The number of clinical negligence claims in the UK is constantly increasing. As a specialty, trauma and orthopaedic surgery has one of the highest numbers of negligence claims.¹ This study analyses NHS Litigation Authority (NHSLA) claims in trauma and orthopaedics between 2004 and 2014.

A formal request was made to the NHSLA under the Freedom of Information Act in order to obtain all data related to claims against orthopaedic surgery. It was found that the number of claims, and percentage of successful claims, has been constantly increasing over this period, with compensation paid of over £349 million.* Errors in clinical management accounted for the highest number of closed claims (2933 claims), costing over £119 million.*

The level of compensation paid out has a significant financial impact on the NHS. Reforms need to be made in order to tackle the high cost of legal fees generated by these claims, which further drain the limited resources available to the NHS.

We present a review of litigation claims relating to foot and ankle surgery in the NHS in England during the 17-year period between 1995 and 2012.

A freedom of information request was made to obtain data from the NHS litigation authority (NHSLA) relating to orthopaedic claims, and the foot and ankle claims were reviewed.

During this period of time, a total of 10 273 orthopaedic claims were made, of which 1294 (12.6%) were related to the foot and ankle. 1036 were closed, which comprised of 1104 specific complaints. Analysis was performed using the complaints as the denominator. The cost of settling these claims was more than £36 million.

There were 372 complaints (33.7%) involving the ankle, of which 273 (73.4%) were related to trauma. Conditions affecting the first ray accounted for 236 (21.4%), of which 232 (98.3%) concerned elective practice. Overall, claims due to diagnostic errors accounted for 210 (19.0%) complaints, 208 (18.8%) from alleged incompetent surgery and 149 (13.5%) from alleged mismanagement.

Our findings show that the incorrect, delayed or missed diagnosis of conditions affecting the foot and ankle is a key area for improvement, especially in trauma practice.

Cite this article: Bone Joint J 2014;96-B:1510–14.

The “Universal Protocol” (UP) was launched as a regulatory compliance standard by the Joint Commission on 1st July 1 2004, with the primary intent of reducing the occurrence of wrong-site and wrong-patient surgery. As we’re heading into the tenth year of the UP implementation in the United States, it is time for critical assessment of the protocol’s impact on patient safety related to the incidence of preventable never-events. This article opens the debate on the potential shortcomings and pitfalls of the UP, and provides recommendations on how to circumvent specific inherent vulnerabilities of this widely established patient safety protocol.

The results of hip and knee replacement surgery are generally regarded as positive for patients. Nonetheless, they are both major operations and have recognised complications. We present a review of relevant claims made to the National Health Service Litigation Authority. Between 1995 and 2010 there were 1004 claims to a value of £41.5 million following hip replacement surgery and 523 claims to a value of £21 million for knee replacement. The most common complaint after hip surgery was related to residual neurological deficit, whereas after knee replacement it was related to infection. Vascular complications resulted in the highest costs per case in each group.

Although there has been a large increase in the number of operations performed, there has not been a corresponding relative increase in litigation. The reasons for litigation have remained largely unchanged over time after hip replacement. In the case of knee replacement, although there has been a reduction in claims for infection, there has been an increase in claims for technical errors. There has also been a rise in claims for non-specified dissatisfaction. This information is of value to surgeons and can be used to minimise the potential mismatch between patient expectation, informed consent and outcome.

Cite this article: Bone Joint J 2013;95-B:122–6.

Wrong-level surgery is a unique pitfall in spinal surgery and is part of the wider field of wrong-site surgery. Wrong-site surgery affects both patients and surgeons and has received much media attention. We performed this systematic review to determine the incidence and prevalence of wrong-level procedures in spinal surgery and to identify effective prevention strategies. We retrieved 12 studies reporting the incidence or prevalence of wrong-site surgery and that provided information about prevention strategies. Of these, ten studies were performed on patients undergoing lumbar spine surgery and two on patients undergoing lumbar, thoracic or cervical spine procedures. A higher frequency of wrong-level surgery in lumbar procedures than in cervical procedures was found. Only one study assessed preventative strategies for wrong-site surgery, demonstrating that current site-verification protocols did not prevent about one-third of the cases. The current literature does not provide a definitive estimate of the occurrence of wrong-site spinal surgery, and there is no published evidence to support the effectiveness of site-verification protocols. Further prevention strategies need to be developed to reduce the risk of wrong-site surgery.

The aim of this study was to prospectively assess the results of a preoperative surgical safety checklist by comparing the initial phase of implementation of the Time Out Procedure (TOP) to the results four years later. We compared the accuracy and acceptance of the TOP to determine whether surgical practice had changed. The TOP was initiated for all elective surgical procedures performed in Christchurch in 2004. An initial audit from September 2004 – April 2005 (Phase 1) was compared to one from October 2008-September 2009 (Phase 2) looking for an improvement in completion of the procedure. Variances were recorded and analysed within the categories of 1 System and process 2 Consent and limb marking 3Incorrect details and 4 Near miss. A questionnaire was also sent to all the surgeons to determine their attitude towards the TOP. Although the TOP was completed more often in Phase 2 (98%, p<0.001) there were more variances (9%, p<0.001). The commonest variance was due to the surgeon and assistant not being present at the TOP which was significantly worse than in Phase 1 (p<0.0001). The results of the surgeon questionaire showed that only 88% agreed that the TOP was valuable in preventing wrong site surgery. This surgical indifference to the TOP is difficult to explain especially when National and International agencies have stressed its role in preventing surgical error. The recent introduction of the expanded WHO Checklist should be ‘surgeon led’ to be effective

Background. There has been widespread interest in medical errors since the publication of ‘To Err is Human’ by the Institute of Medicine in 1999. The Patient Safety Committee of the American Academy of Orthopaedic Surgeons has compiled results of a member survey to identify trends in orthopaedic errors that would help direct quality assurance efforts. Methods. Surveys were sent to 5,540 Academy fellows; 917 were returned (response rate 16.6%) with 53% (483/917) reporting an observed medical error in the last 6 months. Results. A general classification of errors showed equipment (29.0%) and communication (24.7%) errors with the highest frequency. Medication errors (11.4%) and wrong site surgery (5.6%) represented serious potential patient harm. Two deaths were reported, both involving narcotic administration errors. By location, 78% of errors occurred in the hospital (surgery suite 54%, patient room/floor 10%). The reporting orthopaedic surgeon was involved in 60% of the errors, nurses in 37%, another orthopaedic surgeon in 19%, other physicians in 16% and housestaff in 13%. Wrong site surgeries involved the wrong side 59%, another wrong site (e.g. wrong digit on the correct side) 23%, the wrong procedure 14%, on the wrong patient 4% of the time. The most frequent anatomic location was the knee and fingers/hand (both 35%), the foot/ankle 15%, followed by distal femur 10% and the spine 5%. Conclusion. Medical errors continue to occur and therefore represent a threat to patient safety. Quality assurance efforts and more refined research can be addressed towards areas with higher error occurrence (equipment, communication) and high risk (medication, wrong site surgery)

Introduction: Among the pantheon of medical errors, wrong site surgery (WSS) is thankfully rare. However, the results can be devastating particularly if amputation is the proposed surgery. WSS can occur due to simple mistakes in communication between patient and surgeon. This project looks at one particular cause of such miscommunication: toe identification. Method: 100 consecutive patients were asked to label their toes. The first 50 were asked to label their left foot, the subsequent 50 their right. Patients were not asked to number or name their toes as it was felt that this could bias their answers. Instead the patients were asked to imagine a hypothetical situation in which they had pain in their toes. They were asked to explain which toe was painful, as if over the phone so that they were unable to point and thus had to label their toes. No prompting was given. Results: Disagreement between patient and professional terminology was stark. Overall, 3% of patients incorrectly labelled the little toe and a staggering 26% mislabelled the ring toe. 10% gave a contrary label to the middle toe while 17% mislabelled the index toe. The great toe caused least problems with only 2% of patients incorrectly labelling it. Patients who numbered their toes were much more likely to mislabel them than those who named them. Conclusions: There is a huge discrepancy between the terms used by doctors and patients to label toes, increasing the chances of miscommunication and WSS. This study highlights the need for unified terminology amongst the orthopaedic profession. We suggest using the terms great, index, middle, ring and little toes. Numbering the toes should be avoided, as numbers are used in wildly contradictory ways by doctors and patients

Procedures performed at the incorrect anatomical site are commonly perceived as being relatively rare. However, they can be a devastating event for patients and doctors. Evidence from the United Kingdom and North America suggests that wrong-site, wrong-procedure and wrong-patient events occur more commonly than we think. Furthermore, their incidence may be increasing as NHS Trusts increase the volume and complexity of procedures undertaken in order to cope with increasing demands on the system. In previous studies from North America orthopaedic surgery has been found to be the worst-offending specialty.

In this paper we review the existing literature on wrong-site surgery and analyse data from the National Patient Safety Agency and NHS Litigation Authority on 292 cases of wrong-site surgery in England and Wales. Orthopaedic surgery accounted for 87 (29.8%) of these cases. In the year 2006 to 2007, the rate of wrong-site surgery in England and Wales was highest in orthopaedic surgery, in which the estimated rate was 1:105 712 cases.

The purpose for this study was to investigate the site marking practice for emergent and non-emergent orthopedic surgery at the authors’ orthopedic teaching program. One author attended surgeries at two hospitals in 2006, documenting the presence or absence of an unambiguous mark in the prepped and draped surgical field. Although emergent and elective cases were “chosen”, there was no intentional selection bias. Forty-eight surgeries by eleven surgeons were evaluated. After draping a mark was visible in twelve of eighteen (67%) emergent cases, and twenty-seven of thirty (90%) non-emergent cases. In the nine cases in which no mark was visible, two had been draped out, one had been washed off, two had never been marked, and in four cases the cause was uncertain. The authors would suggest that surgeons were near fully “compliant” with the COA protocol in non-emergent cases, but “complacent” in emergent ones. Wrong site surgery is an event that results in irrevocable harm to the patient - orthopaedic surgeons should recognise the value of pre-operative skin marking for all procedures, and re-evaluate their own personal practices in light of our results

Purpose: Wrong sided surgery is a devastating, yet avoidable adverse event. The Committee on Orthopaedic Practice & Economics (COPE) position paper on wrong sided surgery in Orthopaedics in 1994 had proposed to develop a reproducible method of operating on the correct side and to educate the orthopaedic community about the standardized procedure and accept this as the standard of care. An update to the COA Membership on success of the position paper was published in the COA Bulletin in 2002. Correspondence from the Canadian Medical Protective Association (CMPA) had demonstrated that there were some encouraging results. There had been a reduction from approximately 13 cases per year in 1987 to five cases per year in 2000. The most common anatomical site involved the incorrect knee. Now 10 years after its acceptance as the standard of care in Canada for orthopaedic surgeons at the COA Meeting in 1995, have all cases of wrong sided surgery been eliminated?. Methods: A search of the CMPA files of malpractice claims as well as cases that were labeled as threats occurring between January 2001 and September 2005 naming a physician and involving the issue of wrong sided surgery were performed. Results: A review of the synopses found 26 cases where wrong site surgery was the central issue. There were 9 cases in 2001, 10 in 2002, 3 in 2003, 3 in 2004 and 1 in 2005. The 26 cases were reviewed in detail and some of the general characteristics were identified. Of those 26 cases, 10 involved the incorrect knee; in 9 cases, an arthroscopy was performed on the wrong knee; in one case, a total knee replacement was performed on the wrong knee. Hand and foot cases usually involved the wrong finger or toe. Conclusions: Despite the position paper from the COA (OPERATE THROUGH YOUR INITIALS), operating room policies, heightened awareness, information and educational sessions at all levels of training, wrong site surgery continues to recur. Review of the files for risks have identified the following trends: patients had been anesthetized, the extremity prepared and draped without the surgeon seeing the patient first, the surgical area had been marked by a person other than the surgeon, the medical record and/or radiographs were not available in the operating room, and the hospital policy was not followed. Surgeons need to be mindful that wrong sided surgery has not been eliminated, and educate their surgical team in its prevention

Wrong site surgery is a preventable problem. In 1994 the Canadian Orthopaedic Association (COA) began an educational program initiated to prevent such mistakes from occurring. The purpose of this study was to assess the proportion of orthopedic surgeons who mark their sites preoperatively. This study confirms a high proportion (74.9%) of surgeons in Canada follow the COA guidelines at least occasionally with over half (52.1%) consistently “signing their sites.”. Wrong site surgery is often a catastrophic, but preventable problem. Reports of wrong site surgery have been on the rise in the United States every year since 1995. In 1994 the Canadian Orthopaedic Association (COA) began an educational program initiated to prevent such mistakes from occurring. Their recommendations involved marking the incision site preoperatively. Since that time the claims of wrong site orthopedic surgery have diminished. The purpose of this study was to assess the proportion of orthopedic surgeons who mark their sites preoperatively. Two hundred orthopedic surgeons across Canada were asked to complete a survey concerning preoperative incision site marking. A response rate of 89.3% was achieved. Eighty seven (52.1%) stated they always marked their incision site, thirty eight (22.8%) stated they occasionally marked their incision site, while forty two (25.1%) claimed to never mark their incision site preoperatively. Surgeons in academic centers were more likely to sign their sites than their community counterparts (p=0.021) and surgeons in practice longer were less likely to comply with the COA recommendation (p=0.023). The COA and American Academy of Orthopedic Surgeons (AAOS) have recommended marking incision sites preoperatively in an attempt to reduce wrong site surgery. This study confirms a high proportion (74.9%) of surgeons in Canada follow the COA guidelines at least occasionally with over half (52.1%) consistently “signing their sites.”

The purpose of this paper is to review the first six months experience of using the ‘Time Out’ procedure to avoid wrong site/side surgery and to evaluate the usefulness of this procedure in the routine preoperative check. Over a period of 18 months all elective surgical hospitals in Christchurch (both private and public) have coordinated to develop a pre-operative ‘Time Out’ check list to ensure that the correct surgical procedure is performed on the correct site. This procedure involves a final check of patient details, including surgical procedure and site, immediately prior to surgical preparation of the operative site. All forms during this six month period were prospectively collected and evaluated, specifically looking for system errors, which could proceed to wrong site surgery. There were a total of 10,330 procedures performed during this period within the three hospitals of which 9,098 (87.2%) completed time out forms were returned. There were no wrong side or wrong site surgeries performed during this six month period. However, there were three ‘near miss’ situations which were captured by the time out procedure. Analysis of the time out forms also revealed numerous consent issues, incorrect documentation and systems errors which could potentially have lead to serious errors in management and which will be discussed in detail. During this period there were 109 objections (1.2%) to the time out procedure. The time out procedure has been shown to be a useful tool for avoiding wrong site/side surgery and has gained acceptance amongst both medical and nursing staff as being a valuable check prior to surgery. It has accentuated the collective team responsibility for determining the correct site and side of surgery and as such is recommended for use in all centres to eliminate system errors resulting in incorrect site/side surgery