An example of such a study would be repeat surgeries performed at a hospital and by a physician different from those involved in the first procedure. Data sets can also be used to screen the processes and outcomes of ambulatory and inpatient care. Increasingly, they show promise for measuring continuity and for evaluating episodes of care that include several settings of care. A case in point is determining the percentage of patients who are identified as requiring further care but do not return or the percentage of all visits within an episode of illness made to the same provider Weiner et al.
Another example is the proportion of diabetics receiving at least one blood glucose test each year by their regular physicians Weiner et al. An important strength of Level 3 data bases is that they permit some assessment of population access to care and outcomes. Comparative studies should be able to identify possible areas of underuse. However, administrative data bases contain only contacts with the health care system, and, of these, only contacts that generate a claim. A person who is ill but has no encounter with the health care system produces no record.
Copayments and other barriers to access may accentuate this bias and underestimate poor outcomes. Thus, such data bases can never be the sole source of quality information in either individuals or populations. The first public release by HCFA of data on hospital-specific mortality elicited bitter accusations of inaccuracy and highlighted the potential for misunderstanding of data that were not adjusted for severity. Since then considerable work has gone into the development of methods of adjustment; the model now includes such variables as hospital admission during the previous year and comorbid conditions.
The data release scheduled for December will compare data from calendar years , , and These data highlight institutions that have significantly fewer or more deaths than expected in specific surgical or diagnostic categories. Multi-year data will provide comparisons over time to minimize the effect of chance variation. PROs have also been asked to review cases in these "outlier" hospitals. Health service researchers have extensively analyzed the uses of mortality data as a quality indicator Dubois et al.
Both SAVA and studies of volumes of services are special aspects of the use of administrative data bases, and both have become major areas of research in their own right. SAVA can identify areas of high, average, and low rates of use of hospital services, but it cannot discriminate appropriate from inappropriate care. As a problem-detection method, SAVA should be regarded as a screening methodology for alerting analysts to areas where quality problems may be occurring, including areas of underuse, and for which more focused review should follow.
After reviewing the literature on the possible relation between volume of procedures done by institutions and the outcomes of those procedures, OTA concluded that good evidence exists that higher volume is associated with higher rates of good outcomes for a number of diagnoses and procedures. They cautioned, however, that the causal relation is by no means clear, with controversy remaining about whether higher volume permits the development of proficiency e. It is also not yet clear over what range of volume and under what circumstances the volume-outcome relation holds.
Recent research has revealed that 24 percent of surgeons performing carotid endarterectomies did only one such operation in a year in the studied areas, and the authors note that few would regard that volume as sufficient to maintain skills Leape et al. Accordingly, we were told of PRO pre-procedure review in one state that includes an inquiry about the requesting surgeon's complication rate and recommends that approval be conditional on his or her having massed enough eases to provide morbidity rates.
Research on aggregate data has demonstrated their value for studying small area variations, length of stay, and variations in practice patterns and complications over time. Although work is under way to develop methods of risk adjustment, to improve linkages among data bases, and to validate and improve the accuracy of diagnosis and procedure codes, administrative data bases lack specificity in identifying quality problems for a given patient or for a particular episode of care. As a near-term strategy, they are best suited to directing quality assessment efforts toward topics, populations, or providers requiring further study.
Currently, Medicare data bases do not include clinical data, measures of patient need, or outcome assessments. Efforts to devise a uniform needs assessment instrument, to develop a uniform clinical data set UCDS , and to include patient functional status could greatly augment the value of administrative data bases for internal and external quality assurance programs. Problems in care may also be detected by analyzing state and local hospital discharge data. Numerous state-level and purchaser-provider coalition initiatives are under way. The better known include the Statewide Planning and Research Cooperative System SPARCS data base in New York, efforts by several state health-care cost-containment commissions to assemble, analyze, and disseminate data about health care specifically on hospital care , and efforts by the Maryland Hospital Association to develop quality indicators to be used by hospitals to review their own performance.
It can produce both standardized and customized reports on the type and severity of cases specific to a hospital or region and the charges associated with treating those conditions; it can be used by hospitals, researchers, local planning agencies, insurance companies, and local, state, and federal governments. Twenty-eight states have enacted legislation for reporting hospital data. Pennsylvania and Colorado have spearheaded much of this work. In Pennsylvania, the Health Care Cost Containment Commission's Data Council has required all Pennsylvania hospitals to install the MedisGroups software and to provide the state with case-mix-adjusted data on costs and outcomes.
The current and forthcoming reports are intended to help business and labor purchasers as well as the general public to make cost-and quality-informed choices. The Pennsylvania Buy Right Committee is using the same data to educate its employer and hospital members. Since July the Colorado Data Commission has required hospitals with more than 50 beds to collect and report discharge data on their patients.
Data reporting to the state has been delayed, however. Developed as a voluntary hospital effort to provide interhospital quality-of-care data Summer, , it uses a limited number of data elements to be reported on 10 indicators:. The information from the data analyses is returned to participating hospitals for their "internal" use. Summer, personal communication, Recently, RAHC has focused on preventing any adverse effect on quality by distributing funds from a community risk pool. The distribution formula will be based on quality performance as adjusted for admission severity with MedisGroups software Hartman, Patients or their families sometimes file complaints with a local, state, or federal agency with oversight responsibility for hospitals.
One participant in the beneficiary focus groups mentioned the city health commissioner as the most appropriate place to seek recourse for a problem with hospital quality. State departments of health receive complaints regularly; for instance, NYSDOH maintains a hour staffed telephone line and may respond to complaints by making unannounced investigations at hospitals.
During our site visits we were told that only a few complaints lead to identification of quality problems; nevertheless, an extensive amount of staff effort is directed toward following up complaints. On the other hand, at least one PRO visited in this study believed that patient or other complaints were a very useful problem-identification tool and that PRO review of patient complaints helped foster better relations with the patient community. All states have reporting requirements and some states may have incident reporting requirements as well Longo et al.
Although unusual among states in its elaborate regulatory mechanism for detecting problems, NYSDOH requires that certain incidents be reported directly to the state. Injuries or impairments of bodily functions, in circumstances other than those related to the natural course of illness, disease, or proper treatment in accordance with generally accepted medical standards and that necessitate additional or more complicated treatment regimens or that result in a significant change in patient status, shall also be considered reportable under this subsection;.
One-third were patient falls resulting in fractures. The remainder were primarily medication errors. Problems caused by laser surgery and fatal errors in administration of potassium were also identified. NYSDOH reviews about 15 percent of incidents onsite, typically where significant patient harm or unexpected deaths have occurred.
Each year NYSDOH makes about 3, visits to its hospitals, identifies about 2, quality problems, and issues about 40 enforcement actions. When malpractice claims are filed, hospitals may be named as the primary defendant or may be included in a list of defendants. A review by GAO of a sample of closed malpractice claims showed that 71 percent of the health care providers involved were physicians and about 21 percent were hospitals.
In principle, court awards could be considered one way to detect problems in quality, and data on court decisions might be available through a state's Freedom of Information Act OTA, The validity of such data for this purpose is very much in doubt, however. This sampler divides activities according to whether they are intended to prevent, detect, or correct problems, because the focus for each is distinct.
In practice, these activities may be combined by hospitals as "integrated" programs of administrative organization, personnel, and data collection. A representative organizational chart shows the quality assurance function as a responsibility of the governing board and coordinated by a quality assurance department.
This quality assurance function may be integrated in various combinations with utilization management, risk management, and infection control.
The medical staff office typically handles credential and privilege requests and reappointment recommendations from individual departments. It receives, in addition, data provided to it by quality review committees. These committees may be departmental e. The organizational details, methods of data collection, and reporting systems are unique to each hospital.
Some hospitals implement proprietary programs designed to integrate these functions. Other hospitals purchase software to help with individual tasks such as severity measurement, credentialing, or incident tracking. Numerous vendors sell quality tracking software; although the use of such computerized aids is not yet widespread, it is increasing. Possibly the best-known integrated system is the Medical Management Analysis system developed by Craddick Craddick and Bader, It combines specialty-specific criteria, generic screens, and percent concurrent review of medical records with utilization review and discharge planning.
The program permits the hospital to track the findings of generic screening and monitoring activities, to follow corrective actions, and to develop profiles of practitioners.
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A few hospitals have begun to implement a model of quality assurance based on the continuous improvement CI model see Volume I, Chapter 2. Responsibility is to a greater degree dispersed, being vested in those who are closest to where care is performed. Although the CI model strongly emphasizes that final accountability for quality rests with the top leadership of the organization, each group is taught how to identify deficiencies in quality, how to analyze the details of the process, and how to redesign the process to reduce or eliminate errors in CI terminology, ''variations".
The activities included in the CI model must be coordinated so that self-evaluation and records of improvement also follow reporting and accountability requirements for accreditation. Two hospitals visited by the study committee, the Rush Presbyterian-St. The listing that follows describes the component parts of quality assurance systems in hospitals and the Joint Commission requirements related to them.
In the Accreditation Manual for Hospitals Joint Commission, b , the "Quality Assurance" standard states that for each facility,. Required medical staff functions include ongoing monitoring and evaluation of clinical departments or major clinical services all medical staff, if nondepartmentalized , surgical case review, blood usage review, drug usage evaluation, pharmacy and therapeutics review, and medical record review. Required hospitalwide functions include infection control, utilization review, and review of accidents, injuries, patient safety, and safety hazards.
These methods can be described as case-finding methods to identify individual patients who, on retrospective review, may have received suboptimal care. Case-finding as a screening method may be followed by focused review or further review by peers or both as described in more detail in the remainder of this section.
States may also enact statutory requirements. In New York State, for instance, hospital trustees, medical staffs, and administrators are held accountable for the quality of care rendered in an institution. The governing board must approve an integrated, hospitalwide quality assurance program and assign at least one member of the governing board to the quality assurance committee Fisher, The quality assurance committee in some hospitals is a board-level committee. Minimally, its membership typically includes the following: the chief executive officer; the medical director; chairpersons of nursing, risk management, and quality assurance; and chiefs of the major clinical departments.
Members of the governing board may also be members of the committee. The quality assurance committee receives summary reports from the various committees throughout the hospital, considers their findings, and recommends actions to correct problems not managed at committee or department level. The quality assurance department provides direction and guidance to all departments and staff and coordinates the collection and monitoring of data and corrective actions.
It also serves as an institutional resource for methods and information and as the locus for data analysis and reporting. Generic screening is conducted by nurse reviewers in the quality assurance department. This function may be coordinated with that of utilization review, discharge planning, and infection control. We obtained data from an outside survey to learn more about resources and the organization of quality assurance activities in hospitals.
Periodically, organizations need to change the quality management aspects of processes and products in order to suit the demands of their internal and external consumer and competitor market environments. The decision-maker and an expert defined the weights of criteria for the companies, as can be seen in Table 7. Project Management. We hypothesized that the implementation of the QA program within the IDF results in improved quality of care and that evaluation of a specific PCP within the framework of the QA program results in an improved score of the PCP during a second evaluation. Nurse turnover: a literature review.
Data were received from corporate offices of 13 multihospital systems and 58 individual member hospitals in 21 states describing the departmental structure, staffing, reporting arrangements, and time devoted to various quality assurance activities. The Appendix describes the survey methods and results in greater detail. A striking finding was the very wide range of organizational arrangements and extraordinarily wide range of resources reported by hospitals.
In hospitals with fewer than beds, combined quality assurance, utilization review, and risk management functions were most frequently reported. In hospitals with to beds, quality assurance with utilization review was reported almost as frequently as the three-function combination, and in hospitals with more than beds, the dual combination quality assurance and utilization review was most frequently reported 10 of 24 responding hospitals Appendix, Table 6A.
As might be expected, with increasing size of hospital as determined by number of beds designated for medical and surgical services , the numbers of committees, charts reviewed, meetings, and personnel generally increase, but large ranges were reported.
For instance, numbers of records reviewed concurrently averaged per month in 3 small hospitals range, 1 to 1, per month , per month in 10 moderate-sized hospitals range, 12 to 2, , and 2, per month in 11 larger hospitals range, to 5, Table 6. The Joint Commission is moving toward substantial revision of the Accreditation Manual , developing its Agenda for Change using outcome monitoring and modifying its survey and accreditation methods Joint Commission, , a. However, the standards described above are still in effect, and their influence on hospital activities is pervasive.
H3 to be applied to all medical staff quality assurance functions, hospitalwide quality assurance functions, and clinical and support service quality assurance activities. Monitoring is expected to be done by all clinical departments such as nursing, nutrition, and social work and by support service departments such as the clinical laboratory, pathology, radiology, pharmacy, and central supply. Exhibit 6. H4 is an example of the results of such monitoring in several departments of one medical center.
Indicators for monitoring are written screens of acceptable practice, instruments that measure a quantifiable aspect of patient care Lehmann, They are intended to be objective, measurable, and applied consistently to the review of care by nonphysician reviewers O'Leary, ; Lehmann, The clinical indicators may be appropriateness protocols based on adherence to condition- or procedure-specific standards , or they might be positive or negative health status outcomes. Monitoring is intended to signal the need for a more focused review, not to replace case review.
For monitoring, the Joint Commission distinguishes "sentinel events" and "comparative rate indicators. Comparative rate indicators, such as the death rate after coronary artery bypass graft or the rate of vaginal births after cesarean delivery, are rates over time or rates in comparison to other institutions that may trigger further review Joint Commission, d. H5 gives several illustrations. Concurrent monitoring refers to the review of the process and outcome of care during the course of the hospital stay in order to identify potential and actual problems and reportable incidents.
Data for assessment of severity of illness and suitability for discharge may also be monitored. Such concurrent screening may occur at admission and at periodic intervals during the hospital stay. One hospital visited reported percent daily review of their hospital patients.
Rutstein et al. Each adverse event is chosen because it is thought to have a high probability of indicating poor quality and therefore warrants further review and possible intervention. Generic screening is a method of identifying adverse, or sentinel, events by medical record review. Screens are "generic" in the sense that they apply broadly to the institution rather than to specific departments or diagnoses.
Examples of generic screens are "unplanned repair or removal of organ," "severe adverse drug reaction,'' and "inpatient admission after outpatient surgery. Generic screening, now widespread in hospitals, is a two-stage system of medical chart screening by nurse reviewers followed by implicit physician review. Data may be recorded on worksheets that are also used for admission, continued stay, and discharge review. Data may be collected within a designated period after admission e.
Individual events that meet certain explicit criteria sometimes called screen failures or variations are further reviewed by a physician advisor. Direct action is taken if a quality problem is confirmed and individual action is appropriate sometimes called adverse patient occurrences. Data are later aggregated e. If it is done at frequent intervals and if data are reviewed and collated promptly, screening for adverse events can result in immediate action. When potentially dangerous conditions exist, response can be timely enough to prevent further harm to an individual patient and to other patients exposed to similar risks.
If data are retrieved by well-trained reviewers and combined with other tasks such as utilization review and discharge planning, screening supports coordination of care and efficient use of resources. Well-developed screening criteria sets could be generalizable to many sites and could provide benchmark data for comparison across sites and over time. Generic screen data applied by internal quality assurance programs are most frequently reviewed long after the patient has been discharged. As most commonly used, then, they are not helpful for concurrent interventions.
Their value for patient care thus depends on dissemination of data on patterns of problems, but the study committee was unable to assemble evidence that this occurs in hospitals. Screening for adverse occurrences may also be department-specific rather than facilitywide. Exhibits 6. H7 and 6. H8 show some department-specific screens provided during site visits. Surgical case review addresses the indications or justification for all invasive surgical and diagnostic procedures performed in inpatient and ambulatory care settings Longo et al.
For cases in which tissue is removed, surgical review includes a comparison of the surgeon's pre-opera-tire diagnostic findings and the post-operative pathology findings. A discrepancy requires further case review to determine whether the surgery was justified.
Some surgical procedures e. Surgical review for these cases in one model Longo et al. Review of blood usage includes assessment of justification for transfusions, review of transfusion reactions, approval of policies on transfusion, monitoring transfusion services, and blood product ordering Longo et al. As in surgical review, screens are developed based on criteria for justified transfusion episodes Exhibit 6. The clinical review nurse may screen for blood usage while doing utilization review. Cases failing screens are forwarded for review by the blood usage review committee.
Drug usage review has been broadened from what was once the review of antibiotic use only. It includes review of the indications and justifications for drug use, appropriate monitoring of drug levels, and correct dosage and route e. Drugs for review might be high-volume or high-risk drugs or those considered important by the medical staff for other reasons such as unusual toxicity or potential for interaction with other drugs see Exhibit 6. H10 for an example of cardiology drug review.
In addition to medical staff, pharmacy personnel, nursing personnel, and hospital administrators are likely to be involved in pharmacy and therapeutics review. Along with approving pharmacy policies and procedures and maintaining the hospital formulary, the pharmacy and therapeutics review committee also reviews serious untoward drug reactions. Medical record review is conducted by a medical record review committee.
It consists primarily of the review of records—such as admission history, operative notes, and discharge diagnosis for DRG assignment—of discharged patients to determine the timeliness of completion of various elements of care. Focused review of care may take place when occurrence screening or clinical indicators warrant further evaluation.
Unlike the retrospective audits of traditional quality assurance approaches, focused review is usually intended to be a prospective review, aimed at a particular topic or practitioner, and it remains in place until actual performance reaches a level of expected performance Longo et al.
Examples of topics for focused review might include infertility workup or hysterectomy in the obstetrics-gynecology OB-GYN department, workup of newly diagnosed diabetics in an internal medicine department, cholecystectomy in a department of general surgery, and streptococcal endocarditis in a department of infectious disease. Focused review utilizes principles of criteria development, data collection, analysis, and dissemination to the relevant clinical depart-merits or staff committees Longo et al.
One hospital in New York City, for instance, conducts a chart review of all patient deaths within 24 hours of death, or within 72 hours when an autopsy is performed. Peer review as a formal process is part of the functions listed previously. Once screens or monitors indicate further review is necessary, medical records are reviewed by a physician advisor in the clinical department or in the quality assurance department. The physician advisor reviews the record and may ask the responsible physician to discuss the case or to provide further information. Sometimes immediate intervention is warranted to ensure that the patient is given appropriate care.
H6 continues. In contrast to the earlier methods described which might be seen by practitioners as fairly mechanistic , peer review is generally reserved for the last stage, in which a "comparable" physician passes judgment using his or her sense of the entirety of the medical care. This approach offers an opportunity for more evidence to be brought forward and thus a chance to recognize not unreasonable decisions; peer review generally reinforces a strong collegial sense of the complexity and uncertainties in the case.
After reviewing the record, the physician advisor may decide that the quality problem was not practitioner-related. The problem could have re-suited from an unforeseeable patient complication, such as an allergic reac tion to diagnostic contrast media, or it might represent a ''systems'' problem, such as a failure to receive a laboratory report in timely fashion or unavailability of equipment. This information is useful for tracking problems in a department or on a hospitalwide basis; problems of this nature may be more appropriately linked to administrative and policymaking groups than to individual practitioners.
If the case is practitioner-related, the physician advisor may seek additional review from others in the same or a related specialty, the appropriate departmental or other committee, the department chair, or the medical director. One hospital described the tasks of peer review as the following: First, a physician advisor decides whether an adverse patient occurrence has taken place. Second, if questions persist, a medical care evaluation committee can determine that the standard of care was or was not met most prudent physicians given the same set of circumstances, would or would not have managed the situation in a similar fashion , or that it is questionable other practitioners might have managed the case differently with presumably a better outcome, but there was no clear breach of the standard of care.
The attending physician may attend the meeting, but not during voting. The department chairman attends as a nonvoting member. Third, the committee decides which persons, departments, or systems were most closely associated with the event. Fourth, the committee designates a severity score. Fifth, incidental findings that have a direct bearing on the patient's care are recorded.
Various systems for assigning levels of severity were described by hospitals. One guide proposes four severity categories Longo et al. The severity scores may be used in profiling practitioner performance for reappointment and for documentation toward any further action to be taken. Results of review may be presented or distributed in summary form at departmental medical staff meetings.
In the mids, Congress recognized that one of the more important ways that the quality of health care could be assured was through vigorous peer review activity; it also acknowledged that peer review, as conducted by hospitals and medical societies, was encumbered by the perceived threat that antitrust and defamation actions could be brought against the organizations and their individual members. Part A is mainly concerned with peer review; Parts B and C, which relate to reporting of disciplinary actions, are discussed in the section on ambulatory care, later in this chapter.
Part A of the HCQIA provides professional review entities and physicians participating in the peer review process immunity from private civil antitrust suits with a few exceptions arising from review actions that have been "undertaken in good faith by health care entities and professional societies.
The peer review specifications for protection under this act are very explicit; action must be taken in the furtherance of quality health care, after a reasonable effort has been made to obtain the facts, following adequate notice of action and hearing procedures, and with the belief that the disciplinary actions are warranted by the facts. Several individuals and groups are covered under the antitrust immunity provisions of this Act.
They include professional review bodies i. Patrick v. Burget appeared to many members of the medical profession, including the American Medical Association AMA , to pose serious limits to the degree of protection from antitrust liability and its treble damages awards provided by the HCQIA Holthaus, Patrick, claimed that doctors on a hospital peer review committee criticized the care he provided his patients, sought to terminate his hospital privileges at the only hospital in the community, and acted against him because he was in competition with them.
An initial judgment went in Dr. Patrick's favor. The appellate court, however, then found the defendants not liable on antitrust grounds, although it noted that they had engaged in "shabby, unprincipled and unprofessional activities" against Dr. The court grounded its decision on the exemption from antitrust laws of state regulatory authorities and of private parties enforcing state policies through activities "closely supervised" by state officials. In an ruling, the U. The Supreme Court ruled that despite the fact that Oregon law requires reviews for medical competence, the process is not so closely supervised by state authorities to qualify for the "state action" exemption.
The court further noted that the defendants were not protected by the HCQIA because that act insulates only those peer review activities conducted in the reasonable belief that they are in furtherance of quality health care. In the wake of Patrick v. Burget , there was a question of just how vigorous non-Medicare peer review should be. Since the ruling, it has become clear that its impact was not as devastating as first feared Cross and Berman, ; Holthaus, In Bolt v. Halifax Hospital Center et al. Circuit Court of Appeals answered a question left open by Patrick : if the state courts retain the power to overturn a peer review decision, are peer review bodies and their members shielded from federal antitrust scrutiny under the state action doctrine?
The court ruled that:. To be sufficiently probing, the scope of judicial review must first of all encompass the fairness of the procedures used in reaching the decision. Furthermore, it must involve consideration of whether criteria used by decision makers were consistent with state policy and whether the decision had sufficient basis in fact. Our review of Florida case law convinces us that such review is available in Florida courts.
This decision, which technically applies only to the 11th district federal courts, appears to protect peer review under the state action doctrine if it is subject to judicial review to determine whether it incorporates due process and is performed in accordance with the state's law. The Bolt ruling also provides, according to one authority, that state judicial review of peer review will meet state action doctrine requirements "even under circumstances where judicial review is not required in every case" Holthaus, , p. Another case that may prove of some importance in protecting non-Medicare peer review from antitrust liability is Mitchell v.
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