Quality indicators and specifications for the extra-analytical phases in clinical laboratory management

Author(s):  
Carmen Ricós ◽  
Montserrat García-Victoria ◽  
Blanca de la Fuente

AbstractExamples of indicators and specifications for the post-analytical process:

2006 ◽  
Vol 1 (2) ◽  
pp. 97-97
Author(s):  
Christian T. K.-H. Stadtländer

2006 ◽  
Vol 130 (12) ◽  
pp. 1756-1761 ◽  
Author(s):  
Bruce A. Jones ◽  
Molly K. Walsh ◽  
Stephen G. Ruby

Abstract Context.—Monitoring customer satisfaction is an important and useful quality improvement tool and is required of most clinical laboratories in the United States. Objective.—To survey the level of nursing satisfaction with hospital clinical laboratory services. Design.—Participating laboratories provided information regarding laboratory demographics and practices. These laboratories then surveyed hospital nursing personnel regarding their level of satisfaction with defined aspects of laboratory service. Setting.—College of American Pathologists Q-Probes laboratory quality improvement study in 162 hospital laboratories. Main Outcome Measures.—Nursing overall satisfaction score (ranging from 1, not satisfied, to 5, very satisfied) and satisfaction scores for 13 specific aspects of clinical laboratory services. Results.—One hundred sixty-two institutions submitted data from a total of 7033 nursing surveys. The overall satisfaction score for all institutions ranged from 2.5 to 4.6. The median overall score for all participants was 3.9 (10th percentile, 3.2; 90th percentile, 4.2). Nursing personnel were most satisfied with the accuracy of test results, phlebotomy courtesy toward patients and nursing staff, and notification of abnormal results. They were least satisfied with stat test turnaround time, laboratory management responsiveness and accessibility, phlebotomy responsiveness to service requests, and routine test turnaround time. The most important aspect of laboratory service reported by nursing personnel was stat test turnaround time. Conclusions.—Most nursing personnel are satisfied with the clinical laboratory services that are provided to the patients in their care. Although test result accuracy is very highly regarded, there is room for improvement in several aspects of service, particularly in test turnaround time and laboratory management accessibility and responsiveness.


2019 ◽  
Vol 57 (10) ◽  
pp. 1530-1538 ◽  
Author(s):  
Canan Karadağ ◽  
Nafi Nevrez Demirel

Abstract Background Quality indicators (QIs) and risk management are important tools for a quality management system designed to reduce errors in a laboratory. This study aimed to show the effectiveness of QI-based risk management for the continual improvement of pre-analytical processes in the Kayseri Public Health Laboratory (KPHL) which serves family physicians and collects samples from peripheral sampling units. Methods QIs of pre-analytical process were used for risk assessment with the failure modes and effects analysis (FMEA) method. Percentages and risk priority numbers (RPNs) of QIs were quantified. QI percentages were compared to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) performance specifications and RPNs were compared to risk level scale, and corrective actions planned if needed. The effectiveness of risk treatment actions was re-evaluated with the new percentages and with RPNs of predefined QIs. Results RPNs related to four QIs required corrective action according to the risk evaluation scale. After risk treatment, the continual improvement was achieved for performance and risk level of “transcription errors”, for risk levels of “misidentified samples” and “not properly stored samples” and for the performance of “hemolyzed samples”. “Not properly stored samples” had the highest risk score because of sample storage and centrifugation problems of peripheral sampling units which are not under the responsibility of the KPHL. Conclusions Public health laboratories may have different risk priorities for pre-analytical process. Risk management based on predefined QIs can decrease the risk levels and increase QI performance as evidence-based examples for continual improvement of the pre-analytical process.


Author(s):  
Ada Aita ◽  
Laura Sciacovelli ◽  
Mario Plebani

AbstractA large body of evidence collected in recent years demonstrates the vulnerability of the extra-analytical phases of the total testing process (TTP) and the need to promote quality and harmonization in each and every step of the testing cycle. Quality indicators (QIs), which play a key role in documenting and improving quality in TTP, are essential requirements for clinical laboratory accreditation. In the last few years, wide consensus has been achieved on the need to adopt universal QIs and common terminology and to harmonize the management procedure concerning their use by adopting a common metric and reporting system. This, in turn, has led to the definition of performance specifications for extra-analytical phases based on the state of the art as indicated by data collected on QIs, particularly by clinical laboratories attending the Model of Quality Indicators program launched by the Working Group “Laboratory Errors and Patient Safety” of the International Federation of Clinical Chemistry and Laboratory Medicine. Harmonization plays a fundamental role defining not only the list of QIs to use but also performance specifications based on the state of the art, thus providing a valuable interlaboratory benchmark and tools for continuous improvement programs.


1989 ◽  
Vol 11 (3) ◽  
pp. 99-105 ◽  
Author(s):  
N. de Cediel ◽  
C. G. Fraser ◽  
A. Deom ◽  
L. Josefsson ◽  
H. G. J. Worth ◽  
...  

Trainees in laboratory medicine must develop skills in laboratory management. Guidelines are detailed for laboratory staff in training, directors responsible for staff development and professional bodies wishing to generate material appropriate to their needs. The syllabus delineates the knowledge base required and includes laboratory planning and organization, control of operations, methodology and instrumentation, data management and statistics, financial management, clinical use of tests, communication, personnel management and training and research and development. Methods for achievement of the skills required are suggested. A bibliography of IFCC publications and other material is provided to assist in training in laboratory management.


1976 ◽  
Vol 66 (1) ◽  
pp. 132-143 ◽  
Author(s):  
Arthur F. Krieg ◽  
Michael Israel ◽  
Ronald Fink

2000 ◽  
Vol 124 (7) ◽  
pp. 1066-1073
Author(s):  
Tina M. St. John ◽  
Harvey B. Lipman ◽  
John M. Krolak ◽  
Thomas L. Hearn

Abstract Background.—In 1986 and 1989, the Centers for Disease Control and Prevention sponsored institutes on Critical Issues in Health Laboratory Practice. It was noted during the institutes that physician's office laboratories were a rapidly emerging site for clinical laboratory testing, yet no comprehensive data were available regarding the practice of clinical laboratory medicine in physician's office laboratories. As a mechanism to begin addressing this void, the Centers for Disease Control and Prevention added questions on clinical laboratory practice to the National Ambulatory Medical Care Survey, a national probability sample of ambulatory care provided by office-based physicians. Data were collected for survey years 1989, 1991, 1993, and 1994. Methods.—Each survey was conducted among a nationally representative, random sample of office-based physicians who provide ambulatory patient care. Sample physicians were enlisted using both mail and telephone contacts. Clinical laboratory data were obtained via telephone by trained field representatives. Weighted univariate and multivariate analyses were performed on responses from each of the 4 survey years. Analyses were repeated after combining survey responses from years 1989 and 1991 and 1993 and 1994 as representative of physician's office laboratory practices before and after implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) final rule in 1992. Results.—Quality laboratory practice indicators showed significant increases during the study interval, with implementation of the CLIA ’88 final rule in 1992 playing a pivotal role. Relative to 1992, enrollment in proficiency testing programs increased from 32.4% to 52.7% (P < .001), use of daily quality control samples increased from 79.2% to 89.0% (P < .001), and use of daily quality control with written instructions for action following a questionable quality control result (quality control with action step documentation) increased from 62.6% to 77.2% (P < .001). The presence of a medical technologist or technician in the office laboratory was also significantly and independently associated with each of the quality indicators. Although the percentage of physician's offices performing on-site testing decreased from 56% to 45% during the survey interval, overall testing volume appeared unchanged. Conclusions.—The quality of clinical laboratory practice in physician's office laboratories improved during the study interval (1989–1994) as measured by the quality indicators used in the study. The association of this improvement with implementation of the CLIA ‘88 final rule and the presence of a trained laboratory professional in the testing site indicate the importance of minimum practice standards and professional expertise in ensuring use of quality laboratory practices. Overall test volume appeared to be stable despite a decreased proportion of physician's offices at which on-site testing was performed.


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