18-250-SOL-00017_RFP.pdf

18-250-SOL-00017

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 2

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

H

G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

12. In compliance with the above, the undersigned agrees, if this offer is accepted within ______________ calendar days (60 calendar days unless a different period is inserted

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 253 (c) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

X

OAMP

HHS/HRSA/OO/OAMP

Office of Acquisition Management and Policy 5600 Fishers Lane, Rm 14W26B Rockville MD 20857

1500 ED 04/30/2018

PATRICK D MAURO 301

PMauro@hrsa.gov

945-5151

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PAGE(S)

BIJAN MANSOURY

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

2-5

9-26 27-28 28-30

31-39

41-48

49-59

60-66

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 2

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

18-250-SOL-00017

(A) (B) (C) (D) (E) (F)

Organ Procurement and Transplantation Network

Period of Performance: 09/30/2018 to 09/29/2023

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

Organ Procurement and Transplantation Network; 18-250-SOL-00017

SECTION A – STANDARD FORM (SF) 33

This page intentionally left blank.

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Purpose of Contract

The purpose of this Contract is to conduct the operation of the Organ Procurement and Transplantation Network (OPTN). The purpose of the OPTN is to coordinate and improve the effectiveness of the nation’s organ procurement, distribution and transplantation systems and to increase the availability of, and access to, donor organs for patients with end-stage organ failure.

The OPTN was established pursuant to the National Organ Transplant Act (NOTA) of 1984.

The functions of the OPTN are described in statute (42 USC 274), and the OPTN final rule (42 CFR 121) provides further clarification of the structure and functions of the OPTN.

B.2 Compensation Cost/Price

1. This is a cost sharing contract. In consideration of the satisfactory performance of these services, which are described in detail in the Performance Work Statement (PWS) at Attachment A, the total funds currently estimated by the Government and the Contractor for this contract are as follows:

CLINs

Description Government Share Percent

Contractor Share (Patient registration fee) Percent

Total Estimated Costs

0001 Base Period 0002 3.15 Special

Studies Option – Base Period

0003 3.15 Special Studies Option – Base Period

0004 3.16 Contract Period Briefings Option – Base Period

0005 3.17 Innovative Application Enhancements Period – Base Period

0006 3.18 External Dataset Acquisition Option – Base Period

1001 Option Period 1 1002 3.15 Special

Studies Option – Option Period 1

1003 3.15 Special Studies Option – Option Period 1

1004 3.16 Contract Period Briefings Option – Option Period 1

1005 3.17 Innovative Application Enhancements Period – Option Period 1

1006 3.18 External Dataset Acquisition Option – Option Period 1

2001 Option Period 2 2002 3.15 Special

Studies Option – Option Period 2

2003 3.15 Special Studies Option – Option Period 2

2004 3.16 Contract Period Briefings Option – Option Period 2

2005 3.17 Innovative Application Enhancements Period – Option Period 2

2006 3.18 External Dataset Acquisition Option – Option Period 2

3001 Option Period 3

3002 3.15 Special Studies Option – Option Period 3

3003 3.15 Special Studies Option – Option Period 3

3004 3.16 Contract Period Briefings Option – Option Period 3

3005 3.17 Innovative Application Enhancements Period – Option Period 3

3006 3.18 External Dataset Acquisition Option – Option Period 3

4001 Option Period 4 4002 3.15 Special

Studies Option – Option Period 4

4003 3.15 Special Studies Option – Option Period 4

4004 3.16 Contract Period Briefings Option– Option Period 4

4005 3.17 Innovative Application Enhancements Period – Option Period 4

4006 3.18 External Dataset Acquisition Option – Option Period 4

4007 6-Month Extension Option

4008 3.14 Transition- Out Option

TOTAL

For further provisions on funding, see the clause FAR 52.232.20, Limitation of Cost (APR 1984), which is hereby incorporated by reference.

SECTION C – DESCRIPTION/SPECIFICATIONS/ STATEMENT OF WORK

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 task in the Performance Work Statement set forth in Section J (Attachment A) attached hereto and made part of this contract.

C.2 Incorporation of Contractor’s Proposal by Reference

It is understood and agreed that the Contractor shall, in meeting the requirements of this contract, perform the work in accordance with the Contractor’s proposal to the Health Resources and Services Administration originally dated ______________ and revised ___________, provided however, that to the extent that any provisions of sections A through I of this contract are in conflict or inconsistent with any clauses of said proposal, the provisions of sections A through I of this contract shall control and shall supersede the provisions of said proposal. Therefore, the contractor’s proposal is hereby incorporated into this contract by reference, to the extent its provisions are consistent with the provisions of sections A through I of this contract.

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.

a. 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.

E.2 FAR 52.246-5 Inspection of Services—Cost Reimbursement (APR 1984) is hereby incorporated by reference.

E.4 Quality Assurance Surveillance Plan (QASP)

The Government will monitor the Contractors performance under this contract in accordance with the Government’s QASP located at Attachment F.

SECTION F – DELIVERIES OR PERFORMANCE

F.2 FAR 52.242-15 Stop-Work Order (AUG 1989) is hereby incorporated by reference.

F.3 Period of Performance

The period of performance shall be a base period of twelve months and four (4) twelve-month option periods.

The estimated period of performance for the base year is September 30, 2018 through September 29, 2019. The estimated period of performance for option year one is September 30, 2019 through September 29, 2020.

The estimated period of performance for option year two is September 30, 2020 through September 29, 2021.

The estimated period of performance for option year three is September 30, 2021 through September 29, 2022.

The estimated period of performance for option year four is September 30, 2022 through September 29, 2023.

F.5 Schedule of Deliverables

All products and services delivered under this contract must be Section 508 compliant in accordance with the HHSAR provided. The Section 508 Standards applicable to this contract are 1194.21, 1194.22, 1194.23, 1194.24, 1194.25, 1194.26, 1194.31, and 1194.41.

All digital content or communications materials produced as a deliverable under this contract, must be Section 508 compliant to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. Remediation of any materials that do not comply with the applicable requirements as set forth below, shall be the responsibility of the vendor.

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

Number Task Name Frequency Quantity A001 3.1.1 Updated project

Management Plan

10 days after EDOC

A002 3.1.1 Final project Management Plan

10 days after feedback

A003 3.1.1 Kick-off Meeting Agenda

3 days before meeting 1

A004 3.1.1 Kick-off Meeting Summary

5 days after meeting 1

A005 3.1.2 Updated Project Management Plan (Draft)

10 days after BOY

A006 3.1.2 Updated Project Management Plan (Final)

10 days after feedback

A007 3.1.2 Option Period Planning Meeting Agenda

3 days before meeting

A008 3.1.2 Option Period Planning Meeting Summary

5 days after meeting

A009 3.1.3 COR weekly meeting agenda

1 day before meeting

A010 3.1.3 COR weekly meeting summary

1 day after meeting

A011 3.1.3 COR Quarterly progress meeting agenda

10 days before meeting

A012 3.1.3 COR Quarterly progress meeting summary

5 days after meeting

A013 3.1.4 Quarterly written progress report

1 month after quarter

A014 3.1.5 Quarterly list of proposed publications and presentations

10 days beginning quarter

A015 3.1.5 Draft abstracts, manuscripts, and presentations for initial submission

As required 1

A016 3.1.5 Final abstracts, manuscripts, and presentations for initial submission

A017 3.1.5 Draft copies of published articles and presentations

A018 3.1.5 Final copies of published articles and presentations

A019 3.1.6 Draft symposium proposal

Annual 1

A020 3.1.6 Final symposium proposal

A021 3.1.6 Draft symposium materials

A022 3.1.6 Final symposium materials

A023 3.1.7 Draft OPTN governance operations plan

A024 3.1.7 Final OPTN governance operations plan

Annual

A025 3.1.8 OPTN BOD meeting transcript and summary

A026 3.1.8 OPTN BOD meeting summary posted on OPTN web site

2 days after COR approval

A027 3.1.9 Monthly revenue and expenditures report monthly 1

A028 3.1.9 Monthly financial account statement

A029 3.1.10 Registration fee schedule proposal

A030 3.1.10 OPTN BOD approved budget and budget supporting materials to accompany the fee schedule

A031 3.1.11 Access to Web-based platform for electronic submission of deliverables

1 month after EDOC 1

A032 3.1.12 Electronic document management platform

1 month after EDOC

A033 3.2.1 Roster of BOD and EC members including analyses of BOD compositional requirements

A034 3.2.1.1 Annual BOD governance composition report

A035 3.2.1.1 Annual BOD recruiting plan

A036 3.2.1.2 Board independence transition process document

A037 3.2.1.2 Proposed BOD liability policies and quotes

1 month after EDOC

A038 3.2.1.2 Documentation of liability policy purchase

A039 3.2.2 Proposed revisions to OPTN Charter

A040 3.2.3 Name of the OPTN Executive Director

A041 3.2.3 Annual evaluation of the OPTN Executive Director’s performance

A042 3.2.4 OPTN Bylaws, polices, standards and guidelines

A043 3.2.5 Operating committee rosters

A044 3.2.5.1 Draft announcement of nominations Process

A045 3.2.5.1 Final announcement of nomination process

A046 3.2.5.1 Annual slate of nominees

A047 3.2.5.2 Data review report

A048 3.2.5.2 DAC chair report to the BOD and EC

A049 3.2.5.3 OPTN FY Budget

A050 3.2.5.3 Multi-year planning budget Annual 1

A051 3.2.5.3 Recommendations regarding OPTN reserves and investment strategy

A052 3.2.5.4 POC meeting materials

A053 3.2.5.4 POC chair presentation to the BOD and EC

A054 3.2.5.5 Network Operations Metrics and Monitoring Report

A055 3.2.5.5 Committee chair presentation to the BOD and

EC

A056 3.2.6 Annual OPTN policy development plan

A057 3.2.6 List of members and CVs for each governance committee and expert group

A058 3.2.6.1 OPTN Policy development recruiting and nominations plan

180 days after EDOC 1

A059 3.2.7 OPTN strategic plan

A060 3.2.7 Report on strategic plan progress

A061 3.2.8.1 Education plan on legal and regulatory requirements

A062 3.2.8.2 Signed conflict of interest statements

A063 3.2.8.2 List of potential conflicts of interests and mitigating strategies

A064 3.2.8.2 Policies and procedures to identify and address conflicts of interest

A065 3.2.8.3 Calendar of activities updated on OPTN web site weekly 1

A066 3.2.8.3 Closed session criteria

A067 3.2.8.4 Annual report of Contractor staffing expertise

A068 3.2.8.4 Meeting agenda

A069 3.2.8.4 Meeting materials

A070 3.2.8.4 Meeting summary

A071 3.3.1 Draft OPTN Policy development process document

60 days after EDOC 1

A072 3.3.1 Final OPTN Policy document

A073 3.3.1 List of all approved OPTN Bylaws, policies (incl.

variances), and BOD approval and implementation dates (or proposed implementation)

A074 3.3.2 Draft OPTN Policy metrics

A075 3.3.2 Final OPTN Policy metrics

A076 3.3.2 Baseline OPTN Policy development metrics report

A077 3.3.2 Updated OPTN policy development metrics report

Every 6 months 1

A078 3.3.3 Draft plan for review and analysis of current OPTN regional process

8 months after EDOC 1

A079 3.3.3 Final plan for review and analysis of current OPTN regional process

10 months after EDOC 1

A080 3.3.3 Draft regional process review presentation

A081 3.3.3 Final regional process review presentation

A082 3.3.3 Draft regional process review website posting

A083 3.3.3 Final regional process review website posting

A084 3.3.4 Consensus Conference request

A085 3.3.4 Consensus Conference

A086 3.4.1 Matching function operational plan

30 days after EDOC

A087 3.4.1 Documentation of testing and validation outcomes

A088 3.4.2 Matching function innovation and improvement plan

A089 3.4.3 KPDPP operational plan

A090 3.4.3 Quarterly KPDPP performance assessment reports quarterly 1

A091 3.4.3 Monthly statistical report

A092 3.4.4 Technical assistance plan 90 days after EDOC 1

A093 3.4.5 Committee report on performance of review boards

A094 3.4.6 Decision rules of organ allocation algorithms

90 days after EDOC

A095 3.5 List of all official OPTN data

5 months before end of base contract performance period

A096 3.5 OMB ICR data collection forms and supporting materials for official OPTN data not currently collected through OMB approved ICRs

A097 3.5.1 OPTN data repository

A098 3.5.1 Quarterly official OPTN data quality report

A099 3.5.1 Annual official OPTN data quality report

A0100 3.5.2 Draft plan for direct electronic transfer of official OPTN data

A0101 3.5.2 Final plan for direct electronic transfer of official OPTN data

A102 3.5.3 OMB ICR data collection forms and supporting materials for official OPTN disease transmission data

A103 3.5.4 ICD and CPT codes implementation plan

180 days after EDOC

A104 3.5.5 Signed document on HRSA expectations on death data

A105 3.5.5 Signed Data Use Agreement with CMS

A106 3.5.5 Signed Data Use Agreements and/or Memorandum of Agreement for non-official OPTN data

A107 3.5.6 Draft process for post-BOD OMB ICR revision

9 months after EDOC 1

A108 3.5.6 Final process for post-BOD OMB ICR revision

12 months after EDOC 1

A109 3.5.6 OMB Information Collection Request package

A110 3.5.7 Surveys to support OPTN operations and policy development

A111 3.5.7 OMB ICR package for survey data collection

A112 3.6.1 Report of OPTN processes to monitor compliance, evaluate and improve performance and enforce sanctions

A113 3.6.2 Draft performance metrics 180 days after EDOC

A114 3.6.2 Final performance metrics

A115 3.6.2 Quarterly reports on performance metrics

A116 3.6.2 Baseline performance metrics report

8 months after EDOC

A117 3.6.2 Reports to MPSC on performance metrics

A118 3.6.3 Draft Compliance and Enforcement Report

5 months after EDOC

A119 3.6.3 Final Compliance and Enforcement Report

8 months after EDOC

A120 3.6.3 Quarterly Compliance and Enforcement Report update

A121 3.6.3 Reports to MPSC on Compliance and Enforcement

A122 3.6.3 Proposed format and secure delivery mechanism for compliance and enforcement report

2 months after EDOC 1

A123 3.6.4 Documentation of membership review and approval process

30 days after EDOC 1

A124 3.6.4 Plan for periodic reassessment of membership requirements

240 days after EDOC 1

A125 3.6.4 Membership application

A126 3.6.4 Draft membership status

A127 3.6.4 Final membership status

A128 3.6.5 OMB ICR Membership forms packages

A129 3.6.6 Performance Monitoring and Collaborative Improvement Plan

A130 3.6.7 Patient safety event reports as defined by Contractor and HRSA requirements

A131 3.6.7 Draft plan for patient safety reporting process

A132 3.6.7 Final plan for patient safety reporting process

A133 3.6.7 Presentation of proposed changes to OPTN Bylaws

A134 3.6.8 Final report on special review

A135 3.7.1 OPTN standard analysis data set document

60 days after EDOC

A136 3.7.2 Data report or data files produced in response to data requests from COR

A137 3.8.1 Formal written agreement with the current SRTR Contractor for data transfer

30 days after EDOC 1

A138 3.8.2 Data request process plan

A139 3.8.3 Joint meeting agendas 30 days before meeting

A140 3.8.3 Meeting summaries and presentations

14 days after meeting

A141 3.8.4 Comments on the draft Annual Data Report

As required

A142 3.8.5 Participation in working groups to review monthly data quality reports.

A143 3.9 Annual OPTN web site maintenance, improvement, and enhancement project plan

A144 3.9 Draft website postings

A145 3.9 Final website postings

A146 3.10.1 Communication plan 180 days after EDOC 1

A147 3.10.1 Communication products As required

A148 3.10.2 Plan for proposed OPTN educational materials for transplant professionals in training

210 days after EDOC 1

A149 3.10.2 Proposed dissemination plan for educational materials

210 days after EDOC 1

A150 3.10.3 Patient services line

A151 3.10.4 Media Alert electronic notification

A152 3.11 Contributions to official reports, including reports to Congress

A153 3.12.1 Documentation on managing, maintaining, and disposing of Federal records.

A154 3.12.2 Written confirmation certifying completion of records management training by employees

A155 3.13 Transition-in plan

A156 3.14.1 Transition-out plan

A157 3.14.2

Transition-out report As required 1

A158 3.15 Copy of or license to operate all OPTN software systems and documentation.

A159 3.16.1, 3.16.2, 3.16.3

Study plan

A160 3.16.1, Periodic status reports (timeline mutually agreed upon by the Contractor and

COR)

A161 3.16.1, Final report

A162 3.17 In-person briefing

A163 3.17 Briefing materials 14 days before meeting

A164 3.18.1, 3.18.2, 3.18.3

Project plan for each application

A165 3.18.1, Periodic status reports (timeline mutually agreed upon by the Contractor and

COR)

A166 3.18.1, Final report

A167 3.19 Signed Data Use Agreements and/or Memorandum of Agreement

A168 3.20.9.

Cryptographic Module Validation documentation

A169 3.20.9.

Contractor Employee Non- Disclosure Agreement

(NDA)

A170 3.20.9.

Assist in the completion of a PTA/PIA form

A171 3.20.9.

The training records for all mandatory training

A172 3.20.9.

Signed ROB for all employees

A173 3.20.9.

Incident Report (as incidents occur)

A174 3.20.9.

Incident Response Plan

A175 3.20.9.

Background Investigation Prior to performing any work on behalf of HHS

A176 3.20.9.

Roster and as updated

A177 3.20.9.

Certification of record disposal and sanitization of devices and media

A178 3.20.9.

SA&A Package

SSP

SAR

POA&M

Authorization Letter CP and CPT Report E-Auth (if applicable) PTA/PIA (if applicable) Interconnection/Data Use Agreements (if applicable) Authorization Letter Configuration Management Plan (if applicable) Configuration Baseline Other HRSA-specific documents

180 days after EDOC 1

A179 2.4 EPLC deliverables:

See Deliverable A179 Table below

A180 2.5 EVM report

Deliverable A179 - Enterprise Project Life Cycle (EPLC) Requirements

Deliverable Ownership Approach Date Planning Phase

Project Management Plan (PMP)

Program Project Lead, Contractor

The Program project lead and the contractor will prepare the PMP after discussions with COR and appropriate stakeholders. The plan will also address the scope, budget and schedule.

Within 45 days after task is exercised

Project Work Breakdown Structure (WBS)/Schedule

Contractor The Program Project Lead will develop a contract/project level WBS using Microsoft project software.

Within 45 days after task is exercised

Release WBS/Schedule Contractor

The Program Project Lead will develop a schedule and detailed list of tasks for each of the major releases.

Based upon

WBS

Project Budget

Program Project Lead, Contractor

The contractor will develop a detailed budget prior to the commitment of resources for any development activities.

Within 45 days after task is exercised

Schedule Activity List Contractor

The Program Project Lead will develop a detailed list of activities in consultation with the stakeholders.

Once a month

Resource Requirements Log Contractor

The Program Project Lead will develop a detailed software and hardware resource requirements as part of the infrastructure plan.

Based upon project plan

Risk Management Log

Program Project Lead, Contractor

The Program Project Lead will log all the major project risks in the risk log/register and communicate it to the stakeholders

Monthly (as well as when new risks are identified)

Training Plan

Program Project Lead, Contractor

A training plan will be developed which would provide details, including the training approach, training courses offered, duration of each course, intended audience(s).

Based upon project plan

Deliverable Ownership Approach Date Requirements Phase

Business Process Definition (BPD) Contractor

Based upon discussions with the business owners, this document will capture the appropriate business processes. This information will be used to drive additional requirements elaboration activities such as the creation of screen mockups.

Based upon project plan

Business System Requirements (BSR) Document

Contractor

A requirements document reflecting the high level capabilities and attributes of the desired solution will be created.

Based upon project plan

Release-Level Requirements /RTM Contractor

This document will provide of the traceability of project level and release level requirements to the functionality contained within a specific release.

Based upon project plan

Logical Data Model Contractor

The logical data model provides a way to represent the business processes (and depicts the relationship between them). This document will be used to further elaborate the system requirements.

Based upon project plan

Design Phase Technical Design Document (TDD) Contractor This document will explain the system design and architecture.

Based upon project plan

Physical Data Model Contractor

The Physical Data Model will take the logical data model information and create the physical data model structures. This will be developed in compliance with all appropriate EHBs naming conventions and standards.

Based upon project plan

Data Dictionary Contractor This document would explain the detailed definitions for all tables and columns.

Based upon

Test Phase

Deliverable Ownership Approach Date

Test Plan Contractor

The test plan would define the overall plan for performing the QA testing activities for the project. It would contain the proposed testing approach, types of testing that will performed, and details about the testing tools that will be used..

Based upon project plan

Test Scripts/Cases Contractor

Describes the detailed test scripts and test cases that will be used to validate that the system functions as expected.

The contractor will work with the business owners to ensure that the test cases developed exercise all of the business areas/functions of the system.

Based upon project plan

Testing Defects Resolution Report Contractor

An export of the issues from the issue tracker will be provided so the stakeholders can get the insight into the issues found during contractor’s internal testing and their latest status.

Based upon project plan

Implementation/ Deployment Plan

Contractor

The implementation plan will provide details about how the system will be installed and made operational in the production environment for each of the major releases.

Based upon project plan

Operations & Maintenance Phase

Operational Readiness Review

Program Project Lead, Contractor

The Review will ensure that configuration and testing have been completed, documentation has been written and approved, deployment packages have been written and tested, security testing completed, and all other EPLC requirements have been met.

Based upon project plan

Lessons Learned

Program Project Lead, Contractor

A lessons learned document will be created to understand what worked well (and what didn’t) in the last release so that this experience can be used to improve the techniques used to develop future releases/systems.

45 days after production implementatio n

Deliverable Ownership Approach Date

Patch Release/Deployment Plan

Contractor

This plan will provide the details about potential impacts/dependencies, and how to apply the patch in the production environment.

Based upon

F.6 Reporting Requirements and Deliverables

1. The contractor shall submit the items in quantities and during the time periods indicated above to the following address:

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

2. The contractor shall submit each deliverable items individually per the deliverable schedule.

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) for this contract.

TBD

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

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.

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 Personnel

The following individuals are designated as Personnel and considered to be essential to the work being performed under this contract:

Title Name (To be completed at time of award)

Contract Project Director ________________________________

Medical Director ________________________________

Executive Director ________________________________

Deputy Contract Project Director ________________________________

Chief Information Officer ________________________________

Director of Communications ________________________________

Contact Information for personnel:

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

G.5 Submission of Vouchers

See Attachment B.

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 Participation by Federal Staff

The COR and the Director of the Division of Transplantation, HRSA, or their designees, shall serve as ex-officio, non-voting members of the OPTN Board of Directors. Travel expenses, food, and lodging for federal members shall be paid by the Federal Government, not the Contractor.

H.2 Exceptions to Public Participation in Meetings

Unless specifically excluded below, federal representatives and members of the general public will be permitted to be present at all meetings (and telephone conference calls) of the following components of the OPTN: Board of Directors; Executive Committee; and committees, sub-committees and working groups, and other such components of the OPTN that the Board may establish. At its discretion, the Contractor may allow federal representatives and members of the general public to attend meetings relating to the Contractor's internal operation. Federal representatives, but not the general public, will be permitted to be present at all meetings and participate in telephone conference calls relating to:

A. application for OPTN membership and appeals relating to refusal of membership by the

OPTN; and

B. OPTN members who are being reviewed for potential noncompliance with OPTN Obligations, as defined in the OPTN Bylaws, or for risks to patient health and safety.

H.3 Equipment/Computer Needs

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. Also, 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.

The Contractor shall have the necessary computer hardware and software development tools to perform the contract.

H.4 OPTN Funds

During the performance of this contract, the funds from OPTN registration fees that the Contractor receives in accordance with 42 CFR 121.5(c) shall be the OPTN's funds restricted only to the extent expressly agreed in this contract. Such funds derived from registration fees paid to the OPTN may not be expended for any purpose other than to support contract activities under the terms of this contract.

The Contractor shall maintain two segregated bank accounts to be derived from appropriated funds and OPTN patient registration fees. The first such account, herein described as the Primary

Account, shall include all such funds and fees, less the amount identified as the reserve component of the OPTN patient registration fee, which shall be deposited into a separate account, herein described as the Reserve Account. The amount of the proposed fee(s), including the amount of the reserve fund component(s), will be determined consistent with the requirements of the OPTN final rule. The Primary Account shall .be used for the general operations of the OPTN. The funds in the Reserve Account shall be available to pay allowable OPTN operating costs, consistent with the terms of this contract, in the event of insufficient funds in the Primary Account, but shall be replenished from the Primary Account as funds become available. In addition, the OPTN Reserve Account shall be available to support OPTN program activities that are identified by the OPTN Board of Directors as critical to the OPTN but could not otherwise be implemented with available Primary Account funds. The funds from either the Primary Account or the Reserve Account shall only be used for carrying out the purposes of the contract. The Contractor will provide financial statements and summaries to the COR according to the deliverable schedule and Statement of Work in this contract. The COR may at his/her discretion request an annual audit of the OPTN accounts including, but not limited to, the Primary Account and Reserve Account. The Contracting Officer may request such other related information as necessary.

Funds shall only be released from the Reserve Account if either: (1) such a release of funds meets criteria that were established through the adoption of OPTN Bylaws by the OPTN Board of Directors, with the written concurrence of the COR of such criteria; or (2) the COR and the OPTN Contractor mutually agree in writing to such a transfer of funds. In either case, the OPTN Contractor shall notify the COR no fewer than 15 days prior to any such release of funds.

At the conclusion of this contract, the Contractor shall calculate the amount of unreimbursed allowable costs incurred under the contract and retain the amount of funds from the Primary and Reserve Accounts together with the amount of receivables as are necessary to reimburse the Contractor for such unreimbursed allowable costs. The Contractor shall then transfer to any subsequent OPTN Contractor any remaining receivables and funds from the Primary and/or the Reserve Accounts in excess of such amount of the Contractor's unreimbursed allowable costs.

The COR may, at his/her option and at the Government's expense, obtain an independent audit of the OPTN contract and the segregated accounts prior to these transfers.

H.6 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.

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 on 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.

52.204-7 System for Award Management Oct 2016 52.204-9 Personal Identity Verification of Contractor Personnel. Jan 2011 52.204-10 Reporting Executive Compensation and First-Tier Oct 2016

Subcontract Awards.

52.204-13 System for Award Management Maintenance. Oct 2016 52.204-14 Service Contract Reporting Requirements Oct 2016 52.204-18 Commercial and Government Entity Code Maintenance Jul 2016 52.204-19 Incorporation by Reference of Representations and Certifications Dec 2014 52.204-21 Basic Safeguarding of Covered Contractor Information Systems Jun 2016 52.204-22 Alternative Line Item Proposal Jan 2017 http://www.acquisition.gov/far/

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 Jul 2013 Responsibility Matters.

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations Nov 2015 52.210-1 Market Research Apr 2011 52.215-2 Audit and Records—Negotiation. Oct 2010 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 52.215-11 Price Reduction for Defective Certified Cost or Pricing Data Aug 2011

—Modifications.

52.215-12 Subcontractor Certified Cost or Pricing Data. Oct 2010 52.215-13 Subcontractor Certified Cost or Pricing Data—Modifications. Oct 2010 52.215-15 Pension Adjustments and Asset Reversions Oct 2010 52.215-18 Reversion or Adjustment of Plans for Postretirement July 2005

Benefits (PRB) Other Than Pensions.

52.215-19 Notification of Ownership Changes. Oct 1997 52.215-20 Requirements for Certified Cost or Pricing Data. Oct 2010 52.215-21 Requirements for Certified Cost or Pricing Data and Data Oct 2010

Other Than Certified Cost or Pricing Data—Modifications

– Alternate III.

52.215-23 Limitations on Pass-Through Charges Oct 2009 52.216-7 Allowable Cost and Payment Jun 2013 Alternate IV Aug 2012 52.216-12 Cost-Sharing Contract – No Fee Apr 1984 52.219-8 Utilization of Small Business Concerns. Nov 2016 52.219-9 Small Business Subcontracting Plan. Jan 2017 52.219-16 Liquidated Damages—Subcontracting Plan Jan 1999 52.222-3 Convict Labor. June 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 52.222-40 Notification of Employee Rights Under the National Labor Dec 2010

Relations Act 52.222-50 Combating Trafficking in Persons. Mar 2015 52.222-54 Employment Eligibility Verification. Oct 2015 52.223-6 Drug-Free Workplace. May 2001 52.223-18 Encouraging Contractor Policies to Ban Text Messaging Aug 2011

While Driving

52.224-1 Privacy Act Notification. Apr 1984 52.224-2 Privacy Act. Apr 1984 52.224-3 Privacy Training. Jan 2017 52.227-14 Rights in Data—General May 2014 52.227-16 Additional Data Requirements June 1987 52.228-7 Insurance–Liability to Third Persons Mar 1996 52.230-2 Cost Accounting Standards. Oct 2015 52.230-3 Disclosure and Consistency in Cost Accounting Practices. Oct 2015 52.230-6 Administration of Cost Accounting Standards. June 2010 52.232-9 Limitation on Withholding of Payments 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— Jul 2013

System 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 Alternate I Dec1991 52.233-3 Protest after Award. Aug 1996 Alternate I June 1985 52.233-4 Applicable Law for Breach of Contract Claim. Oct 2004 52.237-3 Continuity of Services. Jan 1991 52.239-1 Privacy or Security Safeguards Aug 1996 52.242-1 Notice of Intent to Disallow Costs Apr 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. July 1995 52.243-2 Changes—Cost Reimbursement Aug 1987 Alternate I Apr 1984 52.244-5 Competition in Subcontracting. Dec 1996 52.244-6 Subcontracts for Commercial Items. Nov 2017 52.245-1 Government Property Jan 2017 52.246-25 Limitation of Liability—Services. Feb 1997 52.249-6 Termination (Cost-Reimbursement) May 2004 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 52.222-2 Payment for Overtime Premiums July 1990

(a) The use of overtime is authorized under this contract if the overtime premium does not exceed *______________ or the overtime premium is paid for work—

(1) Necessary to cope with emergencies such as those resulting from accidents, natural disasters, breakdowns of production equipment, or occasional production bottlenecks of a sporadic nature;

(2) By indirect-labor employees such as those performing duties in connection with administration, protection, transportation, maintenance, standby plant protection, operation of utilities, or accounting;

(3) To perform tests, industrial processes, laboratory procedures, loading or unloading of transportation conveyances, and operations in flight or afloat that are continuous in nature and cannot reasonably be interrupted or completed otherwise; or

(4) That will result in lower overall costs to the Government.

(b) Any request for estimated overtime premiums that exceeds the amount specified above shall include all estimated overtime for contract completion and shall—

(1) Identify the work unit; e.g., department or section in which the requested overtime will be used, together with present workload, staffing, and other data of the affected unit sufficient to permit the Contracting Officer to evaluate the necessity for the overtime;

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

(2) Demonstrate the effect that denial of the request will have on the contract delivery or performance schedule;

(3) Identify the extent to which approval of overtime would affect the performance or payments in connection with other Government contracts, together with identification of each affected contract; and

(4) Provide reasons why the required work cannot be performed by using multishift operations or by employing additional personnel.

* Insert either “zero” or the dollar amount agreed to during negotiations. The inserted figure does not apply to the exceptions in paragraph (a)(1) through (a)(4) of the clause.

FAR 52.244-2 Subcontracts Oct 2010

(a) Definitions. As used in this clause— “Approved purchasing system” means a Contractor’s purchasing system that has been reviewed and approved in accordance with Part 44 of the Federal Acquisition Regulation (FAR).

“Consent to subcontract” means the Contracting Officer’s written consent for the Contractor to enter into a particular subcontract.

“Subcontract” means any contract, as defined in FAR Subpart 2.1, entered into by a subcontractor to furnish supplies or services for performance of the prime contract or a subcontract. It includes, but is not limited to, purchase orders, and changes and modifications to purchase orders.

(b) When this clause is included in a fixed-price type contract, consent to subcontract is required only on unpriced contract actions (including unpriced modifications or unpriced delivery orders), and only if required in accordance with paragraph (c) or (d) of this clause.

(c) If the Contractor does not have an approved purchasing system, consent to subcontract is required for any subcontract that—

(1) Is of the cost-reimbursement, time-and-materials, or labor-hour type; or

(2) Is fixed-price and exceeds—

(i) For a contract awarded by the Department of Defense, the Coast Guard, or the National Aeronautics and Space Administration, the greater of the simplified acquisition threshold or 5 percent of the total estimated cost of the contract; or

(ii) For a contract awarded by a civilian agency other than the Coast Guard and the National Aeronautics and Space Administration, either the simplified acquisition threshold or 5 percent of the total estimated cost of the contract.

(d) If the Contractor has an approved purchasing system, the Contractor nevertheless shall obtain the Contracting Officer’s written consent before placing the following subcontracts:

(e)(1) The Contractor shall notify the Contracting Officer reasonably in advance of placing any subcontract or modification thereof for which consent is required under paragraph (b), (c), or (d) of this clause, including the following information:

(i) A description of the supplies or services to be subcontracted.

(ii) Identification of the type of subcontract to be used.

(iii) Identification of the proposed subcontractor.

(iv) The proposed subcontract price.

(v) The subcontractor’s current, complete, and accurate certified cost or pricing data and Certificate of Current Cost or Pricing Data, if required by other contract provisions.

https://www.acquisition.gov/sites/default/files/current/far/html/FARTOCP44.html#wp226845 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%202_1.html#wp1145507

(vi) The subcontractor’s Disclosure Statement or Certificate relating to Cost Accounting Standards when such data are required by other provisions of this contract.

(vii) A negotiation memorandum reflecting—

(A) The principal elements of the subcontract price negotiations;

(B) The most significant considerations controlling establishment of initial or revised prices;

(C) The reason certified cost or pricing data were or were not required;

(D) The extent, if any, to which the Contractor did not rely on the subcontractor’s certified cost…