Litigation and complaints associated with day-case anaesthesia

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1 BJA Education, 17 (9): (2017) doi: /bjaed/mkx011 Advance Access Publication Date: 10 May 2017 Matrix reference 1F01, 2A03, 3A06 Litigation and complaints associated with day-case anaesthesia A Pearson BMedSci BMBS(Hons) FRCA 1, * and T Cook BA(Hons) MBBS FRCA FFICM 2 1 Specialist Registrar, Department of Anaesthesia and Intensive Care, Royal United Hospital, Bath BA1 3NG, UK and 2 Consultant in Anaesthesia and Intensive Care, Department of Anaesthesia and Intensive Care, Royal United Hospital, Bath, UK *To whom correspondence should be addressed. Tel: ; amepearson@doctors.org.uk Key points Increasingly complex and longer procedures are being performed in day-case settings on older, higher risk patients. Patients with diagnosed and treated obstructive sleep apnoea and stable co-morbidities should not be excluded from day surgery providing that opiate-free analgesia is sufficient for postoperative pain control. Before day-case procedures, anaesthetists must ensure that patients have read, understood, and agreed to comply fully with postoperative instructions. Tonsillectomy is a common day-case procedure that may lead to significant complications; anaesthetists are disproportionately implicated in associated medicolegal claims. Despite potential clinical benefits, regional anaesthesia is associated with relatively more litigation than general anaesthesia. Day surgery continues to increase in popularity due to improved patient experience, safety benefits, and economic pressures to increase hospital productivity and efficiency. This approach has been made possible by improved anaesthetic pharmacology, increased use of regional anaesthesia, and innovative surgical techniques, and there is now an expectation that surgery should be day-case based wherever possible. While there are numerous well-accepted benefits for patients and health care organizations in performing surgery on a day-case basis, one problem with this approach is determining exactly what is possible and what is safe. Day-case procedures are no longer specific to American Society of Anaesthesiologists physical status classification grades one and two patients having brief and straightforward procedures; inclusion criteria have expanded to include more high-risk patients (e.g. the elderly and the obese) undergoing increasingly complex and prolonged surgical procedures. Patients with acute conditions presenting for urgent surgery are also now being managed within day-case pathways. 1 These changes increase the risk of patient harm and the possibility of litigation. This article examines the recent literature around litigation and complaints that occur in day-case anaesthesia and discusses themes especially pertinent to this area of practice. Litigation and patient safety incidents The study of litigation associated with medical practice serves two purposes. Firstly, it offers insight into patterns of important patient safety incidents, thereby leading to strategies to reduce patient harm. When patient safety incidents occur, a proportion of each likely leads to a complaint, and a subset of these, to litigation. Notably, however, the patterns and associations are less clear than might be anticipated. Editorial decision: February 25, 2017; Accepted: March 17, 2017 VC The Author Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please journals.permissions@oup.com 289

2 Secondly, understanding why patients litigate, and by implication, which factors lead to dissatisfaction with services provided, enables clinicians to modify practice to reduce patient dissatisfaction and litigation. This has potential benefit in the services provided and also in health economics. Based on UK data, anaesthetists are considerably less likely to be sued than surgeons. In 2009, claims against anaesthetists accounted for 2.5% of claims to the NHS Litigation Authority, both by number and by cost of claims; 2 surgeons and obstetricians accounted for approximately 70% of claims and costs. As anaesthetists are involved in the clinical care of approximately two-thirds of hospital admissions, anaesthesia is a low-risk medicolegal specialty 3 in terms of litigation. General trends in day-case litigation Patient demographics Studies provide some evidence of factors that increase the risk of complaints or litigation in anaesthesia for day surgery. Kynes et al. 4 examined risk factors associated with patient complaints in day-case anaesthesia. Of the follow-up calls made, 307 (1.34%) yielded a complaint. Factors associated with increased risk of complaints included interviewing the patient rather than their relative, younger age, female sex, case delay, sedation, and regional anaesthesia (RA). General anaesthesia (GA) led to a reduced risk of complaint. Complaints were predominantly about care, treatment, and communication. The finding of increased complaint with techniques other than GA is notable; in the UK, approximately 23% of anaesthesia care involves surgery without GA, 5 but RA accounts for approximately 40% of anaesthesia claims. 6 Previous studies have shown that face-toface questioning or telephone conversations yield lower complaint rates than anonymous questionnaires. Inpatient vs outpatient claims Bishop et al. 7 examined > successful malpractice claims in the USA and compared number, magnitude, and type of claim in inpatient and outpatient settings. Although this study was not limited to surgical or anaesthesia care and the outpatient group included numerous non-surgical outpatient settings, the study noted the number of paid malpractice claims from the two settings were similar and generally decreasing, but that the rate of decline for inpatient claims was greater than for the outpatient setting. The mean payment amount for claims from the inpatient setting remained significantly higher than for outpatient claims. Almost two-thirds of successful outpatient claims were for major injury or death. Inpatient claims were more likely to relate to surgical claims and outpatient claims to diagnostic procedures. Most initiatives to prevent injuries to patients have focused predominantly on the inpatient setting and as more surgical procedures are moved into day-case settings, a shift of focus may be needed. Day surgery is increasingly performed in small, high-turnover, protocol-driven units, and it is a challenge to ensure patient-focused quality assurance and quality improvements penetrate these environments. ASA Closed Claims Project The ASA Closed Claims Project (ASACCP) database reported on liability and day-case anaesthesia in The data set represented 552 (23%) outpatient and 1874 (77%) inpatient claims for adverse events since The study noted 23% of claims arising from day surgery, despite nearly 50% of procedures being performed as day surgery. Again, the proportion of day-case-related claims was noted to be increasing: 20% of claims between 1985 and 1989 and 26% between 1990 and 1995 (P < 0.05). Day surgery claimants were younger than inpatient claimants, perhaps reflecting the increased number of paediatric patients undergoing day surgery and the elderly higher risk inpatient population. Female claimants were more common in both groups. 8 Surgical procedures associated with anaesthesia claims differed between settings. In day-case claims, orthopaedic extremity procedures; ear, nose and throat; dental; ophthalmic; and gynaecological surgery predominated. These comprised twothirds of claims and were >two-fold more common in day surgery (66%) compared with inpatient claims (27%). 8 Non-GA techniques (RA and monitored anaesthesia care) again were over-represented. The nature of events leading to a claim also differed between settings. Adverse respiratory events (difficult intubation, inadequate oxygenation or ventilation, and airway obstruction), cardiovascular events, and equipment-related events were similar in both settings. However, events unrelated to these were increased in the day-case setting (26% day case vs 15% inpatient). These included regional block placement (including block needle trauma, high block, or dural puncture), eye injury in ophthalmic patients because of movement or coughing, and wrong-sided surgery or wrong surgical procedure performed. The extent of injuries associated with day-case claims were generally less severe, being mostly temporary or non-disabling, with death or brain damage being significantly more common in inpatients. Payment frequency was similar in both groups, but the payment amounts were significantly lower for day-case claims. Of note, the ASACCP has limitations; it only includes claims from approximately 50% of insurers, only studies closed claims, and its analyses have an inherent lag of up to a decade between most recent claim and publications. Despite this, the data are consistent with other studies, indicating that claims against anaesthetists in the day-case setting involve a different patient group, a different spectrum of events leading to claims, and a different degree of associated injury compared with inpatients. Specific situations relevant to day-case anaesthesia Obesity and obstructive sleep apnoea In 1992, the Royal College of Surgeons (UK) guidelines stated that patients with a body mass index (BMI) >30 kg m 2 should be excluded from day-case services. 9 In 2002, the NHS Modernisation Agency raised this limit to 35 kg m 2 and up to 40 kg m 2 for certain procedures. 10 More recent guidance produced by the British Association of Day Surgery (BADS) and the Association of Anaesthetists of Great Britain and Ireland (AAGBI) set no upper limit, suggesting that obesity in itself is not a contraindication to day surgery and that morbidly obese patients can be managed safely in expert hands. 2 The incidence of obesity is increasing worldwide, and it is therefore likely that such patients will attend for day surgery with increasing frequency. The incidence of complications during the perioperative period is increased in patients with elevated BMI; these patients benefit from the short-duration anaesthetic techniques and early mobilization associated with day surgery. Therefore, patients with an elevated BMI have both an increased perioperative risk and the potential to benefit 290 BJA Education Volume 17, Number 9, 2017

3 Table 1 STOP-BANG questionnaire. High risk of OSA: answering yes to three or more items. Low risk of OSA: answering yes to less than three items. OSA, obstructive sleep apnoea. The higher the score, the greater the risk and severity of OSA. Reproduced with permission from Lippincott Williams and Wilkins/Wolters Kluwers Health: Chung F, Yegneswaran B, Liao P, et al. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008; 108(5): Snoring Do you snore loudly (louder than talking or loud enough to be heard through closed doors)? 2. Tired Do you often feel tired, fatigued, or sleepy during the daytime? 3. Observed Has anyone observed you stop breathing during your sleep? 4. Blood Pressure Do you have or are you being treated for high blood pressure? 5. BMI BMI more than 35 kg m 2? 6. Age Age over 50 yr old? 7. Neck circumference 8. Gender Gender male? Neck circumference greater than 40 cm? from day care, where this can be safely delivered. A specific complication of obesity relevant to day surgery is obstructive sleep apnoea (OSA). The prevalence of OSA is increasing alongside the increase in obesity, and as size limitations are relaxed, anaesthetists are likely to encounter these patients frequently in the day-case setting. 11 Of particular concern is that many patients with OSA are undiagnosed. Singh et al. 12 reported that surgeons (and anaesthetists) failed to identify 58% (15%) of patients with known OSA and 92% (60%) of those with moderate severe undiagnosed OSA. The suitability of patients with OSA for discharge on the day of surgery remains controversial because of the risks associated with the perioperative period. The 2006 ASA practice guidelines 13 for the perioperative management of patients with OSA advised patient selection for day surgery should depend upon the severity of OSA, invasiveness of surgery, associated co-morbidities, type of anaesthesia, postoperative opioid requirements, and adequacy of postdischarge observation. These guidelines were subsequently updated in a consensus statement from the Society for Ambulatory Anesthesia in 2012, 11 including in its evidence base, case series demonstrating success with laparoscopic bariatric surgery, and the value of the STOP-BANG questionnaire 14 screening tool (see Table 1). The statement recommended that (i) patients with diagnosed and treated OSA and stable comorbidities should not be excluded from day surgery and (ii) those identified by screening tools as being at risk of OSA with stable co-morbidities could be offered day surgery, providing that opiate-free analgesia is sufficient for postoperative pain control. A patient s ability to follow postoperative instructions, specifically compliance with existing treatment, particularly the use of continuous positive airways pressure breathing systems, is critical. Those patients with non-optimized comorbidities or those requiring opioid analgesia postoperatively were felt to not be suitable candidates for day surgery. OSA is not exclusive to the obese population and OSA associated with tonsillectomy is discussed below. Available studies examining OSA patients undergoing daycase procedures offer some reassurance. For example, Kurrek et al. 15 reported no death (at 30 days), respiratory failure, or reintubation in 1135 patients with confirmed OSA or at high risk of OSA undergoing day-case laparoscopic gastric banding. Anaesthesia-related morbidity was <0.5%. Transient desaturation (<93%), however, was seen in 39.5%. Risk factors for desaturation include BMI >35 kg m 2, increased age, chronic obstructive pulmonary disease, upper extremity surgery, and use of a peripheral nerve block. While the available studies offer some reassurance, the case series are small and focus on frequent minor complications rather than rare, major complications. They include many patients at risk of OSA rather than diagnosed with OSA and do not stratify risk according to OSA severity. As many studied patients underwent surgery under RA, the implications for GA are uncertain. The studies also focus on complications rather than litigation. A critical message is the high proportion of patients with OSA who are undiagnosed prior to surgery. The STOP- BANG screening tool is recommended to identify patients at risk of OSA. Preoperative screening and careful selection is imperative: patients diagnosed or suspected of having OSA should be managed with a systematic algorithm to improve outcomes. Discharge criteria An area of complication and potential litigation specific to day surgery surrounds discharge safety on the day of surgery. The AAGBI guideline 1 for day-case surgery describes benefits of nurse-led discharge and the adaptation of protocols to enable low-risk patients to be discharged without fulfilling traditional discharge criteria. The British Association of Day Surgery discharge guidelines include suggested discharge criteria to aid decision making (see Table 2). 1,16 It is recommended that patients receive both written and verbal discharge information, preferably in the presence of a responsible adult who is able to care for and escort them home. 1 While some recommend providing this on discharge, it is logical to provide this preoperatively while reinforcing it postoperatively, as recall of new information provided shortly after anaesthesia may not be retained. When provided postoperatively, it should be >40 min after anaesthesia and should include written information. While the consent process for patients undergoing day-case procedures does not differ greatly from those undergoing inpatient procedures, clear discussion of the discharge process and providing the patient with appropriate information for postoperative care may be an important exception. Various studies have shown significant psychomotor and cognitive impairment after anaesthesia and therefore an adult escort should accompany patients home after day surgery/anaesthesia. 17 The AAGBI, the Canadian Anesthesiologists Society, and the Australian Day Surgery Council all recommend that patients do not drive for 24 h after day-case surgery. 18 Studies reveal widespread issues with clinicians and patients underestimating the risks of discharge without an escort, lack of compliance with discharge guidelines, and failure to comply with escort rules. Studies from Canada 17 and the UK 18 both found many patients failed to comply with postoperative instructions including driving vehicles (4%), consuming alcohol (2%), making important decisions or caring for children BJA Education Volume 17, Number 9,

4 Table 2 Discharge checklist for day surgery reproduced with permission. Reproduced from Association of Anaesthetists of Great Britain and Ireland; British Association of Day Surgery. Day case and short stay surgery: 2. Anaesthesia 2011; 66(5): Copyright VC 2011 John Wiley and Sons; 1 and the British Association of Day Surgery. Nurse Led Discharge. London: BADS, Criteria N/A Initials Details Vital signs stable Orientated to time, place and person Passed urine (if applicable) Able to dress and walk (where appropriate) Oral fluids tolerated (if applicable) Minimal pain Minimal bleeding Minimal nausea/ vomiting Cannula removed Responsible escort present Has carer for 24-h post op Written and verbal post op instructions Knows who to contact in an emergency Follow-up appointment Removal of sutures required? Referrals made Dressings supplied Patient copy of GP letter Carbon copy of consent Sick certificate Has taken home medication Information leaflet for tablets Post op phone call required Discharged by: Nurse s signature. Date/Time. Print Name. Next dose: (up to 10%), or not being escorted (13%) within 24 h after day surgery. Similarly, there are reports of incomplete compliance by clinicians, with anaesthetists willing to anaesthetize daycase surgical patients with the knowledge that they did not have an escort to accompany them home. Information about discharge arrangements and aftercare should be provided before admission and reinforced on the day of surgery as part of the consent process. To avoid patient risk, risk to others, and litigation, patients need to be accompanied home after anaesthesia or sedation. Understanding and complying with postoperative instructions and the presence of an escort who will remain with the patient for 24 h after anaesthesia should be reinforced as basic mandatory requirements for undergoing the procedure. That such arrangements are in place should be confirmed for all patients before all procedures. Enforcing these rules is for the protection of all parties. Specific surgical procedures associated with anaesthesia claims Tonsillectomy Tonsillectomy is a very common day-case procedure for both children and adults to treat sleep-disordered breathing (or sleep apnoea) and recurrent infections. It is considered to be a lowrisk procedure in terms of the medicolegal risk compared with frequency of procedures; however, anaesthetists are disproportionately implicated in medicolegal claims associated with this procedure. Tonsillectomy may lead to significant complications, such as life-threatening haemorrhage, difficult intubation during management of bleeding, and opioid-related anoxic injuries or death, each having implications for anaesthetic malpractice claims. Morris et al. 19 reported from the USA that anaesthetists were the principal defendants in 18% of tonsillectomy claims and that awards against anaesthetists were more frequent and higher than against surgeons (mean $5 million vs $ ). Death or major injury occurred in 52% of court cases, with a mean award of $3.8 million, and most cases of death or major injury attributable to airway complications. Subramanyam et al. 20 reported on malpractice claims from a large US litigation database following tonsillectomy in children, with an emphasis on anaesthesia- and opioid-related claims. Of the 242 claims, 40.5% related to fatality (median age 7 years) and 59.5% to non-fatal injuries (median age 14 years). The primary causes for fatal claims were surgical factors (39.8%), anaesthesia factors (36.7%), and opioid-related factors (16.3%). Non-fatal claims showed a higher proportion of surgical cases. The largest contributors for all anaesthesia claims were medications and difficult airways. A total of 16.3% fatal and 4.2% non-fatal injury claims (22 patients) related to opioid use, with morphine and codeine being the most commonly implicated opioids in the fatal group. The opioid-related claims had the largest monetary awards for both fatal and non-fatal claims. Post-tonsillectomy analgesia is a significant challenge, particularly in children. Due to variations in metabolism, codeine poses a risk of opioid-induced respiratory complications in ultrafast metabolizers, and this has led to severe restrictions on the use of codeine in children in any setting in the UK. To complicate matters in some settings, concerns over bleeding risk may lead to local decisions to avoid non-steroidal anti-inflammatory drugs. Safe and effective alternatives to these drugs are currently uncertain. The complexity of post-tonsillectomy analgesia poses both a challenge to clinicians and perhaps a risk for future litigation if not resolved. Tonsillectomy is now increasingly being performed for patients with sleep apnoea. In Subramanyam et al. s study, 20 sleep apnoea was recorded more often in fatal claims than in nonfatal claims. It is recognized that younger children with sleep apnoea have an increased risk of complications when compared with their older counterparts. As it can be difficult to diagnose sleep apnoea in children, careful clinical assessment and appropriate investigation by those experienced in its interpretation is key to identifying those at increased risk. Of note, the studies do not compare the safety of day-case vs inpatient tonsillectomy. Tonsillectomy, performed as a daycase procedure, is generally safe but is associated with significant complications and litigation. Litigation includes a higher than usual proportion of cases citing anaesthetists and fatality. Current concerns and recommendations on analgesic prescription may preclude day-case care for some patients. This likely includes patients with sleep apnoea or known opioid 292 BJA Education Volume 17, Number 9, 2017

5 sensitivity. When performed as day-case surgery, it is vital to ensure patient safety before discharge, and this requires a significant period of observation (e.g. 6 h) to exclude primary bleeding and to establish effective analgesia. Regional anaesthesia Despite potential clinical benefits, RA is associated with relatively more litigation than GA. 2,6 Avoidance of GA is also associated with more patient complaints in ambulatory care. 4 RA offers benefits to patients undergoing day surgery, including rapid return to normal functioning and prolonged post-discharge analgesia. Ophthalmic surgery and orthopaedic extremity surgery are particularly suited as a result of patient frailty and the need for prolonged analgesia. The use of RA is likely increasing in day surgery, including as a sole technique. As patients may be discharged with RA still working, ensuring the patient is informed to avoid inadvertent secondary injury to an insensate part of the body is a particular concern. It is a challenge to monitor patients after discharge, but clinicians must ensure patients are provided with appropriate information and that they can report complications should they arise. Emerging electronic or web-based tools may improve follow-up and surveillance after discharge. RA has obvious benefits for patients undergoing day surgery but, as in all anaesthesia settings, may expose the anaesthetist to an increased risk of litigation. Ensuring informed consent, block performance by an appropriately trained and skilled individual and clear information regarding aftercare are all critical to providing a low-risk service. Conclusion Day surgery has undergone a revolution in the last two decades. Litigation in this area has historically been less frequent than in inpatient settings and associated with lesser injuries and lower payouts. More recently, increasingly complex and longer procedures are being performed in day-case settings on older, less healthy, and more obese patients. There is increasing pressure to avoid unplanned admission and to discharge patients rapidly. The transfer of increasingly complex surgery is likely to increase the extent of surgical-related litigation. RA may offer patient benefits and improve efficiency but may increase the risk of litigation against anaesthetists. Anaesthetists are advised to ensure (whether directly or indirectly) before anaesthesia that patients have read, understood, and agreed to comply fully with postoperative instructions and that they will be accompanied home by an escort and supervised for 24 h. OSA should be specifically screened for before admission and by the anaesthetist at the preoperative visit. Other areas of particular concern for anaesthetists regarding litigation include children and younger adults, tonsillectomy, opioid prescribing, and issues relating to discharge. Analyses in this area are limited due to a lack of recent data and an absence of recent large studies specific to day surgery and anaesthesia. Litigation against anaesthetists in day-case settings is a topic ripe for further research. Declaration of interest None declared. MCQs The associated MCQs (to support CME/CPD activity) can be accessed at by subscribers to BJA Education. References 1. Association of Anaesthetists of Great Britain and Ireland; British Association of Day Surgery. Day case and short stay surgery: 2. Anaesthesia 2011; 66: Cook TM, Bland L, Mihai R, Scott S. Litigation related to anaesthesia: an analysis of claims against the NHS in England Anaesthesia 2009; 64: Audit Commission. Anaesthesia Under Examination. London: Audit Commission, Available from audit-commission.gov.uk/auditcommission/subwebs/publi cations/studies/studypdf/1712.pdf (accessed 11 April 2014) 4. Kynes JM, Schildcrout JS, Hickson GB et al. An analysis of risk factors for patient complaints about ambulatory anesthesiology care. Anesth Analg 2013; 116: Sury MRJ, Palmer JHMG, Cook TM, Pandit JJ. The state of UK anaesthesia: a survey of National Health Service activity in Br J Anaesth 2014; 113: Szypula K, Ashpole KJ, Bogod D et al. Litigation related to regional anaesthesia: an analysis of claims against the NHS in England Anaesthesia 2010; 65: Bishop TF, Ryan AM, Casalino LP. Paid malpractice claims for adverse events in inpatient and outpatient settings. JAMA 2011; 305: Posner KL. Liability profile of ambulatory anesthesia. ASA Newsletter 2000; 64: Royal College of Surgeons of England. Commission on the Provision of Surgical Services. Guidelines for Day Case Surgery. London: HMSO, Department of Health. NHS Modernization Agency: National Good Practice Guidelines on Pre-operative Assessment for Day Surgery. London: The Stationery Office, Joshi GP, Ankichetty SP, Gan TJ, Chung F. Society for Ambulatory Anesthesia consensus statement on preoperative selection of adult patients with obstructive sleep apnea scheduled for ambulatory surgery. Anesth Analg 2012; 115: Singh M, Liao P, Kobah S, Wijeysundera DN, Shapiro C, Chung F. Proportion of surgical patients with undiagnosed obstructive sleep apnoea. Br J Anaesth 2013; 110: Gross JB, Bachenberg KL, Benumof JL et al. American Society of Anesthesiologists Task Force on Perioperative Management. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology 2006; 104: BJA Education Volume 17, Number 9,

6 14. Chung F, Yegneswaran B, Liao P et al. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology 2008; 108: Kurrek MM, Cobourn C, Wojtasik Z, Kiss A, Dain SL. Morbidity in patients with or at high risk for obstructive sleep apnea after ambulatory laparoscopic gastric banding. Obes Surg 2011; 21: British Association of Day Surgery. Nurse Led Discharge. London: BADS, Ip HYV, Chung F. Escort accompanying discharge after ambulatory surgery: a necessity or luxury? Curr Opin Anaesthesiol 2009; 22: Cheng CJ, Smith I, Watson BJ. A multicenter telephone survey of compliance with postoperative instructions. Anaesthesia 2002; 57: Morris LG, Lieberman SM, Reitzen SD et al. Characteristics and outcomes of malpractice claims after tonsillectomy. Otolaryngol Head Neck Surg 2008; 138: Subramanyam R, Chidambaran V, Ding L, Myer CM, Sadhasivam S. Anesthesia- and opioids-related malpractice claims following tonsillectomy in USA: LexisNexis claims database Paediatr Anaesth 2014; 24: BJA Education Volume 17, Number 9, 2017