Comments to the American Medical Associaiton on the Quality Improvement Projects and Human Subjects Research Report of the Council on Scientific Affairs--Oct. 21, 2002

October 21, 2002 Dr. Mark S. Antman Dr. Karen S. Kmetik American Medical Association 515 N. State Street Chicago, IL 60610 SENT VIA E-MAIL Dear Drs. Antman and Kmetik: On behalf of the American Health Quality Association (AHQA), the membership organization of the national network of Quality Improvement Organizations (QIOs), thank you for the opportunity to provide comments on the "Quality Improvement Projects and Human Subjects Research" report of the Council on Scientific Affairs (CSA). While this letter addresses comments from the QIO community, we believe the ESRD Networks, which perform a function analogous to QIOs, may share our concerns. We offer our compliments to the members of the CSA and the staff who drafted this document. Our membership has reviewed the document and we believe it frames the issues very well. We support the policy statements contained in Resolution 807 (A-02) that call for the development of clear guidelines to differentiate quality improvement and human subjects research as well as a comprehensive CMS review to certify that contracted quality improvement (QI) initiatives undertaken by the QIOs and ESRD Networks are exempt from such a review. Our organization did not find anything in the report that we would recommend deleting. Our suggestions are offered for the sole purpose of strengthening the report. Making the Case for Exemption 5. The Office for Human Research Protections (OHRP) defines research to include activities that contribute to generalized knowledge. Without the specific exemptions defined in the "Common Rule," QIOs would most certainly fit into the category of organizations that contribute to general knowledge. It is for this reason that the development of clear guidelines illustrating the application of Exemption 5 is critical to protecting the work of the QIOs from IRB review. The work of the QIOs is, in fact, not research. Should circumstances lead the QIO to conduct research for purposes other than QI, IRB review has been sought in the past and will continue to be sought. To prevent the overly broad definition of research from hindering the work of the QIOs, we believe a stronger case could be made to link the activities of the QIOs and Exemption 5. The CSA appropriately recognizes CMS' position that the QIOs perform "demonstration projects," and this concept is presented well. We believe that two additional clauses exist within Exemption 5, which provide additional evidence supporting a QIO exemption. "Sub-clause (a)" of Exemption 5 allows for consideration of projects that examine "public benefit or service programs." Because the CMS contracts with the QIOs focus on examining the quality of care delivered through the Medicare program, adding language describing QIO work as enhancing the Medicare public service program to the narrative and chart that follows could be helpful. "Sub-clause (c)" of Exemption 5 describes allowances for projects that examine "possible changes in, or alternatives to, those programs or procedures." QIO projects are simply efforts to propose changes or alternatives to current systems of care that lead to the increase in delivery of established best practices. The narrative on page 14, rows 17-20, illustrate this application well through the description a project that used flowcharts to remind physicians to follow a set of treatment and documentation protocols while caring for a patient. We support additional language in the narrative report and chart that follows citing sub-clause (c) as a valid consideration. Already Overburdened IRBs. The CSA is right to describe the concern that IRBs across the nation are already overwhelmed and lack the resources to adequately review the quantity of research proposals received within a reasonable period of time. The CSA makes this case well on Pages 5, 10, and 12 of the report. We also support the opening sentences of the report summary that re-emphasize the inadequacy of the IRB system to address QI and the inadequacy of the criterion, "generalizability" of knowledge, as a requisite for determining what is research. We agree with this finding, and offer a suggestion that may strengthen this report. We ask that the CSA consider adding language describing the financial implications of IRB review. These implications apply both to the IRBs and to the QIOs. Requiring IRB review before implementing a QI activity could subject the 1,951 registered IRBs in the country to a dramatically expanded workload, as each of 53 QIOs is working on multiple interventions to promote improvement in clinical practice as measured by 27 evidence-based quality indicators. In addition to overloading the nation's IRBs with review functions, the QIOs do not have the resources necessary to subject each one of their QI activities to multiple reviews by multiple IRBs. CMS has already directed the QIOs to perform more work with fewer funds. In the 2002-2006 scope of work, QIOs have been directed to add skilled nursing facilities, home health agencies, and expanded physician office support to their workload. In addition, Federal funding for QIO functions performed from 2002-2006 is down $78 million over the previous scope of work. IRB review would not only slow down or stop QI efforts, but the added burden of preparing for IRB review would most certainly drain the already limited Medicare Trust Fund resources allocated to complete the QI program. Emphasizing the Legal Standing of QIOs. The CSA recognizes the "presumed continued exemptions" attributed to QI activities as provided by the original peer review statute. Although the report contains a reference (endnote number 24) to the appropriate portion of the CFR, we ask that the CSA consider including the following specific reference to QI work in the CFR. The definition of a quality review study contained in 42 CFR 476.101(b) is the basis for the definition of a Quality Improvement Project (QIP). The regulations define a quality review study as "an assessment, conducted by or for a PRO [QIO], of a patient care problem for the purpose of improving patient care through peer analysis, intervention, resolution of the problem, and follow-up." This definition clearly describes a national effort that is not conducted for the purposes of research. In addition to the CFR, the QIO Manual Revised 2002, explicitly describes the function of the QI activities as separate from research: "Improvement Projects Versus Research Studies.--In general, improvement projects should rely on scientific evidence from clinical research reported in the peer-reviewed literature, consensus that has already been developed and, where possible, guidelines that have already been written. Carrying out improvement projects may involve applying the results of research studies and may utilize many of the tools and terminology of epidemiological, clinical, or health services research. However, they should not involve: Efforts to prove that a process of care is effective or ineffective; or Development of practice guidelines." (SOURCE: QIO Manual, CMS, 2002) Summary. We support the AMA's intention to secure an active role in the AHRQ/The Hastings Center project that will develop a framework for assessing QI activities in relationship to human subject review. We also wish to thank you for your efforts and serious consideration of this issue. For questions regarding our comments, feel free to contact me or Mark Boesen, Pharm.D. at 202-331-5790 or by e-mail at dschulke@ahqa.org, or mboesen@ahqa.org. Sincerely, David G. Schulke Executive Vice President DGS:mdb

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