B - CHAPTER IV: QUALITY CONTROL IN CLINICAL CHEMISTRY
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– a degree to which a set of inherent characteristics fulfills requirements (ISO 9001:2008)
QUALITY
• part of quality management focused on fulfilling quality requirements (ISO 9000:2000)
QUALITY CONTROL
• System of assuring the quality of total laboratory performance
QUALITY CONTROL
• Involves the periodic systematic surveillance of people, tools, methods and reagents
QUALITY CONTROL
– part of quality management focused on providing confidence that the quality requirements will be fulfilled (ISO 9000:2000)
QUALITY ASSURANCE
• Set of activities or plan that aims to maintain the highest degree of excellence for the diagnosis & treatment of disease and maintenance of health
QUALITY ASSURANCE PROGRAM
AREAS of QUALITY CONTROL: • All [?] are involved. • The laboratory’s relation to other [?] • Laboratory [?] should be collected in a manual to be revised at least once a year or when procedures are changed.
patients, laboratory personnel, laboratory equipment, and laboratory tests hospital departments policies and procedures
SYSTEM CONCEPTS of QUALITY CONTROL:
– establishes norms that must be met
• Quality Control Surveillance System (QCCS)
– established to offer education of why errors occur; provide a program to remedy defects
• Q.C. Corrective System
– established to prove that corrective measures have produced favorable results.
• Objective Q.C. Parameters
PROCEDURES in QUALITY ASSURANCE PROGRAM
A. CONTROL of PRE-ANALYTICAL VARIABLES FACTORS:
B. CONTROL OF ANALYTICAL VARIABLES MAIN FACTORS:
• Choice of analytical methodology • Calibration procedures • Proper documentation of analytical variables • Proper labeling & use of reagents • Preventive maintenance of analytical instruments • Periodic calibration of pipetting devices • Periodic checking of °T of refrigerator & heating units • Periodic checking of procedure manuals • Monitoring of technical competence • Inventory of control materials • Control assurance that safety measures are operational
C. CONTROL of POST-ANALYTICAL VARIABLES FACTORS:
• Verification of calculations of the final results • Check test results for possible transcription errors • Results should be easy to read & interpret • Timeliness of reporting values to patient chart • Procedures for informing physicians about results that require immediate attention
FACTORS Involved in QUALITY CONTROL
• STANDARD • CONTROL MATERIAL
o A substance of known composition
STANDARD
o Its value is established by an analytical procedure different from that used in the clinical laboratory
STANDARD
o A substance which resembles the unknown specimen (patient’s sample)
CONTROL MATERIAL
o Analyzed daily together with the unknown
CONTROL MATERIAL
o The values obtained from the assays are used for the computation of the mean and the SD
CONTROL MATERIAL
Types of Control Material:
a. Commercial Control Sera b. Pooled Sera
• are collected daily in the laboratory and pooled for storage in the refrigerator
Excess non-hemolyzed sera without gross lipemia
• When [?] are collected, centrifuge to remove gross contamination
1 – 2 liters