1431 Final Protocol

Intervention – proposed medical service

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Intervention – proposed medical service

Provide a description of the proposed medical service.

The proposed medical service is for the use of an in vitro diagnostic test instrument that meets defined accepted performance criteria equivalent to laboratory based testing being performed at or near the site of patient care (eg within GP consulting rooms) for the quantification of HbA1c in human whole blood.

If the service is for investigative purposes, describe the technical specification of the health technology and any reference or “evidentiary” standard that has been established.

Generally accepted performance criteria for an HbA1c PoC test system are (16):

  • a total coefficient of variation (CV) <3.0%; and

  • a National Glycohemoglobin Standardization Program (NGSP) manufacturer certification.

The CV specification ensures that the instrument or system provides reproducible results.

NGSP certification is a widely recognised international certification program for both laboratory-based and point of care HbA1c assays. .

The aim of the NGSP program is to standardise HbA1c test results to those of the Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS) which established the direct relationships between HbA1c levels and outcome risks in patients with diabetes.

For NGSP certification, a particular assay (laboratory or point of care) is compared against a reference method in an independent laboratory. Test specimens must be distributed over the clinically meaningful range of concentrations and the assay must meet the internationally accepted specification for agreement with the reference method in order to obtain certification. Certification is valid for 1 year.

The analytical performance of NGSP certified laboratory assays and point of care assays with external proficiency samples (QAP samples) is comparable. The bias compared to the mean result, and %CV of laboratory assays is comparable to those of point of care assays.

NGSP certification indicates appropriate analytical accuracy across the range of clinically relevant HbA1c values, including the diagnostic cut-off of 48 mmol/mol (6.5%), compared to a globally accepted standard and allows comparison of results between different test methodologies.

HbA1c tests are Class 2 in vitro diagnostics and must be included on the ARTG by the TGA before being supplied in Australia. All PoC instruments undergo mandatory technical review by the TGA which assesses the test’s analytical performance and suitability for use at the PoC.

The proposed medical services have analytical performance which meet quality specifications for both trueness and imprecision, and their performance is comparable to that of laboratories.

Indicate whether the service includes a registered trademark with characteristics that distinguish it from any other similar health technology.

The service will be available for all appropriate PoC tests that meet the performance criteria described above, irrespective of registered trademark.

Below are examples of ARTG listed PoC test devices that meet the proposed performance criteria:

  • Afinion Test System:

    • ARTG identifier 204479: Instrument/analyser IVD

    • ARTG identifier 204476: Clinical chemistry substrate IVDs

  • cobas b 101system

    • ARTG identifier 202785: Instrument/analyser IVD

ARTG identifier 201876: Clinical chemistry substrate IVDs

Indicate the proposed setting in which the proposed medical service will be delivered and include detail for each of the following as relevant: inpatient private hospital, inpatient public hospital, outpatient clinic, emergency department, consulting rooms, day surgery centre, residential aged care facility, patient’s home, laboratory. Where the proposed medical service will be provided in more than one setting, describe the rationale related to each.

The proposed medical service will be delivered at the point of patient care, primarily within health care professionals consulting rooms.

Describe how the service is delivered in the clinical setting. This could include details such as frequency of use (per year), duration of use, limitations or restrictions on the medical service or provider, referral arrangements, professional experience required (e.g.: qualifications, training, accreditation etc.), healthcare resources, access issues (e.g.: demographics, facilities, equipment, location etc.).

The details of the PoC HbA1c testing depend on the test instrument or system that is used, with a number of appropriate instruments available in Australia.

Typically, a lancet is used to perform a fingerstick and a small (1 – 10 µl) sample of whole blood is obtained. The whole blood is added to a disposable test cartridge or device which contains the reagents required for the analysis. The test cartridge is inserted into an analyser which provides the HbA1c test result in 3 – 10 min. Most systems require minimal maintenance (if any) and calibration is typically via bar code or chip inserted into the device.

In terms of frequency of use and duration of use, the proposed medical service would reflect current MBS reimbursement criteria (MBS items 66841, 66551 and 66554):

  • Diagnosis of diabetes: a limit of HbA1c diagnostic test once in a 12 month period for the diagnosis of diabetes in asymptomatic patients at high risk.

  • Management in established diabetes: not more than four times in a 12 month period.

  • Management in pre-existing diabetes (pregnant patients): not more than six times in a 12 month period.

PoC testing is proposed to be an alternative to laboratory testing where appropriate and that current limits on frequency of HbA1c testing would continue to apply whether the test is performed in a laboratory or at the point of care e.g. HbA1c testing for management in established diabetes would be limited to not more than four times (laboratory and/or PoC) in a 12 month period.

For clarity, testing outside the direct supervision of a medical or nurse practitioner, such as in pharmacy or other settings, is outside the scope of this application. Per PASC recommendations, the MBS item descriptor will be implicit in stating that the test result interpretation will be conducted by the treating medical or nurse practitioner.

The HbA1c PoC test can be performed in a non-laboratory clinical setting by appropriately trained device operators that may include registered nurses, nurse practitioners, general practitioners or practice staff who meet a required competency level to perform PoC testing. These device operators can perform the test and analyse the data output with the results reported to the treating practitioner for interpretation and action (where the test is not performed by a GP).

It is proposed that a practical framework would be used for the accreditation of sites performing point of care testing. Requirements would include appropriate quality control testing, enrolment an external proficiency program, and staff training requirements. This point of care accreditation would be conducted as part of overall Practice Accreditation.

Healthcare resources required to utilise the proposed medical service will vary depending on the instrument or system that is used but would typically consist of: an appropriate test system and any associated reagents or cartridges; a small amount of space in the consulting rooms for the instrument and equipment required for collecting fingerstick samples such lancets, swabs, etc. Aside from the test system and reagents the costs of additional equipment is not considered to be significant.

The use of PoC testing by health care professionals is likely to significantly improve access to HbA1c testing for the diagnosis and ongoing management of patients with diabetes, particularly in patients in rural and remote areas. Patients in these areas may have limited access to pathology services due to issues of transportation and the distance to approved pathology laboratories.

PASC agreed with the description of the proposed intervention and requested that the following specifications be included in the Protocol:

  • Provider of service – The PoC testing component will be undertaken within General Practice (registered nurses, nurse practitioners, general practitioners or practice staff who meet a required competency level to perform PoC testing). Test results interpretation will be conducted by the treating medical or nurse practitioner.

  • Proposed training – The device manufacturer, device supplier or appropriate training organisation will provide training on use of HbA1c PoC testing devices to practice staff.

  • Accreditation, quality control (QC) and quality assurance (QA) – The Sponsors of this application are currently drafting a proposed guidance document and framework for accreditation, QC and QA. The complete framework will be included in the Submission Based Assessment (SBA). In brief, the framework will include requirements for:

    • Clinical governance

    • Quality control (QC) procedures and external proficiency (external QA) requirements

    • Staff training and competency checks

    • Incorporation of POC testing into the practice’s quality framework with a nominated person responsible for POC testing.

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