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We present details of a large point-of-care testing (PoCT) network embedded within a state-wide pathology service covering 1,730,648 sq km and 4.4 million people. Within this context, we describe one aspect of this network, where PoCT devices are appropriately used as an integral part of acute healthcare in the patient’s home, thus delivering efficiencies to the patient, the home healthcare nurses, the inpatient hospital-based medical team, and therefore to the overall healthcare system.
The last decade has seen the coalescence of a number of factors result in significant changes in the way the healthcare system and traditional laboratory medicine interact. Some predictions forecast at the end of the last century, such as widespread use of genomics and biometrics, and the elimination of strict traditional pathology discipline boundaries,1 have failed to materialise (at least within Australia). However, one key element remains: ‘Through intelligent process control and data management, the laboratory may become the most frequently used – and the most important – source of diagnostic information in medicine’.1 Our paper outlines an extensive integrated and networked approach to PoCT that is embedded and supervised by a state-wide pathology service and that spans hospital, independent clinic and patient home environments. A specific example of the last scenario is provided.
Rapid access to pathology test results is critical to high quality and efficient modern healthcare. Benefits of rapid access to test results have been demonstrated in relation to patient length of stay in emergency departments,2,3 and timeliness of access to information is critical for patient care decisions – such as for therapeutic drug monitoring, and patient flow decisions. The ability of traditional laboratories to meet the turnaround time expectations of patients, clinicians, and healthcare administrators has been limited.4 This deficiency has been particularly evident in a number of key clinical settings such as emergency departments,4 as well as in some niche areas such as the rapid assessment of renal function in radiology departments prior to administration of intravenous contrast agents. In general, large volume testing in centralised laboratories utilising laboratory scientific staff is efficient and cost-effective in terms of cost per test/reportable result. However, it is recognised that low unit cost (per test) at the expense of a long turnaround time is counterproductive.5
The ever increasing demand on hospitals, for example in emergency departments and for inpatient beds, together with workforce shortages, consumer demand and technological advances, has seen a significant increase in the utilisation of PoCT devices.
Good clinical governance and appropriate oversight have delivered improvements in quality and performance of PoCT,6 and it has been clearly demonstrated that PoCT devices can be successfully operated by non-laboratory healthcare professionals.7
Unfortunately the technological advances with PoCT, including device miniaturisation, ease of use and increased accuracy, have not been matched by a co-ordinated approach to data management, connectivity and device software interoperability, thereby limiting integration of PoCT results into the Laboratory Information System (LIS).8
Additionally, the use of PoCT devices outside the laboratory has been impacted by issues relating to regulatory compliance, quality requirements, costs and re-imbursement;9 and the ethical considerations of diagnostic self-testing using PoCT devices are still being debated.10 Consequently PoCT has not been consistently, nor necessarily appropriately, utilised in many places.
Perhaps it is due to all of these factors that the literature lacks a clear consensus on the relative benefits and costs associated with PoCT. Therefore, the decision to implement PoCT depends on a number of factors which may be unique to the clinical unit, and which are likely to go beyond consideration of simple unit cost.11
PoCT devices have been used in the settings of community clinics and pharmacies in a number of countries. Issues associated with the establishment of such pharmacy-based PoCT facilities in the United States (US) have been documented,12 and cost savings in the US have been demonstrated by utilising home health nurses to perform testing of International Normalised Ratios (INR) with PoCT devices.13
Again in the US, it has been demonstrated that patient outcomes were improved and unnecessary specimen recollection events reduced by having healthcare professionals use PoCT devices in home settings.14 Further, as shown in Tasmania, Australia,15 improvements in patient care were significant achieved for patients newly commenced on warfarin therapy when pharmacists performed regular home testing of INR and conducted patient education during the first eight days post-discharge from hospital. Similarly, while there was no significant difference in total cholesterol levels, a significantly higher proportion of patients with a cardiovascular-related diagnosis recently discharged from hospital achieved a total cholesterol of less than 4.0 mmol/L over a six month period when receiving monthly home visits from a pharmacist who conducted PoCT cholesterol measurements and patient education.16 A common theme in a number of these studies is the role of patient education by pharmacists in addition to the real-time use of PoCT.
In contrast to small dedicated studies such as those highlighted above, we describe the use of a PoCT device with a broad test menu in the community setting as part of a total package of diagnostic and clinical services aimed at improving efficiency within the Queensland healthcare system.
Queensland is the second largest state within Australia - spanning the tropics to subtropics, and includes extensive remote desert areas. The population comprises 4.4 million people (20.1% of the total Australian population) spread over 1,730,648 sq km, with a predominance concentrated on the eastern seaboard, and 2.97 million people living in the southeast corner of the state.
Pathology Queensland is a single work unit within Queensland Health comprising 33 networked laboratories at 33 separate hospitals across the state. Providing equitable healthcare across vast distances is a challenge continually faced by Queensland Health. In order to address the needs of the community and to deliver diagnostic services to centres where there was no pathology laboratory, Queensland Health embarked upon a small scale pilot trial of PoCT devices in 2001. Following success of this trial, Queensland Health proceeded with a gradual expansion of the use of PoCT devices. This network now comprises 195 i-STAT (Abbott Laboratories, Illinois) devices located in approximately 140 rural and remote locations where there are no laboratories, together with i-STATs at 32 hospitals with on-site laboratories. Regular use of these devices has made an enormous difference to patient care in terms of: immediate access to diagnostic pathology tests; appropriate patient referral and travel to larger population centres; a reduction in unnecessary medical retrievals and travel from remote areas.
We believe that when compared with some other models of service relating to implementation and use of PoCT devices, there are distinct advantages associated with this co-ordinated approach to the widespread implementation of PoCT devices (see Table).
In order to guide appropriate use of PoCT devices in specific clinical settings, we always take a standard approach by asking three simple questions:
In our PoCT network, the i-STAT analyser is currently used to measure glucose (strip and cartridge methodology), electrolytes, renal function (urea and creatinine), blood gases, ionised calcium, lactate, troponin I, and activated clotting time in various clinically appropriate settings across the state. Indeed, it is the versatility of this analyser platform together with its connectivity to the LIS that affords many of the benefits delivered by PoCT for our pathology organisation and for the state-wide provision of healthcare.
The i-STAT analyser network in Queensland Health now has approximately 4000 healthcare worker operators. The majority of these people are neither scientifically qualified nor laboratory staff. We have recently successfully introduced an on-line education program for all healthcare worker operators of these devices, a program that incorporates an annual competency-based assessment. Separate quality control and quality assurance activities for these devices are performed in accordance with standardised state-wide protocols.
Here we describe the use of a portable PoCT device (i-STAT analyser) by home care nurses to improve overall efficiency in the healthcare system. In this setting, the fact that the total cost of patient care is funded by Queensland Health helps overcome some of the hurdles relating to efficient and appropriate use of PoCT devices highlighted above.
As a result of demand and pressures on acute inpatient hospital beds, Queensland Health has established a number of services whereby patients requiring acute medical care are effectively ‘admitted’ as ‘inpatients’ into a bed in their own home but are provided care by home care nurses and an acute hospital-based medical team. These Home Based Acute Care Services (HBACS) units may care for patients from the very beginning of their ‘admission’ or as a transition arrangement from their acute inpatient hospital bed prior to formal discharge from the hospital.
An example of such a patient is someone who has had a deep vein thrombosis and who has a leg ulcer requiring regular dressings. After an initial period as an inpatient in an acute hospital bed, the patient is transferred to the HBACS unit and is treated at home. During a single visit to the patient’s home, the home care nurse is able to: attend to the leg ulcer dressing; utilise the i-STAT to perform the INR test and review the results; liaise with the inpatient medical team who can order an alteration in the dose of warfarin if required; check the patient’s renal function and electrolytes; administer a dose of low molecular weight heparin appropriate for the patient’s measured renal function if required, and conduct patient education regarding warfarin, care of the leg ulcer and prevention of falls in the home. This example demonstrates the provision of much broader integrated patient care than that outlined in some of the studies highlighted above.
Upon return to the hospital or outpatient clinic base, the i-STAT results are downloaded via an ethernet connection into the LIS where they are stored as a permanent part of the patient’s pathology and medical record. There they can be reviewed by the inpatient team caring for the HBACS patient and by other healthcare workers employed by Queensland Health across the state who may be involved in the patient’s care.
In addition to these roles, the home care nurse can take a digital photograph of the patient’s leg ulcer and send this via the mobile phone network to a dedicated wound care team within Queensland Health. While this system does not yet have the full integration of PoCT devices and mobile telephone technology as postulated by Malik,17 it is feasible that such combination platform PoCT devices may exist in the foreseeable future.
While far from being the only appropriate PoCT device available, for a state like Queensland, the i-STAT analyser has proven to be very useful. It provides an acceptable test menu, is able to accept two points of patient identification (Unit Record Number and an eight digit date of birth), is able to be networked over both a wide-area network and the 3G wireless telephone network, and is interfaced into the statewide pathology LIS.
The challenges and opportunities presented by PoCT have recently been examined,18 and further significant technological advances in the diagnostic capabilities of PoCT devices are currently being developed.19 These technologies may ultimately be tailored to the differing needs and diseases faced by both the developed and developing countries. However, all PoCT devices will require evidence of cost-effectiveness and delivery of efficiency dividends in order to become widely established in the healthcare system whether in developed or developing countries.
While guidelines have been developed in relation to specific tests and/or specific disciplines of pathology,20 the reality is that many PoCT devices already provide a range of tests covering more than a single traditional pathology discipline. Similarly, as recently highlighted,20 there are many clinical scenarios and physical settings in which PoCT devices may be used. It has also been highlighted that ‘even if a test is simple, the test system may have to be complex to eliminate erroneous results’.19 This consideration is particularly relevant as PoCT devices are predominantly used by non-laboratory personnel.
To maximise the potential benefits imminently available from global advances in PoCT, we believe it is essential that there be a co-ordinated national and international approach to the development of cross-discipline guidelines, governance and quality. This approach should apply to the range of PoCT devices, the tests performed on them, their connectivity and to the people using them – including patients, their carers, non-laboratory healthcare workers and traditional laboratory staff.
We have described the use of PoCT in the patient’s home as part of an integrated and state-wide approach to the appropriate use of PoCT. We look forward to advances in PoCT technology and, with many others, to continue the collective drive to establish and refine appropriate guidelines and governance for PoCT in order to maximise its potential benefit to healthcare.
Dr Andrew Francis and Mr Cameron Martin are both members of AACB PoCT Working Party Committee.
Competing Interests: none declared.