Changing Reagents on the GenS - pSMILE



|Author: |Document Number: |Equ30-40 |

|Heidi Hanes | | |

| |Effective (or Post) Date: |15-June-2010 |

|Review History |Date of last review: |1 April 2020 |

| |Reviewed by: |Heidi Hanes |

|pSMILE 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 encouraged to ensure compliance with local laws and study protocol policies when |

|considering the application of this document. If you have any questions contact SMILE. |

Hematology Inter- and Intra-instrument Comparisons

PURPOSE

This procedure provides the instructions for inter- and intra-instrument comparisons for checking correlation of patient results between hematology analyzers at least semiannually. Comparisons are required between the Sapphire and the 3200 analyzers in the closed mode and within the 3200 instrument in the open and closed modes.

INSTRUMENTATION

Abbott Diagnostics Cell-Dyn Sapphire and 3200 hematology analyzers

SPECIMENS

A minimum of five (5) fresh patient specimens collected in EDTA anticoagulated vacuum tubes is required. The selection of normal patient specimens is preferred. Ideally, specimens should be less than four (4) hours from collection time. Ensure that there is enough blood volume in each specimen to perform the required studies. Refer to the following chart for reference ranges of acceptable specimens to be used.

| Analyte |Reference Range |

|WBC |5.0-10.0 |

|RBC |4.0-5.0 |

|HGB |13.5-16.5 |

|HCT |40-46 |

|MCV |80-100 |

|PLTS |150-450 |

NOTE: All specimens must fall within the criteria.

PROCEDURE A

Semiannual inter-instrument comparisons between the Sapphire and the 3200 in closed mode

|Step |Action |

|1 |Analyze a minimum of five (5) patient specimens for WBC, RBC, hemoglobin, hematocrit, MCV, and platelet count, on the Sapphire, |

| |3200 (Core lab), and 3200 (Cancer Center lab) analyzers. Minimize the amount of time between the analyses on the three different|

| |analyzers. |

|2 |For each analyte, compare each specimen’s results from each analyzer and verify that they agree within the acceptability criteria|

| |(based on the normal control quality control material) given below: |

| | |

| |Analyte |

| |Criteria, ( |

| | |

| |WBC |

| |0.4 |

| | |

| |RBC |

| |0.1 |

| | |

| |Hemoglobin |

| |0.25 |

| | |

| |Hematocrit |

| |1.25 |

| | |

| |MCV |

| |2.0 |

| | |

| |Platelet |

| |25 |

| | |

|3 |If 100% specimen acceptability is achieved for all analytes, no further action is necessary. |

| |If 80% specimen acceptability is achieved for any analyte, analyze another five (5) specimens for that analyte and compare those |

| |results to the acceptability criteria. If 100% specimen acceptability is achieved, no further action is necessary. |

| |If ................
................

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