Australia Pathology Lab Accreditation

Reasons for Pathology Laboratory Accreditation in Australia

• Addressed issues such as unethical practices ("sink tests" and "rorts").
• Aimed to resolve lack of standardization in test procedures.
• Ensured uniformity in test results and reporting.
• Prevented unqualified individuals from establishing pathology testing services.

Roles of Key Organizations

• Royal College of Pathologists of Australasia (RCPA) aids in developing the accreditation mechanism in Australia.
• National Association of Testing Authorities (NATA) contributes to the accreditation mechanism development.
• National Pathology Accreditation Advisory Council (NPAAC) plays a role in the accreditation process for pathology laboratories.

Historical Timeline

• 1974: A proposal was submitted to the Minister of Health.
• 1979: The National Pathology Accreditation Advisory Council (NPAAC) was established.
• 1982: RCPA and NATA established a voluntary accreditation scheme.
• 1985: The first medical laboratory was accredited.
• 1986: A link was established with commonwealth legislation for reimbursement (Medicare).
• 1990: The Pathology Services Accreditation Act was enacted in Victoria.
• 1996: NPAAC mandated that labs adopt Quality Systems by January 2000.
• 1999: ISO/IEC 17025 was published.
• 2000: All medical assessments were conducted against ISO/IEC 17025.
• 2005: All medical assessments were conducted against ISO/IEC 15189:2003.
• 2011: Suppliers of in vitro diagnostic medical devices (IVDs) needed to meet Therapeutic Goods Authority (TGA) regulatory requirements.
• 2017: Australian laboratories manufacturing in-house IVDs needed to meet TGA requirements.

Therapeutic Goods Administration (TGA)

• Part of the Australian Government's Department of Health and Aging.
• Responsible for administering the Therapeutic Goods Act 1989.
• Manages various sections dealing with medicines and devices.
• Medical devices include items like medical gloves, bandages, and IVDs.
• TGA regulation (2002) requires all kits to be supplied under the Australian Register of Therapeutic Goods (ARTG).
• IVDs are classified based on public health risk or individual high risk.

National Pathology Accreditation Advisory Council (NPAAC)

• Royal college of pathologist Australasia (RCPA) committee established as NPAAC.
• Membership includes representatives from: RCPA, AIMS, AACB, ASM and AMA.
• Establishes guidelines and standards for accreditation.

National Association of Testing Authorities (NATA)

• Early 1980s: RCPA and NATA agreed to appoint NATA as the accrediting body.
• Victoria established its accreditation requirements in early 1990 used NATA as the accrediting body.

Accreditation Details

• Initially, accreditation was a voluntary activity.
• RCPA introduced the Quality Assurance Program (QAP).
• Concerns that there were no teeth in the accreditation process were raised.
• Accreditation is linked to the Medicare rebate scheme.
• Lack of accreditation prohibits billing Medicare for services rendered.
• Labs need to take part in external QAP for quality accuracy.

Quality Assurance

• ISO 15189 requirements assigned by NATA.
• Programs introduced across all disciplines.
• Aims to improve the quality of results.
• Aims to achieve standardization in test and reporting procedures.
• Confidentiality of results is a key part.
• Laboratories are ranked on performance.
• Linked to continuing education activities.

Medicare and Accreditation

• Granting of APL (accredited pathology laboratory) accreditation linked to Medicare rebate scheme.
• Lack of accreditation prohibits billing Medicare for services rendered.
• Medicare rebates are administered.
• Medicare rebate schedule is defined.
• NATA/RCPA reports of assessment are received.
• Labs must have had an advisory visit from NATA before rebates may be claimed.
• Access by NPAAC.

Categories of Laboratories

• Category GX (general):
  • Covers one or more groups of pathology.
  • Under direction, control, and full-time supervision of an expert pathologist.
  • Employs two or more full-time equivalent (FTE) pathologists.
• Category GY (general):
  • Employs no more than two FTE pathologists.
  • Under direction, control, and full-time supervision of an expert pathologist.
• Category B (branch):
  • Integrated with a category GX or GY laboratory or is part of a regional pathology service.
  • Under the direction and control of either an expert pathologist or a senior scientist.
  • Supervision of at least an expert scientist.
• Category M (medical):
  • Laboratory is under direction, control, and supervision of a medical practitioner.
  • Services are for patients of the medical practice.
• Category S (specialized):
  • Performs a limited range of tests or tests that need specialized skills.
  • Tests are performed for specific target populations (skin biopsy, IVF).

AS ISO 15189:2023 - Main Aims

• Organization and Management:
  • Establishment of a Quality Management System (QMS).
  • Clear quality policy and objectives.
  • Effective document control.
• Evaluation and Improvement:
  • Regular internal audits.
  • Monitoring of quality indicators.
  • Implementation of corrective and preventative actions.
  • Management reviews of the QMS.
• Premises and Environmental Conditions:
  • Suitable facilities and workspace.
  • Regular equipment maintenance and calibration.

ISO 15189:2023 - Key Requirements

• Personnel: Qualified and competent staff with documented training and competency.
• Equipment: Appropriate, validated, and maintained equipment.
• Pre-analytical Processes: Accurate patient identification and sample collection with proper sample transport/storage.
• Analytical Processes: Implementation of quality control measures, validated examination procedures, and traceability of measurements.
• Post-analytical Processes: Timely and authorized reporting of results and secure storage/retention of records.