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Improving Patient Safety: Health Systems Reporting, Analysis, and Safety Improvement Research Demonstrations

Technical Assistance Meeting

Regarding RFA: RFA-HS-01-003, published February 2, 2001, in the NIH Guide to Grants and Contracts

Letter of Intent Receipt Date: April 2, 2001
Application Receipt Date: April 27, 2001

Many questions were posed at the technical assistance meeting held March 16, 2001, regarding RFA HS-01-003, "Improving Patient Safety: Health Systems Reporting, Analysis, and Safety Improvement Research Demonstrations." These questions and the ensuing answers follow.

Question: Can you elaborate on the reporting system requirements, such as 10 hospitals, nursing homes, or health delivery sites? Do all of the sites have to be using the reporting system or can it be rolled out after the grant award? What if they are under the same management?
Answer: The reporting system must be up and running in at least 10 institutions or delivery organizations. The 10 organizations need to be physically separated sites of care. For example, Kaiser has many more than 10 sites of care that are under the same management. This would be fine under the request for applications (RFA). On the other hand, an applicant can not use 10 areas in one hospital (e.g., intensive care unit [ICU], critical care unit [CCU], surgical).

Question: What is a safety improvement? Should we focus just on the reporting of "error" information or more? How do you view observational methods of reporting data?
Answer: Safety improvement is the reduction of the unintentional consequences of care that are the results of error. This RFA anticipates that data on errors, adverse events, and other information can contribute to improving safety and our intent is to fund proposals that will help us learn what types of risks can best be identified by which types of data collection, and what information is most useful in stimulating or informing efforts to reduce those risks. Observational data collection is acceptable as long as it is routine and not just an ad hoc occurrence.

Question: How important is it that our grant applications describe how the reporting system is changing care?
Answer: It is critical that your application focus on improvements. Three areas must be contained within each project: collection of data, analysis of data, and quality improvements.

Question: What about the generalizability and stability of data? What happens if the data collection in our reporting system is still expanding?
Answer: Error reporting is novel; the generalizability and stability of data are important issues. Generalizability is the ability of your data collection strategy to be used by similar organizations. This will clearly be one of the factors considered by the review panel. As for the question of a dynamic regarding changes in your reporting system, the Agency for Healthcare Research and Quality (AHRQ) recognizes that the reporting systems are dynamic, not static. Applications should discuss how you will deal with your expanding system and how you intend to incorporate new data.

Question: In assessment of the efficacy of our reporting system, will the reliance on historical data as a baseline be acceptable?
Answer: Yes, historical data would be accepted. The reviewers would assess the significance and the scientific merit of this historical data.

Question: Our proposed project will include many different data collection tools. How do we adequately describe these in the application given the space limitations?
Answer: Applications should provide a broad overview and description of all the many different data collection tools. The technical appendix can be used for additional specific information; the reviewers will look to the appendix for more detailed descriptions of items.

Question: If my State has two existing reporting systems (one for hospitals, one for clinics), would it be better to focus on one system or to compare them?
Answer: Either approach would be responsive to the RFA.

Question: My system has multiple sites. Would it be better to have one application across the system or several applications?
Answer: The issue of direct costs in excess of $2 million notwithstanding, either approach would be appropriate. However, the application with sites across the system may be more generalizable.

Question: What do we need to include in our application if we intend to use data of the Health Care Financing Administration (HCFA) that we already possess under an existing data use agreement?
Answer: Approval would need to be acquired from HCFA to use the data for the purposes of the grant and you would need to include any necessary costs in your budget.

Question: What type of reporting system is better—mandatory or voluntary?
Answer: That is a good question, and it is the intent of this RFA to fund research that will help us to discern which type of system is better for particular purposes. Within the context of this RFA, we expect to fund proposals that will let us assess the virtues of both types of systems.

Question: Our State does not have mandatory reporting systems; everyone has their own reporting systems. We would like to develop a uniform reporting language for the State. Can the Coordinating Center help in the development of common language?
Answer: I think that your application would have a more fundamental problem because it would not seem to have a common reporting system. Therefore, you would not qualify for funding under this RFA.

Question: If our proposed projects are not suited to this RFA, will there be any funds left for other funding opportunities, such as R01s? What other assistance can AHRQ offer us for existing patient safety grants, such as interagency agreements (IAAs).
Answer: After the money we have committed to patient safety RFAs, we have fairly scant resources for other patient safety projects this year. We of course would like to maximize our scant resources, such as through co-funding opportunities. AHRQ is always open to partnership and would welcome exploring opportunities such as IAAs.

Question: Do new investigators have an advantage in this RFA?
Answer: There is no preference for new investigators in this RFA. Because of the requirements of this RFA, an experienced principal investigator (PI) may be judged as essential by the study section to handle the demands of managing these large and complex projects.

Question: The RFA mentions a set aside for office based practices. Does this mean that you have to be an AHRQ primary based research network (PBRN) grantee to qualify for it?
Answer: No, you do not need to be a PBRN grantee to qualify, but PBRNs are of course welcome to apply.

Question: What is the deadline for institutional review board IRB) approval? What if we can only get IRB approval for the primary site—not for the other sites? Would the primary site IRB approval be sufficient?
Answer: IRB approvals for the primary applicant organization must be submitted before the August 1, 2001, deadline ( i.e., before grant review). The other sites could have only provisional approvals, but no fund will be allocated without all assurances in place.

Question: Who will be on the application review panel? Will consumers be on the review panel?
Answer: We do not know who is on the review panel yet, because it can not be composed until after the application submission deadline. The plan for this RFA review panel is that it will be composed of a variety of individuals with divergent backgrounds, such as academic researchers, state policymakers, quality improvement and safety improvement experts, experts in the maintenance and use of large data sets. We may include individuals with expertise in communication with patients, if enough applications focus on this area.

Question: What is the role of the new Coordinating Center described in the RFA to the funded applications? When is the Coordinating Center RFA going to be released? Is the Coordinating Center a new entity or an existing organization?
Answer: The Coordinating Center will provide technical assistance and support for the grants funded under this cooperative agreement RFA and for other AHRQ funded patient safety grants. A request for proposals (RFP) will be issued soon for the Coordinating Center (we are prohibited by contract law to announce a RFP release date). It is expected that existing organizations will respond to this contract solicitation.

Question: How should we budget for Coordinating Center activities and interventions? Will the Coordinating Center approve economic incentives that we intend to offer some reporters?
Answer: The application should include budget items related to activities, such as attending meetings and teleconferences that will be coordinated by the Coordinating Center. The applicant should only budget for their own interventions; any specific Coordinating Center interventions will need to be dealt with through the Coordinating Center's budget. AHRQ's Grants Management Office approves economic incentives not the Coordinating Center. If an applicant proposes use of incentives, they will need to make a very strong case for the institutional and historical basis for their use.

Question: Is the Coordinating Center intended to be a "glorified switchboard" or will it be providing some analytic capabilities? How much can applications depend on the analysis expertise of the Coordinating Center?
Answer: The Coordinating Center is not intended as a switchboard; it is envisioned as providing coordination among grantees and technical assistance, such as analysis, for the numerous grantees. The vast majority of analysis should be conducted by the applicants and the application should demonstrate the analytic capabilities of the research team. The Coordinating Center could help the grantee find some additional partners, but that is not the major function of the Coordinating Center.

Question: Will the Coordinating Center be developing statistical frameworks and models for the grantees?
Answer: The applications need to reflect some sophistication in their ability to develop statistical frameworks and models. The Coordinating Center will supplement the applicants in this area and can help facilitate the development of methodologies and the expansion of models, particularly across several projects.

Question: Who will look at raw data—AHRQ, the Coordinating Center?
Answer: AHRQ will not be using raw data from the funded grants; however, AHRQ intramural researchers may obtain de-identified data from the grantees. The Coordinating Center will not look at raw data; it will look at data compiled across RFAs and interventions.

Question: We are concerned about confidentiality and data privacy protections surrounding existing error data. What is the relationship between the current laws and statutes and those that would be conferred with these grants? Do existing data have the same guarantees as new data?
Answer: AHRQ currently has very strong data protections. All data collected and used for these research grants is protected; you as a PI cannot be asked to provide this data to others. However, if there are other means or sources for this data, then data that is included in your project can be accessed through these other methods.

Question: Will there be litigation protection for the data collected under these grants? Do you have a description of the legal protections that I can provide to my State such as an Advisory Opinion of the Department of Health and Human Services (HHS)?
Answer: There is not a litigation protection per se for these grants. While AHRQ has strong data protections, these existing protections have never been tested in court. We will obtain an Advisory Opinion from HHS' general counsel.

Question: How will data within these reporting systems that is required to be reported get reported?
Answer: AHRQ grants will not supersede the existing mechanisms and requirements that are in place to assure required reporting. The grants do not provide protections from reporting data that are supposed to be reported.

Question: Our application will include organizations from both mandatory reporting systems and voluntary reporting systems. Is this a conflict of interest?
Answer: Applicants must describe in their application how they will ensure that data that is intended to be kept confidential will be kept confidential and to whom and how they will disclose data that they intend to disclose. The organizations would need to work out an agreement on how non-disclosed data stays confidential.

Current as of April 2001

Internet Citation:

Improving Patient Safety: Health Systems Reporting, Analysis, and Safety Improvement Research Demonstrations. Technical Assistance Workshop. April 2001. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/fund/safetyqa.htm