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SECTION III: COLA CRITERIA FOR QUALITY LABORATORY PERFORMANCEStaff should be trained to routinely review QC results and document acceptability prior to conducting patient testing.Many laboratories elect to have staff initial daily records to indicate that QC was performed and in range.If electronic capabilities exist it is not necessary that computerized reports be printed on a daily basis; however theymust at least be reviewed on screen. This should be documented in some fashion. At a minimum the laboratory mustbe able to demonstrate the QC is reviewed based on corrective action documentation for any unacceptable result.QC 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. When QC is performedat the same time as patient testing and the results are unacceptable, the laboratory will need to investigatethe reason for the unacceptable QC results, as it may have had an adverse affect on the patient results as well. Allresults since the last acceptable control run must be re-evaluated. This evaluation could include repeating all patientspecimens tested since the last acceptable control depending upon the nature of the system failure.QC 28 RDoes the laboratory director or qualified designee regularly review the quality control data with laboratorypersonnel?The laboratory director is responsible to assure that QC is routinely reviewed to detect and correct potential problemsthat may impact the accuracy of patient results. This responsibility may be delegated; however the director is responsiblefor the performance and quality of the review. The QC results which have been reviewed should be initialed bythe person reviewing them. The QC review should assess the following for acceptability 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?3-60. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
SECTION III: COLA CRITERIA FOR QUALITY LABORATORY PERFORMANCE>EVALUATION GROUPING:Specialty-Specific CriteriaThese criteria are part of the Analytic Phase, and apply to thespecific specialties performed in your laboratory. This group ofquestions focuses on testing specialties with specific performancecriteria. Those specialties are Hematology, Coagulation (INR),Blood Gases, Urinalysis (refractometer), Microbiology (general,subspecialties, susceptibilities), Immunology/Syphilis serology, andImmunohematology.If your laboratory is performing laboratory services for TransfusionServices, Cytology, or Histopathology, then there are additionalcriteria sections for each of these specialties following the QualityAssessment criteria.Specialty: HematologyMost frequently, laboratories performing hematology utilize automatedcell counters. You are encouraged to consider your individualoperating environment, instrument stability, and personnelcompetency when determining the total number of times toperform controls each day of patient testing.You are also encouraged to run all levels of quality control providedfor your system each day of testing. This provides a higher level ofassurance that results covering the entire reportable range are reliable.Manual cell counts and blood smear evaluations have their ownrequirements.Guidance on QCPrograms forSpecialtiesAs you establish your quality controlprogram for a specific specialty, youneed to consider the number andfrequency of controls to perform.For example:• If qualitative tests are performed,perform positive and negativecontrols with each run of patientspecimens, or as specified by thespecialty requirements• If quantitative tests areperformed, perform two differentcontrol concentrations with eachpatient run, or as specified by thespecialty requirementsRefer to your instrument or kitmanufacturer’s instructions for detailson the quality control required forthat specific test.HEMATOLOGYHE 1 EIs all venous blood collected in an anti-coagulant which will not affect cellular morphology or interfere with thecell count?EDTA (lavender-top tube) is the anti-coagulant of choice. Heparin will distort the cells and should not be used. Notethat this question addresses venous collections. Capillary collections do not require anti-coagulant if diluted in salineimmediately or may be collected in heparinized tubes, if not being used for the evaluation of cellular morphology.HE 2 EAre specimens checked for clots before testing and rejected if clots are detected?This question applies to instruments that aspirate the specimen, to manual cell counting, and to centrifugal hematologyanalyzers if the specimen is collected in EDTA prior to processing. It does not apply to centrifugal analyzers in the capillarymode. Check for clots by visually inspecting the specimen while tilting the tube or by stirring the specimen with awooden applicator stick and looking for clots adhering to the stick.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org3-61
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COLA LABORATORYACCREDITATION MANUAL
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TABLE OF CONTENTS>I Introduction to
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SECTION I: INTRODUCTION TO ACCREDIT
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SECTION III: CYTOLOGY>CYTOLOGYIntro
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SECTION V: APPENDIX>IN THIS SECTION
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