POCT: A Dedicated Adverse Event Monitoring System
Commentary
Point-of-care testing: High time for a dedicated National Adverse Event Monitoring System *Samarina M A Musaad,1 Shoukat Ali Khan,2 Geoff Herd3 Labtests Auckland,1 The Royal College of Pathologists of Australasia,2 Northland District Health Board3 Disclaimer: This article expresses our own views and not an official position of any institution or funder. For correspondence: Dr Samarina Musaad, [email protected]
Introduction Point-of-care testing (POCT), also known as near-patient testing, is an indispensable branch of conventional laboratory testing. Indeed it is continuously expanding in scope and scale asserting itself as a transformer, changing the landscape of laboratory medicine. While burgeoning the scale of laboratory testing and supporting primary health initiatives, it poses unique and ubiquitous safety challenges. Adverse events are defined as “injuries related to medical management in contrast to complications of disease”.1 In the context of POCT they would be related to the process of near-patient testing. Measures to prevent adverse events such as establishing quality management systems, standard operating procedures, and risk management processes, can be undermined by lack of knowledge of the true scale of events. This article will address the need for a dedicated adverse event monitoring system (AEMS) beyond traditional laboratory systems to meet the increasing requirements of POCT and to inform quality and risk management systems for POCT. The Royal College of Pathologists of Australasia (RCPA) recommend using an AEMS when available2 and we strongly support such implementation at a national level with the possibility of multinational networking both for advancement of patient safety and as an educational tool. To our knowledge this system is the first of its kind to be proposed in the published literature.
In Australasia, adverse events may be collected within individual organisations but a centralised repository for reporting adverse events related to POCT is not available. Acknowledging, reporting and monitoring of adverse events facilitate continuous improvement, audit and risk management; all components of clinical governance.9 It may help change a culture of ambivalence towards POCT practice both outside and importantly within the health sector. Instead of POCT being sporadically used for convenience it would reinforce its value as a safe long term solution to meet clinical demands where conventional laboratory testing cannot. Such a system is capable of dispelling myths about the safety of POCT and its requirements.
Discussion The Unmet Need The need to mitigate harm and minimise system failures is integral in any health system. POCT poses unique challenges compared to conventional laboratory testing due to its nature and amplifiers.3 The sheer number of devices, operators and variables involved, creates potential for errors. In spite of the existence of adverse events in POCT,4,5 exact figures are not known due to the lack of a dedicated AEMS.6-8
While resources in the health sector are finite, POCT can be relatively expensive compared to traditional laboratory testing and establishing a successful POCT AEMS will ultimately increase confidence in its cost-effectiveness.
Reporting and monitoring of adverse events is paramount for secondary prevention of failures and as a learning tool. It ultimately leads to improved models of care and enhances primary prevention. A POCT AEMS may help the in vitro diagnostic (IVD) industry track strengths and weaknesses of their devices to potentially enhance technological improvement for the benefit of patients and the health provider. Furthermore such a system would support post market surveillance and monitoring of devices aiming to improve patient safety.
Adverse Events: Documentation, Reporting and Monitoring The World Health Organisation drafts the foundations for successful reporting systems10 but POCT practices need a customised approach. Table 1 lists some elements of a reporting framework. It should cater both for individuals with and without background laboratory training. Those without
Clin Biochem Rev 36 (1) 2015 3
Musaad SMA, Khan SA, Herd G
Table 1 Elements for a Point-of-Care Testing Adverse Event Monitoring System Framework Details to be captured Patient name, date-of-birth, contact details and a national health identifier Test and device Site of testing/institution Operator name and role if not patient/contact details Date and time of test Incident description (including retrospective or potential hazard/near miss)* More details can be asked of laboratory trained health care providers if the incident occurred in the laboratory, within a hospital environment or a network. This section also needs to capture the actual POCT setting in which the AE occurred e.g. the shift period, staffing levels, patient loads and other factors which may have affected staff performance related to the test and the outcome. Severity of incident i.e. low, medium, high risk or near miss Pre-analytical, analytical or post-analytical Sample from wrong patient/mix up/wrong patient ID Sample integrity: clotted/haemolysed/bubble/inadequate volume/ wrong anticoagulant or delay in analysis Inadequate mixing or sample preparation Wrong technique (e.g. reading pregnancy test too soon) Inadequate QC procedure Equipment or reagent failure Transcription error # Result not viewed/not acted upon/misinterpreted Describe the adverse consequence (or near consequence) e.g. hypoglycaemic attack, chemotherapy, missed deep vein thrombosis, psychological / psychosocial harm Comment: Key: *This would need to be an open-ended question to allow for lay people to describe the incident and capture maximum information. # Transcription errors are most likely to occur where there is no connectivity. ID: identification; QC: quality control
laboratory training include health care professionals and non-healthcare-trained individuals. This amounts to at least three fundamentally different groups with different reporting abilities and knowledge of what to report. Therefore there should be a clear definition of what an adverse event or near miss constitutes, and procedural instructions for reporting should be standardised, clear and concise. The system should be accessible and in simple language with acknowledgement of receipt of the report. Basic information captured should include information on the health provider and patient details for tracking, device 4 Clin Biochem Rev 36 (1) 2015
type and test, date, time and site of testing, and the adverse consequence. Yes/no answers are directive and simple but may miss valuable information10 therefore it is recommended to have the ability to free-text in order to capture important information; this is most relevant to non-pathology trained individuals. Further details that can be entered by laboratory trained individuals and other healthcare personnel include classifying the error into low, medium or high impact based on clinical circumstances and into pre-analytical, analytical and postanalytical phases. A more detailed description of the event
POCT: A Dedicated Adverse Event Monitoring System
includes the perceived source of error e.g. instrument failure, misinterpretation of results, reagent expiry, lack of practitioner training, inadequate quality control procedures, and sample integrity. The quality of information captured will vary considering the different sources but as long as basic information is captured, the system design should be such that parties involved can be contacted for more details if the need arises. Data would feedback to a nominated institution or agency database with oversight from pathologists and medical laboratory scientists. It would be collated, statistically refined, and trends, clusters and “hot spots” identified and defined by time and space. Information and changes should be reported to users, consumers and professional bodies to fill gaps in clinical audit cycles and serve as a learning tool. Corrective and preventative action can be defined and used for secondary prevention of adverse events. Punitive action undermines the exercise and should be avoided. A balance can be found between confidentiality and a means of closing the loop for constructive feedback. Recommendations can take several configurations at the level of the user, consumer, institution, provider, and potentially national level. Professional and Legislative Support The AEMS will benefit from the support of relevant academic societies, Colleges and regulatory bodies and from accreditation bodies for ratification. Managerial buy-in from laboratories or agencies administering the POCT AEMS Program and information technology support is required. Providers and consumers need to see the benefit in the form of feedback so as to continue participating in the Program. The system needs a dedicated infrastructure rather than being a mere extension of a routine laboratory or health provider incident management system. This will address the current and future needs as the scope and scale of POCT rapidly expand. Currently tracking and addressing adverse incidents related to POCT in the relatively controlled laboratory environment, are onerous processes and contribute to a gap in reporting. It is therefore intuitive to reflect on the difficulties involved outside of the laboratory. The continuum of such a reporting system would be fed from tributaries all along the clinical spectrum from the laboratory to the health provider and end user. Successful implementation would be enhanced by a national approach to its application. Expanding the pool of information allows for better standardisation of POCT risk management, sharing and learning.
Sources Information is ample4,5 and needs harnessing. It would come from end users, physicians and general practitioners, nurses and midwives, POCT coordinators, pharmacists and anyone involved in POCT. A dedicated POCT AEMS that is accessible and user friendly would encourage engagement and facilitate reporting. Challenges The approach to the application of the AEMS should be aimed at addressing barriers to reporting, such as fear of punitive action and blame, ignorance on what to report, lack of clear means of reporting, lack of clarity on how reporting will improve patient safety and lack of faith in feedback.11-16 Another challenge is perceived duplication. Many health providers already have clinical incident management systems. Providers need to understand that this AEMS is dedicated to POCT in the interest of patient safety because current systems are inadequate for reporting POCT adverse events. Further challenges faced are those integral to the practice of POCT.3-5,17,18 These include the myriad of health providers and end users, managing risk and quality systems, regulatory compliance, connectivity, ignorance on the role of POCT results in the patients’ management pathways and clinical governance. It is conceivable that in the face of such challenges, obstacles to the establishment of a dedicated National POCT AEMS will inevitably be encountered. This is expected to be from many sectors including less enthusiastic medical personnel and healthcare policy makers. Changes call for a multifaceted approach; education, support from professional bodies and scientific institutions, and raising safety awareness among POCT users. It is expected that there will initially be underreporting that will decline as the system matures. It may be that the only pragmatic means is to politicise the need for a National POCT AEMS in which case a productive approach is to integrate it into the health policy agenda. Power is fundamental to achieve policy change. Theorists describe different sources of power including technical know-how.19 Pathologists and scientists can exercise this tool to influence health policy. In our view, it is a matter of addressing health providers’ and funding agencies’ misconceptions and lack of knowledge on the intricacies of POCT, its value and risk management. Conclusion We encourage health carers, health care organisations, regulatory bodies and health providers to embrace the uniqueness of POCT and adopt a dedicated POCT AEMS; difficulty does not obviate need nor does it excuse passiveness. Establishing a dedicated POCT AEMS aligns with principles
Clin Biochem Rev 36 (1) 2015 5
Musaad SMA, Khan SA, Herd G
of clinical governance, continuous quality improvement, patient safety and a patient-centric approach. Indeed such a system is intended subsequently to be part of an international or regional collaboration where information is shared and lessons learnt. To our knowledge, a National AEMS in New Zealand or Australia, that addresses all phases of the testing process with oversight from pathologists and medical laboratory scientists would be the first of its kind. Competing Interests: None declared. References 1. Hiatt HH, Barnes BA, Brennan TA, Laird NM, Lawthers AG, Leape LL, et al. A study of medical injury and medical malpractice. N Engl J Med 1989;321:480-4. 2. Royal College of Pathologists of Australasia Point of Care Testing Position Statement. http://www.rcpa. edu.au/getattachment/048939b3-b6f4-42cd-89a9cba2590f1b95/Point-of-Care-Testing.aspx (Accessed 20 January 2014). 3. Musaad SM, Herd G. Point-of-care testing governance in New Zealand: a national framework. N Z Med J 2013;126:72-9. 4. Kost GJ. Preventing medical errors in point-of-care testing: security, validation, safeguards, and connectivity. Arch Pathol Lab Med 2001;125:1307-15. 5. Meier FA, Jones BA. Point-of-care testing error: sources and amplifiers, taxonomy, prevention strategies, and detection monitors. Arch Pathol Lab Med 2005;129:12627. 6. Kost GJ. Guidelines for point-of-care testing. Improving patient outcomes. Am J Clin Pathol 1995;104(Suppl 1):S111-27. 7. Kost GJ, Ehrmeyer SS, Chernow B, Winkelman JW, Zaloga GP, Dellinger RP, et al. The laboratory-clinical interface: point-of-care testing. Chest 1999;115:1140-54. 8. Kilgore ML, Steindel SJ, Smith JA. Continuous quality improvement for point-of-care testing using background monitoring of duplicate specimens. Arch Pathol Lab Med 1999;123:824-8.
6 Clin Biochem Rev 36 (1) 2015
9. Starey N. What is clinical governance? http://www. medicine.ox.ac.uk/bandolier/painres/download/whatis/ WhatisClinGov.pdf (Accessed 20 November 2014). 10. World Alliance for Patient Safety. WHO Draft Guidelines for Adverse Event Reporting and Learning Systems: From Information to Action. 2005, WHO/EIP/SPO/ QPS/05.3. http://www.who.int/patientsafety/events/05/ Reporting_Guidelines.pdf (Accessed 15 January 2014). 11. Jennings PA, Stella J. Barriers to incident notification in a regional prehospital setting. Emerg Med J 2011;28:5269. 12. Barach P, Small SD. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. BMJ 2000;320:759-63. 13. Evans SM, Berry JG, Smith BJ, Esterman A, Selim P, O’Shaughnessy J, et al. Attitudes and barriers to incident reporting: a collaborative hospital study. Qual Saf Health Care 2006;15:39-43. 14. Bradley EH, Holmboe ES, Mattera JA, Roumanis SA, Radford MJ, Krumholz HM. Data feedback efforts in quality improvement: lessons learned from US hospitals. Qual Saf Health Care 2004;13:26-31. 15. Gandhi TK, Graydon-Baker E, Huber CN, Whittemore AD, Gustafson M. Closing the loop: follow-up and feedback in a patient safety program. Jt Comm J Qual Patient Saf 2005;31:614-21. 16. Firth-Cozens J. Barriers to incident reporting. Qual Saf Health Care 2002;11:7. 17. Clark KS. Management challenges with point-of-care testing. Point of Care 2013;12:97-8. 18. Gramz J, Koerte P, Stein D. Managing the challenges in point-of-care testing: an ecosystem approach. Point of Care 2013;12:76-9. 19. Buse K, Mays N, Walt G. Making Health Policy: Understanding Public Health. 2nd ed. Open University Press; 2012. p. 20.
Commentary
Point-of-care testing: High time for a dedicated National Adverse Event Monitoring System *Samarina M A Musaad,1 Shoukat Ali Khan,2 Geoff Herd3 Labtests Auckland,1 The Royal College of Pathologists of Australasia,2 Northland District Health Board3 Disclaimer: This article expresses our own views and not an official position of any institution or funder. For correspondence: Dr Samarina Musaad, [email protected]
Introduction Point-of-care testing (POCT), also known as near-patient testing, is an indispensable branch of conventional laboratory testing. Indeed it is continuously expanding in scope and scale asserting itself as a transformer, changing the landscape of laboratory medicine. While burgeoning the scale of laboratory testing and supporting primary health initiatives, it poses unique and ubiquitous safety challenges. Adverse events are defined as “injuries related to medical management in contrast to complications of disease”.1 In the context of POCT they would be related to the process of near-patient testing. Measures to prevent adverse events such as establishing quality management systems, standard operating procedures, and risk management processes, can be undermined by lack of knowledge of the true scale of events. This article will address the need for a dedicated adverse event monitoring system (AEMS) beyond traditional laboratory systems to meet the increasing requirements of POCT and to inform quality and risk management systems for POCT. The Royal College of Pathologists of Australasia (RCPA) recommend using an AEMS when available2 and we strongly support such implementation at a national level with the possibility of multinational networking both for advancement of patient safety and as an educational tool. To our knowledge this system is the first of its kind to be proposed in the published literature.
In Australasia, adverse events may be collected within individual organisations but a centralised repository for reporting adverse events related to POCT is not available. Acknowledging, reporting and monitoring of adverse events facilitate continuous improvement, audit and risk management; all components of clinical governance.9 It may help change a culture of ambivalence towards POCT practice both outside and importantly within the health sector. Instead of POCT being sporadically used for convenience it would reinforce its value as a safe long term solution to meet clinical demands where conventional laboratory testing cannot. Such a system is capable of dispelling myths about the safety of POCT and its requirements.
Discussion The Unmet Need The need to mitigate harm and minimise system failures is integral in any health system. POCT poses unique challenges compared to conventional laboratory testing due to its nature and amplifiers.3 The sheer number of devices, operators and variables involved, creates potential for errors. In spite of the existence of adverse events in POCT,4,5 exact figures are not known due to the lack of a dedicated AEMS.6-8
While resources in the health sector are finite, POCT can be relatively expensive compared to traditional laboratory testing and establishing a successful POCT AEMS will ultimately increase confidence in its cost-effectiveness.
Reporting and monitoring of adverse events is paramount for secondary prevention of failures and as a learning tool. It ultimately leads to improved models of care and enhances primary prevention. A POCT AEMS may help the in vitro diagnostic (IVD) industry track strengths and weaknesses of their devices to potentially enhance technological improvement for the benefit of patients and the health provider. Furthermore such a system would support post market surveillance and monitoring of devices aiming to improve patient safety.
Adverse Events: Documentation, Reporting and Monitoring The World Health Organisation drafts the foundations for successful reporting systems10 but POCT practices need a customised approach. Table 1 lists some elements of a reporting framework. It should cater both for individuals with and without background laboratory training. Those without
Clin Biochem Rev 36 (1) 2015 3
Musaad SMA, Khan SA, Herd G
Table 1 Elements for a Point-of-Care Testing Adverse Event Monitoring System Framework Details to be captured Patient name, date-of-birth, contact details and a national health identifier Test and device Site of testing/institution Operator name and role if not patient/contact details Date and time of test Incident description (including retrospective or potential hazard/near miss)* More details can be asked of laboratory trained health care providers if the incident occurred in the laboratory, within a hospital environment or a network. This section also needs to capture the actual POCT setting in which the AE occurred e.g. the shift period, staffing levels, patient loads and other factors which may have affected staff performance related to the test and the outcome. Severity of incident i.e. low, medium, high risk or near miss Pre-analytical, analytical or post-analytical Sample from wrong patient/mix up/wrong patient ID Sample integrity: clotted/haemolysed/bubble/inadequate volume/ wrong anticoagulant or delay in analysis Inadequate mixing or sample preparation Wrong technique (e.g. reading pregnancy test too soon) Inadequate QC procedure Equipment or reagent failure Transcription error # Result not viewed/not acted upon/misinterpreted Describe the adverse consequence (or near consequence) e.g. hypoglycaemic attack, chemotherapy, missed deep vein thrombosis, psychological / psychosocial harm Comment: Key: *This would need to be an open-ended question to allow for lay people to describe the incident and capture maximum information. # Transcription errors are most likely to occur where there is no connectivity. ID: identification; QC: quality control
laboratory training include health care professionals and non-healthcare-trained individuals. This amounts to at least three fundamentally different groups with different reporting abilities and knowledge of what to report. Therefore there should be a clear definition of what an adverse event or near miss constitutes, and procedural instructions for reporting should be standardised, clear and concise. The system should be accessible and in simple language with acknowledgement of receipt of the report. Basic information captured should include information on the health provider and patient details for tracking, device 4 Clin Biochem Rev 36 (1) 2015
type and test, date, time and site of testing, and the adverse consequence. Yes/no answers are directive and simple but may miss valuable information10 therefore it is recommended to have the ability to free-text in order to capture important information; this is most relevant to non-pathology trained individuals. Further details that can be entered by laboratory trained individuals and other healthcare personnel include classifying the error into low, medium or high impact based on clinical circumstances and into pre-analytical, analytical and postanalytical phases. A more detailed description of the event
POCT: A Dedicated Adverse Event Monitoring System
includes the perceived source of error e.g. instrument failure, misinterpretation of results, reagent expiry, lack of practitioner training, inadequate quality control procedures, and sample integrity. The quality of information captured will vary considering the different sources but as long as basic information is captured, the system design should be such that parties involved can be contacted for more details if the need arises. Data would feedback to a nominated institution or agency database with oversight from pathologists and medical laboratory scientists. It would be collated, statistically refined, and trends, clusters and “hot spots” identified and defined by time and space. Information and changes should be reported to users, consumers and professional bodies to fill gaps in clinical audit cycles and serve as a learning tool. Corrective and preventative action can be defined and used for secondary prevention of adverse events. Punitive action undermines the exercise and should be avoided. A balance can be found between confidentiality and a means of closing the loop for constructive feedback. Recommendations can take several configurations at the level of the user, consumer, institution, provider, and potentially national level. Professional and Legislative Support The AEMS will benefit from the support of relevant academic societies, Colleges and regulatory bodies and from accreditation bodies for ratification. Managerial buy-in from laboratories or agencies administering the POCT AEMS Program and information technology support is required. Providers and consumers need to see the benefit in the form of feedback so as to continue participating in the Program. The system needs a dedicated infrastructure rather than being a mere extension of a routine laboratory or health provider incident management system. This will address the current and future needs as the scope and scale of POCT rapidly expand. Currently tracking and addressing adverse incidents related to POCT in the relatively controlled laboratory environment, are onerous processes and contribute to a gap in reporting. It is therefore intuitive to reflect on the difficulties involved outside of the laboratory. The continuum of such a reporting system would be fed from tributaries all along the clinical spectrum from the laboratory to the health provider and end user. Successful implementation would be enhanced by a national approach to its application. Expanding the pool of information allows for better standardisation of POCT risk management, sharing and learning.
Sources Information is ample4,5 and needs harnessing. It would come from end users, physicians and general practitioners, nurses and midwives, POCT coordinators, pharmacists and anyone involved in POCT. A dedicated POCT AEMS that is accessible and user friendly would encourage engagement and facilitate reporting. Challenges The approach to the application of the AEMS should be aimed at addressing barriers to reporting, such as fear of punitive action and blame, ignorance on what to report, lack of clear means of reporting, lack of clarity on how reporting will improve patient safety and lack of faith in feedback.11-16 Another challenge is perceived duplication. Many health providers already have clinical incident management systems. Providers need to understand that this AEMS is dedicated to POCT in the interest of patient safety because current systems are inadequate for reporting POCT adverse events. Further challenges faced are those integral to the practice of POCT.3-5,17,18 These include the myriad of health providers and end users, managing risk and quality systems, regulatory compliance, connectivity, ignorance on the role of POCT results in the patients’ management pathways and clinical governance. It is conceivable that in the face of such challenges, obstacles to the establishment of a dedicated National POCT AEMS will inevitably be encountered. This is expected to be from many sectors including less enthusiastic medical personnel and healthcare policy makers. Changes call for a multifaceted approach; education, support from professional bodies and scientific institutions, and raising safety awareness among POCT users. It is expected that there will initially be underreporting that will decline as the system matures. It may be that the only pragmatic means is to politicise the need for a National POCT AEMS in which case a productive approach is to integrate it into the health policy agenda. Power is fundamental to achieve policy change. Theorists describe different sources of power including technical know-how.19 Pathologists and scientists can exercise this tool to influence health policy. In our view, it is a matter of addressing health providers’ and funding agencies’ misconceptions and lack of knowledge on the intricacies of POCT, its value and risk management. Conclusion We encourage health carers, health care organisations, regulatory bodies and health providers to embrace the uniqueness of POCT and adopt a dedicated POCT AEMS; difficulty does not obviate need nor does it excuse passiveness. Establishing a dedicated POCT AEMS aligns with principles
Clin Biochem Rev 36 (1) 2015 5
Musaad SMA, Khan SA, Herd G
of clinical governance, continuous quality improvement, patient safety and a patient-centric approach. Indeed such a system is intended subsequently to be part of an international or regional collaboration where information is shared and lessons learnt. To our knowledge, a National AEMS in New Zealand or Australia, that addresses all phases of the testing process with oversight from pathologists and medical laboratory scientists would be the first of its kind. Competing Interests: None declared. References 1. Hiatt HH, Barnes BA, Brennan TA, Laird NM, Lawthers AG, Leape LL, et al. A study of medical injury and medical malpractice. N Engl J Med 1989;321:480-4. 2. Royal College of Pathologists of Australasia Point of Care Testing Position Statement. http://www.rcpa. edu.au/getattachment/048939b3-b6f4-42cd-89a9cba2590f1b95/Point-of-Care-Testing.aspx (Accessed 20 January 2014). 3. Musaad SM, Herd G. Point-of-care testing governance in New Zealand: a national framework. N Z Med J 2013;126:72-9. 4. Kost GJ. Preventing medical errors in point-of-care testing: security, validation, safeguards, and connectivity. Arch Pathol Lab Med 2001;125:1307-15. 5. Meier FA, Jones BA. Point-of-care testing error: sources and amplifiers, taxonomy, prevention strategies, and detection monitors. Arch Pathol Lab Med 2005;129:12627. 6. Kost GJ. Guidelines for point-of-care testing. Improving patient outcomes. Am J Clin Pathol 1995;104(Suppl 1):S111-27. 7. Kost GJ, Ehrmeyer SS, Chernow B, Winkelman JW, Zaloga GP, Dellinger RP, et al. The laboratory-clinical interface: point-of-care testing. Chest 1999;115:1140-54. 8. Kilgore ML, Steindel SJ, Smith JA. Continuous quality improvement for point-of-care testing using background monitoring of duplicate specimens. Arch Pathol Lab Med 1999;123:824-8.
6 Clin Biochem Rev 36 (1) 2015
9. Starey N. What is clinical governance? http://www. medicine.ox.ac.uk/bandolier/painres/download/whatis/ WhatisClinGov.pdf (Accessed 20 November 2014). 10. World Alliance for Patient Safety. WHO Draft Guidelines for Adverse Event Reporting and Learning Systems: From Information to Action. 2005, WHO/EIP/SPO/ QPS/05.3. http://www.who.int/patientsafety/events/05/ Reporting_Guidelines.pdf (Accessed 15 January 2014). 11. Jennings PA, Stella J. Barriers to incident notification in a regional prehospital setting. Emerg Med J 2011;28:5269. 12. Barach P, Small SD. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. BMJ 2000;320:759-63. 13. Evans SM, Berry JG, Smith BJ, Esterman A, Selim P, O’Shaughnessy J, et al. Attitudes and barriers to incident reporting: a collaborative hospital study. Qual Saf Health Care 2006;15:39-43. 14. Bradley EH, Holmboe ES, Mattera JA, Roumanis SA, Radford MJ, Krumholz HM. Data feedback efforts in quality improvement: lessons learned from US hospitals. Qual Saf Health Care 2004;13:26-31. 15. Gandhi TK, Graydon-Baker E, Huber CN, Whittemore AD, Gustafson M. Closing the loop: follow-up and feedback in a patient safety program. Jt Comm J Qual Patient Saf 2005;31:614-21. 16. Firth-Cozens J. Barriers to incident reporting. Qual Saf Health Care 2002;11:7. 17. Clark KS. Management challenges with point-of-care testing. Point of Care 2013;12:97-8. 18. Gramz J, Koerte P, Stein D. Managing the challenges in point-of-care testing: an ecosystem approach. Point of Care 2013;12:76-9. 19. Buse K, Mays N, Walt G. Making Health Policy: Understanding Public Health. 2nd ed. Open University Press; 2012. p. 20.
