract year in Section B.2, Price.

• Submit a revised schedule to the COR within 15-calendar days after the initial/kick-off meeting for review.

4.3.5 Maintain CBU Delivery Schedule

• Have and maintain a delivery schedule for genetically diverse CBUs in accordance with the NCBI CBU quantities specified in B.2 Price for each contract year. The NCBI CBU Delivery Schedule with a monthly breakdown of contract NCBI CBU deliveries by contract year, CLIN, NCBI CBU broad race and ethnicity category, and collection site.

The schedule shall support NCBI CBU delivery by the service delivery period and final delivery dates for each contract year and CLIN.

The monthly progress of the schedule shall be reported per the progress reports and Schedule of Deliverables.

• Deliver licensed NCBI CBUs manufactured in accordance with the Contractor’s U.S.

FDA BLA.

• Deliver NCBI CBUs registered with CWBYCTP SPA-CC contractors as a licensed unit.

NCBI CBUs are not eligible for collection, delivery, and reimbursement while the Contractor’s BLA status is revoked, rescinded, suspended, rejected, inactive, or cannot manufacture a licensed CBU in accordance with its BLA. NCBI CBUs are not eligible for collection, delivery, and reimbursement while the Contractor’s accreditation status with any NCBI accrediting organization is revoked, rescinded, suspended, rejected, inactive, or cannot operate in compliance with cord blood bank accreditation standards.

• Deliver genetically diverse NCBI CBUs meeting the following requirements:

1. Combined Black/African-American and Asian categories: 20 percent or more of the total CBU quantity/contract year. The Contractor shall deliver each contract year by April 30, at least six (6) Asian CBUs each contract year, and at least six (6) Black/African-American CBUs, to be eligible for additional contract funding.

2. Combined American Indian/Alaskan Native, Native Hawaiian/Pacific Islander, and Multi-race categories: 10 percent or more of the total CBU quantity/contract year.

3. White, Non-Hispanic: 45 percent or less of the total CBU quantity/contract year.

4. White, Hispanic: 25 percent or more of the total CBU quantity/contract year.

• Submit a revised schedule to the COR within 15-calendar days after the initial/kick-off

4.3.6 Specify NCBI CBU Characteristics and Specifications

• Have and maintain specified CBU characteristics and specifications for NCBI CBUs.

• Have a minimum total nucleated cell (TNC) count for NCBI CBUs that shall not be higher than the Contractor’s established minimum TNC count for non-contracted public CBUs, by race and ethnicity.

• Submit its NCBI CBU and characteristics and specifications, to the COR, within 15-calendar days after the initial/kick-off meeting for review.

• Submit its established minimum TNC count for non-contracted public CBUs, by race and ethnicity non-contracted CBU to the COR, within 15-calendar days after the initial/kick-off meeting.

4.3.7 Define and Report CBU Broad Race and Ethnicity

• Use the following descriptions and categories to define CBU donors and report CBU broad race and ethnicity:

a. White – A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.

b. Black or African American (B/AA) – A person having origins in any of the Black racial groups of Africa.

c. American Indian or Alaska Native – A person having origins in any of the original peoples of North and South America (including Central America) and who maintains tribal affiliation or community attachment.

d. Asian – A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.

e. Native Hawaiian or Other Pacific Islander – A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.

f. Multi-race – A person identifying as having origins from than one (1) of the broad race categories listed above.

g. White Hispanic – A person having origins in any of the original peoples of Europe, the Middle East, or North Africa and having origins of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture with origins.

4.3.8 Maintain NCBI CBU Availability Status

• Report NCBI CBU availability status to the COR, through progress reports per the Schedules of Deliverables, in one of the following categories defined below: Available, Distributed, Not Available, Removed, or Replacement. For the contract’s Final Progress Report, no CBUs shall be reported as not available. All CBUs in ‘not available’ status on the date of the final progress report shall be removed from the NCBI and replaced by a CBU meeting contract replacement task requirements.

a. Available: An NCBI CBU that is available for unrelated donor hematopoietic transplantation through the CWBYCTP contractors. This includes a CBU that has not been released from the CBB, but has been identified for therapy for a designated patient for release through an FDA BLA or IND.

b. Distributed: An NCBI CBU released for therapy to a designated patient through an FDA BLA or IND that complies with contract requirements.

c. Not Available: An NCBI CBU that is temporarily not available through the CWBYCTP for less than 12 consecutive months. An NCBI CBU that is not available for 12-month consecutive months shall be removed from the NCBI and replaced per the contract replacement task.

d. Removed: An NCBI CBU that is removed and permanently not available through the CWBYCTP. Once the Contractor or CWBYCTP contractors report an NCBI CBU as removed from the NCBI Program, the removal is permanent. A removed NCBI CBU is not eligible for the NCBI Program.

e. Replacement: A CBU that replaced a removed NCBI CBU.

4.3.9 Remove and Replace NCBI CBUs

• Remove and replace CBUs that no longer meet NCBI contract requirements.

• Replace CBUs that are not released through an FDA BLA or FDA IND for therapy to a designated patient.

• Report all CBU removals prior to delivering new CBUs and requesting reimbursement.

CBU deliveries from race and ethnicity categories that have pending replacements shall not be accepted until the COR receives documentation from the Contractor certifying CBU replacements have been provided. The date of the certification report shall be within 30 days of the COR’s receipt of the report.

• Report CBU removals and replacements in accordance with the Schedule of Deliverables and progress reports.

• Replace CBUs removed from the NCBI within 30 calendar days of the removal from the NCBI. CBUs replacements shall meet the following criteria:

1. Meet contract NCBI CBU eligibility requirements, including race and ethnicity. For replacement of CBUs from the combined category, AI/AN, NH/PI, and Multi-race, the CBU may be replaced with a CBU from any race/ethnicity from category.

2. The replacement CBU shall not have been previously invoiced to the NCBI. The CBU collection date is no greater than six (6) months from the date the Contractor notified the COR of the removal. The CBU registration date with the SPA-CC is no greater than six

(6) months from the date Contractor notified the COR of removal. The Contractor shall notify the COR in accordance with the Schedule of Deliverables and contract progress report task. The notification date to the COR is the date the COR receives the corresponding progress report documenting the CBU removal.

3. CWBYCTP SPA-CC contractor’s certification that the CBU is a replacement CBU for removed CBU. The certifying document shall include the same details required for registration certification for delivery of new CBUs for reimbursement for CBUs removed and corresponding replacement CBUs.

4.3.10 Provide CBU for Peer-Reviewed Research

The Contractor shall provide CBUs, for peer-reviewed research, each month it delivers NCBI CBUs for the contract.

4.3.11 Maintain Contingency Plan

• Have and maintain a contingency plan for transferring and receiving NCBI CBU for continued availability through the CWBYCTP, if the Contractor can no longer store, maintain, and release NCBI CBUs or participate with the CWBYCTP or receives NCBI CBUs. The plan shall describe how the Contractor shall transfer NCBI CBUs and receive NCBI CBUs from other CBBs.

• Submit a revised plan to the COR within 15-calendar days after the initial/kick-off

4.3.12 Achieve Self Sufficiency

• Achieve self-sufficiency of its CBU collections and CBB operations within 3-years of the entry date of the contract. Self-sufficiency is defined as the Contractor sustaining its cord blood bank operations, including cord blood collections, without the reliance of NCBI contract funds.

• Have and maintain a plan for achieving or, if already achieved, maintaining self-sufficiency of CBU collections and cord blood bank operations. The implementation date of the plan shall be by per the Schedule of Deliverable. The plan shall have a date for the achievement of self-sufficiency.

• Evaluate its progress each fiscal year, October 1 –September 30, against the plan in accordance with the Schedule of Deliverables.

• Submit the information required per the progress reports tasks. The plan shall not be dependent on receiving NCBI contract funds or other Federal funds to continue non- NCBI CBU collections and CBB operations.

• Submit a revised plan to the COR within 15-calendar days after the initial/kick-off

4.4 Submit Reports

4.4.1 Verify Submissions to the Government for Accuracy

• Verify submissions sent to the Government accurately reflect NCBI CBU availability status and are consistent amongst documents it submits covering a reporting period.

• Reconcile discrepancies between the CWBYCTP contractors’ information and its NCBI

CBU contract records.

4.4.2 Submit Monthly Progress Reports

• Submit monthly reports with contract updates and other information through the monthly progress reports.

• Include a summary note on operational changes that affect the progress of the contract

(including personnel, facility, accreditation, equipment, procedures, and governing changes) or affect a NCBI CBU that has been reimbursed by HRSA (including units that have been distributed). The report shall cover activities for a monthly period, contract totals for Federal fiscal years, and cumulative contract totals in accordance with the contract templates for progress report content

• Report progress and performance against contract plans and schedules.

• Submit the report content as specified in Attachment D, Collection of Progress Reports.

• Report progress in accordance with Table 1, Progress Report Table.

4.4.3 Submit Annual Progress Reports

• Report contract annual updates and other information through the progress reports. The report shall cover from the entry date of the contract through the end of the Federal fiscal year, October 1 – September 30, of that reporting period, contract totals for Federal fiscal years, and cumulative contract totals in accordance with the contract templates for progress report content. The report shall highlight annual contract progress against contract plans and schedules, and cover annual contract activity.

The Contractor shall report progress in accordance with Table 1, Progress Report Table.

4.4.4 Submit Final Progress Report

• Submit a final progress report of the contract. The report must include the same types of information specified for the annual report. The report shall cover information and data from the entry date of contract through the end of the period of performance or specified contract term, contract totals for Federal fiscal years, and cumulative contract totals.

• Include a summary note on operational changes that affected the progress of the contract

(including personnel, facility, accreditation, equipment, procedures, and governing changes) or affect a unit that has been reimbursed by the HRSA (including units that have been distributed).

Template for Reports, progress report tasks.

• Report final contract activity in accordance with Table 1, Progress Report Table.

Table 1, Progress Report Table Progress Report

Report Name Frequency Comments Monthly Annual Final

1. Contract Key Item Updates

X * X N/A

2. CBU Collection Schedule

X * X Submit monthly and annual reports until NCBI CBU deliveries are completed.

3. CBU Delivery Schedule

X * X Submit monthly and annual reports until NCBI CBU deliveries are completed.

4. NCBI CBU Delivery X X X Submit monthly and annual reports until NCBI CBU deliveries are completed.

5. B-1 Invoicing Summary and Cumulative Reports

X X X Submit monthly and annual reports until NCBI CBU deliveries are completed.

6. CBU for Peer- Reviewed Research

X * X Submit monthly reports for months of NCBI CBU delivery.

7. CBU Availability Status Summary

X * X N/A

8. NCBI CBU Shipped X X X N/A

9. CBU Shipped

Summary X * X N/A

10. CBU

Removed/Replaced by

CLIN

X X X N/A

11. CBU Removed Summary

X X X N/A

12. NCBI CBU Transfer or Receipt

X X X N/A

13. Self-Sufficiency N/A X X N/A

* The September report of each year shall be the annual report for that year.