i‐STAT 1 Analysers PHC Remote Guideline
Target Audience All Clinical Employees
Jurisdiction Primary Health Care Remote CAHS; Primary Health Care Remote TEHS Jurisdiction Exclusions N/A
Document Owner Kerrie Simpson
Atlas Development Officer Primary Health Care Remote CAHS
Approval Authority Chair
Clinical Governance Committee PHC CAHS; Primary Health Care Safety and Quality Committee TEHS
Author Professional Practice Nurse PHC CAHS; Professional Practice Nurse PHC TEHS; Flinders University International Centre of Point‐of‐Care Testing
PGC/SharePoint ID: HEALTHINTRA-1880-11703- PGC/Content Manager ID: EDOC2018/22455 Version Number: | | Version: 8.0 Approved Date: 14/11/2019
Purpose
To provide Primary Health Care remote staff with a guideline on the management, including operator training requirements, checks, maintenance and supply of consumables, of the i‐STAT® 1 Analyser used in remote health centres.
Guideline
1. General Information
The Abbott i‐STAT® analyser is a portable medical device used for point‐of‐care (POC) pathology testing for a range of pathology tests including electrolytes, urea, creatinine, blood gases, prothrombin time (PT) / international normalised ratio (INR) and cardiac Troponin I (cTnI). The i‐STAT® analyser is designed to operate as a networked system allowing the electronic download of client, Quality Control (QC) results and error codes, and the upload of software to the device. The i‐STAT® analyser is standard equipment in Northern Territory (NT) remote health centres.
The NT Point‐of‐Care Testing (POCT) Program provides a framework for i‐STAT POCT for the care of clients with both acute and chronic diseases across a network of approximately 80 remote health centres in the NT. The program is delivered through a contractual partnership between the NT Department of Health (DoH) and Flinders University International Centre for Point‐of‐Care Testing (ICPOCT), with governance provided by the NT POCT Management Committee.
Although the i‐STAT® analyser is relatively easy to operate there are potential risks to this valuable equipment, and the quality of results, if misused. This, coupled with the need to appreciate the quality management and supply issues surrounding the use of the analysers, dictates that staff must be appropriately trained and certified as a competent and Qualified i‐STAT Operator, before using the equipment.
Use by non‐certified staff is not authorised.
Information in this document includes:
i‐STAT Training and Competency Performing a Test
Quality Management
Technical and Other Support Information Medicare Claiming
Ordering Consumables
Storage of Cartridges and Quality Controls Maintenance / Cleaning / Location
Instructional documentation can also be accessed via the NT POCT program website (participant login required).
2. Procedure
2.1 i‐STAT Training and Competency
The use of i‐STAT® Analyser is restricted to an appropriately qualified i‐STAT operator. This is an important feature of ensuring the reliability of client results obtained from these devices.
All relevant clinical staff are required to become a qualified i‐STAT Operator. Clinicians who have not previously undertaken POCT training or those who do not have a current Operator ID must apply for a temporary i‐STAT emergency operator ID which allows them to use the i‐STAT Analyser in emergency situations only.
The Application for Temporary i‐STAT Emergency Operator ID must be completed and submitted to ICPOCT who will issue a Temporary ID and i‐STAT Operator instructions to PHCM and staff member within 24 hours of receipt of the application. The i‐STAT Operator instructions must be read and understood prior to using the i‐STAT.
Note: The Temporary ID will expire two weeks from date of issue. During this period staff must complete i‐STAT training and achieve competency to be assigned an ongoing standard Operator ID. If training and competency is not successfully completed within the two week timeframe, the applicant should liaise with ICPOCT re extension / alternative arrangements.
Training sessions are regularly offered and competency assessment processes are coordinated by ICPOCT. Following completion of the Application for Temporary i‐STAT Emergency Operator ID
applicants will be notified of training sessions and requirements. Training is usually conducted weekly via GoToMeeting and teleconference with notification of the date and time and equipment required by the ICPOCT.
If both written and practical assessments are deemed acceptable, ICPOCT will issue a Competency Certificate and an individual Operator ID will be assigned.
All staff are required to update their competency every two years or as deemed necessary by the ICPOCT.
i‐STAT Training Resources and i‐STAT Training Videos produced and supplied by ICPOCT are available to support training.
2.2 Performing a Test
The unique i‐STAT Operator ID must only be used by the person it is assigned to.
Qualified i‐STAT Operators are required to enter their unique Operator ID when preparing the i‐STAT to perform a test.
The use of the i‐STAT analyser is restricted to clinical situations outlined in approved clinical protocols and/ or as directed by a medical officer.
There are different i‐STAT cartridges for different tests. All the i‐STAT cartridge types share similar features and the test procedure for performing any test on the i‐STAT is essentially similar.
To perform a POC test on the i‐STAT, refer to the poster How to do a Patient Test on the i‐STAT for a quick step‐by‐step guide. Also see the i‐STAT Training Manual.
2.2.1 Documentation of Results
All test results must be recorded into the client’s health record. See the relevant Electronic Health Record (EHR) User Reference Guide on recording i‐STAT results.
2.3 Quality Management
An essential part of conducting routine POCT is the regular monitoring or ‘checking’ of the precision and accuracy of the analyser ensuring reliability of results for clinical decisions and client care. Quality procedures are integral components of the quality management system and include:
- i‐STAT Essential Checks (updated annually) - Quality Control Checks
- Software Updates
Quality procedures are also an important component of maintaining a high level of i‐STAT Operator competency. Quality procedures may only be performed by a Qualified i‐STAT Operator.
The required forms should be downloaded from the i‐STAT Key Paperwork webpage.
2.3.1 i‐STAT Essential Checks
The required checks are summarised on the i‐STAT Essential Checks Form and grouped into weekly and fortnightly tasks. Occassionally, other required maintenance tasks (eg ceramic cleaning) may be necessary and staff will be instructed by ICPOCT staff. The Essential Checks Form should be completed and faxed or e‐mailed to ICPOCT during the first week of the next month.
2.3.2 Quality Control (QC) Checks
Quality Control checks are required for each type of cartridge used for patient testing and performed on a fortnightly rotation. Please refer to the How to Complete a Quality Control Test on the i‐STAT for a quick reference step by step guide or the i‐STAT Training Manual.
Staff must ensure that the ‘Lot Number’ on the control solution and the cartridge prefix match the information on the ‘QC Result Sheet’. This ensures that the results can be compared to the assigned values and limits on the QC Result Sheet. Each time a QC test is completed, results should be recorded on the QC Result Sheet and faxed or emailed to the ICPOCT.
If QC results are outside acceptable limits, then patient testing should stop until the reason for poor performance has been rectified through consultation with the ICPOCT. During consultation the QC lot number and the cartridge prefix should be confirmed.
Refer to the i‐STAT Quality Control Action Sheet, which summarises the interpretation of QC results.
2.3.3 Software Update
The i‐STAT® analyser requires regular software updates every 6 months. All QC checks for the current month are required to be completed prior to the software update. If an update is not performed, then the analyser will cease to function until the update occurs. In most instances, the software update will be conducted in the health centre by following some simple instructions issued by the ICPOCT, and involves placing the i‐STAT® analyser in the downloader at the appropriate time. Health centres with satellite IT
connections may experience slower connection speeds, thus requiring an alternative process. For example, emailing software packages and instructions to the health centre or transferring software analyser‐to‐analyser. Alternatively, the the i‐STAT® analyser may need to be sent to the PPN PHC CAHS / TEHS. For instructions on performing software updates please see the i‐STAT Training Manual.
Technical support to perform software updates is also available, see point 4.6 below.
2.4 Technical and Other Support Information
If a test fails, the i‐STAT® analyser will display an error code. Information on the i‐STAT Common Error Codes provides a description of the error and suggests actions which may resolve the issue. If the issue cannot be resolved, a telephone support service is available Monday to Friday during business hours for assistance. Contact details are provided on the Key Contacts for Support Services.
Monthly participant i‐STAT feedback reports are provided by ICPOCT to the PHCM and District Managers. This report provides information regarding the number of tests performed, the device operators, QC participation and commentary on overall device performance and/or required tasks.
2.5 Medicare Claiming
A Medicare rebate is claimable for a haemoglobin measurement using the i‐STAT Chem8+ cartridge (Medical Benefit Schedule item number 73802). In addition, if the client is under 16 years of age or the holder of a Commonwealth concession card (a valid Concession Card must be confirmed), the incentive item number 74991 may also be claimed. See: Point of Care Pathology Overview, and Medicare Overview.
2.6 Ordering Consumables
Testing Cartridges, QCs and batteries can be ordered and faxed to the PPN (number on form) using:
Point‐of‐Care Consumables Order (Central Australia) PHC Remote Form
DoH Health Centres Only Point‐of‐Care Consumables Order (Top End) PHC Remote Form
i‐STAT Consumables Order (Community Controlled Health Service) PHC
Remote Request Form (Atlas Link: https://hdl.handle.net/10137/6945 ) Community Controlled Health Services
Note: Stock levels should be kept to a minimum to avoid wastage. When receiving new stock it should be placed behind existing / older stock so that stock at the front of the refrigerator shelf is the oldest stock and therefore used first.
2.7 Storage of Cartridges and Quality Control Solutions
i‐STAT cartridges and QCs should be stored in a purpose built temperature controlled refrigerator that is separate to the vaccine refrigerator. Where this is not available, a dedicated domestic refrigerator with temperature monitoring may be used to store consumables.
i‐STAT Cartridges and QCs are to be kept refrigerated at 2 – 8ºC until product expiry date. During transportation they should be packed in the same way as vaccines (with an ice brick and cold chain monitor in an esky).
If the cartridges are removed from refrigeration or exposed to room temperature, they should continue to be stored at room temperature (18 ‐ 30ºC) and not returned to the fridge. When stored at room
temperature, cartridge life is shortened to:
- two (2) months for CG4+ and - 14 days for all other cartridge types.
The cartridges should be labelled with a handwritten new expiry date. Once past the new expiry date the cartridge should be discarded or clearly labelled and may be used for training purposes. See Cold Chain PHC Remote Guideline for more information.
2.8 Maintenance / Cleaning / Location
On‐site maintenance is minimal, essentially summarised in the weekly check component of the i‐STAT Essential Checks Form.
In most circumstances the downloader should always be connected to an active network port and the i‐
STAT analyser routinely placed in the downloader when not in use.
The analyser should be cleaned weekly and between client use. It should be wiped with a slightly damp soft cloth, using mild general‐purpose detergent / warm water. Avoid using excessive fluid.
The analyser must be stored in a dust‐free location in an air‐conditioned room in the health centre within a 16 ‐ 30°C temperature range. Outside of this temperature range the analyser will disable client and quality testing capabilities. Transport of the analyser for off‐site use should utilise a dedicated insulated bag, taking care to prevent the device being subject to temperature extremes.
Occassionally, other required maintenance tasks (eg ceramic cleaning of the contact pins) may be required to be performed and will be instructed by ICPOCT staff.
Compliance
Monthly participant i‐STAT feedback reports provided by ICPOCT regarding:
‐ number of tests performed
‐ device operators,
‐ QC participation
‐ commentary on overall device performance and/or required tasks
are reviewed and followed up as required.
Primary Health Care Manager District Manager
Professional Practice Nurse PHC Remote CAHS Professional Practice Nurse PHC Remote TEHS
Monitoring of cold chain rquirements and reporting
breaches for follow‐up Primary Health Care Manager
Professional Practice Nurse PHC Remote CAHS Professional Practice Nurse PHC Remote TEHS
Document Quality assurance
Method Responsibility
Implementation Document will be accessible via the Policy
Guidelines Centre and Remote Health Atlas Health Policy Guidelines Program Review Document is to be reviewed within three years, or
as changes in practice occur Atlas Development Officer, Primary Health Care CAHS Evaluation Evaluation will be ongoing and informal, based on
feedback. Atlas Development Officer,
Primary Health Care CAHS
Key Associated Documents
Forms DoH Health Centres Only:
Point‐of‐Care Consumables Order (Central Australia) PHC Remote Form Point‐of‐Care Consumables Order (Top End) PHC Remote Form Community Controlled Health Services:
i‐STAT Consumables Order (Community Controlled Health Service) PHC Remote Request Form
Application for Temporary i‐STAT Emergency Operator ID
Flinders University International Centre for Point‐of‐Care Testing ‐ NT Program homepage
i‐STAT for Participants Only webpage: Note: Participant log in is required to access the following i‐STAT Key Paperwork documents:
‐ i‐STAT Essential Checks
‐ i‐STAT Quality Control Result Sheet ‐ Fortnight 1
‐ i‐STAT Quality Control Result Sheet ‐ Fortnight 2 Key Legislation, By‐Laws, Standards,
Delegations, Aligned & Supporting Documents Cold Chain PHC Remote Guideline Medicare Overview PHC Remote Guideline
Point of Care Pathology Overview PHC Remote Guideline PCIS User Reference Guide ‐ Recording of i‐STAT results
Flinders University International Centre for Point‐of‐Care Testing – NT Program homepage
i‐STAT for Participants Only webpage: Note: Participant log in is required to access the following i‐STAT webpages:
i‐STAT Key Paperwork
Key Contacts for Support Services i‐STAT Training Resources
i‐STAT Training Videos
Remote Primary Health Care Manuals
Central Australian Rural Practitioners Association (CARPA) Standard Treatment Manual
References As above
Definitions
Preferred Term Description Central Data Station (CDS):
(From 2019 this may also be referred to as InfoHQ)
a specific i‐STAT database (called InfoHQ) located at the ICPOCT, capable of electronically storing client and quality testing data / results of QC testing, as well as performing other system management functions for the i‐STAT network.
Downloader: desktop electronic IT device capable of facilitating transmission of data between the i‐STAT® analyser and the CDS (InfoHQ), via the internet. Some downloader’s also have a recharger function.
Electronic Simulator: a device used to perform an external quality check on the analyser’s electronic signal‐reading function.
Preferred Term Description
ICPOCT: Flinders University International Centre for Point‐of‐Care Testing. A specialist POCT provider, with experience in the delivery of POCT services to rural and remote health services around Australia and Internationally.
i‐STAT Cartridge: a small, single use, disposable pathology test kit.
Qualified i‐STAT Operator: relevant clinical staff who have successfully completed the required training and competency assessment/s and hold a current ICPOCT i‐STAT
Competency Certificate.
Quality Control a matrix‐matched, spiked sample that is produced by the manufacturer. This sample has an assigned, or ‘target’ value, for each POC test being measured, and limits for acceptable analytical performance (consistent with those used in laboratories).
NT POCT Management
Committee: the management committee, comprising representatives of the DoH, Aboriginal Medical Services Alliance NT (AMSANT), ICPOCT and other stakeholder groups, responsible for the overseeing the NT POCT Program for i‐STAT and DCA Vantage Analysers.
Evidence Table
Reference Method Evidence level
(I‐V) Summary of recommendation from this reference
N/A N/A N/A N/A
