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Auto vs. Manual Differential Validation Summary Template
Author:Validation Committee / Document Number: / Equ35-B-09
Effective (or Post) Date: / 2 March 2010
Review History- / Date of last review: / 11 August 2010
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.
Auto vs. Manual Differential Validation SummaryTemplate / Document Number / 375
Effective Date / March 1, 2010
Subject
Template Summary for Auto vs.Manual Differential Validation / Page / 1 of 1
Supersedes / New
Author(s) / Name, Title / Date
Jo Shim, Penny Stevens / March 1, 2010
Approved by / Name, Title / Date
SMILE Validation Committee / March 1, 2010
Review History / Date of last review:
Reviewed by:
Revision History / Version # [0.0] / Revision Date [dd/mm/yy] / Description (notes)
Auto vs. Manual Differential Validation Summary Report
Purpose: Validation Re-Validation Other:
Description of Equipment/Process:
A Correlation study was performed between the Insert full name of the hematology analyzer and 200 cell count manual differentials. Forty (40) samples were used for the correlation study Samples were analyzed on the Insert full name of the hematology instrument within 2 hours of specimen collection. Immediately after sampling, two slides were prepared from each sample and stained according to manual differential SOP used by Insert the name of the laboratory.
Equipment/Process: Insert full name of analyzer (ex: Horiba Pentra 80)
Serial Number: Insert instrument serial number
Stain: Insert the name of the manual differential stain used
Location: Insert name of lab, city, state and country
Date: Insert date range of validation studies
FDA Approval Status of hematology Instrument: ApprovedNot approved
Procedure:
Refer to the insert lab name Validation Plan for Manual Differential correlated with insert instrument name
Ex: Refer to the XYZ LabManual Differential Validation plan.
1)Precision - Not applicable
2)Accuracy
- Sample preparation - Sample slides were prepared in duplicate. One slide was stained and counted using a 200-cell count procedure. 200 cell counts were performed for increased accuracy during the correlation study to control for random error and for comparison with the Rumke 95% confidence limits. The extra slides were held in reserve and used only as needed if the first slides were deemed unacceptable for any reason.
- Data analysis - All analytes were evaluated using the Rumke Table, Appendix I under Auto vs. Manual Differential Plan Template. Results were considered acceptable if at least 80% of the samples tested by manual differential fell within the Rumke acceptable range as determined by the automated differential count. See Appendix I for the Rumke table. Results are summarized in the table below.
Parameter % / Rumke(>80%) / Acceptable?
Neutrophil
Lymphocyte
Monocyte
Eosinophil
Basophil
3)Linearity - Not applicable to a qualitative method
4)Analytical Measurement Range - 0 - 100%
5)Analytic Sensitivity - not applicable
6)Analytic Specificity - not applicable
7)Reportable range of patient test results - 0-100%
Reference ranges –Include reference to the hematology correlation instrument Validation document or the appropriate reference range documents.
Results: All raw data reports and statistical analysis can be found in the Hematology Manual Differential Validation binder.
8)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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