Improving the quality of point-of-care testing

Improving the quality of point-of-care testing Abstract Background It is suggested that new models of primary care should have better access to test results through the use of point-of-care testing (POCT). Objective To determine whether quality management of POCT leads to better results. Methods A comprehensive search of the literature on quality management of POCT in primary care, where the impact of participation in quality management programmes had been investigated with relevant outcome measures. Results Three databases were systematically searched using key words relevant to POCT and quality management, covering from 1945 to January 2017. Titles and abstracts were reviewed for relevance and papers selected for review and data extraction. Five observational studies were found in which the performance of POCT for specific analytes in external quality assurance (EQA) programmes was used to assess improvement over a period of time, varying from 3.5 to 15 years. The tests monitored were HbA1c, urine albumin, C-reactive protein, glucose and haemoglobin. In each case, the performance of the test against defined analytical criteria was used to judge improvement in performance. Different summary performance criteria were used, including the imprecision of results over a period of time (two studies) and meeting defined target values for bias and imprecision of measurement (three studies). Performance improved with time and was associated with regular participation in EQA schemes and with the use of internal quality control (IQC) procedures. Conclusions These findings indicate that adoption of quality management for POCT, including participation in IQC and EQA, with the support of laboratory medicine professionals, will improve the quality of the results ‘produced’. Clinical outcomes, external quality assurance, internal quality control, point-of-care testing, primary care, process outcomes Introduction New models of primary care have been proposed as one means of managing an increasing burden of health care provision including, immediate access to common diagnostics guided by clinical eligibility criteria, the use of point-of-care testing (POCT) for common blood tests during the same practice visit, availability of plain X-ray or ultrasound scanning in local community-based facilities, and direct access to MRI scanning and protocol-controlled access to CT scans (1). POCT has been considered to be a basic design feature of primary care for the future (2). The opportunity for practices to bid for the delivery of diagnostic services has also been recommended as a potential lever for change (3). The NHS Five Year Forward View, published in October 2014, identified group practices as offering the facility to ‘shift the majority of outpatient consultations and ambulatory care out of hospital settings’ as well as expanding access to diagnostic services (2). This theme was extended in the NHS England General Practice Forward View published in 2016 (4). However, access to diagnostic services does not appear to figure in the proposals of the NHS England New Models of Care Programme (5). Point-of-care testing POCT avoids the need to send specimens to a central laboratory facility. POCT devices have become increasingly available, in terms of the repertoire of tests, number of suppliers and availability of research funding. In Denmark, over the period from 2004 to 2013, the overall use of POCT increased by 45.8%, from 147.2 to 247.8 tests per 1000 consultations (6). In a 2015 survey in Scotland, over 60% of the POCT services provided were attributed to primary care sites, estimated at 2 million out of 3.5 million point-of-care tests per year (7). Utilization is expected to increase further (8). One of the key benefits of POCT is rapid access to test results, which is of great importance for faster diagnosis and management of treatment, as well as reducing referrals to secondary care (1,2). However, while speed of access is appreciated, it is also seen as a barrier to the adoption of POCT for a number of reasons: (i) difficulty with integrating the test into the current time allotted to each consultation; (ii) the challenges of changing the patient flow in the management of the whole clinic session and thus (iii) whether this will adversely affect the productivity of the primary care physician, i.e. the number of patient consultations (9). In focus group discussions with primary care clinical staff, five main areas of concern have been identified (i) impact on clinical decision-making; (ii) impact on staff and workflow, (iii) patient experience and patient–provider relationship, (iv) inaccuracy of POCT devices and (v) issues related to cost, regulation and quality management (10). These five themes were also identified in a systematic review of primary care physician’s attitudes towards POCT (11). However, clear patient experience benefits have been identified (12). While concerns have been expressed about the quality of POCT results, they can be addressed through the use of a clinical governance framework, including quality management of POCT (11). Clinical governance, quality management and point-of-care testing The evidence for overall clinical governance in primary care is fragmented, and focuses mainly on processes rather than outcomes. Furthermore, few models enhance safety, efficiency, sustainability and the economics of primary care (13). There are challenges in the governance of POCT—in part because of the limited training (and exposure to analytical devices) by the potential operators (doctors, nurses, health care assistants and patients), compared with laboratory professionals (14). Errors can be classified as pre-analytical, analytical and post-analytical. Pre-analytical errors occur while obtaining the sample or pre-processing the sample if applicable. Errors in the analytical phase can be considered to be a consequence of machine failure, incompetent operators, non-adherence to prescribed procedures and/or use of uncontrolled reagent/equipment (15). Post-analytical errors occur when results are not acknowledged, interpreted incorrectly or not acted upon appropriately. Clinical governance and quality improvement in laboratory medicine and POCT are built on a platform of accreditation combined with internal quality control (IQC), external quality assurance (EQA) and clinical audit. Accreditation of point-of-care testing Laboratories are accredited by the United Kingdom Accreditation Service, to an international standard—ISO 15189:2012 (‘Medical Laboratories’—particular requirements for quality and competence). The introduction of ISO 22870:2006 (‘Point of Care Testing’—particular requirements for quality and competence), applied in conjunction with ISO 15189:2012, has provided a means of using international standards in the accreditation of organizations that provide POCT. This standard has recently been updated and is now published as ISO 22870:2016. It should be noted that ISO 22870 is not a standalone standard, and the POCT provider must also be accredited to ISO 15189. This results in the standard being most applicable to ‘hub and spoke’ services, generally with the laboratory as the hub and the clinical setting, whether that is a hospital, clinic or primary care practice, as the spoke. The standards also apply to transcutaneous measurements, the analysis of expired air and in vivo monitoring of physiological parameters, but patient self-testing in a home or community setting is excluded (although elements of the document could be applicable). The accreditation process itself includes an assessment of the overall competence of the organization as well as key control points such as audits, EQA and IQC. However, the main value of working towards ISO 22870 is delivered through using the standards in the design of your POCT service. Approaches to clinical governance and accreditation of POCT have been described (16), including in primary care (17). The key elements of accreditation of POCT are summarized in Table 1. Table 1. Key elements of an accreditation programme for point-of-care testing in primary care. [Aadapted from reference (17).] Clinical governance  • Improves provision of quality health care  • Non-analytical features of the POCT system comply with the needs of the patient and of the primary care practice, e.g. space, time-to-result, patient flow processes, waste disposal  • Responsibilities for POCT are clearly defined  Analytical aspects  • Analytical performance meets the clinical need  • Concordance of results with local laboratory service documented  Staff training and competence  • Tests are performed by staff with the required skills and knowledge  • Competence in required skill and knowledge is demonstrated  • Opportunity to maintain competence is available  Implementation and performance  • Analytical performance and other features of POCT system meet practice requirements  • Tests are performed in a suitable location  • Tests performed to a high quality  • Data management supports high-quality continuity of care  Quality outcomes  • Internal quality control procedures are in place to ensure that all instruments and consumables are working correctly  • Practice participates in external quality assurance programme  • An up-to-date quality manual describing the practice requirements for the management and performance of POCT is maintained  • Ongoing quality of POCT is assessed against the benchmark of the quality manual  • Practice participates in regular audit of the use of POCT results in relation to patient and practice-related outcomes  Clinical governance  • Improves provision of quality health care  • Non-analytical features of the POCT system comply with the needs of the patient and of the primary care practice, e.g. space, time-to-result, patient flow processes, waste disposal  • Responsibilities for POCT are clearly defined  Analytical aspects  • Analytical performance meets the clinical need  • Concordance of results with local laboratory service documented  Staff training and competence  • Tests are performed by staff with the required skills and knowledge  • Competence in required skill and knowledge is demonstrated  • Opportunity to maintain competence is available  Implementation and performance  • Analytical performance and other features of POCT system meet practice requirements  • Tests are performed in a suitable location  • Tests performed to a high quality  • Data management supports high-quality continuity of care  Quality outcomes  • Internal quality control procedures are in place to ensure that all instruments and consumables are working correctly  • Practice participates in external quality assurance programme  • An up-to-date quality manual describing the practice requirements for the management and performance of POCT is maintained  • Ongoing quality of POCT is assessed against the benchmark of the quality manual  • Practice participates in regular audit of the use of POCT results in relation to patient and practice-related outcomes  View Large Table 1. Key elements of an accreditation programme for point-of-care testing in primary care. [Aadapted from reference (17).] Clinical governance  • Improves provision of quality health care  • Non-analytical features of the POCT system comply with the needs of the patient and of the primary care practice, e.g. space, time-to-result, patient flow processes, waste disposal  • Responsibilities for POCT are clearly defined  Analytical aspects  • Analytical performance meets the clinical need  • Concordance of results with local laboratory service documented  Staff training and competence  • Tests are performed by staff with the required skills and knowledge  • Competence in required skill and knowledge is demonstrated  • Opportunity to maintain competence is available  Implementation and performance  • Analytical performance and other features of POCT system meet practice requirements  • Tests are performed in a suitable location  • Tests performed to a high quality  • Data management supports high-quality continuity of care  Quality outcomes  • Internal quality control procedures are in place to ensure that all instruments and consumables are working correctly  • Practice participates in external quality assurance programme  • An up-to-date quality manual describing the practice requirements for the management and performance of POCT is maintained  • Ongoing quality of POCT is assessed against the benchmark of the quality manual  • Practice participates in regular audit of the use of POCT results in relation to patient and practice-related outcomes  Clinical governance  • Improves provision of quality health care  • Non-analytical features of the POCT system comply with the needs of the patient and of the primary care practice, e.g. space, time-to-result, patient flow processes, waste disposal  • Responsibilities for POCT are clearly defined  Analytical aspects  • Analytical performance meets the clinical need  • Concordance of results with local laboratory service documented  Staff training and competence  • Tests are performed by staff with the required skills and knowledge  • Competence in required skill and knowledge is demonstrated  • Opportunity to maintain competence is available  Implementation and performance  • Analytical performance and other features of POCT system meet practice requirements  • Tests are performed in a suitable location  • Tests performed to a high quality  • Data management supports high-quality continuity of care  Quality outcomes  • Internal quality control procedures are in place to ensure that all instruments and consumables are working correctly  • Practice participates in external quality assurance programme  • An up-to-date quality manual describing the practice requirements for the management and performance of POCT is maintained  • Ongoing quality of POCT is assessed against the benchmark of the quality manual  • Practice participates in regular audit of the use of POCT results in relation to patient and practice-related outcomes  View Large Internal quality control IQC is intended to detect, reduce and correct errors in the analytical process. It checks the operation and performance of the POCT device in real time against previously agreed criteria to ensure that the results produced by the system can be confidently reported for patient care (1), see Figure 1. Typically, it involves testing a control material of known concentration of the analyte(s) of interest, and comparing results with the expected range of values (18). However, there is no consensus, or guidelines, on how to run IQC on POC instruments, e.g. daily, weekly, monthly. An example where this has been specified is in the NHS Health Check Programme where quality standards specified an IQC approach in accordance with the Medicine and Health products Regulatory Agency guidance on the management and use of POCT devices (19) that required ‘at least a daily “go/no go” control sample (use of a liquid sample) on days when the instrument is in use’ (20). In the case of some POCT devices, the IQC can be run automatically within the system. Figure 1. View largeDownload slide Summary of the comparative roles of internal quality control and external quality assurance. This sets out the reasons for performing internal quality control and external quality assurance as part of the quality management of point-of-care testing and explains the meaning of the results produced and actions that should be taken. External quality assurance using commutable samples can also show how a participant’s results compare with a true value. Figure 1. View largeDownload slide Summary of the comparative roles of internal quality control and external quality assurance. This sets out the reasons for performing internal quality control and external quality assurance as part of the quality management of point-of-care testing and explains the meaning of the results produced and actions that should be taken. External quality assurance using commutable samples can also show how a participant’s results compare with a true value. External quality assurance EQA is intended to check the overall quality of testing sites—to check the quality of their results in comparison to other sites by testing an identical sample with an unknown value (21), see Figure 1. It compares the POCT results with those generated by the local laboratory and therefore addresses the issue of the comparability of results in primary and secondary care settings. An example of the results from an EQA programme that is utilized by both primary and secondary care providers is shown in Figure 2. Importantly, EQA specimens cannot be run automatically within the POCT device but need to be sent by an external party: the actual delivery of the test is undertaken by the usual operator so that their competence is also tested. Data from an EQA scheme therefore provide an opportunity for evaluating the impact of quality management on health outcomes—albeit only on the quality of the result delivered. Figure 2. View largeDownload slide Example of the main elements of an external quality assurance report (all details of participant identity anonymized) for the serum cholesterol results performed on two point-of-care testing instruments within the same care organization, and compared with the peer group of participants reporting a cholesterol result, n = 91, for this distribution. (A) The distribution of the results from the 91 instruments participating in this distribution, showing the relative deviation (0.1%) from the reference (target) value; (B) the statistics for the peer group distribution of results; (C) the returned results for this facility are displayed; (D) they have returned results for two analysers; instrument B is one of 13 analysers returning a result of 3.58 mmol/l, instrument A is one of 11 analysers returning a result of 3.65 mmol/l. In addition (not shown), the external quality assurance scheme organizer (WEQAS: http://www.weqas.com/services/poct-eqa/) provides a colour-coded distribution of the results, based on a traffic light system with results ≤12% graded as ‘excellent’, >12% and <24% graded as ‘good’, and >24% graded as ‘unacceptable’. In this return, all of the participants achieved excellent performance. The authors would like to acknowledge the WEQAS team for providing the copy of an anonymized report for this figure. Figure 2. View largeDownload slide Example of the main elements of an external quality assurance report (all details of participant identity anonymized) for the serum cholesterol results performed on two point-of-care testing instruments within the same care organization, and compared with the peer group of participants reporting a cholesterol result, n = 91, for this distribution. (A) The distribution of the results from the 91 instruments participating in this distribution, showing the relative deviation (0.1%) from the reference (target) value; (B) the statistics for the peer group distribution of results; (C) the returned results for this facility are displayed; (D) they have returned results for two analysers; instrument B is one of 13 analysers returning a result of 3.58 mmol/l, instrument A is one of 11 analysers returning a result of 3.65 mmol/l. In addition (not shown), the external quality assurance scheme organizer (WEQAS: http://www.weqas.com/services/poct-eqa/) provides a colour-coded distribution of the results, based on a traffic light system with results ≤12% graded as ‘excellent’, >12% and <24% graded as ‘good’, and >24% graded as ‘unacceptable’. In this return, all of the participants achieved excellent performance. The authors would like to acknowledge the WEQAS team for providing the copy of an anonymized report for this figure. Links with the local laboratory network Strong links with the local laboratory are important for a number of reasons, including access to technical and clinical expertise, e.g. ensuring concordance of results with laboratory results for the same patient population, advice on purchase of POCT devices, obtaining IQC materials and trouble-shooting when problems arise. This can also be provided as part of a national network. As many patients will be managed by a clinical team that spans primary and secondary care, it is also important that there is good concordance of results between POCT and laboratory providers. IT connectivity with the local laboratory can provide valuable support, as well as a means of efficiently integrating results into a comprehensive patient record. In addition, it offers a digital and secure option for reminding primary care POCT teams of the need to perform the relevant IQC and EQA analyses, including a list of competent operators, as well as POCT accreditation and Care Quality Commission (CQC) standards (22). The key elements of a POCT quality management system for use in primary care are given in Table 2. Much of this can be provided with support from the local laboratory (through a service level agreement) and is represented in the POCT accreditation standards. Table 2. Key elements of a quality management system for point-of-care testing in primary care, as embodied in the International Organization for Standardization standards • Evaluation of new or alternative POCT instruments  • Evaluation and approval of end-user proposals/protocols  • Purchase and installation of equipment  • Maintenance of consumable supplies and reagents  • Training, certification, recertification of POCT operators  • Quality control and quality assurance  • Evaluation of new or alternative POCT instruments  • Evaluation and approval of end-user proposals/protocols  • Purchase and installation of equipment  • Maintenance of consumable supplies and reagents  • Training, certification, recertification of POCT operators  • Quality control and quality assurance  View Large Table 2. Key elements of a quality management system for point-of-care testing in primary care, as embodied in the International Organization for Standardization standards • Evaluation of new or alternative POCT instruments  • Evaluation and approval of end-user proposals/protocols  • Purchase and installation of equipment  • Maintenance of consumable supplies and reagents  • Training, certification, recertification of POCT operators  • Quality control and quality assurance  • Evaluation of new or alternative POCT instruments  • Evaluation and approval of end-user proposals/protocols  • Purchase and installation of equipment  • Maintenance of consumable supplies and reagents  • Training, certification, recertification of POCT operators  • Quality control and quality assurance  View Large Benefits of quality management of point-of-care testing Concerns have been expressed about the cost and time commitment to managing the quality of POCT in primary care (7,8,10,14,16,23), while its importance has also been recognized (24–27). This applies not only to the analytical phase, but also to the post-analytical phase (27–29). In the following, we present the findings of a literature review on the effect of quality management of POCT in primary care on the quality of the POCT results produced. We searched and selected studies that used an identifiable, valid measure to assess performance of POCT in primary care (see supplementary material). We identified five studies, all observational in approach, using the performance in EQA programmes over time to assess improvement, see Table 3 for details. Table 3. Summary of studies and results, conducted on external quality assurance programme data, that were reviewed Study  Reference  Type of study  Test  Period of data capture (years)  Number of participant sites in study  Key finding  Shephard and Gill (2003)  30   Observational  HbA1c  3.5  45  84% of results within limits of acceptability  Morandi et al. (2011)  31   Observational  HbA1c  9.0  Not stated  Yearly precision performance improved over time  Sølvik et al. (2013)  32   Observational  HbA1c  6.5  1034–1288  Performance improved over time  Bukve et al. (2015)  33   Observational  Urine albumin  15.0  473–1163  Number of years participation inversely related to number of ‘poor’ results  Bukve, Stavelin and Sandberg (2016)  34   Observational  CRP Glucose Haemoglobin  9.0  2134 (mean) 2357 (mean) 2271 (mean)  Number of participants with good performance increased over time  Study  Reference  Type of study  Test  Period of data capture (years)  Number of participant sites in study  Key finding  Shephard and Gill (2003)  30   Observational  HbA1c  3.5  45  84% of results within limits of acceptability  Morandi et al. (2011)  31   Observational  HbA1c  9.0  Not stated  Yearly precision performance improved over time  Sølvik et al. (2013)  32   Observational  HbA1c  6.5  1034–1288  Performance improved over time  Bukve et al. (2015)  33   Observational  Urine albumin  15.0  473–1163  Number of years participation inversely related to number of ‘poor’ results  Bukve, Stavelin and Sandberg (2016)  34   Observational  CRP Glucose Haemoglobin  9.0  2134 (mean) 2357 (mean) 2271 (mean)  Number of participants with good performance increased over time  HbA1c, glycated haemoglobin; CRP, C-reactive protein. View Large Table 3. Summary of studies and results, conducted on external quality assurance programme data, that were reviewed Study  Reference  Type of study  Test  Period of data capture (years)  Number of participant sites in study  Key finding  Shephard and Gill (2003)  30   Observational  HbA1c  3.5  45  84% of results within limits of acceptability  Morandi et al. (2011)  31   Observational  HbA1c  9.0  Not stated  Yearly precision performance improved over time  Sølvik et al. (2013)  32   Observational  HbA1c  6.5  1034–1288  Performance improved over time  Bukve et al. (2015)  33   Observational  Urine albumin  15.0  473–1163  Number of years participation inversely related to number of ‘poor’ results  Bukve, Stavelin and Sandberg (2016)  34   Observational  CRP Glucose Haemoglobin  9.0  2134 (mean) 2357 (mean) 2271 (mean)  Number of participants with good performance increased over time  Study  Reference  Type of study  Test  Period of data capture (years)  Number of participant sites in study  Key finding  Shephard and Gill (2003)  30   Observational  HbA1c  3.5  45  84% of results within limits of acceptability  Morandi et al. (2011)  31   Observational  HbA1c  9.0  Not stated  Yearly precision performance improved over time  Sølvik et al. (2013)  32   Observational  HbA1c  6.5  1034–1288  Performance improved over time  Bukve et al. (2015)  33   Observational  Urine albumin  15.0  473–1163  Number of years participation inversely related to number of ‘poor’ results  Bukve, Stavelin and Sandberg (2016)  34   Observational  CRP Glucose Haemoglobin  9.0  2134 (mean) 2357 (mean) 2271 (mean)  Number of participants with good performance increased over time  HbA1c, glycated haemoglobin; CRP, C-reactive protein. View Large An education, training and quality assurance programme assessed the performance of HbA1c POCT in the Australian Aboriginal Community Controlled Health Services (12 samples for each 6-month cycle, with the participants analysing two samples each month, an overall participation rate of 88% (range from 81% to 93%) and 3100 results submitted in total). The POCT test performance improved over 3.5 years and was equivalent to that of the central laboratory. The imprecision of the measurements improved across the study period, with a median imprecision (CV%) of 3.8 across the last five cycles in the study. The core of the quality assurance scheme, education, training and analysis, was provided by ongoing support from a national laboratory-based quality management service (30). Similar results were found in a Swiss study on HbA1c POCT in doctors’ offices, comparing the performance with that of central laboratories. A total of 33193 measurements were collected over 9 years, using two POCT systems with differing analytical precision performance. The weighted annual precision of the more precise device improved over the period of the study, achieving better performance than several laboratory-based analysers (31). Finally, one study investigated the performance of two quantitative POCT devices for HbA1c in an EQA scheme over a 7-year period, using their ability to meet specified targets for bias and imprecision as their outcome measures. Sølvik et al. found that between 72% and 96% of the participants had a deviation of the results from the target trueness value of ≤6.0% (32) for both samples within the reference interval and above the upper limit of the reference interval. In the case of imprecision, between 74% and 96% of participants achieved imprecision less than the target (≤3.0%). Between 60% and 90% of the participants met both target specifications over the period of the study. The authors concluded that using one type of instrument users have ‘about 90% probability of passing the quality specifications in each survey’. An EQA scheme for the performance of a quantitative urine albumin measurement POCT device in primary care offices in Norway defined results as ‘very good’, ‘acceptable’ or ‘poor’. Over a 14-year period, the number of years of participation in the scheme was inversely related to the number of ‘poor’ results obtained. The same trend was not found for a qualitative urine albumin device. Using reagents with >3 months to expiration was associated with better performance than using reagents expiring within 3 months (P < 0.001) or reagents that had already expired (P < 0.001). Again, the same trend was not seen for a qualitative method (33). The authors concluded that the improvement in performance was, in part, because their EQA scheme included visits from the local laboratory to review procedures. The same group investigated the impact of a quality improvement strategy, as part of an EQA programme, on the analytical performance of C-reactive protein, glucose and haemoglobin measurement using POCT; there were over 2000 participants in each analyte EQA scheme over 9 years, during which the number of participants with good performance increased gradually. Based on a logistic regression analysis, key factors associated with good performance were the number of times an EQA analysis was performed, weekly performance of IQC analysis, performing 10 or more tests per week and the tests being performed by laboratory-qualified personnel (34). Conclusions Clinical governance and quality management of POCT devices are supported by accreditation, IQC processes and EQA schemes. Observational studies have shown that such clinical governance can improve the performance of the POCT in primary care. Interestingly, some studies (obviously participating in EQA schemes) found that quantitative POCT devices performed as well as the laboratory systems (31,32), an observation that has been supported with data from a routine clinical setting (35). Ongoing support for POCT in primary care, by professionals, appears to contribute strongly to better performance. This should also include operator training and maintenance of competence, as it has been recognized in the evaluation of POCT devices that technically qualified operators can achieve better results than non-technically qualified operators (36). The particular strengths of these studies are that they were embedded in routine practice, as against an experimental setting, and in the majority of cases there is a large cohort of participants. However, there were no control groups, i.e. for comparison with a group of POCT sites not participating in IQC processes and EQA schemes. On the other hand, it could be argued that the participants in IQC processes and EQA schemes acted as their own controls as in some of the studies improvement in quality performance was seen over time following the introduction of the EQA schemes (30,31). The limitations of these studies are that (i) in some cases, the data have been gathered from a number of POCT devices and (ii) the outcome measure is a (distant) surrogate measure of patient outcome, insofar as the result must be acknowledged and acted upon in order for the intended patient outcome to be delivered. These observations would therefore concur with the observations of Phillips et al. (13), in that quality management of POCT is currently limited to one aspect of the pathway. Further research on quality management of POCT in primary care, taking a broader perspective, is required. However, we only looked at the testing part of the POCT strategy. Thus, attention should be paid as to whether tests are performed according to clinical guidelines, should they exist, as in the case of the benchmarking study of HbA1c testing (37), audit of results being acted upon (38), evidence of over and under requesting of tests (39) and impact on true clinical outcomes (40). At the technical level, device selection, operator training and continuing assessment of competence are also important. Clinical governance and quality management are central to assuring quality in the delivery of primary care and will undoubtedly be an important contributor in the development of new models of care—especially as the call for greater access to diagnostic tests gathers momentum. Integration with the local laboratory will play an important part in the quality management of POCT. Supplementary material Supplementary material is available at Family Practice online. Declaration Funding: This article presents independent research funded by the National Institute for Health Research (NIHR) Diagnostic Evidence Co-operative Oxford. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The study sponsors had no role in the design, analyses or reporting of the study. The researchers retained complete independence in the conduct of this study. Conflict of interest: AVdB is an associate editor of this journal. Ethical approval: None. Acknowledgements The authors would like to thank Nia Roberts, Information Specialist and Outreach Librarian at the Bodleian Health Care Libraries, for conducting the literature search. References 1. Kings Fund. Understanding Pressures in General Practice. 2016: 1– 99. https://www.kingsfund.org.uk/sites/files/kf/field/field_publication_file/Understanding-GP-pressures-Kings-Fund-May-2016.pdf. (accessed on 18 July 2017). 2. NHS England. Five Year Forward View. 2014: 1– 39. https://www.england.nhs.uk/wp-content/uploads/2014/10/5yfv-web.pdf. (accessed on 18 July 2017). 3. Nuffield Trust. Transforming General Practice: What Are the Levers for Change? 2015: 1– 31. https://www.nuffieldtrust.org.uk/files/2017-01/1484141771_transforming-general-practice-levers-change-web-final.pdf. (accessed on 18 July 2017). 4. NHS England. 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Google Scholar CrossRef Search ADS PubMed  19. Medicines and Health products Regulatory Agency. Management and Use of IVD Point of Care Test Devices. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/371800/In_vitro_diagnostic_point-of-care_test_devices.pdf. (accessed on 11 October 2017). 20. Public Health England. NHS Health Check Programme Standards: A Framework for Quality Improvement. http://www.healthcheck.nhs.uk/document.php?o=547. (accessed on 11 October 2017). 21. Gill JP, Watkinson L. Quality control and quality assurance in point-of-care testing. In: Price CP, St John A, Kricka LJ (eds). Point-of-Care Testing. Needs, Opportunity and Innovation . 3rd edn. Washington DC; AACC Press, 2010, pp. 225– 36. 22. Siersma V, Kousgaard MB, Reventlow Set al.   The effectiveness of computer reminders versus postal reminders for improving quality assessment for point-of-care testing in primary care: a randomized controlled trial. J Eval Clin Pract  2015; 21: 13– 20. 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Morandi PA, Deom A, Kesseler Det al.   Retrospective analysis of 55,769 HbA1c EQA results obtained from professional laboratories and medical offices participating in surveys organized by two European EQA centers over a nine-year period. J Clin Lab Anal  2011; 25: 337– 43. Google Scholar CrossRef Search ADS PubMed  32. Sølvik UØ, Røraas T, Christensen NGet al.   Diagnosing diabetes mellitus: performance of hemoglobin A1c point-of-care instruments in general practice offices. Clin Chem  2013; 59: 1790– 801. Google Scholar CrossRef Search ADS PubMed  33. Bukve T, Røraas T, Riksheim BOet al.   Point-of-care urine albumin in general practice offices: effect of participation in an external quality assurance scheme. Clin Chem Lab Med  2015; 53: 45– 51. Google Scholar CrossRef Search ADS PubMed  34. Bukve T, Stavelin A, Sandberg S. Effect of participating in a quality improvement system over time for point-of-care C-reactive protein, glucose, and hemoglobin testing. Clin Chem  2016; 62: 1474– 81. Google Scholar CrossRef Search ADS PubMed  35. Mirzazadeh M, Morovat A, James Tet al.   Point-of-care testing of electrolytes and calcium using blood gas analysers: it is time we trusted the results. Emerg Med J  2016; 33: 181– 6. Google Scholar CrossRef Search ADS PubMed  36. McTaggart MP, Newall RG, Hirst JAet al.   Diagnostic accuracy of point-of-care tests for detecting albuminuria: a systematic review and meta-analysis. Ann Intern Med  2014; 160: 550– 7. Google Scholar CrossRef Search ADS PubMed  37. Driskell OJ, Holland D, Hanna FWet al.   Inappropriate requesting of glycated hemoglobin (Hb A1c) is widespread: assessment of prevalence, impact of national guidance, and practice-to-practice variability. Clin Chem  2012; 58: 906– 15. Google Scholar CrossRef Search ADS PubMed  38. Callen JL, Westbrook JI, Georgiou Aet al.   Failure to follow-up test results for ambulatory patients: a systematic review. J Gen Intern Med  2012; 27: 1334– 48. Google Scholar CrossRef Search ADS PubMed  39. Zhi M, Ding EL, Theisen-Toupal Jet al.   The landscape of inappropriate laboratory testing: a 15-year meta-analysis. PLoS One  2013; 8: e78962. Google Scholar CrossRef Search ADS PubMed  40. Tideman P, Simpson P, Tirimacco R. Integrating PoCT into clinical care. Clin Biochem Rev  2010; 31: 99– 104. Google Scholar PubMed  © The Author(s) 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Family Practice Oxford University Press

Improving the quality of point-of-care testing

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Abstract

Abstract Background It is suggested that new models of primary care should have better access to test results through the use of point-of-care testing (POCT). Objective To determine whether quality management of POCT leads to better results. Methods A comprehensive search of the literature on quality management of POCT in primary care, where the impact of participation in quality management programmes had been investigated with relevant outcome measures. Results Three databases were systematically searched using key words relevant to POCT and quality management, covering from 1945 to January 2017. Titles and abstracts were reviewed for relevance and papers selected for review and data extraction. Five observational studies were found in which the performance of POCT for specific analytes in external quality assurance (EQA) programmes was used to assess improvement over a period of time, varying from 3.5 to 15 years. The tests monitored were HbA1c, urine albumin, C-reactive protein, glucose and haemoglobin. In each case, the performance of the test against defined analytical criteria was used to judge improvement in performance. Different summary performance criteria were used, including the imprecision of results over a period of time (two studies) and meeting defined target values for bias and imprecision of measurement (three studies). Performance improved with time and was associated with regular participation in EQA schemes and with the use of internal quality control (IQC) procedures. Conclusions These findings indicate that adoption of quality management for POCT, including participation in IQC and EQA, with the support of laboratory medicine professionals, will improve the quality of the results ‘produced’. Clinical outcomes, external quality assurance, internal quality control, point-of-care testing, primary care, process outcomes Introduction New models of primary care have been proposed as one means of managing an increasing burden of health care provision including, immediate access to common diagnostics guided by clinical eligibility criteria, the use of point-of-care testing (POCT) for common blood tests during the same practice visit, availability of plain X-ray or ultrasound scanning in local community-based facilities, and direct access to MRI scanning and protocol-controlled access to CT scans (1). POCT has been considered to be a basic design feature of primary care for the future (2). The opportunity for practices to bid for the delivery of diagnostic services has also been recommended as a potential lever for change (3). The NHS Five Year Forward View, published in October 2014, identified group practices as offering the facility to ‘shift the majority of outpatient consultations and ambulatory care out of hospital settings’ as well as expanding access to diagnostic services (2). This theme was extended in the NHS England General Practice Forward View published in 2016 (4). However, access to diagnostic services does not appear to figure in the proposals of the NHS England New Models of Care Programme (5). Point-of-care testing POCT avoids the need to send specimens to a central laboratory facility. POCT devices have become increasingly available, in terms of the repertoire of tests, number of suppliers and availability of research funding. In Denmark, over the period from 2004 to 2013, the overall use of POCT increased by 45.8%, from 147.2 to 247.8 tests per 1000 consultations (6). In a 2015 survey in Scotland, over 60% of the POCT services provided were attributed to primary care sites, estimated at 2 million out of 3.5 million point-of-care tests per year (7). Utilization is expected to increase further (8). One of the key benefits of POCT is rapid access to test results, which is of great importance for faster diagnosis and management of treatment, as well as reducing referrals to secondary care (1,2). However, while speed of access is appreciated, it is also seen as a barrier to the adoption of POCT for a number of reasons: (i) difficulty with integrating the test into the current time allotted to each consultation; (ii) the challenges of changing the patient flow in the management of the whole clinic session and thus (iii) whether this will adversely affect the productivity of the primary care physician, i.e. the number of patient consultations (9). In focus group discussions with primary care clinical staff, five main areas of concern have been identified (i) impact on clinical decision-making; (ii) impact on staff and workflow, (iii) patient experience and patient–provider relationship, (iv) inaccuracy of POCT devices and (v) issues related to cost, regulation and quality management (10). These five themes were also identified in a systematic review of primary care physician’s attitudes towards POCT (11). However, clear patient experience benefits have been identified (12). While concerns have been expressed about the quality of POCT results, they can be addressed through the use of a clinical governance framework, including quality management of POCT (11). Clinical governance, quality management and point-of-care testing The evidence for overall clinical governance in primary care is fragmented, and focuses mainly on processes rather than outcomes. Furthermore, few models enhance safety, efficiency, sustainability and the economics of primary care (13). There are challenges in the governance of POCT—in part because of the limited training (and exposure to analytical devices) by the potential operators (doctors, nurses, health care assistants and patients), compared with laboratory professionals (14). Errors can be classified as pre-analytical, analytical and post-analytical. Pre-analytical errors occur while obtaining the sample or pre-processing the sample if applicable. Errors in the analytical phase can be considered to be a consequence of machine failure, incompetent operators, non-adherence to prescribed procedures and/or use of uncontrolled reagent/equipment (15). Post-analytical errors occur when results are not acknowledged, interpreted incorrectly or not acted upon appropriately. Clinical governance and quality improvement in laboratory medicine and POCT are built on a platform of accreditation combined with internal quality control (IQC), external quality assurance (EQA) and clinical audit. Accreditation of point-of-care testing Laboratories are accredited by the United Kingdom Accreditation Service, to an international standard—ISO 15189:2012 (‘Medical Laboratories’—particular requirements for quality and competence). The introduction of ISO 22870:2006 (‘Point of Care Testing’—particular requirements for quality and competence), applied in conjunction with ISO 15189:2012, has provided a means of using international standards in the accreditation of organizations that provide POCT. This standard has recently been updated and is now published as ISO 22870:2016. It should be noted that ISO 22870 is not a standalone standard, and the POCT provider must also be accredited to ISO 15189. This results in the standard being most applicable to ‘hub and spoke’ services, generally with the laboratory as the hub and the clinical setting, whether that is a hospital, clinic or primary care practice, as the spoke. The standards also apply to transcutaneous measurements, the analysis of expired air and in vivo monitoring of physiological parameters, but patient self-testing in a home or community setting is excluded (although elements of the document could be applicable). The accreditation process itself includes an assessment of the overall competence of the organization as well as key control points such as audits, EQA and IQC. However, the main value of working towards ISO 22870 is delivered through using the standards in the design of your POCT service. Approaches to clinical governance and accreditation of POCT have been described (16), including in primary care (17). The key elements of accreditation of POCT are summarized in Table 1. Table 1. Key elements of an accreditation programme for point-of-care testing in primary care. [Aadapted from reference (17).] Clinical governance  • Improves provision of quality health care  • Non-analytical features of the POCT system comply with the needs of the patient and of the primary care practice, e.g. space, time-to-result, patient flow processes, waste disposal  • Responsibilities for POCT are clearly defined  Analytical aspects  • Analytical performance meets the clinical need  • Concordance of results with local laboratory service documented  Staff training and competence  • Tests are performed by staff with the required skills and knowledge  • Competence in required skill and knowledge is demonstrated  • Opportunity to maintain competence is available  Implementation and performance  • Analytical performance and other features of POCT system meet practice requirements  • Tests are performed in a suitable location  • Tests performed to a high quality  • Data management supports high-quality continuity of care  Quality outcomes  • Internal quality control procedures are in place to ensure that all instruments and consumables are working correctly  • Practice participates in external quality assurance programme  • An up-to-date quality manual describing the practice requirements for the management and performance of POCT is maintained  • Ongoing quality of POCT is assessed against the benchmark of the quality manual  • Practice participates in regular audit of the use of POCT results in relation to patient and practice-related outcomes  Clinical governance  • Improves provision of quality health care  • Non-analytical features of the POCT system comply with the needs of the patient and of the primary care practice, e.g. space, time-to-result, patient flow processes, waste disposal  • Responsibilities for POCT are clearly defined  Analytical aspects  • Analytical performance meets the clinical need  • Concordance of results with local laboratory service documented  Staff training and competence  • Tests are performed by staff with the required skills and knowledge  • Competence in required skill and knowledge is demonstrated  • Opportunity to maintain competence is available  Implementation and performance  • Analytical performance and other features of POCT system meet practice requirements  • Tests are performed in a suitable location  • Tests performed to a high quality  • Data management supports high-quality continuity of care  Quality outcomes  • Internal quality control procedures are in place to ensure that all instruments and consumables are working correctly  • Practice participates in external quality assurance programme  • An up-to-date quality manual describing the practice requirements for the management and performance of POCT is maintained  • Ongoing quality of POCT is assessed against the benchmark of the quality manual  • Practice participates in regular audit of the use of POCT results in relation to patient and practice-related outcomes  View Large Table 1. Key elements of an accreditation programme for point-of-care testing in primary care. [Aadapted from reference (17).] Clinical governance  • Improves provision of quality health care  • Non-analytical features of the POCT system comply with the needs of the patient and of the primary care practice, e.g. space, time-to-result, patient flow processes, waste disposal  • Responsibilities for POCT are clearly defined  Analytical aspects  • Analytical performance meets the clinical need  • Concordance of results with local laboratory service documented  Staff training and competence  • Tests are performed by staff with the required skills and knowledge  • Competence in required skill and knowledge is demonstrated  • Opportunity to maintain competence is available  Implementation and performance  • Analytical performance and other features of POCT system meet practice requirements  • Tests are performed in a suitable location  • Tests performed to a high quality  • Data management supports high-quality continuity of care  Quality outcomes  • Internal quality control procedures are in place to ensure that all instruments and consumables are working correctly  • Practice participates in external quality assurance programme  • An up-to-date quality manual describing the practice requirements for the management and performance of POCT is maintained  • Ongoing quality of POCT is assessed against the benchmark of the quality manual  • Practice participates in regular audit of the use of POCT results in relation to patient and practice-related outcomes  Clinical governance  • Improves provision of quality health care  • Non-analytical features of the POCT system comply with the needs of the patient and of the primary care practice, e.g. space, time-to-result, patient flow processes, waste disposal  • Responsibilities for POCT are clearly defined  Analytical aspects  • Analytical performance meets the clinical need  • Concordance of results with local laboratory service documented  Staff training and competence  • Tests are performed by staff with the required skills and knowledge  • Competence in required skill and knowledge is demonstrated  • Opportunity to maintain competence is available  Implementation and performance  • Analytical performance and other features of POCT system meet practice requirements  • Tests are performed in a suitable location  • Tests performed to a high quality  • Data management supports high-quality continuity of care  Quality outcomes  • Internal quality control procedures are in place to ensure that all instruments and consumables are working correctly  • Practice participates in external quality assurance programme  • An up-to-date quality manual describing the practice requirements for the management and performance of POCT is maintained  • Ongoing quality of POCT is assessed against the benchmark of the quality manual  • Practice participates in regular audit of the use of POCT results in relation to patient and practice-related outcomes  View Large Internal quality control IQC is intended to detect, reduce and correct errors in the analytical process. It checks the operation and performance of the POCT device in real time against previously agreed criteria to ensure that the results produced by the system can be confidently reported for patient care (1), see Figure 1. Typically, it involves testing a control material of known concentration of the analyte(s) of interest, and comparing results with the expected range of values (18). However, there is no consensus, or guidelines, on how to run IQC on POC instruments, e.g. daily, weekly, monthly. An example where this has been specified is in the NHS Health Check Programme where quality standards specified an IQC approach in accordance with the Medicine and Health products Regulatory Agency guidance on the management and use of POCT devices (19) that required ‘at least a daily “go/no go” control sample (use of a liquid sample) on days when the instrument is in use’ (20). In the case of some POCT devices, the IQC can be run automatically within the system. Figure 1. View largeDownload slide Summary of the comparative roles of internal quality control and external quality assurance. This sets out the reasons for performing internal quality control and external quality assurance as part of the quality management of point-of-care testing and explains the meaning of the results produced and actions that should be taken. External quality assurance using commutable samples can also show how a participant’s results compare with a true value. Figure 1. View largeDownload slide Summary of the comparative roles of internal quality control and external quality assurance. This sets out the reasons for performing internal quality control and external quality assurance as part of the quality management of point-of-care testing and explains the meaning of the results produced and actions that should be taken. External quality assurance using commutable samples can also show how a participant’s results compare with a true value. External quality assurance EQA is intended to check the overall quality of testing sites—to check the quality of their results in comparison to other sites by testing an identical sample with an unknown value (21), see Figure 1. It compares the POCT results with those generated by the local laboratory and therefore addresses the issue of the comparability of results in primary and secondary care settings. An example of the results from an EQA programme that is utilized by both primary and secondary care providers is shown in Figure 2. Importantly, EQA specimens cannot be run automatically within the POCT device but need to be sent by an external party: the actual delivery of the test is undertaken by the usual operator so that their competence is also tested. Data from an EQA scheme therefore provide an opportunity for evaluating the impact of quality management on health outcomes—albeit only on the quality of the result delivered. Figure 2. View largeDownload slide Example of the main elements of an external quality assurance report (all details of participant identity anonymized) for the serum cholesterol results performed on two point-of-care testing instruments within the same care organization, and compared with the peer group of participants reporting a cholesterol result, n = 91, for this distribution. (A) The distribution of the results from the 91 instruments participating in this distribution, showing the relative deviation (0.1%) from the reference (target) value; (B) the statistics for the peer group distribution of results; (C) the returned results for this facility are displayed; (D) they have returned results for two analysers; instrument B is one of 13 analysers returning a result of 3.58 mmol/l, instrument A is one of 11 analysers returning a result of 3.65 mmol/l. In addition (not shown), the external quality assurance scheme organizer (WEQAS: http://www.weqas.com/services/poct-eqa/) provides a colour-coded distribution of the results, based on a traffic light system with results ≤12% graded as ‘excellent’, >12% and <24% graded as ‘good’, and >24% graded as ‘unacceptable’. In this return, all of the participants achieved excellent performance. The authors would like to acknowledge the WEQAS team for providing the copy of an anonymized report for this figure. Figure 2. View largeDownload slide Example of the main elements of an external quality assurance report (all details of participant identity anonymized) for the serum cholesterol results performed on two point-of-care testing instruments within the same care organization, and compared with the peer group of participants reporting a cholesterol result, n = 91, for this distribution. (A) The distribution of the results from the 91 instruments participating in this distribution, showing the relative deviation (0.1%) from the reference (target) value; (B) the statistics for the peer group distribution of results; (C) the returned results for this facility are displayed; (D) they have returned results for two analysers; instrument B is one of 13 analysers returning a result of 3.58 mmol/l, instrument A is one of 11 analysers returning a result of 3.65 mmol/l. In addition (not shown), the external quality assurance scheme organizer (WEQAS: http://www.weqas.com/services/poct-eqa/) provides a colour-coded distribution of the results, based on a traffic light system with results ≤12% graded as ‘excellent’, >12% and <24% graded as ‘good’, and >24% graded as ‘unacceptable’. In this return, all of the participants achieved excellent performance. The authors would like to acknowledge the WEQAS team for providing the copy of an anonymized report for this figure. Links with the local laboratory network Strong links with the local laboratory are important for a number of reasons, including access to technical and clinical expertise, e.g. ensuring concordance of results with laboratory results for the same patient population, advice on purchase of POCT devices, obtaining IQC materials and trouble-shooting when problems arise. This can also be provided as part of a national network. As many patients will be managed by a clinical team that spans primary and secondary care, it is also important that there is good concordance of results between POCT and laboratory providers. IT connectivity with the local laboratory can provide valuable support, as well as a means of efficiently integrating results into a comprehensive patient record. In addition, it offers a digital and secure option for reminding primary care POCT teams of the need to perform the relevant IQC and EQA analyses, including a list of competent operators, as well as POCT accreditation and Care Quality Commission (CQC) standards (22). The key elements of a POCT quality management system for use in primary care are given in Table 2. Much of this can be provided with support from the local laboratory (through a service level agreement) and is represented in the POCT accreditation standards. Table 2. Key elements of a quality management system for point-of-care testing in primary care, as embodied in the International Organization for Standardization standards • Evaluation of new or alternative POCT instruments  • Evaluation and approval of end-user proposals/protocols  • Purchase and installation of equipment  • Maintenance of consumable supplies and reagents  • Training, certification, recertification of POCT operators  • Quality control and quality assurance  • Evaluation of new or alternative POCT instruments  • Evaluation and approval of end-user proposals/protocols  • Purchase and installation of equipment  • Maintenance of consumable supplies and reagents  • Training, certification, recertification of POCT operators  • Quality control and quality assurance  View Large Table 2. Key elements of a quality management system for point-of-care testing in primary care, as embodied in the International Organization for Standardization standards • Evaluation of new or alternative POCT instruments  • Evaluation and approval of end-user proposals/protocols  • Purchase and installation of equipment  • Maintenance of consumable supplies and reagents  • Training, certification, recertification of POCT operators  • Quality control and quality assurance  • Evaluation of new or alternative POCT instruments  • Evaluation and approval of end-user proposals/protocols  • Purchase and installation of equipment  • Maintenance of consumable supplies and reagents  • Training, certification, recertification of POCT operators  • Quality control and quality assurance  View Large Benefits of quality management of point-of-care testing Concerns have been expressed about the cost and time commitment to managing the quality of POCT in primary care (7,8,10,14,16,23), while its importance has also been recognized (24–27). This applies not only to the analytical phase, but also to the post-analytical phase (27–29). In the following, we present the findings of a literature review on the effect of quality management of POCT in primary care on the quality of the POCT results produced. We searched and selected studies that used an identifiable, valid measure to assess performance of POCT in primary care (see supplementary material). We identified five studies, all observational in approach, using the performance in EQA programmes over time to assess improvement, see Table 3 for details. Table 3. Summary of studies and results, conducted on external quality assurance programme data, that were reviewed Study  Reference  Type of study  Test  Period of data capture (years)  Number of participant sites in study  Key finding  Shephard and Gill (2003)  30   Observational  HbA1c  3.5  45  84% of results within limits of acceptability  Morandi et al. (2011)  31   Observational  HbA1c  9.0  Not stated  Yearly precision performance improved over time  Sølvik et al. (2013)  32   Observational  HbA1c  6.5  1034–1288  Performance improved over time  Bukve et al. (2015)  33   Observational  Urine albumin  15.0  473–1163  Number of years participation inversely related to number of ‘poor’ results  Bukve, Stavelin and Sandberg (2016)  34   Observational  CRP Glucose Haemoglobin  9.0  2134 (mean) 2357 (mean) 2271 (mean)  Number of participants with good performance increased over time  Study  Reference  Type of study  Test  Period of data capture (years)  Number of participant sites in study  Key finding  Shephard and Gill (2003)  30   Observational  HbA1c  3.5  45  84% of results within limits of acceptability  Morandi et al. (2011)  31   Observational  HbA1c  9.0  Not stated  Yearly precision performance improved over time  Sølvik et al. (2013)  32   Observational  HbA1c  6.5  1034–1288  Performance improved over time  Bukve et al. (2015)  33   Observational  Urine albumin  15.0  473–1163  Number of years participation inversely related to number of ‘poor’ results  Bukve, Stavelin and Sandberg (2016)  34   Observational  CRP Glucose Haemoglobin  9.0  2134 (mean) 2357 (mean) 2271 (mean)  Number of participants with good performance increased over time  HbA1c, glycated haemoglobin; CRP, C-reactive protein. View Large Table 3. Summary of studies and results, conducted on external quality assurance programme data, that were reviewed Study  Reference  Type of study  Test  Period of data capture (years)  Number of participant sites in study  Key finding  Shephard and Gill (2003)  30   Observational  HbA1c  3.5  45  84% of results within limits of acceptability  Morandi et al. (2011)  31   Observational  HbA1c  9.0  Not stated  Yearly precision performance improved over time  Sølvik et al. (2013)  32   Observational  HbA1c  6.5  1034–1288  Performance improved over time  Bukve et al. (2015)  33   Observational  Urine albumin  15.0  473–1163  Number of years participation inversely related to number of ‘poor’ results  Bukve, Stavelin and Sandberg (2016)  34   Observational  CRP Glucose Haemoglobin  9.0  2134 (mean) 2357 (mean) 2271 (mean)  Number of participants with good performance increased over time  Study  Reference  Type of study  Test  Period of data capture (years)  Number of participant sites in study  Key finding  Shephard and Gill (2003)  30   Observational  HbA1c  3.5  45  84% of results within limits of acceptability  Morandi et al. (2011)  31   Observational  HbA1c  9.0  Not stated  Yearly precision performance improved over time  Sølvik et al. (2013)  32   Observational  HbA1c  6.5  1034–1288  Performance improved over time  Bukve et al. (2015)  33   Observational  Urine albumin  15.0  473–1163  Number of years participation inversely related to number of ‘poor’ results  Bukve, Stavelin and Sandberg (2016)  34   Observational  CRP Glucose Haemoglobin  9.0  2134 (mean) 2357 (mean) 2271 (mean)  Number of participants with good performance increased over time  HbA1c, glycated haemoglobin; CRP, C-reactive protein. View Large An education, training and quality assurance programme assessed the performance of HbA1c POCT in the Australian Aboriginal Community Controlled Health Services (12 samples for each 6-month cycle, with the participants analysing two samples each month, an overall participation rate of 88% (range from 81% to 93%) and 3100 results submitted in total). The POCT test performance improved over 3.5 years and was equivalent to that of the central laboratory. The imprecision of the measurements improved across the study period, with a median imprecision (CV%) of 3.8 across the last five cycles in the study. The core of the quality assurance scheme, education, training and analysis, was provided by ongoing support from a national laboratory-based quality management service (30). Similar results were found in a Swiss study on HbA1c POCT in doctors’ offices, comparing the performance with that of central laboratories. A total of 33193 measurements were collected over 9 years, using two POCT systems with differing analytical precision performance. The weighted annual precision of the more precise device improved over the period of the study, achieving better performance than several laboratory-based analysers (31). Finally, one study investigated the performance of two quantitative POCT devices for HbA1c in an EQA scheme over a 7-year period, using their ability to meet specified targets for bias and imprecision as their outcome measures. Sølvik et al. found that between 72% and 96% of the participants had a deviation of the results from the target trueness value of ≤6.0% (32) for both samples within the reference interval and above the upper limit of the reference interval. In the case of imprecision, between 74% and 96% of participants achieved imprecision less than the target (≤3.0%). Between 60% and 90% of the participants met both target specifications over the period of the study. The authors concluded that using one type of instrument users have ‘about 90% probability of passing the quality specifications in each survey’. An EQA scheme for the performance of a quantitative urine albumin measurement POCT device in primary care offices in Norway defined results as ‘very good’, ‘acceptable’ or ‘poor’. Over a 14-year period, the number of years of participation in the scheme was inversely related to the number of ‘poor’ results obtained. The same trend was not found for a qualitative urine albumin device. Using reagents with >3 months to expiration was associated with better performance than using reagents expiring within 3 months (P < 0.001) or reagents that had already expired (P < 0.001). Again, the same trend was not seen for a qualitative method (33). The authors concluded that the improvement in performance was, in part, because their EQA scheme included visits from the local laboratory to review procedures. The same group investigated the impact of a quality improvement strategy, as part of an EQA programme, on the analytical performance of C-reactive protein, glucose and haemoglobin measurement using POCT; there were over 2000 participants in each analyte EQA scheme over 9 years, during which the number of participants with good performance increased gradually. Based on a logistic regression analysis, key factors associated with good performance were the number of times an EQA analysis was performed, weekly performance of IQC analysis, performing 10 or more tests per week and the tests being performed by laboratory-qualified personnel (34). Conclusions Clinical governance and quality management of POCT devices are supported by accreditation, IQC processes and EQA schemes. Observational studies have shown that such clinical governance can improve the performance of the POCT in primary care. Interestingly, some studies (obviously participating in EQA schemes) found that quantitative POCT devices performed as well as the laboratory systems (31,32), an observation that has been supported with data from a routine clinical setting (35). Ongoing support for POCT in primary care, by professionals, appears to contribute strongly to better performance. This should also include operator training and maintenance of competence, as it has been recognized in the evaluation of POCT devices that technically qualified operators can achieve better results than non-technically qualified operators (36). The particular strengths of these studies are that they were embedded in routine practice, as against an experimental setting, and in the majority of cases there is a large cohort of participants. However, there were no control groups, i.e. for comparison with a group of POCT sites not participating in IQC processes and EQA schemes. On the other hand, it could be argued that the participants in IQC processes and EQA schemes acted as their own controls as in some of the studies improvement in quality performance was seen over time following the introduction of the EQA schemes (30,31). The limitations of these studies are that (i) in some cases, the data have been gathered from a number of POCT devices and (ii) the outcome measure is a (distant) surrogate measure of patient outcome, insofar as the result must be acknowledged and acted upon in order for the intended patient outcome to be delivered. These observations would therefore concur with the observations of Phillips et al. (13), in that quality management of POCT is currently limited to one aspect of the pathway. Further research on quality management of POCT in primary care, taking a broader perspective, is required. However, we only looked at the testing part of the POCT strategy. Thus, attention should be paid as to whether tests are performed according to clinical guidelines, should they exist, as in the case of the benchmarking study of HbA1c testing (37), audit of results being acted upon (38), evidence of over and under requesting of tests (39) and impact on true clinical outcomes (40). At the technical level, device selection, operator training and continuing assessment of competence are also important. Clinical governance and quality management are central to assuring quality in the delivery of primary care and will undoubtedly be an important contributor in the development of new models of care—especially as the call for greater access to diagnostic tests gathers momentum. Integration with the local laboratory will play an important part in the quality management of POCT. Supplementary material Supplementary material is available at Family Practice online. Declaration Funding: This article presents independent research funded by the National Institute for Health Research (NIHR) Diagnostic Evidence Co-operative Oxford. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The study sponsors had no role in the design, analyses or reporting of the study. The researchers retained complete independence in the conduct of this study. Conflict of interest: AVdB is an associate editor of this journal. Ethical approval: None. Acknowledgements The authors would like to thank Nia Roberts, Information Specialist and Outreach Librarian at the Bodleian Health Care Libraries, for conducting the literature search. References 1. Kings Fund. Understanding Pressures in General Practice. 2016: 1– 99. https://www.kingsfund.org.uk/sites/files/kf/field/field_publication_file/Understanding-GP-pressures-Kings-Fund-May-2016.pdf. (accessed on 18 July 2017). 2. NHS England. Five Year Forward View. 2014: 1– 39. https://www.england.nhs.uk/wp-content/uploads/2014/10/5yfv-web.pdf. (accessed on 18 July 2017). 3. Nuffield Trust. Transforming General Practice: What Are the Levers for Change? 2015: 1– 31. https://www.nuffieldtrust.org.uk/files/2017-01/1484141771_transforming-general-practice-levers-change-web-final.pdf. (accessed on 18 July 2017). 4. NHS England. 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Family PracticeOxford University Press

Published: Dec 15, 2017

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