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Summary of Quality Control (QC) Program

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Key Points

• The QC program emphasizes systematic monitoring, documentation, and corrective actions to ensure reliable laboratory results and improve overall quality in patient care.Responsibilities
• Department Heads and Supervisors must select survey materials and ensure timely testing and result submission.Purpose
• The QC program aims to monitor the performance of analytical systems to ensure reliability in patient sample measurements, facilitating both short-term and long-term medical decisions.Procedures
• Acceptable Ranges: At least 20 measurements over 2-4 weeks are needed to establish control ranges, which must be documented and approved.Corrective Actions
• Systematic Errors: Involve maintenance, recalibration, and retraining.Definitions
• Quality Control Program: A system developed to ensure products or services meet or exceed customer requirements.- Frequency of Testing: QC testing frequency is set to daily for stable analyzers and with each analytical batch if not run daily.Unacceptable results require documented corrective actions and a review of patient results to ensure validity.Policy
• Each laboratory section will create a QC program with specific checklists and control ranges.Documentation of corrective actions is required, and QC records must be retained for a minimum of three years.QC Review Schedule
• Daily: QC results reviewed by technologists and section supervisors.- Random Errors: Typically resolved by re-running samples; if issues persist, further investigation is needed.Split-Sample Procedures
• Used for external proficiency tests or when unavailable.- Monthly: Section Head and Quality Officer review all QC data collectively.Interpretation of Results
• QC results should be plotted over time.Accept or reject results based on established criteria.Samples may be split for testing in other laboratories or re-run internally using different methods.They are also responsible for reviewing QC results before patient results are released.#### 2.#### 3.#### 4.#### 5.#### 6.#### 7.#### 8.#### 9.

Summary of Quality Control (QC) Program

1. Purpose

• The QC program aims to monitor the performance of analytical systems to ensure reliability in patient sample measurements, facilitating both short-term and long-term medical decisions.

2. Definitions

• Quality Control Program: A system developed to ensure products or services meet or exceed customer requirements.

3. Policy

• Each laboratory section will create a QC program with specific checklists and control ranges. Documentation of corrective actions is required, and QC records must be retained for a minimum of three years.

4. QC Review Schedule

• Daily: QC results reviewed by technologists and section supervisors.


• Monthly: Section Head and Quality Officer review all QC data collectively.

5. Procedures

• Acceptable Ranges: At least 20 measurements over 2-4 weeks are needed to establish control ranges, which must be documented and approved.


• Frequency of Testing: QC testing frequency is set to daily for stable analyzers and with each analytical batch if not run daily.

6. Interpretation of Results

• QC results should be plotted over time. Accept or reject results based on established criteria. Unacceptable results require documented corrective actions and a review of patient results to ensure validity.

7. Corrective Actions

• Systematic Errors: Involve maintenance, recalibration, and retraining.


• Random Errors: Typically resolved by re-running samples; if issues persist, further investigation is needed.

8. Split-Sample Procedures

• Used for external proficiency tests or when unavailable. Samples may be split for testing in other laboratories or re-run internally using different methods.

9. Responsibilities

• Department Heads and Supervisors must select survey materials and ensure timely testing and result submission. They are also responsible for reviewing QC results before patient results are released.

Key Points

• The QC program emphasizes systematic monitoring, documentation, and corrective actions to ensure reliable laboratory results and improve overall quality in patient care.