- Email: [email protected]
The reporting of patient safety incidents—first experiences with the chiropractic reporting and learning system (CRLS): A pilot study
Clinical Chiropractic (2006) 9, 139—149
intl.elsevierhealth.com/journals/clch
ORIGINAL PAPER
The reporting of patient safety incidents–—first experiences with the chiropractic reporting and learning system (CRLS): A pilot study Haymo Thiel *, Jennifer Bolton Anglo-European College of Chiropractic, 13-15 Parkwood Road, Bournemouth, UK Received 12 April 2006; accepted 27 April 2006
KEYWORDS Chiropractic; Clinical governance; Clinical risk management; Incident reporting; Patient safety
Summary Objective: To design and test a reporting format for patient safety incidents (PSIs) related to chiropractic practice. Design: A pilot study of adverse event monitoring. Setting: Field chiropractic practice and the teaching clinic of the Anglo-European College of Chiropractic. Subjects: Members of the British Chiropractic Association and final year clinical students. Methods: Following design of a reporting format, chiropractors and/or final year clinical students responded by completing a form and submitting this to a central collection point for analysis. Results: Forms were received from seven field practitioners and from 63 students providing information on a number of PSIs. The low number of field practitioners responding prevented any summative analysis and the results are therefore presented individually. With reference to the final year clinical students, the majority of PSIs were associated with misuse of therapeutic equipment (32%) and the treatment intervention itself (31%). Conclusions: Gathering information on PSIs using this format was shown to be both feasible and fit for purpose. Further work is planned to widen access and to facilitate and promote the attributes for an informed safety culture for the chiropractic profession. # 2006 The College of Chiropractors. Published by Elsevier Ltd. All rights reserved.
Background
* Corresponding author. Tel.: +44 1202 436 317. E-mail address: [email protected] (H. Thiel).
In general terms, clinical risk management can be seen as a mechanism for managing exposure to risk that enables us to recognise the events that may
1479-2354/$32.00 # 2006 The College of Chiropractors. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.clch.2006.04.002
140 result in unfortunate or damaging consequences in the future, their severity, and how they can be controlled.1 Clinical risk management is also at the heart of clinical governance, whose principles demand that lessons have to be learned from failure and clinical incidents involving harm or errors, and that these lessons will inform future clinical care with the intent of reducing the risk of repetition.2 For health care in general, the early efforts linked to the management of clinical risks were primarily related to the setting up of risk management processes in an attempt to control litigation and to reduce associated costs. It is now recognised that there is a greater need to address potential underlying clinical problems proactively, and to introduce strategies to reduce the incidence of harm to patients and improve the quality of their care. In the UK, the recent report Building a Safer NHS for Patients3 recognised that risks must be defined and identified before they can be managed and avoided.4 In February of 2004, the newly formed National Patient Safety Agency (NPSA) released Seven Steps to Patient Safety,5 a framework for achieving improved patient safety across a whole healthcare system. At the same time, the NPSA launched its ‘‘National Reporting and Learning System’’, a nationwide system for collecting data on, and learning from, adverse events and errors.6 Other European healthcare inspectorates have followed the UK and have implemented, or are actively pursuing the introduction of, regional or national systems for the gathering, registering and analysis of data on adverse events and patient safety incidents.7—9
Relevance of a clinical incident reporting and learning system to the chiropractic profession Most of what is known about the risks and adverse events linked to chiropractic practice is based on retrospective case reviews and the analysis of medico-legal claims data. There have been only a limited number of prospective reporting and observational studies so far, and the patient sample sizes have usually been relatively small, making a wide generalisation of their results difficult. Clinical audits into risk factors for chiropractic treatment are few,10 and it has been found that effective audit is generally hard to achieve, time-consuming and relatively complex.11 Therefore, the establishment of a successful clinical incident reporting and learning system would greatly benefit the chiropractic profession in identifying potential risks associated
H. Thiel, J. Bolton with the delivery of its care. However, incident reporting should not solely focus on adverse outcomes. Not all unsafe actions, systems or situations will necessarily lead to bad outcomes all the time. The potential for an adverse outcome may exist but, for any number of reasons, e.g. timely detection or just sheer luck, this outcome may not occur at all. This has been termed a ‘‘dynamic non-event’’ or a ‘‘near miss’’.12 Near misses are, therefore, those events that, while having the potential to do so, do not result in harm. In summary, a patient safety incident may have been a small or a large event, either because of an administrative or clinical error that either led to harm to the patient or had the potential to cause harm. It is important for risk and safety management systems not only to collect and analyse information based on major harm events alone, but also to include details about minor events and near miss situations, as the knowledge gained from these will significantly contribute towards the overall reduction of clinical risk and prevention of harm to patients and clinicians. In many ways, a patient safety incident can be defined by: ‘‘That was a threat to my patient’s well-being, and I don’t want it to happen again’’
Basic design of an incident reporting system The purpose of any patient safety incident reporting and learning system can be summarised as follows: the occurrence of an incident should trigger the completion of a report; incident report data should then be collected and analysed centrally to determine whether there are any trends that could represent potential problems in the delivery of care; the results of the analysis must then be distributed and shared with the individuals and organisations involved.13 These phases have been summarised by Woods (in Secker-Walker14) into four distinct activities relevant to an iterative loop incident reporting system (Table 1). The capture of clinical incidents and near misses with subsequent analysis and learning is one of the cornerstones of risk management in health care, regardless of the profession involved. However, for the reporting of incidents to be successful, it must occur independently, i.e. not be linked to any authority with the power to punish the reporter or the organisation, and it must be based within a blame-free culture and environment. A recent survey of 2500 UK medical doctors has found that, although almost all of the respondents felt that a
The reporting of patient safety incidents Table 1 Issues in the iterative loops in incident reporting activities (modified from Woods (in SeckerWalker14) Activity
Issues
Input
Non-punitive and independent Blame free Voluntary or mandatory and confidential
Data
Primacy of narrative Minimum data set Classification and indexing
Analysis
Expertise Targeted issues/themes Root cause analysis Proactive learning/reactive studies
Feedback
Multiple feedback and organisational learning Demonstrate learning to practitioners Co-ordinate with other methods
reporting system would improve patient care, they also strongly favoured a system that was completely independent from the NHS.15 In ‘‘Organisation with a Memory’’,12 the Department of Health clearly supports the notion that incident reporting should be mandatory for both individuals and organisations whilst ensuring confidentiality for the individual reporting. However, there are some16 that argue that incident and error reporting must be done on a voluntary basis only, as this is the only way for practitioners to tell the complete story without fear of retribution. Practitioners who are forced to report errors are less likely to provide in-depth information. Leape17 suggests an alternative, where reporting systems are speciality based, as these will have the advantages of the commitment of those who run them, the allegiance of reporters who trust their fellow experts, and the ability to be tailored to specific practice needs. It is important that those individuals that have been directly involved with the incident do the reporting. Both the practitioner and, where appro-
141 priate or possible, the patient18 need to be able to give their interpretation of the course of events. Secondary data sources such as medical records or other pertinent material need to be considered where appropriate, but are primarily there to complement the information from the individuals involved.14 A coherent and standardised approach to reporting clinical incidents is necessary to ensure that certain key points about the event are captured each time. This can be achieved by defining a ‘‘minimum data set’’ for reportable information3 (Table 2). All incidents must be reported to a central point for collation and placement on a database. In order to be able to interrogate the database in a consistent fashion, incidents must be classified and indexed for ease of access and retrieval.19,20 The ideal incident reporting system should identify areas where certain adverse events are occurring with a frequency that could suggest some abnormality in process. This could involve the use of semi-intelligent software that facilitates the examination of data for themes, trends, or questions, especially in areas of concern.14 The analysis of incidents should follow a standardised protocol for the organised investigation and reporting of clinical incidents.21 The collected data, especially in relation to the more serious incidents, must be analysed in detail and by individuals with expertise in the interrogation of such information. Root cause analysis is an example of a structured investigatory methodology that aims to identify the true causes of an incident.22 It involves an objective, thorough and disciplined approach to determine the most probable underlying cause(s) of a problem or undesired event. Once identified, the conditions responsible for the incident can be corrected and future mishaps may be prevented. Through root cause analysis, related but not directly causative factors may be identified that could benefit from further research investigation. Finally, it is important that the results from the analysis of patient safety incidents are communicated in a timely fashion to both organisations and
Table 2 Minimum data set for the reporting of adverse events and near misses (modified from3) What happened? (description of event/near miss; severity of actual or potential harm; people and equipment involved) Where did it happen? (location) When did it happen? (date and time) How did it happen? (details of immediate cause(s)) Why did it happen? (details of underlying, or root cause(s)) What actions were taken? (immediate and longer term) What was the impact of the event? (harm to patient, practitioner, organisation, others) What factors did, or could have, minimised the impact of the event?
142 the individual practitioners at the clinical sharp end. As the goal of feedback is to learn from adverse events and near misses, communication systems need to be in place to allow people to see what has changed or is going to change as a result of incident reporting. Where individuals can see that something positive has been achieved through incident reporting, it is more likely to facilitate continued participation in the process. The knowledge gained through an incident reporting and learning system can then complement information on adverse events and clinical risk obtained from other sources.
Objective for the pilot study Owing to the increasing move towards documenting patient safety incidents that may arise from treatment, we had felt for some time that there was a need for the chiropractic profession to be part of this safety culture developing within health care. With this in mind, a relatively simple and straightforward reporting format was designed, reflecting the basic principles of other incident reporting systems and especially as outlined in detail within the NPSA’s Seven Steps to Patient Safety document.5 The help of the British Chiropractic Association (BCA) was then sought in order to distribute and publicise this Chiropractic Reporting and Learning System (CRLS) amongst its members for the purpose of conducting a pilot study on its use and application within the chiropractic field. Simultaneously, the CRLS format was introduced to final year clinical students for implementation in the AECC teaching clinic.
H. Thiel, J. Bolton available for analysis by one of us (HT). Following analysis, all forms were destroyed.
AECC teaching clinic Final year students, having started in clinic in July 2005, were instructed in the purpose and use of the CRLS and copies of the reporting forms were made widely available to the cohort. Students were asked to record individually, and in an anonymous fashion, any patient safety incidents that they had experienced during their patient encounters within their first 6 months of clinical training. All of the reports were collected by one of us (HT) at the end of the autumn term for subsequent analysis. Following analysis, the CRLS forms were returned to the students as these formed parts of their clinical learning portfolio. The data received from the BCA chiropractors and AECC students during the period of mid-July to mid-December 2005 were analysed with descriptive statistics only.
Results Field chiropractors The rate of return of incidents reports by chiropractors was disappointing. During the 4-month data collection period, only eight reporting forms were received from seven individual chiropractors. This low number of reported incidents does not allow for any meaningful statistical analysis nor does it indicate any specific trends regarding risks or complications in association with chiropractic treatment. Table 3 shows a summary of the reported incidents.
Methods AECC teaching clinic Field chiropractors In August 2005, each member of the BCA (approximately 1100 members at the time) was sent a CRLS Starter Pack containing several copies of the CRLS form (Fig. 1) and an accompanying explanation sheet together with an introductory letter by the BCA President. All chiropractors were instructed to use the self-addressed and stamped envelope for private and confidential return of any completed form(s). At the time of initial distribution, explanatory articles about the CRLS were released in the In Touch Newsletter of the BCA, as well as in its professional journal Contact and its international newsletter The Chiropractic News. Shortly thereafter, the CRLS form was made available for downloading from the BCA’s website. The data recorded on all of the returned forms were only seen and
Demographics All of the 63 final year clinical students participated in the data collection and reported 225 individual PSIs. At the close of the data collection period, a total of 19,108 patient contacts (new patient consultations and follow up visits) had occurred. This means that for 1.2% of patient contacts, a PSI was reported. The PSIs involved 137 female and 86 male patients (missing data: n = 2) and patient mean age was 46.7 years (S.D. = 21.1; range: 3 months to 99 years; missing data: n = 8). Where did the PSI happen? The great majority (87%) of PSIs happened in the clinic’s consultation and treatment rooms. This was followed by the administrative areas for either clinic reception and records staff (2.7%) or the
The reporting of patient safety incidents students’ lounge and filing room (2.2%). Just over 1% of PSIs occurred for each location respectively, either within the clinic building’s stairs and hallways, the rehabilitation department, the radiogra-
Figure 1
143 phy department, the tutors’ consultation room or the car parking areas. In 2.2%, the PSI had occurred off-site and, most commonly, within the patient’s home.
(a) Front page of CRLS form and (b) reverse page of CRLS form.
144
H. Thiel, J. Bolton
Types of PSIs reported Fig. 2 shows the distribution of PSIs according to incident type. From this, it is apparent that either misuse of therapeutic equipment (32%) or the treatment intervention itself (31%) were most frequently reported in association with the occurrence of a PSI.
Table 4 shows examples of PSIs reported in the AECC teaching clinic. Grading of harm In 64% of the PSIs, the students felt that no harm had occurred to the patient. Thirty-five percent of the
Figure 1. (Continued ).
Patient gender
Patient age
Location of PSI
Description of PSI
Reason for PSI
Grading of harm and follow up care
Relationship between suspected cause and PSI
Female
39
Treatment room
Dizziness, nausea following cervical spine manipulation
Undetermined, possibly dislodged otoliths
Low GP and medication
Likely
Male
62
Treatment room
Increased low back pain following massage with elbow
New practitioner applying other than usual therapeutic technique
Low Extra treatment
Likely
Female
58
Treatment room
Increased thoracic back pain following spinal manipulation
Undetermined, practitioner reported ‘‘dramatic release of joint with several cracks’’
Low Extra treatment
Likely
Female
59
Treatment room
Dizziness, blurred vision and headache following cervical spine manipulation
Undetermined
Low GP and medication
Likely
Female
39
Treatment room
Delayed diagnosis of Chiari I malformation
Referred by neurosurgeon for treatment of disc herniation, no imaging studies performed due to pregnancy
Near miss Ongoing monitoring
Unlikely
Female
45
Treatment room
Missed diagnosis of lumbar disc herniation
Returning patient with a tendency to exaggerate symptoms in the past
Moderate Surgery
Uncertain
Male
Not reported
Treatment room
Petit mal seizure following spinal manipulation
Undetermined
Low Rest
Likely
Male
Not reported
Treatment room
Fractured rib following spinal manipulation
Undetermined, possibly force of manipulative thrust
Moderate Rest and medication
Likely
The reporting of patient safety incidents
Table 3 Summary of patient safety incidents as reported by individual chiropractors (PSI, patient safety incident)
145
Figure 2 Types and frequency of PSIs reported by final year clinical students *C,C,C, consent, communication, confidentiality.
PSIs involved ‘‘low harm’’ or where the incident required extra observation or minor treatment (additional therapy or medication over short period of time, does not include admission to hospital or attending as an outpatient on repeated occasions). In only two (1%) instances, moderate harm had occurred where the incident resulted in a moderate increase in additional treatment (admission to hospital or attending as an outpatient on repeated occasions, or requiring surgery or prolonged episodes of care) and caused significant but not permanent harm. One hundred and twenty-two (54%) of the PSIs were classified as near misses, i.e. no harm had occurred although the incident had the potential to cause harm but was prevented either by chance or deliberate action.
Relationship between suspected cause and PSI A likely relationship between suspected cause and incident was thought to have existed in 80% of the cases whilst it had been deemed as unlikely in a very small minority 2% and uncertain in 18%.
Discussion To our best knowledge, the CRLS is the first system that has been specifically designed to capture data in a proactive and structured fashion on PSIs associated with chiropractic treatment. As the primary purpose of incident reporting is to reduce harm to patients and practitioners, it would be difficult to accept how the introduction of a specific reporting
Table 4 Examples of PSIs reported (in descending order of occurrence) Stepping on electrical pedals, not locking parts of bench Excessive bruising, scratching of patient Not attending to elderly patient, resulting in slip or fall Wrong file for right patient, right file for wrong patient Faulty patient handling, technique, stepping on patient’s hand Unauthorised treatment, not following supervision protocol Wrong diagnosis, no consent to treatment Lack of tutor availability for supervision, advice Not knowing how to use equipment (treadmill, electrotherapy equipment, ice bag, hot pack) Bean-bag with baby slipping off bench Child’s finger stuck in Activator device mechanism
The reporting of patient safety incidents and learning system designed for chiropractors could not be interpreted as something of benefit. Chiropractic treatment is generally regarded to be a safe and low risk activity. However, the number of clinical studies conducted so far into safety issues of chiropractic treatment and practice could still be considered to be too small to provide a full picture and thorough understanding. Incident reporting by chiropractors would permit the systematic collection of nationwide incident data. This would allow the analysis of trends, which would help to identify certain risks associated with different treatment interventions or patient interactions. Incident reporting could also have a positive effect on chiropractic claims management and legal outcomes. Lessons learnt from previously reported incidents would allow the chiropractic profession to manage possible future and similar claims in a more proactive manner.
Field chiropractors If the above were true, one would therefore have to ask the question why so few reports were returned from the chiropractors in the field. The reliability of any incident reporting system depends primarily on how many of the events that have occurred that it actually captures. Studies involving reporting systems designed for medical care and conducted in North America, the UK and Sweden would suggest that the rate of adverse event reporting can vary significantly between different countries, medical specialities and hospitals, and that quite commonly lower than half of incidents are being reported.14,23 Some of the main reasons why clinicians do not report incidents are fear of blame or of increased medico-legal risk, a high workload and the belief that the circumstances of a particular case did not warrant a report.24,25 Other barriers to reporting may include a sense of failure, in that our professional culture tends to personalise error and seeks and expects perfection. Chiropractors are trained to expect high standards of performance from themselves, and some may find it difficult to acknowledge and learn from things that have not gone as well as expected. It is also likely that, for some, the intent and benefit of standardised reporting were not clear from the outset, or that the reporting of near misses was seen as a pointless and time-consuming activity. Lessons from sectors other than health care, such as commercial aviation and the oil and gas industry, have demonstrated that, in order to achieve exemplary safety records, the development of the right organisational and professional culture is necessary first.26 If the culture of an organisation is safety conscious and people are encouraged to speak up
147 about mistakes, then safety is improved.5 In other words, we need to ask, ‘‘what went wrong’’ and not ‘‘who went wrong’’; we need to cultivate a blamefree environment, without fear of personal reprimand and we need to replace secrecy and misplaced professional solidarity with the attitudes, language and habits of quality improvement. Reporting must occur on a voluntary basis or anonymously, as these are the only ways for practitioners to tell the complete story without fear of retribution.27 An incident reporting system for chiropractors can therefore not be directly linked to, or administered by, the statutory regulator, as a practitioner may not want to report directly to an authority with disciplinary powers. It is a well-known fact that the changing of values, beliefs and attitudes is not easily accomplished, and that it generally takes several years for established clinical practices to be altered or adapted in light of newly established evidence, procedures or protocols. The leadership of any team, organisation or profession is central to setting the values and beliefs of its culture.28 The leaders within the chiropractic profession therefore have a vital part to play in building a safety culture that is both open and fair. They need to promote an environment where chiropractors are encouraged to report, collaborate and learn from PSIs.
AECC teaching clinic It should be of no great surprise to anyone that the response rate and results obtained for the student cohort were so different in comparison to those of the field chiropractors. The fact that having a captive audience of emerging and mouldable clinicians within the setting of a learning environment and culture automatically prevents the transference of most, if not the entire, student results into general chiropractic practice. These results are, however, very much applicable to the pedagogic setting of a chiropractic teaching clinic and, as such, contribute greatly to the knowledge base in reference to patient safety within this background. In this instance, immediate repairs were undertaken of equipment previously unknown to have been defective, and specific notices were put up within some of the clinic’s treatment rooms to minimise the chances of further equipment misuse. Furthermore, the results were distributed amongst members of clinical faculty and discussed with the final year student cohort for reflection and learning to occur. Finally, the students were asked to undertake a second round of PSI data collection with a view to report on any changes or similarities on incident data towards the end of their clinical
148 education. Following this, the CRLS will be adapted to become an integral part of the AECC teaching clinic’s protocols and procedures and contribute towards the learning portfolio of final year students. At this point in time, we do not know whether the frequency of 1.2% for PSIs reported for the AECC chiropractic teaching clinic represents a true or acceptable rate due to the lack of appropriate comparisons. Estimates from the medical literature seem to indicate that 11% of patients admitted to hospitals in England and Wales each year experience a preventable adverse event.29 The rate for PSIs within the primary care setting is less well established, ranging from 5 to 80 per 100,000 consultations.30
Conclusions This pilot study constitutes an initial report on the first experiences gained from the introduction of a voluntary or anonymous incident reporting system within the chiropractic profession in the UK. In itself, it does not provide many helpful answers regarding the frequency and types of PSIs associated with chiropractic care; it rather poses further questions and emphasises the need for ongoing enquiry or study in this area. For example, we plan to embark on a qualitative study to elucidate possible barriers to patient incident reporting by chiropractors. We hope that these preliminary and limited results of this pilot will help to draw the attention of chiropractors within the UK and elsewhere to the importance of implementing the attributes of a safety and informed culture within the chiropractic profession by the introduction of patient safety incident reporting systems. We realise that the knowledge gained from an opportunistic incident reporting system can only provide one part of the puzzle when it comes to the overall assessment of the risks and benefits of a certain treatment approach. Other pieces of information are contributed by clinical trials, specific retrospective or prospective studies on unwanted treatment effects and knowledge gained from medico-legal and insurance claim data. Probably one of the key messages in relation to the reporting of incidents and near misses is that a reporting system will provide an important opportunity to learn from the experiences of one patient or chiropractor in order to reduce the risk of something similar happening to others.
Author contribution statement HT conceived the idea for the pilot study. HT and JB contributed to the design and planning of the
H. Thiel, J. Bolton research and were responsible for the data collection. HT analysed the data. HT and JB wrote the first draft of the manuscript. Conflict of interest HT is Head of Clinic of the AECC and is a member of the BCA. No funding was received for this study.
Acknowledgements We thank the British Chiropractic Association for their help and support with the graphical design and distribution of the CRLS amongst its members. We are especially grateful to those chiropractors who submitted PSI related reports and to the Class of 2006 who pioneered the use of the CRLS in the AECC teaching clinic.
References 1. Dickson G. Principles of risk management. Qual Health Care 1995;4:75—9. 2. Thiel H. Clinical governance, clinical risk management and the chiropractic profession. Clinl Chiropractic 2003;6: 45—8. 3. Department of Health. Building a safer NHS for patients. London: Stationery Office; 2001. 4. Evans D. Learning from clinical claims and complaints. Clin Risk 2001;7:208—9. 5. Seven steps to patient safety. London: The National Patient Safety Agency; 2004. 6. National Patient Safety Agency. The National Reporting and Learning System. Patient Safety. ICC Birmingham; 24—25 February 2004. 7. Sheldon T. Netherlands plans system for reporting errors. BMJ 2004;329:68. 8. Beyer M, Rohe J, Rusitska M, Blauth E, Gerlach F. The German error reporting system for general practice: structure, first results. Z Allg Med 2005;81:147—53. 9. CIRSmedical. Demoversion. In: https://www.cirsmedical.ch/ demo/cirs/cirs.php. 10. Breen A, Krir J, Sutherland J. Risk factors for spontaneous vertebral and carotid arterial dissection in chiropractic patients presenting with neck pain and headache. In: WFC’s 7th Biennial Congress, Orlando; 2003. p. 303—4. 11. Lord J, Littlejohns P. Evaluating healthcare policies: the case for clinical audit. BMJ 1997;315:668—71. 12. Department of Health. An organisation with a memory. London: Stationery Office; 2000. 13. Van Liew D. Using information systems to support risk management. In: Wilson J, Tingle J, editors. Clinical risk modification. A route to clinical governance. Oxford: Butterworth Heinemann; 1999. p. 66—85. 14. Secker-Walker J, Taylor-Adams S. Clinical incident reporting. In: Vincent C, editor. Clinical risk management. Enhancing patient safety. London: BMJ Publishing Group; 2001. p. 419— 38. 15. White C. Doctors mistrust systems for reporting medical mistakes. BMJ 2004;329:12—3. 16. Cohen M. Why error reporting systems should be voluntary. BMJ 2000;320:728—9.
The reporting of patient safety incidents 17. Leape LL. Reporting of adverse events. N Engl J Med 2002;347:1633—8. 18. Williams K. Patients will be able to report drugs’ side effects. BMJ 2004;328:1095. 19. Woloshynowych M, Neale G, Vincent C. Case record review of adverse events: a new approach. Qual Saf Health Care 2003;12:411—5. 20. Rubin G, George A, Chinn D, Richardson C. Errors in general practice: development of an error classification and pilot study of a method for detecting errors. Qual Saf Health Care 2003;12:443—7. 21. Vincent C, Taylor-Adams S. The investigation and analysis of clinical incidents. In: Vincent C, editor. Clinical risk management. Enhancing patient safety. London: BMJ Publishing Group; 2001. p. 439—60. 22. NPSA. Exploring incidents–—improving safety. A guide to root cause analysis from the NPSA. In: www.npsa.uk/rcatoolkit/ course/iindex.htm. 23. Joelson S, Joelson I, Wallander M. Geographical variation in adverse event reporting rates in clinical trials. Pharmacoepidemiol Drug Saf 1997;6:S31—5.
149 24. Vincent C, Stanhope N, Crowley-Murphy M. Reasons for not reporting adverse incidents: an empirical study. J Eval Clin Practice 1998;5:13—21. 25. Shekelle P. Why don’t physicians enthusiastically support quality improvement programmes? Qual Saf Health Care 2002;11:6. 26. Hudson P. Applying the lessons of high risk industries to health care. Qual Saf Health Care 2003;12(Suppl. 1):i7—12. 27. O’Dowd A. Guarantee of anonymity leads to surge in reports of safety incidents. BMJ 2006;332:140. 28. Firth-Cozens J. Teams, culture and managing risk. In: Vincent C, editor. Clinical risk management: enhancing patient safety. London: BMJ Publishing Group; 2001. p. 355—68. 29. Vincent C, Neale G, Woloshynowych M. Adverse events in British hospitals: preliminary retrospective record review. BMJ 2001;322:517—9. 30. Sandars J. The theory and evidence base for clinical risk management. In: Haynes K, Thomas M, editors. Clinical risk management in primary care. Oxford: Radcliffe Publishing; 2005. p. 45—59.
intl.elsevierhealth.com/journals/clch
ORIGINAL PAPER
The reporting of patient safety incidents–—first experiences with the chiropractic reporting and learning system (CRLS): A pilot study Haymo Thiel *, Jennifer Bolton Anglo-European College of Chiropractic, 13-15 Parkwood Road, Bournemouth, UK Received 12 April 2006; accepted 27 April 2006
KEYWORDS Chiropractic; Clinical governance; Clinical risk management; Incident reporting; Patient safety
Summary Objective: To design and test a reporting format for patient safety incidents (PSIs) related to chiropractic practice. Design: A pilot study of adverse event monitoring. Setting: Field chiropractic practice and the teaching clinic of the Anglo-European College of Chiropractic. Subjects: Members of the British Chiropractic Association and final year clinical students. Methods: Following design of a reporting format, chiropractors and/or final year clinical students responded by completing a form and submitting this to a central collection point for analysis. Results: Forms were received from seven field practitioners and from 63 students providing information on a number of PSIs. The low number of field practitioners responding prevented any summative analysis and the results are therefore presented individually. With reference to the final year clinical students, the majority of PSIs were associated with misuse of therapeutic equipment (32%) and the treatment intervention itself (31%). Conclusions: Gathering information on PSIs using this format was shown to be both feasible and fit for purpose. Further work is planned to widen access and to facilitate and promote the attributes for an informed safety culture for the chiropractic profession. # 2006 The College of Chiropractors. Published by Elsevier Ltd. All rights reserved.
Background
* Corresponding author. Tel.: +44 1202 436 317. E-mail address: [email protected] (H. Thiel).
In general terms, clinical risk management can be seen as a mechanism for managing exposure to risk that enables us to recognise the events that may
1479-2354/$32.00 # 2006 The College of Chiropractors. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.clch.2006.04.002
140 result in unfortunate or damaging consequences in the future, their severity, and how they can be controlled.1 Clinical risk management is also at the heart of clinical governance, whose principles demand that lessons have to be learned from failure and clinical incidents involving harm or errors, and that these lessons will inform future clinical care with the intent of reducing the risk of repetition.2 For health care in general, the early efforts linked to the management of clinical risks were primarily related to the setting up of risk management processes in an attempt to control litigation and to reduce associated costs. It is now recognised that there is a greater need to address potential underlying clinical problems proactively, and to introduce strategies to reduce the incidence of harm to patients and improve the quality of their care. In the UK, the recent report Building a Safer NHS for Patients3 recognised that risks must be defined and identified before they can be managed and avoided.4 In February of 2004, the newly formed National Patient Safety Agency (NPSA) released Seven Steps to Patient Safety,5 a framework for achieving improved patient safety across a whole healthcare system. At the same time, the NPSA launched its ‘‘National Reporting and Learning System’’, a nationwide system for collecting data on, and learning from, adverse events and errors.6 Other European healthcare inspectorates have followed the UK and have implemented, or are actively pursuing the introduction of, regional or national systems for the gathering, registering and analysis of data on adverse events and patient safety incidents.7—9
Relevance of a clinical incident reporting and learning system to the chiropractic profession Most of what is known about the risks and adverse events linked to chiropractic practice is based on retrospective case reviews and the analysis of medico-legal claims data. There have been only a limited number of prospective reporting and observational studies so far, and the patient sample sizes have usually been relatively small, making a wide generalisation of their results difficult. Clinical audits into risk factors for chiropractic treatment are few,10 and it has been found that effective audit is generally hard to achieve, time-consuming and relatively complex.11 Therefore, the establishment of a successful clinical incident reporting and learning system would greatly benefit the chiropractic profession in identifying potential risks associated
H. Thiel, J. Bolton with the delivery of its care. However, incident reporting should not solely focus on adverse outcomes. Not all unsafe actions, systems or situations will necessarily lead to bad outcomes all the time. The potential for an adverse outcome may exist but, for any number of reasons, e.g. timely detection or just sheer luck, this outcome may not occur at all. This has been termed a ‘‘dynamic non-event’’ or a ‘‘near miss’’.12 Near misses are, therefore, those events that, while having the potential to do so, do not result in harm. In summary, a patient safety incident may have been a small or a large event, either because of an administrative or clinical error that either led to harm to the patient or had the potential to cause harm. It is important for risk and safety management systems not only to collect and analyse information based on major harm events alone, but also to include details about minor events and near miss situations, as the knowledge gained from these will significantly contribute towards the overall reduction of clinical risk and prevention of harm to patients and clinicians. In many ways, a patient safety incident can be defined by: ‘‘That was a threat to my patient’s well-being, and I don’t want it to happen again’’
Basic design of an incident reporting system The purpose of any patient safety incident reporting and learning system can be summarised as follows: the occurrence of an incident should trigger the completion of a report; incident report data should then be collected and analysed centrally to determine whether there are any trends that could represent potential problems in the delivery of care; the results of the analysis must then be distributed and shared with the individuals and organisations involved.13 These phases have been summarised by Woods (in Secker-Walker14) into four distinct activities relevant to an iterative loop incident reporting system (Table 1). The capture of clinical incidents and near misses with subsequent analysis and learning is one of the cornerstones of risk management in health care, regardless of the profession involved. However, for the reporting of incidents to be successful, it must occur independently, i.e. not be linked to any authority with the power to punish the reporter or the organisation, and it must be based within a blame-free culture and environment. A recent survey of 2500 UK medical doctors has found that, although almost all of the respondents felt that a
The reporting of patient safety incidents Table 1 Issues in the iterative loops in incident reporting activities (modified from Woods (in SeckerWalker14) Activity
Issues
Input
Non-punitive and independent Blame free Voluntary or mandatory and confidential
Data
Primacy of narrative Minimum data set Classification and indexing
Analysis
Expertise Targeted issues/themes Root cause analysis Proactive learning/reactive studies
Feedback
Multiple feedback and organisational learning Demonstrate learning to practitioners Co-ordinate with other methods
reporting system would improve patient care, they also strongly favoured a system that was completely independent from the NHS.15 In ‘‘Organisation with a Memory’’,12 the Department of Health clearly supports the notion that incident reporting should be mandatory for both individuals and organisations whilst ensuring confidentiality for the individual reporting. However, there are some16 that argue that incident and error reporting must be done on a voluntary basis only, as this is the only way for practitioners to tell the complete story without fear of retribution. Practitioners who are forced to report errors are less likely to provide in-depth information. Leape17 suggests an alternative, where reporting systems are speciality based, as these will have the advantages of the commitment of those who run them, the allegiance of reporters who trust their fellow experts, and the ability to be tailored to specific practice needs. It is important that those individuals that have been directly involved with the incident do the reporting. Both the practitioner and, where appro-
141 priate or possible, the patient18 need to be able to give their interpretation of the course of events. Secondary data sources such as medical records or other pertinent material need to be considered where appropriate, but are primarily there to complement the information from the individuals involved.14 A coherent and standardised approach to reporting clinical incidents is necessary to ensure that certain key points about the event are captured each time. This can be achieved by defining a ‘‘minimum data set’’ for reportable information3 (Table 2). All incidents must be reported to a central point for collation and placement on a database. In order to be able to interrogate the database in a consistent fashion, incidents must be classified and indexed for ease of access and retrieval.19,20 The ideal incident reporting system should identify areas where certain adverse events are occurring with a frequency that could suggest some abnormality in process. This could involve the use of semi-intelligent software that facilitates the examination of data for themes, trends, or questions, especially in areas of concern.14 The analysis of incidents should follow a standardised protocol for the organised investigation and reporting of clinical incidents.21 The collected data, especially in relation to the more serious incidents, must be analysed in detail and by individuals with expertise in the interrogation of such information. Root cause analysis is an example of a structured investigatory methodology that aims to identify the true causes of an incident.22 It involves an objective, thorough and disciplined approach to determine the most probable underlying cause(s) of a problem or undesired event. Once identified, the conditions responsible for the incident can be corrected and future mishaps may be prevented. Through root cause analysis, related but not directly causative factors may be identified that could benefit from further research investigation. Finally, it is important that the results from the analysis of patient safety incidents are communicated in a timely fashion to both organisations and
Table 2 Minimum data set for the reporting of adverse events and near misses (modified from3) What happened? (description of event/near miss; severity of actual or potential harm; people and equipment involved) Where did it happen? (location) When did it happen? (date and time) How did it happen? (details of immediate cause(s)) Why did it happen? (details of underlying, or root cause(s)) What actions were taken? (immediate and longer term) What was the impact of the event? (harm to patient, practitioner, organisation, others) What factors did, or could have, minimised the impact of the event?
142 the individual practitioners at the clinical sharp end. As the goal of feedback is to learn from adverse events and near misses, communication systems need to be in place to allow people to see what has changed or is going to change as a result of incident reporting. Where individuals can see that something positive has been achieved through incident reporting, it is more likely to facilitate continued participation in the process. The knowledge gained through an incident reporting and learning system can then complement information on adverse events and clinical risk obtained from other sources.
Objective for the pilot study Owing to the increasing move towards documenting patient safety incidents that may arise from treatment, we had felt for some time that there was a need for the chiropractic profession to be part of this safety culture developing within health care. With this in mind, a relatively simple and straightforward reporting format was designed, reflecting the basic principles of other incident reporting systems and especially as outlined in detail within the NPSA’s Seven Steps to Patient Safety document.5 The help of the British Chiropractic Association (BCA) was then sought in order to distribute and publicise this Chiropractic Reporting and Learning System (CRLS) amongst its members for the purpose of conducting a pilot study on its use and application within the chiropractic field. Simultaneously, the CRLS format was introduced to final year clinical students for implementation in the AECC teaching clinic.
H. Thiel, J. Bolton available for analysis by one of us (HT). Following analysis, all forms were destroyed.
AECC teaching clinic Final year students, having started in clinic in July 2005, were instructed in the purpose and use of the CRLS and copies of the reporting forms were made widely available to the cohort. Students were asked to record individually, and in an anonymous fashion, any patient safety incidents that they had experienced during their patient encounters within their first 6 months of clinical training. All of the reports were collected by one of us (HT) at the end of the autumn term for subsequent analysis. Following analysis, the CRLS forms were returned to the students as these formed parts of their clinical learning portfolio. The data received from the BCA chiropractors and AECC students during the period of mid-July to mid-December 2005 were analysed with descriptive statistics only.
Results Field chiropractors The rate of return of incidents reports by chiropractors was disappointing. During the 4-month data collection period, only eight reporting forms were received from seven individual chiropractors. This low number of reported incidents does not allow for any meaningful statistical analysis nor does it indicate any specific trends regarding risks or complications in association with chiropractic treatment. Table 3 shows a summary of the reported incidents.
Methods AECC teaching clinic Field chiropractors In August 2005, each member of the BCA (approximately 1100 members at the time) was sent a CRLS Starter Pack containing several copies of the CRLS form (Fig. 1) and an accompanying explanation sheet together with an introductory letter by the BCA President. All chiropractors were instructed to use the self-addressed and stamped envelope for private and confidential return of any completed form(s). At the time of initial distribution, explanatory articles about the CRLS were released in the In Touch Newsletter of the BCA, as well as in its professional journal Contact and its international newsletter The Chiropractic News. Shortly thereafter, the CRLS form was made available for downloading from the BCA’s website. The data recorded on all of the returned forms were only seen and
Demographics All of the 63 final year clinical students participated in the data collection and reported 225 individual PSIs. At the close of the data collection period, a total of 19,108 patient contacts (new patient consultations and follow up visits) had occurred. This means that for 1.2% of patient contacts, a PSI was reported. The PSIs involved 137 female and 86 male patients (missing data: n = 2) and patient mean age was 46.7 years (S.D. = 21.1; range: 3 months to 99 years; missing data: n = 8). Where did the PSI happen? The great majority (87%) of PSIs happened in the clinic’s consultation and treatment rooms. This was followed by the administrative areas for either clinic reception and records staff (2.7%) or the
The reporting of patient safety incidents students’ lounge and filing room (2.2%). Just over 1% of PSIs occurred for each location respectively, either within the clinic building’s stairs and hallways, the rehabilitation department, the radiogra-
Figure 1
143 phy department, the tutors’ consultation room or the car parking areas. In 2.2%, the PSI had occurred off-site and, most commonly, within the patient’s home.
(a) Front page of CRLS form and (b) reverse page of CRLS form.
144
H. Thiel, J. Bolton
Types of PSIs reported Fig. 2 shows the distribution of PSIs according to incident type. From this, it is apparent that either misuse of therapeutic equipment (32%) or the treatment intervention itself (31%) were most frequently reported in association with the occurrence of a PSI.
Table 4 shows examples of PSIs reported in the AECC teaching clinic. Grading of harm In 64% of the PSIs, the students felt that no harm had occurred to the patient. Thirty-five percent of the
Figure 1. (Continued ).
Patient gender
Patient age
Location of PSI
Description of PSI
Reason for PSI
Grading of harm and follow up care
Relationship between suspected cause and PSI
Female
39
Treatment room
Dizziness, nausea following cervical spine manipulation
Undetermined, possibly dislodged otoliths
Low GP and medication
Likely
Male
62
Treatment room
Increased low back pain following massage with elbow
New practitioner applying other than usual therapeutic technique
Low Extra treatment
Likely
Female
58
Treatment room
Increased thoracic back pain following spinal manipulation
Undetermined, practitioner reported ‘‘dramatic release of joint with several cracks’’
Low Extra treatment
Likely
Female
59
Treatment room
Dizziness, blurred vision and headache following cervical spine manipulation
Undetermined
Low GP and medication
Likely
Female
39
Treatment room
Delayed diagnosis of Chiari I malformation
Referred by neurosurgeon for treatment of disc herniation, no imaging studies performed due to pregnancy
Near miss Ongoing monitoring
Unlikely
Female
45
Treatment room
Missed diagnosis of lumbar disc herniation
Returning patient with a tendency to exaggerate symptoms in the past
Moderate Surgery
Uncertain
Male
Not reported
Treatment room
Petit mal seizure following spinal manipulation
Undetermined
Low Rest
Likely
Male
Not reported
Treatment room
Fractured rib following spinal manipulation
Undetermined, possibly force of manipulative thrust
Moderate Rest and medication
Likely
The reporting of patient safety incidents
Table 3 Summary of patient safety incidents as reported by individual chiropractors (PSI, patient safety incident)
145
Figure 2 Types and frequency of PSIs reported by final year clinical students *C,C,C, consent, communication, confidentiality.
PSIs involved ‘‘low harm’’ or where the incident required extra observation or minor treatment (additional therapy or medication over short period of time, does not include admission to hospital or attending as an outpatient on repeated occasions). In only two (1%) instances, moderate harm had occurred where the incident resulted in a moderate increase in additional treatment (admission to hospital or attending as an outpatient on repeated occasions, or requiring surgery or prolonged episodes of care) and caused significant but not permanent harm. One hundred and twenty-two (54%) of the PSIs were classified as near misses, i.e. no harm had occurred although the incident had the potential to cause harm but was prevented either by chance or deliberate action.
Relationship between suspected cause and PSI A likely relationship between suspected cause and incident was thought to have existed in 80% of the cases whilst it had been deemed as unlikely in a very small minority 2% and uncertain in 18%.
Discussion To our best knowledge, the CRLS is the first system that has been specifically designed to capture data in a proactive and structured fashion on PSIs associated with chiropractic treatment. As the primary purpose of incident reporting is to reduce harm to patients and practitioners, it would be difficult to accept how the introduction of a specific reporting
Table 4 Examples of PSIs reported (in descending order of occurrence) Stepping on electrical pedals, not locking parts of bench Excessive bruising, scratching of patient Not attending to elderly patient, resulting in slip or fall Wrong file for right patient, right file for wrong patient Faulty patient handling, technique, stepping on patient’s hand Unauthorised treatment, not following supervision protocol Wrong diagnosis, no consent to treatment Lack of tutor availability for supervision, advice Not knowing how to use equipment (treadmill, electrotherapy equipment, ice bag, hot pack) Bean-bag with baby slipping off bench Child’s finger stuck in Activator device mechanism
The reporting of patient safety incidents and learning system designed for chiropractors could not be interpreted as something of benefit. Chiropractic treatment is generally regarded to be a safe and low risk activity. However, the number of clinical studies conducted so far into safety issues of chiropractic treatment and practice could still be considered to be too small to provide a full picture and thorough understanding. Incident reporting by chiropractors would permit the systematic collection of nationwide incident data. This would allow the analysis of trends, which would help to identify certain risks associated with different treatment interventions or patient interactions. Incident reporting could also have a positive effect on chiropractic claims management and legal outcomes. Lessons learnt from previously reported incidents would allow the chiropractic profession to manage possible future and similar claims in a more proactive manner.
Field chiropractors If the above were true, one would therefore have to ask the question why so few reports were returned from the chiropractors in the field. The reliability of any incident reporting system depends primarily on how many of the events that have occurred that it actually captures. Studies involving reporting systems designed for medical care and conducted in North America, the UK and Sweden would suggest that the rate of adverse event reporting can vary significantly between different countries, medical specialities and hospitals, and that quite commonly lower than half of incidents are being reported.14,23 Some of the main reasons why clinicians do not report incidents are fear of blame or of increased medico-legal risk, a high workload and the belief that the circumstances of a particular case did not warrant a report.24,25 Other barriers to reporting may include a sense of failure, in that our professional culture tends to personalise error and seeks and expects perfection. Chiropractors are trained to expect high standards of performance from themselves, and some may find it difficult to acknowledge and learn from things that have not gone as well as expected. It is also likely that, for some, the intent and benefit of standardised reporting were not clear from the outset, or that the reporting of near misses was seen as a pointless and time-consuming activity. Lessons from sectors other than health care, such as commercial aviation and the oil and gas industry, have demonstrated that, in order to achieve exemplary safety records, the development of the right organisational and professional culture is necessary first.26 If the culture of an organisation is safety conscious and people are encouraged to speak up
147 about mistakes, then safety is improved.5 In other words, we need to ask, ‘‘what went wrong’’ and not ‘‘who went wrong’’; we need to cultivate a blamefree environment, without fear of personal reprimand and we need to replace secrecy and misplaced professional solidarity with the attitudes, language and habits of quality improvement. Reporting must occur on a voluntary basis or anonymously, as these are the only ways for practitioners to tell the complete story without fear of retribution.27 An incident reporting system for chiropractors can therefore not be directly linked to, or administered by, the statutory regulator, as a practitioner may not want to report directly to an authority with disciplinary powers. It is a well-known fact that the changing of values, beliefs and attitudes is not easily accomplished, and that it generally takes several years for established clinical practices to be altered or adapted in light of newly established evidence, procedures or protocols. The leadership of any team, organisation or profession is central to setting the values and beliefs of its culture.28 The leaders within the chiropractic profession therefore have a vital part to play in building a safety culture that is both open and fair. They need to promote an environment where chiropractors are encouraged to report, collaborate and learn from PSIs.
AECC teaching clinic It should be of no great surprise to anyone that the response rate and results obtained for the student cohort were so different in comparison to those of the field chiropractors. The fact that having a captive audience of emerging and mouldable clinicians within the setting of a learning environment and culture automatically prevents the transference of most, if not the entire, student results into general chiropractic practice. These results are, however, very much applicable to the pedagogic setting of a chiropractic teaching clinic and, as such, contribute greatly to the knowledge base in reference to patient safety within this background. In this instance, immediate repairs were undertaken of equipment previously unknown to have been defective, and specific notices were put up within some of the clinic’s treatment rooms to minimise the chances of further equipment misuse. Furthermore, the results were distributed amongst members of clinical faculty and discussed with the final year student cohort for reflection and learning to occur. Finally, the students were asked to undertake a second round of PSI data collection with a view to report on any changes or similarities on incident data towards the end of their clinical
148 education. Following this, the CRLS will be adapted to become an integral part of the AECC teaching clinic’s protocols and procedures and contribute towards the learning portfolio of final year students. At this point in time, we do not know whether the frequency of 1.2% for PSIs reported for the AECC chiropractic teaching clinic represents a true or acceptable rate due to the lack of appropriate comparisons. Estimates from the medical literature seem to indicate that 11% of patients admitted to hospitals in England and Wales each year experience a preventable adverse event.29 The rate for PSIs within the primary care setting is less well established, ranging from 5 to 80 per 100,000 consultations.30
Conclusions This pilot study constitutes an initial report on the first experiences gained from the introduction of a voluntary or anonymous incident reporting system within the chiropractic profession in the UK. In itself, it does not provide many helpful answers regarding the frequency and types of PSIs associated with chiropractic care; it rather poses further questions and emphasises the need for ongoing enquiry or study in this area. For example, we plan to embark on a qualitative study to elucidate possible barriers to patient incident reporting by chiropractors. We hope that these preliminary and limited results of this pilot will help to draw the attention of chiropractors within the UK and elsewhere to the importance of implementing the attributes of a safety and informed culture within the chiropractic profession by the introduction of patient safety incident reporting systems. We realise that the knowledge gained from an opportunistic incident reporting system can only provide one part of the puzzle when it comes to the overall assessment of the risks and benefits of a certain treatment approach. Other pieces of information are contributed by clinical trials, specific retrospective or prospective studies on unwanted treatment effects and knowledge gained from medico-legal and insurance claim data. Probably one of the key messages in relation to the reporting of incidents and near misses is that a reporting system will provide an important opportunity to learn from the experiences of one patient or chiropractor in order to reduce the risk of something similar happening to others.
Author contribution statement HT conceived the idea for the pilot study. HT and JB contributed to the design and planning of the
H. Thiel, J. Bolton research and were responsible for the data collection. HT analysed the data. HT and JB wrote the first draft of the manuscript. Conflict of interest HT is Head of Clinic of the AECC and is a member of the BCA. No funding was received for this study.
Acknowledgements We thank the British Chiropractic Association for their help and support with the graphical design and distribution of the CRLS amongst its members. We are especially grateful to those chiropractors who submitted PSI related reports and to the Class of 2006 who pioneered the use of the CRLS in the AECC teaching clinic.
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