#06-5558 Accrd Manual V7 - COLA

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CRITERIA FOR QUALITY LABORATORY PERFORMANCE>SU6.3Are all quality control organisms tested each day of patient testing?SU6.4Are control organisms and PT challenges tested in the same manner as patient isolates?SU6.5Do laboratory procedures and reports identify the method of testing and its limitations?Some laboratories may elect to perform a modification of the Kirby Bauer susceptibility procedure calleddirect susceptibility testing. This procedure is only applicable for susceptibility testing of urine. This procedureis not widely recognized nor practiced in part due to the limitations of the method, and the additionalrequirements necessary to validate the test system. This procedure does allow for faster production ofresults. A laboratory considering using this procedure should carefully evaluate the cost and time involvedthe typical clinical treatment of its patient population, and the volume of testing.The procedure calls for susceptibility testing to be set-up directly from the patient urine specimen at thesame time that testing is performed to identify the organism present. Since the laboratory does not knowwhat organism will be identified, all QC organisms must be tested each day that patients are tested.As the concentration of organisms in a patient specimen is not standardized, the laboratory cannot standardizethe concentration of control or PT organisms when performing this testing. In addition the laboratorycannot adopt the control or patient interpretive ranges provided in package insert for anti-microbial disksor CLSI documents. The values represented in these documents are only applicable to the use of bacterialsuspensions standardized against a 0.5 McFarland standard. The laboratory must design and perform astudy to establish its own individual ranges and ensure control organisms and PT samples have randomizedconcentrations just as a patient specimen would.SU 7 RIf minimum inhibitory concentrations or zones sizes are not within limits when checked with the appropriatecontrol organism, is corrective action taken and documented prior to reporting patient results?If control results are not within acceptable limits this may indicate a problem with the test system whichcould affect the quality of patient results as well. The laboratory will want to investigate the cause of theunacceptable QC and determine whether any concurrent patient testing may be affected. The laboratorydirector should establish policy or make the determination regarding when patient testing must be repeated,results held pending results of additional QC testing, or patient results may be reported.Guidelines for corrective action for daily susceptibility QC:When performing daily testing 1 in 20 results can be expected o be out of range. Any more than this requirescorrective action.Guidelines for corrective action for weekly susceptibility QC:If there is an obvious reason for the failure such as testing the wrong drug, wrong control organism used, orcontrol contaminated document the reason and retest the strain on the day the error is observed. If acceptableperformance obtained, no further action is necessary.If the reason for the failure is not obvious, test the organism/drug combination for 5 consecutive days beginningthe day the error is observed. If all results are acceptable no further action is necessary.If 1 or more of the 5 results exceeds acceptable limits, the laboratory must investigate further and resumedaily QC until the problem is fully resolved. To return to weekly QC, a new 20 or 30 day study is required.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT <strong>COLA</strong> PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org45
CRITERIA FOR QUALITY LABORATORY PERFORMANCEBacteriology SubspecialtyBA 1 RAre urine cultures performed only on clean-catch, midstream, catheterized, or other appropriately collectedurine specimens?Urine cultures should not be performed on random specimens. Even with a clean-catch, midstream collection,contamination with skin flora is not uncommon. Coagulase negative staph, for example, is becoming amore frequent urinary pathogen, thus making it even more important that a clean catch or other appropriatelycollected urine specimen be used.BA 2 RAre urine cultures read at both 24 and 48 hours, unless suggested otherwise by the manufacturer of the media?Some urine culture kits give erroneous results if read past 24 hours. Check the package insert if you are usinga culture kit.BA 3 RIf you perform beta lactamase testing using methods other than Cefinase, do you use control organisms thatprovide positive and negative reactivity each day of testing and document the results obtained?BA 4 RIf you perform Gram stains, do you check for positive and negative reactivity with control organisms each weekof use and document the results obtained?BA 5RIf you use antisera:BA 5.1Do you check the antisera for positive and negative reactivity with control organisms with each new batch, lotnumber and shipment when prepared or opened and document the results obtained?BA 5.2Do you check for positive and negative reactivity with control organisms every 6 months and document theresults obtained?BA 6 RIs susceptibility quality control performed each day of patient testing, or weekly, if the laboratory has met therequirements to qualify for weekly QC?The laboratory may elect to perform QC for susceptibility testing on either a daily basis or weekly. The laboratorymust successfully complete a qualifying study to decrease the frequency of susceptibility QC from dailyto weekly. Refer to BA7 to review the requirements for conducting an acceptable qualifying study.46. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT <strong>COLA</strong> PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
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HISTOPATHOLOGYThe laboratory shall
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#06-5558 Accrd Manual V7 - COLA

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