Quality Management

Types of Quality Control

Internal Quality Control • Monitors the day-to-day performance of lab test, namely precision. External Quality Control • Purpose is to determine the ability of laboratory personnel to achieve the correct analysis Control of Equipment, Reagents and Supplies

•Quality Assessment and Improvement

A quality management program that focuses on the success of the organization in designing and achieving its set goals and objectives.

Important Aspects •Total Quality Management

A quality management program that includes each component (customer, producer and supplier) in the creation process, from the acquisition of supplies to active follow-up after the product or service has been received by a delighted customer.

Quality Management

- A system for continuously analyzing, improving, and reexamining resources, processes, and services within an organization. - Done by benchmarking - Primary objective: achieve best possible outcome - Quality is achieved by reducing variability by standardizing processes across the organization.

Seven Attributes of Quality Assurance

1. Efficacy 2. Effectiveness 3. Efficiency 4. Optimality 5. Acceptability 6. Legitimacy 7. Equity

Quality Assurance

• A program in which the overall activities conducted by the institution are directed toward assuring the quality of products and services provided. • Includes maneuvers encountered during the pre-analytic, analytic and post analytic phases in lab testing.

External Quality Assessment Programs

• Accreditation and Licensure Activities - Involve on - site inspections - May use proficiency surveys as their major evaluation criterion. - Laboratory inspection: seeking voluntary compliance and enforcement of fire and safety regulations

Components of the QC Program

• Assay of control samples • Instrument maintenance • Statistical data analysis • Proficiency testing survey

Philosophy of Quality

• Attitude of people towards work • Common interests in achieving organizational goals • Professionalism in the delivery of products and services • Philosophy of caring and commitment to the delivery of high quality services

Customer Satisfaction Assessment

• Customers can be queried at a time of the service or at a latter day. • Queries can be made face-to-face by telephone or by written questionnaire • Asking customers about their satisfaction with one or more aspects or laboratory services can be an important component of the quality assurance program.

Philip Crosby

• Evangelist of quality management • Author of the book "Quality is Free" Quality is free. Poor quality is expensive. Do things right the first time. "Zero defects" is the only legitimate goal of a quality program.

Operational Systems

• How well managers incorporate quality practices into their management functions • Represent the actual practices taking place

Quality Assurance Program Risk management

• In - service and continuing education • Safety programs • Quality control • Peer review

Census

• Indicating reagent expiration, dates or opening or lyophilization

William Edwards Deming

• Introduced the use of statistical tools in decision making, problem solving, and troubleshooting the production process. "The aim proposed here for any organization is for everybody to gain-stockholders, employees, suppliers, customers, community, the environment - over the long term." - Deming

Walter Shewhart

• Known as the "Father of Statistical Quality Control".

Four measurements constitute the base for most quality assessment efforts:

• MEAN - average • STANDARD DEVIATION - measurement of precision or the tendency of values in each population to scatter around the MEAN • COEFFICIENT OF VARIATION - allows comparison and check on the precision and variability of each method. Smaller CV means more precise procedure • PERCENTAGE and PROBABILITY - probability is usually expressed in stat notation as a decimal (0 to 1) according to the likelihood of an event occurring

Characteristics of Good QC Program

• Maximizes diagnostic efficiency • Minimizes laboratory costs • Ensures clinically acceptable accuracy and reproducibility

Precision

• Measure of random variability • The reproducibility of a lab determination when it is repeatedly under identical conditions. • Independent of accuracy

Storage incubation requirements

• Monitoring lists

Three areas must be properly aligned to achieve quality performance goals:

• Philosophy or attitude of its people • The operational system of the enterprise • The actual quality assessment and monitoring program

Quality Management Programs

• Preventive maintenance • Policy and procedure manual writing and review • Quality control functions • Staff orientation, CPE and development • Participation in proficiency testing • Problem solving and troubleshooting • Laboratory inspection, accreditation and licensure process

External Quality Control External Quality Assessment Programs

• Proficiency Testing - Blind specimens are sent by an external agency for analysis and comparison with other laboratories - Normally required for accreditation and licensure - Failure to meet designated criteria or demonstrate appropriate corrective action may lead to sanctions such as loss of accreditation or license.

Quality assurance stands on three (3) legs:

• Program development • Assessment and monitoring • Quality improvement forming

Assessing the Effectiveness of Quality Control

• Quality control effectiveness should be evaluated a few weeks or a months after completing a new protocol and approximately one year after.

Joseph Juran

• Quality is a continuous improvement process. • Participative management style • Pareto Principle or the 80/20 rule • Vilfredo Pareto - 80% of serious problems arise from only 20% of the causes or trouble points. - Managers should focus their time and effort in identifying and solving the 20%.

Calibration

• Testing of standards and blanks

Quality Control

• The application of statistical methods to the evaluation of the quality of products and services. • Refers to the activities directed toward monitoring the individual elements of care. • In the laboratory, controls are processed periodically to make sure that the procedure is within control limits. • It monitors the overall reliability of lab results in terms of accuracy and precision.

Accuracy

• The extent to which the mean measurement is close to the true value. • Generally reflected by its ability to reproduce the values of reference samples of known concentrations.