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. Information was collected from a set of questions devised in 1941 and asked of all subjects at the time of their initial office visit, follow-up interview conducted in 1976, and a standardized histology review of the slides from the initial benign lesions and the subsequent cancers. The current pathology review indicated that 66 of the women developed breast cancer. The incidence rate was 3.55 per 1,000 person-years, which is 2.10 times that of the general population. When multiple disease types and other variables were controlled for, excess risk of breast cancer was related to the presence of fibrocystic disease. In women with fibrocystic disease, excess risk was particularly related to the presence of epithelial hyperplasia and/or papias not related to the presence of fibroadenoma alone, but it was related to the presence of fibroadenoma in women with concomitant fibrocystic disease. The excess risk was also directly related to the estimated size of the initial benign mass and was greater for women with bilateral than with unilateral benign lesions.

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. Statistically and clinically significant differences occurred together only for an elevated level of creatine kinase.

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.

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.

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.

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.

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. Most fires in which the cause or ignition source can be identified originate in malfunctioning electrical equipment (41.6%) or in the facility's electrical distribution system (14.7%). The prevalence of fire safety deficiencies was measured in the College of American Pathologists Laboratory Accreditation Program. Of the 1732 inspected laboratories, 5.5% lacked records of electrical receptacle polarity and ground checks in the preceding year. Of these inspected laboratories, 4.7% had no or incomplete documentation of electrical safety checks on laboratory instruments. There was no evidence of quarterly fire exit drills in 9% of the laboratories. Deficiencies were also found in precautionary labeling (6.8%), in periodic review of safe work practices (4.2%), in the use of safety cans (3.7%), and in venting of flammable liquid storage areas (2.8%). Fire preparedness would be improved if all clinical laboratories had smoke detectors and automatic fire-extinguishing systems. In-service training courses in fire safety should be targeted to the needs of specific service areas.

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. Finally, the role of the physician in identifying and treating the physical and emotional effects of child abuse are discussed.

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. A column packed with 10-micron silica is used for separation. The internal standard is triphenylene. This method can also be used for the analysis of other carbonyl compounds in tobacco smoke that react to form hydrazone derivatives.

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.