Result card

  • TEC12: What kind of qualification, training and quality assurance processes are needed for the use or maintenance of FIT?
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What kind of qualification, training and quality assurance processes are needed for the use or maintenance of FIT?

Authors: Mirjana Huic, Eleftheria Karampli, Silvia Florescu, Cristian Vladescu

Internal reviewers: Antonio Migliore, Pernilla Östlund, Frida Mowafi, Daniela d’Angela, Jesus Gonzalez

The qualification, training and quality assurance processes are described in detail in the respective European guidelines {6}:

Laboratory staff is necessary in settings where a screening programme is based on a FOBT. The training and skills required are dependent on the type of the test (gFOBT or iFOBT, qualitative or quantitative); staffs require supervision by appropriately qualified individual with expertise in clinical biochemistry, and the day-to-day running of the laboratory must be managed by an appropriate skilled scientific officer.

Laboratory staff required training in good laboratory practice, training in the performance of the FOBT, and training in the use of the IT system used to record results, in addition to basic understanding of the CRC process.

Laboratory Manager required training on managerial skills, internal quality control and external quality assurance; interactions between the laboratory process and the whole screening programme.

Individual with expertise in clinical biochemistry which is responsible for the operation of laboratory required training  on in-depth understanding of CRC, screening process, performance characteristics of different type of FOBT; in-depth understanding of the technology required to perform the FOBT.

All laboratories providing population screening should be led by a qualified clinical chemist trained and experienced in the techniques used for analysis and with clinical quality assurance procedures (Level of evidence VI, Grade of recommendation B).

 

All laboratories providing screening service should be associated with a laboratory accredited to ISO 15189:2007 Medical laboratories-Particular requirements for quality and competence. Also they should perform Internal Quality Control procedures and participate in appropriate External Quality Assessment Scheme (Level of evidence VI, Grade of recommendation B).

 

Automated check protocols should be implemented to ensure correct identification of the screen population and complete and accurate recording of individual screening participation and test results.  Protocols should be implemented to ensure standardised and reliable classification of the test results (Level of evidence VI, Grade of recommendation A).

 

Quality assurance of iFOBT

Manufacturer’s Instructions for Use must be followed. Daily checks of analytical accuracy and precision across the measurement range with particular emphasis at the selected cut-off limit should be performed. Sufficient instrumentation should be available to avoid delays in analysis due to instrument failure or maintenance procedures. Performance data (both internal quality control and external quality assessment data) should be shared and reviewed by a Quality Assurance team working across the programme. (Level of evidence VI, Grade of recommendation B).

 

All laboratory performance outcomes like uptake, undelivered mail, time from collection to analysis, analytical performance, positivity rates, lots and spoilt kits and technical failure rate, technical performance variability and bias should be each subject to rigorous monitoring (Level of evidence VI, Grade of recommendation A).“

 

 

Important
Partially
Huic M et al. Result Card TEC12 In: Huic M et al. Description and technical characteristics of technology In: Jefferson T, Cerbo M, Vicari N [eds.]. Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali; 2014. [cited 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=206

References