There are many “official” and professionally based standards and guidelines which define the manner in which POC testing should be implemented, managed and the performance quality checked and maintained. Most professionally based guidelines follow a similar template and provide similar information which includes specific reference to quality control and quality assurance.
Table 1 provides a summary of the international requirements for quality management of POCT, including the requirement for operator training and proof of competency, QC and EQA. Most jurisdictions provide statements regarding POCT which include mandatory quality procedures as defined by regulation or specific policy.
Formal policy and regulation generally applies to situations where service payments may be provided; that is, where a healthcare funding agency (government) or health insurer provides a service fee for POCT. Excluding home use and personal testing, in countries without specific overall regulation there is little information regarding the use of POC devices in the “private” healthcare setting or where patients are prepared to pay directly for testing services.
Regulations which apply to laboratory testing in general (which includes POCT) are required to:
- assure patients and funding authorities that testing is fit for purpose
- assure patients and funding authorities that quality testing is being provided and maintained
- assure patients and funding authorities that device operators have the required skills and competencies
- assure patients and funding authorities that devices are being appropriately maintained
- assure users that POC devices comply with defined technical specifications
- ensure that testing is provided in a safe environment
- provide a consistent base for all testing procedures and provide some consistency between multiple service providers
- ensure that patient records are managed in an appropriate and consistent manner
- inhibit uncontrolled and inappropriate use of testing
- provide a mechanism for assessing the distribution of valuable healthcare dollars.
When considering the application of POCT and its wider introduction into the healthcare system, appropriate consideration should also be given to the influence which poor quality in one sector of the health system adds costs to another sector as increased resource requirements. Poor quality in laboratory and POC testing often results in increased doctor visits, additional unnecessary test procedures, inappropriately changed medication or additional unnecessary medication, and / or hospitalisation. The real cost of not identifying testing problems, of unnecessary repeat testing and poor patient outcomes, is often hidden until a quality system has been implemented.
“For POCT to be implemented (in general practice), an effective quality management system is essential. Clinicians need reassurance that their decisions are based on reliable, accurate and precise results to ensure that patient safety is not compromised.”159 .