Post hoc assessment of the relationship among coronary stenosis, electrocardiography, and ventricular function in patients with heart disease.

Cardiovascular diseases including cardiac arrhythmias lead to fatal events in patients with coronary artery disease; however, clinical associations from echocardiography, electrocardiography (ECG), and biomarkers remain unknown. We sought to identify the factors that may be related to elevated QRS intervals in patients with risk for coronary artery disease. In this study, we performed analysis of clinical data from 503 patients divided into two groups, i.

Requirements for accreditation by the College of American Pathologists Laboratory Accreditation Program.

The College of American Pathologists Laboratory Accreditation Program expects a participant laboratory or laboratory section to be able to demonstrate that it is in compliance with the Standards for Laboratory Accreditation. The program expects laboratories to demonstrate that they are continually taking steps to identify and correct deficient areas and improve performance, in compliance with the Clinical Laboratory Improvement Amendments of 1988 regulatory requirements, particularly those pertaining to proficiency testing performance, and participating as inspectors in the accreditation process.

Regulatory and accreditation implications of alternate-site laboratory testing.

The expectations of voluntary accrediting organizations and federal regulatory agencies with regard to laboratory performance standards that must be satisfied for alternate-site testing are described. The guidelines and requirements for accreditation of laboratory programs by the College of American Pathologists and the Joint Commission on Accreditation of Healthcare Organizations are demonstrated, along with applicable commentary.

Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988--Part II.

This is the second of two articles summarizing federal regulation of clinical laboratories and reviewing specific aspects of the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). This article includes a review of sanctions and enforcement, how laboratory inspections are likely to be performed, accreditation of private organizations, state exemptions, cytology and other specialty regulations, and the evolving implementation of CLIA 1988.

Accidental fires in clinical laboratories.

The National Fire Protection Association, Quincy, Mass, estimates that 169 fires have occurred annually in health care, medical, and chemical laboratories. On the average, there are 13 civilian injuries and $1.5 million per year in direct property damage.

Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988--Part I.

In this first part of a two-part article, we have summarized some of the pertinent features of CLIA 1988 with review of the complexity model, waived testing, personnel standards, proficiency testing and quality control requirements, and patient test management. In addition to a survey of other Federal regulations applicable to clinical laboratories, we have briefly reviewed events subsequent to the publication of the Final Rule in February of 1992, specifically the recommendations of CLIAC and the Technical Corrections published on January 19, 1993. The second part of this paper will discuss sanctions and enforcement; how laboratory inspections are likely to be performed, accreditation of private organizations, state exemptions, cytology and other specialty regulations, and the evolving interaction between CLIAC, FDA, CDC, DHHS, and the regulated laboratory community.

The history of evaluation criteria for CAP surveys.

I summarize the evolution of target-value assignment methods and laboratory performance assessment (evaluation) within the College of American Pathologists Interlaboratory Survey Programs and review the importance of, and longstanding interest in, medical relevance criteria in setting analytical goals.

Proficiency testing as a regulatory device: a CAP perspective.

The history and development of the proficiency testing programs of the College of American Pathologists are reviewed. Important considerations of external surveys include target value assignment and determination of acceptable ranges. "Blind" proficiency testing and on-site evaluation provide alternative methods of laboratory evaluation but are limited by practical logistics.

The patient with noncardiogenic pulmonary edema.

Based on the content of this article, the reader should be able to (1) identify the differences between cardiogenic and noncardiogenic pulmonary edema (NCPE); (2) identify the most common causes of airway obstruction leading to pulmonary edema; (3) state the mechanism of action for the development of NCPE following laryngospasm; (4) state the signs and symptoms of NCPE; (5) identify the treatment for NCPE; and (6) state three nursing actions that are indicated in the care of the patient with NCPE.

Cigarette smoke composition. Part 1. Limitations of FTC method when applied to cigarettes that heat instead of burn tobacco.

The design of a new cigarette that heats rather than burns tobacco calls for modifications to the Federal Trade Commission (FTC) method for analytical smoking. These changes include eliminating sample conditioning at 75 degrees F and 60% RH, exercising greater care in lighting cigarettes, and smoking cigarettes to self-extinguishment rather than to a predetermined butt length as a measure of complete consumption. By several gross analytical measures, smoke condensate from the new cigarette differs substantially from that of tobacco-burning cigarettes.

The law, regulations, and the clinical laboratory.

Almost every clinical laboratory, regardless of physical location, comes under the daily influence of a plethora of federal bureaus and administrations, state agencies, and local government entities. This article outlines which laws and regulations affect which types of clinical laboratories, who or what governmental organizations must be dealt with, and what impact these requirements have on the clinical laboratory.

Incest and child sexual abuse.

Child sexual abuse was examined nationally and in the Washington, DC and Howard University Hospital area. In an attempt to describe this widespread problem, two case histories are presented which reflect some of the typical characteristics of child sexual abuse cases seen at Howard University Hospital. Pertinent literature is reviewed citing the prevalence rates and the personality and environmental factors which may contribute to the sexual abuse of children in this country.

Risk of breast cancer in women with benign breast disease.

A group of 1,489 white women were treated in a private surgery practice from 1940 through 1975 for biopsy-proved benign breast disease, and 1,441 were followed through 1976 for the development of breast cancer. Average duration of follow-up was 12.9 years for a total of 18,617 person-years of observation.

Effects of bacterial contamination of reagent water on selected laboratory tests.

The effects of three widely spaced levels of bacterial contamination of reagent water on several chemistry, radioimmunoassay, and coagulation procedures were studied. These included determinations of lactate dehydrogenase, creatine kinase, aspartate transaminase, alkaline phosphatase, blood urea nitrogen, total protein, thyroid-stimulating hormone, digoxin, thrombin time, activated partial thromboplastin time, and prothrombin time. Statistical analyses included calculations of means and coefficients of variation, and analysis of variance, as well as correlation coefficients for test results versus logarithm of bacterial contamination.

Analysis of formaldehyde in tobacco smoke by high performance liquid chromatography.

Formaldehyde in tobacco smoke is allowed to react with 2,4-dinitrophenylhydrazine to form the dinitrophenylhydrazone. This derivative is extracted with chloroform and concentrated. The residue in methylene chloride is separated and analyzed by high performance liquid chromatography.