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SMILEJohns Hopkins University

Baltimore, MD USA

Roche Modular Auto-Verification Settings Guidelines

Roche Modular Auto Verification Settings Guideline Number Equ2.9-02-G

Effective Date

Authors: Penny S. Stevens & Kurt L. Michael

Subject

Absurd Values, Delta checks, Indices for interfering

substance flags, and Spot-Check Lists for the Roche

Modular

Page 1 of 3

Supercedes New

PPD Audit:

Not applicable

CAP Accreditation Checklis t:

CHM.10800, GEN.43600, GEN.43881 & GEN.43884

Background Information:

Johns Hopkins University compiled information on absurd values, delta checks and otherreference indices for the Roche Modular. This data was developed from Roche literature andinternal hemolysis studies conducted in the John Hopkins Medical Institutions and intended forinternal use only. This information is provided as example only and should be used as aguideline for labs to determine and establish their own applicable data. Each laboratory should

consult the manufacturers package inserts for Roche recommended limits in each area. Seebelow for guidance on interpreting the appendices. Contact Greg Gerhardt for specificquestions.

Appendix 1 - Absurd and Del ta Values L is t:

Column 1 represents an internal analyte code assigned for use within JHU.

Column 2 is the analyte name

Column 3 is the applicable absurd values. Any result that is outside (greater/less than)the range listed, should be considered absurd and appropriate corrective action applied.

Column 4 lists the delta value for the applicable test. The data lists two delta checkcriteria the first part is an absolute change within an unspecified time period. Thesecond part can be an absolute or percent change as indicate within a specified timeperiod.

o Example: 22-Direct Bilirubin Delta Value - UP TO 5 Absolute 0.5 in last 2 days.

UP TO 5 means if there is a result difference of 5 (absolute) within anytime period, it represents a delta check.

Abso lu te 0.5 in las t 2 days means if there is a result difference of 0.5(absolute) within the past 2 days, it represents a delta check.

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Column 5 lists the applicable clot triggers. If a result is obtained that is outside the rangelisted, less than the lowest single value, or higher than the highest single value, thespecimen should be investigated for the presence of clots.

Appendix 2 - Indices List fo r the Roche Modular: The Roche Modular calculates index

values for each analyte result which can be used to flag specimens suspected of interferingsubstances such as lipemia, hemolysis and Icterus.

Column 1 represents an internal analyte code assigned for use within JHU.

Column 2 is the analyte name

Column 3 is the recommended diluent to be for diluting serum and CSF specimens.

Column 4 is the maximum recommended number of dilutions for serum and CSFspecimens for the applicable analyte.

Column 5 is the recommended diluent to be for diluting urine specimens.

Column 6 is the maximum recommended number of dilutions for Urine specimens for the

applicable analyte.

Column 7-9 Lipemia

o Column 7 lists the index value used to identify the presence of lipemia for eachapplicable analyte.

o Column 8-9 is the code and recommended action for that code.

H = Hold the result and perform the action in column 9 (i.e., airfuge thesample and repeat testing)

R = Reject the specimen

Column 10-12 Hemolysis

o Column 10 lists the index value used to identify the presence of hemolysis foreach applicable analyte.

o Column 11 is the action code. C = Comment

o Column 12 is the recommended action for that code. #1679 is an internalcanned comment used at JHU for reporting the presence of hemolysis with a testresult.

Column 13-15 Icterus

o Column 13 lists the index value used to identify the presence of icterus for eachapplicable analyte.

o Column 14-15 is the code and recommended action for that code.

H = hold the result and perform the action in column 15 (i.e., dilute thesample 1:2 (3X) with Deionized DI Water). A 1:2 dilution is another wayof saying a 3x dilution.

R - Reject the specimen



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Appendix 3 -Spot Check Ranges fo r Hi tachi Tests

This document was developed for verifying the validity of patient results between twoquality control runs where a successful run was followed by a failed run. Spots checksare used to determine if any patient results require amendment (modification).

This document can also be used for recommended delta checks between repeat testson the same sample and to evaluate instrument reliability for the analytes listed. Ifdifferences in repeat test results are greater than the criteria listed, then corrective actionand/or result amendment (modification) should occur.

The spot check limit is an absolute value unless otherwise noted as a percentage. Unitsare not listed. Refer to JHU reference ranges or contact Greg Gerhardt for units ifneeded.

Interpretation Examples:

o ALB - Spot check limi t 0.3:If the difference between replicates is greater than0.3 g/dL, then results are suspect. Investigate and initiate corrective action.

o ALKP - Spot check limi t < 300 = 9: For samples with results less than 300 U/L,if the difference between replicates is greater than 9 U/L, then results aresuspect. Investigate and initiate corrective action.

o ALKP - Spot check limi t >300 = 10%:For samples with results greater than 300U/L, if the difference between replicates is greater than 10%, then results aresuspect. Investigate and initiate corrective action.

Appendices:

1. Modular Absurd and Delta Values List

2. Modular Indices List

3. Modular Spot Check Verification List

Resources

1. College of American Pathologists (CAP) 2007. Commission on LaboratoryAccreditation, Laboratory Accreditation Program; Chemistry & Toxicology ChecklistRevised Sep 2007.

2. College of American Pathologists (CAP) 2007. Commission on LaboratoryAccreditation, Laboratory Accreditation Program; Laboratory General Checklist RevisedSep 2007.


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Arbitrary internal analyte

code assigned forinternal use by JHU.

2.9-02 Appendix 1 - Modular Absurd & Delta Values List


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trary internal analytee assigned for internalby JHU.

ommendedent.

Recommended

number of dilutions.Key:H = Hold ResultR = Reject SpecimenC #1679 = JHUInternal cannedcomment code

Index value

subject to thecode to the

right.

Dilution Instructions.1:2 = 3x dilution

Equ2.9-02 Appendix 2 - Modular Indices List


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qu2.9-02 Appendix 3 - Modular Spot Check Result Verification List

equ29-02 roche modular auto-verfn set guide app

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