Orthopaedics. Specialty Report. Group. MedPro Group Patient Safety & Risk Solutions. Berkshire Hathaway's dedicated healthcare liability solution

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1 Orthopaedics Specialty Report June 2015 MedPro Group Patient Safety & Risk Solutions Group Berkshire Hathaway's dedicated healthcare liability solution

2 MedPro Group is a member of the Berkshire Hathaway group of businesses. The Medical Protective Company and Princeton Insurance Company patient safety and risk consultants provide risk management services on behalf of MedPro Group members, including The Medical Protective Company, Princeton Insurance Company, and MedPro RRG Risk Retention Group MedPro Group. All Rights Reserved.

3 Contents Introduction 1 A Note About MedPro Group Data 1 Orthopaedic Claims Overview 2 Orthopaedic Claims Distribution of Allegations 3 Orthopaedic Claims Severity 4 Orthopaedic Claims Practice Setting 5 Orthopaedic Claims Patient Factors 6 Surgical Treatment Claims 7 Allegation Subcategories 7 Top Procedures Associated With Surgical Treatment Claims 9 Top Injuries Associated With Surgical Treatment Claims 10 Patient Factors Associated With Surgical Treatment Claims 10 Top Contributing Factors in Surgical Treatment Claims 11 Technical Skill 11 Clinical Judgment 12 Communication 13 Documentation and Behavioral Factors 13 Diagnosis-Related Claims 14 Top Contributing Factors 15 Clinical Judgment 15 Communication, Behavioral, Clinical Systems, Administrative, and Documentation Factors 16 Medical Treatment, Medication-Related, and Patient Environment Claims 17 Key Points 18 Orthopaedic Risk Strategies 18

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5 Introduction (Keep for page numbering purposes.) Introduction This report is an analysis of the aggregated data from MedPro Group s orthopaedic claims opened between 2003 and The report is designed to provide our insureds with detailed claims data to assist them in purposefully focusing their risk management and patient safety efforts. Data are based on claim counts, not on dollars paid (unless otherwise noted). The type of claims and the details associated with them should not be interpreted as an actuarial study or financial statement of dollars paid; however, the information may be referenced for issues of relativity. A Note About MedPro Group Data MedPro Group has entered into a partnership with CRICO Strategies, a division of the Risk Management Foundation of the Harvard Medical Institutions. Using CRICO s sophisticated coding taxonomy to code claims data, MedPro Group is better able to identify clinical areas of risk vulnerability. All data in this report represent a snapshot of MedPro Group s experience with orthopaedic claims, including a deep dive into risk factors that drive these claims. 1

6 Orthopaedic Claims Overview Most orthopaedic claims opened between 2003 and 2012 are related to surgical treatment. These claims primarily involve surgical procedure complications and issues with the postoperative management of patients. Figure 1 shows the volume of orthopaedic claims by allegation category. Figure 1. Claim Volume by Allegation Category, % 7% 3% 3% 2% Surgical Treatment Diagnosis-Related Medical Treatment Medication-Related Patient Environment Other 74% Only 26 percent of all allegations against orthopaedic providers fall outside of the surgical treatment category. Allegations related to diagnosis and medical treatment account for more than two-thirds of the remaining claim volume. Diagnosis-related claims primarily involve allegations of failure to diagnose or delay in diagnosis of infections and fractures. Medical treatment claims are broad in scope and mostly related to care that occurs in physician offices or clinics. Other allegations that make up the 26 percent of claims not related to surgical treatment include: Medication-related claims, which primarily are associated with ordering issues, including failure to order a needed medication or ordering the wrong medication Patient environment claims, almost all of which are related to infection prevention issues occurring in the operating room (OR) setting Other claims, in which no one category represents a significant individual amount Most of the analysis in this report is based on surgical treatment allegations, unless otherwise noted. 2

7 Orthopaedic Claims Distribution of Allegations Although allegations related to surgical treatment consistently account for the majority of orthopaedic claims, the average total incurred dollars per claim is higher for medicationrelated and diagnosis-related allegations. (NOTE: Total incurred dollars = indemnity plus expense dollars reserved on open claims and paid on closed claims.) Figure 2 shows the distribution of orthopaedic allegations over a 10-year period, grouped in overlapping 3-year increments. Figure 2. Distribution of Allegations, Surgical Treatment Diagnosis-Related Medical Treatment Medication-Related Patient Environment 100% 80% 1% 1% 5% 10% 83% 1% 5% 10% 14% 71% 3% 5% 10% 16% 67% 3% 4% 9% 16% 68% 3% 3% 7% 13% 73% 2% 3% 6% 11% 78% 1% 3% 6% 10% 79% 1% 2% 7% 10% 80% 60% 40% 20% 0% NOTE: Figure 2 intentionally omits the other allegation category. Any totals not equal to 100 percent are the result of rounding. 3

8 Orthopaedic Claims Severity As shown in Figure 3, slightly less than two-thirds of orthopaedic claims fall into the category of medium clinical severity, and slightly more than one-third are categorized as high clinical severity, which includes claims involving death or permanent injury. Approximately two-thirds of total incurred dollars are tied to high-severity claims. In orthopaedics, high-severity claims most often are associated with allegations of improper performance of surgery particularly total knee replacements and spinal procedures. Of note, approximately 40 percent of inpatient cases fall into the highseverity category, while only 26 percent of the outpatient cases reach this level. Figure 3. Clinical Severity of Claims: Overall and by Practice Setting, % 60% 50% 62% 40% 35% 30% 20% 10% 0% Medium High Low 3% Low Medium High 70% 68% 60% 58% 50% 40% 41% 30% 26% 20% 10% 0% 1% Inpatient 6% Outpatient 4

9 Orthopaedic Claims Practice Setting More than half of orthopaedic claims are associated with care provided in an inpatient setting (see Figure 4). Of these claims, 86 percent are linked to care that occurs in the surgical area. Almost all of the allegations related to the surgical area are associated with care provided in the OR. Only 1 percent of these allegations relates to care provided in the postanesthesia care unit (PACU). Outpatient claims are fairly evenly divided between office and ambulatory surgery settings. Of note, average total incurred dollars per claim is significantly higher for inpatient settings than for outpatient settings and is attributed to the severity of the claims, as noted previously. Figure 4. Claim Volume by Practice Setting, % Outpatient 61% Inpatient 1% Intensive Care Unit Patient Room 13% 48% Physician Office/Clinic 52% Ambulatory Surgery 86% Surgical Area 5

10 Orthopaedic Claims Patient Factors The majority of orthopaedic claims involve middle-aged adults, with a fairly even distribution by gender (see Figures 5 and 6). Figure 5. Claim Volume by Patient Age, % 70% 75% 60% 50% 40% 30% 20% 10% 0% 16% 5% 2% 1% Adult (30-64 Yrs.) Senior (65+ Yrs.) Young Adult (18-29 Yrs.) Teenager (10-17 Yrs.) Child (1-9 Yrs.) NOTE: Any totals not equal to 100 percent are the result of rounding. Figure 6. Claim Volume by Patient Gender, % Male 55% Female 6

11 Surgical Treatment Claims Allegation Subcategories Figure 7 shows a breakdown of the allegation subcategories within orthopaedic surgical treatment claims. Issues related to the technical performance of procedures drive more than two-thirds of these claims. The subcategory referred to as management of surgical patient is reflective of all phases of the surgical process. This subcategory includes wrong site surgeries and postsurgical events in which a known complication exists (such as infection or bleeding), but providers do not adequately treat the complication, which leads to further injury. The other category spans additional situations, including allegations of delay in surgery. Figure 7. Surgical Treatment Claims: Allegation Subcategories, % 2% 3% Performance of Surgery Management of Surgical Patient Retained Foreign Body Unnecessary Surgery Other 24% 69% 7

12 Claim Analysis: Improper Performance of Surgical Treatment A patient who had severe degenerative changes of the knee presented for total knee arthroplasty. Postoperatively, the orthopaedic provider stated that the implant was in good condition. At subsequent postoperative visits, the patient complained of pain and the knee locking. The patient was referred for a second opinion and was diagnosed with synovitis from flexion instability. The patient ultimately underwent a synovectomy with an additional procedure to help balance the unstable ligaments. Expert review indicated that the immediate postoperative X-ray following the arthroplasty revealed that the femoral component was inserted at an improper angle, resulting in ligament instability. However, the orthopaedic provider did not notice this during the arthroplasty and did not correct it. Further, the provider stated that treatment options and risks were discussed; however, the provider did not sign the informed consent form, and the patient alleged that this specific risk was never discussed. Risk Management Issues for This Claim Technical skill issues associated with improperly utilized surgical equipment Clinical judgment issues associated with management of the patient s continued postoperative complaints Inadequate informed consent for the procedure Lack of documentation Claim Analysis: Improper Management of Surgical Patient A patient presented for a right knee arthroscopy. During the preoperative assessment, the anesthesiologist was made aware of the correct side/site. While transporting the patient to the OR, the surgeon s private nurse marked the correct surgical site. However, after the knee was draped, the site marking was not visible. The anesthesiologist was out of the room during the timeout, and the OR nurse stated that although she initiated the timeout procedure, she did not receive a clear response from all parties in the room before the procedure began. The surgeon performed the procedure on the left knee. The error was identified when the patient arrived in the postoperative care area, and surgery was performed on the correct knee the following day. Risk Management Issues for This Claim Administrative issues, including: Failure to follow established policies related to timeout procedures and marking of the surgical site Lack of staff training and education Inadequate communication among providers related to clarification of the surgical site 8

13 Top Procedures Associated With Surgical Treatment Claims Figure 8 shows the top 10 procedures associated with inpatient surgical treatment claims. Total knee and hip replacements top the list, and in this claim set tend to be associated with nerve injuries. Figure 9 shows the top 10 procedures associated with outpatient surgical treatment claims. Knee arthroscopies and carpal tunnel procedures rise to the top of the list in the outpatient setting. Figure 8. Surgical Treatment Claims: Top Procedures in the Inpatient Setting, % Total Knee Replacement 10% Total Hip Replacement Percentage of Inpatient Claims 3% ORIF Humerus 6% Exp/Decompress Exp./Decompress Spinal 5% Excision - Interverterbral Disc 5% Lumbar Fusion 5% ORIF Femur 4% Spinal Fusion - Not Oth. Spec. 4% ORIF Tibia/Fibula 2% Anterior Cervical Cerviacal Fusion 0% 3% 6% 9% 12% 15% Figure 9. Surgical Treatment Claims: Top Procedures in the Outpatient Setting, % Total Carpal Hip Tunnel Replacement Release 17% Arthroscopy Knee Percentage of Outpatient Claims 5% Total Excision Hip Replacement Semilunar Cartilage Knee 4% Total Arthroscopy Hip Replacement Shoulder 4% Excision Intervertebral Disc 3% Total ORIF Hip Tibia/Fibula Replacement 3% Total Cruciate Hip Ligament Replacement Repair 2% Total Closed Hip Reduction Replacement Rad./Ulna 2% Total Arthroplasty Hip Replacement Elbow 2% Total Rotator Hip Cuff Replacement Repair 0% 5% 10% 15% 20% 9

14 Top Injuries Associated With Surgical Treatment Claims Figure 10 shows the top patient injuries associated with surgical treatment claims. Figure 10. Surgical Treatment Claims: Top Patient Injuries, % 14% Percentage of Surgical Treatment Claims With Injury Noted 12% 9% 6% 3% 12% 8% 7% 6% 5% 0% Nerve Damage Punct./Perf. Laceration/Tear Malunion/ Nonunion Infection Aggravated/ Worsened Condition Death Patient Factors Associated With Surgical Treatment Claims Figure 11 shows the top patient comorbidities noted in surgical treatment claims. Obesity, a history of smoking, and hypertension top the list of patient conditions that may affect the overall outcome of procedures. Figure 11. Surgical Treatment Claims: Top Patient Comorbidities, Percentage of Surgical Treatment Claims With Comorbidity Noted 20% 15% 10% 5% 0% 20% Obesity 17% Smoking 15% Hypertension 15% Psych. History/ Substance Abuse 13% Diabetes 8% Cardiovascular Disease 10

15 Top Contributing Factors in Surgical Treatment Claims Contributing factors are broad areas of concern that may have contributed to allegations, injuries, or initiation of claims. These factors reflect issues that might be amenable to lossprevention strategies. A claim can have one or more contributing factors. Technical Skill As expected, technical skill issues the broad category of skill associated with the performance of orthopaedic surgeries are a persistent and recurring factor across surgical claims (see Figure 12). Most of the claims with identified technical skill issues involve known complications of the procedure; however, poor procedural technique and incorrect site issues also are noted. Included in the technical skill category are claims arising from allegations of wrong site surgery, including procedures that are completed and procedures that are started but then stopped. Most of these cases also involve a failure to follow established timeout procedures and a lack of communication among members of the operative team. Less frequently occurring issues associated with technical skill include lack of provider competency with surgical equipment and retained foreign bodies (see Figure 13). Figure 12. Top Contributing Factors in Surgical Treatment Claims, % 84% Percentage of Surgical Treatment Claims With Factor Noted 80% 60% 40% 20% 56% 28% 18% 18% 0% Technical Skill Clinical Judgment Communication Documentation Behavior-Related 11

16 Figure 13. Factors That Contribute to Technical Skill Issues, % 80% 96% 60% 40% 20% 7% 3% 0% Technical Performance Improperly Utilized Equipment Retained Foreign Body Clinical Judgment Clinical judgment is noted in more than half of the surgical treatment claims. Issues with clinical judgment most frequently involve inadequate patient assessment, such as failure or delay in ordering diagnostic testing, maintaining a narrow diagnostic focus, or ordering a premature postoperative discharge. Issues with the selection and management of an appropriate surgical procedure also are frequent within this subset of cases (see Figure 14). Figure 14. Factors That Contribute to Clinical Judgment Issues, % 60% 63% 50% 49% 40% 30% 20% 20% 10% 8% 0% Patient Assessment Issues Selection and Management of Surgery Failure/Delay in Obtaining a Consult or Referral Patient Monitoring 12

17 Communication Communication factors include risks associated with communication among providers and between providers and patients/families (see Figure 15). For the latter, the most common issue is related to obtaining informed consent prior to treatment specifically, failing to inform the patient of a procedure s potential risks. Also noted are issues related to performance of additional procedures during surgery for which the patient has not previously consented, such as blood transfusions and additional resections. Figure 15. Communication Issues by Type, % 60% 68% 50% 40% 39% 30% 20% 10% 0% Communication Between Providers and Patients/Families Communication Among Providers Documentation and Behavioral Factors Documentation and behavior-related issues round out the top five contributing factors in surgical treatment claims. Documentation factors primarily reflect inadequate documentation within patient records (e.g., documentation of clinical findings), inconsistent documentation among all providers of care, and inadequate informed consent (as mentioned previously under Communication ). Behavior-related factors include patient noncompliance with treatment and patients who seek other providers because they are dissatisfied (either with surgical outcomes or with their treatment plans). Patient noncompliance often is related to communication with, and education of, the patient. 13

18 Diagnosis-Related Claims Allegations of failure to diagnose or delay in diagnosis account for just 11 percent of orthopaedic claims opened between 2003 and 2012; however, as noted earlier, the average total incurred dollars per claim is higher for diagnosis-related allegations than for surgical treatment allegations. The conditions implicated in diagnosis-related claims are diverse (see Figure 16). Abscesses/infections and fractures top the list, followed by thromboembolic events, malignancies, and tears/ruptures. Missed diagnoses of cancer primarily are related to incidental findings of lung cancer on chest X-rays; an absence of clinical correlation or communication between the surgeon and the radiologist often triggers these claims. The majority of diagnosis-related claims are associated with outpatient care provided in the physician office setting. Figure 16. Top Conditions Involved in Diagnosis-Related Claims, Percentage of Diagnosis-Related Claims With Condition Noted 7% DVT/VTE 7% Malignancy 7% Tear/Rupture 10% 5% Cardiac/Vascular-Related 10% 5% Compartment Syndrome 10% 5% Device Complication 5% Nerve Injury 10% 5% Nonunion of Fracture 19% Abscess/Infection 19% Fracture 0% 5% 10% 15% 20% DVT/VTE = deep vein thrombosis/venous thromboembolism 14

19 Top Contributing Factors Clinical Judgment A look at the leading risk factors in diagnosis-related claims reveals that clinical judgment is involved in almost 100 percent of this claim type, as shown in Figure 17. Within the clinical judgment category, inadequate patient assessment issues including delays in ordering diagnostic tests and maintaining a narrow diagnostic focus are frequent, as shown in Figure 18. Figure 17. Diagnosis-Related Claims: Top Contributing Factors, % 96% Percentage of Diagnosis-Related Claims With Factor Noted 80% 60% 40% 20% 33% 18% 18% 12% 12% 0% Clinical Judgment Communication Behavior- Related Clinical Systems Administrative Documentation Figure 18. Factors That Contribute to Clinical Judgment Issues, % Failure/Delay in Ordering Diagnostic Tests 32% Misinterpretation of Diagnostic Studies (X-rays, Slides, Films) 23% Failure to Rule Out Abnormal Findings 31% 21% Narrow Diagnostic Focus Failure to Establish Differential Diagnosis 0% 10% 20% 30% 40% 50% 60% 15

20 Claim Analysis: Delay in Diagnosis of Infection A patient underwent laminectomy; postoperatively, he developed evidence of fluid collection at the surgical site. Revision surgery was performed, and cultures were negative for infection. Two months later, the patient presented with a persistent fever and was diagnosed with bacteremia. MRI results were suspicious, but not conclusive, for a spinal infection. After an initial disagreement, the internal medicine provider and the orthopaedic provider agreed that the patient s symptoms were not consistent with an abscess. The patient was discharged on IV antibiotics, but later returned with persistent complaints of fever. Blood cultures were negative, and the results from a second MRI were negative for fluid collection. However, the patient s erythrocyte sedimentation rate was rising. The internal medicine provider halted the IV antibiotics and changed the antibiotic regimen but he did not consult with the orthopaedic provider. Shortly thereafter, the patient was admitted for treatment of osteomyelitis and a staph infection. An MRI revealed a spinal abscess. Surgery was done to drain the abscess and remove the spinal hardware, but the patient developed septic shock and died. Risk Management Issues for This Claim Clinical judgment issue associated with narrow diagnostic focus Overreliance on negative findings despite patient s persistent symptoms Failure or delay in obtaining additional specialty consults Communication among providers regarding the patient s condition Communication, Behavioral, Clinical Systems, Administrative, and Documentation Factors Communication failures among providers regarding patient conditions and treatment are a recurring theme in diagnosis-related claims. This risk factor includes both written and verbal communication failures, such as failing to read the medical record and failing to communicate important findings to the physician coordinating care. Communication 16

21 problems often are related to disagreement among providers about the clinical significance of patients symptoms, including DVT/VTE and infections. As with surgical treatment claims, behavior-related factors are a recurring theme in diagnosis-related claims. These factors mainly are associated with patient noncompliance with treatment regimens and follow-up appointments. Clinical systems factors refer to issues with the processes used to manage the patient care continuum. Examples of these processes include policies for reporting findings and protocols for arranging follow-up care. Clinical system factors often are seen in claims that also involve communication issues. Administrative factors include failure to adhere to policies and procedures. Documentation factors predominately involve inadequate documentation in the patient record of treatment rationale and clinical findings. Medical Treatment, Medication-Related, and Patient Environment Claims As stated earlier, medical treatment claims are broad in scope. Allegations associated with medical treatment often are related to mismanagement of a patient s course of nonsurgical treatment or improper performance of a nonsurgical treatment or procedure. For example, medical treatment claims may involve care related to the treatment of nonsurgical fractures that results in nonunions or malunions, infections, pain, and nerve damage. Further, these claims also are associated with patient care that occurred while assessing the need for surgery. Of note, communication issues between providers and patients, specifically with regard to inadequate informed consent also an issue in surgical treatment claims occur frequently in medical treatment claims. Medication-related claims largely involve allegations associated with ordering errors and failure to select the most appropriate medication regimens. Narcotics and anticoagulants are the medications most frequently implicated in medication-related claims. The most common allegation in patient environment claims is failure to protect against infection. Although infections are a known complication of surgery, patient environment claims involve situations in which it is known or suspected that avoidable, nonsterile conditions existed. Approximately two-thirds of patient environment claims involve care provided in an inpatient OR setting. Therefore, these claims in large part are an extension of the surgical treatment allegations. 17

22 Key Points Allegations related to surgical treatment represent the largest claim category for orthopaedic providers (74 percent of all orthopaedic claims opened between 2003 and 2012). The majority of surgical treatment claims involve surgical procedure complications and issues with the postoperative management of patients. The most common injuries in surgical treatment claims are nerve damage; punctures, perforations, lacerations, or tears; malunion or nonunion of surgically repaired fractures; and infections. Various contributing factors particularly technical skill, clinical judgment, and communication are persistent in surgical treatment claims. Diagnosis-related claims represent only 11 percent of orthopaedic claim volume; however, the average total incurred dollars per claim is higher for diagnosis-related allegations than for surgical treatment allegations. Diagnosis-related claims primarily involve allegations of failure to diagnose or delay in diagnosis of infections and fractures. Clinical judgment is the major contributing factor in diagnosis-related claims and is involved in almost 100 percent of these claims. Diagnosis-related claims that have clinical judgment as a contributing factor often involve patient assessment issues, including failure or delay in ordering diagnostic tests, misinterpretation of diagnostic studies, failure to rule out abnormal findings, and maintaining a narrow diagnostic focus. Orthopaedic Risk Strategies The following strategies may help orthopaedic providers improve patient safety and address the factors that contribute to liability risks: Ensure that provider privileges are based on training, credentials, and competency. Enhance technical surgical skills through ongoing performance improvement efforts, such as mentoring, proctoring, and continuing education. Participate actively in surgical team timeouts prior to the commencement of surgeries/procedures. Document a complete, concise, and accurate operative report the day of the procedure. Ensure timely ordering of tests and consults to prevent problems associated with ruling out or documenting abnormal findings. Communicate adequate and appropriate information to patients. Conduct informed consent, provide patient education, and encourage patients to participate in their care. Carefully consider selection and management of therapy. Review patient selection criteria for each procedure, reconcile patient medications, and utilize evidence-based guidelines. Implement protocols for team-based communication, including care transitions, telephone triage, and communication with radiology providers regarding incidental findings on diagnostic studies. 18

23 This document should not be construed as establishing professional practice standards or providing legal advice. Compliance with any of the recommendations contained herein in no way guarantees the fulfillment of your obligations as may be required by any local, state, or federal laws, regulations, or other requirements. Readers are advised to consult a qualified attorney or other professional regarding the information and issues discussed herein, and for advice pertaining to a specific situation.

24 Group Berkshire Hathaway's dedicated healthcare liability solution 5814 Reed Road Fort Wayne, IN (NJ/NY) MedPro Group is a member of the Berkshire Hathaway group of businesses. MedPro Group includes The Medical Protective Company, Princeton Insurance Company, and MedPro RRG Risk Retention Group; its insurance products are underwritten and provided by these and other Berkshire Hathaway affiliates. Product availability varies based upon business and regulatory approval and differs between companies MedPro Group. All Rights Reserved.