Roche Modular Auto-Verification Settings Guidelines

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1 SMILE Jhns Hpkins University Baltimre, MD USA Rche Mdular Aut-Verificatin Settings Guidelines Rche Mdular Aut Verificatin Settings Guideline Number Equ G Authrs: Penny S. Stevens & Kurt L. Michael Subject Absurd Values, Delta checks, Indices fr interfering substance flags, and Spt-Check Lists fr the Rche Mdular Effective Date Page 1 f 3 Supercedes New PPD Audit: Nt applicable CAP Accreditatin Checklist: CHM.10800, GEN.43600, GEN & GEN Backgrund Infrmatin: Jhns Hpkins University cmpiled infrmatin n absurd values, delta checks and ther reference indices fr the Rche Mdular. This data was develped frm Rche literature and internal hemlysis studies cnducted in the Jhn Hpkins Medical Institutins and intended fr internal use nly. This infrmatin is prvided as example nly and shuld be used as a guideline fr labs t determine and establish their wn applicable data. Each labratry shuld cnsult the manufacturer s package inserts fr Rche recmmended limits in each area. See belw fr guidance n interpreting the appendices. Cntact Greg Gerhardt fr specific questins. Appendix 1 - Absurd and Delta Values List: Clumn 1 represents an internal analyte cde assigned fr use within JHU. Clumn 2 is the analyte name Clumn 3 is the applicable absurd values. Any result that is utside (greater/less than) the range listed, shuld be cnsidered absurd and apprpriate crrective actin applied. Clumn 4 lists the delta value fr the applicable test. The data lists tw delta check criteria the first part is an abslute change within an unspecified time perid. The secnd part can be an abslute r percent change as indicate within a specified time perid. Example: 22-Direct Bilirubin Delta Value - UP TO 5 Abslute 0.5 in last 2 days. UP TO 5 means if there is a result difference f 5 (abslute) within any time perid, it represents a delta check. Abslute 0.5 in last 2 days means if there is a result difference f 0.5 (abslute) within the past 2 days, it represents a delta check. Equ Rche Mdular Settings Guidelines Versin#: 1.0 Page 1 f 3

2 SMILE Jhns Hpkins University Baltimre, MD USA Clumn 5 lists the applicable clt triggers. If a result is btained that is utside the range listed, less than the lwest single value, r higher than the highest single value, the specimen shuld be investigated fr the presence f clts. Appendix 2 - Indices List fr the Rche Mdular: The Rche Mdular calculates index values fr each analyte result which can be used t flag specimens suspected f interfering substances such as lipemia, hemlysis and Icterus. Clumn 1 represents an internal analyte cde assigned fr use within JHU. Clumn 2 is the analyte name Clumn 3 is the recmmended diluent t be fr diluting serum and CSF specimens. Clumn 4 is the maximum recmmended number f dilutins fr serum and CSF specimens fr the applicable analyte. Clumn 5 is the recmmended diluent t be fr diluting urine specimens. Clumn 6 is the maximum recmmended number f dilutins fr Urine specimens fr the applicable analyte. Clumn 7-9 Lipemia Clumn 7 lists the index value used t identify the presence f lipemia fr each applicable analyte. Clumn 8-9 is the cde and recmmended actin fr that cde. Clumn Hemlysis H = Hld the result and perfrm the actin in clumn 9 (i.e., airfuge the sample and repeat testing) R = Reject the specimen Clumn 10 lists the index value used t identify the presence f hemlysis fr each applicable analyte. Clumn 11 is the actin cde. C = Cmment Clumn 12 is the recmmended actin fr that cde. #1679 is an internal canned cmment used at JHU fr reprting the presence f hemlysis with a test result. Clumn Icterus Clumn 13 lists the index value used t identify the presence f icterus fr each applicable analyte. Clumn is the cde and recmmended actin fr that cde. H = hld the result and perfrm the actin in clumn 15 (i.e., dilute the sample 1:2 (3X) with Deinized DI Water). A 1:2 dilutin is anther way f saying a 3x dilutin. R - Reject the specimen Equ Rche Mdular Settings Guidelines Versin#: 1.0 Page 2 f 3

3 SMILE Jhns Hpkins University Baltimre, MD USA Appendix 3 -Spt Check Ranges fr Hitachi Tests This dcument was develped fr verifying the validity f patient results between tw quality cntrl runs where a successful run was fllwed by a failed run. Spts checks are used t determine if any patient results require amendment (mdificatin). This dcument can als be used fr recmmended delta checks between repeat tests n the same sample and t evaluate instrument reliability fr the analytes listed. If differences in repeat test results are greater than the criteria listed, then crrective actin and/r result amendment (mdificatin) shuld ccur. The spt check limit is an abslute value unless therwise nted as a percentage. Units are nt listed. Refer t JHU reference ranges r cntact Greg Gerhardt fr units if needed. Interpretatin Examples: ALB - Spt check limit 0.3: If the difference between replicates is greater than 0.3 g/dl, then results are suspect. Investigate and initiate crrective actin. ALKP - Spt check limit < 300 = 9: Fr samples with results less than 300 U/L, if the difference between replicates is greater than 9 U/L, then results are suspect. Investigate and initiate crrective actin. ALKP - Spt check limit >300 = 10%: Fr samples with results greater than 300 U/L, if the difference between replicates is greater than 10%, then results are suspect. Investigate and initiate crrective actin. Appendices: 1. Mdular Absurd and Delta Values List 2. Mdular Indices List 3. Mdular Spt Check Verificatin List Resurces 1. Cllege f American Pathlgists (CAP) Cmmissin n Labratry Accreditatin, Labratry Accreditatin Prgram; Chemistry & Txiclgy Checklist Revised Sep Cllege f American Pathlgists (CAP) Cmmissin n Labratry Accreditatin, Labratry Accreditatin Prgram; Labratry General Checklist Revised Sep Equ Rche Mdular Settings Guidelines Versin#: 1.0 Page 3 f 3

P02-03 CALA Program Description Proficiency Testing Policy for Accreditation Revision 1.9 July 26, 2017

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