#06-5558 Accrd Manual V7 - COLA

More documents

Recommendations

Info

CRITERIA FOR QUALITY LABORATORY PERFORMANCE>PT 4 RFor each unregulated analyte tested in your laboratory that you have not enrolled in a COLA-approved PT program,do you perform and compare the results of external split-specimen testing on at least five specimenstwice a year in periodic intervals?Proficiency testing or split specimen testing with another laboratory is an acceptable check. For split specimentesting, five specimens should be split twice a year. The laboratory must determine the acceptable variationpermitted when comparing results on the same sample. The laboratory should consider the amount ofvariation that represents a clinically significant difference for the analyte being tested. Most often the acceptablevariation is stated as plus or minus a percentage or constant factor. (For example ± 10 percent or ± 0.2.)Refer to COLA LabGuide 9–“Split Specimen Analysis.”PT 5 RDo you follow the same procedures for testing PT samples as you do for patient samples?PT specimens should be treated just like patient specimens—e.g., if a patient specimen is routinely run once,the PT specimen must be run once. In addition, the person who performs PT testing should vary if more thanone person normally performs the test on patients. (For instance, the supervisor should not be the only personwho performs testing on PT specimens; all persons who perform testing on patients should take a turnat performing PT testing.) Notify your PT program prior to the cut-off date for result submission of any problemswith PT specimens or lab accidents with your PT specimens. The PT program is obligated to providereplacement samples for specimens not received on time or for “problems” such as samples received in acondition that renders them unacceptable for testing. Notify your PT program and COLA, in writing, of anyincorrect grading in final reports.PT 6 EDoes your laboratory policy prohibit communication with another laboratory to discuss PT results, for both regulatedand unregulated analytes, prior to the cut-off date for submission of test results for that event?No communication is allowed prior to the cut-off date for submission of test results for that event.PT 7 EDoes your laboratory policy prohibit sending PT samples, for both regulated and unregulated analytes, toanother laboratory for analysis?Sending PT samples to another laboratory to be tested is a direct violation of the CLIA regulations and willresult in loss of your CLIA certificate.PT 8 RAre all PT results reviewed and evaluated by the laboratory director or other qualified designee?Be sure to document this review by dating and initialing.PT 9 EWhen PT results are unsatisfactory, do you evaluate the results and take appropriate corrective action?Unsatisfactory performance is defined as a score of
CRITERIA FOR QUALITY LABORATORY PERFORMANCEPT 10 EDoes your laboratory verify the accuracy of any analyte, specialty, or subspecialty that is assigned a PT scorethat does not reflect the accuracy of the laboratory’s actual test performance?The laboratory must carefully review graded PT reports received from its PT provider. There are cases wherealthough the laboratory performed and reported PT results, these results may not have been scored or evaluatedfor accuracy or the laboratory may have received scores that do not truly reflect laboratory performance.This frequently occurs as a result of one of the following situations:1) The PT program assigns an artificial score of 100% with a comment that results were not evaluated due tolack of a peer group or lack of consensus within the peer group.2) The PT Program assigns an artificial score of 0% due to nonparticipation, such as whena. the laboratory did not test the samples (due to oversight, instrument problems, reagents on backorder,etc)b. the laboratory fails to submit test results; orc. the results were submitted after the cutoff date for submission.When such a situation occurs the laboratory must perform and document its own verification of accuracy forthe analyte, specialty, or subspecialty affected. The laboratory may compare its performance against thestated target and allowable range of the PT specimen as defined in the participant summary available fromthe PT provider.In some cases this “self grading” may enable the laboratory to demonstrate acceptable performance. Inother cases, the laboratory will have to take additional steps to verify the accuracy of its results, such as conductingsplit sample analysis or other external assessment.There are a number of methods that may be used to conduct external accuracy verification. The LaboratoryDirector should determine the best method considering the analyte and methodology in use. Some manufacturershave established special programs just for their users.If analytes are consistently not graded due to lack of a peer group (at least 10 participants using the sameinstrument or method) the laboratory should seek assistance from their PT provider. This is not uncommonwhen a laboratory is using an older methodology or very new technology. In both of these instances the totalnumber of laboratories performing the same method is too small to enable analysis. In such cases the laboratorymay need to consider updating its methodology or consulting the manufacturer to see if a user groupprogram might be available for comparison.*Repeated scores of 0% for failure to participate may result in a cease testing order for the analyte, specialtyor subspecialty. Be sure to inform the PT provider if you are unable to perform testing, prior to cutoff dateto avoid receiving an automatic score of 0%.PT 11 RWhen graded PT results are unsuccessful, do you seek consultation to remedy the causes of failure, and/orundertake additional training of personnel if this is the cause of the failure?Unsuccessful PT performance is defined as receiving unsatisfactory scores for an analyte, subspecialty, orspecialty in two consecutive PT events or two out of three PT events.PT 12 EDo you cease patient testing for specified analytes when required by COLA until you have successfully completedthe reinstatement process?10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
Page 1 and 2: COLA LABORATORYACCREDITATION CRITER
Page 3 and 4: CRITERIA FOR QUALITY LABORATORY PER
Page 9: CRITERIA FOR QUALITY LABORATORY PER
Page 61 and 62:
CRITERIA FOR QUALITY LABORATORY PER
Page 63 and 64:
CRITERIA FOR QUALITY LABORATORY PER
Page 65 and 66:
IMMUNOHEMATOLOGY & TRANSFUSION SERV
Page 67 and 68:
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77 and 78:
Page 79 and 80:
Page 81 and 82:
CYTOLOGY706. EThe cytotechnologists
Page 83 and 84:
CYTOLOGYLaboratory Safety and Envir
Page 85 and 86:
CYTOLOGY726. EAre the proper method
Page 87 and 88:
CYTOLOGY740. EAre non-gynecologic s
Page 89 and 90:
CYTOLOGYEnsuring Quality of Examina
Page 91 and 92:
CYTOLOGYAre there documented evalua
Page 93 and 94:
CYTOLOGY795. EAre unsatisfactory sp
Page 95 and 96:
CYTOLOGY94. . . . . . . . . . . . .
Page 97 and 98:
HISTOPATHOLOGY816. EResponsibilitie
Page 99 and 100:
HISTOPATHOLOGY830. EHIV and AIDS831
Page 101 and 102:
HISTOPATHOLOGYThe laboratory shall
Page 103 and 104:
HISTOPATHOLOGY859. EAre the stained
Page 105 and 106:
HISTOPATHOLOGY873. EAre unsatisfact
show all

#06-5558 Accrd Manual V7 - COLA

Create successful ePaper yourself

Delete template?

Save as template?