Medical Errors/The Future of Surgery

Educational Objectives

The goal of this program is to improve the quality of patient care  and anticipate the impact of health care reform on surgical practice.  After hearing and assimilating this program, the clinician will be better able to:

1.   Identify the root causes of surgical errors.

2.   List the components essential for reducing surgical errors.

3.   Recognize the most common errors and diagnoses missed by surgeons.

4.   Describe Florida House Bill 699 and its implications for surgeons and other physicians.

5.   Discuss probable consequences of health care reform on surgical practice.  

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.

Acknowledgements

Mr. Nuland spoke at the 55th Annual Scientific Meeting of the Florida Chapter of the American College of Surgeons, held May 22-25, 2008, in Palm Beach, FL, and sponsored by the Florida Chapter of the American College of Sur­geons. Dr. Goodnight was recorded at the 30th Annual Postgraduate General Surgery Update, held September 13, 2008, in Sacramento, CA, and sponsored by the University of California, Davis. The Audio-Digest Foundation thanks the speakers and the sponsors for their cooperation in the production of this program.

Medical Errors: Lessons from Florida

Christopher L. Nuland, JD, General Counsel, Florida Chapter, American College of Surgeons, Jacksonville

Root cause analysis: choice of patient  —  at root of »50% of surgical errors; for in-office surgery, only patients classi­fied by American Society of Anesthesiologists (ASA) as physical status I (normal) or II (mild systemic disease) considered appropriate; source of problem  —  anesthesia or surgery; actual surgical mistakes rare; over last 15 yr, >50% of deaths from in-office surgery resulted from anesthesia complications (eg, postoperative pulmonary em­boli); condition or intervention  —  determine whether problem arose from patient’s medical condition, or from in­tervention meant to treat it; not considered adverse event if injury resulted from condition being treated, rather than surgical intervention itself; example  —  patient dies in hospital while awaiting surgery (however, failure to provide timely care may be deemed malpractice); flawed protocols vs. flawed performance  —  surgical team may follow protocol perfectly, but problem may still arise if protocol itself flawed

Essential components of error reduction: standardized approach  —  clear evidence of fewer complications associ­ated with open-heart surgeries performed at high-volume centers; “repetition makes for good outcomes”; electronic prescribing  —  reduces medication errors, sometimes at expense of face time with patients; errors may occur if var­ious systems not linked, such as those storing inpatient and outpatient records; time-out rule  —  know patient’s iden­tity and which procedure patient scheduled for, and take time to ensure everything done correctly

Principles of patient safety: hospitals and office surgery units must have patient safety programs and staff, including risk managers associated with office facilities; ambulatory surgery centers and hospitals must employ risk man­agers to ensure compliance with Joint Commission on the Accreditation of Healthcare Organizations guidelines for protocols and standards

Clear delineation of duties: surgical nurse, rotating nurse, and surgical technician all do different jobs

Appropriate setting: complicated by realities of reimbursement; insurers often do not pay for in-hospital procedure if  in-office or ambulatory surgery center considered plausible options; finding appropriate setting under those circumstances sometimes challenging

Appropriate providers: certified registered nurse anesthetists (CRNAs) acceptable in some settings; in others, phy­sician anesthesiologist preferable; physician assistants (PAs) acceptable as first surgical assistants in some set­tings; in others, surgeon preferable; adequate reimbursement sometimes difficult

Florida Board of Medicine standards: essential for patient safety

Errors and misdiagnoses most commonly seen among surgeons: wrong-site or wrong-patient surgery  —accounts for ³50% of all surgeon disciplinary actions by Florida Board of Medicine (BOM); minimum penalty $10,000 and probation, extra continuing medical education course, 40 hr of community service, and 2-hr presentation to hospital medical staff describing error; entered into National Practitioner Databank; cancer  —  surgeon often sued for miss­ing questionable lesions, even if very faint or subtle on imaging study; cardiac problems in patient presenting for noncardiac surgery  —  surgeon should always communicate with patient’s primary care physician, who should clear patient before surgery; “absolutely crucial” to check and document cardiac report before operating; surgeon not deemed responsible if previously undiagnosed cardiac condition discovered during surgery; follow-up for surgi­cal complications  —surgeon may finish procedure and leave with no clear assignment of responsibility should pa­tient develop infection, internal bleeding, or other complication; BOM holds surgeon ultimately responsible for patient’s postoperative care; surgeon’s office and hospital must establish protocols ensuring that patient seen imme­diately after surgery, followed consistently, and that any complications reported to surgeon; acute abdomen  —  easy to underestimate or overlook, but common cause of complaints before BOM; stroke and related cranial conditions  —  patients presenting to emergency department with complaint of headaches now frequently undergo magnetic resonance imaging (MRI) due to defensive medicine (fear of missing dangerous intracranial condition)

Avoiding common errors: poor patient selection  —  in speaker’s experience, major cause of surgical errors; sees “a disturbing number of cases in which the patient just should not have been operated on”; pay attention to patient’s ASA physical status classification; wrong-site surgery  —  follow the “time-out” rule; poor or lazy follow-up  —  surgeon held responsible

Avoiding problems with the BOM: stay current on continuing medical education credits, including 2 hr on domestic violence and 2 hr on preventing medical errors every 6 yr; observe Truth in Medical Education Act (TIME)  —  “any healthcare practitioner must disclose, whether orally, by name tag, or in writing, the license under which they are operating”, such as registered nurse, medical doctor, or doctor of osteopathy; failure to comply elicits fine and stays on record

Florida House Bill 699: states that surgeons may have £2 satellite offices in which PAs or advanced registered nurse practitioners (ARNPs) work; physician must schedule time in each office; every patient who sees PA or ARNP must also have opportunity to see physician if they wish; immediacy of physician appointment not required; phy­sician extender must notify patient of his or her licensure; dermatologists or plastic surgeons without board certi­fication may not supervise physician extenders at spas; rule applies only to satellites that offer primarily aesthetic skin care services; does not apply if office provides other services as well

Time-out rule: as established by BOM, has decreased incidence of wrong-site or wrong-patient surgery by 20% to 30%; now applies to anesthesiologists and surgeons, so anesthesiologist as responsible as surgeon and hospital for ensuring accuracy; before starting procedure, responsible physician must verbally confirm patient’s identifi­cation, intended procedure, and correct procedural site; procedural notes (nursing notes acceptable) must include documentation of confirmation of each item, and of person documenting it; surgeon ultimately responsible for postsurgical care; surgeon may delegate postsurgical care, but need to have protocols and personnel in place to ensure appropriate care

The Future Direction of American Surgery

James E. Goodnight, MD, PhD, Associate Dean for Clinical Affairs, and Executive Director, Practice Manage­ment Board, University of California, Davis, Health System, Sacramento

Immediate future: expect greatest impact from public’s demand for redesign of health care delivery; issues ad­dressed by American College of Surgeons include practice in multidisciplinary teams, value-driven practice and payment, outcome measurement, National Surgical Quality Improvement Program (NSQIP), public reporting of outcomes, patient safety, and avoiding futility

Technology: innovations and experience likely to lead to progressively less invasive surgery, with consequent re­duction in morbidity and enhanced value for patient; surgeons sometimes slow to adopt new methods, eg, lapa­roscopy; surgeons should embrace innovations and new technologies, but with healthy skepticism and stringent review; surgeons should guide application of new technology to benefit patients

Redesign of health care delivery: per 2008 Commonwealth Fund survey, >90% of people believe next president should address health care quality, costs, and coverage; insured and uninsured gave similar answers; other sur­veys have yielded similar results

Health care delivery features most important to Americans: one doctor to act as advocate and guide them through system; access to nonemergency health care at night and on weekends; easy access to medical records for them­selves and their doctors; information on quality of care from individual doctors and hospitals; and information on cost

Value-based care: standard formula is value = quality ÷ cost; quality difficult to define; must occur at patient’s level, in treating specific medical conditions; surgery usually provides good patient value due to curative nature; doctors who can deliver health care in organized and coordinated fashion “21st-century heroes of medicine”

Future practice conditions and demands on surgeons and surgery: surgeons probably will function as part of multidisciplinary groups of specialists who improve quality and coordination of care by focusing on select group of medical conditions; surgeons will need to measure outcomes and publicly report them, encouraging patients to shop around for excellence; will result in competition (positive result if it enhances value for patients); surgeons will have to avoid futility and operate only for valid indications; surgeons will have to comply with universal de­mand for consistent quality and safety

Vascular center at University of California, Davis, Health System: consists of team of physician specialists and nurses under leadership of surgeon; provides excellent product based on expertise; emphasizes value delivered to patient; remaining issues  —  cost control; effective data collection to allow public to compare providers; fee-for-service payment structure without good system for sharing revenue among providers (results in less emphasis on value); management of and billing for chronic diseases such as diabetes, heart disease, and hypertension; “medi­cal home” concept advanced by American College of Physicians possible model

Public reporting of outcomes: demanded by patients due to problems with access and uneven delivery of care; meaningful only if data good; currently, Society of Thoracic Surgeons (STS) has respected database; data con­tributed by cardiothoracic surgeons across country; allows risk stratification and assessment of program quality; state reporting systems also provide information on outcomes; STS and states have teams that validate data; ac­cepted by Centers for Medicare and Medicaid Services; databases now used as models for other programs; al­lows physicians to check data from their institutions and make changes when necessary; greatest benefit thus far in weeding out weak practitioners; may also help “right-size” centers (outcomes deteriorate as centers become too large)

Competition: goal to create value for patients by providing uniform product

Patient safety: requires constant vigilance

Avoiding futility: example  —  complete lymph node dissection following detection of sentinel lymph node not yet proven to save lives; majority of patients derive no benefit and experience morbidity due to procedure (ie, re­duces value to patient); policy needs reconsideration

Benefits of new practice structure: model survivable; care organized around patient’s requirements; goal to maxi­mize value for patient; deals with economic realities of health care costs; competition will promote innovation and enhance patient care

Suggested Reading

Antonacci AC et al: A report card system using error profile analysis and concurrent morbidity and mortality review: surgical outcome analysis, part II. J Surg Res 153:95, 2009; Cima RR et al: A multidisciplinary team approach to re­tained foreign objects. Jt Comm J Qual Patient Saf 35:123, 2009; Gupta P, Varkey P: Developing a tool for assessing competency in root cause analysis. Jt Comm J Qual Patient Saf 35:36, 2009; Healy GB et al: Error reduction through team leadership: seven principles of CRM applied to surgery. Bull Am Coll Surg 91:24, 2006; How SKH et al. Public Views on US Health System Organization: A Call for New Directions. The Commonwealth Fund, August, 2008; James TA, Russell TR: The future of the American College of Surgeons: uniting two perspectives. Bull Am Coll Surg 92:14, 2007; Percarpio KB et al: The effectiveness of root cause analysis: what does the literature tell us? Jt Comm J Qual Patient Saf 34:391, 2008; Rogers SO Jr: The holy grail of surgical quality improvement: process mea­sures or risk-adjusted outcomes? Am Surg 72:1046, 2006; Russell TR: The future of surgical reimbursement: quality care, pay for performance, and outcome measures. Am J Surg 191:301, 2006; Zohar E et al: Perioperative patient safety: correct patient, correct surgery, correct side–a multifaceted, cross-organizational, interventional study. Anesth Analg 105:443, 2007.