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6 A Quality Assurance Sampler: Methods, Data, and Resources MolIa S. Donaldson and Kathleen N. Lohr INTRODUCTION Purpose of Chapter Two of the charges to the Institute of Medicine (IO M) study committee in the Omnibus Budget Reconciliation Act of 1986 were to `'evaluate the adequacy and focus of the current methods for measuring, reviewing, and assuring quality of care" (Sec. 9313 [Gl) and to "evaluate the adequacy and range of methods available to correct or prevent identified problems with quality of care (Sec. 9313 EF]~. Because no comprehensive evaluations of quality assurance have been published, responding literally to these charges would have required a series of new empirical investigations that were well beyond the scope of the study. The committee concluded that it could best address its charges by an overview of strengths and limitations of methods of quality assessment and assurance, as provided in Volume I, Chapter 9 of this report, and by a description of the rich mix of methods in use in hospitals, ambulatory care groups, and home health care, as given here. This chapter describes a wide variety of techniques of quality assess- ment, drawing on information from several different study sources. It docu- ments the many approaches to quality measurement (and sometimes quality assurance) being pursued by practitioners, facilities, government and pri- vate sector agencies, and other interested parties. It provides a large num- ber of exhibits and citations to the pertinent literature. 140

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A QU~ASSU~CE S~PLER Site Visits 141 Sources of Information We conducted nine major site visits to all regions of the country from September 1988 to April 1989. During them, we visited a range of institu- tions: public, teaching, community, and rural hospitals; staff and group model health maintenance organizations (HMOs); large multi-specialty clin- ics; free-standing and hospital-based home health agencies; small group practices; Medicare Peer Review Organizations (PROs); state boards of medical examiners; hospital associations; and accrediting groups. We did not limit our inquiry to methods of quality review used by the Medicare program or by regulatory or external bodies. Rather, the site visits were an attempt to learn about the range of activities in use inside and outside institutions. It was evident from these site visits that organizations try, modify, and combine numerous approaches to quality assessment and assurance. This apparently happens because no single, dominant theory of quality assess- ment techniques exists and because information about the relative effective- ness of various techniques to identify serious quality problems is scarce or nonexistent. Some organizations we visited were struggling to implement recent changes imposed by external groups; some had put in place innova- tive programs that went beyond minimal external requirements. All were very generous with their time and experience. At most health care facilities we were given materials describing plans for and the current approaches used in quality review. Some facilities provided examples of their criteria and data collection forms. A few described examples of the types of prob- lems they found and the corrective actions they had taken. In planning the site visits the IOM staff made a special attempt to identify facilities that would include a range of efforts and levels of commitment. Other Sources The "sampler" derived from the site visits is supplemented by examples of methods described in research studies; of reports of model programs in journals such as Quality Review Bulletin; and of approaches described in legislation, manuals of accreditation, and guidebooks published by health care associations. Some techniques of quality assessment and assurance, such as credentials review, have become time-honored; some approaches, such as the use of tracer conditions, have been more theoretical than widely implemented; and some, such as generic outcome screening, have been developed so recently that the technology is still rapidly changing and diffi- cult to assess.

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142 MortA S. DONALDSON AND KATHLEEN N. LOHR We know very little about the frequency with which various methods are used. Data provided to this study from a survey by 13 multi-hospital sys- tems provide an estimate of the allocation of quality review resources in 58 hospitals located in 21 states. Our site visits indicated that resources de- voted to quality assessment vary greatly from a small hospital with one staff member responsible for coordination of quality assurance, utilization review, risk management, discharge planning, and infection control to ma- jor urban hospitals with numerous staff and considerable computer support devoted to these functions. We also relied on several papers commissioned for this study, which include the following: Hawes and Kane (1989), for issues in quality assur- ance in home health care; Reerink (1989), for international experience in quality assurance; Roos et al. (1990), for an examination of the use of administrative databases to detect quality problems; and Smith and Mehlman (1989), for a review of legal issues and regulatory mechanisms related to quality assurance. Published reports of research studies that validate methods of assessment do not encompass the range of programs and approaches that are under way in organizations such as hospitals, HMOs, and home health agencies. Occa- sional reports of model programs by institutions only rarely include data on the frequency or type of problems found, the sensitivity and specificity of the methods of assessment, or most importantly, their effect on quality. The more usual publication describes how quality assessment should be conducted, but not necessarily how it is conducted. We know even less about the value of various methods of correcting problems. Organization of Chapter Quality assessment and assurance activities are not guided by any cur- rently recognized topology (Donabedian, 1988~. To provide some structure to this very complex topic, therefore, we have organized the sampler ac- cording to three levels: setting of care, purpose of the activity, and focus of the activity. The outline and order that this chapter will follow is shown in Table 6.1. Setting of Care First, the setting of care acute hospital, office-based ambulatory, and home health reflects the three settings of care that the committee empha- sized during this study. Some methods apply to more than one setting; for instance, accreditation applies to hospitals, ambulatory care facilities, and home health care agencies. Similarly, physician licensure and board certifi- cation apply to physicians as hospital attending staff and as office-based practitioners. Some methods could be applied in several settings but are

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A QUALITY ASSURANCE SAMPLER 143 TABLE 6.1 Organization of Volume II, Chapter 6 Hospital Setting Preventing Problems External Methods Internal Methods Detecting Problems External Methods - Internal Methods Correcting Problems -External Methods Internal Methods Ambulatory Office-Based Setting Preventing Problems External Methodsa Internal Methods Detecting Problems -External Methods Internal Methods Correcting Problems -External Methods Internal Methods Home Health Care Setting Preventing Problems - External Methods Internal Methods Detecting Problems External Methods Internal Methods Correcting Problems -External Methods Internal Methods aIndividuals (physicians), institu- tions, and prepaid or managed health care plans. more commonly used in one setting; for example, patient care algorithms are most developed in ambulatory care settings. For brevity we discuss these methods in detail only once. Purpose of Quality Activity Second, we categorize quality assurance activities according to their pur- pose namely, to prevent, detect, or correct problems in quality. "Prevent

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144 MOL1JA S. DONAlDSON AND KATHLEEN N. LOHR ing" problems corresponds to those structures that are intended to ensure that care is provided as intended. Methods may be directed at individuals, subsystems within the health care organizations, or the entire organization. For external bodies these approaches consist primarily of licensure of both practitioners and organizations, physician specialty certification, and organ- izational accreditation by private accrediting groups. For health care or- ganizations, methods include credentialing systems, policies, and patient care systems to structure or guide patient management at both administra- tive and clinical levels. "Detecting" problems is the quality assessment or monitoring function. This includes systematic attempts to monitor the process of care and mecha- nisms to capture adverse events such as complications. There are three broad categories of assessment methods: case finding, provider profiling that identifies "outlier" patterns of practice, and population-based methods that compare information on preventive care, health status, and outcomes of care for those who use services and those who do not (Steinwachs et al., 1989~. Of the three methods, case finding is, by far, the most commonly reported. Case-finding methods use criteria to identify patients who may have received inadequate care. Examples include generic screening, clini- cal indicators, and surgical and mortality review. "Correcting" problems refers to the assurance function targeted and specific action taken in response to a recognized problem. Correcting prob- lems that have been identified through quality review implies that the prob- lem is of a known magnitude and that identification was based on measure- ment using explicit standards, professional judgment, or a verified patient complaint. Correcting problems is also that portion of the quality assurance cycle most often left dangling left to intuitive approaches or common wisdom after careful and extensive efforts of problem detection have been made. Two classes of corrective action can be distinguished: corrective action addressed to an individual, based on an individual event or pattern of events. and corrective action addressed to a group or system within an institution. Both may be externally or internally imposed. Corrective actions include feedback of information to the practitioner, educational efforts, incentives, and penalties. Distinctions among the activities (i.e., preventing, detecting, and correct- ing) are, in practice, not always clear because activities may have joint purposes and effects. "Correcting" a problem is related to "preventing" further problems (in the sense of secondary prevention), but it is differenti- ated in practice because it has a specific focus a setting, a clinical behav- ior, and sometimes specific individuals as targets. Similarly, malpractice action might have the effect of preventing problems (e.g., practitioners tak- ing extra care to document their actions or to inform patients), detecting

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A QuALrryAssuRANcE SAMPLER 145 problems (when a claim is filed), or correcting problems (e.g., resulting in withdrawal of hospital privileges). Locus of Activity Third, we emphasized in Chapter 2 of Volume I that our overall quality assurance model should distinguish external and internal programs, even though these distinctions are not always clear cut. Many internal activities occur in response to external pressures. For example, the requirements of the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) and some external activities may depend on activities that are internal, such as reporting incidents to a state department of heals. Comment We emphasize that the examples in this chapter are illustrative only; we do not intend to imply that they are exemplary or that, in practice, they perform as described. The reader is referred to Volume I, Chapter 9, for a discussion of the apparent strengths and limitations of many of the ap- proaches enumerated in this chapter. Formal evaluations of the effective- ness of various methods are almost nonexistent; this fact must temper any conclusions and recommendations about specific approaches. HOSPITAL External Methods of Preventing Problems in Hospitals Medicare Conditions of Participation Hospitals are eligible to receive reimbursement from Medicare by meet- ing a set of Conditions of Participation. Under Section 1865 of the Social Security Act, hospitals that are accredited by the Joint Commission or the American Osteopathic Association are "deemed" to have met all the regula- tory requirements specified in the Act, except for a rule concerning utiliza- tion, the psychiatric hospital special conditions, and the special require- ments for hospital providers of long term care. Hospitals that are not so accredited for whatever reason can seek to meet the conditions by electing to undergo a state certification process. Most hospitals that participate in Medicare do so by meeting the require- ments of the Joint Commission. Approximately 77 percent of the 7,000 participating hospitals have received such accreditation; of this accredited group, only 13 percent have 50 or fewer beds. The remaining 1,600 unac- credited (but certified) hospitals are, for the most part, small rural institu

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146 MOLLA S. DONALDSON AND KATHLEEN N. LOHR lions; about 70 percent of the unaccredited hospitals have 50 or fewer beds. Conditions of Participation and the certification process for hospitals are addressed in greater detail in Volume I, Chapter 5, and Volume II, Chap- ter 7. The Joint Commission The Joint Commission is undoubtedly the most important external influ- ence on hospitals that seek its accreditation. Briefly, the Joint Commission's Accreditation Manual (Joint Commission, 1989b) is designed for use in hospital self-assessment and is the basis for the hospital survey, which for hospitals in "substantial compliance" occurs every 3 years. The surveys are scheduled at least 4 weeks in advance and are conducted by a physician, a nurse, and an administrative surveyor over a 3-day period using explicit scoring guidelines. After a concluding educational exit interview, hospitals may receive full accreditation or may be notified that accreditation is con- tingent on its carrying out a plan of correction. A hospital with contingen- cies may submit written evidence or may undergo a return site visit. It may then be fully accredited or, in due course, nonaccredited. In 1978 the loins Commission's Board of Commissioners decided to replace their prescriptive, structure-oriented standards with a standard re- quiring ongoing, hospital-wide monitoring of care. Nevertheless, structural standards designed to prevent problems and to ensure the capacity of the hospital to operate safely are still in effect. The Accreditation Manual (Joint Commission, l989b) is organized around sets of`'standards" defining requirements related to 24 hospital service areas, including the governing board, medical staff and nursing services, quality assurance, hospital de- partments, special care units (e.g., intensive care unit, burn unit), and hospi- tal-sponsored ambulatory care services. Medical Staff Standards, for in- stance, emphasize clear definition and assumption of responsibility by the medical staff and review of physician credentials. Governing Board Stan- dards specify the responsibilities of the governing board and the required content of hospital bylaws (two examples are shown in Exhibit 6.H1~. Other Accreditation Programs Hospitals may also participate in other voluntary accreditation and certi- ficaiion programs. Among these are the College of American Pathologists certification of hospital laboratories. According to information provided during site visits, military hospitals are surveyed by two external groups. In addition to a Joint Commission survey, for instance, Air Force hospitals have a 2-week survey process involving some 50 surveyors from the Office of the Air Force Inspector

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A QUALITY ASSURANCE SAMPLER EXHIBIT 6.H1 Example of Two Governing Board Standards 147 GB.1.14. The governing body requires that only a member of the medical staff with admitting pnvileges may admit a patient to Me hospital and that such individu- als may practice only within the scope of the privileges granted by the governing body, and that each patient's general medical condition is the responsibility of a qualified physician member of We medical staff. GB.1.15. The governing body requires a process or processes designed to assure that all individuals who provide patient care services, but who are not subject to the medical staff privilege delineation process, are competent to provide such services. SOURCE: Joint Commission, 1989b. General. Regional military hospitals review smaller local hospitals of 25 beds or less. Care in military hospitals is also reviewed by an external civilian peer review group (Meyer et al., 1988~. State Licensing and Safety Requirements Hospitals must comply with often extensive state legislation that regu- lates their structure and operations. These regulations pertain, for instance, to compliance with Life Safety Codes, explicit medical staff standards (Couch, 1989), and, more recently, risk management programs. For example, 10 states have enacted legislation or promulgated regulations requiring hospi- tals to implement risk management programs (GAO, 1989~. In some states, a state survey of hospitals is conducted along with the Joint Commission. In other states the survey occurs on a separate cycle. Other Hospital-Related Requirements Various other external efforts have been legislated to protect the rights of hospitalized patients. First, hospitals are required to provide Medicare bene- ficiaries, at the time of their admission, with a notice regarding their right to appeal a discharge decision, presumably in an effort to forestall prema- ture discharges. (See Volume I, Chapter 6, and Volume II, Chapter 8, on the Medicare PROs for more detail, as the PROs are required to monitor hospital performance in this regarde) Admitting physicians on the site visits repeatedly told us that their patients are unable to understand the notice. Second, Congress enacted what is commonly called`'anti-dumping" leg- islation by amending the Medicare statute in the Consolidated Omnibus Budget Reconciliation Act of 1985 (amending Social Security Act Section 1867, 42 U.S.~. Section 1395dd).: Under this legislation, hospitals with

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148 MOllA S. DONAl~SON AND KATHl~E;NN. LOHR emergency departments are required to conduct a medical screening for any individual who comes to the hospital emergency room and requests exami- nation or treatment for a medical condition (or has had such requested on his or her behalf). The hospital must provide for an appropriate medical screening examination to determine whether an emergency medical condi- tion exists or to determine if a woman is in active labor. The hospital must provide for whatever further examination and treatment by the staff and other facilities of the hospital may be required to stabilize the medical condition or to treat the active labor, or it must provide for transfer of the individual to another medical facility in accordance with restrictions on transfer until the patient is stabilized. As a third example, the Board of Registration in Massachusetts has been designated by the state as a centralized repository of quality-of-care infor- mation. Included in its functions (Code of Massachusetts Regulations, 243 CMR 3.01 to 3.16) is patient care assessment (PC A). A PCA unit requires each hospital semiannually to submit acceptable plans for patient care as- sessment; this requirement is in addition to hospital licensure, which is handled by a different agency. The PCA unit requires, for instance, that there be a PCA committee and coordinator, that an internal incident report- ing system include procedures for "focused occurrence reporting," that major incidents be reported to the Board of Registration, and that policies and practices concerning patient complaints, informed consent, and patients rights be established. Malpractice Insurance Underwriters Hospitals insured by some insurance underwriters receive discounts for compliance with risk management standards established by the company. For instance, Virginia hospitals may receive a"basic risk management dis- count" on their premium from the The Virginia Insurance Reciprocal. This requires compliance with quality assurance and risk management functions, biomedical equipment, emergency power, medical and allied staff insur- ance, and competence-based appointment and privilege procedures. The hospitals are also eligible for three special discounts concerning anesthesia and surgical services, emergency services (relating to physician staffing and nursing policies and procedures), and obstetrical services (again relating to physician staffing and credentials, nursing staffing and credentials, facili- ties and equipment, and written policies about certain procedures). . International Efforts Reerink (1989) compared quality assurance systems, in particular exter- nal efforts such as those implemented for the Medicare program in the

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A QU4~ASSU~CES~PLER 149 United States, with similar activities in other countries on the basis of materials provided by expert contacts in 20 countries in Europe, the Middle East, the Far East, Scandinavia, and North America. He found that descrip- tions of national quality assurance systems were generally meager and re- flective of a near absence of well-developed national systems of assessment and assurance. Publications describe individual efforts by private institu- tions or practitioners. Some countries have implemented versions of hospi- tal accreditation adapted from the Joint Commission approach (e.g., Ku- wait, Saudi Arabia). The Netherlands has embarked on a systematic exami- nation of the quality of health care through resource centers such as CBO (The National Organization for Quality Assurance in Hospitals), SDH (The Foundation for Skills Improvement in General Practice), and NZI (The Na- tional Hospital Institute) for nursing homes and mental health institutions. These are supported financially by providers and insurance companies and are encouraged, but not mandated, by the Dutch government (which is tradi- tionally an outsider in health care matters). Internal Methods of Preventing Problems in Hospitals Medical Staff Standards The Joint Commission's Medical Staff Standards (Joint Commission, 1989b) include bylaw requirements designed to prevent or minimize un- wanted events. They also call for departmental evaluation of the clinical performance of each individual holding clinical privileges. Relevant find- ings from quality assurance activities are to be considered when the hospital reappoints medical staff or renews and delineates clinical privileges and may be used for feedback to the physicians. Typically conducted or coordi- nated by the medical staff office, activities in this area can involve tracking credentials, including licensure, training, and experience; tracking compe- tence, including malpractice claim history, challenges to or relinquishment of licensure or registration; and monitoring physician performance, includ- ing such measures as numbers of procedures performed, average patient length of stay, complication rates, and findings of quality assessment com- mittees concerned with blood and drug usage. The director of one clinic believed that the departmental evaluation of clinical performance is an es- pecially fertile area for quality improvement. In addition to specifying credentialing and reappointment requirements, some sections of the Accreditation Manual state that certain policies and procedures are required (e.g., policies for decontamination of personnel, equipment, and instruments). Other parts of the manual specify the requi- site structural characteristics themselves. For instance, in the cardiac inten

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150 MOLLA S. DONALDSON AND KATHLEEN N. LOHR sive care unit each bed must be equipped with monitoring equipment. In another standard, a defibrillator and resuscitative equipment must be avail- able at the bedside when certain procedures are conducted. Common Internal Organization Actions Hospitals have incorporated numerous administrative and clinical sys- tems to prevent problems. Examples of these include the following: staffing ratios, such as numbers of nurses per staffed beds; opportunities for continuing medical education and "inservice" educa- tional programs for staff; . limiting services offered to patients to those services for which staff- ing and volume are adequate (such as closing a wing or a special care unit, or not performing some procedures); . safety precautions for patients at risk for medical complications such as falls or aspiration pneumonia (Exhibit 6.H2~; safety precautions for the maintenance and operation of equipment and backup systems in case of equipment failure; and design of backup systems such as patient identification wrist bands, medication allergy flags on medical records, unit doses of medication, and policies requiring written (not oral) drug orders. Risk Management Risk management is more than controlling financial losses from a mal- practice claim.2 Risk management techniques are designed to prevent unde- sirable occurrences, where possible, and reduce the severity of those that occur. They are prospective interventions and thus should be seen as a system to prevent problems as well as interventions employed once an ad- verse event has occurred. From this point of view, risk management en- compasses the activities of a broad range of personnel throughout the hospi- tal. These may include the finance officer, security officer, legal counsel, personnel officer, biomechanical engineer, nursing director, chiefs of de- partments, medical director, quality assurance director, and' of course, the risk manager, whose responsibilities have usually been cast as pertaining principally to malpractice loss control. In recognition of the mutual goals of quality assurance and the patient care component of risk management, a new Joint Commission standard requires an operational link between quality assurance functions and those risk management functions related to patient care safety and quality assur- ance. Although the goals of risk management and quality assurance are not entirely coincident, their integration is intended to maximize the use of

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282 MOll"A S. DONAIDSON AND KATHIlENN. LOHR TABLE A.5 Average Number of Hospital Departments and Services, Medical Staff Departments, and Medical Staff Committees, by Hospital Size Hospital Size (No. of Beds) Orgaruzaiional Components 250 Hospital departments and services 17 49 51 Medical staff departments 5 9 12 Number of medical staff committees 9 20 18 TABLE A.6 Types of Quality Assurance Programs in Hospitals, by Hospital Size Hospital Size (No. of Beds) Type of Program 250 All Hospitals QM/UMa ] 7 10 18 Combined QM/UM/RMa 4 9 4 17 Combination with medical staff office 3 3 3 9 Separate QM 1 2 4 7 Formation systems 1 2 2 5 QM/RM O O 1 1 Combination with focus on nursing Total 1 0 0 l 11 23 24 58 meet. aQM is quality management, UM is utilization management, RM is risk manage Sta~ time spent on quality management functions. Tables A.7 to A.11 show the amounts of time in hours per quarter estimated by respondents to be spent on various functions. The tables are divided by type of program and hospital size; for instance, hospitals with 100 to 250 beds and combined quality and utilization management programs. The hours, however, refer only to quality management functions. Despite this attempt at homogene- ous grouping, there are enormous ranges reported in the amount of time spent for many functions. For instance, Table A.10 shows that for com- bined quality, utilization, and risk management programs, the time spent on concurrent record review ranges from 72 to 1,040 hours per quarter in midsize hospitals.

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284 MOllA S. DONAIDSON AlID KATHILEENN. LOHR TABLE A.8 Hours Per Quarter (Hrs/Q) for Quality Management Func- tions in Quality/Risk Management Departments, by Hospital Size (Number of Beds) 250 Beds Activity Mean Mean N (Hrs/Q) N(HrslQ) Range Hospitalwide functions Indicator development 1 lSO 15 Committee time 1 750 223 21- 25 Concurrent record review Retrospective record review 1 54 1256 Adverse patient occurrence 1 21 292 64-120 Data collection/analysis 1 90 19 Medical staff Indicator development 15 Committee time 1 420 2372 9-735 Concurrent record review Retrospective record review 11,500 Adverse patient occurrence 278 27-130 Data collection/analysis 2170 144-195 Reappointment/privileging 130 Medical staff functions Blood usage Surgical case review Medical records Pharmacy and therapeutics 1 36 1 108 Cable A.6 shows no respondent in this category. Total resources for quality management functions. Tables A.12 to A.15 show the resources total budget, personnel budget, and full-time equiva- lent staff (ladles) now and 3 years ago. Resources are also grouped by program type and hospital size. Again, reported budgets for quality man- agement in large hospitals ranged from $13,000 to $127,000. Patient surveys. Table A.16 shows the frequency of pahent surveys as reported by hospitals. Ninety-four percent of hospitals reported using inpa- tient surveys, generally at the time of discharge, but they also report con- ducting surveys monthly, quarterly, and according to special sampling frames. About half of the hospitals (52.9 percent) reported surveying outpatients. It is likely that the hospitals that survey patients 'constantly" were referring to readily available patient comment forms.

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A pU4~ASSU~CES~PL~ 291 Discussion The survey was not conducted with a random sample of hospitals, and response rate could not be determined. Nor is it possible, except very crudely, to determine the understanding of respondents, the accuracy of their responses, or any systematic bias in response. However, the survey includes a wide range of hospital sizes, geographic regions, organizational arrangements, and resources allocated to quality management. The num- bers of departments, committees, functions, staff, and approaches are proba- bly representative of many U.S. hospitals and demonstrate patterns in pro- gram organization and resources by hospital size. The smaller hospitals have simpler organizational arrangements and fewer staff and resources, and the two larger groupings are more comparable and tend to divide de- partments and personnel among their dozens of functions. Although corporate offices, by and large, do not yet have separate qual- ity management functions, it appears that they have begun to move in the last few years to greater integration of activities (e.g., systemwide quality indicators) between hospitals and to see this as a desired task. Very little specifically designed computer support, other than spreadsheet applications and word processing, was reported in the survey. The need for data system support was widely voiced. Notes 1. For follow-up, contact Joann Richards, R.N., M.S.N., Principal Investigator, whose current address is Visiting Assistant Professor, 434 O'Dowd Hall, School of Nursing, Oakland University, Rochester, Michigan 48309. Telephone: (313) 370- 4070. 2. The term quality management used in this survey instrument broadly encom- passes the monitoring and evaluation resources, management, and reporting related to quality management and assurance, utilization management, and risk management activities, regardless of the hospital department in which the function might be located.