A summary of deliberations on strategic planning for continuous quality improvement in laboratory medicine.

On September 24-26, 2007, the Centers for Disease Control and Prevention convened the 2007 Institute on Critical Issues in Health Laboratory Practice: Managing for Better Health to develop an action plan for change for the immediate and long-term future. A wide variety of stakeholders, including pathologists, pathologist extenders, clinicians, and researchers, examined means to improve laboratory service communication, quality parameters, and potential future laboratory contributions to health care. In this summary document, we present the identified gaps, barriers, and proposed action plans for improvement for laboratory medicine in the 6 quality domains identified by the Institute of Medicine: safety, effectiveness, patient centeredness, timeliness, efficiency, and equity.

Measuring quality in anatomic pathology.

This article focuses mainly on diagnostic accuracy in measuring quality in anatomic pathology, noting that measuring any quality metric is complex and demanding. The authors discuss standardization and its variability within and across areas of care delivery and efforts involving defining and measuring error to achieve pathology quality and patient safety. They propose that data linking error to patient outcome are critical for developing quality improvement initiatives targeting errors that cause patient harm in addition to using methods of root cause analysis, beyond those traditionally used in cytologic-histologic correlation, to assist in the development of error reduction and quality improvement plans.

Frequency and outcome of cervical cancer prevention failures in the United States.

We measured the frequency and outcome of cervical cancer prevention failures that occurred in the Papanicolaou (Pap) and colposcopy testing phases involving 1,646,580 Pap tests in 4 American hospital systems between January 1, 1998, and December 31, 2004. We defined a screening failure as a 2-step or greater discordant Pap test result and follow-up biopsy diagnosis. A total of 5,278 failures were detected (0.

Urine cytology discrepancies: frequency, causes, and outcomes.

Although urine cytology is used for the early detection and surveillance of urothelial carcinoma, there has been little study of the frequency, causes, and outcomes of cytologic-histologic discrepancies. We obtained histologic follow-up in 361 (6.2%) of 5,785 voided, 124 (19.

Use of a new method in reaching consensus on the cause of cytologic-histologic correlation discrepancy.

Pathologists exhibit very poor agreement in adjudicating the cause of cytologic-histologic correlation discrepancies, which contributes to problems in designing interventions to reduce discrepancy frequency. In this observational study, we developed a visual method of adjudicating discrepancy cause, termed the No-Blame Box method, which consisted of initially assessing specimen interpretability by separately evaluating specimen quality and the presence of tumor. Five pathologists blindly adjudicated the cause of discrepancy in pulmonary specimens from 40 patients.

Effectiveness of Toyota process redesign in reducing thyroid gland fine-needle aspiration error.

Our objective was to determine whether the Toyota Production System process redesign resulted in diagnostic error reduction for patients who underwent cytologic evaluation of thyroid nodules. In this longitudinal, nonconcurrent cohort study, we compared the diagnostic error frequency of a thyroid aspiration service before and after implementation of error reduction initiatives consisting of adoption of a standardized diagnostic terminology scheme and an immediate interpretation service. A total of 2,424 patients underwent aspiration.

Errors in thyroid gland fine-needle aspiration.

Scant published data exist on redesigning pathology practice based on error data. In this first step of an Agency for Healthcare Research and Quality patient safety project, we measured the performance metrics of thyroid gland fine-needle aspiration, performed root cause analysis to determine the causes of error, and proposed error-reduction initiatives to address specific errors. Eleven cytologists signed out 1,543 thyroid gland aspirates in 2 years, and surgical pathology follow-up was obtained in 364 patients.

Clinical impact and frequency of anatomic pathology errors in cancer diagnoses.

Background: To the authors' knowledge, the frequency and clinical impact of errors in the anatomic pathology diagnosis of cancer have been poorly characterized to date.

Methods: The authors examined errors in patients who underwent anatomic pathology tests to determine the presence or absence of cancer or precancerous lesions in four hospitals. They analyzed 1 year of retrospective errors detected through a standardized cytologic-histologic correlation process (in which patient same-site cytologic and histologic specimens were compared).

Database construction for improving patient safety by examining pathology errors.

A critical component of improving patient safety is reducing medical errors. "Improving Patient Safety by Examining Pathology Errors" is a project designed to collect data about and analyze diagnostic errors voluntarily reported by 4 academic anatomic pathology laboratories and to develop and implement interventions to reduce errors and improve patient outcomes. The study database is Web-mediated and Oracle-based, and it houses de-identified error data detected by cytologic-histologic correlation and interdepartmental conference review.

Pathology and patient safety: the critical role of pathology informatics in error reduction and quality initiatives.

Understanding the role of pathology informatics in patient safety entails an introduction to terminology and projects that have represented efforts to date in this area. The authors provide a short alphabetized introduction to several "buzzwords" and terms related to tools and processes that are used by health care research experts and workers involved in patient safety initiatives. The authors also include short descriptions of key health care research and patient safety projects that are relevant to pathology.

Barriers to the implementation of patient safety initiatives.

Since release of the Institute of Medicine Report "To Err is Human:Building a Safer Health System" in 1999, a huge effort has been expended on error-related clinically applied research and on the implementation of new standards and practices related to quality improvement and patient safety. Nonetheless, measurable improvements in the quality of delivered care and reductions in medical errors have been variable and modest in most cases. Multiple barriers to the implementation of patient safety and error reduction initiatives have been identified in the literature.

Use of physician extenders in surgical pathology practice.

Context: Use of a variety of nonphysician personnel for surgical pathology gross examination is generally known to be increasing, although detailed information regarding nonphysician use is currently unavailable.

Objective: To measure and describe the use of nonphysician personnel for surgical pathology gross examination in order to gain a better understanding of the current surgical pathology workforce.

Design: A voluntary, mailed questionnaire containing items related to the use of multiple nonphysician personnel types in surgical pathology was distributed to (1) a cross-sectional sample (n = 968) of US pathologists and (2) a purposive sample of pathologist directors of surgical and/or anatomic pathology (n = 77) located at teaching institutions.

Sensitive cytologic criteria for the identification of follicular variant of papillary thyroid carcinoma in fine-needle aspiration biopsy.

The cytologic diagnosis of follicular variant of papillary thyroid carcinoma (FVPTC) can be extremely challenging and may be associated with false negative diagnoses. The purpose of this study was to determine the minimal cytologic criteria needed to identify FVPTC. We examined sixty-nine fine-needle aspiration (FNA) cases, processed with Diff-Quik and Papanicolaou stains, that were either diagnostic or suspicious of FVPTC.

Pathology resident attitudes and opinions about pathologists' assistants.

Context: Changes in health care economics and organization have resulted in increased use of nonphysician providers in most health care settings. Attitudinal acceptance of nonphysician providers is important in the current health care environment.

Objectives: To obtain descriptive information regarding pathology resident attitudes and opinions about pathologists' assistants in anatomic pathology practice and to assess the implications of resident attitudes and opinions for pathology practice and training.

Willingness to pay for new Papanicolaou test technologies.

The amount of money a woman is willing to pay for liquid-based cytology technology has not been measured. In the present study, 175 women answered a questionnaire asking how much they would pay to decrease their risk of dying of cervical cancer if a new (liquid-based) Papanicolaou (Pap) test was used in place of the conventional smear. When women assumed that the new Pap test reduced the risk of dying of cervical cancer from 1 in 37,000 to 1 in 50,000, the mean amount they were willing to pay was $237.

Estimation of performance and sequential selection of diagnostic tests in patients with lung lesions suspicious for cancer.

Context: Measuring variation in clinician test ordering behavior for patients with similar indications is an important focus for quality management and cost containment.

Objective: To obtain information from physicians and nonphysicians regarding their test-ordering behavior and their knowledge of test performance characteristics for diagnostic tests used to work up patients with lung lesions suspicious for cancer.

Design: A self-administered, voluntary, anonymous questionnaire was distributed to 452 multiple-specialty physicians and 500 nonphysicians in academic and private practice in Pennsylvania, Iowa, and North Carolina.