Clinical practice guidelines (Guidelines)

In a similar manner, the term guideline as used in medicine (or more often clinical practice guideline) is usually defined as … “systematically developed statements to assist practitioners with decisions about appropriate health care for patients in specific circumstances”.⁸ Guidelines are designed to support the decision-making processes in patient care. Clinical practice guidelines are based on the best available evidence derived from a systematic evidence-based review of available data (see section below, evidence- based medicine).

Standards and guidelines developed for POCT using evidence-based procedures are designed to assist with the implementation, management, operation and on-going quality assessment of the selected technology. With adherence to appropriate standards and guidelines, POCT provides significant benefits for both patients and healthcare providers. As stated in the introduction to ISO 22870 “Advances in technology have resulted in compact, easy-to-use in vitro diagnostic medical devices that make it possible to carry out some examinations at, or close to, the location of the patient. Point-of-care or near patient testing may benefit the patient as well as healthcare facilities.” Provided that “risk to the patient and to the facility can be managed by a well-designed, fully implemented quality management system that facilitates:

• evaluation of new or alternate POCT instruments and systems
• evaluation and approval of end-user proposals and protocols
• purchase and installation of equipment
• maintenance of consumable supplies and reagents
• training, certification and recertification of POCT systems operators
• quality control and quality assurance.”⁶

Australian standards and guidelines

Many countries have developed their own “standards” for laboratory practice and POCT.

In Australia, the National Pathology Accreditation Advisory Council (NPAAC) advises the Commonwealth, state and territory health ministers on matters relating to the accreditation of pathology laboratories. NPAAC is also responsible for the development and maintenance of standards and guidelines which help define the quality procedures for the practice of pathology.¹¹ NPAAC documents are updated regularly and current listings are available on the internet.¹²

Standards Australia also plays a significant role with the development of national standards or promulgating standards developed by ISO. With regard to pathology, ISO 15189 is reproduced as Australian Standard AS 4633. In addition to coordinating activities with ISO, Standards Australia may develop specialized standards in its own right for “local” applications such as those which have been developed for urine and oral fluid drug of abuse testing and others as shown in appendix 3.

In association with ISO and AS standards, NPAAC is the principal Australian provider of standards for pathology. In this regard, AS 4633 / ISO 15189 has been confirmed by NPAAC as the principal standard which is used as the basis for accreditation of pathology laboratories in Australia. Other NPAAC standards are developed to cover specific areas as required or to provide more detailed information not specifically available in AS 4633 / ISO 15189.

In addition to NPAAC, other Government agencies have developed specific purpose standards and guidelines for defined applications. In particular, Interim standards for point-of-care testing in general practice were prepared by the Royal Australian College of General Practitioners in association with the Department of Health and Ageing general practice trials’ technical advisory committee.¹³ These approved standards were used as the basis for pathology testing during the Australian Government Point-of-care testing in general practice trial.¹⁴ The introduction to these interim standards provide a succinct overview of the requirement for appropriate POCT standards, which incorporate training and competency, clinical governance, quality control and the requirement for participation in an external proficiency testing program.

The Medical Services Advisory Committee (MSAC), who’s brief, is to advise the Australian Minister for Health and Ageing on evidence relating to the safety, effectiveness and cost-effectiveness of new medical technologies and procedures, also provides application and assessment guidelines to assist with the preparation of application documentation.¹⁵ Current guidelines which may be applicable to POCT are: Page 7

Guidelines for the assessment of diagnostic technologies - May 2007,¹⁶ and Funding for new medical technologies and procedures: application and assessment guidelines - September 2005.¹⁷

In addition to government sanctioned standards and guidelines, the Australasian Association of Clinical Biochemists (AACB) and the Royal College of Pathologists of Australasia (RCPA) provide professional guidelines for POCT.¹⁸,¹⁹,²⁰