BSMT/NU MED 221 Year 2: Laboratory Quality Management System

Quality Management System in a Laboratory

• The purpose of a Quality Management System (QMS) in a laboratory is to ensure the quality of laboratory results and services.

Standard-Setting Organizations

• Organizations that set standards for laboratory operations include ISO (International Organization for Standardization) and CAP (College of American Pathologists).

Consequences of Inaccurate Results

• Inaccurate results in the laboratory can lead to misdiagnosis, wrong treatment, and harm to patients, as well as legal and financial consequences.

Laboratory Workflow

• The pre-analytical phase of the laboratory workflow involves Sample Collection.
• The three phases in the workflow of a health laboratory are: • Pre-analytical phase (sample collection and preparation) • Analytical phase (testing and analysis) • Post-analytical phase (result interpretation and reporting)

Record Keeping in a Laboratory

• The purpose of Record Keeping in a laboratory is to maintain a complete and accurate record of laboratory data, including testing, results, and quality control.

Achieving a 99% Level of Quality

• Achieving a 99% level of quality means that the laboratory has a 1% error rate or 1 error per 100 tests.

Characteristics of Laboratory Results

• The essential characteristics of laboratory results include accuracy, precision, sensitivity, specificity, and reproducibility.

Most Important Resource in a Laboratory

• The most important resource in a laboratory for productivity is a qualified and competent workforce.

Purpose of the Quality Policy

• The purpose of the Quality Policy in an organization is to establish a framework for quality objectives and ensure a commitment to quality.