Basic Quality Assurance Research Articles

The oncologic pathology report. Quality by design.

To review tenets of basic quality assurance and identify opportunities for quality improvement in the laboratory assessment of prognostic factors. College of American Pathologists Q-Probes data obtained from hundreds of American laboratories throughout the 1990s are used to illustrate laboratory performance and practice opportunities in the preanalytic, analytic, and postanalytic phases of the total testing process. A wide range of performance deficiencies are documented, most in the preanalytic and postanalytic phases, and contributed by individuals outside and not under the control of the laboratory. In the analytic phase, the effectiveness of checklists on the content and completeness of reported diagnostic and prognostic data for breast and colon cancers is proven. In the preanalytic phase, marked enhancements in quality would result from improvements in (1) patient and specimen identification, (2) adherence to patient-sampling and specimen-handling requirements, and (3) communication to the laboratory of the pertinent clinical context of the individual test. Once basic analytic quality control and laboratory quality assurance issues are resolved, a focus on standardization and enhancement of preanalytic and postanalytic communications and satisfaction of clinical expectations becomes the source of improved laboratory performance.

The Principles of Clinical Cytogenetics

By Steven L. Gersen and Martha B. Keagle, 558 pp, with illus, Totowa, NJ, Humana Press, 1999.The Principles of Clinical Cytogenetics is a textbook and reference covering the gamut of cytogenetics; topics include basic molecular biology, cytogenetic nomenclature, quality control and quality assurance, prenatal cytogenetics, cancer cytogenetics, fluorescence in situ hybridization, imprinting, and genetic counseling, among others. Considering its large number of illustrations, this book is a relative bargain and should find wide applications. It will certainly fill a previously empty spot on the bookshelves of cytogenetic technologists and laboratory directors, genetic counselors, and clinical geneticists. Because of its clinical orientation, it should also be welcome in other clinical settings, such as in pathology residents' rooms. Teachers of some undergraduate and graduate courses in genetics and cytogenetics may find the book a good choice for their reading lists.Because this book is a compilation of works by different authors, the various chapters are not uniformly targeted to a particular audience. Some of the chapters cover very basic principles, while others resemble literature reviews. The chapter entitled “DNA, Chromosomes, and Cell Division” is a primer that covers elementary molecular biology and cell biology. In contrast, the chapter on cancer cytogenetics essentially assumes that the reader possesses an understanding of the concepts of oncogenes and tumor suppressor genes and their applications in cytogenetics. It does not contain a single molecular diagram of a gene fusion resulting from a recurring translocation. However, cancer cytogenetics is a massive subject suitable for an entire book on its own. Furthermore, this chapter focuses on the cytogenetic aspects of cancer and has a large number of useful tables and an impressive reference list. Some of the more circumscribed topics, such as structural rearrangements and spontaneous abortions, permit a more complete treatment and are well written. The chapter-to-chapter variation of this book has a very positive aspect in that there is something for everyone.Because chromosomes are inherently beautiful to those who work with them, a comment on the figures is in order. Most are good to excellent, but some could be improved. For example, the Q-banded karyotype on page 34 is speckled with white debris, the silver staining on page 84 will not be evident to those not already familiar with the process, and the fluorescence in situ hybridization signal over the marker chromosome on page 459 is not at all clear.There are a few inevitable mistakes. Perhaps predictably, some of the ones that may go unnoticed by novice cytogeneticists are in the nomenclature chapter. For example, the long form description on page 47 of an interstitial deletion is incorrect, and genes are not listed in pter to qter order in 2 fluorescence in situ hybridization examples on page 59. In the autosomal aneuploidy chapter, the definition of aneuploidy is at best confusing; it would have been better to stick with the usual definition of a chromosome number other than 23n.I point out these small problems in the hope that there will be future editions. This book was a substantial undertaking and provides a convenient resource for information not previously available in one place.

Colorectal high-grade adenomas: incidence, localization and adenoma-adenocarcinoma ratio in a retrospective and comparative population-based study of 225 consecutive cases between 1988 and 1996.

Colorectal high-grade adenomas can be regarded as precancerous lesions. This study collected epidemiological data from a defined region (Luxembourg) that can serve as reference data for designing a national screening program for early colorectal cancer detection. Nine pathologists diagnosed and reviewed slides retrospectively from 288 new colorectal and anal in situ carcinomas from the period 1988-1996 (63 were excluded for various reasons). In all, 225 new colorectal high-grade adenomas were considered. There were 129 men (57%) and 96 women (42%), and 78% of patients were aged over 60 years. Over this period we found an increase in incidence of high-grade colorectal adenomas (11 cases in 1988, 40 cases in 1996) for both sexes. The overall incidence rate was 2.9 x 100,000 in 1988 and 9.6 x 100,000 in 1996. The average annual age-standardized incidence rate for this period was 3.7+/-0.5 (95% confidence interval); the cumulative rate (0-74 years) was 0.4%. Three-fourths of the adenomas were situated in the rectum (n=78, 35%) or sigmoid colon (n=92, 41%). Histological diagnosis was provided by 160 total polypectomy specimens (71%), 30 surgical resections (13.3%), and 35 biopsy specimens (16%). Over the study period there was an increased incidence of new colorectal adenocarcinomas. There were eight times as many adenocarcinomas (n=1782) as adenomas (n=225); the distribution of anatomical sites was comparable. These epidemiological data on 225 new colorectal high-grade adenomas can be the basis for quality assurance in clinical and histological diagnostic procedures, especially in regard to the 1:8 ratio between high-grade adenomas and invasive adenocarcinomas and may provide additional data for the design of a regional or national colorectal cancer screening program.

Analysis for the stability of platinum‐containing species in soil samples using capillary electrophoresis interfaced on‐line with inductively coupled plasma mass spectrometry

AbstractOnline interfacing of capillary electrophoresis (CE) with inductively coupled plasma‐mass spectrometry (ICP‐MS) has been accomplished using a laboratory‐made nebulizer. The high resolution of CE is used for the separations of Pt species of standard solutions and real samples, followed by ICP‐MS for element‐specific detection within 12 min. The samples are analyzed immediately after sample preparation or after 2–4 h of aging in order to elucidate undesired species transformations which may occur before analysis. The method was proven not to impair the species during the analytical procedure while being a necessary prerequisite to judge time‐dependent species transformations. Quality control aspects concerning species stability during the analytical procedure and stability of electrical current during nebulization were studied. A possibly interfering suction flow was estimated and found to be negligible. The results will serve as a basis for quality assurance in future investigations about Pt speciation in soil.

Value Purchasing in Medicare Law: Precursor to Health Reform

Since the advent of Medicare in 1966, a major focus of federal policy and legislation has revolved around the purchase of health care. Although initial programmatic content demonstrated some concern for both cost containment and basic quality assurance, by the late 1970's congressional cost control anxiety had reached a fever pitch, culminating in a completely revamped Medicare hospital reimbursement methodology enacted in 1982, combined with a retooled utilization control mechanism in the form of the Peer Review Organization (“PRO”) program.At the same time, in the private sector, as the cost of health care increased, major corporate purchasers of health care services became increasingly concerned about the “value” of the health care benefits they were making available to their employees. In response to perceived consumer demand, these same corporations eventually, for reasons unrelated to health care, began to incorporate quality improvement into their core manufacturing and service missions.

Quality assurance for bone densitometry research studies: Concept and impact

A concept for quality assurance (QA) in bone densitometry has been developed for clinical multicenter studies. Major elements provided by a coordinating center comprise (1) consulting services and certification of participating centers in the start-up phase of the study, (2) review of scan data acquired on QA standards for cross-calibration and longitudinal assessment of scanner stability, (3) review of selected patient data as well as of problem cases during the study, and (4) comprehensive review and correction of patient results based on QA data after conclusion of the study. Limitations of phantom-based QA data should be acknowledged. Typical problems encountered during research studies and guidelines for solutions are presented. Successful implementation of QA measures may yield substantial enhancement of statistical power. Depending on the study design and the variability of response within patient groups, improvement in precision due to QA measures may reduce the smallest detectable difference between subject groups or, alternatively, sample size by a few to more than 50%, and thus may contribute to a substantial reduction in study cost. Formulae for calculation of the magnitude of these effects are presented. To maximize the net benefit, QA efforts have to be limited to levels that assure reliability of the data at acceptable QA cost. While QA programs at individual clinical sites or for local practitioners may not need to be as extensive as for multicenter clinical trials, awareness of the potential problems and implementation of basic QA measures will help in obtaining high-quality bone densitometry results.

Basic quality assurance tests for Linac-based radiosurgery

Basic quality assurance tests for Linac-based radiosurgery

Formatting Departmental Quality Assurance Minutes to Meet Internal and External Needs

This article presents a method that is helpful in achieving compliance with the JCAHO medical staff monitoring standards. Since the QA activity of the medical staff is of great importance to the institution, it is imperative that monitoring activities are clearly documented and easily evaluated. Through the use of a standardized departmental minutes format, each clinical department is prompted to address the monthly activity relating to each of the basic quality assurance functions. These minutes can be "scored" using an evaluation tool suitable for review by the Medical Executive Committee. This enables the committee to track the status of each department's use of the "Ten Step Process." This method has successfully met the challenge of a recent JCAHO accreditation visit. The use of the standardized departmental minutes format and the evaluation tool provide a method to successfully meet the JCAHO medical staff quality assurance standards.

Electronic Fetal Monitoring: Education Quality Assurance

Although electronic fetal monitoring (EFM) has been widely used in clinical practice for more than two decades, educational standards and competency validation for EFM use in hospitals have been developed only recently. This article highlights a community hospital's program for EFM. Basic education, staff development, and quality assurance activities involving staff nurses and managers are discussed.

A case mix procedure for matching the clinical characteristics of patients with dual disorders to planned treatment and treatment costs.

A procedure for matching the clinical characteristics of patients with a dual substance abuse psychiatric disorder to planned treatment resource consumption is described. The procedure uses current standards and practices within the mental health literature on dual diagnosed patients, providing an empirical basis for quality assurance, utilization review, and program evaluation. These procedures permit an empirical linking of clinical service performance to the costs of clinical resources, thereby providing a means of: (a) evaluating program costs in terms of the specific clinical characteristics of patients and (b) planning budgets based on the patients' clinical needs. The methods are sufficiently flexible so that as new clinical research recommend changes in assessment and treatment, the case mix definitions and evaluation procedures can be easily modified.

Measures of testability as a basis for quality assurance

Program testing is the most used technique for analytical quality assurance. A lot of time and effort is devoted to this task during the software lifecycle, and it would be useful to have a means for estimating this testing effort. Such estimates could be used, on one hand, for guiding construction and, on the other, to help organise the development process and testing. Thus the effort needed for testing is an important quality attribute of a program; they call it its testability. They argue that a relevant program characteristic contributing to testability is the number of test cases needed for satisfying a given test strategy. They show how this can be measured for glass (white) box testing strategies based on control flow. In this case, one can use structural measures defined on control flowgraphs which can be derived from the source code. In doing so, two well researched areas of software engineering testing strategies and structural metrication are brought together.< >

The SafetyNet project

SafetyNet is a computerised, networked patient care system currently under development in the South Camden sector of Bloomsbury Health Authority. The project is primarily targeted at the clinical monitoring of people suffering from schizophrenia and the system incorporates measures which can provide a basis for quality assurance of care and a clinically driven approach to audit. SafetyNet is being designed to help keep track of individual sufferers, chart their needs as they change over time, prompt the services to action and knit together the responses needed from different agencies. It is a modular system which can be adapted to the needs of people with different kinds of mental illness and to different community populations.

Acceptance Testing of a Computerized Tomographic Scanner

Computerized tomographic scanners have gained quick and widespread acceptance in diagnostic radiological practice. The cost of such units is currently about a half million dollars. Technologically, they are one of the most complicated pieces of equipment to be found in a radiology department. Because of the cost and complexity, it seems logical to set up performance specifications, acceptance tests, and a quality assurance program for a CT scanner. Pertinent performance specifications are herein described and discussed. In order to assure that the CT unit does meet specifications, appropriate acceptance tests are likewise discussed. Finally, a basic quality assurance program is outlined with an indication of the tests to be performed and their time frequency.

New trends in product testing

The traditionally prosaic practice of product testing within the manufacturing communi ty is becoming more dramatic and profit sensitive. Of course, product testing has always been respectable, but it is now both fashionable and essential. Moreover, new forms of testing are emerging to cope with the rapidly changing climate. Approaches to the problem range from no testing at all to highly sophisticated zero defec t scrutiny. The average manufacturing organization, however, has confined its testing program within narrowly defined functions and limits. The major direction of such programs is the identification of rejects, merchandise so defective that it is not salable. These minimum product testing programs serve two basic quality assurance functions: they prevent shipment of items which do not meet minimum standards and they warn of actual or potential problems in the production process which can result in items below standard in quality. Minimum standards have been related to function, appearance, and hazard. An item must function as represented at the time of purchase. For example, a light bulb which does not light is bad news from the beginning. In addition, the item must meet its expected potential; the light bulb that fails a week after installation is not acceptable. As for appearance, organizations with a minimal testing program may use only a simple visual judgment as a basis for acceptance or rejection. Concern for hazard or product liability implications has always been a factor in testing programs but has jaot been so strong as today. In short, the traditional approach to product testing was based on a set of economic trade-offs. These balanced, however crudely or intuitively, the probabilities and costs of such adverse events as lost sales, handling complaints, and liability actions against the cost of testing at various levels of assurance. The marketing and manufacturing climate has been altered in the past ten years. The cumulative impact of a series of changes is not fully appreciated in many companies. Consumerism is the most significant and far 31

Interim Checks For Machine Tools

Interim checks of machine tools allow preventative maintenance and are a basis for quality assurance in manufacturing. Interim checks should be fast, and therefore fast checks, like the diagonal displacement test, are introduced. Another possibility for interim checks is the manufacturing of standardized test pieces. Possibilities with the ISO test piece for machining centres are discussed. Standardized test pieces or just elements of test pieces or fast and comprehensive tests will give manufacturers more information on their machine tools at lower costs. 1 Why interim checks? The aim of interim checks is to monitor the performance of the machine tool and to recognize any changes in the performance. An optimum monitoring of the machine tool allows machine maintenance before workpieces are out of tolerance or before a mechanical breakdown occurs. On universal NC machine tools programming errors can cause crashes, after those an interim check may provide information on whether the crash caused any damage to the machine. On a single purpose machine tool the periodic check of the workpiece gives the necessary information on the performance of the machine and on any changes in its performance. On a universal machine tool, like a machining centre or a turning centre, the workpieces produced can have significant different features. Transactions on Engineering Sciences vol 16, © 1997 WIT Press, www.witpress.com, ISSN 1743-3533