Quality Control is defined as a system for verifying and maintaining a desired level of quality in an individual test or process. Quality control activities span the testing process from the moment of specimen collection until the time the physician receives the report. Quality Assurance (QA) is defined by the College of American Pathologists as systematic monitoring of quality control results and quality practice parameters to assure that all systems are functioning in a manner appropriate to excellence in health care delivery. [فقط الأعضاء المسجلين والمفعلين يمكنهم رؤية الوصلات . إضغط هنا للتسجيل] Quality assurance is a coordinated system designed to detect, control and prevent the occurrence of errors and, ultimately, to further a clinician’s ability to appropriately care for his or her patient. A number of quality control/quality assurance measures for cytopathology have been specified by the Clinical Laboratory Improvement Amendments of 1988. [فقط الأعضاء المسجلين والمفعلين يمكنهم رؤية الوصلات . إضغط هنا للتسجيل] All quality assurance processes must be described and documented in a quality assurance program in the laboratory.
VII.A. Pre-analytical Quality ControlEach laboratory must perform and maintain records of routine quality control relating to specimen receipt, preparation and staining. Most of these activities are required by lab accreditation agencies and include such things as review of stain quality and maintenance records, microscope and instrument maintenance, as well as instrument calibration records.[فقط الأعضاء المسجلين والمفعلين يمكنهم رؤية الوصلات . إضغط هنا للتسجيل]
VII.B. Screening and Reporting of Gynecologic Specimens
Federal regulations require that the individual examining a gynecologic cytology specimen be a qualified cytotechnologist or pathologist in a certified laboratory. These individuals may examine up to 100 slides per 24 hours (average 12.5 slides/ hour) and in not less than eight hours. This number is not a performance target but a maximum allowed by law. Pathologists are limited by this ceiling when they perform primary screening. Each laboratory must establish individual workload limits for each cytotechnologist. These limits must be reviewed every six months by the Technical Supervisor of the lab and re-assessed using lab defined performance standards. The record of slides reviewed by the primary screening cytotechnologist or pathologist must be documented and retrievable for inspectors during the retention period prescribed by CLIA ’88 or applicable state law. Cytotechnologists and pathologists must also maintain work logs for any primary screening site (in cases of multiple site employment), again, for the applicable retention period. As discussed in section VI, all specimens must be reported using descriptive nomenclature; use of a numerical reporting system alone is unacceptable.