Unit 3 - Quality Management

Quality Management

Overall process used to ensure that laboratory results meet the requirements for healthcare services to patients

Quality Control

Application of statistical methods to the evaluation of products or services

Quality Control

Running control samples before running patient samples

Quality Assurance

Program in which overall activities conducted by the laboratory are directed toward assuring quality of the services provided

Quality Assurance

Quality control is under what?

Quality Assurance

Personnel orientation is under what?

Quality Assurance

Laboratory documentation is under what?

Quality Assurance

Knowledge of laboratory instrumentation is under what?

Quality Assurance

Proficiency testing program is under what?

Quality Assurance

Standard Operating Procedures (SOPs) or staff competency checks are examples of what?

Continuous Quality Improvement

Quality management program that focuses on the success of the laboratory and a cycle of improving the system

Continuous Quality Improvement

Regularly analyzing turnaround times or performing Root Cause Analysis for gaps and unmet targets is an example of what?

Total Quality Management

Program that starts from acquisition of supplies until the product or service has been received by the delighted customer or patient

Total Quality Management

Everyone in the laboratory, from staff to management, is responsible for quality is an example of what?

• Assay of Control Samples

• Statistical Data Analysis

• Instrument Maintenance

• Proficiency Testing Survey

Quality Control Associated Activities

Standard or Calibrator

Reference with which unknowns are compared

Standard or Calibrator

A solution of known absolute concentrations

Standard or Calibrator

Established by an analytical procedure different from that used in the clinical laboratory

Control

Reference samples for which the correct answer is known

Control

Stimulate the chemical composition and physical characteristics of unknown

Control

Lyophilized sera containing constituents of interest

• Recovery study

• Interference study

• Comparison of methods study

Methods of determining accuracy

Repeated analysis study

Method of determining reliability

Practicability

The method is simple enough to permit rapid and repeated analysis of many samples

Reliability

Ability of an analytical procedure to maintain its original accuracy, precision, specificity, and sensitivity over an extended period of time

Reference Interval / Reference Range

A pair of medical decision points that span the limits of results expected for a given condition

Normal Range

Range of results between two medical decision points that correspond to the central 95% of results from a healthy patient population

Limit of Blank

Highest apparent analyte concentration expected when testing a sample that truly has no analyte

Limit of Detection

Lowest concentration of an analyte that can be reliably distinguished from the LOB and therefore detected

Limit of Quantitation

Lowest analyte concentration that can be measured quantitatively with acceptable precision and accuracy

Analytical Sensitivity

Ability of a procedure to detect small differences in the concentration of a component in a series of specimens

Mean

Most widely recognized measure of central tendency

Arithmetic mean / average

Mean is also referred to as the?

Median

Derived by dividing all data points exactly in half, with one half being higher and one half lower

50th percentile

Other name for median

Median

Not calculated from a formula because it is taken from a straight count of the data point

Mode

Most common value or the most frequently occurring number/ data points

Mode

Not a very useful measure for describing or comparing data sets

Range

Represents the extremes of data one might encounter

Standard Deviation

Average distance from the center of the data (mean) and every value in the data set

Square root of variance

Another name for standard deviation

Coefficient of Variation

Calculated as the SD divided by the mean

Coefficient of Variation

Monitored to assess consistency in precision of an assay

68-95-99

Rule for the Gaussian Distribution

Inferential Statistics

Used to draw conclusions regarding means or SDs of two sets of data

Random Errors

Accidental, indeterminate errors with no trend or means of predicting it

Random Errors

Manifested by variations in the results of repeated analyses of the same sample-the results vary around a mean value

Random Errors

Unavoidable but recognizable

Random Errors

Employment of concepts of “standard deviation” and “mean value”

Random Errors

Voltage fluctuation not compensated for by the instrument circuitry

Random Errors

Temperature fluctuation

Random Errors

Improper mixing of sample and reagent

Random Errors

Mislabeling of sample

Random Errors

Pipetting errors

Random Errors

Reading a meniscus

Systematic Errors

Determinate errors which occur regularly and are measurable when recognized

Systematic Errors

Can always be traced back to a definite cause which may be isolated and eliminated

Systematic Errors

Seen as a trend in the data

Systematic Errors

Improper calibration

Systematic Errors

Deterioration of reagents

Systematic Errors

Sample instability

Systematic Errors

Instrument drift

Systematic Errors

Changes in standard materials

Systematic Errors

Poorly made reagents and standards

• Constant Errors

• Proportional Errors

Types of systematic errors

Shewhart Plot

Other name for Levey Jennings Chart

Westguard Multirule

Consists of set of criteria to improve quality monitoring

1_2S

1 measurement exceeds 2 SD above or below the mean

1_3S

1 measurement exceeds 3 SD above or below the mean

2_2S

2 consecutive measurements exceed 2 SD of the reference range on the same side of the mean

R_4S

2 measurements have a 4 SD (such as 1 exceeding 2 SD above the mean and another exceeding 2 SD below the mean)

4_1S

4 consecutive measurements exceed 1 SD on the same side of the mean

10_X

10 consecutive measurements are on the same side of the mean

7_T

6+ consecutive control values increase or decrease by gradually moving in one direction above or below the mean

6_x

6+ consecutive control values maintain a constant level above or below the mean

Internal QC or Intralab

Monitors the day-to-day performance of lab test (precision)

External QC or Interlab

Monitors the accuracy of the lab test. Proficiency Testing programs done by accrediting agencies

6_x

An abrupt change is followed by six or more consecutive QC results that fall on one side of the mean