Quality Control in Internal Medicine Labs

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Questions and Answers

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?

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?

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?

Two levels of controls for each day of testing. Signup and view all the answers

How long are quality control records retained by the laboratory?

2 years. Signup and view all the answers

How are quantitative quality control results visualized?

Plotted on a graph either manually or via an L.I.S. system. Signup and view all the answers

What defines the acceptable limits for control results?

Manufacturers' instructions and package inserts. Signup and view all the answers

Who is responsible for reviewing and initialing the quality control results in the laboratory?

The laboratory Director or qualified designee. Signup and view all the answers

Who may be responsible for the annual review of procedures if there are no changes?

Technical Consultant or General Supervisor Signup and view all the answers

What is prohibited to store in the laboratory refrigerator designated for reagents?

Glucose tolerance beverages Signup and view all the answers

What kind of water should be available for use when recommended by the manufacturer?

Reagent-grade deionized or distilled water Signup and view all the answers

How often must semi-automated pipettes without a calibration mechanism be verified?

Once a year Signup and view all the answers

What is the maximum allowed distance for a fire extinguisher from the laboratory?

Within distance limits Signup and view all the answers

What must be done with damaged pipettes?

Discarded immediately Signup and view all the answers

How frequently are temperatures recorded for laboratory appliances like refrigerators and freezers?

Each day of testing Signup and view all the answers

What is an essential criterion related to the laboratory space?

It must meet type and volume testing requirements Signup and view all the answers

What should be documented regarding temperature checks in a laboratory setting?

The date and initials of the person performing the check. Signup and view all the answers

What is the acceptable range for control values in a laboratory quality control test?

Within plus or minus two standard deviations. Signup and view all the answers

Which of the following statements is true regarding quality control values?

One control can read within plus or minus two standard deviations even if the other control does not. Signup and view all the answers

What is the purpose of maintaining documentation of equipment maintenance in a laboratory?

To provide a record that can be reviewed by laboratory staff. Signup and view all the answers

What is a consequence of having control values that are considered unacceptable?

The quality control test must be repeated. Signup and view all the answers

How often should laboratory temperature and humidity checks be performed?

As specified by the quality control protocol. Signup and view all the answers

Which type of thermometer is used to perform temperature checks in the laboratory?

Thermometers checked against a NIST standard or NIST-approved thermometers. Signup and view all the answers

What should be done if one control in a quality control test reads between plus or minus 2-3 standard deviations?

A random error may be expected; it does not guarantee a repeat. Signup and view all the answers

How long will the Risk Assessment documentation be retained after an IQCP is discontinued?

Two years Signup and view all the answers

What must be done if one level of quality control is out of range when running two levels?

Repeat the quality control Signup and view all the answers

What will trigger a re-evaluation of the IQCP plan?

Too many quality control failures Signup and view all the answers

Which of the following instruments uses three levels of controls?

Abbott Ruby Signup and view all the answers

What is required for patient results to be accepted in Hematology?

Both control levels must be acceptable Signup and view all the answers

What action should be taken if the new control specimen is within accepted limits?

Patient sample testing may proceed. Signup and view all the answers

Which condition indicates a 'shift' in control values?

Both control values exceed plus or minus two standard deviations for two consecutive days. Signup and view all the answers

What should be done if control values remain unacceptable after testing with a new control specimen?

Follow troubleshooting steps and consult with a supervisor if necessary. Signup and view all the answers

How is 'imprecision' defined in quality control?

When more than one out of 20 control values exceed plus or minus two standard deviations. Signup and view all the answers

What is required when implementing an Individualized Quality Control Plan (IQCP)?

Perform a risk assessment to identify potential errors. Signup and view all the answers

What constitutes a 'trend' in quality control results?

Control values exhibit a consistent increase or decrease for six consecutive days. Signup and view all the answers

What documentation is required when a corrective action is taken?

An entry must be made on the quality control chart or log. Signup and view all the answers

When can patient sample testing not proceed?

When acceptable control values are not achieved. Signup and view all the answers

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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Description

This quiz covers the essential aspects of quality control in internal medicine laboratories. It outlines the policies, procedures, and standards that ensure the accuracy and reliability of laboratory testing processes. Test your knowledge on how controls are implemented and monitored in a clinical setting.