Point of Care Department Information
Definition:
Point of Care Testing (POCT) is the performance by non-laboratory staff of an analytical test outside the conventional laboratory, at the site of or in the vicinity of the patient.
Devices:
Devices for POCT testing range from basic dipsticks, to simple hand held devices such as glucose meters, through to complex analysers more commonly seen in a conventional laboratory, like blood gas analysers.
POCT Governance:
Laboratory Advisory Group also referred to as the POCT Committee.
Benefits:
The use of Point of Care Testing may have a number of benefits for clinicians and patients. Thus POCT can be an important addition to laboratory-based analysis.
Benefits may include:
- improved turnaround time by shortening pre-analytical, analytical and post-analytical steps
- reduced therapeutic turnaround time
- improved monitoring of certain conditions where frequent testing is desirable such as diabetes and oral anticoagulant monitoring
- improved convenience and access to service e.g. for elderly patients
- smaller sample volumes which may be less invasive
- availability of rapid results to facilitate patient management
- opportunistic screening of the public for early identification of certain conditions
- ability to provide laboratory tests in remote locations or outside laboratory hours
- economic benefits may also be realised because although POCT testing is generally more expensive than conventional laboratory testing, POCT may offer economic benefits in terms of reduced clinic visits, length of hospital stay and hospital admissions
However, it should be noted that faster availability of results is only an advantage if the availability of results is the rate-limiting step in clinical care.
Risks:
There are risks involved in the use of POCT devices, and therefore this testing should be limited to those circumstances where they are the only or the best solution to obtain test results when compared with testing in the central laboratory. Risks may include:
- POCT introduction without adequate investigation of clinical need
- inaccurate results due to lack of training or expertise, insufficient quality testing, or failure to recognise erroneous results, which may cause patient harm
- problems of comparability of results between different methods (laboratory versus POCT)
- increased costs due to additional instrumentation, expensive reagents, enrolment in external quality assurance programmes
- inadequate documentation of results and reporting
- increased workload for clinical staff
- the availability of arrays of screening tests which may result in inappropriate testing
- risks to patients as a result of implementation of non-performing devices or failure to recognise the limitations of POCT devices
To overcome the disadvantages requires significant resources and so careful consideration should be given to the clinical need before contemplating this type of testing. The advantages of POCT only hold true if the test result provided is accurate and reliable, and improves patient outcomes.
Assessment of Clinical Need:
In many cases improving the patient pathway and experience will be major considerations when introducing POCT. To be effective, POCT must deliver an equivalent level of quality and be at least as clinically effective as the alternative, and applied within the correct setting. These questions will help in assessing the clinical need for POCT:
- Does the current method of providing the service adequately meet the clinical need, and if it does not, what is the problem and can it be rectified?
- Is access to the laboratory a problem for patients, and can that be rectified?
- Which groups of patients need testing and what test(s) need to be performed?
- Will POCT enable more rapid or effective diagnosis, treatment or management?
- Will POCT provide a cost-effective alternative to laboratory testing?
- How would a POCT service compare to the current service in terms of quality?
- Would any change in quality be appropriate for best management of the patient?
- Can you provide evidence that POCT will provide a measurable clinical benefit
Selection Criteria:
All new POCT devices or systems must undergo a rigorous evaluation procedure prior to their introduction. This will include a laboratory evaluation and may also include an on-site clinical evaluation.
For a candidate POCT device to be accepted the following criteria must be established:
- The results produced must be required for a rapid (urgent) clinical decision within a timescale that the central laboratory cannot achieve.
- The performance of the device and the results produced must consistently be of acceptable quality, and compatible with laboratory test ranges.
- The resource implications must be acceptable.
- The risks must be identified and manageable.
- There should be a strong evidence base for the test in question.
Information Technology:
All results obtained from POCT testing must be recorded and become part of the patient health record. Information technology (IT) capability can aid in minimising some of the potential sources of error in POCT testing and promote compliance with operator and patient identification procedures, test procedures and quality control requirements. Wherever possible, IT capable devices must be the selection of choice, and include software that:
- requires operator identification
- requires patient identification
- checks quality control
- transfers results directly to the patient record
Other desirable features which should be considered include:
- bidirectional data communication to allow patient data to be uploaded to the device, and results matched with patient information to be fed back to the information system
- access and data should be secure to ensure patient confidentiality
- ability to scan barcodes to facilitate accurate information entry, - operator ID, patient ID and lot numbers for consumables
- allow easy and regular monitoring of QC information to continually evaluate system performance
Applications for POCT:
In the first instance, application for new or additional POCT should be made to the POCT Quality Manager using the application form in Appendix 1 of the DHB policy. Once the application is passed on and approved by the Laboratory Committee, the POCT Quality Manager is responsible for the evaluation and recommendation of appropriate equipment in consultation with the Product Evaluation Committee.
Financial Implications:
The clinical areas installing POCT testing/devices are responsible for the costs of:
- The device
- The consumables
- Quality control material (QC)
- Enrolment and participation in external quality assurance programmes (EQA)
- Maintenance, repair and replacement
- An appropriate share of any connectivity costs and ongoing licence fees
Laboratory staff will have oversight of these activities, and provide guidance regarding suitable alternatives which must comply with laboratory IANZ accreditation requirements.
References
For detailed information on Point Of Care Testing requirements refer to:
HBDHB Point of Care Testing Policy HBDHB/CPG/101 (2020)
New Zealand Best Practice Guidelines for Point of Care Testing (2022)
The HBDHB POCT Manager (as appointed by the laboratory) is responsible for the implementation and maintenance of the POCT Quality Management System (QMS) for HBDHB clinical areas. The QMS is based ISO 5189:2022, in line with IANZ accreditation requirements and national and international best practice. Refer to HBDHB POCT Policy CPG/SPG101 and relevant POCT Manuals for further information regarding the POCT QMS.
Point of Care Quality Manager Job Description:
- Document, implement and maintain the POCT Quality Management System
- Be responsible for ensuring that all POCT is performed to an appropriate standard.
- Maintain a record of all POCT equipment within the HBDHB.
- Be responsible for ensuring that all POCT users have current competency training and documentation.
- Be responsible for ensuring regular quality assurance is maintained and quality control samples are analysed on POCT devices, with up to date documentation and history.
- Maintain (monitor) service records for each device.
- Be responsible for trouble shooting of POCT devices and overseeing the maintenance of up to date documentation and history.
Competency of users is undertaken annually and documented appropriately.
All methods manuals and associated POCT documents are also reviewed annually.
As a general rule all POCT equipment is owned, operated and funded by the clinical areas.
The exceptions to this are:
Wairoa I-STAT, poch-i100 and Lactate meter in the Acute Ward is owned by the Laboratory. There is no maintenance agreement for these instruments.
Hastings
| Equipment | Tests | Location |
| Nova Glucose Meters | Glucose, Ketone | Inpatient Wards, Radiology |
| Xpress Glucose Meters | Glucose | Villa’s (OPD), District Nurses incl Napier |
| Hemocue, CoaguChek, TEG | Hgb, INR, TEG | Tech Room, Theatre |
| Nova Lactate Meter, Fetal Fibronectin | Lactate, FFN | Maternity |
| Cobas b101 | HbA1c | Diabetes Centre |
| ABL90 | Blood Gas | ICU |
| Credo VitaPCR | Covid-19, Influenza A&B | ED, Maternity and Ballantyne House |
| Siemens Clinitek | Urinalysis | ED |
Wairoa
| Equipment | Test | Location |
| Nova Glucose Meter | Glucose, Ketones | Acute Ward |
| Nova Lactate Meter | Lactate | Acute Ward, Laboratory |
| Nova Xpress Glucose Meter | Glucose | District Nurses |
| I-STAT | UECG, Blood Gas, Trop I, INR | Acute Ward, Laboratory |
| CoaguChek | INR | Laboratory |
| Pochi 100i | FBC | Acute Ward, Laboratory |
| Credo VitaPCR | Covid-19, Influenza A&B | Acute Ward |
Central Hawke’s Bay Health Centre (CHB)
| Equipment | Tests | Location |
| Nova Glucose Meters | Glucose, Ketones | General Ward |
| I-STAT | Trop I | Laboratory |
Quality Control
| EQA Programme | Test | Frequency |
| RCPA –ICU ABL90 | Blood Gas | Monthly |
| RCPA -Wairoa | Blood Gas, Chem 8+, Troponin I | Monthly |
| RCPA – Wairoa/Hastings | INR | Bi-Monthly |
| RCPA - Wairoa | Ketones | Bi-Monthly |
| Waikato EQA - ED | Urinalysis | Monthly |
| Waikato EQA – Wairoa/Hastings | Glucose | Monthly |
| HB Labs Sample Swap - Wairoa | FBC | Weekly |
| Sample Comparison (b101 vs D100 Hastings) | HbA1c | Monthly |
| Sample Comparison (meter vs ABL Hastings) | Lactate | Monthly |
| Sample Comparison (Hemocue vs XN-3000) | Haemoglobin | Monthly |
| Sample Comparison (ABL800 Lab vs ABL90 ICU) | Blood Gas | Weekly |
| RCPA sample comparison - CHB | Troponin I | Bi-Monthly |
| RCPA Rapid Molecular | Covid-19, Influenza A&B | Bi-Monthly |
| Internal QC | Frequency | Performed by |
| ABL90 | 3x Daily | Analyser - automated |
| FBC | Daily | Wairoa Laboratory Staff |
| Nova Glucose & Ketone | Daily | Ward Staff |
| Nova Xpress Glucose | Weekly | District Nurses or HCA’s |
| I-STAT – electronic checks | Daily (NOT required for Alinity) | Wairoa/CHB |
| I-STAT – liquid QC | Monthly or New lot number/Delivery | Wairoa/CHB |
| Coaguchek | Monthly or New lot number/Delivery | Wairoa Laboratory Staff/ Anaesthetic Technician |
| Cobas b101 | Monthly or New lot number/Delivery | Diabetes Clinic Staff Nurse |
| Hemocue | Monthly or New lot number/Delivery | Anaesthetic Technician |
| Lactate | Weekly | Wairoa/Maternity Staff |
| TEG | Fortnightly | Anaesthetic Technicians |
All Internal and External QC is regularly reviewed and commented on by the POC QM and/or relevant HOD/Senior Scientist and acted upon if required.
Out of Hours Support:
Wairoa For problems with POCT equipment on the ward after hours, consult with Associate Clinical Nurse Manager. If further support is required contact Wairoa Laboratory staff or POC QM.
Glucose /Ketones For problems with glucose meters out of hours contact the laboratory for a loan meter.
Lactate No out of hours support, send sample to the laboratory.
Hemocue No out of hours support, send sample to the laboratory.
ABL90 ICU No out of hours support, send sample to the laboratory.
Fetal Fibronection No out of hours support.
TEG No out of hours support.
CHB, Not used out of hours.
B101 Not used out of hours.
Urinalysis No out of hours support.
VitaPCR No out of hours support. Send sample to the laboratory.
Equipment Inventory:
All POC devices and instruments are documented and recorded on a spreadsheet located at:
J:\Departments\Equipment Inventory\MASTER Equipment Inventory
Under the POC tab. This contains information relating to age of device, model, asset number and also hyperlinks to the individual devices Equipment Log. This log documents issues and troubleshooting.