Buyers guide. Point of care devices for the measurement of HbA 1c and low concentration albumin in urine CEP08057

Transcription

1 Buyers guide Point of care devices for the measurement of HbA 1c and low concentration albumin in urine CEP08057 June 2009

2 Contents 2 Introduction... 3 Technical considerations... 6 Operational considerations Economic considerations Purchasing Market review Acknowledgements Glossary References Appendix 1: Supplier contact details Appendix 2: EU procurement procedure Appendix 3: Technical evaluation data Author and report information...86

3 Introduction 3 Devices that provide analyses at the point of care are now commonplace. Obtaining prompt results can increase clinical effectiveness and can contribute to improved outcomes for patients, but results must be accurate and reliable. The improved reliability and range of point of care testing (POCT) devices has led to their increased use in community clinics, general practitioner (GP) surgeries and the home environment. There is a growing demand for POCT as patients exercise choice and have a greater range of healthcare facilities available to them [1]. Clinical effectiveness of POCT needs further evaluation with respect to patient outcomes [2]. In the 2006 report on the NHS Pathology Services in England, chaired by Lord Carter of Coles [1], it is stated that these developments in near-patient testing must be safe, accurate and foolproof. POCT services must be well supported by a robust management structure, and accreditation, audit and clinical governance should be integrated with that of the laboratory [3]. Information technology (IT) links with local laboratories play an important part in facilitating appropriate transfer and storage of POCT results, which currently are not always added to the patient s notes. The 2006 report recognised that by locating test equipment near to the patient, test results can be made available more rapidly, and decisions on appropriate treatment taken with minimal delay. This could be especially valuable when: a patient s life is under threat managing a long term condition where results can inform the consultation between patient and carer the patient has heightened concern about the outcomes of the test more efficient triage of patients is needed. POCT can increase the costs of testing, but has the potential to generate savings elsewhere in the patient pathway, through earlier treatment, reduction in the number of clinic visits required, shortened in-patient stays etc [1]. Scope This buyers guide describes POCT devices for haemoglobin A 1c (HbA 1c ) and low concentration albumin in urine that are currently available in the UK. Comparative information is presented for quantitative measurement of HbA 1c and quantitative, semi-quantitative and qualitative measurement of low concentration albumin in urine (tables 1-3). The tables include the results of a short sustainable development survey (tables 11 and 12) an ergonomic assessment (tables 5 and 6), a survey of current users (tables 5-8) and a limited technical evaluation (tables and figures 5-11). Technical, operational and economic considerations and information on purchasing are also presented.

4 Introduction 4 Background The incidence of both type 1 and type 2 diabetes is rising in the UK [4]. It has been shown in the Diabetes Control and Complications Trial (DCCT) and the UK Prospective Diabetes Study (UKDPS) that good control of blood sugar concentrations in both types of diabetes reduces the risk of microvascular disease such as renal failure and reduces the long term risk of macrovascular disease such as coronary heart disease [5-7]. HbA 1c concentration is an indicator of the level of blood glucose control over the past 3 months, weighted towards the control of the last 30 days. HbA 1c measurements therefore provide a good means of monitoring diabetic glycaemic control and response to treatment. It is widely accepted that the risks of developing micro- or macrovascular disease are minimised by maintaining HbA 1c concentrations as low as possible without increasing hypoglycaemic episodes. Patients with diabetes and those suffering from hypertension are at risk of developing renal disease. Early detection of renal disease permits prompt treatment and better patient outcomes [7, 8]. Urine albumin measurements can be used to screen for the presence of elevated urine albumin concentrations (albuminuria) and to monitor the progression of kidney disease and response to treatment. This guide covers products for point of care measurement of HbA 1c and low concentration albumin in urine on the UK market in June The products are described in detail in the market review (page 23). This guide includes four urine albumin analysers, three of which use single-use disposable cartridges or cuvettes, and five non-quantitative albumin urine reagent strips. Two of the analysers also measure creatinine allowing the calculation of the albumin:creatinine ratio (ACR) as recommended in NICE guidance [9]. Three of the urine reagent strips measure creatinine as well as albumin. One strip is used with an electronic reader which removes subjective visual reading and provides accurately timed reading and recording of results. Three of the analysers offer HbA 1c and urine albumin measurement. In addition the guide includes two analysers which only measure HbA 1c. National guidance National service frameworks The National Service Framework for Diabetes [10] recommends that all laboratories measuring HbA 1c should participate in an external quality assessment (EQA) scheme for HbA 1c and should use a method of proven accuracy and reproducibility. POCT analysers should also be subject to EQA. The National Service Framework for Renal Services [11] indicates that diabetes and hypertension are the greatest risk factors for the development of chronic kidney

5 Introduction 5 disease (CKD). Early stage CKD can be detected by testing urine for low concentration albumin in at risk populations. Early detection will permit timely intervention before dialysis or transplantation become necessary. NICE Guidance from the National Institute for Health and Clinical Excellence (NICE) states that, provided there is no disabling hypoglycaemia, the target HbA 1c concentration for children, young people and adults with type 1 diabetes is 7.5% HbA 1c [12]. For adults with increased risk of developing complications of diabetes the target is 6.5% HbA 1c. HbA 1c should be measured by a DCCT harmonized method 2-4 times a year as required. If the HbA 1c concentration is consistently >9.5% additional support should be offered. Lowering HbA 1c levels in type 2 diabetes reduces tissue damage [13]. Patients with type 2 diabetes should be encouraged to keep HbA 1c concentration to 6.5% or below if it is safe and appropriate for that individual, to improve their longer term quality of life. Individual targets may be set above this following agreement with the individual s health care team. It is inappropriate to monitor glycaemic control by measurement of HbA 1c in the presence of haemoglobinopathies or increased red blood cell turnover [9, 12]. Microalbuminuria should be monitored annually to screen for signs of complications of type 1 diabetes from the age of 12 [12]. NICE defines microalbuminuria in patients with diabetes as urine albumin concentration greater than or equal to 20 mg/l or an ACR greater than or equal to 2.5 mg/mmol (men) or 3.5 mg/mmol (women), and recommends that urinary ACR concentration is measured annually in patients with type 2 diabetes [9]. Microalbuminuria can predict total and cardiovascular mortality. Measurement of ACR is recommended for patients with chronic kidney disease (CKD) in preference to other tests of proteinuria, including urine reagent strips, unless they specifically measure albumin at low concentrations [14]. A summary of the NICE guidance [15] highlights that reagent strips for detecting albumin in urine are not quantitative. Quantitative ACR measurement is more sensitive for early detection of CKD than the protein:creatinine ratio (PCR). Those patients without diabetes should be referred for specialist assessment when the ACR is > 30mg/mmol. The Department of Health has produced leaflets for GPs and laboratories highlighting the advice on the detection and quantitation of proteinuria given in the NICE guidance on chronic kidney disease [16, 17, 14].

6 Technical considerations 6 POCT devices are likely to be used by staff with little clinical laboratory experience. They must therefore be robust, simple to use, and designed to prevent reporting of erroneous results. POCT results should ideally match those produced by the laboratory so that a patient s progress can be consistently monitored whichever testing method is employed. Technical guidelines Calibration of laboratory and POCT methods to the same standard material ensures comparability of results, facilitating interpretation. Analysers are usually calibrated by the manufacturers using a secondary reference material which has itself been calibrated against a primary reference material. HbA 1c All POCT and laboratory methods should be certified by the National Glycohemoglobin Standardization Program (NGSP) and traceable to DCCT. Interassay imprecision should be < 5%, preferably < 3%, and laboratories should be aware of potential interference by haemoglobin variants [18]. Method calibration should be traceable to the International Federation for Clinical Chemistry (IFCC) reference measurement system for HbA 1c [18,19]. NGSP certification [20] requires specific bias criteria with respect to an NGSP secondary reference laboratory method: level 1 certification 95% confidence intervals (CI) of differences must be within 0.75% HbA 1c level 2 certification 95% confidence intervals (CI) of differences must be within 0.85% HbA 1c. Albumin The analytical coefficient of variation (CV) of methods for the detection of microalbuminuria should be <15%. Semi-quantitative or qualitative screening tests should be positive in > 95% of patients with microalbuminuria. Positive results must be confirmed by an accredited laboratory [18]. Devices for the measurement of HbA 1c Sample True point of care measurements require freshly collected samples which require no further processing. For these devices, whole blood capillary samples give optimum performance, although some can also use venous blood samples. Heparin, ethylenediaminetetraacetic acid (EDTA) or fluoride oxalate are acceptable anticoagulants for most HbA 1c measurement devices.

7 Technical considerations 7 Calibration and reportable ranges The IFCC has established an international reference measurement system for HbA 1c which should be used for calibrating all HbA 1c methods. In the UK it is recommended that HbA 1c results should be reported in both IFCC units (mmol/mol) and derived NGSP units (%), synonymous with DCCT, from June 2009 onwards. Conversion between the IFCC and NGSP units is achieved by the IFCC-NGSP master equation [19]. The reportable ranges of POCT devices must be suitable for monitoring glycaemic control in patients with diabetes and should extend from at least 4-14% HbA 1c. Analytical errors and interference POCT results must be reliable as operators may not be aware of potential sources of error. Analysers should give error messages when an error in the analytical procedure has occurred, (whether due to the analyser or the operator), and should not provide a numerical result in such circumstances. However, the presence of interfering substances in the sample may produce erroneous results. Haemoglobin (Hb) variants, including fetal haemoglobin (HbF), are the most significant source of interference and they can be present in glycated and non-glycated forms. Their presence is detectable by high performance liquid chromatography (HPLC) methods but not by current POCT methods. Therefore all patients to be monitored using a POCT device should have an initial sample measured by an HPLC method to check for the presence of haemoglobin variants. Analysers using methodology based on boronate affinity chromatography are not susceptible to interference by variant haemoglobins but those based on immunological techniques will have variable susceptibility depending on the specific antibody used [21]. The prevalence of haemoglobin variants is raised in some ethnic groups. The antenatal and newborn screening programmes for sickle cell disease and thalassaemias have raised awareness of the prevalence of haemoglobin variants [22]. HbA 1c concentrations are disproportionately low in patients with increased red blood cell turnover or anaemia, and should not be used to monitor glycaemic control in such patients. Devices for the measurement of urine albumin and ACR Sample A timed urine collection without added preservative is the recommended sample type for urine albumin or ACR measurement. Screening using an untimed sample (preferably early morning) is acceptable if an appropriate cutoff concentration is used for increased albumin excretion. The measurement of creatinine in addition to

8 Technical considerations 8 albumin improves the reliability of results from untimed urine collections [11, 18]. If the sample cannot be measured shortly after collection it should be refrigerated for no more than a week, but should not be frozen. A transparent container is required to aid dipping of the urine reagent strips. Calibration and reportable ranges The majority of the urine albumin POCT measurement devices are calibrated to the Certified Reference Material (CRM) 470 (also named ERM-DA470) from the Reference Preparation for Proteins in Human Serum (RPPHS). The quantitative creatinine methods are calibrated to Standard Reference Material (SRM) 914a from the National Institute of Standards and Technology (NIST). The reportable ranges of POCT devices for albumin and creatinine should be suitable for screening purposes given the usual cutoff concentration for a normal urine albumin of 20 mg/l and a normal ACR of 2.5 or 3.5 mg/mmol for patients with diabetes and 30 mg/mmol for clinically significant proteinuria for those patients without diabetes [23, 12, 16]. Quantitative urine albumin measurements must be used for monitoring disease progression and response to treatment. Analytical methodology Immunologically based tests for urine albumin are more specific than those involving a chemically based colour change. Some methods for creatinine measurement involve use of an enzyme and a chemically based colour change and others only involve a chemically based colour change. Analysers which measure urine creatinine provide the ACR results alongside results for albumin and creatinine. Analytical errors and interference Analysers measuring albumin, quantitatively or semi-quantitatively, should give error messages when an error in the analytical procedure has occurred (whether due to the analyser or the operator), and should not provide a result in such circumstances. One possible interferent is haemoglobin. It is also important to check whether the device is adversely affected by very high levels of albumin giving rise to erroneously low results. Sources of error in POCT A variety of errors can occur throughout a POCT procedure in addition to those occurring during the measurement. Pre-analytical errors for POCT include incorrect reagent or consumable storage and preparation for use, incorrect sample collection and patient identification. Post-analytical errors include mis-recording of the result.

9 Technical considerations 9 Quality control and quality assurance At least two quality control (QC) materials with different values should be analysed as an independent measure of assay performance [18]. Material suitable for internal QC of this type of device is generally supplied or recommended by device suppliers. Some devices store QC results but none currently have data management systems which would allow the production of Levey Jennings plots to monitor long-term analyser performance and therefore rely on downloading results to a computer to produce these plots. Participation in external quality assessment schemes (EQAS) enables the user to monitor both the performance of the device and the operator. It is important that all these POCT devices used for clinical analysis should participate in an accredited EQAS [10] and several national schemes are available.

10 Operational considerations 10 POC testing by non-laboratory healthcare professionals requires well organised support from laboratory staff to ensure the provision of accurate and reliable results. The organisational structure needed for this has been detailed by the CLSI, the Medicines and Healthcare products Regulatory Agency (MHRA) and in International Standard ISO [24-27]. Space requirements, accessories, consumables, storage and disposal POCT analysers ideally should have a small footprint. Where a separate printer is supplied more space is needed and a second power point might be required. Care must be taken to place analysers so that all operators can see the screen easily in ambient lighting, avoiding glare. Space for consumable storage needs to be considered. Most consumables for these analysers require long-term storage at 2-8 C; some can be used directly from the fridge. Refrigerated space may be difficult to provide at POC. Some consumables can be kept at room temperature for 1-3 months and therefore room temperature storage space will be required. Good stock control measures need to be adopted. Infection control procedures should be adopted and the analyser placed in a suitable location to avoid contamination of other products. Portability can be convenient for POCT devices and purpose-made carrying cases to hold the analyser and consumables can be very useful. Battery operation can allow greater flexibility of location for use, however the most common use would be in a hospital or GP surgery diabetic clinic where, in the UK, mains electricity is readily available. Some analysers have on-board printers and others may have separate printers available to use with them. The ability to print onto labels is an asset when securing results into a patient s notes. Printouts from thermal printers are subject to fading making them unsuitable for storage. Photocopies of thermal printouts are acceptable but this may not be convenient at the POC. Use of an inkjet printer would overcome the problem of printout fading. As IT links across the NHS improve, the goal of recording and transferring all results to an electronic patient record comes closer. The use of bar code readers to enter patient details into the analyser is becoming more important and reduces the risk of transcription errors at this point. The ability to record patient and operator IDs is also important to reduce reporting errors due to misidentification of results. Electronic storage and transfer of results are only of use if the patient ID is part of the stored

11 Operational considerations 11 result. The record of patient and operator IDs is also important to the point of care coordinator who requires them to be able to check an operator s frequency of use and error record to determine any need for retraining. Some point of care analysers offer the possibility of locking out poorly performing operators. Production of a full audit trail requires access to the record of patient and operator ID. Complete audits of quality control values can also be recorded if QC results are stored separately from patient results. A touchscreen or a keypad can be used to enter information into POCT analysers. It is essential that any touchscreen or keypad is designed to be easy to clean. Consumables for the quantitative analysers vary from self-contained cartridges or cuvettes to multiple individual components. The non-quantitative devices are all urine reagent strips of varying design. Cartridges and cuvettes are packaged individually and the packet should not be opened until a measurement is to be made. Urine reagent strips are supplied in pots usually containing strips. It is essential to replace the lid on the pot as soon as a strip has been removed, to prevent deterioration of the remaining strips. The safe disposal of the used consumables from POCT must be considered. These should not contain hazardous chemicals requiring special treatment but will all contain patient sample and therefore have to be disposed of as biohazardous waste. Most areas where POCT is performed will already have suitable systems for the disposal of biohazardous waste. Service provision, workflow and impact on patient pathways POCT devices are designed for relatively low sample throughput. More than one analyser may be needed by busy clinics. In a well run clinic, the patient can have the HbA 1c and urine albumin or ACR measurements performed alongside weight and blood pressure checks before seeing the clinician. With all results available, the doctor can discuss them with the patient and when necessary alter the treatment without the need for a second visit. There is good evidence that the use of POC measurement of HbA 1c in both primary and secondary care settings leads to an improved clinical outcome for the patient when compared to measurement in a laboratory [6, 7, 28]. There is no evidence to show that POC measurement of urine albumin concentrations results in improved clinical outcome for the patient but there is clear evidence linking raised urine albumin excretion with early diabetic nephropathy [28]. POC urine reagent strip testing for albumin could not be recommended for assessing non-diabetic nephropathy with respect to improved clinical outcomes [29].

12 Operational considerations 12 It is the combined use of the test and treatment that yields an improved health outcome in diabetes [28]. Staff requirements, training and instructions Most POCT device manufacturers recommend that their devices are used by healthcare professionals; generally all staff grades are suitable provided training and competency are documented. Staff chosen to perform POCT must be skilled in obtaining good patient samples and in the case of the visual reading of urine reagent strips must have good colour vision. Training is essential even though some suppliers do not offer it. Sufficient training sessions must be offered to allow for multiple users of the devices, staff turnover and refresher training. Sessions may take between 30 minutes and 2 hours depending on the complexity of the device. Regular competency checks must form part of the training scheme. Only staff recorded as trained and competent should be allowed to carry out POCT. Many hospitals use cascade training; supplier-trained hospital staff can train other hospital staff, often a role for laboratory trained POC support team staff. Some manufacturers produce electronic or online information to assist with training and competency checks. Instruction for use (IFU) and operator manuals supplied with all devices should meet the requirements of the In Vitro Diagnostic Medical Device Directive (IVDD). Ergonomic assessment POCT analysers vary in the amount of operator time and input required to achieve a result; those using a self-contained cartridge or cuvette require the least. Participants in an ergonomic assessment concluded that the most important attributes of these analysers should be, in order of importance: accuracy of results ease of use availability of an audit trail including identities and lot numbers time taken for the test lack of any subjective aspect in carrying out the test and reading the result simple screen instructions using words and symbols room temperature storage of consumables. Devices should be sufficiently robust and foolproof to work reliably even when the operator is under pressure e.g. in accident and emergency departments.

13 Operational considerations 13 Urine reagent strip good features: an automated reader is required to remove all subjective elements of reading the correct concentrations sufficient time between reading different analyte results improves accuracy for visually read strips. strips should fit into the widely available universal sample container. Poor design features for analysers and urine reagent strips are: numerous operator dependent steps awkward or unfamiliar procedures e.g. pipetting wiping the sample collection device with potential for sample loss by wicking noisy accessories which might go missing small display screen and font excess information obscuring clear display of the result on screen or printout slow running test results operator distracted by alternative task manual result recording, open to transcription errors manual timing of urine reagent strips reading result dependence on subjective colour matching risk of overturning sample container when urine dip-stick needs to be dipped for several minutes. Servicing and maintenance Some suppliers offer a service contract or an extended warranty to support their analysers. Most suppliers offer an exchange service for a faulty analyser so that the clinical site has a functioning analyser while the faulty one is being repaired. The ideal POCT device should have minimal maintenance and remain reliable. The maintenance must be manageable by non-laboratory staff although laboratory staff may need to replace parts. Some analysers provide on screen maintenance prompts. Software and IT connectivity Currently POCT patient results can be recorded directly into patients notes and QC results into a specific log but electronic storage of results is preferable [24] and becoming more common. Provision of electronic plotting of QC results on a Levey Jennings plot is an efficient means of monitoring analyser performance. Welldeveloped analyser software is required for the secure electronic storage of results together with the patient and operator identities needed for reliable result recall and audit trails. It is therefore very important that entry of patient and operator IDs should be mandatory, especially where multiple operators use the device. The ability to send the results to a laboratory information system (LIS) or hospital information system

14 Operational considerations 14 (HIS) and in the future to an electronic patient record requires a good IT connectivity system. Good software features suggested during an ergonomic assessment were: selection of results by a variety of identifiers e.g. date, patient, lot number bar code use infrequent/untrained user lockout timed countdown to result availability error code with description and solutions on the screen electronic system checks as back up to QC measurement. Some POCT devices, such as blood gas analysers, can be supplied with an IT connectivity package enabling such activities as transmission of results to a LIS and remote monitoring of analyser performance from the laboratory. Connectivity packages are less common amongst smaller POCT devices such as those for measuring HbA 1c and or urine albumin and ACR, but there is a move towards greater provision. The most important features of a good connectivity system have been outlined by the CLSI [30] and include: bi-directional connectivity standard connections e.g. plug and play compatibility with commercial software secure passage of information much of which may be confidential not likely to cause any delay to the use of the POC result ease of use intuitive and functionally simple availability of remote access real time verification of patient and operator IDs. IT connectivity is more important to point of care co-ordinators and support staff than device operators. The most desirable features listed during an ergonomics assessment were: remote checking of QC and calibration monitoring analyser status in real time maintenance alerts when there is maintenance outstanding stock control system easy downloading to LIS maintenance of operator training and competency registers good archiving facilities. Bi-directionality is useful but not so relevant to small POCT analysers since most do not carry on-board QC materials. Connectivity systems that include remote real time

15 Operational considerations 15 monitoring of analyser activity allow POCT support staff to use their time most effectively.

16 Economic considerations 16 Published evidence on cost-effectiveness HbA 1c There is limited evidence indicating that POCT for HbA 1c will result in an economic benefit [28]. DCCT and UKPDS trials established that there is an economic benefit from tight glycaemic control with long-term health benefits even though there are short term cost increases [5, 7]. Although POCT monitoring of HbA 1c is more costly than laboratory measurement, savings could be achieved in long-term healthcare due to better control of HbA 1c levels and the number of clinic visits can be substantially reduced [31-33]. Albumin POCT measurement of low concentration urine albumin or ACR can be used to screen out patient samples which are negative for microalbuminuria and therefore reduce the number of samples sent to the laboratory for measurement. One UK hospital that funds the supply of suitable urine reagent strips to local GP practices found a 60% drop in the number of samples sent to the laboratory for urine albumin measurement, making their scheme cost neutral [34]. Views differ on the cost effectiveness of POCT screening for microalbuminuria. Kiberd and Jindal [35] found the cost per Quality Adjusted Life Year (QALY) was high and more information on the effects of screening was required. Davidson and Croal recommended screening at POC even though they found a 35% increase in measurement cost/investigation (including laboratory confirmation of POCT positive tests). The turnaround time for results was greatly reduced and 93% of the clinicians found it helpful to discuss the result with the patient at the same visit [36]. Suggested costs of implementing the recommendations of NICE guidance on chronic kidney disease [14] have been calculated in the costing report which is part of this guideline [37]. ACR measurement is more expensive than PCR measurement but there is considerable variation between suppliers and economies of scale may decrease the unit cost with increased use of ACR. The model is based on the following costs: ACR 2.16; PCR 1.42 and urine reagent strip (URS) There would be savings on URS and PCR costs but the overall cost rise for increased ACR testing for patients with an estimated glomerular filitration rate (egfr) of < 60 ml/min/1.73m 2 was calculated as 2.69 million. The estimated cost of assessing those at increased risk of chronic kidney disease as indicated by family history or the presence of other diseases such as hypertension, diabetes or cardiovascular disease was 8.6 million. Quantitative POC measurement of ACR would increase these costs but the benefits to the patient in instant results and decreased travel and appointments should be added to the benefits of decrease in kidney disease progression and delay in end stage renal disease requiring haemodialysis (estimated annual cost 29,800/patient).

17 Economic considerations 17 Potential costs and benefits When deciding if a point of care service should be provided, consideration must be given to the clinical need, the effect on service provision and costs [24]. Costs will include: purchase of equipment with the necessary features and software running costs of the tests internal and external quality control measurements space for the POCT analysers storage of the consumables e.g. refrigeration operator s time disposal of consumables and analyser technical staff support time for maintenance and troubleshooting IT connectivity system including the interface to the LIS/HIS maintenance contracts with the supplier for both the equipment and the interface training by the supplier or in-house staff time to supply cascade training competency / proficiency testing of new and existing operators. Potential savings and benefits of POCT to the patient and healthcare organisation: reduced travel if the patient is seen in primary care reduced turnaround time for the sample result reduced number of patient appointments needed negative screening tests for microalbuminuria reduces the need for quantitative laboratory tests positive effect on patient motivation to achieve better control of diabetes since results can be discussed with the doctor at a single appointment immediate treatment change, when appropriate, giving better continuity of care. An organisation may have to pay more for POCT than laboratory testing but can benefit from reduced treatment costs, including those for hospital admissions [24]. Costs Whole-life costs Calculation of whole life costs of providing an analyte measurement should include the lifetime of the analyser, the costs of the analyser and consumables and their disposal, the cost of power consumed and the cost of laboratory staff support and supplier servicing for the analyser. The cost of the operator time should also be included.

18 Economic considerations 18 Cost of analysers The purchase prices reflect the complexity of the analysers. The more expensive analysers generally have more features and better software. None of the devices or consumables for POCT measurement of HbA 1c or urine albumin is currently on the drug tariff. Cost of analyser consumables Self contained cartridges or cuvettes are more expensive than multiple component consumables. The number of analytes measured by the cartridge/cuvette is not always reflected in the cost. Urine reagent strips provide the least expensive urine albumin measurements but they do not provide quantitative results. Pricing is often volume-dependent and potential customers should always obtain a quote from the supplier before making any procurement decision. Costs of operation The cost of refrigerated storage space should be considered. Minimal refrigerated space may be needed at POC, sufficient only for QC material, but much more may be needed in the laboratory for consumable stocks (eg cartridges). Device maintenance should be minimal and cost very little. The majority of waste is biohazardous, and will incur some additional disposal costs. The bulkiest consumables are the single use cartridges. Servicing costs/extended warranty The price of service contracts reflects the complexity of the analyser (tables 1-3). Value added features These features may affect the quality of the result or service provided, the analysis time or the costs of the service, but all can also be viewed in terms of economic benefits.an analyser has greater potential if it can offer additional analyte measurements especially if the transition from one to another is quick and simple. Quantitative methods require smaller patient sample volumes which can be an important factor, particularly for children. Analysers with either or both of these features could provide savings in space, staff training and purchasing and running costs. Provision of an on-board printer saves the space and cost required for a separate printer. A robust system for the prevention of measurement and reporting errors can help to minimise costs (including legal costs) associated with inappropriate and ineffective

19 Economic considerations 19 treatment. Use of an external bar code reader can reduce data entry errors. Mandatory entry of patient and operator IDs would allow the use of IT connectivity packages. These allow the transfer of patient results with their patient and operator IDs to the LIS and/or HIS thus facilitating audit. The facility to print results allows them to be placed into the patient s notes removing the risks of transcription errors. Mandatory QC measurement and QC lockout if the QC results are out of range ensure that the analyser is only used when functioning properly. Automatic reading of urine reagent strips avoids subjective reading and result recording errors. Some features can provide savings in staff time. The optimum analysis time in a clinic is less than 4 minutes although 5-6 minutes would be acceptable. The ability to print results onto labels allows direct attachment to the patient s notes saving operator time. Automatic reading of urine reagent strips reduces operator time. Use of a bar code reader and an IT connectivity package both permit efficient use of operating and support staff time. A well developed IT connectivity system would also allow for secure long-term storage and retrieval of results by all healthcare professionals involved with the patient. The time taken for training will reflect the complexity of the device and the range of features. Most suppliers offer initial training free of charge but further training sessions on site may incur charges. Training generally requires 1-2 hours for an analyser and minutes for very simple devices such as urine reagent strips. Some suppliers do not offer any training sessions. Specific information provided by suppliers to assist with cascade training will save time for hospital staff responsible for these issues. The cost of a POCT service is influenced by the need for quantitative or nonquantitative results, dictated by clinical requirements. Single cartridges specifically for checking the optics temperature and electronics of the analyser can be used repeatedly to check the functioning of the analyser between liquid QC measurements without incurring the cost of measuring a liquid QC. The cost of an interface between the connectivity package and the LIS will probably be the responsibility of the customer not the supplier. Any charges incurred in the exchange of a faulty analyser for a working one during repair need to be balanced against the impact on the patient of not providing the test results for the clinic.

20 Purchasing 20 Purchasing procedures The Trust Operational Purchasing Procedures Manual provides details of the procurement process [38]. European Union procurement rules apply to public bodies, including the NHS, for all contracts worth more than 90,319 (from January 1 st 2008) [39] (appendix 2). The purpose of these rules is to open up the public procurement market and ensure the free movement of goods and services within the EU. In the majority of cases, a competition is required and decisions should be based on best value. NHS Supply Chain (NHS SC) offers national contracts or framework agreements for some products, goods and services. Use of these agreements is not compulsory and NHS organisations may opt to follow local procedures. Purchasing options This type of analyser has three main purchasing options. Outright purchase and lease purchase are straightforward. Reagent rental involves provision of an analyser in exchange for a guaranteed purchase of reagents over the contract period. Purchasing considerations for local use The following issues should be considered: space and the cost of preparing the location for POCT measurements in accordance with health and safety regulations eg at a GP surgery need for quantitative or non-quantitative test need for one or more analyte results number of tests likely to be performed stability of reagents refrigerated storage space IQC and EQA availability and requirements funding availability and source ease of use in relation to staff who will use the device, including removal of any subjective steps maintenance requirements relative to available staff level of device software development relative to audit requirements desirable test time reporting of results - electronic, paper/labels, manual transcription on-board data storage capacity, especially if connectivity not available connectivity availability for linking to local IT system allowing central monitoring from laboratory can be very useful if few POCT support staff.

21 Purchasing 21 Some manufacturers claims to provide a connectivity system may be misleading. They may not be able to provide a working demonstration of the device being interfaced since the provision of an interface is usually the responsibility of the customer. This can be developmental work with additional hidden costs. There are very few, if any, truly open connectivity systems able to connect to devices produced by all manufacturers. As a result several separate data streams may have to come into the LIS and/or HIS. Supplier stability Large multinational companies with significant resources are generally more economically stable than relatively small individual companies. But the stability of such an individual supplier can be indicated by how long they have been in the market. Sustainable procurement The UK Government launched its current strategy for sustainable development, Securing the Future [40] in March The strategy describes four priorities in progressing sustainable development: sustainable production and consumption working towards achieving more with less natural resource protection and environmental enhancement protecting the natural resources and habitats upon which we depend sustainable communities creating places where people want to live and work, now and in the future climate change and energy confronting a significant global threat. The strategy highlights the key role of public procurement in delivering sustainability. This section identifies relevant sustainability issues and provides some guidance on how these can be incorporated into procurement decision making processes. Significant sustainability issues for these devices are the source of materials from which the analysers and consumables are manufactured and their safe disposal after use. Packaging is also an important consideration. Power consumption is less significant as it is low. Materials There is a high level of plastic use in the manufacture of the devices and their consumables therefore the choice of plastic type has the potential to make a marked impact on the sustainability of the products. Manufacture of the devices and their consumables does not currently use any recycled materials (recyclate), nor any

22 Purchasing 22 natural materials therefore none of the materials can be sourced from renewable resources. Disposal of consumables Generally used consumables and single use devices will be disposed of in existing containers for biohazardous waste in the clinical areas where they are used, therefore it is important to generate the minimum volume of waste from POCT. Cuvettes and urine reagent strips generate the smallest volume of waste, whereas single use cartridges are relatively bulky. Packaging Consumable packaging can consist of individual spray foil wrapping, a cardboard box which has an outer cellophane wrapper on some products. Some IFUs are shrink wrapped in plastic within the box. None of this material is recyclable if it has been in a clinical area as it may have been contaminated and must be disposed of as a biohazard. Outer packaging used for transport of the consumables will usually be recyclable and in some instances is made from recyclate; in other instances virgin materials are used but they are sourced from Forest Stewardship Council (FSC) certified sustainable sources. Batteries, power supply and energy consumption A minority of this type of analyser can use battery power including rechargeable batteries. All the analysers are intended for use at room temperature and their power consumption is very low (tables 1-3). Power saving features are few, but some analysers automatically switch to standby mode after a short period of inactivity. A few of the analysers utilize LEDs to reduce energy demand (tables 11 and 12). Noise output The noise output of the analysers falls well below the Health and Safety Executive recommended noise reduction action limits of 85 dba or 140 db [41]. End of life disposal Consideration should be given to the likely financial and environmental costs of disposal at the end of the product s life. Where appropriate, suppliers of equipment placed on the market after the 13 th August 2005 should be able to demonstrate compliance with the UK Waste Electrical and Electronic Equipment (WEEE) regulations (2006) [42]. The WEEE regulations place responsibility for financing the cost of collection and disposal on the producer. Electrical and electronic equipment is exempt from the WEEE regulations where it is deemed to be contaminated at the point at which the equipment is scheduled for disposal by the final user. However, if it

23 Purchasing 23 is subsequently decontaminated such that it no longer poses an infection risk, it is again covered by the WEEE regulations, and there may be potential to dispose of the unit through the normal WEEE recovery channels. Currently suppliers of these analysers are compliant with the WEEE regulations. Aspirational discussion Use of recyclate For plastic recyclate to be used for the cartridges and cuvettes it would need to be of optical quality. If plastic recyclate cannot be used, biodegradeable plastic would reduce the environmental impact of the waste. Use of biodegradeable plastic might be more appropriate for packaging materials, where the same benefit would arise. IT connectivity Further IT integration of POCT devices with bedside monitoring devices to allow all results to be displayed on a single screen could provide the clinician with an instant view of patient status. A similar development for laboratory results could include POCT where it is linked to the LIS. This would aid the provision of the optimum treatment and shorter patient stay, with possible cost savings. These developments and the linking of results to the electronic patient record accessed across different healthcare providers could reduce the risk of test duplication and also reduce the amount of paper generated in recording/reporting results. This may bring savings to the patient, the healthcare provider and the environment.

24 Market review 24 Introduction This market review includes all devices for point of care measurement of HbA 1c and low concentration albumin in urine on the UK market in June All the devices are CE marked. The prices quoted are list prices (Spring 2008); discounts may be available. The analysers included in this guide could be used in a diabetic clinic setting within secondary care and some are suitable for use within primary care if demand is sufficient. The urine reagent strips are often used in primary care. Any grade of appropriately trained staff could use these devices with one exception which required laboratory trained staff. Axis Shield now market the NycoCard only for laboratory use since the procedure includes pipetting which is a laboratory skill. The information presented in the market review tables 1-3 was selected and gathered from the following sources: stakeholders following consultation on the best information to include specification data for all devices from the manufacturers or suppliers a small survey on sustainable development conducted with the manufacturers and suppliers of these devices. Comparable information from this is presented in tables 11 and 12 ease of use ratings gathered from an ergonomic assessment conducted by evaluators and potential users, tables 5 and 6 a survey of device users was conducted during June-August Where possible at least 6 users of each device were contacted (tables 5-8). A five point scoring system was used for the ergonomic assessment and user survey (very poor to very good). The results were translated into a three star rating system (Satisfactory, Good, Very good ) for tables 5-8 with a poor rating for poor and very poor scores. Technical considerations The specifications of the devices are detailed in tables 1-3. The results of a limited technical evaluation are discussed (page 36) and tables and graphs of the results are presented in appendix 3.

25 Market review 25 Table 1. HbA 1c quantitative measurement comparative table (page 1 of 4) Device A1cNow+ Afinion DCA Vantage in2it NycoCard UK launch date Analysis information Methodology basis Immunological Boronate affinity Immunological Boronate affinity Boronate affinity Calibration traceable to: IFCC standard IFCC standard IFCC standard IFCC standard IFCC standard Reportable range HbA 1c (%) Measurement consumable Cartridge Cartridge Cartridge Cartridge Test disc Sample volume (µl) Analysis time (min) Quality control material supplied Advice only 2 levels 2 levels 2 levels 2 levels Affected by Hb variants HbF, HbS, HbC and others No effect of HbAS, HbAE, HbF, HbS or HbC HbF >10%, HbS, HbC, HbE No effect of Hb S and HbD No effect of HbAC, HbAD, HbAE, HbF, HbAJ, HbAS Electronics check During analysis During start up 1 self-test/day if analyser left switched on During start up Optics cartridge During start up Test cartridge Calibration check

26 Market review 26 Device A1cNow+ Afinion DCA Vantage in2it NycoCard Troubleshooting information on screen Error codes Error codes Error codes, explanation + resolution Error code + brief explanation Error messages Consumable storage long-term 2-8 C 2-8 C 2-8 C 2-8 C 2-8 C Consumable storage at room temperature Waste collection and disposal 90 days 90 days 90 days 30 days Used cartridge biohazard Used cartridge compressed, biohazard Used cartridge liquid absorbed, biohazard Used cartridge biohazard Other analytes measured None ACR, CRP ACR None Value added features Reagent 2 + discs only, to expiry date Used disc and pipette tips, biohazard Albumin, D-Dimer, CRP Bar code reader available N/A N/A Touch screen On-screen procedure instructions Minimal Brief + symbols Concise Minimal symbols Brief Mandatory ID entry N/A Patient only N/A Mandatory QC + lockout both mandatory QC Locked while analysing N/A N/A Printer and use of labels N/A External On-board + labels External + labels Analyser result storage (Patient + QC) None 500 P QC 4000 P + QC 200 P + QC 1 until next test Data management on-board Patient trending Connectivity currently available N/A but planned