Divergences between IFCC recommendations for internal quality control and ISO standards.

Area of Science:

• Clinical Laboratory Science
• Quality Management Systems

Background:

• The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) established a Task Force on Global Lab Quality (TF-GLQ).
• TF-GLQ published recommendations concerning Internal Quality Control (IQC).
• These recommendations are stated to be derived from the ISO 15189:20222 standard.

Purpose of the Study:

• To analyze the TF-GLQ recommendations in relation to the ISO 15189:20222 standard.
• To identify discrepancies between TF-GLQ recommendations and ISO 15189 requirements.
• To clarify adherence requirements for laboratories and accreditation bodies regarding ISO 15189.

Main Methods:

• Comparative analysis of TF-GLQ recommendations against ISO 15189:20222.
• Identification of deviations and inaccuracies in referenced documents.

Main Results:

• The TF-GLQ recommendations exhibit several deviations from the ISO 15189 standard.
• Specific references to Clinical and Laboratory Standards Institute (CLSI) documents within the recommendations are incorrect.
• Laboratories and Accreditation Bodies are mandated to comply strictly with the original ISO 15189 text.

Conclusions:

• Deviations from ISO 15189 by TF-GLQ are noted.
• Strict adherence to ISO 15189:20222 is required for clinical laboratories and accreditation bodies.
• Compliance with compliant guides is permitted, but not deviation from the core standard.