In April 2018 CSA group published a new National Standard of Canada developed by the Canadian Standards Association (CSA) Technical Committee, Medical Laboratory Quality Systems (Z252), which also serves as the Standards Council of Canada (SCC) Mirror Committee (SMC) for ISO Technical Committee ISO/TC212 Clinical Laboratory Testing and In Vitro Diagnostic Test Systems. IQMH expects to incorporate important details from the first edition of CSA Z316.8 Requirements for the design, development, and validation of laboratory-developed tests used for the screening, diagnosis, and management of clinical conditions. into the IQMH Accreditation Requirements, which is due for full review in 2019.

According to Z316.8-18, the definition of a “laboratory-developed test” is a test developed (or modified) and used within a single laboratory to carry out testing on samples, where the results are intended to assist in clinical diagnosis or be used in making decisions concerning clinical management. These are often methods for which there is no commercially available test or for which modern technology provides a superior test result to what is available on the market. They are often referred to as “in-house” tests. Advancements in technology are seeing more complex techniques being introduced to the medical laboratory, by way of development in a clinical research laboratory and transference to the medical laboratory. These complex techniques include:

• Liquid chromatography-mass spectrometry (LC-MS/MS)
• Time-of-flight mass spectrometry (TOFMS)
• Nuclear magnetic resonance (NMR) spectrometry
• Next-generation sequencing (NGS)
• Molecular diagnostic testing
• In situ hybridisation (ISH)
• Immunohistochemistry (IHC)

and whole slide scanning and imaging, although this Standard equally applies to simpler tests. Prior to the release of Z316.8-18, there was no Canadian Standard to define the requirements on the development and validation of laboratory-developed tests.

• Specifies the minimum requirements and best practices for the development, validation, and use of laboratory-developed tests in clinical and research laboratories for the screening, diagnosis, and management of clinical conditions.

• Many of the requirements in this document are already a part of provincial laboratory accreditation requirements

• This document represents a consensus on best practices for the laboratory developed tests for all disciplines in laboratory medicine

• Acts as a resource for any research laboratory intending to develop tests in-house

• Acts as guidance for any laboratory planning to use an in-house test for clinical reporting

• Acts as a resource for accreditation bodies for setting best practice expectations for clinical laboratories 

Z316.8-18 Outline:

1. The standard requires any laboratory developing tests to operate within a quality management system.

2. The pre-validation steps:

• Design and development of the test requirements

• Development of a validation master plan

• Analytical instrument qualification:

– design qualification
– installation qualification
– operational qualification
– performance qualification

• Risk assessment
  

3. The validation steps:

• Preliminary experiments

• Setting up performance characteristics
  

  – Excluded performance characteristics (if we’ve left some out, why were they left out?)   
  – Measurement of uncertainty    

• Software Verification

4. The post validation steps:

• Transfer to routine use

• Test interpretation

• Documentation
  – Document retention for as long as a method is in use

• Life cycle management – what are the criteria for revalidation?

 Any laboratory embarking on the development or modification of tests should purchase a copy from CSA Group to ensure they are meeting this National Standard, and in anticipation of the next version of the IQMH Accreditation Requirements.

Visit the CSA Group store to purchase the CSA Z316.8-18 National Standard.