18-250-SOL-00017_OPTN_RFP_Amendment_1.pdf

(x)

18-250-SOL-00017

x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT

THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

Rockville MD 20857

OAMP

5600 Fishers Lane, Room 14W26B Management and Policy Office of Acquisition

HHS/HRSA/OO/OAMP

Rockville MD 20857

OAMP

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

HHS/HRSA/OO/OAMP

04/13/2018000001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

03/30/2018

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not, is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Organ Procurement and Transplantation Network

The purpose of this amendment is to a) extend the due date for proposals, b) provide responses to questions received, and c) update the Request for Proposal (RFP) and

Attachment A - Performance Work Statement (PWS).

a) The due date for proposals is changed from 3:00 PM EDT, April 30, 2018 to 10:00 AM EDT, May 4, 2018.

b) The following are responses to questions received:

Question 1:

Continued ...

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

BIJAN MANSOURY

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

NSN 7540-01-152-8070

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

The RFP for this contract is very detailed and will require thousands of person-hours to prepare. For a new applicant, it will be impossible to complete in a 30-day time frame.

This time frame favors the incumbent contractor.

Will HRSA consider extending the time frame for submission to 90 days? Or at least 75 or 60 days?

Otherwise, bids from new contractors cannot be prepared and submitted.

Response:

The response time provided is in accordance FAR

5.203(c), "agencies shall allow at least a 30-day response time for receipt of bids or proposals from the date of issuance of a solicitation . .

Prior to release of the solicitation, the

Government conducted market research by releasing an RFI with a draft version of the PWS, allowing prospective offerors to review the requirement.

In addition, the Government responded to questions submitted in response to the RFI and ensured that prospective offerors had access to its responses to prepare for the RFP. The

Government will extend the deadline for receipt of proposals to 10:00 AM EDT, May 4, 2018. The response time provided is to ensure timely review of proposals received.

Question 2:

The draft PWS alluded to a transition in and transition out plan. The current contract, dated

Sept 30, 2005, also alludes to a Transition Plan

(Item 15, Appendix A page 40) which provides for the consistent operation of the match capabilities and an orderly transfer of data files and pertinent software to direct the management of the OPTN, and its web site (page

41). This appears to be at odds with the current

PWS. Will HRSA consider providing a reasonable transition period to allow for the orderly transfer of activities to run the OPTN? We recommend a timeline of a minimum of 6 months to transition all activities to a new contractor.

Response:

HRSA seeks to procure services to operate the

OPTN. HRSA is required by statute to provide

OPTN services to the Nation at all times

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

3 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

The current OPTN contract includes an optional transition task, Task 15 Transition to New OPTN

Contractor. The current OPTN contract states that the transition task is optional. Unless optional tasks are executed by exercising, these services cannot be performed by the current contractor.

The PWS of the subject solicitation will be updated to reflect 6-month transition-in and transition-out periods. The optional task for a transition-in period identified in the RFP is not intended to provide a period of time for a contractor to develop an OPTN matching function.

If an Offeror were to propose using a matching function that is documented to be in all ways capable of listing candidates and matching organs to candidates, but for inclusion of detailed OPTN organ allocation algorithm programming, the

Government may exercise Optional Task 3.13

Transition-In Plan.

Question 3:

Consistent with a transition period, will HRSA consider naming some of the leadership positions at a later date after the contract is awarded? In the last contract, dated Sept 30, 2005, only three officers were required to be named in the contract bid.

Response:

The requirement in the 2005 contract is outdated and has been updated to reflect the leadership positions deemed critical for success of the 2018 contract effort. The Government cannot consider proposals that name personnel at a later date as

Personnel are required elements of the technical proposal. See section G.4 on page 28, section

L.4.2.4 on pages 55-56, and section M.4.2 on pages 61 and 63-64.

Question 4:

The Final Rule requires the Board of Directors confirm the Executive Director. How can a new contractor list an Executive Director until they are approved by the BoD?

Response:

Offerors shall name a proposed Executive Director

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

4 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

in their proposal. The OPTN Board of Directors can consider and approve the proposed Executive

Director after contract award.

Question 5:

The amount of detail requested in the business plan portions of the contract bid is excessive and favors the incumbent contractor, UNOS. UNOS is at an unfair advantage over any other organization, because of their intimate involvement with the operation of the OPTN. Will

HRSA entertain the possibility of a contractor providing less detailed information at the time of application submission with appropriate milestone submission of details of the business plan during a reasonable transition period?

Similarly, budget details will need to be updated as some current employees chose to take advantage of relocation.

Response:

The detail requested in the business plan is required by the Federal Acquisition Regulations

(FAR) clause 52.215-20 and by FAR part 15.4 -

Contract Pricing. The proposed contract is governed by FAR Part 15, Negotiated Contract, as such it requires that the contracting office obtain certified cost and pricing data in accordance with FAR 15.403-4.

Question 6:

The new RFP requires the contractor to have all computer hardware and software to begin the work of the OPTN at the time of the beginning of the contract. This is not possible for a new contractor, and clearly favors the incumbent contractor. It is also inconsistent with a transition period, which will be necessary for success of any new contractor. If a new contractor proposes to subcontract data acquisition and storage, then some computer hardware will need to be acquired by the subcontractor after funds are available from the contract? Will HRSA allow the gradual acquisition of computer hardware and software to allow a successful transition to a new contractor? Or will the current requirement, which can only be met by the incumbent contractor, remain in place, effectively precluding any new contractor?

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

5 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

Response:

HRSA seeks to procure services to operate the

OPTN. HRSA is required by statute to provide

OPTN services to the Nation at all times.

Similar to question 2 regarding the OPTN matching function, at the beginning of the contract period, a Offeror needs to have at its disposal data storage and management capacity and the computer hardware necessary to provide OPTN services.

The transition periods identified in the RFP are not intended to provide a period of time for a contractor to develop or arrange for data storage and management capacity and computer hardware and software development.

Prospective offerors are required to have the staff, facilities, and equipment to perform the services required in the solicitation. Per section H.3 on page 29, federal funding available through this contract shall not be used to reimburse the Contractor for purchase of computer hardware and/or software without prior

Contracting Officer approval.

Question 7:

The Final Rule stipulates that OPTN contractor revenue come from the contract and registration fees (91% of revenue). Would HRSA consider two registration lists? A waiting list registration fee, and a fee for being registered on a transplanted list? Both would be considered registration fees, and are consistent with

"listing" fees. The purpose of this change is to incentivize organ transplants. The current system incentivizes listing patients, not transplanting them. If waiting time no longer accounted for transplant priority (as recommended in the Final

Rule), then the number of registrations would be reduced substantially. This happened with introduction of the Lung Allocation Score.

Response:

The OPTN regulation (final rule) provides that

OPTN members shall pay a registration fee for each transplant candidate it places on the waiting list and that the amount of such fees, together with contract funds awarded by the

Secretary, shall be calculated to cover the

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

6 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

reasonable costs of operating the OPTN.

Question 8:

I request that HRSA extend the April 30th deadline for responses. Any organization preparing a new bid would require more time than the allotted 30 days to prepare a response to this extensive RFP. The last time that the OPTN contract was offered competitively was in 2005, when prospective contractors were given from

April 15th until June 13th to prepare their bids.

The RFP that has just opened requires considerably more work to prepare because HRSA requests more meticulously detailed business and technical information. Therefore, we ask HRSA to allow 90 days for respondents to complete their proposals.

In response to a question about the 21-day timeline for responding to December's OPTN RFI, HRSA stated, "The RFI only seeks questions and/or comments on the proposed PWS whereas the RFP requires potential bidders to submit a full proposal. HRSA does typically allow a longer window for interested parties to submit a proposal in response to an issued RFP but the window for responses to an issued RFI is typically shorter." However, the OPTN RFP has been released with only a few more days to respond than were allowed for the RFI.

Response:

Please see the response to question 1.

Question 9:

The RFP specifies as an evaluation factor for the award, "The Vendor (organization) experience as not-for-profit entity in the field of organ transplantation based on a minimum of three (3) years of corporate experience in managing projects of similar scope and complexity in the field of organ transplantation." Could HRSA provide some examples of projects managed by not-for-profit corporations in the field of organ transplantation that are of similar scope and complexity to operating the OPTN? This requirement seems to set a bar that would be extremely difficult for anyone other than the current contractor to reach.

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

7 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

Response:

The Offeror is responsible for identifying and documenting its experience managing projects of scope and complexity similar to the OPTN in the field of organ transplantation. The Offeror must demonstrate its capacity to manage the contract and provide all OPTN services as of the beginning of the contract period.

HRSA considers the criteria listed under L.4.2.4 of the RFP, Organization and Personnel Experience and Expertise, to provide points of reference for organizational experience.

Question 10:

Will HRSA release the current contractor's transition plan, or a detailed summary?

Organizations wishing to submit a competitive bid would require at least some outline of the transition plan to appropriately resource the transition. In particular, what software will be transferred in the event of a transition to a new contractor? The 2005 OPTN contract included the following language:

Task 15 Transition to New OPTN Contractor

The Purpose of Task 15 is to maintain continuity of OPTN operations.

15.a In recognition of the fact that the transplant candidate waiting list and matching program must be in operation at all times, the purpose of this task is to provide for an orderly transition from the current Contractor to any subsequent Contractor. The incumbent Contractor shall develop a transition plan, and upon approval of the Project Officer, the Contractor shall implement the plan and cooperate with the new Contractor to provide all necessary data, data systems, and documentation for continued operation of patient listing, organ allocation, and data collection systems as described in Tasks

2, 3, and 4. These data, data systems, and documentation shall include but not be limited to the following:

1. a copy of all OPTN data files to include documentation of all file layouts relating to the

OPTN and SRTR; 2. a copy of current OPTN organ allocation policies, including any exceptions to approved policies (e.g., approved variances, sharing agreements, and alternative local units);

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

8 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

3. detailed documentation on the decision logic used to implement all approved organ allocation policies and exceptions to policies including the logic used to establish and maintain waiting lists and to match transplant candidates with donor organs; 4. software and related documentation used to implement the organ allocation policies including but not limited to software used to place and maintain individuals on organ waiting lists and software used to match transplant candidates with donor organs; 5.

software and related documentation used to capture and maintain pre- and post-transplant data for purposes of listing patients, matching patients to donor organs, and for conducting research on pre- and post-transplant events; 6.

software and programming used to produce and maintain optn.org website; and 7. amendments to the above items as they change during the course of the transition period.

The Contractor shall develop a transition plan and submit it to the Project Officer for approval.

This provision of the 2005 OPTN contract is analogous to a similar provision in the current

Scientific Registry for Transplant Recipients

Performance Work Statement, which reads:

3.11.2 The Contractor shall submit a

transition-out plan for transfer of all materials and meeting with the new Contractor during transition.

Three months prior to the close of this contract or three months before the end of the last option year exercised by the Government, the Contractor shall submit a list of all materials that would be transferred to subsequent Contractor for review and approval by the COR. Upon completion of this contract, the Contractor shall transfer all materials approved by the COR to the subsequent Contractor.

When the Minneapolis Medical Research Foundation took over the SRTR contract in 2010, the previous contractor, Arbor Research, transferred the software it had developed under its contract to

MMRF, including the Simulated Allocation Models

(SAMs) and associated input data sets, allocation rules, programming sources codes and documentation.

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

9 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

HRSA responded to an RFI query about this, stating "there are no assets, property, or computer equipment that will be provided to the awardee. A bidder's proposal must demonstrate that they have the staff, facilities, equipment, including software, to perform the required services that support the OPTN." The staff, facilities, and equipment required to perform the functions of the OPTN might reasonably exist or be quickly acquired within a non-profit that delivers analogous services. However, it is infeasible to engineer, build, and test completely new software for all the functions of the OPTN within the three-month transition period specified for a prospective new contractor. As a comparison, UNOS has estimated that it will take ten months or more to program the recently approved change to liver allocation. Considering ten months is the timeline to build software to implement the logic for one organ's allocation, does HRSA consider it feasible that a competitive contractor could re-engineer software for all of organ allocation and OPTN data collection in three months?

Alternatively, would HRSA allow a transition period longer than three months, say, at least

9-12 months if new software is to be built?

Response:

HRSA does not have the contractor's transition plan because it can only obtain it if it exercises optional Task 15 Transition to New OPTN

Contractor. Prospective offerors are required to have the staff, facilities, and equipment to perform the services required in the solicitation.

The optional task for a transition-in period identified in the RFP is not intended to provide a period of time for a contractor to develop an

OPTN matching function.

Please also see the response to question 2.

Question 11:

The RFP very helpfully allows for innovative approaches that do not conform to the performance work statement to be submitted as alternate technical proposals. However, HRSA requires that an offeror submit both a technical proposal that

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

10 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

conforms to the performance work statement, and an additional stand-alone alternative technical proposal that does not. This creates burdens that might discourage innovation, both in the effort required to submit two standalone proposals, and in the requirement that the offeror be willing to operate the OPTN exactly as stated in the performance work statement in the event that the alternative technical proposal is not selected.

Would HRSA consider allowing offerors to submit alternative technical proposals without an accompanying proposal that conforms to the PWS?

Response:

In accordance with section L.3 on page 50, alternate technical proposals may be submitted;

however, alternate technical proposals are not considered stand-alone proposals and will not be considered for award purposes.

The subject OPTN solicitation uses a Performance

Work Statement, which is written incorporating measurable standards that inform the potential offeror of the Government's desired outcomes. How an offeror achieves those outcomes is up to them.

Offerors are thus empowered to use best practices and their own innovative ideas to achieve the desired results.

Question 12:

Section L.1.2, subparagraph: Organization of

Solicitation Response (Page 49 of 88) states that the proposal shall be submitted in three (3) parts. It appears there are only two parts -

Volumes I and II, with the HRSA Section 508

Product Accessibility Template (PAT) as an

Appendix to Volume 1, Technical Proposal. Please clarify the parts and associated volumes of the proposal.

Response:

Volume I shall consist of the Technical Proposal with the HRSA Section 508 Product Accessibility

Template attached as an appendix that will not count against the page limit. Volume II shall consist of the Business Proposal.

Question 13:

Section H.5 is omitted. Will the Government clarify if H.5 was intentionally omitted or is

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

11 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

will there be an amendment with H.5?

Response:

Section H.5. was not intentionally omitted. H.6 will be renumbered as H.5

Question 14:

Section L.1.4 (Page 50 of 88) states that proposals shall be submitted single spaced, printable on 8.5 x 11 inch paper, paginated front to back, 12 point font (Times New Roman). Will the Government allow 10 point font Times New

Roman for tables and graphics?

Response:

Yes.

Question 15:

Section L.1.4 (Page 50 of 88) states that proposals shall be submitted single spaced, printable on 8.5 x 11 inch paper, paginated front to back, 12 point font (Times New Roman). Will the Government allow 8 and 9 point font in the header and footer?

Response:

Yes.

Question 16:

Section L.1.4 (Page 50 of 88) states that the

Business Proposal must be submitted in

Excel-compatible format with formulas preserved.

There are other sections of the Business proposal that are not typically excel-compatible, such as the representations and certifications. Will the

Government allow the Excel-compatible formatted content to be a separate attachment/appendix to the Business Proposal?

Response:

Yes. Excel-compatible formatted content may be submitted as a separate attachment/appendix to the Business Proposal. Additionally, the

Excel-compatible content does not need to meet the 12 point font and 8.5 x 11 inch paper requirements.

Question 17:

Section L.1.4 (Page 50 of 88) states that the proposals shall be submitted by email in PDF and

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

12 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

Excel formats. For components of the proposal comprising hundreds of pages, we anticipate relatively large files sizes in excess of a standard file size for attachments sent to government email addresses. To address these issues of attachment size limitations and information security, will the Government allow proposals to be submitted via Cisco Secure email, which is consistently used when sharing confidential files and information with the

HRSA/DoT program staff?

Response:

Offerors may submit their proposals in multiple emails.

Question 18:

Will the government evaluate the technical approach to optional tasks any differently than the evaluation of technical approach to standard tasks?

Response:

All tasks will be evaluated in accordance with technical factors and evaluation criteria as stated in the RFP.

Question 19:

Section F.6 (Page 26 of 88) directs the contractor to submit deliverable items to the following address:

Health Resources and Services Administration

Health Systems Bureau

U.S. Dept. of Health and Human Services

5600 Fishers Lane

Rockville, VD 20857

Per PWS 3.1.11, the contractor must maintain a web-based platform to facilitate electronic submission of all contract deliverables. Please clarify if there are any deliverables HRSA wishes to be delivered in hardcopy.

Response:

The majority of deliverables are to be provided through the web-based platform. Materials that need to be physically provided to HRSA at the identified address include materials related to security clearance of employees and periodic encrypted data transfers.

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

13 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

Question 20:

PWS 3.4.2 states that the Contractor may include in the plan a request to fund development of applications through optional task 3.17. Will the

Government clarify if this should reference 3.18

(Innovative Enhancement Applications) rather than

3.17?

Response:

The reference to task 3.17 is a typographical error; the reference should be to optional task

3.18.

Question 21:

There are some inconsistencies in the Section B request for summary cost data which is a requirement to submit for the OPTN RFP as it relates to the Optional tasks. The task numbers on this sheet don't seem to line up with the statement of work.

For example:

"CLINs 0002/0003 3.15 Special Studies Option-

Base period". SOW Option Task 3.15 is

Acquisition of the Contractors Computer System.

This is also repeated twice in each of the years of the contract throughout the document.

"CLINs 0004 3.16 Contract Period Briefings- Base

Period." SOW Option Task 3.16 is Execution of

Special Studies and should have somewhere to put small, medium or large cost estimates 3.16.1, 3.16.2, 3.16.3 etc. - also consistent for all years of the document

"CLINs 0005 3.17 - Innovative Application

Enhancements" SOW Option 3.17 is Contract Period briefings.

"CLINs 006 3.18- External Dataset Acquisition" -

SOW Option task 3.18 is the Innovation

Applications and need a spot for small/medium and large for 3.18.1, 3.18.2, 3.18.3

And on throughout the document. Is the government able to put out a correct sheet to fill out, or shall we just create our own assuming what you were looking for here?

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

14 14

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

18-250-SOL-00017/000001

Response:

Please see the updated RFP and PWS.

c) The RFP and Attachment A - PWS have been updated to reflect the responses hereby provided.

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

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

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 Base Period –

Special Studies Option

0003 Base Period – Special Studies Option

0004 Base Period – Contract Period Briefings Option

0005 Base Period – Innovative Application Enhancements

0006 Base Period – External Dataset Acquisition Option

0007 Optional Transition-In Plan

0008 Base Year – Optional Transition-Out

1001 Option Period 1 1002 Option Period 1 –

Special Studies Option

1003 Option Period 1 – Special Studies Option

1004 Option Period 1 – Contract Period Briefings Option

1005 Option Period 1 – Innovative Application Enhancements

1006 Option Period 1 – External Dataset Acquisition Option

1007 Option Period 1 – Optional Transition-Out

2001 Option Period 2 2002 Option Period 2 –

Special Studies Option

2003 Option Period 2 – Special Studies Option

2004 Option Period 2 – Contract Period Briefings Option

2005 Option Period 2 – Innovative Application Enhancements

2006 Option Period 2 – External Dataset Acquisition Option

2007 Option Period 2 – Optional Transition-Out

3001 Option Period 3 3002 Option Period 3 –

Special Studies Option

3003 Option Period 3 – Special Studies Option

3004 Option Period 3 – Contract Period Briefings Option

3005 Option Period 3 – Innovative Application Enhancements

3006 Option Period 3 – External Dataset Acquisition Option

3007 Option Period 3 – Optional Transition-Out

4001 Option Period 4 4002 Option Period 4 –

Special Studies Option

4003 Option Period 4 – Special Studies Option

4004 Option Period 4 – Contract Period Briefings Option

4005 Option Period 4 – Innovative Application Enhancements

4006 Option Period 4 – External Dataset Acquisition Option

4007 Option Period 4 - Transition-Out Option

4008 6-Month Extension 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 Documentation of liability policy purchase

A038 3.2.2 Proposed revisions to OPTN Charter

A039 3.2.3 Name of the OPTN Executive Director

A040 3.2.3 Annual evaluation of the OPTN Executive Director’s performance

A041 3.2.4 OPTN Bylaws, polices, standards and guidelines

A042 3.2.5 Operating committee rosters

A043 3.2.5.1 Draft announcement of nominations Process

A044 3.2.5.1 Final announcement of nomination process

A045 3.2.5.1 Annual slate of nominees

A046 3.2.5.2 Data review report

A047 3.2.5.2 DAC chair report to the BOD and EC

A048 3.2.5.3 OPTN FY Budget

A049 3.2.5.3 Multi-year planning budget Annual 1 A050 3.2.5.3 Recommendations regarding OPTN reserves and investment strategy

A051 3.2.5.4 POC meeting materials

A052 3.2.5.4 POC chair presentation to the BOD and EC

A053 3.2.5.5 Network Operations Metrics and Monitoring Report

A054 3.2.5.5 Committee chair presentation to the BOD and

EC

A055 3.2.6 Annual OPTN policy development plan

A056 3.2.6 List of members and CVs for each governance committee and expert group

A057 3.2.6.1 OPTN Policy development recruiting and nominations plan

180 days after EDOC 1

A058 3.2.7 OPTN strategic plan

A059 3.2.7 Report on strategic plan progress

A060 3.2.8.1 Education plan on legal and regulatory requirements

A061 3.2.8.2 Signed conflict of interest statements

A062 3.2.8.2 List of potential conflicts of interests and mitigating strategies

A063 3.2.8.2 Policies and procedures to identify and address conflicts of interest

Annual 1

A064 3.2.8.3 Calendar of activities updated on OPTN web site weekly 1

A065 3.2.8.3 Closed session criteria

A066 3.2.8.4 Annual report of Contractor staffing expertise

A067 3.2.8.4 Meeting agenda

A068 3.2.8.4 Meeting materials

A069 3.2.8.4 Meeting summary

A070 3.3.1 Draft OPTN Policy development process document

60 days after EDOC 1

A071 3.3.1 Final OPTN Policy document

A072 3.3.1 List of all approved OPTN Bylaws, policies (incl.

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

A073 3.3.2 Draft OPTN Policy metrics

A074 3.3.2 Final OPTN Policy metrics

A075 3.3.2 Baseline OPTN Policy development metrics report

A076 3.3.2 Updated OPTN policy development metrics report

Every 6 months 1

A077 3.3.3 Draft plan for review and analysis of current OPTN regional process

8 months after EDOC 1

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

10 months after EDOC 1

A079 3.3.3 Draft regional process review presentation

A080 3.3.3 Final regional process review presentation

A081 3.3.3 Draft regional process review website posting

A082 3.3.3 Final regional process review website posting

A083 3.3.4 Consensus Conference request

A084 3.3.4 Consensus Conference

A085 3.4.1 Matching function operational plan

30 days after EDOC

A086 3.4.1 Documentation of testing and validation outcomes

A087 3.4.2 Matching function innovation and improvement plan

A088 3.4.3 KPDPP operational plan

A089 3.4.3 Quarterly KPDPP performance assessment reports quarterly 1

A090 3.4.3 Monthly statistical report

A091 3.4.4 Technical assistance plan 90 days after EDOC 1 A092 3.4.5 Committee report on performance of review boards

A093 3.4.6 Decision rules of organ allocation algorithms

90 days after EDOC

A094 3.5 List of all official OPTN data

5 months before end of base contract performance period

A095 3.5 OMB ICR data collection forms and supporting materials for official OPTN data not currently collected through OMB approved ICRs

A096 3.5.1 OPTN data repository

A097 3.5.1 Quarterly official OPTN data quality report

A098 3.5.1 Annual official OPTN data quality report

A099 3.5.2 Draft plan for direct electronic transfer of official OPTN data

A100 3.5.2 Final plan for direct electronic transfer of official OPTN data

A101 3.5.3 OMB ICR data collection forms and supporting materials for official OPTN disease transmission data

A102 3.5.4 ICD and CPT codes implementation plan

180 days after EDOC

A103 3.5.5 Signed document on HRSA expectations on death data

A104 3.5.5 Signed Data Use Agreement with CMS

A105 3.5.5 Signed Data Use Agreements and/or Memorandum of Agreement for non-official OPTN data

A106 3.5.6 Draft process for post-BOD OMB ICR revision

9 months after EDOC 1

A107 3.5.6 Final process for post-BOD OMB ICR revision

12 months after EDOC 1

A108 3.5.6 OMB Information Collection Request package

A109 3.5.7 Surveys to support OPTN operations and policy development

A110 3.5.7 OMB ICR package for survey data collection

A111 3.6.1 Report of OPTN processes to monitor compliance, evaluate and improve performance and enforce sanctions

A112 3.6.2 Draft performance metrics 180 days after EDOC

A113 3.6.2 Final performance metrics

A114 3.6.2 Quarterly reports on performance metrics

A115 3.6.2 Baseline performance metrics report

8 months after EDOC

A116 3.6.2 Reports to MPSC on performance metrics

A117 3.6.3 Draft Compliance and Enforcement Report

5 months after EDOC

A118 3.6.3 Final Compliance and Enforcement Report

8 months after EDOC

A119 3.6.3 Quarterly Compliance and Enforcement Report update

A120 3.6.3 Reports to MPSC on Compliance and Enforcement

A121 3.6.3 Proposed format and secure delivery mechanism for compliance and enforcement report

2 months after EDOC 1

A122 3.6.4 Documentation of membership review and approval process

30 days after EDOC 1

A123 3.6.4 Plan for periodic reassessment of membership requirements

240 days after EDOC 1

A124 3.6.4 Membership application

A125 3.6.4 Draft membership status

A126 3.6.4 Final membership status

A127 3.6.5 OMB ICR Membership forms packages

A128 3.6.6 Performance Monitoring and Collaborative Improvement Plan

A129 3.6.7 Patient safety event reports as defined by Contractor and HRSA requirements

A130 3.6.7 Draft plan for patient safety reporting process

As required 1

A131 3.6.7 Final plan for patient safety reporting process

A132 3.6.7 Presentation of proposed changes to OPTN Bylaws

A133 3.6.8 Final report on special review

A134 3.7.1 OPTN standard analysis data set document

60 days after EDOC

A135 3.7.2 Data report or data files produced in response to data requests from COR

A136 3.8.1 Formal written agreement with the current SRTR Contractor for data transfer

30 days after EDOC 1

A137 3.8.2 Data request process plan

A138 3.8.3 Joint meeting agendas 30 days before meeting

A139 3.8.3 Meeting summaries and presentations

14 days after meeting

A140 3.8.4 Comments on the draft Annual Data Report

As required

A141 3.8.5 Participation in working groups to review monthly data quality reports.

A142 3.9 Annual OPTN web site maintenance, improvement, and enhancement project plan

A143 3.9 Draft website postings

A144 3.9 Final website postings

A145 3.10.1 Communication plan 180 days after EDOC 1 A146 3.10.1 Communication products As required

A147 3.10.2 Plan for proposed OPTN educational materials for transplant professionals in training

210 days after EDOC 1

A148 3.10.2 Proposed dissemination plan for educational materials

210 days after EDOC 1

A149 3.10.3 Patient services line

A150 3.10.4 Media Alert electronic notification

A151 3.11 Contributions to official reports, including reports to Congress

A152 3.12.1 Documentation on managing, maintaining, and disposing of Federal records.

A153 3.12.2 Written confirmation certifying completion of records management training by employees

A154 3.13 Transition-in plan

A155 3.14.1 Transition-out plan

A156 3.14.2

Transition-out report As required 1

A157 3.15 Copy of or license to operate all OPTN software systems and documentation.

A158 3.16.1, 3.16.2, 3.16.3

Study plan

A159 3.16.1, 3.16.2, 3.16.3

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

COR)

A160 3.16.1, 3.16.2, 3.16.3

Final report

A161 3.17 In-person briefing

A162 3.17 Briefing materials 14 days before meeting

A163 3.18.1, 3.18.2, 3.18.3

Project plan for each application

A164 3.18.1, Periodic status reports (timeline mutually agreed upon by the Contractor and

COR)

A165 3.18.1, Final report

A166 3.19 Signed Data Use Agreements and/or Memorandum of Agreement

A167 3.20.9.

Cryptographic Module Validation documentation

A168 3.20.9.

Contractor Employee Non- Disclosure Agreement

(NDA)

A169 3.20.9.

Assist in the completion of a PTA/PIA form

A170 3.20.9.

The training records for all mandatory training

A171 3.20.9.

Signed ROB for all employees

As required 1

A172 3.20.9.

Incident Report (as incidents occur)

A173 3.20.9.

Incident Response Plan

A174 3.20.9.

Background Investigation Prior to performing any work on behalf of HHS

A175 3.20.9.

Roster and as updated

A176 3.20.9.

Certification of record disposal and sanitization of devices and media

A177 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

A178 2.4 EPLC deliverables:

See Deliverable A179 Table below

A179 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.