Solicitation_A_thru_M_NCBI_07222019.pdf

NCBI Solicitation; 19-250-SOL-00062

SECTION A – STANDARD FORM (SF) 33

SECTION A - TABLE OF CONTENTS

SECTION DESCRIPTION

A Table of Contents

B Supplies or Services and Prices/Costs

C Description/Specification/Work Statement

D Packaging and Marking

E Inspection and Acceptance

F Deliverables or Performance

G Contract Administration Data

H Special Contract Requirements

I Contract Clauses

J List of Attachments

K Representations, Certifications and Other Statements of Offerors

L Instructions, Conditions, and Notices to Offerors

M Evaluation Factors for Award

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Purpose of Contract

The purpose of this contract is to increase cord blood collections by public cord blood banks, add new, high-quality, genetically diverse cord blood units (CBUs) to the National Cord Blood Inventory (NCBI) and make these units available through the C.W. Bill Young Cell Transplantation Program (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;

8. Demonstrate self-sufficiency by financial and operational sustainability.

B.2 Compensation

a. In consideration of the satisfactory performance of the services that are described in detail in the Performance Work Statement (PWS) at Attachment A and Contract Section F.2, the Contractor shall be compensated as follows:

Line Item

Description

Quantity

Unit Price

Total Price

0001 Collection and Cryopreservation of Cord Blood Units in accordance with the Quota set forth in Paragraph b, below.

ea

Storage and Distribution of Cord Blood Units

N/A

NSP1

Reports and Deliverables in accordance with Section F.

N/A

Total

0004 Option for Units in Year 22,3

0005 Option for Units in Year 32,3

0006 Additional option for Units in Year

12,3,4

0007 Additional option for Units in Year 22,3,4

0008 Additional option for Units in Year 32,3,4

1Not Separately Priced, these services are included in the base unit and option collection prices.

2Optional funding for additional units (up to the specified number) may be exercised at HRSA’s discretion if sufficient funds are available.

3If a different unit price, previous race/ethnicity targets must be achieved prior to receiving reimbursement at the new rate.

4The race/ethnicity distribution of these CBU to be negotiated separately.

b. The Cord Blood Units delivered shall conform to the following Race/Ethnicity specifications.

Delivered

CBU

Quantity: Number (#) and Percent (%) Year 1 Year 2 Year 3 Year 4 Year 5 Total

Race/Ethnicity # % # % # % # % # %

B/AA*

Asian* White (non- Hispanic)

White (Hispanic)

AI/AN*,

NH/PI*, and Multi-race*%

Total

#If the Options for Years are exercised.

*Hispanic or non-Hispanic ethnicity.

%Two or more broad races (i.e., AI/AN, B/AA, Asian, NH/PI, or White). Note that Hispanic is not a race and cannot, in conjunction with any single broad race category, move a unit into the Multi-race category.

a. Additional Requirements for CBU quantities:

i. Combined Asian and Black/African-American categories: 20 percent or more of the total CBU quantity/contract year. The delivery shall include at least six (6) Asian cord blood units and at least six (6) Black/African-American cord blood units delivered each contract year by April 30.

ii. Combined Multi-race, American Indian/Alaskan Native, and Native Hawaiian/Pacific Islander: 10 percent or more of the total cord blood unit quantity/contract year.

iii. White, Non-Hispanic: 45 percent or less of the total cord blood unit/ quantity/contract year.

iv. White, Hispanic: 25 percent or more of the total cord blood unit/ quantity/contract year.

b. The price for services fulfilling the requirements of this contract is a firm fixed price of

SECTION C – DESCRIPTION / SPECIFICATIONS / PERFORMANCE WORK

STATEMENT

C.1 Performance Work Statement

Independently, and not as an agent of the Government, the contractor shall furnish all personnel, material, facilities, services, and equipment as needed to perform the PWS set forth at Attachment A and made part of this document.

C.2 Incorporation of Contractors Proposal

It is understood and agreed that the Contractor shall, in meeting the requirements of this contract, perform the work in accordance with the Contractors proposal to the Health Resources and Services Administration dated _____________ , provided however, that to the extent that any provisions of the articles of this contract are in conflict or inconsistent with any provisions of said proposal, the provisions of the articles of this contract shall be controlling and shall supersede the provisions of said proposal.

SECTION D – PACKAGING AND MARKING

All reports and documents shall have, at a minimum in the document header, the contract number, and the COR’s name. All reports and documents shall have, at a minimum in the document footer, the author in the lower left corner, the page # of total # of pages in the center bottom of the page, and the date and /or version of the document (not the auto date) in the lower right corner.

The contractor shall deliver all items at the time indicated in the Deliverables Schedule at the Task Order level.

All deliverable reports are to carry at the top of the first page the following information:

1. Contract number

2. Deliverable item number

3. Deliverable item delivery due date

4. Date of submission

SECTION E – INSPECTION AND ACCEPTANCE

E.1 Inspection and Acceptance

The Contracting Officer Representative (COR), as a duly authorized representative of the Contracting Officer, shall assume the responsibilities for monitoring the Contractor’s performance, evaluating the quality of services provided by the contractor and performing final inspection and acceptance of all deliverables. Each Task Order issued under this contract will designate a COR to inspect and accept all work and services performed.

E.2 Inspection

FAR 52.246-4 Inspection of Services - Fixed-Price (Aug 1996) applies to fixed-price type task orders and is hereby incorporated by reference.

(a) Definition. "Services," as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services.

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

(c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties.

(e) If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may-

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce the contract price to reflect the reduced value of the services performed.

(f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may-

(1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service; or

(2) Terminate the contract for default.

SECTION F – DELIVERIES OR PERFORMANCE

F.1 Period of Performance

Per legislation:

The term of each contract entered into by the Secretary under this section shall be for a period of at least 10 years beginning on the last date on which the recipient of a contract under this section receives Federal funds under this section.

F.2 Place of Performance

The Place of Performance for this shall be at the contractors’ facilities

F.3 Observance of Federal Holidays

It is anticipated that no services or deliveries shall be performed on Saturdays, Sundays or Federal legal holidays, or any other Government closures unless superseded by the language set forth in the contract.

Official Holidays:

New Year’s Day January 1st Martin Luther King, Jr. Birthday 3rd Monday in January Washington’s Birthday 3rd Monday in February Memorial Day Last Monday in May Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th

*Inauguration Day January 20th (following a Presidential election)

For work to be performed at Government site(s):

1. No services or deliveries shall be performed, nor shall HRSA reimburse a contractor for work performed on Saturdays, Sundays, Federal legal holidays, holidays set forth by Presidential Executive Order and any other Government closures, including closures for inclement weather, unless otherwise provided for in the terms of the contract. The contractor may not bill for hours not worked.

2. When the Government site is closed, there may be a rare emergency situation or a necessity for critical work to continue where the Contracting Officer or the Head of Contracting Activity may authorize work at the fixed hourly rate set forth in the contract.

F.4 Schedule of Deliverables

The contractor shall ensure all products and services delivered under this contract are compliant with Section 508 in accordance with the Health and Human Services Acquisition Regulation (HHSAR). These Section 508 Standards were issued by the United States Access Board (https://www.access-board.gov/) and published in the Federal Register, on January 18, 2017, as the final rule (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule). The final rule updates the Section 508 Standards along with accessibility guidelines for telecommunication products and equipment covered by section 255 of the Communications Act.

The Section 508 Standards applicable to this contract are:

Section 508 Standards and Guidelines (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines)

• Web Content Accessibility Guidelines (WCAG) 2.0

• Success Criteria, Level A and AA

• Chapter 3: Functional Performance Criteria (FPC)

• Chapter 5: Software

• Chapter 6: Support Documentation and Services

Regardless of format, all digital content or communications materials produced as a deliverable under this contract must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. The contractor is responsible for remediating all deliverables that do not comply with the applicable requirements as set forth below.

HHS guidance regarding accessibility of documents can be found at http://www.hhs.gov/web/section-508/making-files-accessible/index.html

ICT vs. EIT

In various places throughout HHS procurements and other Federal agencies’ contracting documents, you will see references to “EIT” (Electronic and Information Technology) and “ICT” (Information and Communications Technology). HHS considers these terms to be interchangeable, and “EIT” should always be interpreted to be “ICT” in any HHS procurement.

Note – The HHS Section 508 Product Assessment Template (PAT), that is referenced in 352.239-73 Electronic Information and Technology Accessibility Notice. Paragraph (c) and 352.239-74 Electronic and Information Technology Accessibility. Paragraph (b), (d) and (e) has been replaced with the Voluntary Product Accessibility Template Version (VPAT) 2.1 or later, is considered to meet HHS PAT requirement. The new form can be downloaded from https://www.itic.org/policy/accessibility/vpat.

https://www.itic.org/policy/accessibility/vpat

Deliverable Number

Deliverable Description

PWS

Task

Due Date

1 Federal Records Management:

Submit documentation on maintaining Federal Records.

1 Initial, annually, and upon changes

Initial: Provide documentation on maintaining Federal Records to include Records Management Schedule and Disposition Plan – Due Date 30 calendar Days after Award.

Annual: Submit annual updates by fiscal year:

December 1. The first update shall be for FY 2020 and is due on December 1, 2020.

Changes: Submit documentation 30 calendar days after change.

2 Federal Records Management Training:

Implement HRSA Records Management Training.

Submit training progress reports.

2 Initial, annually, and upon changes

Initial: Provide initial training progress report by December 1.

Annual: Submit annual updates by fiscal year:

December 1. The first update shall be for FY 2020 and is due on December 1, 2020.

Interim: New training or other than annual updates: Due 30 calendar days after training or notification of updates.

3 HRSA OIT:

Baseline Security Requirements

3.1 Initial and

upon changes

Meet with COR 30 days after

EDOC.

Submit security and privacy documents within 15 calendar days after the kick-off meeting.

Updates due within 15 calendar of change.

4 HRSA OIT:

Incident Response

3.2 Initial and

upon changes

Meet with COR 30 days after

EDOC.

Submit security and privacy documents within 15 calendar days after the kick-off meeting.

Deliverable Number

Deliverable Description

Updates due within 15 calendar of change.

5 HRSA OIT:

Contract Initiation and Expiration

3.3 Initial and

upon changes

Meet with COR 30 days after

EDOC.

Submit security and privacy documents within 15 calendar days after the kick-off meeting.

Updates due within 15 calendar of change.

6 SCTOD CBU Pre-transplant Data:

Description of Data Submission

4.1 1 Within 15 calendar days after Initial/Kick-off Meeting.

7 Attend Initial/Kick-off Meeting: Meet with Government staff to review the requirements and schedule for the contract. The meeting shall be by telephone.

4.2.1 1 Within 15 calendar days of Effective Date of Contract

(EDOC).

8 Initial/Kick-off Meeting Minutes

4.2.1 1 Within three (3) calendar days after the kick-off meeting.

9 Attend Annual Progress Meetings:

Meet with Government staff to review contract progress against plans and schedules.

4.2.2 Annually As scheduled by the COR.

10 Annual Progress Meeting Minutes

4.2.2 One (1) for

each meeting

Within three (3) calendar days after each meeting.

11 Host Site Visits:

Meet with Government staff for a site visit.

The initial site visit shall be at the Contractor’s cord

4.2.3 Each year

there are

NCBI CBU

Deliveries

Initial visit: No later than December 13, 2019.

Subsequent visits: As scheduled by the COR.

Deliverable Number

Deliverable Description blood bank.

Subsequent site visits shall be at the Contractor’s cord blood bank or at up to two of its collection sites.

12 Site Visit Agenda 4.2.3 One (1) for each site visit

Ten (10) calendar days before the site visit.

13 Site Visit Minutes 4.2.3 One (1) for each site visit

Within three (3) calendar days after each site visit.

14 U.S. FDA

Biologics License Application, Hematopoietic Progenitor Cell (HPC), Cord Blood Approval:

Submission of copies of the approval letters for the Contractor’s FDA BLA for HPC, Cord Blood.

4.3.1 Once and

upon any re-approvals or new BLAs.

Within 15 calendar days after Initial/Kick-off Meeting For any re-approvals or new BLAs: Within three (3) calendar days of receipt from the FDA.

15 U.S. FDA

Biologics License Application, Hematopoietic Progenitor Cell (HPC), and Cord Blood Notification of Changes: Notify COR of any changes to the BLA affecting the contract and any status changes to the license.

4.3.1 Upon

changes per task

Within three (3) calendar days of receipt from the FDA.

Deliverable Number

Deliverable Description

16 NCBI

Accrediting Organizations’ Cord Blood Bank Accreditation Certification:

Submission of copies of Certificate(s) or Approval Letter(s)

4.3.1 Once and

upon new or renewal

Within 15 calendar days after Initial/Kick-off Meeting For any re-accreditations or new accreditations: Within three (3) calendar days of receipt from the accrediting organizations.

17 NCBI

Accrediting Organizations’ Cord Blood Bank Accreditation

COR

Notification of Changes: Notify COR of changes to accreditation affecting the contract including CBU delivered to the contract.

4.3.1 Upon

changes per task

For any re-accreditations or new accreditations: Within three (3) calendar days of receipt from the accrediting organizations.

18 Collection Site Agreements:

Submit executed agreements.

4.3.2 Once and

upon changes to agreements

Initial: Within 15 calendar days after Initial/Kick-off Meeting For Changes: Prior to the expiration of executed agreements. For New Collection Sites: Prior to beginning collections for NCBI CBUs at the site(s).

19 Expanding CBU Collections Plan:

Submission covers all contract years listed in Section B.2 Price.

4.3.3 One (1)

and annual progress updates

Within 15 calendar days after Initial/Kick-off Meeting.

Plan Implementation Date:

No later than January 1, 2020. Annual Progress Updates by fiscal year:

December 1. The first update

Deliverable Number

Deliverable Description shall be for FY 2020 and is due on December 1, 2020.

20 CBU Collection Schedule:

Submission covers all years listed in B.2 Price.

4.3.4 1 Within 15 calendar days after Initial/Kick-off Meeting.

21 CBU Delivery Schedule:

Submission covers all years listed in B.2 Price.

4.3.5 1 Within 15 calendar days after Initial/Kick-off Meeting.

22 NCBI CBU

Characteristics and Specifications:

Submit specified description of

NCBI CBU

characteristics, specifications, and established minimum TNC count for non-contracted CBUs.

4.3.6 1 Within calendar 15 days after Initial/Kick-off Meeting.

23 Contingency Plan for NCBI CBU Transfers

4.3.11 1 Within 15 calendar days after Initial/Kick-off Meeting.

24 Self-Sufficiency Plan

4.3.12 Once and

annual progress updates

Within 15 calendar days after Initial/Kick-off Meeting.

Plan Implementation Date:

No later than January 1, 2020.

Annual Progress Updates by fiscal year: December 1. The first update shall be for FY 2020 and is due on December 1, 2020.

25 Progress Reports, Monthly #1 Contract Key Item Updates

#2 CBU,

Collection Schedule

4.4.2

Monthly The first reports are for October 2019. All reports are due first day of the month, two months after the end of the reporting period.

Report Month

Due date

Oct Dec 1 Nov Jan 1

Deliverable Number

Deliverable Description

#3 CBU Delivery Schedule

#4 NCBI CBU

Delivery #5 B-1 Invoicing Summary and Cumulative Reports #6 CBU for Peer- Reviewed Research

#7 CBU

Availability Status Summary

#8 NCBI CBU

Shipped #9 CBU Shipped Summary

#10 CBU

Removed/Replace d by CLIN

#11 CBU

Removed Summary

#12 NCBI CBU

Transfer or Receipt

Dec Feb 1 Jan Mar 1 Feb Apr 1 Mar May 1 Apr Jun 1 May Jul 1 Jun Aug 1 Jul Sep 1 Aug Oct 1 Sep Nov 1

26 Progress Reports, Annual

#4 NCBI CBU

Delivery #5 B-1 Invoicing Summary and Cumulative Reports

#8 NCBI CBU

Shipped

#10 CBU

Removed/ Replaced by CLIN

#11 CBU

Removed Summary

4.4.3

Annually December 1 following each FY. The first report shall be for FY 2020 and is due on December 1, 2020. No annual report is due for FY 2019.

Contract Year

FY

Annual Report Due

Year 1 December 1, 2020

For example , Year 2

December 1, 2021

Deliverable Number

Deliverable Description

#12 NCBI CBU

Transfer or Receipt #13 Self- Sufficiency

27 Progress Reports, Final #1 Contract Key Item Updates

#2 CBU,

Collection Schedule #3 CBU Delivery Schedule

#4 NCBI CBU

Delivery #5 B-1 Invoicing Summary and Cumulative Reports #6 CBU for Peer- Reviewed Research

#7 CBU

Availability Status Summary

#8 NCBI CBU

Shipped #9 CBU Shipped Summary

#10 CBU

Removed /Replaced by

CLIN

#11 CBU

Removed Summary

#12 NCBI CBU

Transfer or Receipt #13 Self- Sufficiency

4.4.4

1 Thirty days before the period of performance ends.

F.5 Clauses and Provisions

Clause No. Title Date

52.242-15 Stop-Work Order AUG 1989 52.242-15 Stop-Work Order, Alternate I APR 1984 52.242-17 Government Delay of Work APR 1984

SECTION G – CONTRACT ADMINISTRATION DATA

G.1 Designation of Contracting Officer Representative (COR)

The person identified below is hereby designated as the Contracting Officer Representative (COR). Each contract will designate a COR to ensure the technical objectives are met. The COR shall provide the necessary information, direction, coordination, within the contractual work description.

Contract COR:

TBD at time of award U.S. Dept. of Health and Human Services Health Resources and Services Administration Health Systems Bureau 5600 Fishers Lane Rockville, MD 20857

Phone Number: ____________ Fax Number: ____________ Email: ____________

G.2 Contracting Officer’s Representative’s Responsibility

1. Technical Direction

The COR will provide the necessary information, direction, and coordination within the confines of the existing contractual work description in order for the contract to have a successful outcome for the government.

This includes providing technical direction to the contractor to guide the contract effort in order to accomplish the contractual performance work statement. This may include providing information to the contractor for assistance in the interpretation of government provided information, specifications or technical portions of the work description, and where required by the contract, review and approval of product deliverables of the contractor to the Government under the contract.

2. Contract Progress and Performance Management

The COR will be responsible for preparing performance evaluations in accordance with FAR 42.1502.

G.3 Restrictions on the Contracting Officer’s Representative’s Authority

Direction given by the COR to the contractor must be within the parameters of the performance work statement as stated in the Contract.

The COR may not issue any direction to the contractor that:

1. Solicits a proposal, or

2. Constitutes an assignment of additional work outside the performance work statement of this Contract, or

3. In any manner causes an increase in the total contract cost or the time required for contract performance, or

4. Changes any of the express terms, conditions, or specifications of the Contract (e.g., changes in the price or scope of work, instructions to start or stop work, approval of any actions that will result in additional charges to the government).

Issuance of changes that affect the articles, terms, or conditions of this contract will be accomplished through the Contracting Officer, who is the only party who can determine if a direction is within the performance work statement.

G.4 Key Personnel

Pursuant to the Key Personnel clause (HHSAR 352.242-70) referenced in SECTION I of this contract, the following individual(s) is (are) considered to be essential to the work being performed under this contract:

Project Director: INSERTED AT TIME OF AWARD Coordinator INSERTED AT TIME OF AWARD

The clause cited above contains a requirement for review and approval by the Contracting Officer of written request for change of Key Personnel reasonably in advance of diverting any of these individuals. Receipt of written request at least thirty (30) days prior to a proposed change is considered reasonable.

The person identified above as Project Director shall direct the necessary work and services toward fulfillment of the contractual requirements.

G.5 Evaluation of Contractors Performance

Interim and final evaluation of contractor performance (including options) on this contract shall be conducted in accordance with FAR Subpart 42.15 and entered into the contractors Performance Assessment Reporting System (CPARS) (www.cpars.gov) (see Attachment E).

The Government will conduct an evaluation of contractor’s performance based on the completion of tasks.

G.6 Submission of Invoice

Invoices may be submitted at the beginning of each calendar month for the costs incurred during the preceding month.

The Contractor may submit an invoice for payment based on the quantity of CBUs delivered and in compliance with the quantity and race/ethnicity information in Section B.2.b. tables. In addition to information required in HRSA Billing Instructions, the following items must accompany the invoice submission:

1 Progress Report # 4, NCBI CBU Delivery, PDF Format 2 Progress Report # 5, NCBI CBU B-1 Invoice Summary Reports, PDF Format 3 CWBYCTP SPA-CC Report, PDF Format, verifying CBU Registration and CBU information, as specified in the Performance Work Statement.

Invoices under this contract must not contain units that could be invoiced under the other contract. That is, if a Race/Ethnicity target from the previously awarded contract has not been met, the Contractor may not include units from that Race/Ethnicity category on invoices under this contract.

Submit invoices as follows to expedite payment:

See Attachment F, Billing Instructions.

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 Organizational Conflict of Interest (OCI)

Disclosure Clauses

In accordance with FAR Subpart 9.5:

1. Contractors shall disclose all OCIs that arise in any Task Order proposals.

2. The Government may terminate the contract for convenience if an OCI arises after award.

3. The contractor is required to flow down to its subcontractor OCI restrictions (if applicable).

4. Misrepresenting or failing to disclose information related to OCIs may result in termination or default, debarment, prosecution for making of false statement, or other severe consequences.

H.2 Quality Assurance

The contractor shall perform all the requirements identified in this contract/task orders. The contractor shall supervise the reviews in accordance with Government Auditing Standards. The COR shall review and approve all work products and deliverables submitted by the contractor in accordance with the terms and conditions identified under the contract.

HRSA reserves the right to obtain and review working papers from the contractor for the period beginning with the effective date of the contract through its termination. These reviews shall be conducted at HRSA’s discretion at either the contractor’s site or at the appropriate HRSA office.

When reviewed at the HRSA’s site, the working papers will be sent to the HRSA office for review and evaluation by HRSA staff. After completion of the review, HRSA may hold a conference with the contractor to discuss any issues. HRSA may choose to visit the contractor or subcontractor site during the audit to assess performance of the review. The contractor shall maintain an internal quality control program adequate to ensure that the requirements of the contract are met.

As with the working paper review, HRSA reserves the right to obtain and review all working papers associated with the contractor’s internal quality control program. These reviews shall be conducted at HRSA’s site, the working papers will be sent to the HRSA office for review and evaluation by HRSA staff. After completion of the review, HRSA may hold a conference with the contractor to discuss any issues. HRSA may choose to visit the contractor and/or the subcontractor’s site during the review to assess performance of the reviews.

H.3 Equipment

The contractor shall not use federal funding available through this contract for costs incurred for services or equipment which are reimbursable as part of another government contract. HRSA does not intend to authorize or provide funds for the purchase, lease, rental, or maintenance of any equipment under this contract. The federal funding available through this contract shall not be used to reimburse the contractor for the purchase of computer hardware and/or software without prior Contracting Officer approval.

H.4 Use of Appropriated Funds to acquire Food/Light Refreshments

It is the Department's policy that appropriated funds (whether from an annual appropriation, multi-year appropriation, appropriated user fee, mandatory appropriation, gift funds, or reimbursements from such appropriations, etc.) shall not be used to purchase food (whether for conferences or meetings; for meals, light refreshments, or beverages) for federal or nonfederal participants.

H.5 Rights in Data/Publication

The Contractor shall state on reports and publications required by this contract that data and analyses contained in the report or publication have been supplied by the Contractor, that the authors alone are responsible for reporting and interpretation and that all or part of the data used to compile these publications were collected pursuant to a contract with the Depart of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation. Where there has been a substantial contribution by HRSA staff in the initial analysis or in the writing of the report or publication, those staff shall be included as authors. The Contractor must not publish or disseminate data or information from this project without providing an advanced copy to the COR for review, comment and approval.

The Contractor shall provide any and all data collected by the Contractor to the Federal Government upon request, including data that contain patient-identifiable, donor-identifiable, bank-identifiable, or transplant-center identifiable information.

H.6 Printing and Duplicating

The printing of government documents must be accomplished through the Government Printing Office or its field printing plants, unless otherwise approved by the congressional Joint Committee on Printing (JCP). Contractors and grantees are not intended to be prime or substantial sources of printing for government agencies. Contractors may prepare copy, illustrative material, forms, etc. and/or camera-ready copy for the purpose of producing publications.

Regarding the use of private funds for printing, the regulations state that when appropriated funds are used to create information for publication, the printing of that information cannot be made available to a private publisher for publication without prior approval of the JCP.

SECTION I – CONTRACT CLAUSES

I.1 Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Contract Clauses

FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998)

The contract incorporates one or more clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. In addition, the full text of a clause may be accessed electronically at http://www.acquisition.gov/far/.

Clause No. Title Date

52.202-1 Definitions NOV 2013 52.203-3 Gratuities APR 1984 52.203-5 Covenant Against Contingent Fees MAY 2014 52.203-6 Restrictions on Subcontractor Sales to the Government SEP 2006 52.203-7 Anti-Kickback Procedures MAY 2014 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal MAY 2014 Or Improper Activity 52.203-10 Price or Fee Adjustment for Illegal or Improper Activity MAY 2014 52.203-12 Limitation of Payments to Influence Certain Federal OCT 2010 Transactions 52.203-13 Contractor Code of Business Ethics and Conduct OCT 2015 52.203-17 Contractor Employee Whistleblower Rights and Requirement APR 2014 To Inform Employees of Whistleblower Rights 52.203-18 Prohibition on Contracting with Entities that Require Certain JAN 2017 Internal Confidentiality Agreements or Statements – Representation 52.203-19 Prohibition on Requiring Certain Internal Confidentiality JAN 2017 Agreements or Statements 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber MAY 2011 Content Paper 52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011 52.204-10 Reporting Executive Compensation and First-Tier OCT 2018 Subcontract Awards 52.204-13 System for Award Management Maintenance OCT 2018 52.204-15 Service Contract Reporting Requirements for Indefinite OCT 2016 Delivery Contracts 52.204-22 Alternative Line Item Proposal JAN 2017 52.209-6 Protecting the Government’s Interest When Subcontracting OCT 2015 with Contractors Debarred, Suspended, or Proposed for Debarment

52.209-9 Updates of Publicly Available Information Regarding OCT 2018 Responsibility Matters

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations NOV 2015 http://www.acquisition.gov/far/

52.210-1 Market Research APR 2011 52.215-2 Audit and Records—Negotiation OCT 2010 Alternate II AUG 2016 52.215-8 Order of Precedence—Uniform Contract Format OCT 1997 52.215-10 Price Reduction for Defective Certified Cost or Pricing Data AUG 2011 52.215-12 Subcontractor Certified Cost or Pricing Data OCT 2010 52.215-15 Pension Adjustments and Asset Reversions OCT 2010 52.215-17 Waiver of Facilities Capital Cost of Money OCT 1997 52.215-18 Reversion or Adjustment of Plans for Postretirement JUL 2005

Benefits (PRB) Other Than Pensions 52.215-19 Notification of Ownership Changes OCT 1997

(a) The Contractor shall make the following notifications in writing:

(1) When the Contractor becomes aware that a change in its ownership has occurred, or is certain to occur, that could result in changes in the valuation of its capitalized assets in the accounting records, the Contractor shall notify the COR within 30 days.

(2) The Contractor shall also notify the COR within 30 days whenever changes to asset valuations or any other cost changes have occurred or are certain to occur as a result of a change in ownership.

(b) The Contractor shall--

(1) Maintain current, accurate, and complete inventory records of assets and their costs;

(2) Provide the COR or designated representative ready access to the records upon request;

(3) Ensure that all individual and grouped assets, their capitalized values, accumulated depreciation or amortization, and remaining useful lives are identified accurately before and after each of the Contractor's ownership changes; and

(4) Retain and continue to maintain depreciation and amortization schedules based on the asset records maintained before each Contractor ownership change.

(c) The Contractor shall include the substance of this clause in all subcontracts under this contract that meets the applicability requirement of FAR 15.408(k).

52.215-21 Requirements for Certified Cost or Pricing Data and Data OCT 2010

Other Than Certified Cost or Pricing Data—Modifications Alternate III OCT 1997 52.215-23 Limitations on Pass-Through Charges OCT 2009 52.216-7 Allowable Cost and Payment AUG 2018 Alternate II AUG 2012 Alternate IV AUG 2012 52.216-8 Fixed Fee JUN 2011

52.217-7 Option for Increased Quantity - MAR 1989 Separately Priced Line Item (within 30 days) 52.219-8 Utilization of Small Business Concerns OCT 2018 52.219-9 Small Business Subcontracting Plan AUG 2018 Alternate II NOV 2016 52.219-16 Liquidated Damages - Subcontracting Plan JAN 1999 52.219-28 Post-Award Small Business Program Representation JUL 2013 52.222-3 Convict Labor JUN 2003 52.222-21 Prohibition of Segregated Facilities APR 2015 52.222-26 Equal Opportunity SEPT 2016 52.222-35 Equal Opportunity for Veterans OCT 2015

52.222.36 Equal Opportunity for Workers with Disabilities JUL 2014 52.222-37 Employment Reports on Veterans FEB 2016 52.222-39 Notification of Employee Rights Concerning DEC 2004 Payment of Union Dues or Fees 52.222-40 Notification of Employee Rights Under the National Labor DEC 2010

Relations Act 52.222-50 Combating Trafficking in Persons JAN 2019 52.222-54 Employment Eligibility Verification OCT 2015 52.222-55 Minimum Wages Under Executive Order 13658 DEC 2015 52.222-62 Paid Sick Leave Under Executive Order 13706 JAN 2017 52.223-6 Drug-Free Workplace MAY 2001 52.223-10 Waste Reduction Program MAY 2011 52.223-18 Encouraging Contractor Policies to Ban AUG 2011

Text Messaging While Driving 52.224-1 Privacy Act Notification APR 1984 52.224-2 Privacy Act APR 1984 52.224-3 Privacy Training JAN 2017 52.225-1 Buy American Act - Supplies MAY 2014 52.225-13 Restrictions on Certain Foreign Purchases JUN 2008 52.226-1 Utilization of Indian Organizations and Indian-Owned JUN 2000

Economic Enterprises 52.227-1 Authorization and Consent DEC 2007 52.227-2 Notice and Assistance Regarding Patent and DEC 2007

Copyright Infringement 52.227-14 Rights in Data—General MAY 2014 52.228-7 Insurance–Liability to Third Persons MAR 1996 52.229-3 Federal, State, and Local Taxes FEB 2013 52.230-2 Cost Accounting Standards OCT 2015 52.230-3 Disclosure and Consistency of Cost Accounting OCT 2015

Practices 52.230-5 Cost Accounting Standards – Educational Institution AUG 2016 52.230-6 Administration of Cost Accounting Standards JUN 2010 52.232-1 Payments APR 1984 52.232-7 Payments Under Time-and-Materials and Labor-Hour Contracts AUG 2012 52.232-8 Discounts for Prompt Payment FEB 2002

52.232-9 Limitation on Withholding of Payments APR 1984 52.232-11 Extras APR 1984 52.232-17 Interest MAY 2014 52.232-20 Limitation of Cost APR 1984 52.232-23 Assignment of Claims MAY 2014 52.232-25 Prompt Payment JAN 2017 52.232-33 Payment by Electronic Funds Transfer – System OCT 2018 for Award Management 52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business DEC 2013

Subcontractors 52.233-1 Disputes MAY 2014 52.233-3 Protest after Award AUG 1996 Alternate I JUN 1985 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.242-1 Notice of Intent to Disallow Costs APT 1984 52.242-3 Penalties for Unallowable Costs MAY 2014 52.242-4 Certification of Final Indirect Costs JAN 1997 52.242-5 Payments to Small Business Subcontractors JAN 2017 52.242-13 Bankruptcy JUL 1995 52.243-1 Changes – Fixed Price AUG 1987 Alternate I APR 1984 52.243-2 Changes -Cost Reimbursement AUG 1987 Alternate I APR 1984 52.243-3 Changes – Time-and-Materials or Labor-Hours SEP 2000 52.244-2 Subcontracts OCT 2010 Alternate I JUN 2007 52.244-5 Competition in Subcontracting DEC 1996 52.244-6 Subcontracts for Commercial Items JAN 2019 52.245-1 Government Property JAN 2017 Alternate I APR 2012 52.245-9 Use and Charges APR 2012 52.246-25 Limitation of Liability—Services FEB 1997 52.249-2 Termination for Convenience (Fixed Price) APR 2012 52.249-6 Termination (Cost-Reimbursement) MAY 2004 Alternate V SEPT 1996 52.249-8 Default (Fixed-Price Supply and Service) APR 1984 52.249-14 Excusable Delays APR 1984 52.253-1 Computer Generated Forms JAN 1991

FAR 52.203-14 Display of Hotline Posters (Oct 2015)

(a) Definition.

“United States,” as used in this clause, means the 50 States, the District of Columbia, and outlying areas.

(b) Display of fraud hotline poster(s). Except as provided in paragraph (c)—

(1) During contract performance in the United States, the Contractor shall prominently display in common work areas within business segments performing work under this contract and at contract work sites—

(i) Any agency fraud hotline poster or Department of Homeland Security (DHS) fraud hotline poster identified in paragraph (b)(3) of this clause; and

(ii) Any DHS fraud hotline poster subsequently identified by the Contracting Officer.

(2) Additionally, if the Contractor maintains a company website as a method of providing information to employees, the Contractor shall display an electronic version of the poster(s) at the website.

(3) Any required posters may be obtained as follows:

Poster: OIG Hotline Ops Poster - Grant & Contract Fraud Obtain from:

https://forms.oig.hhs.gov/hotlineoperations/posters/OIG%20Hotline%20Ops%20Poster%20- %20Grant%20&%20Contract%20Fraud.pdf

(c) If the Contractor has implemented a business ethics and conduct awareness program, including a reporting mechanism, such as a hotline poster, then the Contractor need not display any agency fraud hotline posters as required in paragraph (b) of this clause, other than any required DHS posters.

(d) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (d), in all subcontracts that exceed $5.5 million, except when the subcontract—

(1) Is for the acquisition of a commercial item; or

(2) Is performed entirely outside the United States.

FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Jun 2016)

a) Definitions. As used in this clause–

“Covered contractor information system” means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

“Federal contract information” means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public websites) or simple transactional information, such as necessary to process payments.

“Information” means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

“Information system” means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C.

3502).

“Safeguarding” means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures.

(1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial items, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

I.2 Options

FAR 52.217-8 Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 66 months.

I.3 Department of Health and Human Services Acquisition Regulation (HHSAR) (48 CFR Chapter 3) (http://www.hhs.gov/regulations/hhsar/)

Clause No. Title Date

352.203-70 Anti-Lobbying DEC 2015 352.208-70 Printing and Duplication DEC 2015 352.211-1 Public Accommodations and Commercial DEC 2015

Facilities 352.211-3 Paperwork Reduction Act DEC 2015 352.219-70 Mentor Protégé Program DEC 2015 352.219-71 Mentor Protégé Program Reporting JAN 2010 352.222-70 Contractor Cooperation in Equal Employment Opportunity DEC 2015 Investigations 352.224-70 Privacy Act DEC 2015 352.227-70 Publications and Publicity DEC 2015 352.231-70 Salary Rate Limitations DEC 2015 352.233-71 Litigation and Claims DEC 2015 352.239-73 Electronic Information and Technology DEC 2015 Accessibility Notice

352.224-71 Confidential Information (DEC 2015)

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the government,

(i) The publication or dissemination of the following types of information are restricted under this contract: personally identifiable information about patients and donors.

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are:

maintain patient and donor confidentiality and safety.

(iii) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The Contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

352.239-74 Electronic and Information Technology Accessibility (DEC 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the "Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194.

Information about Section 508 is available…