Question

Chapter 41 Assistng n the Clinical Labonaory 14. FDA 15 PPM: 16 OSHA: C. Quality Assurance Guideline Describe quality assurance (QA) in the laboratory. List the three stages of laboratory QA. Define calibration in your own words. Define quality control or control materials. Why is preventive maintenance so important in the laboratory? 5 D. Quality Control Guideline What is the purpose of running quality control (QC) samples in the laboratory? 1 is a measure of how close a test result is to the true value of the control mate rial, as established by the manufacturer. The ability to consistently reproduce a test result is the definition of Copyright 2019 Elevier Inc. All Rights Reserved

Answer 1

14. FDA: Food and Drug Administration

15. PPM: Parts Per Million

16. OSHA: Occupational Safety and Health Administration

C. Describe quality assurance in the laboratory?

Refers to all the process a laboratory takes to ensure quality in test results. The purpose of quality assurance is to give relevant, reliable, timely test results which are interpreted correctly. Quality assurance involves activities both inside and outside the laboratory, good laboratory practice and proper management skills.

The WHO definition of quality assurance is a total process whereby the quality of lab reports can be guaranteed. It has been summarised as the

• right result, at the

• right time, on the

• right specimen, from the

• right patient, with result/interpretation based on

• correct reference date, and at the

• right place

2. List the three stages of laboratory quality assurance?

The various quality assurance areas in each of these three phases of a medical lab include:

• Pre-analytical: All patient information and documentation is correct, patient information is kept private, proper procedures are followed when taking the sample (e.g., medical professional wears gloves)
• Analytical: Standard operating procedures (SOPs) are maintained during the testing of the sample (e.g., proper temperature is maintained, the sample is not contaminated), patient privacy is maintained
• Post-analytical: Samples are analyzed using the correct equipment, equipment is routinely calibrated, patient privacy is maintained.

3. Define calibration?

Instrument calibration is one of the primary processes used to maintain instrument accuracy. Calibration is the process of configuring an instrument to provide a result for a sample within an acceptable range. Eliminating or minimizing factors that cause inaccurate measurements is a fundamental aspect of instrumentation design.

4. Define quality control and control materials?

Quality control (QC) or the other hand covers the part of quality assurance which primarily concerns the control of errors in the performance of tests and verification of test results. Quality control must be practical, achievable and affordable. The primary aim of quality control is to do the test reliably. The broad aim of quality control is that results from one lab should be comparable with that from any lab in the world provided the same method is followed

Control material or control product to refer to a control solution that is available, usually commercially, in liquid, frozen, or lyophilized form, packaged in small bottles suitable for use on a daily basis. Such control materials are widely available today for most laboratory tests. They can be obtained from manufacturers who specialize in the production of control materials, and also are often provided by the same companies who are selling you the reagents, methods, and instrument systems. It is common today to purchase complete testing packages that include the necessary control materials.

5. Why is preventive maintenance so important in the laboratory?

Engaging in a routine program for maintaining sensitive laboratory instruments is key when reliable results and 100 per cent uptime is required. Much like oil changes and checkups help to keep your vehicle running, regular preventive maintenance can help eliminate catastrophic failures that can eventually lead to lost or inconsistent data points.

– Ensure the quality of your results
– Enable traceability via visit records
– Extend the life of your system
– Controlled and predictable maintenance costs
– Increase Lab ROI
– Maximize productivity and efficiency by minimizing instrument downtime and repair costs

D.

1. What is the purpose of running quality control samples in the laboratory?

Quality control is designed to detect, reduce, and correct deficiencies in a laboratory’s internal analytical process prior to the release of patient results. Quality control samples are special specimens inserted into the testing process and treated as if they were patient samples by being exposed to the same operating conditions. The purpose of including quality control samples in analytical runs is to evaluate the reliability of a method by assaying a stable material that resembles patient samples. Quality control is a measure of precision or how well the measurement system reproduces the same result over time and under varying operating conditions. Pathologists need to be involved in the development of quality control protocols, the selection of quality control materials, long term review of quality control data, and decisions about repeating patient samples after large runs are rejected. These quality control activities play an important part in assuring the quality of laboratory tests.

2. _______________ is a measure of how close a test results into the true value of the control material as established by the manufactures.

Accuracy

3. The ability to consistently reproduce a test result is the definition of?

Precision