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Chemistry Validation Summary Template

Author: Validation Committee / Document Number: / Equ35-A-02
Effective (or Post) Date: / 23 March 2011
Review History / Date of last review: / NA
Reviewed by: / Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE.
Chemistry Validation Summary Template / Document Number / 265
Effective Date / Feb 2009
Subject
Template Summary for Chemistry Validation / Page / 1 of 1
Supersedes / Version 1.0
Author(s) / Name, Title / Date
Mark Swartz, Heidi Hanes, Jo Shim, Penny Stevens, Anne Sholander / Feb 2009
Approved by / Name, Title / Date
SMILE Validation Committee / Feb 2009
Review History / Date of last review: / May 28, 2010
Reviewed by: / Anne Sholander
Revision History / Version # [0.0] / Revision Date [dd/mm/yy] / Description (notes)
1.1 / 28 May 2010 / Revised reference range example table to reflect current practice.
1.2 / 11 Mar 2011 / Update Linearity section of template and examples to improve clarity.


Validation Summary Report

Purpose: oValidation oRe-Validation oOther:

Description of Equipment/Process:

Equipment/Process: Insert full name of analyzer (ex: Cobas Integra 400+)

Serial Number: Insert instrument serial number

Location: Insert name of lab, city, state and country

Date: Insert date range of validation studies

FDA Approval Status: oApproved oNot approved

Procedure:

Refer to the insert lab name Validation Plan for insert instrument name

Ex: Refer to the XYZ Lab Validation plan for Cobas Integra 400

Results: All raw data reports and statistical analysis can be found in the insert instrument name Validation binder.

1.  Precision- refer to tab A

Analyte / Expected Results / Observed Results / Acceptability
Between Day
Manufacturer’s Precision / 33% of CLIA / Normal Control
CV% / Abn Control
CV%
Ex:ALT / 3.3% / 6.6% / 3.8% / 4.3% / Acceptable
Analyte / Expected Results / Observed Results / Acceptability
Within Run
Manufacturer’s Precision / 25% of CLIA / Normal Control
CV% / Abn Control
CV%
Ex:ALT / 2.6% / 5% / 2.6% / 4.3% / Acceptable

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2.  Accuracy-refer to tab B

Identify the method or materials used to establish accuracy. For example, if correlation with another lab is used, identify the lab, location and methodology. If a proficiency panel is used, provide the panel name, year and provider

i.  Correlation with Insert name Laboratory, Insert location, Insert test method

Ex. Correlation with XYZ Laboratory, Baltimore, Maryland, Cobas Integra

OR

Accuracy established using insert proficiency provider, year and panel name with results compared to the peer means.

Ex. Accuracy established using the CAP2008 Chemistry C-A, C-B, C-C and LN2-A samples with results compared to the peer means.

Analyte / Total Allowable Error / Correlation Coefficient (R) / Linear Regression Statistics / Error Index Range / % of Error Indices
-1.0 to 1.0 / Acceptability
Expected
>0.975 / Slope / Intercept / Expected
-1.0 to1.0 / Expected
≥ 95%
Ex.ALT / 0.5U/L or 20% / 0.997 / 1.002 / 2.19 / -0.29-1.05 / 95% / Acceptable

ii.  (Required only for analytes identified as unacceptable in column 2. i.)

Correlation with Insert name Laboratory, Insert location, Insert test method

Ex. Correlation with XYZ Laboratory, Baltimore, Maryland, Cobas Integra

(Evaluated Using the Alternate Comparison and Six Sigma Module)

Analyte / Total Allowable Error / Correlation Coefficient (R) / MDP Error Index Range / Worst
Sigma Metric / Acceptability
Expected
>0.975 / Expected
-1.0 to1.0 / 100% of Error Indices:
-1.0 to 1.0 / Expected:
>2.0
Ex.ALT / 0.5U/L or 20% / 0.997 / -0.29-1.00 / yes / 4.0 / Acceptable

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3.  Linearity -refer to tab C

Identify the method or materials used to establish linearity. If a proficiency panel is used, provide the panel name, year and provider

i.  Linearity using the insert provider, year and panel name

Ex. Linearity using the CAP2008 Chemistry Linearity LN2-B

Analyte / Linear Regression Statistics / Allowable Systematic Error / Linear Range Verified / Evaluation
Slope / Intercept / 50% of TEa
Ex:ALT / 0.970 / 0.282 / 10% / 20-350 / Linear

4.  Analytical Measurement Range (AMR) and Clinical Reportable Range (CRR)-refer to tab D

Analyte / Mfg’s AMR / Low Value Verified / High Value Verified / Reportable Range / Dilutions / CRR / DAIDS Toxicity Grade 4
Ex:ALT / 5-700 U/L / 2.5 / 770 / 5-700 / 1:10 / 5-7000 / >381

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5.  Sensitivity and Specificity-refer to tab E for instrument package inserts

**See below for example of how to enter information from the package insert into the summary form

Summary of Manufacturer’s Claims for Sensitivity and Specificity
Analyte / Specificity (Interfering Substances) / Sensitivity
ALT / Icterus – No significant effect
Hemolysis – No significant effect
Lipemia – No significant effect; >Abs flagging may occur
Other –Calcium dobesilate may cause low results / 5 U/L
AST / Icterus – No significant effect
Hemolysis – No significant effect
Lipemia – No significant effect; >Abs flagging may occur / 5 U/L
Albumin / Icterus –No significant effect
Hemolysis- No significant effect
Lipemia- No significant effect / 0.2 g/dL

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6.  Reference ranges-refer to tab F

**See example data below

Analyte / Adult Reference Ranges / Reference Range Cited / % Verified
(Expected ≥90%)
Albumin / 3.4-5.0 mg/dL / Dimension Manufacturer’s range / 100%
Alk Phos / 38-126 U/L / Caribbean Reference ranges / 95%
ALT / 9-72 U/L / Caribbean Reference ranges / 95%
Amylase / 25-125 U/L / Panamanian Reference ranges / 95%
AST / 0-37 U/L / Panamanian Reference ranges / 100%
BUN / 7-18 mg/dL / Dimension Manufacturer’s range / 100%
Cholesterol / 0-200 mg/dL / N/A* / N/A*
Creatinine / 0.5-1.4 mg/dL / Panamanian Reference ranges / 95%
D. Bilirubin / 0.0-0.3 mg/dL / Dimension Manufacturer’s range / 100%
Glucose / 70-110 mg/dL / Dimension Manufacturer’s range / 100%
HDL Cholesterol / 40-60 mg/dL / N/A* / N/A*
LDL Cholesterol / <130.00 mg/dL / N/A* / N/A*
LDH / 100-190 U/L / Dimension Manufacturer’s range / 95%
Lipase / 20-300 U/L / Caribbean Reference range / 90%
T. Bilirubin / 0.1-1.2 mg/dL / Caribbean Reference range / 95%
Total Protein / 6.4-8.2 g/dL / Dimension Manufacturer’s range / 100%
Triglycerides / 0-150 mg/dL / N/A* / N/A*
Uric Acid / 2.6-7.2 mg/dL / Dimension Manufacturer’s range / 100%

Reference Range Approval

Medical Director: ______Date: ______

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Insert Medical director name here

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Method Approval

Approved / Not Approved

If not approved, provide recommendations/corrective actions below.

Laboratory Director: ______Date: ______

Insert Lab director name here

Prepared by: ______Date:______

Insert name and title here

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