Podcast
Questions and Answers
What is the primary purpose of the quality control program in the laboratory?
What is the primary purpose of the quality control program in the laboratory?
- To manage patient records and documentation.
- To ensure that all tests are run in a timely manner.
- To reduce the number of personnel required for testing.
- To evaluate the quality of the analytical testing process. (correct)
When are quality control records documented in the lab?
When are quality control records documented in the lab?
- Whenever patient samples are tested. (correct)
- Only when errors are identified.
- On a quarterly basis for auditing purposes.
- Only at the end of the testing day.
What happens if quality control results exceed acceptable limits?
What happens if quality control results exceed acceptable limits?
- Quality control records are erased to prevent data loss.
- The testing is immediately stopped and restarted.
- Patient results are reported with notes.
- Corrective action is taken and patient results are held. (correct)
What type of controls are run for quantitative tests each day of testing?
What type of controls are run for quantitative tests each day of testing?
How long are quality control records retained by the laboratory?
How long are quality control records retained by the laboratory?
How are quantitative quality control results visualized?
How are quantitative quality control results visualized?
What defines the acceptable limits for control results?
What defines the acceptable limits for control results?
Who is responsible for reviewing and initialing the quality control results in the laboratory?
Who is responsible for reviewing and initialing the quality control results in the laboratory?
Who may be responsible for the annual review of procedures if there are no changes?
Who may be responsible for the annual review of procedures if there are no changes?
What is prohibited to store in the laboratory refrigerator designated for reagents?
What is prohibited to store in the laboratory refrigerator designated for reagents?
What kind of water should be available for use when recommended by the manufacturer?
What kind of water should be available for use when recommended by the manufacturer?
How often must semi-automated pipettes without a calibration mechanism be verified?
How often must semi-automated pipettes without a calibration mechanism be verified?
What is the maximum allowed distance for a fire extinguisher from the laboratory?
What is the maximum allowed distance for a fire extinguisher from the laboratory?
What must be done with damaged pipettes?
What must be done with damaged pipettes?
How frequently are temperatures recorded for laboratory appliances like refrigerators and freezers?
How frequently are temperatures recorded for laboratory appliances like refrigerators and freezers?
What is an essential criterion related to the laboratory space?
What is an essential criterion related to the laboratory space?
What should be documented regarding temperature checks in a laboratory setting?
What should be documented regarding temperature checks in a laboratory setting?
What is the acceptable range for control values in a laboratory quality control test?
What is the acceptable range for control values in a laboratory quality control test?
Which of the following statements is true regarding quality control values?
Which of the following statements is true regarding quality control values?
What is the purpose of maintaining documentation of equipment maintenance in a laboratory?
What is the purpose of maintaining documentation of equipment maintenance in a laboratory?
What is a consequence of having control values that are considered unacceptable?
What is a consequence of having control values that are considered unacceptable?
How often should laboratory temperature and humidity checks be performed?
How often should laboratory temperature and humidity checks be performed?
Which type of thermometer is used to perform temperature checks in the laboratory?
Which type of thermometer is used to perform temperature checks in the laboratory?
What should be done if one control in a quality control test reads between plus or minus 2-3 standard deviations?
What should be done if one control in a quality control test reads between plus or minus 2-3 standard deviations?
How long will the Risk Assessment documentation be retained after an IQCP is discontinued?
How long will the Risk Assessment documentation be retained after an IQCP is discontinued?
What must be done if one level of quality control is out of range when running two levels?
What must be done if one level of quality control is out of range when running two levels?
What will trigger a re-evaluation of the IQCP plan?
What will trigger a re-evaluation of the IQCP plan?
Which of the following instruments uses three levels of controls?
Which of the following instruments uses three levels of controls?
What is required for patient results to be accepted in Hematology?
What is required for patient results to be accepted in Hematology?
What action should be taken if the new control specimen is within accepted limits?
What action should be taken if the new control specimen is within accepted limits?
Which condition indicates a 'shift' in control values?
Which condition indicates a 'shift' in control values?
What should be done if control values remain unacceptable after testing with a new control specimen?
What should be done if control values remain unacceptable after testing with a new control specimen?
How is 'imprecision' defined in quality control?
How is 'imprecision' defined in quality control?
What is required when implementing an Individualized Quality Control Plan (IQCP)?
What is required when implementing an Individualized Quality Control Plan (IQCP)?
What constitutes a 'trend' in quality control results?
What constitutes a 'trend' in quality control results?
What documentation is required when a corrective action is taken?
What documentation is required when a corrective action is taken?
When can patient sample testing not proceed?
When can patient sample testing not proceed?
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Study Notes
Quality Control Overview
- Quality control (Q.C.) ensures accuracy in analytical testing processes and is essential for detecting immediate and long-term errors.
- Written policies and procedures document Q.C. activities, maintaining consistency in testing.
Standards and Procedures
- Controls must be executed in parallel with patient samples.
- Testing personnel rotate to perform Q.C. tests, and actions are taken if Q.C. results exceed predefined limits.
- Control results are plotted for visual trend analysis using manual or Laboratory Information System (L.I.S.) methods.
- Records of Q.C. results are maintained for a minimum of two years.
Quality Control Criteria
- Acceptance of control values relies on specific criteria centering on standard deviations from established means.
- Controls must remain within prescribed limits; unacceptable results necessitate retesting, and patient sample testing cannot commence until control values are validated.
Laboratory Facilities and Safety
- Laboratory environment is equipped with adequate work surfaces, temperature and humidity controls, waste disposal, and safety equipment.
- Regular inspections are performed on safety equipment, including fire extinguishers.
Reagents and Supplies Management
- Reagents and controls are stored per manufacturer specifications.
- Expired materials are discarded and not utilized in testing procedures.
- Food storage is prohibited in reagent-designated areas.
Measuring Devices
- Measuring devices are calibrated for precision, with annual checks required for non-calibrated models.
- Non-disposable measuring devices are discarded after a single use to maintain accuracy.
Temperature Checks and Equipment Maintenance
- Daily temperature logs for refrigerators, freezers, incubators, and water baths ensure proper functioning.
- Maintenance and function checks are documented and adhere to operator manuals to guarantee proper test performance.
Individualized Quality Control Plan (IQCP)
- IQCP is implemented per CLIA and COLA standards, focusing on identifying potential error risks.
- A risk assessment is conducted to validate the effectiveness of the IQCP without compromising patient care, with documentation retained for two years.
Instrument-Specific Procedures
- Various instruments (e.g., Roche Cobas, Abbott Ruby) require Q.C. tests at different control levels before accepting patient results.
- Retesting protocols are in place if control results are outside acceptable ranges, followed by troubleshooting if necessary.
Documentation and Review
- Quality control reviews are documented, allowing for transparency and follow-up on corrective actions taken, ensuring continuous improvement of laboratory practices.
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