Laboratory Proficiency Testing Programme
Programme using external comparison to find bias internal quality control cannot see, because a laboratory consistently wrong is consistently wrong against its own controls. Enrolment mapped from the live test menu, samples handled exactly as routine work, a results register, unacceptable results investigated to a cause with the already-reported results reviewed, and consistent bias inside the acceptable range treated as a trend rather than a pass. Maps to ISO 15189:2022 and 42 CFR Part 493.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
Internal quality control detects drift against your own values. It cannot detect bias, because a laboratory that is consistently wrong is consistently wrong against its own controls too. Interlaboratory comparison is the only routine mechanism measuring a laboratory against the outside world, and its most useful output is the consistent bias inside the acceptable range that never fails a round.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
ISO 15189:2022 requires participation in interlaboratory comparison, evaluation of the results obtained, and action where performance is unsatisfactory; 42 CFR Part 493 sets the US proficiency testing enrolment, handling and performance requirements, including the referral prohibitions. Neither decides which schemes you enrol in, what you do where no scheme exists, or what counts as an actionable trend inside the acceptable range. Those determinations are the laboratory’s. The programme structure is SPEQ practitioner synthesis.