5.3 - Fundamental Concepts of TQM (Establishing Quality Goals and Analytical Performance Limits)

Question 1

Fundamental requirements for all objective quality control systems are clearly defined quality goals. Laboratories must define their _______ goals and establish ______and analytical quality requirements for testing processes. Without such quality goals, there is no objective way to determine whether acceptable quality is being achieved or to identify processes that have to be improved, or to design new processes that ensure that specified level of quality will be attained.

Answer 1

service; clinical

Question 2

The establishment of analytical performance goals may represent a compromise between what would be optimal for best medical practice and what is realistically achievable by current technology, given healthcare cost limitations. Two types of system analysis are used to determine what analytical performance is achieved with a particular laboratory system.

The two types of system analysis are:

Answer 2

1. Bottom-up Analysis
2. Top-down analysis

Question 3

What type of system analysis?

• this is divided into multiple components. The uncertainties of all components are defined and statistically combined to obtain the total uncertainty of the complete system. Error limits for each of these components are obtained from the manufacturers, published literature and in-house validation studies

Answer 3

Bottom-up Analysis

Question 4

What type of system analysis?

• generally utilizes quality control measurements and/or proficiency testing results.
• In-house quality measurements may underestimate the total errors, particularly if the target values for the controls are not independently assigned, or if the data are collected only over a short period of time.
• Potential differences across multiple calibrators and differences across multiple reagent lots should be accounted for in estimating total analytical variations. On the other hand, between laboratory proficiency testing data may overestimate the analytical variation within an individual laboratory

Answer 4

Top-down analysis

Question 5

Quality goals cannot be set on ______________ because they vary from one laboratory to another depending on the medical mission and professional interests of physicians using the laboratory tests.

Answer 5

absolute basis

Question 6

Quality goals must also be considered in relation ______. A goal of achieving the highest possible quality is not realistic when costs are being cut. In establishing quality goals, it is therefore more realistic to specify the quality that is necessary or adequate for medical applications of the laboratory test results to be produced.

Answer 6

cost

Question 7

___________ is the first step in validating that analytical performance satisfies quality goals. Quality control procedures provide for continuing verification that these goals are met during routine laboratory services.

Answer 7

Method evaluation