CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters July 2011
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1 CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters July West Valley Road Suite 1400 Wayne, PA F:
2 Automation and Informatics Auto02-A2 x x x Auto03-A2 x Auto07-A x x x Auto08-A x x x x Auto09-A x Auto10-A x x x Auto11-A x Auto12-A x x x Clinical Chemistry and Toxicology C03-A4 x x C24-A3 x x x x C28-A3c x x x x C30-A2 x x x x x C34-A3 x x x x C40-A x x x x x C43-A2 x x x x C45-A x x x x C46-A2 x x x x C48-A x x x x C49-A x x x x x C50-A x x x x C52-A2 x x x x C53-A x x x 2 * Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges sources of error; reagent handling 3
3 Clinical Chemistry and Toxicology (Continued) C54-A x x x x x T/DM06-A x x x x Evaluation Protocols EP05-A2 x x x x EP06-A x x x x EP07-A2 x x x x EP09-A2-IR x x x x EP10-A3 x x x x EP12-A2 x x x x EP14-A2 x x x x EP15-A2 x x x x EP17-A x x x x x EP18-A2 x x x x x EP21-A x x x x EP25-A x x x x x Quality Systems and Laboratory Practices GP02-A5 x x x x GP05-A3 x x GP09-A x GP10-A x x x GP15-A3 x x x GP16-A3 x x x x GP17-A2 x x x 4 * Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges sources of error; reagent handling 5
4 Quality Systems and Laboratory Practices (Continued) GP18-A2 x x x GP20-A2 x x x x GP21-A3 x x GP22-A3 x x x x x x x x GP26-A4 x x x x x x x x x x x x GP27-A2 x x x x x GP28-A x x x GP29-A2 x x x x x GP31-A x x x x x x GP32-A x x x GP33-A x x x GP34-A x x GP35-A x x HS02-A x x x x Hematology H01-A6 x x x H02-A5 x x x x H03-A6 x x x x H04-A6 x x x x H07-A3 x x x x H11-A4 x x x H15-A3 x x x x 6 * Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges sources of error; reagent handling 7
5 Hematology (Continued) H17-A x x x H18-A4 x x x H20-A2 x x x H21-A5 x x x x H26-A2 x x x x H30-A2 x x x H42-A2 x x x H43-A2 x x x H44-A2 x x x H45-A2 x x x H47-A2 x x x H48-A x x x H49-A x x x x H51-A x x x H52-A x x x H54-A x x x H56-A x x x H57-A x x x H58-A x x x H59-A x x x Immunology and Ligand Assay I/LA02-A2 x x x I/LA20-A2 x x x 8 * Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges sources of error; reagent handling 9
6 Immunology and Ligand Assay (Continued) I/LA21-A2 x x x x x x I/LA23-A x x x I/LA24-A x x x I/LA25-A2 x x x x I/LA26-A x x x x I/LA27-A x x x x I/LA28-A2 x x x x x x x x x x I/LA29-A x x x I/LA31-A x x x x I/LA32-A x x x I/LA33-A x x x x LA04-A5 x x Microbiology M02-A10 x x x x M06-A2 x x x M07-A8 x x x M11-A7 x x x M15-A x x x M21-A x x x M22-A3 x x x M23-A3 x x x x M24-A2 x x x M26-A x x x 10 * Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges sources of error; reagent handling 11
7 Microbiology (Continued) M27-A3 x x x x M28-A2 x x x M29-A3 x x M33-A x x x M35-A2 x x x M38-A2 x x x x M39-A3 x x x x x M40-A x x x M41-A x x x M44-A2 x x x M45-A2 x x x M47-A x x x x M48-A x x x M50-A x x x M51-A x x x M100-S21 x x x x Molecular Methods MM01-A2 x x x x MM02-A2 x x x MM03-A2 x x x MM05-A x x x MM06-A2 x x x MM07-A x x x 12 * Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges sources of error; reagent handling 13
8 Molecular Methods (Continued) MM09-A x x x MM10-A x x x MM11-A x x x MM12-A x x x MM13-A x x x MM14-A x x x x MM16-A x x x MM17-A x x x MM18-A x x x x Point-of-Care Testing POCT01-A2 x x x x POCT02-A x x x x POCT04-A2 x x x x POCT05-A x x x x x POCT07-A x x x x x x POCT08-A x x x x POCT09-A x x x x Reports X03-R x x x X04-R x x X05-R x x x x 14 * Elements of the QSA Chapters: PT; QC; record retention; verification; validation and calibration; reference and reportable ranges sources of error; reagent handling 15
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