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4 site visits Molia S. Donaldson and Kathleen N. Lohr The site visits occupied a central place in fact-finding for this study. The Institute of Medicine (IOM) study committee comprised individuals whose diverse backgrounds and experience provided breadth to the committee's deliberations. Because of this diversity and the range of settings and issues included in the legislative charges, the committee chose to devote a sub- stantial amount of time to site visits; the committee members believed such activities would provide a collective understanding of the variety of meth- ods, concerns, and viewpoints of groups with roles in quality assurance. Site visits of this kind are often carried out in IOM projects precisely to bring committee members to some common understanding of the issues under study. The committee members emphasized the educational objectives of the site visits. The principal goals were as follows: (lj to increase their under- standing of the strengths and limitations of methods of quality assessment and assurance from the point of view of those involved in them; (2) to come to appreciate the kinds of problems that are (or are not) identified by such techniques; (3) to learn more about the types of quality assurance interven- tions that are implemented by various quality assurance programs around the country; and (4) to use this information in generating recommendations for the Medicare program. The committee did not, therefore, try to evaluate the soundness or effectiveness of any organization's quality assurance pro- gram. The remainder of this chapter describes the site visit process and docu- ments the main groups, organizations, and facilities visited. It also dis- cusses major issues raised during the visits and gives examples of the types of quality-of-care problems that health care providers identify through their quality assessment systems or that they consider basic health care systems Issues. 91

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92 MOll A S. DONALDSON AND KATHLEEN N. LOHR METHODS Site Visit Schedule and Planning IOM staff began site visit planning in mid-1988. They selected locations that included different regions of the country as well as organizations that conduct quality assurance activities and those that are the object of external quality assurance. For instance, a Medicare Peer Review Organization (PRO) and providers such as hospitals, risk-contract health maintenance organiza- tions (HMOs), and practicing physicians were all included. In addition, the staff and committee believed it important to visit large urban, small community, and rural settings and to see a range of facilities, for instance large and small institutions and academic and nonacademic settings. They also believed it important to visit groups with "exemplary" quality assurance programs and those struggling to implement programs. To tap community perceptions, staff planned site visits to include represen- tatives of consumer and local community groups. Finally, special meetings were also arranged with experts in quality assurance, ethics, geriatrics, and related issues. Early in the study, members of the study committee and this study's technical advisory panel were asked to recommend organizations and con- tacts. The staff first contacted possible site visit locations and visitees by telephone and then sent a confirming letter that outlined the objectives of the site visit (see Appendix A). Staff also determined potential dates for all major site visits and the dates on which committee members could be avail- able and then assigned individuals to specific site visits. Some effort was made to have committee members visit cities and states outside their own location. When committee members could not remain for an entire site visit, they were asked to participate at least partially in more than one visit. The nine major site visits took place between October, 1988, and March, 1989. Each lasted about 3 days and included two or more committee mem- bers and two IOM staff members. During April and May, 1989, several 1- day site visits were made. Tables 4.1 and 4.2 identify the states and cities visited and list the major organizations visited and main meetings con- ducted. Visits to Organizations During the site visits to organizations such as hospitals, hospital associa- tions, HMOs, home health agencies (HHAs), and Medicare PROs, the com- mittee generally used the "Guide for Site Visitors" (Appendix B). Individ- ual committee members and staff were, however, also guided by their own interests and those of the group being visited.

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SITE VISITS 93 Each site visit included an introduction of participants and an overview of the study objectives presented by a committee member. Generally, the formal site visits then included an overview of quality assurance concerns and activities from the site visitees and a broad discussion of issues in defining and measuring quality. When appropriate, the work of Medicare PROs and concerns directly related to care of the elderly were discussed. Organizations were asked to identify important quality problems faced by the elderly, the kinds of quality problems identified by their quality assess- ment programs, and the strategies used to correct those problems. During some visits, the participants broke into smaller groups for more informal . . c .lscusslons. Meetings All site visits included meetings organized around specific themes or groups representing various views of health care delivery. A highly selec- tive listing includes: setts); physicians in office practice (Minnesota, Virginia, and Texas); HMO representatives (Minnesota, Texas, California, and Massachu hospital administrators and medical directors (Washington, including representatives from Idaho); HHAs (Washington); geriatric experts (Pennsylvania and Washington); rural health care (Washington and Texas); data base development and retirement benefits (Illinois); community and minority health concerns (New York and Georgia); ethical aspects of quality assurance (Virginia). In several instances, committee members and IOM staff met with experts in a particular area of quality assurance, health services research, nursing quality assurance, or geriatrics. Although all of the meetings concentrated on quality assurance for Medicare, each brought forward somewhat differ- ent views. Documentation After the site visits, each IOM staff member and some committee mem- bers prepared lengthy trip reports based on written and tape-recorded obser- vations. Materials gathered at the site visit or forwarded to the study com- mittee later were logged and filed. A study consultant cataloged this mate- rial for later reference and use (particularly for Chapter 6 of this volume). At the committee meetings following the site visits, time was allotted for

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94 MOLLA S. DONALDSON AND KATHLEEN N. LOHR TABLE 4.1 States and Cities Visited on Major (Multi-day, Mulii-city) Site Visits to Major Organizations, and Meetings with Participants from Several Organizations Illinois (October 12-14, 1988j: Chicago and flaperville Organizations Crescent Counties Foundation for Medical Care (PRO) (Napervilleja Edward Hospital (Naperville) Illinois Health Care Cost Containment Commission (Chicago) Joint Commission on Accreditation of Healthcare Organizations (Chicago) Michael Reese Health Plan (Chicago) Rush-St. Luke's Presbyterian Medical Center (Chicago) Meetings Experts in data base development and employee retiree benefits (Chicago) Metropolitan Chicago Hospital Council and member hospitals (Chicago) New York No. 1 (November 24, l9B89: New York City, Albany, and Troy Organizations Beth Israel Medical Center (New York City) Hospital Association of New York State (Albany) Health Insurance Plan (HIP) of Greater New York (New York City) Health and Hospital Corporation (New York City) New York State Department of Health (Albany) St. Mary's Hospital (Troy) Meetings New York Community Trust, Center for Policy on Aging (New York City) Practicing physicians in Albany area (Albany) New York No. 2. (November 2 - , 1988~: New York City, Rochester, and Buffalo Organizations Buffalo General Hospital (Buffalo) Columbia Presbyterian Medical Center (New York) Health Care Plan (Buffalo) Island Peer Review Organization (PRO) (Rego Park) Physician's Network (Rochester) Rochester Area Hospitals Corporation (RAHC) (Rochester) Sisters of Charity Hospital (Buffalo) Strong Memorial Hospital (Rochester) Visiting Nurse Service of Rochester (Rochester) Meetings New York Community Trust, Center for Policy on Aging (New York City) Rural-urban hospitals in Rochester area (Rochester)

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SITE VISES 95 Pennsylvania (November 30-December 2, 19881: Lemoyne, Harrisburg, Blue Bell, and Philadelphia Organizations Hospital Association of Pennsylvania (Harrisburg) KePRO (PRO) (Lemoyne) Pennsylvania Health Care Cost Containment Council, Data Commission (Harris burg) Thomas Jefferson University Hospital (Philadelphia) U.S. Healthcare (Blue Bell) Meetings American Board of Internal Medicine (Philadelphia) Experts in gerontology and functional assessment (Philadelphia) Hospital quality assurance representatives~uality assurance and use of Medis- Groups in teaching, community, and rural hospitals (Philadelphia) Joseph Gonnella, M.D., Dean and Vice President, Jefferson Medical College (Philadelphia) Minnesota and Iowa (December 13-15, 1988~: Minneapolis, St. Paul, Golden Val- ley, Excelsior, Minn.; Des Moines and West Des Moines, Iowa Organizations Becklund Home Health Care (Golden Valley) Blue Plus (St. Paul) Fairview Hospital System, Southdale Hospital (Minneapolis) Healthcare Education and Research Foundation (St. Paul) Honeywell (Minneapolis) Iowa Foundation for Medical Care (PRO) (West Des Moines) Iowa Methodist Medical Center (Des Moines) Minnesota Coalition on Health (St. Paul) Minnesota Hospital Association (Minneapolis) Quality Quest (the Medicare peer review organization for HMOs) (Excelsior) United Hospital (St. Paul) Meetings Health Policy Corporation of Iowa and Iowa Health Data Commission (Des Moines) Hennepin County Medical Society and Minnesota Medical Association (Mir~nea polis) Medicare risk-contract HMOs in Minneapolis (Minneapolis) TABLE 4.1 continues

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96 TABLE 4.1 Continued MOLLA S. DONALDSON AND KATHLEEN N. LOHR Washington (January 9-11, 19894: Seattle, Davenport, and Spokane Organizations Group Health Cooperative of Puget Sound (Seattle) Lincoln County Hospital (rural hospital) (Davenport) Peer Review Organization of Washington (PRO) (Seattle) Providence Medical Center (Seattle) Visiting Nurse Service (Seattle) School of Nursing, University of Washington (Seattle) Meetings Health Care Purchasers Association (Seattle) Home Care Association of Washington and representatives of several home health care agencies Medical directors and hospital administrators of hospitals in eastern Washington State and western Idaho (Spokane) Medical directors of major Seattle hospitals (Seattle) Physician staff of the Pike Market Community Clinic (Seattle) Representatives of Area Agency on Aging, home health care agencies, and local geriatric programs in Spokane and eastern Washington State (Spokane) James LoGerfo, M.D., University of Washington (Seattle) Texas (January 30-February 1, 1989~: Austin, San Antonio, Houston, and Pasedena Organizations Bexar County Health District (hospital and outpatient clinic) (San Antonio) Pasadena-Bay Shore Hospital (Pasadena) PruCare (Southwest Region headquarters) (Houston) St. Luke's Episcopal Hospital (Houston) Texas Medical Foundation (PRO) (Austin) Wilford Hall Air Force Medical Center (San Antonio) Meetings Practicing physicians from southwest Texas (San Antonio) Carmault B. Jackson, Jr., M.D., Medical Advisory Services (San Antonio) California (February 13-15, 1989~: Los Angeles, Santa Monica, and San Francisco Organizations California Medical Review, Inc. (PRO) headquarters (San Francisco) and re gional offices (Los Angeles) Kaiser Foundation Health Plans-Northern California Region (San Francisco) The RAND Corporation (Santa Monica) University of Southern California Medical Center (Los Angeles County) Value Health Sciences (Santa Monica)

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SITE VISITS 97 Meetings HMO Medical Directors and experts in HMO quality assurance and California Department of Corporations (Los Angeles) Hospital Council of Southern California and member hospitals (Santa Monica) Professional Risk Management Group, Institute for Medical Risk Studies (Los Angeles) Michael McCoy, M.D., University of California, Los Angeles (Los Angeles) Virginia and Georgia (March 13-15, 1989~: Annandale and Richmond, Va.; Atlanta and LaGrange, Ga. Organizations Instructional Visiting Nurse Association Home Health Care (Richmond) Medical Society of Virginia Review Association (PRO) (Richmond) Richmond Community Hospital (Richmond) Richmond Memorial Hospital (Richmond) West Georgia Medical Center (LaGrange) West Paces Ferry Hospital (Atlanta) Woodburn Internal Medicine Medical Associates (private office-based internal medicine practice) (Annarldale) Meetings Representatives of HCFA Regional Office and State Office of Regulatory Ser vices (Atlanta) Representatives of the Virginia Society of Internal Medicine (Richmond) Community, minority, and geriatric issues (Atlanta) Robert Centor, M.D., Medical College of Virginia (Richmond) Edward Hook, M.D., University of Virginia, Charlottesville (meeting in Richmond) NOTE: PRO is Peer Review Organization, HMO is Health Maintenance OrgaTu- zation, arid HCFA is Health Care Financing Adrninis~ation. aLocation of meeting shown in parentheses. committee members and staff to report on their observations at the site visits and to compare their findings. ISSUES Topics discussed during the site visits can be divided into two major classes: issues of concern to study committee members and staff or to site visitees (some of which were couched as "recommendations" or "messages" to the Health Care Financing Administration); and quality-of-care problems

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98 TABLE 4.2 Single City Site Visits MONA S. DONALDSON AND KATHLEEN N. LOHR Boiling Air Force Base (January 31, 1988) Col. Michael Torma, Surgeon General's Office Cleveland, Ohio (April 4, 1989) Meeting of multispecialty group practices (Lahey, Mayo, Oschner, and Cleveland Clinics) Washington, D.C. (April 17, 1989) Kaiser Permanente Foundation Health Plan (Mid Atlantic) Boston and Brookline, Massachusetts (April 25, 1989) Massachusetts Board of Registration in Medicine (Boston) Harvard Community Health Plan (Brookline) New England Medical Center (Staff of Institute for the Improvement of Medical Care and Health) (Boston) Madison, Wisconsin (May 19~1989) Wisconsin Peer Review Organization (PRO) identified by the quality assurance programs of those organizations and facilities that had such programs. These issues are briefly summarized here. Among the subjects raised fairly consistently across the site visits were the following: general health care issues including special health care needs of the elderly; benefits and reimbursement issues in the Medicare program; environmental issues such as shortages of nurses and other health care professionals and of community-based long-term-care beds; consumer education and participation in health care decisions; . setting-related topics of health care delivery and quality assessment and assurance that focused on particular difficulties or circumstances of ambulatory care settings, home health care, teaching hospitals, and small and rural hospitals; internal health care organization issues such as leadership, systems of health care delivery, and accountability for quality; quality assessment methods, including data issues, guidelines, and outcomes assessment; quality assurance methods, including concerns about duplication of efforts, the value of education and feedback of quality-of-care information, disclosure, dealing with very poor practitioners, legal issues in peer review, . . . and Improving average practice; the Medicare PRO program. Because of the salience of the PRO program to the core issues of this study, the site visits allotted considerable time to hear the views of PROs

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SITE VISITS 99 and of the health care institutions subject to PRO review. Among the more contentious topics were the overall focus of the PRO program, case-finding techniques (e.g., usefulness of generic screens), the need for flexibility in responding to local or special problems, the strengths and weaknesses of "peer review," problems with sanctions and other corrective actions and the need for more innovative interventions, the "paper burden" of providing medical records, and rules regarding review. Many site visitees noted both beneficial effects (which some believed is a "sentinel" effect for their own organization-based programs) and the perverse effects of PRO review on health care providers. These issues are also discussed in Chapter 8 of this volume. PROBLEMS OF QUALITY AND QUALITY ASSURANCE The organizations and facilities we visited identified many different types of problems. Some problems were classified as the most important problem for Medicare, some as the most important problem at the institution, and some simply as examples of problems found by the quality assurance pro- gram of the facility. Although some problems are narrowly clinical, the majority can and should be seen as problems of "systems,' rather than of individual providers. The emphasis on systems problems, rather than on problems attributed to individual practitioners, was an important finding from the site visits. Problems Reported by PROs and Other External Regulatory Bodies Generic Screens The first set of problems were those identified by the inpatient generic screens that PROs use in their retrospective review of hospital charts.2 PROs reported that the screens frequently flagged the following problems: abnormal results of diagnostic services that are not addressed and resolved or where the record does not explain why they are unresolved; care resulting in serious or life-threatening complications that were not related to admitting signs and symptoms, generally involving the neuro- logical, endocrine, cardiovascular, renal, and respiratory systems; medical instability at discharge; nosocomial infections (specifically, temperature elevation greater than 2 degrees more than 72 hours after admission and indications of infection following an invasive procedure); trauma suffered in the hospital (specifically, hospital-acquired decu- bitus ulcer). One PRO downplayed the value of generic screens in identifying quality

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100 MONA S. DONAl~SON AND KATHLEE;N N. LOHR problems. Instead it noted that the best yield of quality problems came from review of cost outliers, readmissions, some beneficiary complaints, and some calls and reports from physicians and fiscal intermediaries. Other Problems PROs also reported a broad range of more general problems. These included poor access to care and inappropriate or inadequate resources (tran- sitional, extended care, home care) in the community that led to use of acute care hospitals for convalescence. They also mentioned lack of knowl- edge and understanding of the Medicare program or of how to obtain care through an HMO as problems. Various PROs noted the following: lack of thorough diagnosis and ap- propriate follow-up;3 poor monitoring of patient status; premature discharge; poor technical knowledge of physicians; specialists who practice beyond their competence in performing some procedures; surgical specialists not calling in medicine consultants soon enough; nurses not calling in physi- cians appropriately (as a function of inexperience and work overload); lack of supervision of house staff (particularly in large public hospitals); and general problems of quality of care in rural areas. Among the specific clinical problems mentioned by PROs were appropri- ate use of pacemakers (a particular problem earlier in the PRO program) and improper respiratory therapy. Poor medical management of critical care patients included diagnosis, treatment, and monitoring of cardiopul- monary pathophysiology (often among rural physicians and nurses) and, especially, difficulties with fluid and electrolyte management, recognition of arrhythmias, and advanced cardiac life support. Among the diagnoses noted as posing particular patient management problems were diabetes and "infectious disease"; especially troublesome in the latter case was the use of cultures and sensitivities in identifying the infectious organism and pre- scribing appropriate antibiotics. Pharmacology, especially cardiacs and pulmonary drugs and antibiotics, poses its own significant problems. Prob- lems relating to surgery included appropriate use of procedures, surgery in geriatric patients, and post-procedure management. The New York State Department of Health (NYSDOH) has considerable experience with a form of generic screening and incident reporting. With respect to incident reports (relating mainly to generic screens) from all their hospitals (8,000 to 9,000 reports for all ages), one-third concerned patient falls resulting in fracture, and most of the rest involved administration of medications. The NYSDOH incident reporting system also highlighted two particular problems for the elderly; pneumothorax following placement of central lines, and adverse reactions to contrast media (including anaphylac- tic reactions).

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SITE VISITS 101 Problems Reported by Hospitals The comments from one hospital illustrate a widely held belief about the types of quality problems found in hospitals: "Eighty percent of problems are system problems, not medical diagnosis and management problems." These system problems include timely receipt of laboratory test reports, X- ray films and interpretations, and reports of consults; delayed or missing medical records as patients are transferred from site to site or even cared for within a site was also a significant issue. One hospital noted that their procedures for "intake and admissions" and for "communication and infor- mation transfer" all needed improving. One unusual issue was timeliness of autopsies. Hospital staff could not find the charts necessary to do the daily mortality review of the deceased patients because records were being held in the pathology department pending autopsy. Several hospitals raised poor documentation as a particular problem. Among the specific examples were lack of documentation of reasons for sinus surgery and lack of documentation of preoperative status. More gen- erally, poor documentation in medical records and information flow were mentioned by site visit participants. Other system-oriented clinical problems reported by hospitals were the following: infiltrates of intravenous lines; problems with central line cathe- ters; aspiration pneumonia; unplanned transfers to the intensive care unit (ICU); nosocomial infections and patient falls (both of which are PRO ge- neric screens); and lack of informed consent. Long waiting times to go from the emergency room to the ICU or hospital bed were cited at one facility. Diagnosis-specific problems included phlebitis in stroke patients and dementia-related problems (e.g., excessive use of medications, poor use of occupational therapy). Problems linked to surgery were complications of coronary artery bypass graft (which was traced to length of intubation), hematomas after cardiac catheterization, and post-anesthesia headaches. One institution mentioned that generic screens had helped them discover that a particular type of spinal anesthesia was resulting in slower patient recovery. Inappropriate use of drugs and medications always figures high in qual- ity problems. Cases in point included inappropriate use of coumadin, mis- use of antibiotics, and prolonged use of prophylactic antibiotics both before and after surgery. Falls related to medications were reported by at least one hospital. Blood transfusions and general overuse of blood products are other tradi- tional quality problems that were noted by more than one hospital. In some cases, the blood usage problem was confined to a single department (e.g., orthopedic surgery) rather than present across the facility.

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SITE VISITS 105 with the real world was considered imperative for a study that could easily have become quite academic. The locales and institutions visited represented a very broad set of view- points and expertise in health care delivery and in quality assurance. The documents and reports provided during and after the site visits demon- strated forcefully the breadth of quality problems that can be identified by good quality assessment and surveillance programs and the many different, often idiosyncratic, approaches that are taken to solve these problems. The variety of issues and problems mentioned in this chapter underscores this immense diversity, adding to the perception that inflexible and centrally directed quality assurance will not be-able to identify, let alone properly address, these deficiencies in quality of care. This chapter has not documented the different ways that our site visit participants dealt with the quality-of-care problems they identify or encoun- ter. These quality assurance methods, which are discussed more fully in Chapter 6 of this volume, are as diverse as the problems they are intended to overcome. It became quite clear that there is much ferment about, ex- perimentation with, and lingering hostility to quality assessment and assur- ance. Notwithstanding the latter, the interest in this study and the respon- siveness of those visited are hard to overstate. The contributions of the site visit participants to our understanding of the many difficulties and opportu- nities facing a quality assurance effort were very great indeed. NOTES 1. The six major categories of PRO generic screens are as follows: (1) adequacy of discharge planning; (2) medical stability of the patient at discharge for instance, signs such as blood pressure, temperature, pulse, or purulent drainage of postopera- tive wounds at the time of discharge that would indicate that the patient was not stable as well as abnormal results of diagnostic tests that were evidently not ad- dressed during the hospital stay; (3) certain unexpected deaths; (4) nosocomial (hospital-acquired) infections; (5) unscheduled return to surgery; and (6) trauma suffered in the hospital, for example, falls, certain life-threatening events, and hos- pital-acquired decubitus ulcer. See Chapter 8 for more details. 2. At the time of the site visits, very few PROs were involved in "intervening care" review of home health agencies or skilled nursing facilities. One that was reported that an important failed quality screen for skilled nursing home care was "signs and symptoms not reported to physician within four hours from the time detected." 3. One PRO offered the following example. A 92-year-old woman was admitted to the hospital in septic shock, but the facility was unable to find a responsible physician for almost 3 hours, as her usual physician was on vacation. She subse- quently died. The PRO took the case through to possible sanctioning. 4. One PRO, for instance, reported that a rural hospital stocked tissue plasmino- gen activator (tPA) but had no protocol available for its use. The PRO gave them one.

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106 Dear : i: MOLLA S. DONAIDSON AND KATHIEEN N. LOHR APPENDIX A CONFIRMATION LETTER REGARDING SITE VISIT INSTITUTE OF MEDICINE NATIONAL ACADEMY OF SCIENCES 2101 CONSTITUTEION AVENUE WASHINGTON. D.C. 20418 I am writing to follow-up our conversation about the Institute of Medi- cine Study to Design a Strategy for Quality Review and Assurance in Medi- care and to confirm the date and time of our visit to on Tuesday, January 31, 1989 at 3:00 - 5:30 p.m. Each site visit team includes Commit- tee and IOM staff members. I am enclosing a brief description of each member of the site visit team to The study is being conducted in response to a request from the United States Congress and will result in a report to Congress early in 1990; it is funded by the Health Care Financing Administration. I enclose a descrip- tion and an update of study activities for your further information. You will also find enclosed a brochure on the Institute of Medicine. The study is under the direction of an IOM committee of experts that is chaired by Steven A. Schroeder, MD, who is Chief of the Division of General Internal Medicine and a member of the Institute for Health Policy Studies at the University of California, San Francisco. A list of the other members of the Committee is included on the back of the blue descriptive sheet. One of the study activities is a series of ten site visits to a number of cities throughout the country; included in the site visits will be provider institutions and associations? PROs, public sector agencies, and the like. The purpose of the visits is to provide Committee and staff members with a more thorough first-hand understanding in the following areas: (a) the varieties of approaches that exist today for measuring and assur- ng the quality of health care to the elderly; (b) the barriers experienced by health care facilities in developing effec- tive quality assurance (QA) programs, and the solutions they may have devised to overcome those obstacles; (c) the experience of groups responsible for QA activities (e.g., regula- tory agencies, Medicare PRO s) and of providers and practitioners who are the targets of such activities (e.g., hospitals, health maintenance organiza- tions, ambulatory care centers, home health agencies, private practice phy

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SITE VISITS 107 sicians) in terms of (1) the effectiveness of these QA or regulatory pro- grams and (2) the direct and indirect monetary or other costs of such pro- grams; (d) promising initiatives related to quality assurance that are planned or under way (whether or not they are specifically related to the Medicare program); and finally, (e) the nature and extent of possible problems in the quality of health care delivered to the elderly today. In short, the intention expressed by the Committee in undertaking these site visits is to gain a "real-world" understanding of what challenges exist in the quality-of-care area, what is being done to meet those challenges, and how well they are being met beyond what can be learned from published reports. The Committee is also especially interested in hearing your recom- mendations for increasing the effectiveness of quality assurance strategies for the Medicare program and for health care delivery more broadly. To achieve our goals for these site visits means that we need to have a frank and open exchange between your group and our site visit team; we need also to hear from people in your organization who have "front line experience" in the quality assurance area. The purpose of the site visits is educational, not evaluative, and the final report will not identify informa- tion by individual sites. Please be assured that all information shared will be treated with strict confidentiality. We believe that it would be helpful to us if the site visitors could meet with a group of no more than 6-8 individuals, including, for instance, a Member of the Board of Trustees or Directors, the Medical Director, the Chairman of the QA Committee, the QA Coordinator, and perhaps the di- rector of your Medical Records or Data Processing Department; it might also be very informative for us to meet with some clinicians on your staff (physicians, nurses, discharge planners and the like) who may have a spe- cial perspective on quality review and assurance activities within the insti- tution. We would be particularly interested in learning more about your risk management program and how it may function to improve quality of care. In discussing their objectives for the site visit Committee members have expressed their strong preference for the site visit to include the following components; 1. A brief introduction to the IOM study by one of the Committee members. 2. A relatively brief (20 - 30 minutes) overview of your quality assurance program (in this regard, we would be pleased to receive ahead of time any background materials).

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108 MONA S. DONALDSON AND KATHLEEN N. LOHR 3. An open discussion of the functioning of your quality assurance pro- gram, that will enable us to understand: How you know when you might have a clinical quality problem, . How you analyze the causers) of a problem and determine if it is an occasional error or ~ pattern, What kinds of interventions you use to resolve the problem, How you know whether what you are doing has an impact, . The burdens and costs of the program, The overall impact of the program in the organization, and Your views about what would enable the internal quality assessment/ quality assurance process to be more effective. 4. A discussion of the external (state and federal) environment. The overall impact of external programs in terms of both intended and unintended effects, and The burdens and costs of responding to external review and regulatory requirements, and your views about how the process could be made more effective. 5. A discussion among those present concerning your thoughts as to the crucial elements of a successful quality review and assurance system that might be applicable to the Medicare program and special quality of care issues related to the elderly. We hope the discussion will include: The nature and extent of current and emerging problems in the quality of health care delivered to the elderly today, . Whether any problems you identify tend to be concentrated in a rela- tively small fraction of providers, practitioners, or special groups of elderly or are more diffusely spread among the provider commu- nity or elderly population, Whether quality problems you see are primarily those of overuse, underuse, or misuse of services, Promising quality assurance initiatives. 6. During the remaining time the Committee may want to divide into two groups to meet with no more than 1-3 people in each group who are very familiar with the operations of the quality assurance program and could discuss the QA program from a"front-lines" perspective. Perhaps you could help identify for us (at the time of the visit) those individuals you think would be most appropriate for the two groups to meet with.

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SITE VISITS 109 Again, we would very much appreciate receiving ahead of time any avail- able background materials describing your organization and QA program so that we may be better prepared for the visit. It would be particularly useful if you could provide us at the time of the visit with an estimate of the annual cost of your QA activities (direct costs for personnel, data process- ing, etc., for both internal review and in response to external requests). Also, might we have copies of any quality indicators, screens, guidelines, and clinical protocols that are currently in use? These would be of great interest to the Committee and staff for use as background materials in pre- paring the final report. No materials will be quoted or duplicated outside the Committee. On behalf of the Study Committee and the Institute of Medicine, I would like to thank you for sharing your time and allowing us to visit. We are certainly looking forward to our visit. I or someone from our staff will call your office before the visit for any specific location directions. If you should have any questions I can be reached at 202/334-2165. Sincerely, Molla S. Donaldson, M.S. Associate Study Director Enclosures: Study description IOM Brochure Description of site visitors APPENDIX B GUIDE FOR SITE VISITORS STRATEGIES FOR QUALITY REVIEW AND ASSURANCE IN MEDICARE PLANNING Site visitors should meet for at least a half hour every morning to plan strategy. DEBRIEFING The site visit team should try to meet for an hour at the end of each day and definitely before the departure of team members for a general debriefing. Consider taping these debriefings. Try to cover at least the following

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110 Af Ol LA S. DONALDSON AND KATlILEEN N. LOHR major points: problem identification and verification, interventions, restudy, costs and burdens, and three important three quality problems identified by sites with an internal QA program and members' general observations. TEAM CAPTAIN RESPONSIBILITIES The Team Captain (assigned in rotation) should plan to introduce the study, its purposes, and the team members. Suggested points to cover: 1. Introduction What the IOM is (part of NAS - independent, nonfederal, private, non- profit, research) Who commissioned the study (US Congress) Composition of Committee (about 1/2 physicians, health experts, chosen for their own expertise not special interests) Due date (Jan. 1990) Assumptions or lack thereof (not starting with assumption about HCFA, PROs, etc.) Medicare (not Medicaid) study Educational purpose Focus is truly on quality not cost containment Settings hospitals, free-standing clinics, MD offices, and HMOs, HHAs Other activities of study public hearings, written testimony, focus groups, commissioned pa- pers' site Visits Confidentiality of quality information Invite them to speak not only for organization, also as individuals Desire for materials now or later - follow-up Introduction of those present How you would like visit to be organized (large/small groups) 2. Keep questioning on track. 3. Keep track of time for splitting into smaller groups and for departure. RECOMMENDATIONS TO ALL SITE VISITORS: Seek specific examples, and ask if we can follow-up, be provided with materials, etc. GENERAL {OPICS OF INTEREST Mandate from Congress: A. Definitions of quality of care; B. The role of structure, process and outcome;

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SITE VISITS 111 C. Prototype criteria and standards; D. Adequacy and focus of current methods for assessment and assurance; E. Evaluate current research on methodologies, needed research; F. Adequacy and range of methods for assurance; G. Review mechanisms for promoting, coordinating supervising at the national level; H. Criteria for establishing priorities in allocation of funds and personnel also: Conditions of participation (hospitals) Topics of interest: Definition of "quality of health care" Level of quality of care now provided to the elderly? - differ by the type of care, setting of care, or other factors? - differ for different groups within the elderly population? Maior existing or emerging problems? the mailer stren~th.~? i,,, _ ~ Is quality of health care adequately monitored or assessed today? (too ex- tensive, adequate, or too little) Responsible agencies, institutions, associations, or individuals? Coordination - among local, state, and federal agencies? - among private accrediting and review organizations? and - between the public and private sectors? What kinds of activities are the most effective and what are the least effec- tive in improving quality of health care? Research - conducting - priorities for needed research Medicare benefits and access Effect of gaps in Medicare coverage (benefits) on quality Effect of Medicare reimbursement on quality Special characteristics of the Medicare population - effect on quality Access barriers that exist - that they have overcome

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112 AlOLLA 5. DONAlDSOlI AND KATHLEEN N. LOHR HEALTH CARE FACILITIES WITH INTERNAL OUALITY ASSURANCE PROGRAMS: The following is the pool of questions suggested by the Committee. ** (asterisks) mark those questions emphasized at the Committee meeting. ASSESSMENT Problem Identification ** How do you identify a potential problem? ** What kinds of problems can your QA system identify, and what kinds can it not identify? For instance; overuse, underuse, a single practitioner or service with a pattern of poor care, bad outcomes, misdiagnosis, missed diagnosis, rates of occurrences, case finding, fragmentation in care by set- ting, service, or dept. What data do you use to monitor quality? How do you adjust for confoun- ders such as severity? How do you assure the quality of the data itself? What data (if any) do you collect that is unique for the Medicare patients? Are there data elements you collect beyond what is required for HCFA? Does your data system allow you to respond to current HCFA requests for data? For HMOs: Can you provide, for instance, no-pay bills? Problem Verification ** How do you verify a problem found in retrospective review as a real quality problem? Do you use peer groups, expert opinion, other methods? How do you select a given problem (among a number) for review set priorities among"competing" problems? ** To what extent do you focus on the occasional error as compared to a pattern of bad care? ** What is the yield of real quality problems compared to potential prob- lems that fail "screens" or other methods of first level problem identifica- tion? ** What are three important quality problems you have found recently? (frequency, potential harm to patient) If answer does not include clinical problems, guide questioning to this. ** Are problems concentrated in a relatively small fraction of practitioners or are they more diffuse? ** Are the quality problems, in general, related to overuse, underuse or misuse of services?

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SITE VISITS INTERVENTIONS/AS SURANCE 113 What do you do if a practitioner or facility is identified as providing sub- standard care? - education, feedback, privileging, jawboning by Chairman - anything different if identified internally or externally? How useful and effective are these interventions? lIow many (and what kind of) different methods for assurance have you tried? What changes have occurred in response to the Patrick case - has peer review been "chilled?" What are the disincentives? Have doctors backed off from making hard decisions? IMPACT OF INTERVENTIONS/ RESTUDY ** How do you know that your interventions have had an impact? - What has been changed as a result of this process? ** Please take one quality problem you have identified in the last year and walk us through the steps in identifying it, verifying it, identifying and implementing changes, and reevaluating the problem or impact? Press for . . SpeC1 1C answers. - Who has been told about the information - Board of Trustees, medical staff, nursing, etc.? - What methods of information sharing are used? ** What would improve the effectiveness of your efforts? - for instance, better measurement tools? expanded financing? greater support from management, providers, or patients? greater integration of quality assurance into the organization's other activities? or other factors? COSTS AND BURDENS (for internal and external review) ** What is the effect of your internal QA program on the institution, medi- cal staff? What is the effect of the external QA review on the institution, medical staff? How much burden does the quality assessment system place on providers? Have you identified ways to reduce the burden? Have you identified ways to reduce the burden but haven't been able to implement them because of regulatory restrictions? For HMOs: What has been your experience with PRO (or QRO) review of care (e.g., the "13 conditions?") and with hospitals and PROs for review of acute hospital care?

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114 MOLLA S. DONALDSON AND KATHLEEN N. LOHR How much of your time is spent on quality assessment in comparison to utilization review? Has this changed recently? What is your opinion of the distribution? What do you estimate is the cost of your assessment and assurance aciivi- ties for instance, dollars spent per case reviewed, or percentage of your total annual budget spent on quality-related activities? What is the local environment for health care quality issues? For instance, does the press or a business coalition affect your internal activities? How does your QA system affect other actors within the health care system (em, physicians)? As a subject of external quality assessment and assurance activities (PRO review, licensure, accreditation, etc.) What kinds of problems and benefits do you experience with those efforts? forts? What do you believe would improve the effectiveness of those ef How many (and what kind of) different methods for quality assessment have you tried? How do they compare for yield, cost, validity, and ability to identify true quality problems? ADVOCACY/ SHARED DECISION MAKING Is there a well-defined role for `'patient advocates', in your organization? If so, what are their responsibilities? To whom do they report? What are institutional/organizational objectives of the patient advocacy process? What methods do you use for grievance resolution? What are the established mechanisms for promoting and targeting provider education - both clinical education and education about the review process? What are the established mechanisms for promoting, targeting, and monitor- ing the effectiveness of patient education and participation in decision mak- ing? Is outcome information routinely collected following major medical or sur- gical procedures or following diagnostic studies? If so, what kinds of outcomes are ascertained? At what point in time? - Is patient satisfaction specifically addressed? Is this information regularly made available to providers? To patients? Describe any requirements and review mechanisms regarding informed consent.

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SITE VISITS 115 How does the organization influence providers' decisions about indications for procedures, special care, or hospital admission and length of stay? How do you (your institution) make decisions about patient care when a particular service Is scarce (e.g., ICU beds)? Are there any mechanisms designed specifically to blunt volume-driven, fee-for-service incentives, or capitaiion-based disincentives, to perform procedures or render care? Are decisions to perform or forego major therapeutic interventions reviewed? If so, how are procedures and specific cases selected for such review?