Lab Name Department of Pathology

AddressAutomated Hematology

Blind Duplicate Patient Testing on the GenS

Author:
Heidi Hanes / Document Number: / Equ30-43
Effective (or Post) Date: / 15-June-2010
Review History / Date of last review: / 7 Feb 2012
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.

Document: HEA.1620Effective: ______

Version 1.0

PURPOSE

This procedure provides instruction for using patient specimens as an additional quality control process for both the primary and secondary modes on the GenS and HmX Hematology Analyzers.

POLICY

Blind duplicate samples are used in conjunction with manufactured controls and XB samples to provide a comprehensive quality program.

  • Each day a new high and low patient specimen is run through both the primary and secondary mode of the GenS.This act both as a QC for the secondary mode and a correlation of the two modes.
  • A microhematocrit procedure is run on both specimens for agreement.
  • Both specimens are run through the primary mode only at designated times throughout the shifts.
  • Samples are run the following morning until new patient controls are chosen from the morning run.
  • Refrigerate samples when not in use.

NOTE: The same samples will be used on both the GenS and the HmX instruments each day.

SAMPLES

Use the following table to select patient samples for use as blind duplicates:

Sample Type / WBC / HGB
High / 5.0-10.0 x 103/mm3 / 12.0-15.0 mg/dL
Low / 10.0-15.0 x103 /mm3 / 7.0-10.0 mg/dL

PROCEDURE

Step / Action
1 / Run a hematocrit on each Low and High sample.
2 / Record on Hematocrit log sheet located above microcentrifuge.
3 / Monitored parameters should agree within +/- 2 SD at 0 days with back up method.
If / Then
  • Any parameter exceeds limits
/
  • Rerun

  • Still out
/
  • Run on alternative method to determine if an instrument problem or sample problem
  • If
/
  • Then

  • Same results on both instruments
/
  • Sample problem
  • Mark “Sample Deterioration” Attach to Hct result.

  • Different results
/
  • Instrument problem
  • Run on alternate instrument until problem resolved
  • Call Coulter Service.

  • Consistent problem with Blind Duplicates
/
  • Inform QC tech.

RESULTS

A.The parameters below are monitored on the GenS to ensure proper instrument function and correlation between instruments and modes. Each parameter should agree within the following ranges:

Parameter / High / Low
WBC
RBC
HGB
HCT
MCV
PLT / ± 0.6
± 0.14
± 0.3
± 2.0
± 2.0
± 40.0 / ± 1.4
± 0.14
± 0.3
± 2.0
± 2.0
± 40.0

B.Control decisions are as follows:

If / Then
  • All parameters on the high and low samples read within ± 2 SD when compared to the results of each original run
OR
  • One parameter of either the high or low reads with ± 2-3 SD when compared to the results of the original run and all others are within 2 SD.
/
  • Proceed with patient testing

  • Any parameter on either the high or low sample reads greater than +3 SD
/
  • Do not proceed with patient testing
  • Repeat sample.
If / Then
  • Acceptable
/
  • Proceed with patient testing

  • Still out
/
  • Use back up methods

  • Results still the same on backup
/
  • Sample deterioration, proceed with patient testing

  • Results acceptable on backup
/
  • Indicates instrument problem, use back up instrument
  • Inform QC tech or supervisor

  • A single parameter on both high and low is greater than +2 SD
/
  • Repeat test on each sample:
If / Then
  • Acceptable
/
  • Proceed with patient testing

  • Still out
/
  • Use back up methods

  • Results still the same on backup
/
  • Sample deterioration, proceed with patient testing

  • Results acceptable on backup
/
  • Indicates instrument problem, use back up instrument
  • Inform QC tech or supervisor.

C. Run 5C controls.

If / Then
  • Similar problems with 5C as with patient controls
/
  • Call Coulter Hotline
  • Use back up instrument

  • 5C controls acceptable
/
  • Run 10-12 patients on back –up instrument and compare results.
If / Then
  • Parameters match
/
  • Proceed with patient testing
  • Monitor moving averages

  • Moving averages show same problem
/
  • Call Coulter Hotline
  • Use backup instrument
  • Inform QC Tech and Supervisor of any unresolved or recurring problems.

D. Handling insufficient or deteriorated samples:

If / Then
  • Insufficient sample remaining
/
  • Go to function MEM
  • Go to Test
  • For GenS use worksheet to enter (to go to correct workload)
  • Enter CBC
  • Enter blind dup acc. number, B-Acc No.
  • At prompt, enter 0.0-QNS for all parameters and accept.

  • Sample deteriorated
/
  • Attach onto Hematocrit, “Sample Deteriorated”

  • Both high and low samples become deteriorated before 24 hours are completed
/
  • Select 2 new samples from previous run
  • Follow protocol for selection of new blind patient duplicates
  • Follow Procedure A-C above.

Approval Signature:______Date: ______

Blind Duplicate Patient Testing on the GenSPage 1 of 4

Document HEA.1620 Version 1.0