Guidelines and Recommendations from Professional Organizations
Clinical Laboratory Improvement Amendments (CLIA) ▸42 CFR Part 493.1256 Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule
For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytical process.
The control procedures must --
(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance.
(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and vairance in operator performance.
(8) Test control materials in the same manner as patient specimens.
Clinical and Laboratory Standards Institute (CLSI) ▸CLSI C24-A3, Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition, 6.2.1 Relation to Calibrators
. . . quality control materials should be different from the calibrator materials to ensure that the QC procedure provides an independent assessment of the measurement procedure’s performance in its entirety, including the procedure for calibration of the measurement.
College of American Pathologists (CAP) ▸Chemistry and Toxicology (Web File) CHM.14125
In general, calibrators should not be used as QC materials.
Department of Standards Malaysia ▸Laboratory Accreditation Scheme of Malaysia. SC 2- Specific Criteria for Accreditation in the Field of Medical testing. 5.6.1 Quality Control
The use of controls independent of those produced by the manufacturer of the test or analyzer is preferable.
Dubai Accreditation Department ▸Dubai Municipality Accreditation Requirements for Medical Field of Testing DAC-REQ-10 Issue 1, Rev. 1 September 2010 5.6 Assuring Quality of Examination Procedures
Use of third party human matrix controls independent of those produced by the manufacturer of the test or analyzer should be used when applicable.
International Organization for Standardization (ISO) ▸ISO 15189 Medical Laboratories – Particluar Requirements for quality and competence assuring quality of laboratory procedures 5.6.1
The laboratory shall design internal quality control systems that verify the equipment of the intended quality of results.
NATA (National Association of Testing Authorities), Australia ▸Supplemental Requirements for accreditation in the field of Medical testing, AS 4633 (ISO 15189) Field Application Document, May 2007. 5.6.1 (ii) Internal quality control
Controls independent of those produced by the manufacturer of the test or analyzer should be used.
The laboratory must have a system of long-term monitoring of internal quality control results to assess method performance.
Quality Council of India ▸Essential Standards for Registration of Medical Testing Laboratories in India. First Edition, January 2007. 3.5.2 Quality Assurance
Medical laboratories shall perform internal quality control. Use of third party human matrix quality control is recommended for all analytes.