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CAN CSA Z22870-07: Point-of-Care Testing (POCT) — Requirements for Quality and Competence
Ensuring Quality and Competence in Point-of-Care Testing – A Comprehensive Overview of the Canadian Standard
Scope and Application
CAN CSA Z22870-07 is the Canadian adoption of ISO 22870:2006, establishing specific requirements for quality and competence in point-of-care testing (POCT). This standard applies to organizations performing POCT in healthcare settings, whether inside or outside a clinical laboratory. It is intended for use by medical laboratories, hospital wards, outpatient clinics, and any entity where diagnostic testing is conducted near the patient and results are used for immediate clinical decision-making.
The standard covers POCT devices and processes that include blood glucose monitoring, coagulation testing, cardiac markers, blood gas analysis, and other near-patient diagnostics. It complements the general quality management requirements of ISO 15189 (Medical laboratories — Requirements for quality and competence) by addressing the unique challenges of decentralized testing, such as operator training, device connectivity, and result documentation.
Important: CAN CSA Z22870-07 does not replace ISO 15189 but is intended to be used alongside it. Organizations that already comply with ISO 15189 can use this standard to extend their quality system to POCT locations outside the main laboratory.
Technical Requirements
The standard is organized around key management system elements and technical competence criteria. Core requirements include establishment of a POCT committee, risk management, device selection and evaluation, operator training and competency assessment, quality control procedures, and documentation of results. The table below summarizes the major clauses and their focus.
| Clause | Requirement | Implementation Note |
|---|---|---|
| 4.1 | Organizational structure and responsibility | Define a POCT committee with representatives from laboratory, nursing, administration, and information technology. |
| 4.2 | Quality management system | Integrate POCT into the facility’s existing QMS; include document control, incident reporting, and internal audits. |
| 4.3 | Risk management | Perform failure mode and effects analysis (FMEA) for each POCT method. |
| 4.4 | Device selection and evaluation | Validate performance characteristics (accuracy, precision, interference) using manufacturer’s data and local studies. |
| 4.5 | Operator training and competence | Provide initial and ongoing training; document annual competency assessment for all test operators. |
| 4.6 | Quality control | Run two levels of controls daily; participate in an external quality assessment (EQA) program at least twice yearly. |
| 4.7 | Result recording and reporting | Ensure results are recorded in the patient record with operator identification and device/sample information. |
| 4.8 | Information management | Implement data management systems for device connectivity, result verification, and audit trails. |
Each requirement is designed to address the vulnerability of POCT to errors arising from non-laboratory personnel, varying environmental conditions, and lack of supervision. The standard emphasizes that POCT must deliver results that are at least comparable in quality to central laboratory results.
Tip: When implementing CAN CSA Z22870-07, start with a gap analysis comparing current POCT practices against the standard’s clauses. Prioritize training and quality control, as these are the most frequently cited areas of non-compliance in audits.
Implementation Highlights
Successful implementation of CAN CSA Z22870-07 requires coordination across multiple departments. A key recommendation is the establishment of a multidisciplinary POCT committee that oversees policy development, device approval, and complaint investigation. The standard calls for documented agreements between the laboratory and clinical areas, specifying responsibility for reagent supply, maintenance, and troubleshooting.
Another highlight is the requirement for a comprehensive training program. All operators must undergo structured training that includes hands-on use, infection control, and interpretation of control results. Retraining is required when there is a change in device, procedure, or after a critical quality event. Competency must be re-evaluated annually using direct observation, test performance, and review of quality control records.
Quality control practices under this standard are rigorous. The standard requires two levels of liquid quality control to be tested on each day of patient testing. Results must be reviewed before any patient result is reported. If control results are out of range, corrective action must be documented and patient results from the affected period evaluated. The integration of electronic QC logs and middleware can help automate this process.
Success Story: A medium-sized hospital network in Ontario achieved full compliance with CAN CSA Z22870-07 by deploying a unified POCT data management system. This allowed real-time QC review, automated result flagging, and streamlined competency tracking. The time spent on manual audits was reduced by 60%.
Compliance and Certification
Compliance with CAN CSA Z22870-07 is typically assessed by accreditation bodies such as the Standards Council of Canada (SCC) or the College of American Pathologists (CAP) when combined with ISO 15189. Organizations seeking to demonstrate conformity must undergo an external audit covering all clauses. Non-conformities must be addressed through corrective action plans within agreed timelines.
The standard does not prescribe a specific certification format, but many facilities choose to integrate its requirements into their existing ISO 15189 management system. In Canada, some provinces have incorporated CAN CSA Z22870-07 into their laboratory licensing requirements. It is advisable to check with local regulatory bodies for specific mandates.
Key compliance considerations include:
- Documentation: Maintain a controlled POCT policy manual, standard operating procedures (SOPs) for each device, and records of training, competence, QC, and maintenance.
- Audit trails: Electronic systems must provide an audit trail of result modifications and access.
- Adverse event reporting: Instances of harm due to POCT errors must be investigated and reported through the facility’s patient safety system.
- Continual improvement: Review quality indicators (e.g., QC pass rate, critical result turnaround time) at least quarterly.
Caution: Using non-compliant POCT devices or failing to document operator competence can result in accreditation sanctions. In jurisdictions where CAN CSA Z22870-07 is referenced by regulation, non-compliance may also lead to legal liability.
As healthcare moves toward more decentralized and remote testing, the principles of CAN CSA Z22870-07 are becoming increasingly relevant. The standard provides a robust framework to ensure that while testing moves closer to the patient, quality and patient safety remain paramount.
Frequently Asked Questions
Q: Is CAN CSA Z22870-07 mandatory in all Canadian provinces?
A: No, but it is recognized as the national standard for POCT. Some provinces (e.g., Ontario, Alberta) reference it in laboratory licensing regulations, making it effectively mandatory for accredited facilities. Always verify with your provincial health authority.
A: No, but it is recognized as the national standard for POCT. Some provinces (e.g., Ontario, Alberta) reference it in laboratory licensing regulations, making it effectively mandatory for accredited facilities. Always verify with your provincial health authority.
Q: Can a clinic without a main laboratory comply with CAN CSA Z22870-07?
A: Yes. The standard is designed for any setting performing POCT. The organization must still have a quality management system and access to laboratory oversight (e.g., a consulting pathologist or medical laboratory technologist). Requirements for quality control and EQA still apply.
A: Yes. The standard is designed for any setting performing POCT. The organization must still have a quality management system and access to laboratory oversight (e.g., a consulting pathologist or medical laboratory technologist). Requirements for quality control and EQA still apply.
Q: How does this standard relate to ISO 22870?
A: CAN CSA Z22870-07 is identical to ISO 22870:2006 (technically equivalent). The Canadian version includes a national foreword and may reference Canadian regulatory requirements. When ISO 22870 was revised in 2020, the C22 version (currently pending) will likely update this standard.
A: CAN CSA Z22870-07 is identical to ISO 22870:2006 (technically equivalent). The Canadian version includes a national foreword and may reference Canadian regulatory requirements. When ISO 22870 was revised in 2020, the C22 version (currently pending) will likely update this standard.
This article is for informational purposes and does not substitute for the full text of the standard. Always refer to the official CAN CSA Z22870-07 document for precise language and requirements.
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