36C10G23R0012.docx

36C10G23R0012 The Department of Veterans Affairs Strategic Acquisition Center (SAC) intends to negotiate a five year firm fixed price Indefinite Delivery/Indefinite Quantity (IDIQ) contract for Evidence-Based Clinical Practice Guidelines (EBCPG/CPG). Implementation of EBCPGs is one strategy the Veterans Health Administration (VHA) has embraced to improve care by reducing variation in practice and systematizing “best practices.”

This requirement will be solicited on an unrestricted basis. The NAICS Code is 541990. The IDIQ contract will include facilitation to develop guidelines, updating published CPG, conversion of CPG, Focus Groups, and Website development.

Solicitation No. 36C10G23R0012 is hereby posted to Contract Opportunities for Request for Proposals (RFPs). Please contact Contract Specialist Lisa Thompson at lisa.thompson10@va.gov with questions regarding this opportunity.

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1. REQUISITION NO.

2. CO

NTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF

SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF

REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

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24.

ITEM NO.

SCHEDULE OF

SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

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ARE NOT ATTA

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28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES W

HICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND

TITLE OF SIGNER (TYPE OR PRINT)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C10G23R0012 Lisa Thompson 720-402-1560 07-13-2023

12PM

EDT

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 X 541990 $17 Million N/A X

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

VAFSC

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

(see Section B.1 invoicing/payment) Austin TX 78714-8917 1 (877) 489-6135 See CONTINUATION Page Evidence Based Clinical Practice Guidelines- Development/Updates See attachments.

Questions must be received by June 16, 2023 no later than 12PM Eastern Time.

See CONTINUATION Page X x Kristal Hall

VA-OPAL-SAC-2022-392841

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

36C10G23R0012

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B.1 CONTRACT ADMINISTRATION

1. All contract administration will be handled by the following individuals:

CONTRACTOR:

TBD

GOVERNMENT:

Contracting Offer 36C10G Kristal Hall, Contracting Officer 240-917-9690 kristal.hall@va.gov

Contract Specialist 36C10G Lisa Thompson, Contract Specialist 720-402-1560 lisa.thompson10@va.gov Strategic Acquisition Center (SAC) Department of Veteran Affairs 10300 Spotsylvania Avenue, Suite 400 Fredericksburg, VA 22408

Program Manager –TBD Contracting Officer Representative - TBD

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with FAR 52.232-33, Payment by Electronic Funds Transfer—System for Award Management.

3. INVOICES: Payments shall be made monthly in arrears upon receipt of a properly prepared invoice.

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Request.

5. FSC MANDATORY ELECTRONIC INVOICE SUBMISSION: Contractors are required to submit payment requests in electronic form in accordance with the submission instructions below.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Contracting POC: TBD COR (Contracting Officers Representative): TBD Contract/Task Order Number: TBD Purchase Order Number: TBD

a. VENDOR ELECTRONIC INVOICE SUBMISSION METHODS:

Fax, email and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted data transmissions below.

b. VENDOR E-INVOICE SET UP INFORMATION:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center (FSC) in Austin, TX for payment processing. If you have questions about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

See https://www.fsc.va.gov/einvoice.asp for more information ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

B.3 SUBCONTRACTING PLAN--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-9, Small Business Subcontracting Plan, and VAAR 852.219-9, VA Small Business Subcontracting Plan Minimum Requirement. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing the contractor's compliance with the plan, including reviewing the contractor's accomplishments in achieving the subcontracting goals in the plan. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting plan.

B.4 PERFORMANCE WORK STATEMENT

1.0. PROJECT TITLE: Evidence Based Clinical Practice Guidelines Development/Updates

2.0. BACKGROUND: Implementation of evidence-based clinical practice guidelines is one strategy the Veterans Health Administration (VHA) has embraced to improve care by reducing variation in practice and systematizing “best practices”. Guidelines address patient cohorts, serve to reduce errors, and provide consistent quality of care and utilization of resources throughout and between the VA and DoD health care systems. Guidelines are also cornerstones for accountability and facilitate learning and the conduct of research. The guidelines on the VA/DoD Clinical Practice Guidelines website are those endorsed by the VA/DoD Evidence Based Practice Work Group (www.healthquality.va.gov)

In 1992, The Department of Veterans Affairs (VA) through a contract with the West Virginia Medical Institute, Inc. (WVMI), developed explicit criteria to be used to review patient care. These criteria were largely advanced by leading clinicians in healthcare and were intended to represent state-of-the-art practice in the community.

In 1992, the Institute for Healthcare Improvement in collaboration with VA clinicians ensured the criteria developed under the contract were followed when developing fundamental clinical practice guidelines for rehabilitation of patients following a stroke or lower extremity amputation.

VHA’s first endeavor to integrate evidence into the development of clinical practice guidelines was conceived in the pioneering work that developed the VHA CARE-GUIDE RT (Care Aided and Refined with Guidelines in Real Time) for Ischemic Heart Disease that was published in September 1996.

2.1.1. In 1998, the Department of Defense and VA collaborated to advise the DoD/VA Executive Council on the use of practice guidelines to improve the quality of health and support population health management across both Departments. The VA/DoD Evidence-Based Clinical Practice Guideline (CPG) Work Group was established to:

a. Advise the Executive Council regarding the development and implementation of clinical practice guidelines.

b. Identify areas for clinical practice guideline adaptation based on the operationally defined needs of VA and the DoD.

c. Facilitate the Federal guideline adaptation process.

d. Identify a maintenance process for fielded VA/DoD guidelines that monitors the development of new technologies/practices/pharmacotherapy that should be incorporated into the guidelines to keep them current.

e. Champion the integration of clinical practice guidelines into current and developing information systems to further optimize guideline implementation.

f. Ensure integration of practice guidelines with existing VA/DoD health promotion, disease prevention, and wellness initiatives.

g. Encourage research related to practice guidelines within VA/DoD.

2.1.2. VA and DoD have collectively produced the following evidence-based clinical practice guidelines (included in list are archived and active CPG’s):

Table 1. List of Evidence Based Clinical Practice Guidelines

Insomnia

The CPG products can be viewed via the internet at:

http://www.healthquality.va.gov.

Intranet users can view CPG information and policy on the Office of Quality and Patient Safety Evidence-Based Practice site: https://vaww.oqsv.med.va.gov/functions/integrity/cpg/clinicalPractic.aspx.

“Guideline for Guidelines” describes the current development and update process used by VA and DoD Departments.

All current guidelines are posted on the ECRI Guidelines Trust Website: ECRI Guidelines Trust®.

3.0. TYPE OF CONTRACT: This contract is for a single award, Indefinite-Delivery, Indefinite-Quantity (IDIQ) with terms and conditions for firm-fixed-price (FFP) Task Orders.

4.0. CONTRACT MINIMUM AN MAXIMUM DOLLAR VALUE: In accordance with FAR 16.504(a)(4)(ii), the total maximum dollar value for the contract is $35,000,000.00. The contract minimum dollar value is $5,000.00.

5.0. ORDERING PERIOD: The ordering period for this IDIQ contract is five years from date of award. The areas/topics of development and revision will change from year to year based upon the program’s experience and VA/DoD program needs.

6.0. PLACE OF PERFORMANCE: Tasks performed under this contract shall primarily be performed at the Contractor’s provided facility.

7.0. PERFORMANCE PERIOD: The period of performance shall be for five years from the date of award. Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO).

There are eleven (11) Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, five are set by date:

Table 2. Observed Holidays

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six are set by a day of the week and month:

Table 2. Observed Holidays Continued

8.0. DEFINITIONS

Terminology used throughout this document will be interpreted in the following manner:

Clinical Practice Guideline (CPG): “Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances" (Institute of Medicine, 1990). The purpose of guidelines is to help clinicians and patients make appropriate decisions about health care.

Guidelines attempt to do this by:

· Describing a range of generally accepted approaches for the diagnosis, management, or prevention of specific diseases or conditions.

· Defining practices that meet the needs of most patients in most circumstances.

The recommendations are not fixed protocols that must be followed. Responsible clinician's judgement on the management of patients remains paramount. Clinicians and patients need to develop individual treatment plans that are tailored to the specific needs and circumstances of the patient. (NHLBI, 2011), http://www.nhlbi.nih.gov/guidelines/about.htm

Contracting Officer's Representative (COR): An employee of a Contracting Activity designed by a Contracting Officer to perform contract administration activities regarding technical issues.

Evidence- Based Clinical Practice Guideline (EBCPG): A clinical practice guideline that is based on a rigorous systematic review and synthesis of the published medical literature.

Evidence Chaperone: An independent observer who participates in the guideline development process and ensure adherence to the specified evidence grading system thus ensuring that the guideline and its recommendations are truly evidence based. The evidence chaperone intervenes if the "guideline for guidelines" or the specified evidence grading system and processes are not being followed.

Evidence Synthesis: A critical examination of existing scientific evidence on a clinical topic that summarize what is known and not known from the current science base. (Agency for Healthcare Research and Quality, 2011, http://www.ahrq.gov/clinic/epc/#Devt)

Guideline Champion: A member of the VA or DoD who is a leading clinical expert on the topic of the guideline within their organization.

Systematic Review: A summary of the clinical literature. A systematic review is a critical assessment and evaluation of all research studies that address a particular clinical issue. The researchers use an organized method of locating, assembling, and evaluating a body of literature on a particular topic using a set of specific criteria. A systematic review typically includes a description of the findings of the collection of research studies. The systematic review may also include quantitative pooling of data, called a meta-analysis.

VA/DoD Clinical Practice Guideline Working Group: A group of VA and DoD clinicians who are convened over a period of months via a series of conference calls and face-to-face meeting to develop an evidence-based clinical practice guideline on the specified topic according to the process specified in "Guideline for Guidelines" (Attachment 5).

VA/DoD Evidence-Based Clinical Practice Guideline: An evidence-based clinical practice guideline developed by a working group of clinicians from the VA and DoD, headed by VA and DoD champions, who develop a clinical practice guideline for use within the VA and DoD. These guidelines are high quality, are developed by VA and DoD providers for VA and DoD providers and have minimal conflict of interest.

VA/DoD Evidence-Based Practice Working Group: A working group comprised of VA and DoD quality improvement staff, chartered by the VA/DoD Health executive Committee, who identify the need for specific clinical practice guidelines in the VA and DoD and oversee the VA/DoD guideline development process.

9.0. EXTENT OF OBLIGATION: The Government is obligated only to the extent of authorized task orders issued under this IDIQ contract. All work detailed in the Performance Work Statement (PWS) is effort that may be required during the five-year ordering period of the IDIQ contract.

10.0. ORDERING: Task Orders shall be placed in writing by the Contracting Officer during the contract’s period of performance.

11.0. INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE IDIQ: Warranted Department of Veterans Affairs (VA) Contracting Officers (CO) at the Strategic Acquisition Center (SAC) are the only individuals authorized to place orders under this contract.

12.0. SCOPE: Veterans Health Administration seeks to award a contract with an organization that has a proven record of accomplishment of facilitating every aspect of guideline production from question development through development of evidence syntheses through development of recommendations and final production of the evidence-based clinical practice guideline documents, to include meeting documentation support and document development, pertaining to CPGs and associated tools (pocket cards, patient summary, etc.), editing and production, to include document digital enriched media content navigation menu and clickable buttons with associated hyperlinks for a digital web experience for the online clinical practice guidelines that are 508 compliant. In general, requests will be to accomplish guideline development and revisions, evidence reviews, patient and provider tools, and to facilitate guideline implementation including electronic versions of those documents suitable for down-loading to mobile devices as well as placement on VA’s web site.

Contractor support includes planning, conducting virtual or face-to-face meetings of the development groups; facilitating and documenting expert work group sessions; coordinating the review of guideline revisions by designated work group members; developing provider education tools (summary and pocket card); grammatical/technical editing, version control and producing a revised guideline in the designated formats (hard-copy and enduring material) that will be used for clinicians and patients to assist in making appropriate decisions about healthcare.

The Contractor shall assist the Offices of Quality and Patient Safety, Patient Care Services, Chief or designee, Defense Health Agency, and clinicians in Veterans Health Administration (VHA) of the Department of Veterans Affairs and the Department of Defense (DoD) with developing “evidence-based clinical practice guidelines”. Evidence-based CPGs translate “best evidence” into “best practices” and can be used to:

· Reduce variation and ensure predictable quality of care and resource utilization.

· Reduce errors and ensure the safety of the care provided; and

· Promote accountability to the optimum standard of care based on the most current state of scientific knowledge.

A key element in the development of evidence-based CPGs is iterative editing and document preparation to ensure the final CPG reflects the evidence presented and consensus of the clinical experts. To be clear these are not Clinical Pathways and/or Protocol development they do not reach the same level of rigor required of evidence based clinical practice guidelines. Evidence Based Clinical Practice Guidelines requires the highest level of scientific, statistical and clinical rigor and as such results in significant more work than a pathway/protocol, which can be completed in weeks to months versus months to years with a CPG.

13.0. SPECIFIC TASKS AND DELIVERABLES

13.1. KICK-OFF MEETING:

Task: The Contractor shall coordinate and conduct kick-off meetings before the development/update of each CPG included on a task order.

Deliverable: An agenda shall be provided to the Contracting Officer’s Representative (COR) that includes discussions for the following topics: (1) appointment of key personnel and support, (2) education offerings, (3) service point of contacts, (4) the designated account representative, (5) and a description of the services the Contractor will provide with a schedule of milestones, objectives, and deliverables.

Deliverable: Kick-off meeting agenda.

Deliverable due date: No later than 5 days after issuance of order.

13.2. Program Management Plan (PMP)/Conflict of Interest Statements (COI) From Contractors:

Task: The Contractor will establish a written plan for completion of each guideline assigned. As part of the PMP, the Contractor will develop a quality control plan to ensure deliverables are provided in a timely manner and services meet the quality standards listed in the contract, section 18.0. The Contractor shall facilitate the completion of conflict-of-interest statements for all contractor employees. The contractor shall also obtain COI’s and CV/Resumes from Government employees working on guideline development and send directly to the COR.

Deliverable: PMP

Deliverable due date: Submit NLT 15 business days after Contract has been awarded or after CPG kick-off meetings.

Deliverable: Conflict of Interest Statements from Contractors.

Deliverable due date: Submit NLT 15 business days after the Contract is awarded or CPG Kick-off meeting.

13.3. Wiki Website Creation:

Task: The Contractor shall create a password protected web site/Wiki to post the guideline and/or related materials for general use by the development group and to solicit comments from key clinical leaders, as well as a broader group of end users. Comments collected will be provided to the group to assist in focusing the guideline effort. The Contractor shall create a separate website/Wiki for the general public when it is time for peer review and comments of the CPG’s. Comments collected shall be provided to the group to assist in focusing the guideline effort.

Deliverable: Wiki Website

Deliverable due date: Submit NLT 14 business days after the contract is awarded.

13.4. CPG Scope Determination/Champion Training:

Task: For each CPG, the Contractor shall orient/train all Clinical Champions and work group members, chosen by their respective program offices, regarding the evidence-based approach and process, and facilitate the identified experts in defining the scope, objectives, key Population Intervention Comparative Outcome (PICO) questions, and timeline. The Contractor shall facilitate VA and DoD work group members to maintain engagement including all appropriate clinical specialties with the development of guidelines. The Contractor shall facilitate disclosure of conflict-of-interest issues to the group and how they will be handled in development discussions. The Contractor shall also research to identify any relevant guidelines published on the specified guideline topics and provide approaches that can be used to support VA/DoD collaboration with the broader community. The broader community is considered other institutes, organizations, etc. that develop clinical practice guidelines. Evidence synthesis and related activity papers generated by VA and/or DoD Health Services Research and Development (HSR&D), Evidence Synthesis Program (ESP), Quality Enhancement Research Initiative (QUERI) and other similar evidence/research programs shall be considered.

13.5. Key Question Development:

The Contractor shall work with the Government Champion(s) and work group members to identify key questions which inform the systematic evidence reviews, within defined admissible boundaries, and shall solicit comments, via the guideline development website/Wiki site, from the Champions and work group, as well as patient focus group participants to confirm the questions. Input from all stakeholders shall be presented to the guideline Government Champions by the Contractor. If the input is found acceptable by the Government Champions, it shall be considered or reviewed in the guideline development.

13.5.1. Participants involved in these efforts shall submit disclosure statements to the Government to reveal any areas of potential conflict of interest. (See Guideline for Guidelines Attachment 5).

13.5.2. Task: At the discretion of the Government, the Contractor shall conduct systematic reviews of the clinical and academic evidence to support the guideline recommendations for each question, when required. The searches, using the parameters set by the guideline working groups, shall focus on up-to-date information from relevant, valid research evidence to address each question, and ensure maximum coverage of studies at the top of the hierarchy of study types: systematic reviews, meta-analyses, randomized controlled trials, and evidence-based guidelines as appropriate and available. Evidence synthesis and related activity papers generated by VA and/or DoD Health Services Research and Development (HSR&D), Evidence Synthesis Program (ESP), Quality Enhancement Research Initiative (QUERI) and other similar evidence/research programs shall be considered. For any questions that cannot be answered by systematic reviews, the search shall be extended using defined criteria identified by the guideline working group. To grade the quality of individual studies, the reviews will apply the U.S Preventive Services Task Force (USPSTF) or Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria for quality adapting those to specific clinical areas. The results of these extended searches shall be organized and reported using any encrypted password protected reference manager software.

Deliverable due date: Submit NLT 7 months after the CPG kick-off meeting.

13.5.3. The body of evidence for each question shall be reviewed and analyzed by the Contractor. The Evidence Reports will include tables of evidence as well as:

· Summary of Findings/Bibliography

· Methodology

· Search terms

· Resources searched

· Articles critically appraised

· Articles excluded as per search protocol

· Evidence Tables

· Findings

At the time of completion of the CPG a publication ready evidence summary and table shall be delivered electronically in MS Word document format.

Deliverable due date: Electronic format Submit NLT 14 business days after approval by the VA/DoD EBPWG.

13.5.4. Task: The Contractor shall assist the clinical experts in their review of the evidence and the evidence report for each key question, which shall be oriented to the USPSTF criteria for evaluating individual studies and the GRADE criteria for evaluating the body of evidence as defined by the Government.

U.S. Preventive Services Task Force (2007) Current methods of the U.S. Preventive Service Task Force. Refining evidence-based recommendation development, Annals of Internal Medicine, 147(2), pp 117-124. Retrieved from http://www.ahrq.gov/clinic/uspstf07/methods/currprocess.pdf .

Guyatt, G. H., Oxman, A. D., Vist, G. E., Kunz, R., Falck-Ytter, Y. Alonso-Coello, P. Schünemann, H. J. & the GRADE Working Group. (2008). GRADE: going from evidence to recommendations. BMJ, 336, 1049-1051.

Deliverable: The scope of the CPG and the key questions as developed by the guideline working group.

Deliverable due date: NLT 3 months after the kick-off meeting

13.6. Evidence Review/Synthesis:

13.6.1 Task: The Contractor shall perform evidence synthesis; facilitate guideline development by government-identified experts; provide analytic and education support; coordinate all communication and meetings; and provide administrative support for the development and revision of CPGs. The Contractor shall train and supervise all Contractor staff, subcontractors and agents regarding all aspects of work included in this Contract and will use appropriate safeguards to prevent conflicts of interest as result of work performed under this contract. The Contractor shall conduct the evidence synthesis for the guideline when required, to support guideline development, to include evidence synthesis obtained from other sources that have previously conducted evidence synthesis if available and beneficial.

Deliverable: Evidence review should begin NLT 14 days after completion of Key Question identification.

The Contractor shall produce any written materials necessary to document the guideline development process, culminating in production of a full CPG which shall include (1) algorithms, (2) recommendations, (3) evidence tables, (4) bibliographies, (5) appendices, and (6) 508 conformant reference tools to support CPG implementation. The Contractor must make the document compliant with the Section 508 standards which include WCAG 2.0. The 508 office will accept a CommonLook report as a validation artifact that the report indicates no defects to include verified reading order, color contrast and all the manual checkpoints, the VA 508 office will accept the document as compliant. The 508 office retains the right to audit product at any time. The CommonLook report will be maintained as an artifact by the Contractor to provide proof of compliance. VA 508 compliance office has 508 training and contractors will have access to the training when needed. The 508 standards are found in their entirety at: https://www.access-board.gov/ict/ The reference tools shall include print-ready, PDF versions, simplified versions of the:

(1) provider tools (pocket card (Attachment 1) and guideline summary (Attachment 2) and (2) patient tool (patient guideline summary see Attachment 3).

Deliverable: Conduct systematic evidence review, evaluate the literature, and create evidence tables for inclusion in the Evidence Report.

Deliverable due date: Submit NLT 10 business days prior to the Recommendation Development Meeting (RDM). The RDM is a meeting where the guideline development team reviews the Evidence Report and drafts recommendations for clinical care.

Deliverable: Complete evidence summary and table in hard-copy and electronic format for Government leadership, Government Champions and work group members.

Deliverable due date: Submit NLT 14 business days after final approval from the EBPWG meeting.

13.7. Patient Focus Groups

13.7.1. The Contractor shall conduct patient focus groups for each CPG that informs key question development. They will prepare meeting materials, including an interview guide and other documents as deemed necessary by the Champions and work groups, as well as organize and prepare the meeting facility on the day of the focus group. The meeting facility and recruitment of patients will be arranged by the Government. Meeting preparation also includes time to discuss with the CPG Champions the main topic areas for discussion with the focus group patients and to ensure that the Champions are briefed on and concur with the focus group material.

13.7.2. The Contractor shall conduct a one-day focus group for each CPG. No more than nine patients will participate in each focus group and each focus group will convene only once. If needed, a second focus group may convene if the COR and Contractor approve at no cost to the Government. As each CPG addresses a separate clinical area, patients in each focus group will be provided only materials for the specific CPG for which they are being asked to provide feedback and will be asked to comment only on that CPG. During the meeting, the Contractor will share the purpose and goals of the CPG and facilitate discussion with the patients regarding their perspectives, for consideration and inclusion in developing the evidence-based recommendations.

13.7.3. The Contractor will develop detailed meeting summaries that will be used to inform each CPG Work Group and VA/DoD Leadership regarding the information generated by the focus group participants and how this additional information can be integrated into the CPG, e.g., as modified recommendation (content and/or grading), accompanying narrative, or research needs. All documents shall be provided in MS Word or MS PowerPoint.

Deliverable: Agenda and meeting summary Deliverable due date: Submit Agenda NLT 2 business days before the focus group and submit a summary NLT 10 business days after the focus group.

13.8. Guideline Development:

13.8.1. The CPG Work Group members, under the direction of the Government Champion(s), shall provide the clinical expertise for guideline development. Guideline development shall be facilitated by the Contractor and shall be in accordance with Guideline for Guidelines (See Attachment 5) as well as the standards for quality guidelines as set by the National Academy of Medicine (NAM) (Formerly the Institute of Medicine (IOM)). If needed the Guideline for Guidelines can be flexible when communicated to the Director of the Evidence Based Practice Program for approval. To be clear these are not Clinical Pathways and/or Protocol development as they do not reach the same level of rigor required of evidence based clinical practice guidelines. Evidence Based Clinical Practice Guidelines requires the highest level of scientific, statistical, and clinical rigor and as such they result in significantly more work than a pathway/protocol, which can be completed in weeks to months versus months to years with a CPG.

The IOM references are specified below:

IOM (2011) Clinical Practice Guidelines We Trust, Washington, DC, Institute of Medicine.

IOM (2011) Finding What Works in Health Care: Standards for Systematic Review, Washington, DC, Institute of Medicine.

13.8.2. The Contractor shall serve as a communications coordinator and shall facilitate the working group in the algorithm development and iterative editing and review of the recommendations to be incorporated in the guideline.

13.8.3. The final CPG’s, to include full CPG, provider summary (Attachment 4), patient summary (Attachment 3), algorithms, pocket cards (Attachment1 and Attachment 2), and tables, shall be produced as an editable electronic (Word and PDF Format) deliverable and the final PDF version with document digital enriched media content navigation menu and clickable buttons with associated hyperlinks for a digital web experience. PDF files shall be 508 compliant per VA accessibility standards and ready for placement on the production side of the EBP internet website at http://www.healthquality.va.gov. All revisions and edits made to final copies must be 508 compliant. The Contractor must make the documents compliant with the Section 508 standards which include WCAG 2.0. The 508 office will accept a CommonLook report as a validation artifact that the report indicates no defects to include verified reading order, color contrast and all the manual checkpoints. The VA 508 office will accept the document as compliant. The 508 office retains the right to audit product at any time. The CommonLook report will be maintained as an artifact by the Contractor to provide proof of compliance. VA 508 compliance office has 508 training and Contractors will have access to the training when needed. These standards are found in their entirety at: https://www.access-board.gov/ict/

13.8.4. The Contractor shall prepare a monthly progress report outlining all work accomplished during the previous month and send to the COR and VA/DoD leadership the second business day of each month.

Deliverable: Monthly Progress Report

Deliverable due date: The initial format for the report will be submitted by the Contractor NLT 20 business days after Contract is awarded and submit NLT the second business day of each month, thereafter.

Deliverable: Develop and deliver Draft 1 of CPG; Post Draft 1 on website/Wiki for review and comment period for the CPG Work Group. (see Guidelines for Guidelines-#10)

Deliverable due date: Submit NLT 1 month after the face-to-face meeting.

Deliverable: Develop and Deliver Draft 2 of CPG; Post Draft 2 on website/Wiki for review and comment period for the CPG Work Group.

Deliverable due date: Submit NLT 2 months after Draft 1.

Deliverable: Develop and deliver Draft 3 of CPG; Post Draft 3 on website/Wiki for external peer review and comment period.

Deliverable due date: Submit NLT 2 months after Draft 2.

Deliverable: Present CPG to Evidence Based Practice Work Group (EBPWG) for review and comment and final approval.

Deliverable due date: Submit agenda and slide deck NLT 10 business days prior to the EBPWG presentation and submit meeting summary NLT 5 business days after the EBPWG meeting.

Deliverable: The Contractor shall deliver final guidelines in electronic formats: MS Word document as well as a 508 compliant PDF version that is ready for placement on the production side of the Evidence Based Practice internet website http://www.healthquality.va.gov. All revisions and edits made to final copies must be 508 compliant. Upon completion of the contract, and at the discretion of the Government, the Contractor will return all data and files, including temporary files that were created as a part of the process. The files will be delivered in a format that is Government approved.

Deliverable due date: Submit NLT 14 business days after final approval from the EBPWG meeting.

Deliverable: Provider and patient tools that include but are not limited to the guideline, summary, pocket cards, patient guideline summaries and other adjuncts to facilitate guideline implementation.

Deliverable due date: Submit NLT 14 business days after final approval from the EBPWG meeting.

13.9. Ongoing Meetings:

Details of meeting coordination include:

13.9.1. Most of the face-to-face meetings, if not conducted virtually via a web conferencing application, shall be conducted in the Washington, DC, metropolitan area using space provided by the Contractor to accommodate 25 to 35 participants and VA/DoD administrative staff. Typical duration of face-to-face/virtual meetings is 3.5 days for a new guideline or update to a complex or less complex CPG. Face-to-face/virtual meetings for a conversion of a CPG developed by another organization will be 2 full days. Provision of supporting documentation, e.g., meeting agenda, complete evidence synthesis tables of the population, intervention, comparison, outcome (PICO) format questions developed by the work group in hard copy and electronic format, iterative development of the guideline algorithm and recommendations, handouts and meeting minutes will be supplied by the Contractor.

If available, Federal Government facilities may be provided. It may be in the best interest of the Government to occasionally conduct face-to-face meetings in locations other than in the Washington, DC, metropolitan area. If necessary, the Contractor shall be responsible for coordinating and acquiring meeting space in these instances. The meeting space shall be coordinated by the Contractor and the Government to ensure the meeting will be held at either party’s location.

13.9.2. The Contractor is responsible for planning, coordinating and facilitating meetings and conference calls with designated guideline Government Champion(s) and work group members to develop the clinical recommendations of the guidelines. Web based conferencing applications and/or the Contractors conferencing system will be used whenever possible for ongoing development work outside of the face-to-face meeting.

13.9.3. The Contractor shall meet by teleconference on a twice a month basis with the COR and other staff involved with contract administration. The Contractor will provide an agenda prior to each meeting to the COR.

Deliverable: COR check-in teleconference meeting agenda

Deliverable due date: Submit NLT 1 days prior to the meetings with the COR Deliverable: COR meeting summaries.

Deliverable due date: Submit NLT 5 business days after the meetings with the COR

Deliverable: Face-to-face meeting summaries

Deliverable due date: Submit NLT 14 business days after each face-to-face meeting.

Deliverable: Minutes after each CPG teleconference

Deliverable due date: Submit NLT 5 business days after each CPG meeting

14.0. TECHNICAL REQUIREMENTS: PRODUCTS AND SERVICES

14.1. The Contractor shall facilitate the development/revision of the evidence-based clinical practice guidelines and provider tools for typically four full-length guidelines or updates but no more than six or the equivalent effort for a larger number of smaller/less complex evidence-based practice recommendations per year. The number of complex/less complex and new CPGs versus updated CPGs will vary from year to year.

14.2. Assumptions For New Development Activities of a Guideline Requiring a Complex Evidence Review: The level of effort quoted to facilitate the development of a guideline requiring complex evidence review assumes that the number of questions researched for the guideline will be limited to no more than 20 (subject to CLIN’s ordered). Existing guidelines and evidence review to support the guidelines will be the subject of initial consideration. The expected period of performance is 18 months.

14.3. Assumptions For Update Development Activities of a Guideline Requiring a Complex Evidence Review: The level of effort quoted to facilitate the development of a new guideline of this nature assumes that the number of questions researched for the guideline will be no more than12 (subject to CLIN’s ordered). Existing guidelines and evidence review to support the guidelines will be the subject of initial consideration. The expected period of performance is 12 months.

14.4. Assumptions For Update Activities of a Guideline Requiring a Less Complex Evidence Review: The level of effort quoted to facilitate updating the activities assumes that the number of questions researched for guideline updates will be no more than 5 and will rely heavily upon meta-analysis and systematic reviews published since the previous evidence review was completed (usually 5 years). The expected period of performance is 10 months.

14.5. Assumptions For Conversion of Guidelines: The level of effort quoted to facilitate the conversion of guideline activities assumes there is a guideline developed by another organization that the Government wishes to adopt and modify to comply with VA guideline format to include algorithms and provider and patient education tools. The expected period of performance is 6 months.

15.0. TRAVEL

Travel is anticipated for this contract and must be in accordance with the Joint Federal Travel Regulations and the PWS. Travel CLINs will include a Not to Exceed amount. Before commencing, travel must be approved by the COR.

16.0. GOVERNMENT FURNISHED SUPPORT

16.1. The Director, Evidence Based Practice, Office of Quality and Patient Safety or designee will collaborate with clinical leaders in Patient Care Services and the VISNs as well as the Chief or designee, Defense Health Agency Clinical Practice Guideline program office to identify guideline Government Champion(s) and other appropriate clinical experts from the VA and DoD health care systems. Costs of travel and per diem for VA and DoD participants to participate in the guideline development or revision will be the responsibility of VA/DoD.

16.2. The Government is not responsible for providing computers, forms, conferencing space, 508 compliant software or other equipment and supplies.