Sunday, October 17, 2010

Quality Control Metrics

Quality Control Metrics

Introduction

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. Regardless, the value of autopsies can easily be demonstrated. In multiple studies spanning many decades, authors have demonstrated that the autopsy uncovers previously undiagnosed major findings, such as cancer, cirrhosis, or cardiovascular disease, in up to 40% of cases.

The focus of this chapter is on quality control and quality assurance (QA) measures that may be implemented as part of an autopsy service in a hospital setting.1,2 Many of the principles discussed apply to forensic autopsies3 ; however, this chapter does not cover features that are specific to forensics, and it does not address issues related to legal procedures, both of which will be discussed in other chapters in the Pathology section.

Autopsy Quality Assurance Plan

There should be an autopsy quality assurance (QA) plan. In most laboratories, the autopsy quality assurance (QA) plan is a subset of the anatomic pathology QA program, which also includes surgical pathology and cytology QA. There is no ideal plan for autopsy pathology. The monitors that are put into place largely depend on 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 10 autopsies are performed annually.

The Laboratory Accreditation Program (LAP) of the College of American Pathologists (CAP) has mandated many elements of the autopsy quality assurance (QA) plan as part of its accreditation requirements; these elements include maintaining an appropriate turnaround time for preliminary and final diagnosis. The autopsy quality assurance (QA) plan should be outlined and reviewed annually. A timeline for reporting of monitor results should be prepared with specific individual responsibility for those monitors.

Ideally, the pathologist who oversees the autopsy service also oversees the autopsy quality assurance (QA) plan. Frequently, the data derived from the QA monitors may be used to improve the autopsy service.

QA Program Monitor Components

The Laboratory Accreditation Program of the Joint Commission mandates that all laboratories have quality assurance (QA) programs. Laboratory QA programs typically have 5 components; 3 address the test cycle (preanalytic, analytic, and postanalytic), and 2 address global measures of turnaround time and customer satisfaction. These components have to be tailored to the autopsy service. Ideally, the quality assurance (QA) monitor data should provide a picture of the level of performance.

To help aid in evaluating 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 quality improvement program should be continuous quality improvement. Therefore, benchmarks can and should change over time 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 assurance (QA) is 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.

Test Cycle Monitors: Preanalytic

The preanalytic phase of the test cycle for autopsy includes obtaining and delivering an autopsy permit signed by the appropriate person with all the appropriate clinical and demographic data, as well as information concerning the care and delivery of the body (see Autopsy Request Process). 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.

The simplest monitor for the preanalytic phase of the test cycle is to check if permits are being filled out adequately. 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.

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Case #

1. Was the patient identified correctly (2 unique identifiers) on the permit? (Y/N)

2. Was permit signed by the correct next of kin? (Y/N)

3. Was there a delay in obtaining the permit? (Y/N)

4. Was the permit signed by a requesting physician? (Y/N)

5. Was the permit signed by a witness? (Y/N)

6. Was the extent of the autopsy clear in the permit? (Y/N)

7. Was there adequate clinical contact information? (Y/N)

8. Were specific questions included in the request? (Y/N)

9. Did the pathologist have the opportunity to discuss the case with the clinician before starting? (Y/N)

AU10-#









AU10-#









AU10-#










AU10-# = sample case numbers, in which AU = autopsy, 10 = the year (2010), and # = the specific case number.

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

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Case #

1. Is the body identified in accordance with hospital policy?(usually with either wrist band or toe tag with 2 unique identifiers)? (Y/N)

2. During transportation and storage, is the body properly shrouded? (Y/N)

3. Was the body appropriately logged into the morgue in accordance to policy? (Y/N)

4. Were the permit and/or chart delivered to pathology in a timely manner (as defined by the institution)? (Y/N)

AU10-#




AU10-#




AU10-#




Test Cycle Monitors: Analytic

The analytic phase of the cycle for autopsy includes gross and microscopic examination of the body, as well as the histologic processing. Unless the autopsy service has its own histology laboratory, the effectiveness of the histology laboratory is generally covered within the surgical pathology quality assurance (QA) program and thus is not be included in this discussion.

Clinicopathologic correlation is also an analytic function; this is a controversial area because of current medicolegal concerns, but it is a key to physician education and clinical improvement. Although numerous monitors may be devised when processes are unacceptable, it is best to simplify the analytic phase of the test cycle to 3 main areas: gross examination and dissection; microscopic examination and diagnosis; and clinicopathologic correlation. The monitors are listed below.

Gross examination and dissection

Although gross examination and dissection may be done 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.

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Case #

1. During examination and dissection of the body, were appropriate personal protective equipment used? (Y/N)

2. Were the autopsy permit limitations honored? (Y/N)

3. Was the examination adequate to demonstrate findings? (Y/N)

4. Were appropriate weights and measures taken? (Y/N)

5. Did the PAD accurately reflect the gross findings ? (Y/N)

6. Were tissues appropriately fixed and sectioned for microscopic examination? (Y/N)

AU10-#






AU10-#






AU10-#







PAD = provisional/preliminary anatomic diagnosis.

Microscopic examination and diagnosis

Ideally, microscopic examination and diagnosis should be done by review of the slides and reports, retrospectively. The goal regarding these items should be 100% compliance.

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Case #

1. If a microscopic description is used, does it accurately reflect the histology findings? (Y/N, N/A)

2. Do the diagnoses accurately reflect the gross and microscopic findings? (Y/N)

3. Is there appropriate use of consultants? (Y/N)

4. Were special stains and other ancillary tests used appropriately in this case? (Y/N)

AU10-#



AU10-#




AU10-#




N/A = not applicable.

Clinicopathologic correlation performed for each autopsy

The clinicopathologic correlation evaluation is best completed by the pathologists who performed the autopsy at the time of finalization or verification of the autopsy diagnoses. This evaluation should be maintained within the quality assurance (QA) records, but methods should be devised to allow sharing of information with appropriate clinical colleagues.

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Autopsy diagnosis
Clinical diagnosis
Agreement classification*
Comment

















* Agreement is based on the following classification:
  • I. Major unexpected findings contributing to the patient's death. These major findings include any principal underlying disease that contributed to the patient's death. The disease may or may not have been treated, depending on whether the disease was known before the patient's death.
  • II. Major unexpected findings that did not contribute to the patient's death. These are major disease processes that may have eventually required treatment or that may have contributed to the patient's death. Examples include a malignant neoplasm, severe coronary artery atherosclerosis, cirrhosis, and atherosclerotic aortic aneurysm that did not contribute to the patient's death.
  • III. Minor unexpected findings contributing to the death of the patient. These are secondary findings related to a principal underlying disease, therapeutic intervention, or diagnostic procedure.
  • IV. Other minor unexpected findings that might have eventually required treatment.

Test Cycle Monitors: Postanalytic

The postanalytic phase of the cycle includes care of the body after autopsy and reporting of the results.

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.

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Case #

1. Was the body cleaned and prepared appropriately? (Y/N)

2. Was the body properly shrouded? (Y/N)

3. Was the body properly identified with a toe tag and on the shroud? (Y/N)

4. Was the body available for the funeral home in an acceptable time? (Y/N)

5. Was the funeral home notified when the body was available? (Y/N)

6. Was the body appropriately released (signed out) to the funeral home? (Y/N)

AU10-#





AU10-#





AU10-#







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 the following table.

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Case #

1. Does the autopsy report include the final diagnoses? (Y/N)

2. Does the autopsy report include an adequate external and internal gross examination? (Y/N)

3. Does the autopsy report include a microscopic description? (Y/N, N/A)

4. Was the report delivered to the requesting physician? (Y/N)

5. Was the report delivered to the appropriate departmental and/or hospital committees for quality assurance purposes as per local policy? (Y/N)

6. If departmental policy includes communication of results to the family, was this performed? (Y/N, N/A)

AU10-#





AU10-#






AU10-#





Test Cycle Monitors: Turnaround Time

The LAP mandates that preliminary or gross autopsy diagnoses be released within 48 hours of the performance of the autopsy. The LAP also mandates that the final report of an uncomplicated case be released within 30 working days of the autopsy. A number of intermediate turnaround times (TATs) may also be measured to document the contribution of various segments of the test cycle. Most laboratories usually only implement such monitors when there is a prolonged turnaround time and interventions are necessary.

Most laboratories maintain a log of the autopsies performed; this log includes the preliminary and final turnaround times, as shown in the table below. This is typically collected and summarized; the goal is to have 90% of cases meet the PAD goal of 2 days and the final anatomic diagnosis (FAD) goal of 30 days.

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Case #
Pathologist
Date and time accessioned
Date and time PAD finalized
PAD TAT
Date and time FAD finalized
FAD TAT
AU10-#





AU10-#





AU10-#






Test Cycle Monitors: Satisfaction Survey

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 done annually or every other year. However, a survey could be conducted on an ongoing basis after the completion of every autopsy. Clinician surveys should be different from surveys of families. The tables below may be expanded or contracted, depending on the level of service provided; they are only meant as templates.

Clinician survey

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

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What is your level of satisfaction with

High level
5


4



3


2

Low level
1

Overall autopsy quality





Communication with the pathologist





The timeliness of the autopsy





Answers to specific questions posed at the time of the autopsy





The ability to use autopsy results as an educational tool





The completeness of the autopsy





The preliminary autopsy report





The final autopsy report





The ability to get autopsy information before requesting an autopsy






YES

NO

Were you able to incorporate the autopsy results into the death certificate?


Was sufficient information present in the report to allow you to explain the results to the family?


Comment:



Family survey

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What is your level of satisfaction with

High level
5


4


3


2

Low level
1

How the idea of the autopsy was presented to you?





The level of detail provided to you regarding an autopsy at the time of request?





The results of the autopsy?





The time it took to get the results?





The extent to which your questions were answered by the autopsy?





The opportunity to ask questions when the autopsy was requested?





The opportunity to ask questions when the autopsy results were explained?





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