In most countries, including Australia, there are no regulations which prevent the use of POCT. The main impediment to the widespread use of POCT is related to funding. In most countries where healthcare funding is provided by government or by a private health insurer, some form of regulation is required which governs the manner in which POCT may be implemented. Regulations which apply to laboratory testing in general (and 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.
In many countries, reimbursement of testing costs is used to insure compliance with the required standard or guideline. That is, reimbursement for testing is only provided under specified circumstances and only if defined guidelines or quality procedures are being used.
Reimbursement arrangements with respect to POCT only appear problematical when performed outside of a formal accreditation system. Even though some POC testing is available as waived tests in the US (see discussion below), basic quality control is still required as specified by the manufacturer. In general, it would appear that when POCT is performed within an approved accreditation system, government or health insurer reimbursement is usually available. A tabular summary comparing reimbursement arrangements for several countries (Australia, France, Germany, Italy, Spain, United Kingdom and United States) is provided by Wittels etal.105