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Voluntary dental laboratory certification program. Council on Prosthetic Services and Dental Laboratory Relations.

Laboratory certification does not offer concrete guarantees of consistent high quality of products or services. It does, however, identify, for the dental profession, a competency and acceptability factor on which to base a predication of performance by the laboratory. Also, laboratory certification establishes a framework within which the dental laboratory industry can work to continue upgrading its facilities and personnel, demonstrates the concern of certified laboratories for continuing competence, and indicates to government and third-party payers a willingness to develop standards endorsed by the industry.

Certification

The impact of laboratory improvement programs on laboratory performance: the CLIA 67 experience.

The experience acquired by the Center for Diseases Control during the past 7 years in the administration of the Clinical Laboratories Improvement Act of 1967 suggests that the key indicators of reliability have been identified and that sensitive measurement of those indicators is now possible and practical. The costs of assuring high quality are inconsequential compared to the costs to the patient and taxpaying public of inaccurate test results. This objective system for evaluating clinical laboratories has been applied to licensed interstate laboratories and has been shown to be effective. This proven system has been offered to the Bureau of Health Insurance of the Social Security Administration for application to Medicare laboratories.

Communicable Disease Control

Chromosome aberrations and sister-chromatid exchange in workers in chemical laboratories and a rotoprinting factory and in children of women laboratory workers.

Cultured lymphocytes from 73 workers in chemical laboratories and the printing industry were found to have a significantly increased frequency of chromatid and isochromatid breaks, in comparison with 49 control subjects (42 adults and 7 children). An increase of the same magnitude was also found in 14 children, aged 4 days--11 yr, of 11 women laboratory workers who had worked during pregnancy. A significant correlation between age and frequency of chromosome aberrations was noted for both the exposed and control children but not for the adults. The frequency of sister-chromomatid exchange was significantly increased in 12 technicians working in laboratories performing hormone analysis. 4 children of 2 female technicians working during pregnancy also had a significnatly increased frequency of sister-chromatid exchange. The cause and biological significance of these findings are not yet known.

Adolescent

Diagnosis of liver diseases by laboratory results and discriminant analysis. Identification of best combinations of laboratory tests.

Patients with different liver diseases were studied by discriminant analysis. Groups of patients classified mainly on the basis of liver biopsy findings showed functional differences which permitted a consistent reclassification by discriminant functions using laboratory results. Optimal combinations of laboratory tests for the separation of liver diseases were defined. Different combinations were found, dependent on the subsets of liver diseases studied.

Acute Disease

The diagnostic laboratory and its relationship to practitioners. Diagnostic laboratory professional staff.

Diagnostic services provided to practitioners include necropsy, histopathology, bacteriology, virology, parasitology, immunopathology, clinical pathology and toxicology. Services are also available at the college in avian and aquatic diseases. The laboratory expects to continually upgrade its services through the addition of appropriate tests, re-evaluation of existing tests, development of methods for more convenient specimen collection and shipment, increased responsiveness to veterinarians' needs, epidemiological investigations, and continuing education.

Animals

Quality control in laboratory investigations on Schistosoma mansoni in St. Lucia, West Indies. Maintenance of artificial prevalence as a laboratory aid.

A method is described of maintaining an apparent S. mansoni prevalence rate of 10% in an area estimated to have a natural rate of below 5% following two chemotherapy campaigns. To sustain interest and therefore accuracy among microscopists engaged on screening, known S. mansoni-positive stools were seeded, without their knowledge, among those collected in the field. The problems of achieving a desired level of seeding, and of a possible further dimension of the scheme are discussed.

Clinical Laboratory Techniques

Survey of diagnostic laboratories highlights need for improved standards in somatic genomic testing and reporting.

There is a growing international need to support somatic genomic testing, standardised variant curation and improved patient access to molecular profiling for somatic conditions, including cancer. We conducted a survey of scope, curation, reporting and sharing practices of diagnostic laboratories performing somatic testing in Australia and New Zealand. Laboratories with accreditation (n = 41) were invited in 2023 to complete a semi-structured, 25-question interview. Responses were received for 27 laboratories (66% response rate) offering solid tumour, haematological malignancy and non-cancer services. Only 36% of laboratories offered tests capturing the full breadth of variants, from single-nucleotide variants to gene fusions. Knowledge sharing was rare, with only one laboratory submitting variant classifications to a public knowledge base. Most laboratories (96%) conducted somatic testing in oncology. Of cancer laboratories, 35% offered testing considered capable of comprehensive genomic profiling (CGP). Almost half of cancer laboratories had already adopted the 2022 ClinGen/CGC/VICC oncogenicity guidelines, and 84% were using AMP/ASCO/CAP 2017 clinical significance guidelines. Only 47% of mixed discipline cancer laboratories reported biomarkers such as tumour mutational burden, with wide variation in reporting of matched therapy options. Our study has generated a unique overview of somatic laboratory practices in the region, and areas for global standardisation in somatic molecular testing and reporting. We also provide a model for practice and guideline uptake assessment, for application by other country-wide networks. This is particularly relevant in anticipation of CGP mainstreaming, with the increasing complexity of sequencing interpretation for laboratories and clinicians.

Humans

Comprehensive Genomic Profiling Timeliness Beyond Laboratory Turnaround Time: A Patient-Facing Pathway Analysis.

AIM: We evaluated the timeliness of the patient-facing comprehensive genomic profiling (CGP) pathway by separating laboratory and post-laboratory intervals within an expert panel-mediated process, using direct disclosure of results to patients as the endpoint. METHODS: This single-center retrospective study included adult CGP test episodes performed under government-funded cancer genomic medicine at a Japanese university hospital between October 2019 and November 2025. The primary outcome was patient-centered turnaround time (TAT), defined as the interval from informed consent to direct disclosure of the CGP result to the patient. Laboratory TAT and pathway intervals were summarized descriptively, and laboratory TAT was compared across assays. RESULTS: Among 882 CGP test episodes, median laboratory TAT was 14 days (interquartile range [IQR], 12-16) among 871 evaluable episodes. Among 828 evaluable episodes, median patient-centered TAT was 41 days (IQR 35-45). The laboratory analysis retained observed long intervals, including a maximum of 72 days; no episode was excluded solely because laboratory TAT exceeded 56 days. These findings indicate that laboratory TAT was only one component of the longer consent-to-disclosure pathway. CONCLUSION: In this routine-care CGP pathway, patient-facing timeliness depended on the full process from consent to direct patient disclosure. Patient-centered TAT should be monitored alongside laboratory TAT as a care-delivery measure.

comprehensive genomic profiling

Clinical laboratories. Profit center, production industry or patient-care resource?

The clinical laboratory is an essential component of the medical-care system. Rapidly increasing expenditures for laboratory services, fraudulent practices and reports of laboratory error are precipitating legislative and regulatory actions that will affect clinical laboratories and how they are used by physicians in caring for their patients. Many problems related to clinical laboratories are due to the rapid introduction of new technologies, to methods of educating medical students and house officers, to the rapidly expanding scientific base of medicine and to economic factors that have subordinated medical and scientific objectives in the laboratory to economic ones. Implementation of existing legislation would settle many of the economic issues, but more effective integration of the clinical laboratory into the patient-care process and better methods for educating medical students in the use of laboratory information are critical tasks for the medical profession.

Accounting