Closed Claims/Medical Mistakes

From Scottsdale Anesthesia: New Developments and Controversies

Robert A. Caplan, MD, Department of Anesthesiology, Virginia Mason Medical Center, Seattle, WA

Educational Objectives

The purpose of this program is to improve anesthesia care and reduce the likelihood of medical errors which lead to malpractice litigation. After hearing and assimilating this program, the clincian will be better able to:

1.   Use the information generated by the American Society of Anesthesiologists’ Closed Claims Project to im­prove clinical practice, evaluate new therapies, and anticipate problems.

2.   Recognize the procedures and injuries most likely to lead to malpractice lawsuits.

3.   Identify techniques that may prevent injuries associated with respiratory challenges.

4.   Discuss the implications of changes seen in claims for death and brain damage since the 1970s and the impact of these changes on anesthesiologists’ insurance premiums.

5.   Describe the concept of source inspection.

Faculty Disclosure

In adherence to ACCME Standards for Commercial Support, Audio-Digest requires all faculty and members of the planning committee to disclose relevant financial relationships within the past 12 months that might create any per­sonal conflicts of interest. Any identified conflicts were resolved to ensure that this educational activity promotes quality in health care and not a proprietary business or commercial interest. For this program, the faculty and plan­ning committee reported nothing to disclose.

Acknowledgments

Dr. Caplan was recorded at Scottsdale Anesthesia: New Developments and Controversies, held November 1-5, 2009, in Scottsdale, AZ, and sponsored by Holiday Seminars. The Audio-Digest Foundation thanks Dr. Caplan and Holiday Seminars for their cooperation in the production of this program.

Lessons Learned from the American Society of Anesthesiologists’ Closed Claims Project

Background: Closed Claims Project of American Society of Anesthesiologists (ASA) started in 1985; Pediatric Peri­operative Cardiac Arrest Registry and Postoperative Visual Loss Registry followed in 1990s; Anesthesia Aware­ness Registry most recent area of interest; number of lawsuits involving anesthesiologists tripled from 1970 to 1980; in 1985, ASA president suggested studying malpractice cases in depth to determine relationships between treatment, injury sustained, and bases of lawsuit; Closed Claims Project examines major anesthetic injuries; in­cludes cases from 35 insurance companies that provide coverage to one-third of practicing anesthesiologists in United States (US); database now has >7,000 cases spanning interval from 1970 to 2006; represents world’s larg­est collection of major adverse events in anesthesiology

Closed Claims database: claim  —  demand for payment made by injured patient or patient’s representative; triggers legal investigation (takes 1-3 yr); after resolution, claim made accessible for examination by Closed Claims Proj­ect; Closed Claims Project procedure  —  70 anesthesiologists trained to review claims using standardized confi­dential anonymous form; reviewers work voluntarily; »350 new cases collected annually; uses  —  identification of key targets for improvement in anesthesiology; provision of progress reports on efficacy of novel preventive strategies; anticipation of emerging challenges before they become major problems

Key lessons from Closed Claims database: overall injury rate in US hospitals 4% (unchanged over past few de­cades); 1 in 8 injured patients file claim; claims data not overall incident data; probably represent most serious in­juries (“tip of an iceberg”); 90% of files state amount of settlement or jury award (information sealed in 10% of cases); size of payouts ranges from $34 to $35,960,000; claims >$1 million represent only 4% of monetary awards (percentage stable over last 30 yr); in 2002, amount paid out in all malpractice claims totaled $230 billion (2% of gross domestic product); other systems (eg, no-fault, expert panel) associated with even higher costs

Priority 1: patients most likely to sue  —  healthy adults undergoing routine elective general anesthesia; slight pre­ponderance of females; lesson  —  most risk arises from everyday routine care

Priority 2: recurring adverse outcomes  —  majority of lawsuits due to death (29% of database), peripheral nerve damage (19%), and brain damage (9%); remaining outcomes each account for <7% of claims; 50% of death and brain damage claims derive from adverse respiratory events; two-thirds of adverse respiratory events caused by inadequate oxygenation, esophageal intubation, and difficult intubation

Advent of capnometry: previously, took >5 min to confirm correct placement of endotracheal tube; deaths often misdiagnosed as cardiac events; with widespread use of capnometer, death and brain damage from esophageal intubation decreased from 11% to 3% of database claims

Difficult airway cases: most occur during perioperative care by anesthesiologist; 67% of related injuries occur during induction; from 1985 to 1992, 67% of difficult airway claims involved death or brain damage; dropped to 35% between 1993 and 1999 (exact reason unknown; difficult airway algorithm introduced in 1993)

Remote-location anesthesia: procedures increasingly taking place outside of operating room; respiratory events (often due to inadequate oxygenation) constitute largest claims category from these procedures

Limitations of technology: anesthesiologists’ intubation tools old inventions; fiberoptic scope currently most powerful tool, but cumbersome to use and difficult to sterilize; claims often occur because monitors broken, turned off, or rendered inaudible during patient care

Priority 3: respiratory challenges occurring in newer areas of database

Monitored anesthesia care (MAC): examination of recurring features in claims from 1990 to 2002  —40% in­volved death or brain damage; 25% arose from excessive sedative or opioid administration; 50% of excessive sedation claims considered preventable with better monitoring

Acute pain care: 50% of claims involved obese patients; one-third involved respiratory depression; one-third in­volved death or brain damage; suggests interaction of sedatives, opioids, and difficult monitoring greatly in­creases risk for adverse outcomes; some hospitals now asking pharmacies for list of all rescue doses of naloxone (Narcan) used on ward (indicates that patient received excessive postoperative dose of sedative or narcotic); examination of such cases may shed light on what should be done differently in monitoring patients at high risk for respiratory depression

Complex spine surgery: overall mortality associated with lumbar fusion 2%; opioid overdose responsible for 21% of deaths; strongly associated with use of hardware instrumentation, middle-age, and presence of degen­erative joint disease; anesthesiologists often called for consultation, due to problems with postoperative pain control; opportunity for anesthesiologists to consider novel strategies to increase patient safety; main themes in preventing overdose  —  improve identification of high-risk patients; recognize that intermittent monitoring in­sufficient; moving toward having ³2 continuous monitors on high-risk patients at all times

Burns: before 1995, most anesthesia-related burn claims due to insufficient protection of patient against heated in­travenous (IV) bags or bottles; after 1995, most burn claims result from operating room fires caused by surgeon’s cautery or laser; all claims involve use of supplemental oxygen; 95% of burns occurred during head, eye, face, or neck surgery; in 55% of cases, alcohol or drapes provided fuel source; anesthesiologists’ liability arises from control of oxygen (enriched oxygen [>30%] greatly increases risk for combustion); surgeon provides heat source (cautery); nurses provide fuel source (prep, drapes, and masks); anesthesiologist provides oxidizer (supplemental oxygen or nitrous oxide; acts as accelerant for fires)

Liability from peripheral catheters: comprise 2% of database; median payout »$50,000 (payment frequency »50%); most claims due to soft tissue injury from IV catheter extravasation; strongest association occurred in setting of cardiac surgery; results from delayed recognition of IV catheter malfunction in tucked arm

Trends in database: since 1970s, total claims from death and brain damage decreasing, from 57% in 1970s to 32% in 1990s (even lower in subsequent decade); in 1980s, anesthesiologists among most expensive practitioners to in­sure (rated 5-7 on 7-point risk scale); current risk rating 2 (similar to family physician who performs minor in-of­fice suturing); premiums have dropped accordingly; inflation-adjusted premium decrease over past decade »$10,000 (total of »$300 million saved by »30,000 practicing anesthesiologists); expense associated with malprac­tice suit estimated at 50% of award (ie, plaintiff keeps only 50% of award); decrease in premiums shows that, by improving safety, anesthesiologists have reduced “symbolic injury” by $150 million per year over period of 10 yr; premiums for chronic pain practitioners slightly higher than those for general anesthesiologists (even more for phy­sicians using invasive procedures)

Source Inspection:
Preventing Medical Mistakes

Institute for Healthcare Improvement’s 100,000 Lives campaign: in 1970s, rate of iatrogenic injuries among pa­tients in all California hospitals 4%; in 1980s, similar survey in upstate New York found similar rate of iatrogenic injuries; same in 1990s in Colorado and Utah

Explanations for persistence of injury rate: medicine risky (in general, 1 fatality occurs in every 500 medical en­counters); high-volume processes unmask and/or magnify relatively tiny defect rates (eg, 99.9% perfection in av­erage community hospital would result in 15 retained instruments, 17 transfusion reactions, or 1,000 medication delivery errors annually); patient with problem “100% dissatisfied”, while patients with good outcomes “invisi­ble”

Solutions from industry: distinguish mistakes from defects; implement source inspection; use outcomes engineering to achieve high levels of safety

Lessons from Toyota consultant Shigeo Shingo: mistakes  —  differ from defects; mistakes by humans inevitable, but usually reversible if caught early enough; defects  —  mistakes not fixed early which then become relatively per­manent or difficult to correct (eg, inserting IV without checking for free flow [mistake]; folding patient’s arm, re­sulting in infiltration [defect])

Source inspection theory: mistakes least harmful and easiest to correct soon after their occurrence; if mistake fixed early enough, work will be free of defects

Level 1 inspection: customer inspects product, finds defect; mistake found too late to correct; medical examples  —  Office of Inspector General discovers mistakes in billing forms, demands return of several million dollars in incorrectly billed fees; Department of Health discovers mistakes in labeling medications and issues citation; patient experiences bad outcome and files malpractice suit

Level 2 inspection: company’s own inspector discovers problem after all work completed; medical example  —discrepancy in narcotics count; inspection at end of process too late to correct mistake; defect now embedded; level 2 inspection common in hospitals (eg, quality assurance review of charts)

Level 3 inspection: staff in unit inspects work as care being delivered; prevents mistake from becoming defect; medical example  —  needle and sponge count in operating room; allows for immediate correction of error

Level 4 inspection: people doing work find and correct problem immediately; medical examples  —discovery and correction when patient found to have wrong identification band; substitution of different IV line after discov­ery that existing line has high risk for infiltration

Level 5 inspection: development of mechanical or technical systems, such as computers, to conduct checks; have lower risk of missing mistakes than humans; medical examples  —  gas pin index system (prevents anesthesiolo­gist from administering wrong gas); pressure bag (bleeding valves prevent filling to pressure >300 psi)

Key strategies of source inspection: assume something wrong; inspect every part of work at each step; when nec­essary, stop and fix at source to prevent mistakes from becoming embedded

Examples of source inspection in anesthesia: asking if patient received antibiotic before cardiac surgery during preprocedure time-out; checking orders and asking questions before procedure; in speaker’s hospital, computer system will not allow physician to order antibiotic unless information about patient’s allergies has been entered first (level 5 inspection)

Suggested Reading

Bhananker SM et al: Injury and liability associated with monitored anesthesia care: a closed claims analysis. Anes­thesiology 104:228, 2006; Bhananker SM et al: Liability related to peripheral venous and arterial catheterization: a closed claims analysis. Anesth Analg 109:124, 2009; Fitzgibbon DR et al: Chronic pain management: American So­ciety of Anesthesiologists Closed Claims Project. Anesthesiology 100:98, 2004; Furman C, Caplan R: Applying the Toyota Production System: using a patient safety alert system to reduce error. Jt Comm J Qual Patient Saf 33:376, 2007; Juratli SM et al: Mortality after lumbar fusion surgery. Spine 34:740, 2009; Liang BA, Tran KM: Trust but verify: cooperation cannot mean abdication in the operating room. J Clin Anesth 20:436, 2006; Metzner J, Posner KL et al: The risk and safety of anesthesia at remote locations: the US closed claims analysis. Curr Opin Anaesthe­siol 22:502, 2009; Robbertze R, Posner KL et al: Closed claims review of anesthesia for procedures outside the op­erating room. Curr Opin Anesthesiol 19:436, 2006; Stoelting RK, Weinger MB: Dangers of Postoperative Opioids: Is There a Cure? Anesthesia Patient Safety Foundation Newsletter 24:25, 2009; Szalados JE: Anesthesia in remote locations: medicolegal risks and strategies for minimizing liability. Int Anesthesiol Clin 47:105, 2009.