King Faisal Specialist Hospital and Research Centre - PO Box 3354, Riyadh 11211, Saudi Arabia
DEPARTMENT OF PATHOLOGY AND LABORATORY MEDICINE - INTERNAL POLICY / PROCEDURE (IPP)
TITLE / DESCRIPTION: INDEX NUMBER:
QUALITY CONTROL PROGRAM LAB-OM-01-41C
EFFECTIVE DATE: REPLACES NUMBER: APPLIES TO: APPROVED BY:
3 RAA 1423 LAB-OM-01-41B Department of Pathology and SIGNITURE ON FILE
15 MAY 2002 Laboratory Medicine Chairman
PURPOSE
The purpose of quality control (QC) is to monitor the performance of an analytical system to ensure the reliability of
the process or measurement performed on a patient sample. An effective QC program identifies areas for process
improvement and ensures reliable results for both short-term and long-term medical decisions.
POLICY
Each laboratory section will develop and implement a quality control program that meets or exceeds the College of
American Pathologists (CAP) general and section specific checklist requirements. Whenever feasible sections will
establish their own control ranges and employ the applicable Westgard rules. All implemented corrective actions
must be documented. QC records must be retained for a minimum of two years. QC results must be reviewed as
per the following schedule:
Daily- all QC results must be reviewed by the technologist with regular review by the area senior to determine if
they meet the acceptability criteria.
Weekly - all QC results must be reviewed and documented by the area senior.
Monthly - the Section Head, Section Supervisor, and area seniors must collectively review and document all
QC data.
External proficiency surveys will be reviewed, documented and corrective action taken when necessary, per
IPP LAB-OM-01-49A, as soon as survey reports are available.
MATERIALS
1. Commercially available solutions or lyophilized control material (may be assayed or unassayed) are most
commonly used. Typically control materials should be very stable, tested for the presence of transmissible
disease agents, easily prepared, and allows peer group comparisons. The laboratory must determine the
acceptable ranges for each lot number of control. A large, continuous supply of control material with the same
lot number is beneficial as this reduces the necessity of frequent control range establishment.
2. Commercial stabilized blood cell preparation. Has a limited shelf life, tested for the presence of transmissible
disease agents and allows peer group comparisons. The assayed control values provided by the manufacturer
should be used only as a guide. The laboratory must verify the manufacturer’s acceptable ranges for each lot
number of control and if at all possible establish their own control ranges.
3. Pooled frozen patient samples prepared and assayed in the laboratory. This is the least expensive way to
prepare controls but there are several disadvantages including: requires specialized expertise and time,
biohazard risk due to possible presence of transmissible disease agents, and the inability to compare results to
other labs. If commercial products are unavailable this is often the only way to verify the reliability of patient
test results.
The analyte concentrations in the control solutions should reflect the values at which clinical medical decisions are
made and not coincide with the calibration points. Some examples include:
Low control: within the normal range (negative)
High control: at a concentration where a medical decision may be made (positive)
PROCEDURE
A. Determining acceptable range of unassayed control material.
LAB-OM-01- 41C Page 1 of 3
Printed copies of this document are considered valid only on the date printed. Date Printed: 01-01-25
King Faisal Specialist Hospital and Research Centre - PO Box 3354, Riyadh 11211, Saudi Arabia
DEPARTMENT OF PATHOLOGY AND LABORATORY MEDICINE - INTERNAL POLICY / PROCEDURE (IPP)
TITLE / DESCRIPTION: INDEX NUMBER:
QUALITY CONTROL PROGRAM LAB-OM-01-41C
EFFECTIVE DATE: REPLACES NUMBER: APPLIES TO: APPROVED BY:
3 RAA 1423 LAB-OM-01-41B Department of Pathology and SIGNITURE ON FILE
15 MAY 2002 Laboratory Medicine Chairman
At least 20 measurements should be collected over a 2- 4 week period. The mean, standard deviation and %
coefficient of variation are calculated in the usual fashion. These values should be used for the Levey-Jennings
plot and should not be changed without careful consideration of the reasons for such action. Any changes must be
documented and pre-approved by the Supervisor and Section Head. Monthly statistics (mean, SD and CV) should
be kept in the computer system and used to monitor changes and/or trends in QC values.
B. Determining acceptable range of assayed control material
The published assayed control values and ranges are to be used only as guides. The procedure described
for determining the acceptable range of unassayed control material should be used whenever possible. If this
cannot be done, due to unavailability of control material or short shelf life of material, the required 20 data points
can be collected in an abbreviated amount of time. Test the new control material, in parallel with the material
currently in use, four times a day for 5 days. The data obtained can be used as described in procedure A to
develop the Levey-Jennings plot.
C. Frequency of QC testing
The frequency of QC analysis is outlined as follows:
At least as often as specified by CAP or the manufacturer, whichever is most frequent.
For analyzers with documented stability, QC may be analyzed once per shift
At the minimum, at least once per day or with each analytical batch if the test is not run daily. Refer to CAP for
test/instrument specific QC frequency requirements.
If unsure, run more often rather than less often, until reliability is established and documented.
D. Interpretation of QC results
All results for each control should be plotted versus time on a chart that has lines drawn for the mean, 1SD, 2SD
and 3SD. Plotting can be accomplished manually or through the use of the Laboratory Information System (LIS) or
a PC computer system. This type of display gives a visual indication of drifts or shifts that have occurred in QC
results. Once recorded, a decision to accept or reject the result must be made. All QC data should be accepted
and included on the QC plot unless an obvious assignable cause for the error is known i.e. no reagent added,
mechanical failure. Indiscriminate rejection of QC data will mask problems, make troubleshooting difficult and lead
to unreliable patient reporting.
Use of the applicable Westgard rules will minimize the false rejection of analytical runs while maximizing error
detection. If Westgard rules cannot be applied, the QC results for all controls must be within the +/- 2 SD of the
mean to accept the run. When the QC results are out-of-control, the cause of the problem must be identified and
appropriate corrective action implemented. Re-running the QC until the results are in-control is not an acceptable
solution.
Each laboratory section must establish guidelines for dealing with patient samples when the QC results are out-of-
control. Whatever method is selected must ensure that the reported patient results are valid and reliable. All
decisions must be fully documented and approved by the Section Head or designee. Some strategies to be
considered are:
Repeat or review, for clinical significance, every sample analyzed since the last successful QC with
acceptance/rejection justification of results clearly documented.
Repeat the samples run during the 1-2 hours (for example) before the out-of-control QC.
LAB-OM-01- 41C Page 2 of 3
Printed copies of this document are considered valid only on the date printed. Date Printed: 01-01-25
King Faisal Specialist Hospital and Research Centre - PO Box 3354, Riyadh 11211, Saudi Arabia
DEPARTMENT OF PATHOLOGY AND LABORATORY MEDICINE - INTERNAL POLICY / PROCEDURE (IPP)
TITLE / DESCRIPTION: INDEX NUMBER:
QUALITY CONTROL PROGRAM LAB-OM-01-41C
EFFECTIVE DATE: REPLACES NUMBER: APPLIES TO: APPROVED BY:
3 RAA 1423 LAB-OM-01-41B Department of Pathology and SIGNITURE ON FILE
15 MAY 2002 Laboratory Medicine Chairman
Run a group of 5-6 samples on another analyzer, if available, and compare these results to the original results.
If the means agree within a specified concentration, the results can be accepted.
REFERENCES
College of American Pathologists, Laboratory Accreditation Manual, October 2001 Edition
College of American Pathologists, Inspection Checklists. 06/21/2001 Edition
NCCLS Document C24-A2, Statistical Quality Control for Quantitative Measurements: Principles and Definitions.
February 1999
Review History
NAME TITLE DATE
LAB-OM-01- 41C Page 3 of 3
Printed copies of this document are considered valid only on the date printed. Date Printed: 01-01-25
King Faisal Specialist Hospital and Research Centre - PO Box 3354, Riyadh 11211, Saudi Arabia
DEPARTMENT OF PATHOLOGY AND LABORATORY MEDICINE - INTERNAL POLICY / PROCEDURE (IPP)
TITLE / DESCRIPTION: INDEX NUMBER:
QUALITY CONTROL PROGRAM LAB-OM-01-41C
EFFECTIVE DATE: REPLACES NUMBER: APPLIES TO: APPROVED BY:
3 RAA 1423 LAB-OM-01-41B Department of Pathology and SIGNITURE ON FILE
15 MAY 2002 Laboratory Medicine Chairman
LAB-OM-01- 41C Page 4 of 3
Printed copies of this document are considered valid only on the date printed. Date Printed: 01-01-25
