For any facility that operates a laboratory — or is a laboratory.
Who this module is for
All hospitals operate a laboratory. This module adds to your hospital accreditation. Prerequisite: active ASF hospital accreditation.
Clinics operating an in-house laboratory. Declare the lab at registration. Module assessed alongside your ambulatory accreditation.
Diagnostic centres with no clinical services.
What the 65 criteria cover
These 65 criteria cover the technical half in full.
Qualifications, ongoing training, competency assessment and authorisation for each examination type performed.
Temperature, humidity, lighting, contamination controls and workspace separation for each examination area.
Selection, installation, calibration, maintenance and records for all analytical instruments.
Request handling, patient preparation instructions, sample collection procedures and primary sample identification.
Validation and verification of examination methods, measurement uncertainty, biological reference intervals and quality control.
Review and authorisation of results, critical value reporting, result format and turnaround time targets.
Report content requirements, amended reports, verbal reporting protocol and result retention.
Participation in proficiency testing or interlaboratory comparison programmes for every examination performed.
How the assessment works
The laboratory module requires a dedicated assessment day in the laboratory, separate from the facility’s clinical accreditation visit. The assessor is a qualified laboratory specialist — not a general healthcare surveyor.
The assessment follows the same practice-based evidence standard: the assessor observes actual processes, reviews working documents in whatever format your laboratory uses, and interviews bench-level staff. No documentation needs to be created for the assessment.
- Hospital / ambulatory: active ASF accreditation
- Laboratory declared at facility registration
- Examination-type specific compliance record
- QR-verified certificate page on the ASF registry
Formal laboratory accreditation requires engagement with a national accreditation body.