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Medical Liability Reform and Patient Safety

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Technical Assistance Conference Call


This document is a summary of a technical assistance teleconference call that took place on November 12, 2009, from the Agency for Healthcare Research and Quality (AHRQ), on the Agency's Funding Opportunity Announcements (FOAs):

Introductions | Highlights | Questions and Answers


Introductions

Coordinator: Welcome and thanks for standing by. At this time, I would like to inform all parties that they are in "listen" mode only. I'd like to also remind all parties that the call is being recorded. If you have any objections, you may disconnect at this time. I'd now like to turn the call over to Francis. Thank you sir, you may begin.

Francis Chesley: Good afternoon and welcome. This is Francis Chesley at AHRQ. I direct the Office of Extramural Research, Education, and Priority Populations. Before we get started, I'm going to ask folks in the room here at AHRQ to go around and introduce themselves.

David Hsia: David Hsia (Scientific Contact)
Jim Battles: Jim Battles (Scientific Contact)
Boris Aponte: Boris Aponte (Scientific Review Officer at AHRQ)
Kishena Wadhwani: Kishena Wadhwani (Director, Division of Scientific Review)
Ying Tian: Ying Tian (Scientific Review Officer at AHRQ)
Michelle Burr: Michelle Burr (Grants Management)

Francis Chesley: This is the AHRQ team associated with these two Funding Opportunity Announcements (FOAs). Again, thank you for calling in today.

The purpose of today's call is to review the Medical Liability and Patient Safety Requests for Applications (RFAs) and answer submitted clarifying questions. If any statement I make today erroneously contradicts the RFAs, the instructions in the RFAs take precedence over my statements. First, I will provide a brief overview of the RFAs. Following that, I will go through submitted questions and provide answers. The two RFAs constitute components of a multipart initiative on patient safety and medical liability.

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Highlights

RFA-HS-10-021 supports demonstration projects to allow States and health care systems to develop, implement, and evaluate medical liability models that put patient safety first and work to reduce preventable injuries, foster better communication between doctors and their patients, and ensure that patients are compensated fairly and quickly and in a timely manner for medical injuries, while also reducing the incidence of unnecessary lawsuits and liability premiums. It uses the R18 Research Demonstration Grant Mechanism. An application responding to this RFA may request up to $3 million total. It may allocate this total across the three-year project period in accordance with the applicant's work plan. AHRQ plans to commit about $21 million to this RFA.

RFA-HS-10-022 solicits applications for planning grants from States and health care systems for patient safety and medical liability innovations that put patient safety first and work to reduce preventable injuries, foster better communication between doctors and their patients, and ensure that patients are compensated fairly and in a timely manner for medical injuries, while also reducing the incidence of unnecessary lawsuits and liability premiums. This RFA uses the R21 Planning Grant Mechanism. An application may request up to $300,000 for the one-year project period. AHRQ plans to commit about $4 million to this RFA.

Please note that both RFAs require a focus on both patient safety and medical liability in order to be eligible for consideration. AHRQ will publish an addendum to the RFAs clarifying this point. The addendum will be published in the NIH Guide for Grants and Contracts.

Turning to Eligible Institutions, you may submit an application if your Sponsoring Organization is either a State or a health care system. A "State" includes State governments, units of State governments, and established organizations of State governments. Both RFAs use Roemer's definition of a health system. According to Roemer, a health system has capacities (for example, hospitals and physicians), activities (for example, health services), interconnections (for example, financing, oversight, and management), and purpose. Its components might include multiple States, localities, Tribal governments, universities, colleges, hospitals, nonprofit organizations, faith-based organizations, community-based organizations, and Federal agencies. Applicants to these RFAs must share a long-established, legal entity as sponsor and sufficient service volume to statistically power any proposed intervention. Applicant organizations must also be nonprofit entities. For-profit organizations or foreign institutions may participate in projects only as third parties.

Moving on to the Principal Investigator, any individual with the skills, knowledge, and resources necessary to carry out the proposed project as a Principal Investigator should work with their Sponsoring Organization to develop an application. AHRQ does not recognize multiple Principal Investigators on a single grant application. AHRQ encourages individuals from underrepresented racial and ethnic minority groups as well as individuals with disabilities to apply as Principal Investigators. The RFAs expect a minimum time commitment of 20 percent annual effort from either the Principal Investigator or the Project Manager.

When you submit an application, use the SF424 (R&R) Application and Electronic Submission at http://www.grants.gov. To download the SF424 Application package and application guide for completing the SF424 forms for these RFAs, use the "Apply for Grants electronically" button in these RFAs or link to http://www.grants.gov/applicants/apply_for_grants.jsp. Please follow all directions provided on that Web site. AHRQ will not accept paper applications. Importantly, please note that a one-time registration is required for Institutions and the Principal Investigator at both http://www.grants.gov and on the NIH eRA Commons. See the RFAs for Web links to these registration requirements. Additionally, the RFAs summarize the application submission process.

In terms of peer review, applications that respond to the RFAs will undergo evaluation for scientific and technical merit by an appropriate scientific peer review group.

This concludes the overview of some specific elements of the RFAs, and I will now turn to submitted questions, read those questions, and provide answers. Please note that AHRQ has posted these questions along with answers on the agency Web site at http://www.ahrq.gov. Once on the agency Web site, select Funding Announcements to reach the questions and their answers.

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Questions and Answers

Question 1: Does the prohibition on submitting an application that is essentially the same as one currently pending initial review mean that an applicant can only apply to either the R18 or the R21 RFA?
Answer 1: No. Applicants that meet the RFA's requirements may apply to either or both. Each application must be clearly distinct. Applicants should not submit an identical application to both RFAs.

Question 2: Can an application propose only a patient safety intervention without a medical liability component or a medical liability intervention without a patient safety component?
Answer 2: No. The RFAs both require than an application address both patient safety and medical liability. AHRQ will publish an addendum in the NIH Guide that clarifies the requirement than an application must address both patient safety and medical liability.

Question 3: Who may apply for these grants?
Answer 3: The RFA describes two Eligible Institutions: States and established health care systems. For additional details, please review Section 3 in the RFAs.

Question 4: How does the Eligibility Information section describe established health care systems?
Answer 4: Please refer to Section 3, Eligibility Information, for a complete description of who may apply for these grants and a description of health care systems.

Question 5: Would a single hospital, university, professional practice, professional association, consulting firm, or law firm constitute an established health care system?
Answer 5: Under Roemer's description, provided in both RFAs, a health system must have multiple capacities of multiple types, interconnections between them, and common purpose. A single capacity (for example, a hospital), would not appear to conform to this description. An organization that does not meet the description could serve as a third party to an Eligible Institution.

Question 6: Would Kaiser Permanente, Intermountain Healthcare, Group Health Cooperative, and Geisinger, for example, constitute an established health care system?
Answer 6: This type of health care organization would appear to conform to Roemer's description.

Question 7: Would a small chain of hospitals constitute a health system?
Answer 7: Depending on their organizational relationship, non-hospital capacity (for example, practitioners and financing), their integration and history, such a chain might conform to Roemer's description.

Question 8: Would AHRQ further define established health care systems?
Answer 8: AHRQ will not further define an established health care system. Applicants should be guided by the definition provided in the RFA.

Question 9: Would AHRQ further define coalitions of state governments?
Answer 9: AHRQ will not further define coalitions of state government beyond the text provided in the RFAs.

Question 10: Would AHRQ consider expanding the description of Eligible Institutions that may apply for these grants?
Answer 10: AHRQ has no plans to modify or change the description of Eligible Institutions. An organization not eligible to apply may participate as a third party to an Eligible Institution. The applicant organization must perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party that may not be eligible to receive funding directly.

Question 11: How can a patient advocacy group participate in these grants?
Answer 11: A patient advocacy group could act as a third party to an eligible Institution. An application might include a patient advocacy group among its key stakeholders.

Question 12: Would AHRQ provide additional guidance about the qualifications of a Principal Investigator?
Answer 12: AHRQ will not provide additional information about qualifications for the Principal Investigator.

Question 13: Can an application have more than one Principal Investigator?
Answer 13: An application can have only one Principal Investigator. AHRQ has not adopted the multiple Principal Investigator designation described in NIH Guide Notice Announcement OD-07-017.

Question 14: Who are the key stakeholders considered in the review and selection criteria?
Answer 14: The identity of key stakeholders would vary depending upon objectives of the application.

Question 15: Can an existing demonstration apply under these RFAs?
Answer 15: Yes, if it meets the RFAs' requirements.

Question 16: What is the specific distinction between a grant and a planning grant?
Answer 16: AHRQ defines a grant as a financial assistance mechanism providing money, property, or both, to an eligible entity to carry out an approved project or activity. A grant mechanism is used whenever the federal funding agency anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. AHRQ uses a variety of activity codes to differentiate the different research-related programs it supports. For example, the R21 mechanism for planning grants encourages new, exploratory, and developmental research projects by providing support for the early stages of project development. It is sometimes used for pilot and feasibility studies. No preliminary data are generally required. The R18 mechanism for demonstration projects provides support designed to develop, test, and evaluate health services activities and to foster the application of existing knowledge.

Question 17: If a grantee receives one of the R21 planning grants and produces a plan for addressing patient safety and medical liability, then will AHRQ fund implementation of the plan with a new RFA in 2011?
Answer 17: AHRQ has no plans for future funding of patient safety and medical liability beyond the current RFAs.

Question 18: If a successful grantee collects sensitive data during the course of its R18 study, can a third party obtain access to the data by pretrial discovery during a court case?
Answer 18: 42 U.S. Code 299c-3(c) limits the disclosure of research data that identifies individuals or establishments. No judicial cases [test] its interaction with the discovery provisions of the Federal Rules of Civil Procedure.

Question 19: How does AHRQ define significant State involvement, and what role should the State play in an application?
Answer 19: AHRQ will not provide additional information about expectations for State involvement or roles beyond that provided in both RFAs.

Question 20: Is a State university a unit of State government?
Answer 20: It depends. Grant peer review might find that a State university with characteristics of a State executive agency constitutes a unit of State government; for example, being largely State-funded, having workers employed by the State, and management that serves at the pleasure of the elected State government. A State university with characteristics of a private university would not constitute a unit of State government; for example, substantial private, charitable, and/or grant funding; workers employed by the university; and management responsibilities to an independent board of trustees. An applicant sponsored by a State university should clearly justify how its Eligible Institution meets the RFA's stated criteria.

This concludes the list of submitted questions and related answers. Please note that AHRQ will continue to accept written questions and will post answers and questions of general interest on its Web site.

Additional information about questions and answers can be found on the AHRQ Web site at http://www.ahrq.gov/fund/grantix.htm.

This concludes our technical assistance call. Thank you.

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Current as of December 2009

The information on this page is archived and provided for reference purposes only.

 

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