“We are what we repeatedly do. Excellence, then, is not an act, but a habit.”—Aristotle
In 1986, the late Dr Israel (“Dick”) Diamond stated that “in the clinical laboratory our product is dependable, timely, and economical information. Quality assurance must determine whether this is what the patient is receiving and whether the laboratory has contributed to the patient's optimum and frugal care.” 1
Dr Diamond's words, still relevant today, were written as part of a dialogue with the leaders of the Joint Commission on Accreditation of Healthcare Organizations (now The Joint Commission). At this time (1987), the Joint Commission on Accreditation of Healthcare Organizations had embarked on a major multiyear project designed to identify “clinical indicators that active practitioners and experts in specific clinical fields determine to be most relevant to quality care.” 2
This project elicited concern within the pathology and laboratory community in that Joint Commission on Accreditation of Healthcare Organizations inspectors—not always familiar with the realities of laboratory practice—would seek to make pathologists fully accountable for practices and clinical outcomes that were often beyond the immediate control of the laboratory service. The conceptualization of the Q-Probes program arose primarily from the long-term and pioneering commitment of the College of American Pathologists and pathologists to well-established programs of quality assurance and improvement (eg, accreditation, proficiency testing). The rapid implementation of the Q-Probes program reflected the recognition by the College of American Pathologists leadership of the need to develop a comprehensive portfolio of periodic, specific, and robust off-the-shelf indicators (“snapshots”) of laboratory performance that were susceptible to quantitative and statistical analysis and would provide pathologists and their laboratory colleagues with the tools to measure their individual performance against group benchmarks and then to use the results to monitor, identify priorities, and improve performance. The Q-Tracks monitors were developed later to establish critical benchmarks in quality metrics and to monitor changes in performance over time. This program has successfully defined multiple benchmarks in many disciplines of the laboratory and has demonstrated significant performance improvement in benchmarks and in individual laboratory performance over time.
As the 3 papers in this special section devoted to the Q-Probes and Q-Tracks programs demonstrate, the goal has been achieved and, during the past 25 years, the programs have resulted in the accumulation of a vast database of laboratory and pathology service performance. The benchmarks of performance continue to serve as a guide to improved performance for laboratories in the United States and worldwide. Many of the indicators are a routine component of quality assurance practice in most laboratory settings and have become components of compliance with accreditation and regulatory requirements.
The scope and depth of the data concerning laboratory performance are told in the numbers (Table). The accumulated database is a comprehensive snapshot of laboratory medicine during the past 25 years but also is a valuable source of information and benchmarks for laboratories looking for ways to improve the quality and efficiency of their practices.
Will Q-Probes and Q-Tracks still be viable programs 25 years from now? If so, what will they look like, and what will be the challenges to Q-Probes and Q-Tracks and possible successor programs in the future? Any attempt to make predictions over time brings to mind the words of the Nobel laureate physicist Niels Bohr that prediction is very difficult, especially if it's about the future. Nonetheless, a short-term perspective identifies 3 key themes that will characterize health care and laboratory medicine and pathology.
The constantly increasing volume and complexity of data—particularly molecular and genetic—will require interpretive, operational, and computational capabilities not currently available. In the short term, recent requirements from the Department of Health and Human Services with regard to electronic health records will challenge pathologists and laboratory services.3,4
Can we envisage a Q-Probes study or Q-Tracks monitor in 2020 or sooner that will provide data on the integration of laboratory data into the electronic health record?
It is almost a certainty that current economic pressures and constraints on the health care system will continue and that pathologists and laboratory services will be under increasing mandates to provide increasingly complex services with fewer resources. As part of this trend, payment for laboratory and pathology services will be linked to demonstration of clinical utility and applicability to patient care. Perhaps the Q-Probes and Q-Tracks programs will be able to identify practices of “best performers” that are linked to cost-efficient solutions that do not excessively compromise quality of care. Can we envisage a Q-Probes study or Q-Tracks monitor in 2020 or sooner that will identify the most cost-efficient and best practices in the performance of next-generation sequencing?
Finally, regulatory and accreditation requirements designed to ensure quality and patient safety will increase in number and stringency. Although at present Clinical Laboratory Improvement Amendments of 1988 are the major determinant of regulation of pathology and laboratory services, initiatives by the Food and Drug Administration to regulate laboratory-developed tests may add additional regulatory requirements, particularly pertaining to clinical validity and the related issues raised by companion diagnostic tests.5
To help meet these challenges, can we envisage a Q-Probes study or Q-Tracks monitor in 2020 or sooner that will establish practical and reliable benchmarks for evaluating laboratory developed tests as to both analytic and clinical validity?
What, then, in conclusion, have we learned from the Q-Probes and Q-Tracks programs as we look back at the past 25 years? First and foremost, we have learned that a systematic and structured analysis of laboratory practice and performance is possible and that these studies can identify trends as well as attributes, determinants, and predictors of better performance that can be applied by laboratories to improve their own performance. We have also learned that the Q-Probes studies and Q-Tracks monitors have encouraged and enabled pathologists and laboratory professionals to emerge from the comfortable cocoon of the microscope and the clinical laboratory and engage in the rough-and-tumble world of the clinical environment.
And, finally, we have learned that pathologists and laboratory professionals in the United States and in other countries are willing to voluntarily devote time, effort, and money to improve the quality of preanalytic, analytic, and postanalytic practice as well as contribute to the significantly increased emphasis on patient safety issues initiated 15 years ago by the Institute of Medicine report.6
This, then, is the definitive message as we recognize and honor 25 years of effort and achievement by the College of American Pathologists and the volunteer members and staff of the Q-Probes studies and Q-Tracks monitors for their foresight in developing and implementing these landmark programs and for their outstanding contribution to the professional practice of pathology and laboratory medicine.
The author has no relevant financial interest in the products or companies described in this article.