#06-5558 Accrd Manual V7 - COLA

More documents

Recommendations

Info

CRITERIA FOR QUALITY LABORATORY PERFORMANCE>QC 16 RFor each quantitative test performed, are quality control data prepared and plotted with each testing event, orare statistical indices calculated to permit the laboratory to assess continued accuracy and precision of themethod?Control charts, graphs, or statistical indices should be maintained for all quantitative tests performed by thelaboratory. Many instruments and Laboratory Information systems have the capability to track this informationelectronically.This data should be reviewed weekly or following every 5-7 data points if performed infrequently to detectchanges such as shifts or trends that may be indicators of test system problems that need to be addressed.Such routine reviews may permit the laboratory to recognize a potential problem developing and take actionto prevent unacceptable results, which could ultimately impact the quality of patient results or create disruptionsin access to needed testing due to instrument, test system, or environmental failures.QC 17 EIf you perform qualitative tests, are positive and negative controls performed each day of patient testing?QC 18 RIf you perform any direct antigen tests with an extraction phase included, do you check the test system with 2control materials (including one capable of detecting errors in the extraction process) each day of patient testing?QC 19 EIf you perform an immunology test which includes titering, is a positive control of known titer or graded reactivityand a negative control run each day a patient test is performed?QC 20 EIf you use fluorescent and /or immunohistochemical stains, are the stains checked for positive and negativereactivity each time of use?QC 21 RAre stains (other than gram or acid-fast stains) checked, for positive and negative reactivity (if applicable), andmake sure they provide the expected characteristics on each day of use?QC 22 EIf you perform a molecular amplification procedure, are two control materials run each day a patient test is performed?Be aware that if reaction inhibition is a significant source of false negative results, one control must be capableof detecting the inhibition. Check the manufacturer’s package insert and supplemental documentationregarding potential sources of error.QC 23 EIf you run electrophoresis tests, do you perform at least one control per cell, concurrent with each patient run,which contains all fractions to be reported?QC 24 REquivalent Quality Control Option:COLA recognizes that the CLIA regulations provide laboratories an alternative to performing two levels ofexternal quality control each day of testing for eligible test systems that have successfully completed a qualificationprocedure. COLA will permit accredited laboratories an option to use two of the three EquivalentQuality Control Procedures in place of external QC each day of testing. Laboratories that desire to use theseprocedures must:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org31
CRITERIA FOR QUALITY LABORATORY PERFORMANCE1. Verify the eligibility of their test system,2. Select the appropriate Equivalent Quality Control Procedure,3. Successfully complete the qualifying study, and4. Monitor test and test system performance to include taking corrective action and resuming daily externalquality control as indicated in the descriptions below.EligibilityTo determine if a test system meets COLA’s requirements for eligibility to use the Equivalent Quality ControlOption, the laboratory must verify that the following requirements are met:1. The test system provides qualitative, semi-quantitative, or quantitative results.2. The test system includes an internal quality control mechanism.3. The test system does not use molecular amplification, thin layer chromatography, or electrophoretic procedures.4. The test system is not subject to specialty or subspecialty quality control requirements included in any ofthe following sections of COLA criteria.a. General Microbiology, General Susceptibility, Bacteriology, Mycobacteriology, Mycology, Parasitology,or Virology.b. Syphilis Serology,c. Immunohematology,d. Pathology.Selecting the Appropriate Equivalent Quality Control ProcedureThe Laboratory Director, in consultation with the manufacturer, must explore the potential sources of errorwithin the test system and determine whether the internal control mechanisms are capable of detecting eachof the potential sources of error. If the laboratory utilizes a test system that incorporates internal quality controlmechanisms that monitor all or some potential sources of error, and meets the criteria for eligibilitydescribed above, the laboratory director may make the determination to perform equivalent quality controlin place of daily external control, in accordance with the protocol outlined below.Option 1:If the internal control mechanisms monitor all sources of error, the laboratory must conduct a qualifyingstudy by performing both internal QC and two (2) levels of external QC for ten (10) consecutive testing days.If all results are acceptable for both internal and external QC the laboratory may then perform and documentinternal QC daily, and perform and document external QC once per month unless the manufacturer requiresmore frequent and/or additional testing of external controls.Option 2:If the internal control mechanisms monitor only some sources of error, the laboratory must conduct a qualifyingstudy by performing both internal QC and two (2) levels of external QC for thirty (30) consecutive testingdays. If all results are acceptable for both internal and external QC the laboratory may then perform anddocument internal QC daily, and perform and document external QC once per week unless the manufacturerrequires more frequent and/or additional testing of external controls.> NOTE: For each option, if any of the following situations occur, the laboratory must stop using the equivalentQC protocol until corrective actions as described below have been completed and documented.32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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 31: CRITERIA FOR QUALITY LABORATORY PER
Page 65 and 66: IMMUNOHEMATOLOGY & TRANSFUSION SERV
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?