#06-5558 Accrd Manual V7 - COLA

CRITERIA FOR QUALITY LABORATORY PERFORMANCEProficiency TestingPT 1 ESince enrolling with COLA, have you been continuously enrolled in one or more COLA-approved ProficiencyTesting (PT) program(s).Enrollment is required for all regulated analytes on your test menu. See the list of approved PT programs.You should authorize your PT program to send your PT data to COLA. COLA requires completion of a PT DataRelease Form in addition to Laboratory Director Signature Form. These forms serve as confirmation thatCOLA may receive your PT data. Please complete these forms and forward to COLA if you have not done so.PT 2 EFor each regulated analyte tested in your laboratory, do you perform and report PT results to the PT program forall events, unless you have been granted an exemption by the PT program and COLA for voluntarily ceasing totest an analyte?Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testingevent. Consideration may be given to those laboratories failing to participate in a testing event only if-1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testingresults;2) The laboratory notifies COLA and the proficiency testing program, within the time frame for submittingproficiency testing results, of the suspension of patient testing and the circumstances associated with failureto perform tests on proficiency testing samples; and3) The laboratory participated in the previous two proficiency testing events.PT 3 EIf your laboratory tests any regulated analyte(s) for which compatible proficiency testing samples are notoffered by a COLA-approved PT program, do you perform and compare the results of external split-specimentesting on at least five specimens twice a year?When compatible PT specimens are available for regulated analytes, the laboratory must participate in PT.COLA-approved PT programs strive to provide PT samples for the most commonly performed laboratorymethods and maintain sufficient participants to ensure peer groups are available for providing gradedresults. At times this can be quite a challenge especially as new technologies are available in the marketplace.When the laboratory is choosing its PT provider, it is important to verify that specimens provided will be compatiblewith the methods in use in the laboratory. If the current PT provider does not offer a compatible specimenfor any regulated analyte/test system, the laboratory must investigate whether a suitable sample canbe obtained from another PT provider.If it is not possible to obtain a compatible specimen from any PT Provider for a regulated analyte, the laboratorymust perform Split Specimen analysis at least twice per year, testing 5 samples each time. The laboratoryshould try to obtain and test samples that span the reference range typically seen in the patient population.Ideally there should be specimens among the 5 that have low, normal, and high values or positiveand negative values as applicable.It is the laboratory’s responsibility to check with the various PT providers each year to determine if a compatiblespecimen might now be available. When compatible PT specimens are available for regulated analytes,the laboratory must participate in PT.8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org