RFP No.: NHLBI-WH-04-17
DATE ISSUED: October 08, 2003
DATE DUE: January 23, 2004
TIME DUE: 04:00 PM (Local Time)

Reference: RFP NHLBI-WH-04-17, Field Centers for the Women's Health Initiative Extension

Dear WHI Principal Investigators and Business Representatives:

The Women's Health Initiative (WHI), National Heart, Lung, and Blood Institute (NHLBI), is interested in receiving your proposal to fulfill the requirements of this Request for Proposal (RFP) as described in Attachments 1 through 9. This solicitation is for the Extension of the existing WHI Field Center contracts to continue outcomes ascertainment and mammography in the hormone therapy trial participants and to continue analysis and publications by investigators. This solicitation is limited to current contractors for the Clinical Trial and Observational Study of the Women's Health Initiative.

It is expected that the existing contract will be extended 2.5 years on a cost reimbursement, completion basis as a result of this RFP. To assist you in preparation of your proposal, the Government has estimated a range for the level of effort which is outlined in the statement of work (Attachment 1) and in the Uniform Cost Assumptions (Attachment 5). The Extension of the Field Center contracts will be performance-based with specific measurable performance requirements identified in the Performance Assessment Plan (PAP), see Attachment 7. It is anticipated that award of this contract will be made during the fall of 2004.

Your proposal shall be prepared in two parts and clearly identified as a "Technical Proposal" and a "Business Proposal." Proposals shall be in sufficient detail to permit proper evaluation, negotiation and/or acceptance thereof. The technical proposal shall not contain reference to cost, however, resource information such as data concerning FTEs, labor categories, materials, subcontracts, etc., shall be contained in the technical proposal so that your understanding of the statement of work may be evaluated.

Offerors are encouraged to limit the overall size of the Technical Proposal, inclusive of appendices, attachments, etc. The entire Technical Proposal shall not exceed 50 single-sided pages or 25 double-sided pages. Pages in excess of this will be deleted and will be neither read nor evaluated. Each page of the Technical Proposal must be numbered sequentially. Note that although no page limit has been placed on the Business Proposal, offerors are encouraged to limit its content to only those documents necessary to provide adequate support for the proposed prices or costs.

The original and ten copies of your technical proposal and the original and six copies of your business proposal and one electronic copy of the business proposal (disk or e-mail) using the Excel based spreadsheet (see Attachment 6) must be received by the Contracting Officer no later than January 23, 2004, 4:00 PM local time at the address listed at Attachment 3. The required spreadsheet may be downloaded from the NHLBI website for the WHI Field Center RFP. To access it, go to http://www.nhlbi.nih.gov/funding/inits/index.htm, then scroll down to Request for Proposals (RFP).

The proposal must be signed by an official authorized to bind your organization. Specific Instructions for the packaging and delivery of your proposal are provided as Attachment 3.

Human Subjects

It is anticipated that research involving human subjects will be conducted under the Extension awarded as a result of this solicitation. Therefore, the following areas shall be addressed in the Technical Proposal:

Please Note: Specific instructions regarding requirements for research involving human subjects is located in SECTION L.III. Technical Proposal Instructions, Item 53 at the following website:

http://rcb.cancer.gov/rcb-internet/wkf/sectionl.pdf

The Technical Proposal shall be evaluated in accordance with the Technical Evaluation Criteria set forth as Attachment 9.

Proposal Preparation Instructions:

  1. Your Technical Proposal should include:

    1. A detailed work plan indicating how each task of the Statement of Work will be accomplished.

    2. Information about how the project will be organized, staffed and managed, including consultants and subcontractors, if appropriate.

    3. A discussion of current/updated facilities and equipment to be used on the project.

  2. Your Business Proposal should include:

    A detailed breakdown of all cost items that are involved in the completion of the contract. For this purpose use the spreadsheet available under this RFP on the NHLBI website (format at Attachment 6). Note: All salary rates proposed must be based on the actual current salary rate of each individual proposed under this contract as identified in the payroll documentation submitted.

The following website provides a sample contract and general clauses that may be applicable for any contract resulting from this RFP.

Sample Contract: http://rcb.cancer.gov/rcb-internet/wkf/sample-contract.htm
General Clauses: http://rcb.cancer.gov/rcb-internet/clauses/clauses.html

In addition, the prescriptions for applicable substitutions and/or additions to the General Clauses can be found at:

General Clause Substitutions and/or Additions:
http://rcb.cancer.gov/rcb-internet/wkf/sectioni.pdf

This solicitation does not commit the Government to pay for the cost of preparation and submission of a proposal. It is brought to your attention that the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition.

The Government may award a contract on the basis of the initial offer received, without discussions. Therefore, the initial offer should contain the offeror's best terms from a cost or price and technical standpoint.

If you have any questions concerning this Request For Proposal (RFP), please call Theresa Koomson on 301-435-6674 or email your concerns to koomsont@nhlbi.nih.gov.

Sincerely,



Betty Nordan
Contracting Officer

Attachments


Attachments included in this Request for Proposal (RFP) package:

  1. Statement of Work
  2. Reporting Requirements, Packaging and Marking, and Deliverables
  3. Packaging and Delivery of the Proposal
  4. Contact Points
  5. Uniform Cost Assumptions
  6. Format for Cost Proposal Spreadsheet
  7. Performance Assessment Plan (PAP)
  8. Explanation of Performance Based Contracts
  9. Evaluation Factors for Award/Technical Evaluation Criteria

Additional attachments available from RFP on NHLBI website:


Attachment 1

ARTICLE C.1. STATEMENT OF WORK: WHI Field Centers

  1. Background Information

    The WHI was initiated in 1992 with a planned completion date of September 2007. In the first phase of WHI, beginning in 1993, the protocol and procedures were evaluated among 16 vanguard clinical centers, before the addition of the remaining 24 clinical centers in 1994. Recruitment began in September 1993 and concluded in December 1998. At the 40 Clinical Centers, participant follow-up is planned to continue through March 2005, with a five and one-half month data clean up period to continue through September 14, 2005. Four clinical trials and a companion observational study comprise the WHI, which is focused on evaluating overall risks and benefits of preventive interventions for the major causes of morbidity and mortality among post-menopausal women in the United States. The interventions include a low fat dietary pattern, calcium and vitamin D supplementation, and two trials of post-menopausal hormone therapy, one examining Estrogen plus Progestin (E+P) and one examining Estrogen alone. The E+P trial was stopped early in July 2002, yielding unexpected results with health risks that exceeded the health benefits. Though the Estrogen alone trial results are unknown at this point, the study has communicated some early unexpected risks to participants. Extension of hormone therapy trial participant follow up through September 2007, with a six month data clean up period through March 2008, is needed to increase power for and ascertain the persistence of the observed effects. Extension of the CCC contract through September 2010 is needed to maintain the government-owned study database and biologic specimens and extend the infrastructure to enable maximal use of study resources by both WHI investigators and non-WHI investigators.

  2. General Description of the Required Objectives and Desired Results

    The overall goal of the Extension is to continue health surveillance of the WHI Hormone Therapy trial participants through September 2007. The contractor shall enroll current HT trial participants into the follow-up study and:

    1. Ascertain health outcomes, obtain supporting medical records, adjudicate, and record in database
    2. Ensure annual mammograms and record results in database
    3. Continue to publish WHI findings after the main study results are presented

  3. Detailed Description of the Technical Requirements

    The contractor shall perform follow-up study activities in accordance with the protocol and manual of operating procedures. Specific performance requirements are:

    1. Enroll current hormone therapy participants into the WHI Extension
    2. Retain study participants over the 2.5 year follow-up period (April 1, 2005-September 30, 2007)
    3. Collect participant self-reported outcomes (non-responders to annual central mailings only), investigate self-reports by collecting supporting medical records, adjudicate outcomes of interest, and record outcomes into the WHI database as directed in the manual of operating procedures
    4. Annually collect screening mammogram reports; record into the WHI database as directed in the manual of operating procedures
    5. Annually provide screening mammograms for those unable to obtain them through usual medical care sources

      Note to Offerors: The first 5.5 months of the 2.5 year participant follow-up period overlaps with the final 5.5 months of the current contracts; both the current and WHI Extension statements of work will apply. During the period of April 2004 through September 14, 2005, expenses for the WHI Extension activities will be reimbursable under the current contracts.

    6. Generate ideas for publications and ancillary studies; publish scientific manuscripts in accordance with WHI policies
    7. Contribute to study management through service on study operations and/or advisory committees.
    8. Submit required technical and financial reports at specified intervals; respond to Contract Office and Project Office inquiries regarding contract management

  4. Level of Effort

    The costs for the staffing required to accomplish the technical requirements, with the exception of the Principal Investigator effort, shall be contained within the unit prices for outcomes ascertainment and mammogram tracking. This includes effort for outcomes coordination (follow-up on non-responders to central F33 mailings, medical records collection, case packet assembly, and local adjudication) and clerical effort for tracking mammogram reports. The level of effort for these tasks will vary according to the number of participants followed, and the average numbers of outcomes. Estimates for outcomes ascertainment effort over a range outcomes workload is presented below. Offerors can use these estimates to interpolate needs at their Field Centers.

    Outcomes cases/mo.* Estimated Effort (in annual FTE)
    (HT ppts only) Oct 05-
    Sept 06
    Oct 06-
    Sept 07
    Oct 07-
    March 08**
    Low ~ 8 .22 .22 .22 * ½ = .11
    Average ~12 .34 .34 .34 * ½ = .17
    High ~18 .5 .5 .5 * ½ = .25

    * Currently, an average WHI Field Center assembles packets for 50-60 outcomes cases per month. Allowing for a projected 30% increase in outcomes by the end of the current study, and outcomes ascertainment for HT participants only, it is estimated that an average WHI Field center will process approximately 12 cases per month during the WHI Extension. Note to offerors: Outcome workload estimates are derived from the Outcomes Collection and Processing Backlog Report from the Clinical Coordinating Center. Effort estimates are derived from the time-motion study completed by five Clinical Centers in 1998.
    ** To calculate the period salary cost for the FTE, multiply the annual salary using the math above.

    Estimates for mammogram report collection effort over a range workload is presented below. Offerors can use these estimates to interpolate needs at their Field Centers.

    # Annual Mammograms Estimated Effort (in annual FTE)
    (HT ppts only) Oct 05-
    Sept 06
    Oct 06-
    Sept 07
    Oct 07-
    March 08**
    Low 421 .1 .1 .1 * ½ = .05
    Average 632 .15 .15 .15 * ½ = .075
    High 843 .2 .2 .2 * ½ = .1

    ** To calculate the period salary cost for the FTE, multiply the annual salary using the math above.

    The following annual level of effort is estimated to be necessary for the Principal Investigator to supervise Field Center operations, generate hypotheses and publish papers:

    Estimated Effort (in annual FTE)
      Oct 05-
    Sept 06
    Oct 06-
    Sept 07
    Oct 07-
    March 08**
    Principal Investigator .05 .05 .05 * ½ = .025

    ** To calculate the period salary cost for the FTE, multiply the annual salary using the math above.

    Note to offerors: Investigator effort for study management activities will be supported through the Clinical Coordinating Center contract.

  5. Phasing

    Phase: Period:
    1. Subject enrollment and informed consent
    04/01/2004-03/31/2005
    1. Subject follow-up
    04/01/2005-09/30/2007
    1. Data clean-up
    10/01/2007-03/31/2008

  6. Clinical Research/Human Subjects

    The Contractor shall recruit current Hormone Therapy trial participants for enrollment in the WHI Extension. Participants who agree to enroll will be required to sign informed consent documents that reflect current standards.

  7. Special Requirements

    Participant population for this acquisition is limited to currently enrolled WHI Hormone Therapy trial participants. The WHI Clinical Trials are currently operating under a clinical exemption from OMB clearance. Since data collection for the WHI Extension will remain consistent with the current study, OMB clearance is not needed.


Attachment 2

ARTICLE C.2. REPORTING REQUIREMENTS

Semi-annual technical reports shall discuss progress toward performance requirements and proposed solutions to any difficulties encountered. Work completed during phase 1 (i.e., obtaining informed consent from current HT participants) will be described in semi-annual technical reports required under the current contracts. The first report, covering the period of September 16, 2005 through March 31, 2006, will be due April 30, 2006. Subsequent reports covering six month periods from April through September and October through March are due on October 31 and April 30, respectively. Copies of all scientific papers published with WHI must be submitted by the first author on a semi-annual basis in conjunction with the semi-annual technical report. A final technical report summarizing the work performed and results obtained over the life of the contract shall be submitted on or before the completion date of the contract.

Delivery addresses:
Project Officer, Women's Health Initiative
6705 Rockledge Drive, Ste. 300, MSC 7966
Bethesda, MD 20892-7966
(20817 if using delivery service)

Contracting Officer, Women's Health Initiative
6701 Rockledge Drive, Ste. 6016, MSC 7902
Bethesda, MD 20892-7902
(20817 if using delivery service)

ARTICLE D.1. PACKAGING AND MARKING

All data shall be packaged and shipped or transmitted in accordance with the Manual of Operations.

ARTICLE E.1. INSPECTION AND ACCEPTANCE

Inspection and acceptance will be performed at the offices of the Women's Health Initiative, 6705 Rockledge Drive, Ste. 300, MSC 7966, Bethesda, MD 20892-7966. Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

ARTICLE F.1. DELIVERABLES

Item No. Description Quantity Delivery Schedule
1. Semi-annual Technical Report 2 One month after the 6 month reporting period ends
2. Study outcomes recorded into WHI database 1 As completed
3. Screening mammogram results recorded into WHI database 1 Each participant annually
4. Copies of published papers 1 Lead author to submit twice per year with biannual technical reports
5. Financial Report 2 Monthly or quarterly, in accordance with contract instructions
6. Data and data documentation, Biologic Specimens All To be delivered or disposed according to instructions from the contracting officer on the schedule provided by the contracting officer, no later than the contract expiration date

The items listed above shall be addressed and delivered to:

Project Officer, Women's Health Initiative
6705 Rockledge Drive, Ste. 300, MSC 7966
Bethesda, MD 20892-7966
(20817 if using delivery service)
Items 1, 4
Contracting Officer, Women's Health Initiative
6701 Rockledge Drive, Ste. 6016, MSC 7902
Bethesda, MD 20892-7902
(20817 if using delivery service)
Items 1, 5
WHI Clinical Coordinating Center
Fred Hutchinson Cancer Research Center
1124 Columbia Street
Seattle, WA 98104
Items 2, 3, 4


Attachment 3

PACKAGING AND DELIVERY OF THE PROPOSAL

Your proposal shall be organized as specified in Section L.2., "Instructions to Offerors"'General Instructions. Shipment and marking shall be as indicated below:

EXTERNAL PACKAGE MARKING

In addition to the address cited below, mark each package as follows:

RFP: NHLBI-WH-04-17, Field Centers for the Women's Health Initiative Extension
"TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

The number of copies required of each part of your proposal are:

TECHNICAL PROPOSAL: ORIGINAL * AND TEN COPIES BUSINESS PROPOSAL: ORIGINAL * AND SIX COPIES

*DELIVER PROPOSAL TO:
If using U.S. Postal Service:

National Heart, Lung, and Blood Institute, NIH
Women's Health Initiative
Rockledge 2, Room 6016
6701 ROCKLEDGE DR MSC 7902
BETHESDA, MD 20892-7902

If courier delivery service:

National Heart, Lung, and Blood Institute, NIH
Women's Health Initiative
Rockledge 2, Room 6016
6701 ROCKLEDGE DR MSC 7902
BETHESDA, MD 20817-7902

*THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES.

Note: Upon delivery to 6701 Rockledge Drive, all proposals must be screened by X-ray before delivery to the room cited above. ALLOW EXTRA TIME for this process!


Attachment 4

OFFEROR'S POINTS OF CONTACT

Complete the following and return with the BUSINESS PROPOSAL.

For the Business Representative

Name: Telephone:
Title: Fax:
Office: E-Mail:
Institution:  
*Street Address:  
City, State, Zip Code:  



For the Principal Investigator

Name: Telephone:
Title: Fax:
Office: E-Mail:
Institution:  
*Street Address:  
City, State, Zip Code:  

These exact addresses are necessary to ensure contact with the proper individuals in the most expeditious manner.

*Please provide the street address and room number, sufficient for delivery by a delivery service. If a different address is required for US Mail delivery, provide the mail address below.


Attachment 5

Uniform Cost Assumptions for the WHI Centers

  1. Proposal Format

    The required format for the cost proposal is shown at the Exhibit, 'Centers Cost Proposal'. An electronic version of the cost proposal is required, in addition to the paper copies.

  2. Discussion of Status as of September 14, 2005

    1. Any amount to be awarded for the Extension will be adjusted in consideration of the financial status as of the end of the currently awarded period. For this purpose, provide an estimate of the amount for the total actual cost of performance as of September 14, 2005. From that and the awarded contract budget, estimate the amount of any expected unexpended balance or cost overrun as of September 14, 2005. For this purpose, ignore the requirements and costs for the Extension, the consenting, and the two weeks in September 2005. That is, prepare this discussion based only on the current contract.

      Consider all subcontracts in estimating the total cost of performance. Note that costs for blood tubes obtained from McKesson BioServices will be paid by the CCC contract. Any funds that had been held in reserve by clinics to pay McKesson for the tubes will become available for other purposes. (In 1996 WHI began obtaining blood draw tubes from McKesson in an attempt to achieve cost savings. Clinics were told to plan to pay McKesson at an unspecified future date. NHLBI later determined that clinics need not reimburse McKesson for the tubes. However, clinics should monitor need closely and do not over-order or stockpile the tubes.)

    2. Discuss proposed uses for any available balance as of September 14, 2005.

  3. Cost Estimate for April 2004 through September 30, 2005

    During the period April 2004 through September 14, 2005, costs for the Extension activities will be reimbursed under the current contract. NHLBI anticipates that the currently awarded budget will be adequate to provide support for the current contract and for the Extension, EXCEPT that additional costs may be proposed for (1) consenting effort April 2004 through September 2005, and (2) other salaries during the two-week period September 15 through September 30, 2005.

    Follow the below guidelines in developing the estimated costs for consenting level of effort. Note that the cost information for consenting is duplicative of the information submitted October 17. However, for a complete cost proposal, please provide the information electronically using the spreadsheet "Consenting" and incorporate the costs into the "Summary" spreadsheet.

    NHLBI has made some initial estimates of the effort needed to complete the new consent forms. We anticipate that the blood/genetics and the hormone trial extension consent forms will be mailed (with the usual closeout visit packets for CT participants and in a separate mailing from the CC for OS), allowing participants to review the forms prior to interaction with WHI staff. Experience from other studies indicates that almost all participants, having already consented to the use of their blood, will probably agree to continued use. A minority of participants will have some questions and require additional counseling. Using the average time estimate (20") given for the CaD consent form in the "templates" completed by five Clinical Centers in 1998 as a guide, we estimate that the shorter, simpler Blood/Genetics and HT Extension consent forms will require 10" each for an average CT participant, and 5" each for an average OS participant by mail. Allowing additional effort for data entry, preparation of OS mailings, and telephone follow-up of participants who do not respond to initial contacts, the following table presents a range of effort estimates for a range of workloads. Please use these estimates to interpolate the effort required for your site.

    # Participants Estimated Effort Annualized *
    Low:

         1860 CT+OS (Blood/Genetics)
         315 HT (Extension

    .35 total

    .30
    .05

    Average:

         3730 CT+OS (Blood/Genetics)
         630 HT (Extension)

    .70 total

    .60
    .10

    High:

         4970 CT+OS (Blood/Genetics)
         850 HT (Extension)

    .95 total

    .80
    .15

    * This effort will be spread over the 18 month period April 2004 through September 2005. The effort may be proposed when needed, perhaps Low at 0.30 FTE during the first 12 months and Low at 0.10 FTE during the final 6 months, which would total 0.35 FTE annualized.

  4. Cost Estimate for October 1, 2005 through March 31, 2008

    Costs shall be estimated for Years 1 and 2 and for the final six months. Cost reimbursement contracts are anticipated, with certain tasks reimbursed on a fixed price per unit basis. It is anticipated that the existing approach for reimbursement will remain in effect until September 30, 2005 and that the billing approach envisioned below for mammograms and outcomes ascertainment (fixed unit prices) will begin October 1, 2005.

    1. Propose the following on a cost reimbursement basis:

      1. The Principal Investigator at 5% effort for 2½ years.
      2. Fringe benefits for the PI in accordance with the organization's DHHS Rate Agreement, or local policy if the DHHS Rate Agreement does not specify the fringe benefits rate.
      3. Estimated storage costs for certain participant files and source documents. Assume files and source documents will be stored at contract expense October 2005 through December 2007. Assume that clinics will then destroy participant files and source documents. For all stored documents, requirements of the Privacy Act and the limitations of the applicable informed consent remain in effect.
      4. Any center specific costs not addressed elsewhere. (Explain and justify any center specific costs.)
      5. Indirect costs associated with the above direct costs.

    2. Propose the following on a fixed price per unit basis:

      1. Outcomes Ascertainment, inclusive of labor (outcomes specialist or equivalent and local adjudicator), fringe benefits, supplies, local travel, miscellaneous other costs (copying, postage, long distance calls to participants or hospitals, medical records fees, equipment repairs, etc), and indirect costs. The unit for reimbursement is "case packets assembled".

        Current technical and procedural requirements for local and central adjudication will continue unchanged during the Extension period.

      2. Mammogram Screening Procedure, provided to a participant without third party coverage (insurance, Medicare, Medicaid, etc), inclusive of the charge for the procedure. Costs for obtaining and reporting the mammogram results may be billed as Mammogram Reporting. Staff effort is provided under Mammogram Reporting.

      3. Mammogram Reporting, inclusive of 1) all costs for obtaining and reporting the results of a screening mammogram (labor, fringe benefits, supplies, long distance calls, miscellaneous other direct costs, and indirect costs) and 2) inclusive of any balance remaining after all third party coverage has been applied for participants with third party coverage.

      The cost proposal shall provide the anticipated number of units for Outcomes Ascertainment, Mammogram Screening Procedures, and Mammogram Reporting. Supporting documentation shall be provided to justify the proposed number of each payment unit. Actual experience at the Center (by quarter over the last two years) shall be provided to support the proposed numbers of Mammogram Screening Procedures. Actual experience at the Center (by quarter over the last two years) shall be provided to justify the proposed costs for balances remaining after payment by third parties for mammograms.

      Level of Effort: The costs for staff, with the exception of the Principal Investigator effort, shall be contained within the unit prices for Outcomes Ascertainment and Mammogram Reporting. This includes effort for outcomes coordination (follow-up on non-responders to central F33 mailings, medical records collection, case packet assembly, and local adjudication) and clerical effort for tracking mammogram reports. The level of effort for these tasks will vary according to the number of participants followed, and the average numbers of outcomes.

      Estimates are presented below for Outcomes Ascertainment effort over a range of outcomes workload. These estimates are inclusive of effort for the local adjudicator. Offerors should use these estimates to interpolate needs at their Field Center.

        Outcomes cases/mo.* Estimated Effort (in FTE)**
      (HT ppts only) 10/01/05-
      09/30/06
      10/01/06-
      09/30/07
      10/01/07-
      03/31/08
      Low ~ 8 .22 .22 .22 * ½
      Average ~12 .34 .34 .34 * ½
      High ~18 .50 .50 .50 * ½

      * Currently, an average WHI Field Center assembles packets for 50-60 outcomes cases per month. Allowing for a projected 30% increase in outcomes by the end of the current study, and outcomes ascertainment for HT participants only, it is estimated that an average WHI Field center will process approximately 12 cases per month during the WHI Extension. Outcome workload estimates are derived from the Outcomes Collection and Processing Backlog Report from the Clinical Coordinating Center.

      ** Effort estimates are derived from the time'motion study completed by five clinical centers in 1998. The estimated effort for all periods is 0.22, 0.34, or 0.50 FTE for low, average or high, respectively. To calculate the period salary cost for the FTE, multiply the annual salary using the math above. That is, the final period is six months.

      Estimates are presented below for Mammogram Reporting effort over a range of workload. Offerors should use these estimates to interpolate needs at their Field Center.

        # Annual Mammograms Estimated Effort (in FTE)*
      (HT ppts only) 10/01/05-
      09/30/06
      10/01/06-
      09/30/07
      10/01/07-
      03/31/08
      Low 421 .10 .10 .10 * ½
      Average 632 .15 .15 .15 * ½
      High 843 .20 .20 .20 * ½

      * The estimated effort for all periods is 0.10, 0.15, or 0.20 FTE for low, average or high, respectively. To calculate the period salary cost for the FTE, multiply the annual salary using the math above. That is, the final period is six months.

    3. Incentives

      Incentives will be available for successful performance under the performance based contract. Propose incentives at $2000 per Center for Years 1 and 2 and at $1000 per Center for the final six months. If successful performance results in the award of incentives, the funds may be used for activities within WHI such as employee awards, travel to professional meetings, training, or participant newsletters.

    4. Exclusions

      The following costs will be supported by the Clinical Coordinating Center contract and should not appear on the Center proposal:

      Travel costs for WHI management meetings
      Long distance telephone costs for the writing groups and scientific study groups
      Costs for the study-wide leadership positions (probably through subcontracts with the CCC)
      Additional support for investigators who actively contribute to writing groups and to scientific study groups (probably through professional services or consulting contracts with the CCC)

  5. For cost reimbursement and fixed unit price components:

    For all estimates: Provide detailed supporting documentation (effort by person, documentation of current actual salary, fringe benefits, supplies, medical records fees, local travel costs, indirect costs, etc).

    For salaries, assume a 3% escalation at the end of each year.


Attachment 7

PERFORMANCE ASSESSMENT PLAN (PAP)
WHI FIELD CENTERS

  1. Introduction

    The purpose of this Performance Assessment Plan (PAP) (formally called Quality Assurance Surveillance Plan or QASP) for the WHI Field Centers is to define the basis for comparing actual performance with established performance goals in terms of technical requirements and timeliness. The PAP specifies the level of performance that will be considered acceptable (Performance Standards and Allowable Deviation from Standard), the methods that will be used to monitor and measure performance, the application of the performance evaluation to incentive awards, and the roles and responsibilities of participating Government officials.

  2. Roles and Responsibilities of Government Officials

    The Project Officer (PO) will be responsible for monitoring and assessing the technical performance of the Contractor on a routine basis. The Project Officer is responsible for providing timely feedback to the Contractor on all deliverables.

    The Contracting Officer (CO) will have overall responsibility for overseeing the Contractor's performance. The CO will also be responsible for the routine monitoring of the Contractor's performance in the areas of contract compliance, contract administration, cost control, and property control; reviewing the PO's assessment of the Contractor's performance, and resolving any differences. The CO may call upon the expertise of other individuals as required.

  3. Performance Evaluation Methodology

    Even though the Government will monitor the Contractor's performance on a continuing basis, the volume of tasks makes technical inspection of every task impossible. Accordingly, the NHLBI will use a quality assurance review process to evaluate the Contractor's performance under this contract. The Contractor's performance of the Key Performance Requirements will be evaluated as follows:

    Following the contract year October 2005 through September 2006 and the year October 2006 through September 2007, the Contractor will include in their semi-annual technical report a comparison of actual performance during the year to the Key Performance Requirements, the Performance Standards, and the Allowable Deviation from the Standard (See IV. Below.) Using this information, coupled with reports from the Clinical Coordinating Center, and other information available to NHLBI, the PO and CO will evaluate performance and determine the Total Score using the point system in IV. below. Partial points can be awarded for performance that does not meet the performance standard, yet is within the allowable deviation from the standard. The Total Score earned can range from 0 to 100. The Contracting Officer will notify the Contractor of the NHLBI determination of any resulting incentive award. Separate key performance requirements and performance standards will be developed for the final six months of the performance period.

    In the event of an Excusable Delay (reference FAR 52.249-14, Excusable Delays), the NHLBI and the Contractor shall work together to modify the contract in regard to the impact of the Excusable Delay on the Performance Requirements Summary.

  4. Performance Requirements Summary

    The contractor shall perform all tasks in the Statement of Work and provide all Deliverables in accordance with the contract. For purposes of this PAP, the Contractor's performance will be evaluated using the Performance Requirements Summary below.

    Performance Requirements Summary—WHI Field Centers

    Key Performance Requirement Performance Standard Allowable Deviation from Standard Method of Surveillance Points
    Collect and record study outcomes less than or equal to 1 month outcomes processing backlog* AND less than or equal to 5% F33 missing* Up to 1.5 month outcomes processing backlog and 7% F33 missing Outcome reports from CCC Meets standard: 60

    Within Allowable Deviation: 40

    Below Allowable Deviation: 0
    Collect and record mammogram reports greater than or equal to 90% of mammogram reports are recorded for the performance period greater than or equal to 85% of mammogram reports are recorded for the performance period Mammogram completion reports from CCC Meets standard: 40

    Within Allowable Deviation: 25

    Below Allowable Deviation: 0

    * From Outcomes Collection and Processing Backlog Report

    Separate key performance requirements and performance standards will be developed for the final six months of the performance period.

  5. Award/Incentive Fee Payment Plan

    An annual incentive award will be paid to the Contractor if the Total Score for the year is 40 or higher. For example, if, for the first evaluation period, the Contractor receives a Total Score of 95, the incentive award for the period would be $2,000 (100% of $2,000). The incentive payment, if any, is additional to the Total Estimated Cost of the contract. The use of the incentive payments is at the discretion of the Contractor, although employee awards are recommended for some portion of the incentive award.

    Evaluation
    Period
    Maximum
    Incentive
    Award
    Total Score
    < 40
    Total Score
    40-79
    Total Score
    80 or higher
    Oct 05-
    Sept 06
    $2000 0% 75% 100%
    Oct 06-
    Sept 07
    $2000 0% 75% 100%
    Oct 07-
    Mar 08
    $1000 0% 75% 100%

    Total Estimated Cost of the Contract $
    Maximum Incentive Award $   5,000
    Total Possible Contract Amount $


Attachment 8

Performance Based Contracts

During the period October 1, 2005 through March 31, 2008, the Center contracts will be "performance based." This is a contracting approach intended to ensure that required quality levels are achieved. Under performance-based contracting, a formal plan is incorporated into the contract to define the basis for comparing actual results with the established performance goals. Incentives are available under the plan to encourage quality performance.

Most NHLBI trials and studies are performance-based in nature if not by name. The statements of work specify performance requirements and the protocols specify standards. NHLBI routinely monitors quality through contracting and program staff, coordinating center reports, Steering Committees, and quality assurance visits. For the Extension period this inherent approach will be formalized for the Centers by inclusion and application of the Performance Assessment Plan (PAP).

The PAP states performance indicators that will be used to measure the required services. In this instance, the required services are outcomes ascertainment and mammogram reports. The PAP defines the basis for comparing actual results with the established performance goals. Finally the PAP states the available incentives or "penalties." $2000 per year per Center will be available in the Center contracts as incentives. It is anticipated that no "penalties" will be applied. The incentive awards may be used as preferred by the Center. However, employee awards or other employee recognition are encouraged. Center performance will be evaluated once per year by NHLBI using reports from the Clinical Coordinating Center and additional information provided by the Center.

Additional information on performance based contracting is available at http://www.ogam2000.com/acquisition/pbc.htm, at http://oamweb.osec.doc.gov/pbsc/introduction.html and in the Federal Acquisition Regulation (FAR) at Subpart 37.6.


Attachment 9

SECTION M—EVALUATION CRITERIA/METHOD OF REVIEW

Through this Request for Proposal NHLBI seeks forty WHI Field Centers. Selection of these contractors will be based on evaluation of proposals against the following factors in order of importance: technical (which encompasses experience and past performance) and cost/price. Technical evaluation factors will be more important than cost/price. However, the trade-off process described in FAR 15.101-1, Best Value Continuum, will be employed. This process permits trade offs among cost/price and non-cost factors and allows the Government to consider award to other than the lowest priced or highest technically rated offeror. In any event, the Government reserves the right to make an award to obtain the best value for the Government.

Technical Evaluation Criteria—WHI Field Centers

Evaluation of proposals will be based on the demonstrated capabilities of the prospective Contractor in relation to the needs of the project set forth in the RFP. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. The merits of the proposal will be evaluated carefully. Offerors must submit information sufficient to evaluate their proposals based on the criteria listed below. The Government reserves the right to make an award to the best advantage of the Government, cost and other factors considered.

A Technical Evaluation group (TEG) will use the following criteria to assess the technical proposals. The criteria are listed in the order of relative importance with weights assigned.

Factor Weight
  1. Proposed Technical Approach: The offeror"s understanding of the requirements of the RFP and approach to performing the work will be evaluated for the following components
    1. Adequate plans to invite current Hormone Therapy (HT) trial participants to enroll in the WHI Extension
    2. Feasible and adequate plans to ascertain outcomes and collect mammogram reports
    3. Feasible arrangements to provide screening mammograms for participants who cannot obtain them through usual medical care
    4. Feasible management plan for Field Center operations, including maintaining continuity in the event of staff turnover
    5. Adequate plans for human subjects protection
40
  1. Current Performance: Evidence, based on performance in the current contract period, that the offeror can meet performance goals stated in Performance Assessment Plan (PAP)
    1. Timeliness and completeness of outcomes ascertainment
    2. Mammogram report collection
40
  1. Qualifications and Availability of Personnel: Experience and skill of proposed personnel in outcomes ascertainment, mammogram report retrieval, and data management
20
TOTAL 100

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