Overview
ISO/TS 22583:2019 - Guidance for supervisors and operators of point-of-care testing (POCT) devices - is a Technical Specification from ISO that provides practical guidance where POCT is performed without medical laboratory training, supervision or support. It focuses on the key components needed to deliver safe, reliable POCT results and explicitly excludes self‑testing. The document is written in accessible language and is intended to support appropriate test selection, operator skill requirements, quality arrangements and result interpretation.
Key topics and requirements
The specification addresses the full POCT lifecycle and organizational controls, including:
- Personnel
- Roles and responsibilities for supervisors and operators
- Training and competence requirements (Annex A)
- POCT equipment selection
- Considerations for choosing suitable devices and tests (Annex B)
- Process management
- Pre‑testing (planning, environment, consumables, patient consent and identity verification, sample collection)
- Testing (internal quality control, external quality assessment, performing tests, problem resolution) - Annex D covers IQC and EQA
- Post‑testing (result interpretation, reporting, recipient management, disposal and cleaning)
- Quality oversight
- Internal quality control, external quality assessment and external audits of POCT services
- Information management
- Confidentiality, security and recordkeeping considerations
- Documentation and records
- Document control, storage, corrections and retention (Annex C)
- Health and safety
- Infection prevention and biosafety, use of sharps, personal protective equipment and waste disposal (Annex E)
Practical applications
ISO/TS 22583:2019 is intended to ensure that POCT performed outside traditional laboratories:
- Produces reliable, clinically meaningful results
- Reduces patient safety risks from incorrect testing or interpretation
- Supports decision-making in time‑critical or remote settings
Common use cases:
- Diabetes management (glucose monitoring)
- Anticoagulation and clotting tests
- Infectious disease screening in outreach clinics
- Pregnancy testing, cardiac marker screening, hemoglobin testing
- Drug testing in occupational, forensic or sports settings
Who should use this standard
- POCT supervisors setting up or overseeing non‑laboratory testing programs
- Operators and trainers working with POCT devices outside clinical laboratories
- Healthcare managers in hospitals, primary care, pharmacies, long‑term care, emergency services, remote clinics and public safety organizations
- Manufacturers and purchasers of POCT devices seeking guidance for safe deployment
Related standards
- ISO 15189 - Medical laboratories - Requirements for quality and competence
- ISO 22870 - Point‑of‑care testing (POCT) - Requirements for quality and competence
ISO/TS 22583:2019 complements these standards by focusing on practical guidance for non‑laboratory supervisors and operators to maintain quality, safety and traceability in POCT services.
