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The 1980 comprehensive blood bank survey of the College of American Pathologists.

Results of the 1980 Comprehensive Blood Bank Survey of the College of American Pathologists are summarized in tabular form. The overall mean of correct responses among participating laboratories showed a high degree of correlation with Referee Laboratory results in ABO and Rh D typing as well as in crossmatching. Some problems existed in the identification and recognition of multiple alloantibodies and in the identification of an alloanti-c in the presence of rouleaux. Ungraded sample results are reported as well as responses to questions regarding the current standards of practice in hospital blood banks.

ABO Blood-Group System↗

A survey of speech pathologists: current trends in the diagnosis and management of velopharyngeal insufficiency.

A questionnaire designed to survey methods of diagnosis and management of velopharyngeal insufficiency associated with cleft palate was distributed to over 1,000 speech pathologists in the United States and Canada. There was a 60% response, and 65% of those responding were associated with cleft palate teams. Findings included: (1) 90% of responding cleft palate team members primarily rely on listener judgment, oral examination, and articulation testing in the diagnosis of velopharyngeal insufficiency (VPI) and for the recommendation of pharyngoplasty. (2) Only 11% indicated that their team had a radiologist. (3) More than half of those responding said that they would prefer palatal repair to be completed after the age of two. (4) 60% of those responding regarded VPI as a voice disorder, yet 84% treated the symptoms of VPI with articulation therapy rather than voice therapy.

Age Factors↗

The surgical pathologist as researcher.

Most surgical pathologists have the opportunity to perform research. Research in surgical pathology can be classified as: (1) observational; (2) manipulative with human tissues; (3) experimental with nonhuman models; and (4) technical, instructional, and delivery. Examples of each of these forms of research are presented, as are comments on the academic stature and funding problems of research in surgical pathology.

Animals↗

Current status of rubella testing: a report based on data from the College of American Pathologists' surveys, 1978-1980.

Data from national survey programs were used to define selected attributes of popular rubella methods. Of those participating in the College of American Pathologists' survey, 47% used passive hemagglutination (PHA); 45% used hemagglutination-inhibition (HI), 7% used indirect immunofluorescence, and less than 1% used enzyme immunosorbent assays for rubella testing. Enzyme assays were not evaluated. The other methods had sensitivities and specificities exceeding 94% and 88%, respectively. The predictive value of a negative test was used to identify differences among the various methods. The HI tests using human O cells had a 90-95% prediction rate for a true-negative result. Indirect immunofluorescence, PHA, and HI using kaolin had the lowest predictive values (68-72%) values for other methods were intermediate. Levels of reactivity also differed. The HI methods using human O cells yielded higher titers than did the reference method (1- to 3-day-old chick/heparin MnCl2), while the titers for HI methods using kaolin tended to be lower.

Animals↗

The speech pathologist and management of children with tracheostomies.

Troublesome airway problems necessitating the presence of a tracheostomy for extended periods of time are now not uncommon in children. To date, little attention has been devoted to the communication problems these young patients encounter. Experience with 44 children with tracheostomies, some of whom are ventilator-dependent, at the Children's Hospital of Philadelphia has enabled us to develop a therapy program that we feel would be useful to other speech professionals treating such patients. The speech pathologist must take an active role in the evaluation and management of these patients and the education of the family and hospital staff. The ultimate goal is to provide communicative and feeding skills to these handicapped children.

Bronchopulmonary Dysplasia↗

Long-term stability of glucose in lyophilized quality control serum. A study utilizing data from the Quality Assurance Service (QAS) Program of the College of American Pathologists.

The long-term stability of glucose in 45 commercial pools of lyophilized quality control serum is evaluated. The pools have been used in conjunction with the Quality Assurance Service (QAS) of the College of American Pathologists by laboratories participating in Regional Quality Control Programs. Directional instability of glucose was detected by at least one analytic method in 69% of the pools studied. Two distinct and opposite directional trends in glucose concentration were found. Increasing concentration of analyte, averaging 4.7 mg/dl per year, were observed with manual and automated glucose oxidase methods and the automated neocuproine procedure in approximately one fourth of pool--method combinations. Decreasing concentrations of glucose, averaging 3.0 mg/dl per year, were found with automated ferricyanide and hexokinase methods and the manual orthotoluidine procedure in approximately one third of pool--method combinations. The results are best explained by postulating that in affected pools there is a gradual diminution of free and bound glucose and/or a shift of glucose from the protein-bound to the free state.

Autoanalysis↗

Interlaboratory performance of disk agar diffusion and dilution antimicrobial susceptibility tests, 1979-1981. A summary of the microbiology portion of the College of American Pathologists (CAP) surveys.

The antimicrobial susceptibility test results of the 1979-1981 College of American Pathologists (CAP) Microbiology Surveys are summarized for the disk diffusion and dilution test methods. Improved interpretive accuracy (97.5%) was detected for the Special Bacteriology participants compared with those reported for 1972 and 1977-1978. The performance accuracy rates for the Comprehensive and Basic Surveys subscribers was 95.8% and 93.7%, respectively (all surveys accuracy rates was 95.2% from 196,775 responses). The dilution methods were graded since 1980 and showed an acceptable or good performance rate of 98.0%. Most reported MICs were from commercial systems, especially those performed in frozen broth microdilution systems. Eighteen per cent of all susceptibility tests are now reported as MICs. Quality control data shows a trend away from costly daily control practices without compromise of test accuracy. Several problem areas continue to plague these methods: (1) poor predictive value of disk results for enterococci; (2) availability of low potency disks with suboptimal accuracy rates, e.g., the 50 micrograms carbenicillin disk; (3) the release of more new drugs requiring individual testing beyond the capacity of the test systems; (4) vague recommendations for reporting and testing certain bacterial species, e.g., methicillin-resistant staphylococci and penicillin-resistant pneumococci; and (5) the lack of contemporary modification in FDA package insert quality control and interpretive criteria guidelines that might reflect new test or therapeutic information. Overall, the 1979-1981 surveys results show improved performance to a high level of predictive and interpretive accuracy among all subscriber groups coupled with a shift toward the more informative quantitative dilution methodologies.

Agar↗

Analytical goals and the College of American Pathologists.

Classifications of measurement procedures rank routine control and laboratory simulation as the most difficult measurements. Their use in laboratory medicine has led to the development of a science whose purpose is to quantitate various characteristics of laboratory performance. The College of American Pathologists application of the science takes the form of its quality assurance programs, notably the Survey Programs. Until recently, however, the concern for reduction of analytical error and the engrafted aspects of regulation have diverted attention from the major purpose of the programs: the establishment and achievement of analytical goals based on clinical utility. The College is working toward these ends, and its work is based on the following principles: (1) formulation of analytical goals is the responsibility of the profession; (2) the analytical goals are a scientific composite of total analytical error, biologic variation, and medical judgement; (3) analytical goals must be adjustable to accommodate laboratory and clinical advances.

Data Collection↗

Performances of urine pregnancy tests on College of American Pathologists Survey specimens.

The participant performances on the College of American Pathologists (CAP) Urine Survey specimens distributed during 1979 and 1980 for pregnancy testing are reviewed. Almost all the reagent methods used by the participants performed well on the negative specimens. Prominent differences in results on the positive specimens were found. Awareness by laboratorians of the reagent sensitivity, limitations, and capabilities of commercial tests for determining human chorionic gonadotropin in urine is recommended.

Chorionic Gonadotropin↗

Interlaboratory survey of Enzyme Analyses iii. Does College of American Pathologists' survey serum mimic clinical specimens?

Participants in the last College of American Pathologists Enzyme Surveys in 1978 were asked that they provide results for lactate dehydrogenase (LD), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatine kinase (CK), for the six interrelated Enzyme Survey serum specimens, and were also asked to provide results for the same enzymes from six healthy persons and from 50 patients. Extensive data analysis revealed that porcine LD and CK in the Survey serum had kinetic properties similar to the native enzymes in fresh human serum. On this basis, we were able to merge the normal data from laboratories using diverse methods and to establish a "universal" reference range for these two enzymes. Survey serum may serve as a bridge for the clinical comparison of very diverse methods for determining LD and CK, possibly for AST and ALT, but not for ALP.

Alanine Transaminase↗

Intralaboratory analytic precision as estimated from two distinct programs from the College of American Pathologists.

Results for serum sodium and calcium analysis reported to the College of American Pathologists' (CAP) Basic and Comprehensive Chemistry Surveys and to the CAP Quality Assurance Service Program showed good consistency in estimates of intralaboratory analytic precision. The results compare favorably with those obtained in independent studies and indicate that CAP data sources can be used as reliable indices of analytic performance in the clinical laboratory.

Blood Chemical Analysis↗

The battered child syndrome: a forensic pathologist's viewpoint.

Most evidence in child abuse cases is circumstantial, and thus the main thrust of the defense is to create doubt, by arguing that the child did not die as a result of being beaten, or by arguing lack of intent. The pathologist will be most helpful to the case if he can give a strong opinion backed by scientific conclusions. A painstakingly detailed autopsy protocol will be of value.

Abdominal Injuries↗

The Comprehensive Blood Bank Survey of the College of American Pathologists--1978.

Approximately 2,200 laboratories participated in the 1978 Comprehensive Blood Bank Survey of the College of American Pathologists. Correct responses of the test results on the blood specimens were determined by 13 Referee Laboratories. Participants' results were compared with Reference Laboratory results. Overall performance on ABO and Rh D typing revealed 98.3% concurrence. Errors in ABO grouping and Rh typing were most frequently found to be "clerical" rather than "technical." Antibody studies and crossmatching revealed variable results in the detection, identification, and evaluation of the clinical significance of a weak, naturally occurring antibody (anti-P1) and in the crossmatching of weak immune antibodies (anti-e and anti-D). Over 95% of participants correctly responded on antibody studies and crossmatching results with a serum containing a moderately strong anti-Fya. Ungraded specimens provided during the year yielded "state of the art" information on a variety of problems.

Antibodies↗

Recruitment and training of the surgical pathologist.

Training programs in surgical pathology currently produce and in the future will produce surgical pathologists with two levels of expertise. The first is the product of the four-year combined residency program. The training program must take into consideration the need of these trainees to attain an acceptable level of expertise in surgical pathology at the time they complete a four-year AP-CP pathology residency program. The trainees in the subspecialty of surgical pathology develop special knowledge and technical skills, often with expertise in a special area. Training of the subspecialists should be limited to those institutions with adequate case material, senior staff, and technical capabilities. Recruitment of the subspecialists from the general pool of trainees in pathology is likely to continue. The ASCP/CAP/APC Joint Task Force on Pathology Manpower in future studies should assess the needs for surgical pathology subspecialists so that funding for traineeships can be sought.

Curriculum↗

College of American Pathologists Conference XXVIII on alternate site testing: introduction.

The College of American Pathologists Conference XXVIII, Alternate Site Testing Conference: Venturing Beyond the Boundaries of the Clinical Laboratory, was held from January 29 through February 1, 1995. This open format consensus conference gathered together individuals with many different points of view on the topic of hospital laboratory testing in noncentralized laboratories. The goals of the conference were to establish a basis for common beliefs about alternate site testing, to discover where consensus existed, and to establish future directions for consensus development and resolution of disputes in this sometimes contentious and confusing area of laboratory medicine. Attainment of the goals was attempted through a variety of conference activities, including plenary addresses, poster sessions, and, most importantly, through open-forum breakout sessions. During the breakout sessions all conference attendees were invited to contribute ideas toward the development of consensus about critical issues surrounding alternate site testing. Although it is clear that much work remains to be done if we are to learn how to use alternate site testing strategies to the best advantage, an important beginning has been made. The stage has been set as we continue to provide high-quality laboratory testing in an era that demands both fast turnaround time and optimal cost effectiveness.

Centralized Hospital Services↗

Timeliness of clinical laboratory tests. A discussion based on five College of American Pathologists Q-Probe studies.

Along with accuracy and reliability, timeliness is considered an essential quality for laboratory tests. Only for highly specific instances involving situations in operating theaters has timeliness been shown to affect outcome. Some studies have shown timeliness can shorten length of stay in certain emergency department situations, but rarely for hospital inpatients. Clinicians' expectations for emergency department laboratory test timeliness call for results in less time than the laboratory expects to or does provide. Data from five College of American Pathologists Q-Probes studies on test turnaround time support these observations, but also show central laboratories can provide results in a timely fashion if they optimize the total testing process.

Diagnostic Tests, Routine↗

The confidential unit exclusion and allogeneic blood donation. Results from supplementary questions to the Donor Center and Viral Markers surveys of the College of American Pathologists.

OBJECTIVE: The confidential unit exclusion (CUE) is a mechanism for allogeneic blood donors to confidentially indicate whether they feel their blood is safe for transfusion to others. The purpose of this national survey was to determine the extent of use of the CUE procedure and its related policies. DESIGN: Supplementary questions related to the use of the CUE were asked of those 1994 DC-C, W1-C, and W2-C College of American Pathologists survey subscribers who collect allogeneic blood for transfusion. SETTING: National survey. PARTICIPANTS: Blood collection facilities who collect allogeneic blood components. MAIN OUTCOME MEASURES: Survey responses. RESULTS: There were a total of 2966 total participants in the 1994 DC-C, W1-C, and W2-C surveys. A potential total of 444 participants indicated that they collected allogeneic blood and were eligible to participate in the CUE survey. A variety of approaches are used concerning donor deferral, reinstatement, and follow-up in the use of the CUE. Documentation and donor counseling issues also show variation. CONCLUSIONS: Different approaches and procedures have been developed by collection facilities to address issues related to the use of the CUE. More data on the efficacy and cost-effectiveness of the CUE are needed.

Blood Donors↗

Rescreening in gynecologic cytology. Rescreening of 3762 previous cases for current high-grade squamous intraepithelial lesions and carcinoma--a College of American Pathologists Q-Probes study of 312 institutions.

OBJECTIVE: To quantitate, characterize, and analyze errors identified in the rescreening of previous gynecologic cytology specimens with original diagnoses of "within normal limits" or "benign cellular changes" for current cases diagnosed as carcinoma or high-grade squamous intraepithelial lesion. DESIGN AND SETTING: College of American Pathologists Q-Probes laboratory quality improvement study in 312 laboratories. MAIN OUTCOME MEASURE: False-negative rate in cases rescreened as a result of a current cytologic diagnosis of carcinoma or high-grade squamous intraepithelial lesion. RESULTS: During the examination and reporting of 1,741,515 current Papanicolaou smear cases, participating laboratories rescreened a total of 3762 previous cases that were originally diagnosed, during the 5 years prior to the current case, as being within normal limits or having benign cellular changes. For the rescreened cases, the overall false-negative rates were 10.1% using a narrow definition and 19.7% using a broad definition. The majority of errors for cases originally diagnosed as within normal limits were screening errors, while interpretive errors predominated in those cases originally diagnosed as having benign cellular changes. Eighty-six percent of all false negatives were identified in those previous cases that were originally diagnosed and reported in the 3 years prior to the current case. CONCLUSIONS: Rescreening of previously reported smears, in patients with current abnormal findings, as one component of a complete quality improvement program, identifies errors that may provide information that will enable a laboratory to improve future performance.

Carcinoma↗