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PRO-101 RFP January 24, 2017 1 REQUEST FOR PROPOSAL FOR THE AMERICAN HEART ASSOCIATION RESUSCITATION AND FIRST AID SYSTEMATIC REVIEW UNITS DUE DATE: Intent to Submit: February 13th, 2017, 5:00 PM CDT Proposals: March 20th, 2017, 5:00 PM CDT Deliver Complete Proposal Package By Email To: Digit Moolayil Procurement Services American Heart Association 7272 Greenville Avenue Dallas, Texas 75231 [email protected] 214-706-1268 PROPOSAL # 160014

REQUEST FOR PROPOSAL FOR THE AMERICAN HEART … · prophylactic antiarrhythmic drugs given immediately after ROSC (I), compared with compared with not giving antiarrhythmic drugs

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Page 1: REQUEST FOR PROPOSAL FOR THE AMERICAN HEART … · prophylactic antiarrhythmic drugs given immediately after ROSC (I), compared with compared with not giving antiarrhythmic drugs

PRO-101 RFP January 24, 2017

1

REQUEST FOR PROPOSAL FOR THE

AMERICAN HEART ASSOCIATION

RESUSCITATION AND FIRST AID SYSTEMATIC REVIEW UNITS

DUE DATE: Intent to Submit: February 13th, 2017, 5:00 PM CDT

Proposals: March 20th, 2017, 5:00 PM CDT

Deliver Complete Proposal Package By Email To:

Digit Moolayil Procurement Services

American Heart Association 7272 Greenville Avenue

Dallas, Texas 75231 [email protected]

214-706-1268

PROPOSAL # 160014

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REQUEST FOR PROPOSAL

The American Heart Association is seeking applications from national or international systematic review units or knowledge synthesis units to complete complex and comprehensive systematic reviews with or without meta-analyses as indicated with the International Liaison Committee on Resuscitation (ILCOR).

Please respond to this request by March 20th, 2017 at 5:00 PM CDT. Failure to respond by this

date or sending an incomplete submission may result in automatic elimination from consideration.

If you have any questions concerning this Request, please contact me using the information below.

Please respond electronically in the document format requested:

Digit Moolayil

American Heart Association

E-mail: [email protected]

Thank you in advance for your participation in our Request for Proposal process.

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TABLE OF CONTENTS

1. GENERAL OVERVIEW

2. GENERAL INFORMATION

3. PROPOSAL REQUIREMENTS/CONDITIONS

I. Award

II. Provider’s Responsibilities

III. Assignments

IV. Contract Terms

V. Insurance Requirements

A. Worker’s Compensation & Employer’s Liability

B. Liability Requirements

VI. Additional Provider Responsibilities

VII. Accessibility Requirements

4. SCOPE OF WORK

5. PRICING SPECIFICATIONS

6. EVALUATION CRITERIA/TIMELINE

I. Evaluation Components

II. Timeline

7. PROVIDER INFORMATION

I. Organization and Experience

II. Quality

III. Implementation

IV. Contract Requirements

8. SUPPLIER QUESTIONNAIRE

9. ATTACHMENTS

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1. GENERAL OVERVIEW

The American Heart Association (AHA) is comprised of the National Center (located in Dallas, TX) and 7 affiliates that cover the United States. Support of the AHA mission is also provided by thousands of volunteers and donors.

The American Heart Association is dedicated to working with our employees, volunteers, partners, providers and customers to "Building healthier lives, free of cardiovascular diseases and stroke." The organization is committed to the responsible use of AHA assets, to provide accurate, complete and objective information, to respect the confidentiality of financial and other information, to act in good faith and exercise due care in all we do, to comply with all rules and regulations and to proactively promote ethical behavior.

The International Liaison Committee on Resuscitation (ILCOR) is the international committee

responsible for coordination of all aspects of cardiopulmonary and cerebral resuscitation and first

aid worldwide. AHA is a founding member of ILCOR. ILCOR continually evaluates the scientific

evidence and publishes the Consensus on Science with Treatment Recommendations on

resuscitation science, resuscitation education and first aid.

2. GENERAL INFORMATION

I. The American Heart Association will not be liable for any costs incurred in the preparation and presentation of the proposal.

II. The provider must submit the proposal electronically, no later than 5 p.m. (CDT) on March 20th, 2017 to Digit Moolayil ([email protected]) and should reference RFP #160014 in the subject line. Be sure to complete the attached Supplier Questionnaire (Exhibit A).

III. Technical questions regarding the scope of work and questions about the RFP process should be directed to Digit Moolayil ([email protected]). IV. Please limit your response to no more than 30 pages excluding financial statements and annual reports or other requested documents.

V. Any provider who desires to change or withdraw its proposal shall do so in writing.

3. PROPOSAL REQUIREMENTS/CONDITIONS

I. AWARD

A. The American Heart Association reserves the right to reject any and all proposals and to waive any non-conformities, whenever such actions are in its best interest, as determined solely by the American Heart Association. B. Nothing contained herein creates any contractual relationship between the American Heart Association and the Provider, or any of its providers and subcontractors. Following receipt of

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the proposal, the AHA will determine, at its sole discretion, which providers to invite for further discussions regarding the desired services.

II. PROVIDER’S RESPONSIBILITIES

The Provider will be fully responsible for the quality and accuracy of any and all Work performed in conjunction with a Contract. The terms “Contractor” or “Bidder” may be used interchangeably. Neither acceptance of such Work by the AHA, nor payment thereof, will relieve the Provider of this responsibility. The Provider will complete all services in conformity with professional standards, and will provide qualified personnel to meet agreed upon schedules.

III. ASSIGNMENTS

The successful Provider may not assign its rights and duties or outsource core responsibilities of the agreement. No subcontracting of the work involved will be allowed following the AHA’s issuance of a Contract without prior written approval of the AHA.

IV. CONTRACT TERMS

This Contract, if awarded, will be for up to 2 years commencing on or about May 10th, 2017. The AHA may renew this agreement, upon mutual written agreement, for one-year terms. These services and agreement are non-exclusive and AHA reserves the right to engage in other similar or identical services with other Providers. Additional provisions will be determined based on contract award.

V. INSURANCE REQUIREMENTS

An awardee of an agreement with AHA will be required to meet contractual insurance requirements and provide a Certificate of Insurance or other suitable proof of insurance. Please provide a sample document of such proof with your submission.

VI. ADDITIONAL PROVIDER RESPONSIBILITIES

At its own expense, the Provider will:

• Take all precautions necessary per state regulations to protect persons or property against injury or damages occurring as a result of its operations. Maintain AHA properties in compliance with regulations and protect AHA employees and visitors from injury.

• Obtain all permits/licenses required to operate this type of business.

• Provide competent supervisors and workers. Provider must conduct appropriate background checks of all employees assigned to the AHA operation, including replacements or temporary staffing.

• Perform the Work without unnecessarily interfering with AHA operations.

• Provide all vehicles and tools as necessary for its use.

• Protect existing properties and assets from damages and promptly repair or replace any damages caused by its employees or arising out of its operations. The Provider will be responsible for reasonable care and shall restore the AHA or make whole any reparations due to acts of negligence or lack of proper care.

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• Indemnify, defend and hold the AHA harmless against any and all suits, proceedings, actions, demands, claims, losses, liability, damages or expenses, including reasonable attorney’s fees, that the AHA may sustain or incur by reason of or which may arise or result in any way from the actions or omissions of Provider, its employees, agents and/or sub-contractors, and/or from Provider performance under this Agreement.

VII. ACCESSIBILITY REQUIREMENTS

1. The AHA is committed to providing “full and equal” access to users of its online presence. Accordingly, Provider agrees that all content developed and other services provided for the AHA’s websites under this Agreement shall at Provider’s expense comply with all of the requirements below. • Law --local, state and federal applicable web content accessibility requirements, including but not limited to accommodations for disabled persons under the then current version of the Americans with Disabilities Act (ADA), the Rehabilitation Act, Title IX, and any other then current applicable accessibility law or regulation. • WCAG/ISO -- the “A” and “AA” level accessibility standards set forth in the Website Accessibility Initiative’s (WAI) Web Content Accessibility Guidelines (WCAG) version 2 (ISO/IEC 40500:2012).

• Guidelines and SOW’s – The AHA’s Accessibility Guidelines documents provided to Provider, and the tasks and implementation schedule in any applicable statement of work (SOW) to a services agreement between the AHA and vendor. The Guidelines documents state the AHA’s requirements about which WCAG/ISO standard level (e.g. A, AA, AAA) will be required for each website feature.

4. SCOPE OF WORK ILCOR is looking at two possible PICO topic areas for KSU reviews:

Advanced Life Support PICO

Post-resuscitation treatment protocol

(P) For adults and children in any setting (in- or out-of-hospital) with cardiac arrest and a shockable rhythm (I) Does administration (intravenous or intra-osseous) of an antiarrhythmic drug during CPR or after ROSC (C) Compared with another anti-arrhythmic drug or placebo during CPR or after ROSC (O) Improve outcomes (any clinical outcome)1?

1Please refer to additional caveats and defined terms: Combination of: a. Among adults and children who are in cardiac arrest in any setting (P), does does administration

of antiarrhythmic drugs (eg, amiodarone, lidocaine, other) (I), compared with not using antiarrhythmic drugs (no drug or placebo) (C), change (O)?

b. Among adults and children with ROSC after cardiac arrest in any setting (P), does do prophylactic antiarrhythmic drugs given immediately after ROSC (I), compared with compared with not giving antiarrhythmic drugs (C), change (O)?

• Antiarrhythmic drugs include but are not limited to: amiodarone, lidocaine (also called lignocaine) magnesium, procainamide, bretylium and nifekalant.

• Anti-arrhythmic = antiarrhythmic = dysrhythmic drug

• ROSC = return of spontaneous circulation.

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• Patients with cardiac arrest are currently given an antiarrhythmic drug if they have a shockable cardiac arrest rhythm = ventricular fibrillation (VF) or pulseless ventricular tachycardia (pVT) which does not initially respond to a shock from the defibrillator

• Patients may have an initial shockable rhythm, or develop a shockable rhythm during CPR.

• After ROSC, we want to know if patients should be given an antiarrhythmic drug prophylactically if they had a shockable rhythm.

• Key recent study: Kudenchuk et al. N Engl J Med. 2016 Aug 25;375(8):802-3.

• Recent systematic review: Amiodarone or lidocaine for cardiac arrest: A systematic review and meta-analysis. Sanfilippo F et al. Resuscitation. 2016 Oct;107:31-7.

First Aid PICO

Control of bleeding

(P) Among adults and children with severe or life-threatening external bleeding, does the application of any advanced management technique to control bleeding (I) compared with direct pressure alone or with each other (C) change (outcomes, O)?2

2Please refer to additional caveats and definitions: Caveats and definitions:

• ‘Severe, life-threatening bleeding’ is bleeding that a first aid provider feels may be potentially life-threatening, and may include bleeding that is pulsatile, spurting, associated with an amputation, avulsion or crush injury, associated with multiple wounds or in a location that cannot be accessed (i.e., trapped extremity), or bleeding associated with signs or symptoms of shock.

• ‘Advanced management techniques’ may include use of devices or techniques to control external bleeding and that can be used by a first aid provider or layperson, with prior training or just-in-time instructions. They may include use of commercial or improvised tourniquets; hemostatic agents, dressings or gauze (which are used with direct pressure); ice packs or cryotherapy; elevation of the injured part; proximal or junctional pressure point devices if approved for first aid use; and pressure dressings with devices such as elasticized/rubber wraps.

• ‘Direct (manual) pressure’ has traditionally been considered the ‘gold standard’ method for controlling bleeding but is known to not be possible, practical or effective in some circumstances.

• We are interested in comparing one technique with another and/or direct pressure. For instance, we would be interested in comparisons of a hemostatic dressing for severe, life-threatening bleeding from an extremity wound with use of a tourniquet. This will help Guidelines developers with creating algorithms for when to use one technique versus another.

• We are interested in knowing if one technique can or cannot be used on a wound in a specific body part, such as torso, extremity, or neck wounds.

• Major outcomes we are interested in include overall mortality, blood loss/replacement, major bleeding complications, and time to control of bleeding. Minor outcomes might include ease if application or use of a technique (i.e., is training required), and cost of a technique compared to another.

• a series of questions to look at what the best sequence of treatments should be might include:

o Among adults and children with severe bleeding does the application of cold/ice (I) compared with direct pressure alone (C) change (O)

o Among adults and children with severe bleeding does the application of a haemostatic dressing(I) compared with cold/ice application (C) change (O)

o Among adults and children with severe bleeding does the application of a tourniquet (I) compared with application of a haemostatic dressing (C) change (O)

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o Among adults and children with severe bleeding does the application of a tourniquet (I) compared with application of cold/ice(C) change (O)

o Among adults and children with severe bleeding does the application of a tourniquet (I) compared with direct pressure alone (C) change (O) The end result of this Mega PICO would enable the task force to make an evidence-based recommended sequence of actions for the management of severe

bleeding.

The scope of service includes:

1) Conduct a systematic review of the literature using a methodology consistent with the Cochrane Handbook in collaboration with two content experts and one mentee recruited from the ILCOR website open to all those interested in resuscitation, education and first aid as selected by ILCOR.

2) Coordinate and communicate with appropriate ILCOR task force(s) and domain lead regularly and at each step of the workflow to review progress and findings .

3) Complete the evidence profile tables (www.guidelinedevelopment.org) and GRADE Evidence to Recommendation Framework (BMJ 2016;353:i2089 http://dx.doi.org/10.1136/bmj.i2089 within 4 months of initial search. This will be used by the content experts to generate the Consensus on Science and Treatment Recommendation Complete a systematic review with or without a meta-analysis as appropriate within 6 months, including PROSPERO registration and compliance with PRISMA reporting.

4) Submit manuscript for peer review within 6-8 months for a systematic review or 12 to 14 months for systematic reviews involving a network meta-analysis and provide support through to successful publication within 12 months for a Systematic Review from initial search.

The deliverables are: 1. Executive summary. 2. Detailed report including methodology, GRADE tables, inclusion and exclusion tables. 3. Draft Consensus on Science and Treatment Recommendation and knowledge gaps

using the ILCOR template. 4. Manuscript on systematic review (and meta-analyses where appropriate) submitted for

peer review after approval by ILCOR oversight body.

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5. PRICING SPECIFICATION AHA requests that the Provider (potential KSU) provide their standard price list as well non-profit discounted pricing. The description should include a budget justification and description for each item for the contracted work. Providers should also note that the contracted work will not exceed $50,000 in compensation and should provide the systematic reviews within the suggested timelines that are previously outlined. Please limit response to a maximum of two (2) pages, 11-point font minimum.

6. EVALUATION CRITERIA/TIMELINE I. Evaluation Components

The selected provider will have responsibility for all aspects of the required services awarded. AHA

desires to focus on business issues and rely on the selected company to provide expertise. The

following criteria among others will be considered by the AHA to determine Contract award:

o Ability to provide required services (refer to the scope of work section)

o Proposed fees (Total cost of each component to AHA

o Proposed service delivery method

o References

o Provider’s reputation and longevity in the marketplace

Provider must have:

o Experience working for third parties and providing scoping reviews, systematic reviews,

meta- analyses, network meta-analyses

o Experience building and conducting comprehensive literature searches using Embase,

Medline and Cochrane as a minimum

o Access to all the relevant information electronic databases required to conduct a

comprehensive literature search

o Methodological expertise in systematic reviews and meta-analyses and network meta-

analyses

o Expertise and track record in GRADE methodology

o Track record of collaborations with content experts to complete systematic reviews and

meta-analyses

Any of the following is considered an asset but is not essential:

o Experience in the conduct of systematic reviews of experimental/animal trials

o Experience in the conduct of systematic reviews in the field of resuscitation

o Experience in the conduct of systematic reviews of qualitative studies and economic

analyses

AHA expects all materials it provides to providers to be treated as proprietary, whether or not

labeled as such. Specifically, this Proposal is confidential and should not be discussed outside of

your organization. Similarly, AHA will hold your proposal response confidential.

II. Timeline

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Items Due Date

Proposals emailed to suppliers and posted online January 24, 2017

Suppliers declare their intent to respond by returning signed NDA to AHA by 5:00PM CDT

Feburary 13, 2017

Questions to AHA regarding RFP and its components due by 5:00PM CDT.

February 20, 2017

AHA emails responses to questions February 24, 2017

Proposals due to AHA by 5:00PM CDT March 20, 2017

Notify short listed suppliers (if needed) March 27, 2017

Supplier interviews if needed (via video conference) April 3, 2017

Supplier selection April 10, 2017

Tentative contract start date May 10, 2017

7. PROVIDER INFORMATION:

I. ORGANIZATION AND EXPERIENCE (to be responded to in spread sheet provided)

SECTION A. General Information If some of these questions do not apply to you, please respond with N/A. 1. Please provide brief summary information, including institution/organization name; contact

person, address, phone number, email; ; annual revenue, and; number and location of domestic and international offices.

2. Please provide a brief history of your organization, institution and/or department.

3. Has your institution and/or organization experienced reorganization and/or accreditation issues? 4. Attached is AHA’s standard Master Provider Agreement template that provides a baseline of

term and condition requirements. Please review and state whether you can accept the provisions as is. If you are not able to accept the standard template, please indicate which sections would be in question.

5. Please include your most recent Annual Report and/or Financial Statements (How would this

relate to KSU, please include a list of your most recent annual report and/or financial contracts. SECTION B. Team Composition

1. Provide a clear and concise description of the team composition highlighting the expertise and skills in the team related to:

• clinical epidemiology

• biostatistics including network meta-analysis;

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• resuscitation or first aid or critical care or emergency medicine or emergency medical services or education;

• systematic review methodologies (range of methods including qualitative, quantitative, economic analyses);

• prevention interventions;

• specific topic expertise (as outlined in the objectives and background)

2. Team members should have experience, methodological and statistical expertise to conduct high-quality evidence synthesis and meta-analyses. Experience in economic analyses, network analyses and modelling is also beneficial. The team should include information specialist with expertise in review synthesis. Please outline how the expertise of the applicant and team members ultimately benefits the relevant ILCOR task force(s).

Please limit response to a maximum of 1000 words, 11-point font minimum. SECTION C. Unit/Center Management (infrastructure)

1. Please describe the core infrastructure of the Centre. 2. How is the Centre managed? 3. What relevant affiliations does the Centre have?

Please limit response to 500 words, 11-point font minimum. SECTION D: Relevant Experience Provide a description of the Provider’s experience working jointly with organizations or individuals in the production and use of systematic reviews in health/healthcare settings. Provider should have demonstrated expertise in 1) systematic review/meta-analysis methodology; 2) statistics for meta-analysis and network meta-analysis; and 3) information sciences for systematic reviews, as well as a proven track record of timely productivity. A list of publications should be provided, as appropriate. Please limit response to a maximum of 1000 words, 11-point font minimum.

QUALITY (to be responded to in spread sheet provided)

The AHA requires references to confirm the quality of the contracted work. We request that the contracted KSU provide references for us to determine what type of previous relationships that the contracted KSU has had and how these relationships reflect the KSU’s ability to perform and quality of their delivered work.

• Please provide the names, titles, addresses and phone numbers of three individuals who would be willing to provide references on your behalf. Describe the length of time, relationship, and/or what capacity that you have with the individual and/or client that can confirm your expertise, quality of work delivered and previous work ethic.

III. IMPLEMENTATION PLAN

In a separate document (.doc or .pdf) please provide your company’s implementation plan based

on the services you propose to support. Please limit response to a maximum of 2000 words, 11-

point font minimum.

The detailed implementation plan should outline:

• Technical approach

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• Plan for how the systematic reviews, communications and reporting will be conducted and

managed Understanding the objectives of the ILCOR Continuous Evidence Evaluation

process

• Effective timely communication with the relevant ILCOR Task force(s), domain lead(s) and

the Continuous Evidence Evaluation (CEE) working group.

Implementation plans will be assessed for practicality and feasibility within the timelines.

IV. CONTRACT REQUIREMENTS AHA standard Master Provider Agreement is attached. This is a good representation of term and

condition requirements for doing business with AHA. While this contract might not be a direct fit for

the services, many of the provisions are required. Please complete this form and say whether you

can accept the terms as is or state which terms you would negotiate.

An awardee of an agreement with AHA will be required to meet contractual insurance requirements

and provide a Certificate of Insurance or other suitable proof of insurance. Please provide a

sample document of such proof with your submission.

8. SUPPLIER QUESTIONNAIRE

Respond to questions in spreadsheet.

9. ATTACHMENTS

Supplier Questionnaire (.xls)

AHA Standard Master Provider Agreement Template (.pdf)