Solicitation_A_thru_M_NCBI_20190808_Amd_0001.pdf

NCBI Solicitation; 19-250-SOL-00062

Revised as of Amendment 0001

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 on the first day of the month, two months after the end of the reporting period.

Report

Month

Due date

Oct Dec Jan

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

Nov Feb 1

Dec Mar 1

Jan Apr 1

Feb May 1

Mar Jun 1

Apr Jul 1

May Aug 1

Jun Sep 1

Jul Oct 1

Aug Nov 1

Sep Dec 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/.

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/)

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 at http://www.hhs.gov/web/508. The complete text of

Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Performance Work Statement.