Autopsy Quality Metrics

Historically, the autopsy has been a cornerstone for medical discovery. However, for many reasons, autopsy rates and interest in autopsies have been steadily declining for the past half century. The rate of autopsy in the USA has fallen to less than 5% of hospital-based deaths. Factors contributing to this decline include the confidence of physicians in new investigative tools for in vivo diagnosis of disease, concerns about malpractice litigation, administrative burdens in requesting an autopsy, and inadequate information about the value of autopsy. Yet, the autopsy remains a vital tool for quality control and is essential for good medical practice. Previous studies have shown that autopsy uncovers previously undiagnosed major findings, such as cancer, cirrhosis, or cardiovascular disease, in 4.1%-49.8% of cases. In approximately 9% of these cases, the most serious undiagnosed findings likely affected patient outcome. ^[1]

Autopsy is also critical for the assessment of new laboratory technologies and evaluation of novel medical devices. The focus of this article is on the quality assurance and quality management programs that may be implemented as part of an autopsy service in a hospital setting. ^{[2, 3]} Many of the principles discussed also apply to forensic autopsies ^{[4, 5]} ; however, this article does not cover features specific to forensics, and it does not address issues related to legal procedures, both of which are discussed in other articles in Medscape Pathology.

An autopsy quality management (QM) program should provide active surveillance of the quality of the autopsy services through monitoring of key indicators of quality in the preanalytic, analytic, and postanalytic phases (quality assurance [QA] monitors); evaluating processes and techniques to adequately detect, reduce, and control deficiencies within the analytic phase (quality control [QC] monitors); and continuously assessing and adjusting performance according to available benchmarks (quality improvement [QI] monitors). ^[6]

In most laboratories, the autopsy QA plan is a subset of the anatomic pathology QM program, which also includes surgical pathology and cytology. There is no ideal plan for autopsy pathology. The monitors put into place should be standardized for the type of service provided. A large hospital program in which hundreds of autopsies are performed annually should have more formality and rigor than a small hospital where a few autopsies are performed annually. Ideally, the pathologist who oversees the autopsy service also oversees the autopsy QM program. The autopsy QM program should be outlined and reviewed annually.

The Laboratory Accreditation Program (LAP) of the College of American Pathologists (CAP) has mandated the monitoring of key indicators as they relate to the autopsy quality management (QM) program as part of its accreditation requirements; these indicators include maintaining appropriate turnaround times for preliminary and final reports. The LAP of the Joint Commission mandates that all laboratories have quality assurance (QA) plans that include monitoring that addresses the test cycle (preanalytic, analytic, and postanalytic) and global measures of turnaround time and customer satisfaction.

Both LAPs have emphasized promoting patient safety through a systems approach and are aimed at error reduction. In addition to the LAP, the Joint Commission monitors sentinel events defined as unexpected occurrences involving a death or serious injury. Reportable sentinel events relative to autopsy pathology include unanticipated deaths not related to the natural course of illness.

A timeline for reporting of monitor results should be prepared with specific individual responsibility for those monitors. Frequently, the data derived from the quality monitors may be used to improve the autopsy service. To help aid in evaluating the level of performance, external benchmarking and peer-group comparison may be used.

External benchmarks may be derived from the literature; they may also be sought from other institutions. The use of a benchmark derived from wide experience is an excellent way to determine adequacy of the level of performance. Benchmarks provide accessible data and a reasonable idea of the level of performance that has been achieved at other institutions. However, a performance level that is currently considered good may not be considered so in the future. The goal of a QM program should be continuous quality improvement (QI) through ongoing monitoring of processes that identify opportunities for systems enhancement and best practices. Therefore, benchmarks can and should change overtime as performance improves.

If data are used for evaluation of an individual's performance, they should always be used in the context of peer group comparison with other measures. Because autopsies are performed relatively infrequently in most institutions, one needs to be careful that the data include a sufficient sample to reflect actual performance.

Perhaps the most frequently overlooked but important aspect of autopsy quality is the clinicopathologic correlation. This measure is not a reflection of how well an autopsy is done, but it is the key to fully understanding the importance and potential of the autopsy in driving improvements in overall clinical care. Traditionally, autopsies were the basis for educating young and established physicians; this was most effective at the autopsy table. Today, this educational function is typically carried out at formal clinical pathologic conferences (CPCs) or morbidity and mortality (M & M) conferences. Unfortunately, the use of autopsy data for medical education and for examination of demographic changes in disease has become much more sporadic and variable.

The preanalytic phase of the test cycle for autopsy includes proper identification of the patient, obtaining and delivering an autopsy permit signed by the appropriate person with all the appropriate clinical and demographic data, and information concerning the care and delivery of the body (see Autopsy Request Process). Assessment should also include adequacy of the clinical chart review and communication between the clinical care team and/or family. In addition, this may also include communication between the decedent affairs/admitting department or other personnel who may be involved in the preanalytic phase of the autopsy process.

Quality improvement (QI) processes include service expectations from funeral homes, physicians, nurses, law enforcement, or researchers involved in clinical trials study protocols. The number of variables that may be audited may be exhaustive, but there are key components that are basic to all autopsies that should be included.

Autopsy permits and communication

The simplest monitor for the preanalytic phase of the test cycle is to check if permits are being filled out adequately. This process is multifactorial and involves many individuals outside the laboratory. A number of items must be in the permit; the absence of these items is likely to lead to delays and confusion. The following table may be used to audit the autopsy permits for completion. This is best done prospectively as cases are performed. Much of the data may be collected retrospectively, but some items, such as the pathologist's ability to contact the physician, may be lost in time. The goal of any department should be 100% compliance with items 1-6.

Table 1. Autopsy Permission and Communication (Open Table in a new window)

Patient transport

The identification of the body is the single most important aspect of performing an autopsy. In the inpatient setting, bodies are identified by wristbands and toe tags. A potential monitor of the effectiveness of body identification, transportation, and delivery of chart/permit is shown in Table 2. Again, a service should have the goal of 100% compliance with items 1-3.

Table 2. Patient Transport (Open Table in a new window)

Quality control (QC) processes during the analytic phase of the test cycle for autopsy include safe practices such as adequate personal protective equipment use and formalin monitor data, adequate physical environment (eg, photography space, supplies), and turnaround times. Quality assurance (QA) processes include gross and microscopic examination, ancillary testing, and histologic processing. From a communication standpoint, QA also includes the attendance of members of the clinical team at the autopsy when feasible. Unless the autopsy service has its own histology laboratory, the effectiveness of the histology laboratory is generally covered within the surgical pathology QA program and thus is not included in this discussion. Quality improvement (QI) integration includes the use of best-practice protocols for autopsy performance.

Organ-specific evaluations may be important in certain clinical settings. A common question at autopsy is whether a patient died of myocardial infarction or resulting from sudden cardiac death. Detailed pathologic analysis of the coronary arteries and atherosclerotic plaque morphology is essential for identifying coronary plaques that cause acute coronary events. ^[7] In addition, through postmortem examination, pathologists also have the unique opportunity to offer clinicopathologic assessment of the safety and efficacy of health care technology and medical devices. For example, the pathologic mechanisms and risk factors for in-stent thrombosis were elucidated following careful postmortem examination of coronary stents using stent registry data. ^[8] The systematic collection of pathology data to assess biomaterials and novel medical devices should be emphasized and incorporated into the laboratory QM program. Below is a sample checklist for the gross and microscopic examination of the heart (Table 3). Laboratories may wish to develop checklists for other organs depending on the practice setting.

 

Table 3. Gross and Microscopic Examination of the Heart ^[9] (Open Table in a new window)

Modified from Sens MA, et al. Quality management in autopsy pathology. Nakhleh RE, Fitzgibbons PL, eds. Quality Management in Anatomic Pathology: Promoting Patient Safety Through Systems Improvement and Error Reduction. Northfield, Ill: College of American Pathologists; 2005. 172.

Clinicopathologic correlation is both an analytic and postanalytic QA function. In the analytic phase, the greatest benefit of the clinical pathologic conference (CPC) is in education, particularly if it is used for interdisciplinary communication and learning. Although this function is being used less frequently in current practice in part due to medicolegal concerns, its educational benefit and potential impact on patient care cannot be denied. The CPC is critical in other instances. The importance of communication or clinical case review in suspected cases of air embolus or tension pneumothorax that require special autopsy techniques or ancillary testing (eg, imaging studies) to adequately diagnose is an example. Clinicopathologic correlation is also essential to accurately interpret the autopsy findings as they pertain to the cause of death. As a postanalytic QA function, it has an important role in clinical audit.

Although numerous monitors may be devised when autopsy processes are unacceptable, it is best to simplify the analytic phase of the test cycle into two main areas: (1) gross examination and dissection and (2) microscopic examination and diagnosis. The monitors are listed below.

Gross examination and dissection

Although gross examination and dissection may be performed prospectively on an ongoing basis, most of these items may be performed retrospectively with review of the reports. The goal regarding most of these items should be 100% compliance.

Table 4. Gross Examination and Dissection (Open Table in a new window)

Microscopic examination and diagnosis

Ideally, the accuracy of the microscopic examination and correlation with the slide key, gross findings, and diagnosis should be checked prior to finalizing the autopsy report. When consultants are used, this should be indicated in the report or filed with the report. In teaching programs, providing a checklist for the trainee can help ensure the accuracy of the report. Compliance can be checked by review of the slides and reports, retrospectively. The goal regarding these items should be 100% compliance.

Table 5. Microscopic Examination and Diagnosis (Open Table in a new window)

In the postanalytic phase of the autopsy test cycle, quality assurance (QA) monitors include care of the body after autopsy, correlation of previous pathology and other testing, clinical pathologic conference (CPC) assessment, and communication of findings (informally via phone to the clinical team and/or family, or formally through presentations at morbidity and mortality conferences and autopsy reports). The information in the autopsy report should be adequate to ascertain the primary pathological process or cause of death. Quality improvement (QI) integration can be used both to improve autopsy service processes and institutional processes and quality of care. Examples include evaluating cumulative inpatient autopsy rates and case reviews with integration into institutional committees (eg, epidemiology and infection control, QA, and professional staffing).

Postautopsy care

Preparation of the body in an appropriate and efficient manner is important to the family and in facilitating the grieving process. The body should be available to the funeral home as soon as possible. It should be in a condition that is appropriate for preparation for viewing. The following table is a suggested monitor for the evaluation of postautopsy care. The goal regarding most of these items should be 100% compliance. A monitor could be set up on the basis of Table 6.

Table 6. Postautopsy Care (Open Table in a new window)

 

Autopsy report adequacy

The reporting of results is the other part of postanalytic monitors. Monitors should include examination of adequacy and completion of the report and delivery to the appropriate clinical colleagues. A monitor could be set up on the basis of Table 7.

Table 7. Autopsy Report Adequacy (Open Table in a new window)

 

Autopsy and clinical audit

Clinicopathologic correlation also has a function in clinical audit by routine assessment of whether the autopsy findings altered the clinical understanding of disease processes previously known or not known to be present or by resolving clinical differential diagnoses. In this role, evaluation of diagnostic accuracy differs from that of surgical pathology or cytology. It is different because it does not assess the accuracy of pathologic diagnoses (although autopsy anatomic diagnoses should also be incorporated into the cytology/surgical pathology correlation audits), but instead assesses the appropriateness of treatment and adequacy of care at a function similar to that of a tissue committee.

Evaluation may require clinical diagnostic expertise outside the field of pathology. Initial correlation between clinical and autopsy diagnoses is best completed by the pathologist who performed the autopsy at the time of finalization or verification of the autopsy diagnoses. Major discrepancies suspected to affect patient outcome are best reviewed at a higher level (eg, QA committee), which may involve clinical specialty expertise. This evaluation should be maintained within the QA records, but methods should be devised to allow integration and sharing of information with appropriate clinical colleagues, institutional committees, and systems of care in areas that can impact patient safety and the quality of healthcare. A monitor could be set up on the basis of Table 8.

Table 8. Autopsy and Clinical Audit Monitors (Open Table in a new window)

Turnaround times (TATs) for autopsy reporting are key indicators of the overall function and quality of the autopsy service. The Laboratory Accreditation Program (LAP) of the College of American Pathologists (CAP) mandates that 90% of all preliminary autopsy diagnoses (PADs) be released to the attending physician and institutional record within a reasonable time. The recommended TAT for a routine PAD is two working days, with an extended TAT of up to four working days for complicated dissections. The LAP also mandates that 90% of all final reports are released within 60 working days of the autopsy to allow for occasional unusual cases (eg, outside consultations) that require additional time for completion.

A number of intermediate TATs may also be measured to document the contribution of various segments of the test cycle. Most laboratories usually only implement such monitors when TATs are prolonged and interventions are necessary.

Most laboratories maintain a log of the autopsies performed; this log includes the preliminary and final TATs, as shown in Table 9. This is typically collected and summarized; the goal is to have 90% of cases meet the preliminary anatomic diagnoses (PAD) goal of four days and the final anatomic diagnosis (FAD) goal of 60 working days.

Table 9. Autopsy Report TAT Monitors (Open Table in a new window)

Satisfaction surveys are useful for many reasons. In clinical practice, the surveys provide a tool to discover and understand perceptions regarding expectation and satisfaction with the autopsy service. They are particularly important because of the sporadic nature of the autopsy.

General surveys should only be performed annually or every other year. However, a survey could be conducted on an ongoing basis after the completion of every autopsy. The table below may be expanded or contracted, depending on the level of service provided; it is only meant as a template.

Clinician survey

Clinicians should be instructed to rate each of the elements listed in the table below.

Table 10. Clinician Survey (Open Table in a new window)

A high quality autopsy service should monitor and evaluate the quality and appropriateness of its services within the context of the quality management (QM) program of its institution. As part of the Laboratory Accreditation Programs (LAPs), a QM plan is required to improve laboratory services, patient care, and safety through systems improvement and error reduction by ensuring continued surveillance and management of the autopsy service. This article has provided an initial framework for an approach to continuous quality improvement (QI) through ongoing monitoring of processes that identify opportunities for systems enhancement and best practices in the autopsy laboratory. 

For further reading, the College of American Pathologists has published several excellent references to provide pathologists with the tools to develop and maintain quality management programs. ^[2] The autopsy offers the ultimate clinicopathologic assessment and it is therefore of paramount importance to integrate autopsy findings with clinical diagnoses. Ongoing communication between clinicians and pathologists must continue in order to improve care for future patients and the overall healthcare system.