#06-5558 Accrd Manual V7 - COLA

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CRITERIA FOR QUALITY LABORATORY PERFORMANCE>Document or Record MinimumTime frame CommentsQuality System Assessment 2 years Previously called Quality AssuranceRecordsTest Reports – (Preliminary,final, & corrected)Pathology & CytologyTest ReportsCytology slidesHistopathology slidesPathology Specimen blocksTissue Remnants2 years beyond the dateof reporting10 years beyond the dateof reporting5 years from date ofexamination10 years from date ofexamination2 years from date ofexaminationPreserve until a diagnosisis made on the specimen.Quality AssessmentQA 1 EHave you established a written Quality Assessment Program comprised of policies and procedures for ongoingmechanisms to monitor, assess, and correct problems in general, pre analytic, analytic, and post analyticprocesses?A written Quality Assessment Program incorporates all the processes in the laboratory (general, pre-analytic,analytic, and post analytic). The intent of the program is to utilize a systematic approach to monitoring,assessing, and correcting problems identified in laboratory processes on an ongoing basis.A complete plan includes establishment of communication mechanisms for staff, documentation of all activities,and follow-up reviews to determine the effectiveness of corrective actions.QA 2 EHas the laboratory implemented a process to monitor its Quality Assessment Plan on an ongoing basis?Assessments or reviews should be performed on an ongoing basis and should evaluate the general, pre-analytic,analytic, and post-analytic phase of laboratory processes throughout the year. COLA suggests that youconsider what activities, that if not performed properly, has the most significant impact on the quality of testingor the level of service provided by your laboratory. Select a minimum of one monitor for each phase notedabove. Conduct assessments of each monitor throughout the year to assess performance, design processimprovements, and monitor the effect of their implementation.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org55
CRITERIA FOR QUALITY LABORATORY PERFORMANCEQA 3 RDo your Quality Assessment reviews, enable the laboratory to identify and correct problems?The purpose of the Quality Assessment review is to monitor whether processes and procedures related topre-analytic, analytic, and post-analytic phases of laboratory testing are being performed properly.As the assessments reveal deviations between policy and performance this alerts the laboratory that a problemexists. The laboratory must then review the process and data obtained by the assessment to developcorrective actions aimed at preventing recurrence.QA 4 RDoes your Quality Assessment Program include a process to conduct follow-up reviews to assess the effectivenessof corrective actions?The Quality Assessment Program can only be effective if it permits timely identification and correction ofproblems and implementation of solutions to prevent reoccurrences. A follow-up review and analysis insuresthat corrective actions have corrected the problem identifiedQA 5 RIs the information obtained during a quality assessment reviews shared with the laboratory staff and other individualsas appropriate and is this documented?The director or consultant should discuss the quality assessment review with all appropriate staff so thateveryone knows what problems were identified and what corrective actions are being implemented. Byinvolving staff in the review and correction, one can better assure that the root cause of the problem will beidentified and corrected.Effective communication of Quality Assessment issues is essential in preventing recurrences. Documentationof these activities is essential to create a record that can be referred to in the future, should questions arise.56. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
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#06-5558 Accrd Manual V7 - COLA

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