#06-5558 Accrd Manual V7 - COLA

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CRITERIA FOR QUALITY LABORATORY PERFORMANCE>Monitor test and test system performance:In the event that any of the following situations occur, the laboratory must stop performing the EquivalentQuality Control Procedures and take corrective action.• Either internal or external QC failures that are not resolved by repeating the control one (1) time.• PT failure• Any problems identified with this testing as a result of analytic quality assessment activities.Corrective Actions to Resume Equivalent Quality Control Procedures:The laboratory must revert to performing two levels of external QC every day of patient testing during thecorrective action period.• Conduct an investigation to troubleshoot the problem.• Take corrective action to alleviate the identified or suspected problems.• Conduct an evaluation of all patients tested since the last acceptable external QC to determine whetherpatient results may have been affected due to the identified problem. Notify practitioners as necessary.• Successfully complete another qualifying study prior to resuming Equivalent Quality Control Procedures.QC 24.1Has the laboratory determined which equivalent QC protocol will be followed for each eligible test system?24.2Did the laboratory successfully complete the appropriate qualifying study?24.3Is the laboratory performing and documenting internal and external QC at the appropriate frequency?24.4If QC is unacceptable, unsatisfactory PT results were obtained, or QA indicates other problems with the test system,has the laboratory taken appropriate corrective action?QC 25 RAre control results reviewed by testing personnel in order to detect possible errors that may occur due to thefollowing conditions:• Instrument or procedural failures,• Adverse environmental conditions, AND• Variance in operator performance?Testing personnel need to be aware of the importance of ensuring acceptability of results prior to conductingpatient testing. A failure in control results can be related to a number of different causes such asreagents, instrumentation, operator error, or environmental conditions. All of which can also impact theaccuracy of patient results.Staff should be trained to routinely review QC results and document acceptability prior to conducting patienttesting. Many laboratories elect to have staff initial daily records to indicate that QC was performed and inrange.If electronic capabilities exist it is not necessary that computerized reports be printed on a daily basis; howeverthey must at least be reviewed on screen. This should be documented in some fashion. At a minimumthe laboratory must be able to demonstrate the QC is reviewed based on corrective action documentationfor any unacceptable result.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT <strong>COLA</strong> PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org33
CRITERIA FOR QUALITY LABORATORY PERFORMANCEQC 26 RBefore you begin patient testing, do you take appropriate action and record it when controls exceed acceptablelimits?Daily quality control results must meet your criteria for acceptability prior to reporting patient test results.QC 27 EIf you run controls at the same time as patient specimens, and you find the controls to be unacceptable, do youre-evaluate patient results that were tested since the last acceptable controls?Quality Control results must meet your criteria for acceptability prior to reporting patient test results. WhenQC is performed at the same time as patient testing and the results are unacceptable, the laboratory willneed to investigate the reason for the unacceptable QC results, as it may have had an adverse affect on thepatient results as well. All results since the last acceptable control run must be re-evaluated. This evaluationcould include repeating all patient specimens tested since the last acceptable control depending upon thenature of the system failure.QC 28 RDoes the laboratory director or qualified designee regularly review the quality control data with laboratory personnel?The laboratory director is responsible to assure that QC is routinely reviewed to detect and correct potentialproblems that may impact the accuracy of patient results. This responsibility may be delegated; however thedirector is responsible for the performance and quality of the review. The QC results which have beenreviewed should be initialed by the person reviewing them. The QC review should assess the following foracceptability with laboratory policy:• Number, type and frequency of QC performance• Acceptability of QC results• Corrective action for out of range results.QC 29 RAre quality control records retained for at least two years?QC 30 RAre all immunohematology quality control records retained for a period of at least five years?34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT <strong>COLA</strong> 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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