RFP_5-26-15.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration

Office of Acquisition Management and Policy

Rockville, MD 20857-5600

May 26, 2015

You are invited to submit a proposal in accordance with the requirements of FAR Part 15 and the requirements of this Solicitation Number15-250-SOL-00059. This is a full and open requirement which is a re-competition for a contractor to provide services to support the operation of the Scientific Registry of the Transplant Recipient (SRTR), a national database of patients on the national organ waitlist, transplant recipients, and other transplant related data. The Contractor will be responsible for providing statistical and other analytic support to the Organ Procurement and Transplantation Network (OPTN) for purposes including the formulation and evaluation of organ allocation and other OPTN policies. Additionally, the Contractor will provide analytic support to HHS in a variety of areas including: policy formulation and evaluation, system performance metrics, economic analysis, and preparation of recurring and special reports to Congress. The NAICS code for this requirement is 541690. It is anticipated a cost only type contract will result from this solicitation. The period of performance is a base of twelve (12) months and four (4) twelve-month option periods.

Questions or issues for which you require clarification or correction by the Government must be furnished electronically to vdhaness@hrsa.gov. In order to allow a reply to be provided to all prospective Offerors before submission of proposal, your questions must be received no later than 10:00 am Eastern Standard Time (EST) on June 4, 2015. Questions received after the due date and time will not be considered. No Exceptions.

Your proposal must be signed by an official authorized to bind your organization and submitted to Veronica Dhaness by email in PDF format at vdhaness@hrsa.gov. no later than July 2, 2015 at 10:00 am Eastern Standard Time (EST). You must also request a delivery receipt to ensure timely receipt of proposals.

Your proposal shall be prepared in accordance with Section L and the "Statement of Work". This RFP does not commit the Government to pay any costs for the preparation and submission of a proposal nor does it commit the Government to make an award.

It is also brought to your attention that the Contracting Officer is the only individual who can legally commit the Government to expenditure of public funds in connection with this proposed acquisition.

Your proposal must provide a contact name and number, your company name and complete address, including street, city, county, state, zip code, e-mail address, Tax Identification Number mailto:vdhaness@hrsa.gov

(TIN). The TIN must match the name of the vendor to whom the payments will be made. Please note that FAR 52.204-7 System for Award Management Maintenance . Contractor Identification Number Data Universal System (DUNS Number). The Contractor must be registered in the SAM database at www.sam.gov. "Registered in the SAM database" means that (1) the Contractor has entered all mandatory information, including the DUNS number or the DUNS+4 number, into the SAM database; and (2) The Government has validated all mandatory data fields and has marked the record "Active".

By submission of an offer, the Offeror acknowledges the requirement that a prospective awardee shall be registered in the SAM database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. If the determined successful offeror is not registered in the SAM database at the time of award, the Contracting Officer will proceed to award to the next otherwise successful registered Offeror.

Any questions concerning this RFP should be referred to Veronica Dhaness at vdhaness@hrsa.gov or 301-443-5131.

Sincerely yours, Veronica Dhaness Contract Specialist http://www.sam.gov/

SECTION A – STANDARD FORM (SF) 33

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SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Purpose of Contract

The Health Resources and Services Administration (HRSA) is seeking a contractor to operate the Scientific Registry of Transplant Recipients (SRTR). The Contractor will be responsible for providing statistical and other analytic support to the Organ Procurement and Transplantation Network (OPTN) for purposes including the formulation and evaluation of organ allocation and other OPTN policies. Additionally, the Contractor will provide analytic support to HHS in a variety of areas including: policy formulation and evaluation, system performance metrics, economic analysis, and preparation of recurring and special reports to Congress.

B.2 Compensation Cost/Price

1. In consideration of the satisfactory performance of the services and tasks detailed in Section J– Attachment A-Statement of Work, the Contractor shall be compensated in accordance with the following amounts:

a) Base Period (Period of Performance X – X) The cost to the Government for full performance of the base period under this contract will be

b) Option Period One (Period of Performance X – X) The cost to the Government for full performance of Option Period One, if exercised, under this contract will be $___________.

c) Option Period Two (Period of Performance X – X) The cost to the Government for full performance of Option Period Two, if exercised, under this contract will be $___________.

d) Option Period Three (Period of Performance X – X) The cost to the Government for full performance of Option Period Three, if exercised, under this contract will be $___________.

e) Option Period Four (Period of Performance X – X) The cost to the Government for full performance of Option Period Four, if exercised, under this contract will be $___________.

2. The total cost for the Base Period and the four options periods is _________________.

SECTION C – DESCRIPTION/SPECIFICATIONS/ STATEMENT OF WORK

C.1 Statement of Work

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 Statement of Work set forth in Section J (Attachment A) attached hereto and made part of this document.

C.2 Incorporation of Contractor’s Proposal

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 clauses of the articles of this contract are in conflict or inconsistent with any clauses of said proposal, the provisions of the articles of this contract shall control and shall supersede the provisions of said proposal; therefore, the contractor’s proposal is hereby incorporated into the resultant contract.

SECTION D – PACKAGING AND MARKING

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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 52.246-5 -- Inspection of Services -- Cost-Reimbursement (Apr 1984)

(a) Definition. “Services,” as used in this clause, includes services performed, workmanship, and material furnished or used in performing 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 places and times 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 any of the services performed do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, for no additional fee. When the defects in services cannot be corrected by reperformance, the Government may -

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

(2) Reduce any fee payable under the contract to reflect the reduced value of the services performed.

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

(1) By contract or otherwise, perform the services and reduce any fee payable by an amount that is equitable under the circumstances; or

(2) Terminate the contract for default.

SECTION F – DELIVERIES OR PERFORMANCE

F.1 Observance of Federal Holidays

Official Holidays New Year’s Day January 1st Martin Luther King’s Birthday 3rd Monday in January Presidents’ Day 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 Every fourth year, Washington, DC

F.2 Period of Performance

The period of performance shall be a base period of twelve months and four (4) twelve-month option periods. The period of performance under this contract shall commence with the effective date of the contract (EDOC).

F.3 Schedule of Deliverables

The contractor shall submit deliverables as described in subsequent table to the COR via an email. The format of the deliverables shall be specified by the COR.

Number Name Date of

Delivery and Frequency

Quantity

D01 Updated transition plan 21 days after

EDOC

D02 Meeting agenda 21 days after

EDOC

D03 Status updates on the transition via email Weekly 1 D04 Written notification to the COR upon the completion of the transfer of contract materials 90 days after

EDOC

D05 Formal written agreement with the current OPTN contractor for data transfer

30 days after

EDOC

D06 Strategic plan Yearly and As updated

D07 Project conference call agenda Twice per month

D08 Minutes of project conference call Twice per month

D09 Joint SRTR and OPTN CORs and contractors meeting agenda items

Twice per year 1

D10 Quarterly written progress reports Quarterly 1 D11 Written request for participation in meeting or give presentation as SRTR contractor As required 1

D12 In-person briefing to the COR and other appropriate Government staff

Once

D13 Briefing materials including recommendations Once 1 D14 OPTN committee analytical support plan 90 days after

EDOC and as updated

D15 Review process for patient identified datasets 90 days after EDOC and as updated

D16 List of nominees for DAC membership As requested 1 D17 Documentation of steering committee structure and roles and responsibilities and membership 90 days after EDOC and as updated

D18 Steering Committee meeting agenda and background materials

14 days before meeting

D19 Steering Committee meeting minutes 14 days after meeting

D20 Visiting Committee Charter Once and as updated

D21 List of members of the Visiting Committee with CV for each committee member

Yearly and as updated

D22 Statement of purpose for each subcommittee and workgroup under the Visiting Committee

As required 1

D23 List of members with a CV for each subcommittee and workgroup

As required 1

D24 Visiting Committee meeting agenda and background materials

7 days before meeting

D25 Visiting Committee meeting minutes 30 days after meeting

D26 Conflict of interest certificate for each of the members of the Visiting Committee

Yearly and As updated

D27 Documentation of procedures to address conflict of interest

120 days after EDOC and as updated

D28 Documentations requested by HRSA OIT 30 days after request

D29 Security Authorization package 180 days after

EDOC

The initial package should be delivered within 180 days following contract award.

D30 SRTR secure website management procedure documentation

120 days after EDOC and as updated

D31 Websites improvement and enhancement project plan

180 days after EDOC and as updated

D32 SAF operations manual 180 days after EDOC and as updated

D33 Quarterly SAF Quarterly 1 D34 Monthly data quality report to the OPTN

Contractor Monthly 1

D35 Signed Data Use Agreement with CMS in Year 1 and as updated

D36 Signed Data Use Agreements and/or Memorandum of Agreement for non-OPTN data

As required 1

D37 De-identified copy of the linked database provided to NCI and notification to the COR

Up to 5 times per year

D38 Document describing archiving process 90 days after EDOC and as updated

D39 Status updates of archived materials 30 days before year end

D40 Data requests requiring release of PII As requested 1 D41 Data report or data files produced in response to data requests from COR As requested 1

D42 Analysis plan to COR and OPTN liaison As requested 1 The actual due date is based on the agreement between the OPTN COR, the SRTR COR, the OPTN contractor, and the SRTR contractor.

D43 Written report to COR and OPTN liaison As requested 1 The actual due date is based on the agreement

D44 Presentation Slides to COR and OPTN Liaison As requested 1 The actual due date is based on the agreement

D45 Analysis plan for HRSA request 15 days after request

D46 Written report for HRSA request As requested 1 D47 Presentation slides for HRSA request As requested 1 D48 Analysis plan 30 days after

EDOC

D49 Status report Quarterly 1 D50 Report on living donor registry feasibility assessment 9 months after

EDOC

D51 Analysis plan 30 days after

EDOC

D52 Status report Quarterly 1 D53 Report on geographic variation in kidney 12 months after 1 allocation EDOC D54 Schedule for updating SAMs, input files, and allocation rules 120 days after EDOC and as updated

D55 Updated SAMs Yearly and as updated

D56 Plan for enhancement of the SAMs 180 days after EDOC and as updated

D57 Draft PSRs for COR review Every 6 months

D58 Post Transplant Program and OPO-specific information on the SRTR Public Website (http://www.srtr.org/csr/current/Centers/Default.a spx)

Every 6 months

D59 Manual for developing risk-adjusted models used in the PSRs

180 days after EDOC and as updated

D60 Plan for providing technical assistance 120 days after EDOC and as updated

D61 Notification of requests for customized technical assistance

As requested 1

D62 Posting data review tools on SRTR secure website

Every 6 months

D63 Posting expected survival worksheets on SRTR secure website

Every 6 months

D64 Posting CUSUM charts on SRTR secure website Monthly 1 D65 CUSUM Charts for additional metrics Monthly 1 D66 Draft ADR Yearly 1 D67 Final ADR Yearly 1 D68 Draft Biennial Report to Congress Every two years

D69 Final Biennial Report to Congress Every two years

D70 Draft abstracts and/or manuscripts Upon completion

D71 Post published journal articles on SRTR web site After journal publication

D72 Plan for transitioning SRTR contract to subsequent Contractor

90 days before contract end

HHSAR Clauses DELIVERABLE DUE DATE HHSAR 352.239-73(c)- Electronic and Information Technology Accessibility

HHS Section 508 Product Assessment Template (GPAT)

HHSAR 352.239-73(c)- Electronic and Information Technology Accessibility

Section 508 Annual Report End of each contract year

Reporting Requirements And Deliverables

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

Monica Lin

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

Email: mlin@hrsa.gov

a. All deliverable reports shall include a cover page with the following information:

1) Contract number

2) Deliverable item number

3) Deliverable item delivery due date

4) Date of submission

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.

b. All deliverables items are to be separate physical entities.

c. All deliverables are subject to the review and approval of the COR.

F.4 52.242-15 Stop-Work Order (Aug 1989)

(a) The Contracting Officer may, at any time, by written order to the Contractor, require the Contractor to stop all, or any part, of the work called for by this contract for a period of 90 days after the order is delivered to the Contractor, and for any further period to which the parties may agree. The order shall be mailto:mlin@hrsa.gov specifically identified as a stop-work order issued under this clause. Upon receipt of the order, the Contractor shall immediately comply with its terms and take all reasonable steps to minimize the incurrence of costs allocable to the work covered by the order during the period of work stoppage. Within a period of 90 days after a stop-work is delivered to the Contractor, or within any extension of that period to which the parties shall have agreed, the Contracting Officer shall either-

(1) Cancel the stop-work order; or

(2) Terminate the work covered by the order as provided in the Default, or the Termination for

Convenience of the Government, clause of this contract.

(b) If a stop-work order issued under this clause is canceled or the period of the order or any extension thereof expires, the Contractor shall resume work. The Contracting Officer shall make an equitable adjustment in the delivery schedule or contract price, or both, and the contract shall be modified, in writing, accordingly, if-

(1) The stop-work order results in an increase in the time required for, or in the Contractor’s cost properly allocable to, the performance of any part of this contract; and

(2) The Contractor asserts its right to the adjustment within 30 days after the end of the period of work stoppage; provided, that, if the Contracting Officer decides the facts justify the action, the Contracting Officer may receive and act upon the claim submitted at any time before final payment under this contract.

(c) If a stop-work order is not canceled and the work covered by the order is terminated for the convenience of the Government, the Contracting Officer shall allow reasonable costs resulting from the stop-work order in arriving at the termination settlement.

(d) If a stop-work order is not canceled and the work covered by the order is terminated for default, the Contracting Officer shall allow, by equitable adjustment or otherwise, reasonable costs resulting from the stop-work order.

(End of clause)

Alternate I (Apr 1984). If this clause is inserted in a cost-reimbursement contract, substitute in paragraph (a)(2) the words “the Termination clause of this contract” for the words “the Default, or the Termination for Convenience of the Government clause of this contract.” In paragraph (b) substitute the words “an equitable adjustment in the delivery schedule, the estimated cost, the fee, or a combination thereof, and in any other terms of the contract that may be affected” for the words “an equitable adjustment in the delivery schedule or contract price, or both.”

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. The responsibility of the COR is to ensure that the Government’s technical objectives are met. To this end, the COR will provide necessary information, direction, coordination, etc., within the contractual work description. Issuance of changes which affect the articles, terms, or conditions of this contract will be accomplished through the Contracting Officer who is the only party authorized to bind the Government to contract:

Monica Lin Division of Practitioner Data Banks Bureau of Health Professions Health Resources and Services Administration U.S. Dept. of Health and Human Services 5600 Fishers Lane, 11W09C Rockville, MD 20857

Phone Number: 301- 443-2776 Email: mlin@hrsa.gov

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 statement of work. 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. Only the Contracting Officer has the authority to make a formal change to the contract.

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 Statement of Work 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 Statement of Work 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 (i.e., changes in the cost or scope of work, instructions to start or stop work, approval of any actions that will mailto:mlin@hrsa.gov 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 authorized to bind the Government to contract and the only party who can determine if a direction is within the Statement of Work.

G.4 Submission of Invoices and Place of Payment

1. The Contactor shall submit payment requests to hrsainvoices@hrsa.gov as often as monthly using Standard Form 1034, Public Voucher for Purchases and Services Other Than Personal. The SF 1034 and supporting documentation must be submitted in PDF format.

Payment shall be made in accordance with the terms of the contract.

2. The Contractor agrees to submit a voucher in accordance with Section J, Attachment B, Billing Instructions. VOUCHERS WITHOUT ALL REQUIRED INFORMATION WILL

BE DENIED UNTIL THE PROPER INFORMATION IS SUBMITTED.

3. For inquiries regarding voucher submission, e-mail your concerns to hrsainvoices@hrsa.gov .

4. For inquiries regarding technical issues, inspection and acceptance, call your Contracting Officer Representative (COR).

5. For inquiries regarding suspension or rejection of costs submitted, call your Contract Specialist.

6. Payment shall be made by:

PSC/Financial Management Service DFO Accounting Operations, Suite 200 12501 Ardennes Avenue Rockville, MD 20857 Telephone: 301-443-3020 Fax: 301-443-0562

G.5 Electronic Funds Transfer

The Contractor shall designate a financial institution for receipt of electronic funds transfer payments and it shall be reported in Systems for Award Management (SAM) and shall be submitted in writing to the finance office set forth in Section G.5.6. All data stored in the CCR and ORCA has been transferred to the new Systems for Award Management (SAM) and can be found at www.sam.gov. Contractors are encouraged to periodically review their file for accuracy and are required to re-reregister before their expiration date, which is the same date as their CCR expiration date. SAM will notify users by e-mail that their file is due to expire beginning 60 days prior to expiration, then 30 days and finally 15 days before expiration. Directions on how to navigate SAM can be found on the site’s Home Page by clicking Help in the navigation bar at the top of the page.

G.6 Evaluation of Contractor’s Performance evaluation of Contractor performance shall be conducted on this contract in mailto:hrsainvoices@hrsa.gov mailto:hrsainvoices@hrsa.gov http://www.sam.gov/

Interim and final evaluation of Contractor performance on this contract shall be conducted in accordance with FAR Subpart 42.15, and HHSAR 342.7001(d). Upon contract completion, a final evaluation of the Contractor’s performance shall be completed by the Government; see Section J, Attachment E.

The Government will conduct an evaluation of Contractor’s performance based on the completion of the tasks stated in the SOW. HRSA documents contractor performance using the Contractor Performance Assessment Rating System (CPARS) (www.cpars.gov). The evaluation shall be conducted by the COR and be comprised of an evaluation of contractor performance completed by the Contractor and Federal staff, and a review of progress reports and financial reports (deliverables).

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 Communication

Any HRSA communication products developed under this contract will require an additional separate clearance on an HHS-615 (for text and/or graphic publications and products that will be printed, posted on the Web, or disseminated through other electronic methods, such as by email) or an HHS-524A (for audiovisual products, including those that will be posted on the Web). Communication clearance for this contract itself does not satisfy the requirement to seek clearance of the specific HRSA communication products.

H.2 Printing and Duplicating

The printing of government documents must be accomplished through the Government Printing Office (GPO). Contractors and grantees shall not be used as sources of printing for the Department or OPDIVS.

Therefore, the inclusion of printing in contracts and grants is prohibited unless authorized by the Joint Committee on Printing (JCP). All requests for waivers must go through the HHS Department Printing Officer. Contractors may prepare copy, illustrative material (forms etc.) and /or camera ready copy for the purpose of producing publications.

The Contractor shall not engage in, nor subcontract for, any printing (as the term is defined in Title 1 of the Government Printing and Binding Regulations in effect on the effective date of this contract) in connection with the performance of work under this contract; except that performance of a requirement under this contract involving less than 25,000 production units in the aggregate of multiple pages will not be deemed to be printing. A production unit is defined as one sheet, size 8.5 x 11 inches, one side only, and one color.

Regarding the use of private funds for printing, the regulations state that when appropriated funds are to be 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 congressional Joint Committee on Printing by way of the office of HHS Department Printing Officer. For any questions, please contact the HHS Department Printing Officer at 301-594-3185.

H.3 Clearance/Production of Information Products/Services

The U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Public Affairs, requires clearance for any external communication products, which includes publications, audiovisual products, multimedia products, exhibits (including exhibit structures), conferences (including program/agenda books and other meeting materials), or public affairs services produced for or by HRSA through this contract as a deliverable. An external communication product is one that will be distributed outside of HRSA in any quantity. This clearance, which takes approximately 4 weeks, is obtained by the project officer through HRSA’s Office of Communications.

It is the policy of HHS that HHS must be prominently and dominantly identified as the primary publisher/producer, to include the name of HHS and placement of the HHS logo, on all communication materials, including those produced for Government publications and Government printed matter by contractors.

The name of the U.S. Department of Health and Human Services and the Health Resources and Services Administration must be spelled out on the front cover of publications and on the opening and closing frames of audiovisual products. The HHS and HRSA logos must be displayed in addition to spelling out the names of the Department and the Agency. Use of the HHS and HRSA logos that include the names of the Department and the Agency as part of the graphics in the logos does not satisfy the requirement to spell out the names of HHS and HRSA. All publications and audiovisual products must display the month and year of issuance. The HHS and HRSA logos must be displayed on the front cover of any publications and on the opening and closing frames of any audiovisual products. The requirement for placement of the logos may be satisfied by displaying the HHS logo on the bottom left corner and the HRSA logo on the bottom right corner. The HHS logo should be larger than the HRSA logo. Government publications or other Government printed matter may not include the contractor’s logo unless specifically authorized in accordance with agency policy and procedures (http://www.hhs.gov/web/policies/webpolicies/logopolicies/logos_contractors.html)

Communication products are any and all products intended for audiences outside the Agency, including but not limited to:

• reports, booklets, manuals, fact sheets, newsletters, brochures, flyers

• Internet publications

• press releases, advisories, other media materials (including press kits)

• exhibits, exhibit structures

• conferences, meeting materials (including program/agenda books)

• summaries, monographs, proceedings

• slides, overhead transparencies, posters

• audio and videotapes, films, CDs, DVDs, and other audiovisual products

• multimedia products, educational or information modules

• advertisements and/or scripts for radio, TV, Web, or other venue

Internal publications (no copies will be distributed outside of the Agency in print; electronically by any means, including by email or listserv; and will not be posted on the Internet) are exempted from this requirement. Where appropriate, the words Health Resources and Services Administration, Bureau …, Office of, Division of …, shall be included above the HRSA logo.

Title 44 of the U.S. Code requires that the printing of any publication developed under this contract shall be done by the Government Printing Office. Printing shall be coordinated through the Contracting Officer Technical Representative.

NOTE: OMB clearance must be obtained if you (the contractor) intend to survey or interview more than 9 people outside of HRSA and/or the Department, including grantees. Failure on the part of the Contractor to comply with the printing and duplicating, and publication clearance requirements stated above will be deemed unauthorized services and reimbursement will be denied.

H.4 Language Disclaimer

The views expressed in written conference materials, publications, audiovisual products, and by speakers and moderators at HHS-sponsored conferences, do not necessarily reflect the official policies of the U.S.

http://www.hhs.gov/web/policies/webpolicies/logopolicies/logos_contractors.html

Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

H.5 Rights in Data

The Contractor will be prohibited from copyrighting, publishing or disseminating information resulting from work performed under this contract, and/or, using data produced or obtained under this contract, and/or any other information or products provided by the Government, or which the Contractor develops, for any purpose other than performance under this contract without prior written approval from the Contracting Officer.

Ownership of Documents, Materials and Records: All documents, materials (including any computer code) or records provided to the Contractor, developed or maintained by the Contractor in the performance of this contract are deemed to be property of the Government.

H.6 Limited Use of Data

Performance of this effort may require the Contractor to access and use data and information proprietary to a Government agency or Government Contractor which is of such a nature that its dissemination or use, other than in performance of this effort, would be adverse to the interests of the Government and/or others.

Contractor and/or Contractor personnel shall not divulge or release data or information developed or obtained in performance of this effort, until made public by the Government, except to authorize Government personnel or upon written approval of the Contracting Officer (CO). The Contractor shall not use, disclose, or reproduce proprietary data that bears a restrictive legend, other than as required in the performance of this effort. Nothing herein shall preclude the use of any data independently acquired by the Contractor without such limitations or prohibit an agreement at no cost to the Government between the Contractor and the data owner which provides for greater rights to the Contractor.

H.7 Disclosure of Information

Information made available to the Contractor by the Government for the performance or administration of this effort shall be used only for those purposes and shall not be used in any other way without the written agreement of the Contracting Officer.

The Contractor agrees to assume responsibility for protecting the confidentiality of Government records, which are not public information. Each Contractor or employee of the Contractor to whom information may be made available or disclosed shall be notified in writing by the Contractor that such information may be disclosed only for a purpose and to the extent authorized herein.

H.8 Confidentiality Agreement Requirement

The Contractor shall implement a confidentiality agreement related to all data provided by the Government staff. All Contractor staff that work with the Federal Government and are provided information and access to databases shall sign such an agreement and a copy of the signed agreement for each relevant staff member shall be submitted to the COR prior to receipt of relevant documents.

H.9. Homeland Security Presidential Directive-12

To perform the work specified herein the Contractor personnel may require access to sensitive data, regular access to HHS-controlled facilities and/or access to HHS information systems, the Government may require that this effort entail a background investigation.

• Upon receipt of the Government’s notification of applicable Suitability Background Investigation required, the Contractor shall complete and submit required forms within 30 days of the notification. Additional submission instructions can be found at the NCI Information Technology Security Policies, Background Investigation Process: (http://ais.nci.nih.gov/).

• The Contractor shall submit a roster, by name, position and responsibility, of all staff working under the contract. The roster shall be submitted to the Contracting Officer Representative (COR), with a copy to the HRSA Division of Workforce Management and Contracting Officer, within 14 days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within fifteen (15) calendar days of the change. The COR will submit the list to the HRSA Personnel Security Officer for determination of the appropriate level of suitability investigations to be performed.

Contractors should ensure that the employees whose names they submit have a reasonable chance for approval. While delays in performance caused by successful investigations will be the Government's responsibility, delays associated with rejections will be the Contractor's responsibility. Typically, the Government conducts investigations and checks at no cost to the Contractor. Multiple investigations for the same position, whether- resulting from rejections or resulting from an employee's move to another position(s) or company, may at the Contracting Officer's discretion, justify reductions(s) in the contract coat of no more than the cost of the extra investigation.

H.10. Food

It is the Department's policy that OPDIVs and STAFFDIVs shall not use appropriated funds (whether from an annual appropriation, multi-year appropriation, appropriated user fee, mandatory appropriation, gift funds, or reimbursements from such appropriations, etc.) to purchase food (whether for conferences or meetings; for meals, light refreshments, or beverages; or for Federal or non-Federal participants). Food and meals are not to be provided and are an unallowable expense.

H.11. Medical Records

The contractor shall ensure the confidentiality of the record under the Privacy Act of 1974 and HIPAA as it relates to the release of medical information.

H.12. Quality Assurance

The contractor shall perform all the requirements identified in this contract. 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.

http://ais.nci.nih.gov/

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.13 Requirement of Senior Contractor Personnel

To maintain objectivity in providing evidence based analysis in support of OPTN policy development process, principals in SRTR contractor shall not accept nor serve in significant leadership positions in major professional or advocacy organizations or transplant centers or OPOs unless under special circumstances with the prior approval of the SRTR COTR.

SECTION I – CONTRACT CLAUSES

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

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

This 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.

Also, the full text of a clause may be accessed electronically at 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 SEPT 2006 52.203-7 Anti-Kickback Procedures MAY 2014 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity

MAY 2014

52.203-10 52.203-11

Price or Fee Adjustment for Illegal or Improper Activity Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions

MAY 2014

SEP 2007

52.203-12

52.203-13 52.203-16 52.203-17

52.204-1

Limitation on Payments to Influence Certain Federal Transactions Contractor Code of Business Ethics and Conduct Preventing Personal Conflicts of Interest Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights Approval of Contract

OCT 2010

APR 2010

DEC 2011

APR 2014

DEC 1989

52.204-4

52.204-5

Printed or Copied Double-Sided on Postconsumer Fiber Content Paper Women-Owned Business (Other Than Small Business

MAY 2011

OCT 2014

52.204-7 52.204-8

System for Award Management Annual Representations and Certifications

JUL 2013

DEC 2014

52.204-9 52.204-10

52.204-13 52.204-16 52.204-17 52.204-18 52.204-19

52.207-3 52.209-2

Personal Identity Verification of Contractor Personnel Reporting Executive Compensation and First Tier Subcontractor Awards System for Award Management Maintenance Commercial and Government Entity Code Reporting Ownership or Control of Offeror Commercial and Government Entity Code Maintenance Incorporation by Reference of Representations and Certifications Right of First Refusal of Employment Prohibition on Contracting with Inverted Domestic Corporations-Representation

JAN 2011

JUL 2013

JUL 2013

NOV 2014

NOV 2014

NOV 2014

DEC 2014

MAY 2006

DEC 2014

52.209-6

Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

AUG 2013

http://www.acquisition.gov/far

52.209-9

52.209-10

Updates of Publicly Available Information Regarding Responsibility Matters Prohibition on Contracting with Inverted Domestic Corporations

JUL 2013

DEC 2014

52.215-2 Audit and Records–Negotiation OCT 2010 52.215-8 52.215-10 52.215-11

52.215-12 52.215-13 52.215-15

Order of Precedence–Uniform Contract Format Price Reduction for Defective Cost or Pricing Data Price Reduction for Defective Certified Cost or Pricing Data-Modifications Subcontractor Certified Cost or Pricing Data Subcontractor Certified Cost or Pricing Data-Modifications Pension Adjustments and Asset Reversions

OCT 1997

AUG 2011

AUG 2011

OCT 2010

OCT 2010

OCT 2010

52.215-18

52.215-19 52.215-20 52.215-21

52.215-22

52.215-23 52.216-7 52.216-11

52.219.8 52.219-9

Reversion or Adjustment of Plans for Postretirement Benefits (PRB) Other Than Pensions Notification of Ownership Changes Requirements for Certified Cost or Pricing Data Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data – Modifications Limitations On Pass-Through Charges—Identification Of Subcontract Effort Limitations on Pass-Through Charges Alt 1 Allowable Cost and Payment Cost Contract-No Fee

Utilization of Small Business Concerns Small Business Subcontracting Plan

JUL 2005

OCT 1997

OCT 2010

OCT 2010

OCT 2009

OCT 2009

JUN 2013

APR 1984

OCT 2014

OCT 2014

52.219-16

Liquidated Damages—Subcontracting Plan

JAN 1999

52.222-1 Notice to the Government of Labor Disputes FEB 1997 52.222-3

Convict Labor

JUN 2003

52.222-21 Prohibition of Segregated Facilities APR 2015 52.222-26 Equal Opportunity APR 2015 52.222-35 Equal Opportunity for Veterans JUL 2014 52.222-36 Equal Opportunity for Workers with Disabilities JUL 2014 52.222-37 Employment Reports Veterans JUL 2014

52.222-50

Combating Trafficking in Persons

MAR 2015

52.223-6 Drug-Free Workplace MAY 2001 52.223-18

Encouraging Contractor Policies to Ban Text Messaging While Driving

AUG 2011

52.224-1 Privacy Act Notification APR 1984 52.224-2 Privacy Act APR 1984 52.225-13 Restrictions on Certain Foreign Purchases JUN 2008 52.227-14 Rights in Data–General MAY 2014 52.227-17 52.230-2

Rights in Data–Special Works Cost Accounting Standards

DEC 2007

MAY 2014

52.230-3 Disclosure and Consistency of Cost Accounting Practices MAY 2014

52.230-6 Administration of Cost Accounting Standards JUN 2010 52.232-17 52.232-20

Interest Limitation of Cost

MAY 2014

APR 1984

52.232-23 Assignment of Claims MAY 2014 52.232-25 Prompt Payment JUL 2013 52.232-33

Payment by Electronic Funds Transfer–System for Award Management

JUL 2013

52.232-40

52.232-39

Providing Accelerated Payment to Small Business Subcontractors Unenforceability of Unauthorized Obligations

DEC 2013

JUN 2013

52.233-1

Disputes

MAY 2014

52.233-3 Protest After Award–Alternate I (JUN 1985) AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.237-3 52.237-7

Continuity of Services Indemnification and Medical Liability Insurance

JAN 1991

JAN 1997

52.239-1 52.242-1 52.242-4 52.242-13

Privacy or Security Safeguards Notice of Intent to Disallow Costs Certification of Final Indirect Costs Bankruptcy

AUG 1996

APR 1084

JAN 1997

JUL 1995

52.243-2 Changes– Cost-Reimbursement – Alternate 1 AUG 1987 52.244-2 Subcontracts OCT 2010 52.244-5 Competition in Subcontracting DEC 1996 52.244-6 Subcontracts for Commercial Items APR 2015 52.246-25 Limitation of Liability–Services FEB 1997 52.249-6 52.249-14

Termination (Cost-Reimbursement) Excusable Delays

MAY 2004

APR 1984

52.253-1 Computer Generated Forms JAN 1991

A. Department of Health and Human Services Acquisition Regulation (HHSAR) (48 CFR Chapter

3) (http://www.hhs.gov/regulations/hhsar/)

Clause No. Title Date

352.202-1 352.203-70 352.216-70 352.219-70 352.219-71 352.222-70

Definitions Anti-Lobbying Additional Cost Principles Mentor-ProtegeProgram Mentor-Protégé Program Reporting Requirements Contractor cooperation in equal employment opportunity investigations

JAN 2006

JAN 2006

JAN 2006

JAN 2010

JAN 2010

JAN 2010

352.224-70 Privacy Act JAN 2006 352.227-70 Publications and Publicity JAN 2006 352.228-7 Insurance - Liability to Third Persons DEC 1991 352.231-70 Salary Rate Limitation JAN 2010

352.233-71 352.234-3 352.239.70 352.239-71 352.239-72 352.239-73

Litigation and Claims Full Earned Value Management Systems System Standard for Security Configurations Standard for Encryption Language Security Requirements for Federal Information Technology Resources Electronic information and technology accessibility

JAN 2006

OCT 2008

JAN 2010

JAN 2010

JAN 2010

JAN 2010

352.242-73 Withholding of Contract Payments JAN 2006 352.242-74 Final Decisions on Audit Findings APR 1984 324.1

Protection of Individual Privacy

JAN 2006

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 the period specified in the Schedule

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 60 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 5 years.

I. 3 Protest

FAR 52.233-2 Service of Protest Service of Protest (Sept 2006)

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer by obtaining written and dated acknowledgment of receipt from:

https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2033_1.html#wp1088681

Mr. Jun Ji

Director for Division of Primary Care and Health Infrastructure Support Office of Acquisition Management & Policy Health Resources & Services Administration 5600 Fishers Lane Room 14W24 Rockville, MD 20857 Office: 301-945-9484 Mobile: 301-346-9825

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

I.4 Changes

FAR 52.243-7 Notification of Changes (Apr 1984)

(a) Definitions.“Contracting Officer,” as used in this clause, does not include any representative of the Contracting Officer.

“Specifically Authorized Representative (SAR),” as used in this clause, means any person the Contracting Officer has so designated by written notice (a copy of which shall be provided to the Contractor) which shall refer to this paragraph and shall be issued to the designated representative before the SAR exercises such authority.

(b) Notice. The primary purpose of this clause is to obtain prompt reporting of Government conduct that the Contractor considers to constitute a change to this contract. Except for changes identified as such in writing and signed by the Contracting Officer, the Contractor shall notify the Administrative Contracting Officer in writing promptly, within 5 calendar days from the date that the Contractor identifies any Government conduct (including actions, inactions, and written or oral communications) that the Contractor regards as a change to the contract terms and conditions. On the basis of the most accurate information available to the Contractor, the notice shall state—

(1) The date, nature, and circumstances of the conduct regarded as a change;

(2) The name, function, and activity of each Government individual and Contractor official or employee involved in or knowledgeable about such conduct;

(3) The identification of any…