INTENDED USE

An ISO-accredited Clinical Chemistry, Monthly Program, that monitors accuracy of both manual techniques and assays on automated clinical chemistry analyzers. Any laboratory working in the field of routine clinical chemistry and dealing with human specimens can participate in this program. The program is designed to provide an independent and confidential external assessment of individual laboratory performance together with a simultaneous comparison of the methods currently in use in those laboratories. It is a 12-Month scheme consisting of 12 vials (rounds); one vial to be analyzed and its results submitted every month.

ACCREDITATION

This program is accredited to ISO/IEC 17043

REACTIVE LYOPHILIZED COMPONENTS

Human-based lyophilized 5-ml serum samples with chemical additives and tissue extracts of human and animal origin. Samples are prepared as closely as practicable to match the matrix, measurands and concentrations of items

PROCEDURE

• Each month, one sample is analyzed according to the unique date printed on its label. The table below summarizes the schedule for result submission.
• Any combination of the 28 analytes mentioned below can be measured in any sample.
• These samples should be treated the same as patient specimens and run in accordance with the instructions accompanying the instrument, kit or reagent being used.
• The results should be submitted electronically to EQA-Darts before the “Submit Before” date printed on each vial. Results received after this dead-line will not be accepted.
• It is encouraged to report the result using the same number of significant figures/decimal places used while reporting actual patient results.
• It is recommended to analyze each sample within two-weeks of its dead-line.
• In the event that a sample result exceeds the linear range of the method used, handle high (out-of-range) samples in accordance with established laboratory procedures. Do not report results as more than (>) the linearity limit.

DESIGN, IMPLEMENTATION & DATA ANALYSIS OF THE PROGRAM

• Design, implementation and data Analysis of EQA-Darts strictly follow the guidelines of ISO/IEC 17043:2010 and ISO 13528:2015 standards.
• Assigned values and their uncertainties are based on consensus values from participant results. Analysis is conducted at three levels: all participants “All Methods group”, participants using the same method “Method group” and participants using the same instrument/method combination “Peer group”.
• Whenever possible, the participant is evaluated versus “Peer group” as it is the most homogeneous subset of participants, provided the number of this group is at least 5. The comparison group is bolded and underlined in the report and is mentioned for each analyte under “Comparator” column. If less than 5, performance is compared to the next larger group with at least 5 participants; the “Method group” or even to “All Methods group” in this order of preference.
• Robust analysis is used for calculation of target means and standard deviations, based on Algorithm A in Annex C of ISO 13528.
• Standard deviation for proficiency assessment is based on robust estimate of the standard deviation of the results reported by all the participants.

CONFIDENTIALITY

EQA-Darts maintains a high respect for participant confidentiality. To protect the identity of a participant, each laboratory is identified by a unique code known only to EQA-Darts and the participant.

CURRENT SCHEME (CCM 2021)