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Medical errors
Medical errors

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Between a Rock and a Hard Place: DisclosingMedical Errors
Kimberley G. Crone,
Michele B. Muraski,
 Joy D. Skeel,
Latisha Love-Gregory,
 Jack H. Ladenson,
and Ann M. Gronowski
Healthcare-related errors cause patientmorbidity and mortality. Despite fear of reprimand,laboratory personnel have a professional obligation torapidly report major medical errors when they areidentified. Well-defined protocols regarding how andwhen to disclose a suspected error by a colleague do notexist.
We describe a woman with a well documentedallergy to sulfamethoxazole who was treated with sul-fadiazine that led to toxic epidermal necrolysis. Afterthe patient’s death, the laboratory medicine residentwas asked by one of the patient’s physicians to measureserum sulfadiazine, but only if the results were notreported in the patient’s electronic medical record. Thecase was brought to the attention of a laboratory medi-cine faculty member and the hospital risk managementteam.
Laboratorians are patient fiduciaries and areresponsible for reporting errors. Most medical associa-tions have codes of ethics that address disclosure ofincompetence and errors, although the AACC’s Guide toEthics does not. New types of error, risk management,and root-cause analyses help to shift the focus to systemerrors and away from individuals’ errors. This can leadto a healthcare environment that encourages truth anddisclosure rather than fear and reprimand.
The individuals involved in the presentedcase fulfilled their fiduciary duty to the patient byreporting this incident. An extensive investigationshowed that, in fact, no medical errors or misconductshad occurred in the care of the patient.
© 2006 American Association for Clinical Chemistry
Prevention of medical errors is a major goal of healthcare.Error prevention and ethical conduct is important for allhealthcare workers. However, the role of the laboratory inerror reporting is sometimes misunderstood. A recentcase highlighted some salient issues regarding the role of laboratorians in identifying and reporting errors.
A 44-year-old woman with HIV/AIDS presented to theemergency department (ED) with a generalized rash. Inthe 12 years since her disease was diagnosed, her poorcompliance with medications had led to several hospitaladmissions for HIV-related complications. Only a fewdays before this presentation, she had been dischargedwith home medications, including sulfadiazine (a sulfon-amide antibiotic) for central nervous system toxoplasmo-sis. Her last CD4 count was 45 cells/mm
.Her past medical history was considerable for hyper-tension, gastroesophageal reflux disease, iron deficiencyanemia, and alcohol abuse. Her medications includedatenolol, azithromycin, dapsone, iron, leucovorin, lisino-pril, pyrimethamine, ranitidine, and sulfadiazine. She hada well-documented allergy to sulfamethoxazole (also asulfonamide antibiotic).In the ED, the patient was febrile and appeared un-comfortable. A painful, generalized erythematous papu-lar skin rash was present, with several bullous lesionsoozing on the upper extremities. Sloughing of the oro-pharynx mucosal membranes was noted, as was crustingaround her eyes and the orifices of her nose and mouth.Her skin was warm to the touch. The consulting derma-tology team’s impression was toxic epidermal necrolysis,a severe drug-induced reaction with high morbidity andmortality. The patient was admitted to the intensive careunit, where she rapidly declined and subsequently died.A resident in laboratory medicine was contacted byone of the patient’s physicians who inquired about which
Department of Pathology and Immunology, Washington UniversitySchool of Medicine, Saint Louis, MO.
Patient Safety and Quality, Barnes-Jewish Hospital, Saint Louis, MO.
Department of Psychiatry, Medical University of Ohio, Toledo, OH.* Address correspondence to this author at: Washington University Schoolof Medicine, Box 8118, 660 S. Euclid, St. Louis, MO 63110. Fax 314-362-1461;e-mail Gronowski@wustl.edu.Received April 28, 2006; accepted June 9, 2006.Previously published online at DOI: 10.1373/clinchem.2006.072678
Clinical Chemistry
52:91809–1814 (2006)
Case Conference
reference laboratory could measure serum sulfadiazine.Attempts to gather information about the patient and theclinical rationale for the testing were resisted by theclinician. The laboratory medicine resident was able todetermine that a serum sample had been obtained fromthe patient just before death, but postmortem examinationhad not been performed. The purpose of the requestappeared to be documentation of perimortem sulfadia-zine in a patient with known hypersensitivity to sulfa- based drugs. However, the clinical team asked if theresults could remain off the patient’s electronic medicalrecord for “legal reasons”. When the laboratory medicineresident said that results could not be withheld from thepatient’s chart, the inquiring physician said, in that case,they did not want the testing performed. The laboratorymedicine resident, with feelings of “fear” and “confusionabout the right thing to do”, brought the case to theattention of a laboratory medicine faculty member. Theresident felt ”stuck between a rock and a hard place“.
We use this case to discuss, from the laboratorian’sviewpoint, the ethical problems of error disclosure.
errors in medicine
An error is something that unintentionally deviates fromwhat is correct or true. In a discussion of medical errors(medical mistakes), it is important to recognize that errorsare of several types. Some are preventable, others are not.Some errors are made by instrument malfunction, someare made by individuals, and others reflect system designflaws rather than errors of a single individual or instru-ment. Furthermore, differentiation must be made betweenerrors caused by unintentional mistakes and those caused by misconduct. Misconduct is considered a deliberateviolation of clearly articulated rules and procedureswhereas a mistake is unintentional. Individuals should beaccountable for misconduct, whereas some mistakes may be unavoidable. There should be constant effort to mini-mize both misconduct and mistakes.In 2000, the Institute of Medicine published a reportentitled “To Err is Human: Building a Safer HealthSystem”
. The findings about the magnitude and scopeof preventable errors in healthcare came as a surprise tomuch of the medical profession and captured the public’sinterest. According to the report, more than one millionpreventable adverse events occur each year in UnitedStates hospitals as a result of healthcare
. Of theseadverse events, an estimated 100 000 caused patientsserious harm, and between 44 000 and 98 000 led to death
. Even conservative estimates indicate that more pa-tients die annually of preventable adverse events relatedto healthcare than from motor vehicle accidents (43 458), breast cancer (42 297), or AIDS (16 516)
.Within healthcare, the field of laboratory medicine hasfor years recognized quality assurance and error preven-tion priorities. Scrutiny of preventable analytic errors byregulatory and accreditation groups has influenced labo-ratory processes, including automation, quality control,proficiency testing, and programs to define error fre-quency such as Q-Probes and Q-Tracks from the Collegeof American Pathologists
(2, 3)
. As a result, preanalyticerrors, not measurement errors, are now the most com-mon type of error, with poor specimen quality and patientmisidentification being the most frequent
. Publishederror rates in the clinical chemistry laboratory range from0.045% to 2.3%, depending on the definition of “error”(for example, whether sample mix-ups are included)
.Although these low rates are encouraging, the field of medicine continues to tolerate error rates higher than, orequal to, many other nonmedical industries
(5, 6)
. Forinstance, even airline baggage handling has a comparableerror rate (0.5%), despite less life threatening conse-quences
. It is likely that the reported clinical chemistryerror rates are actually an underestimate of actual errorrates. Laboratory professionals have a duty to try to avoidpreventable errors and rapidly report identified errors(both preventable and nonpreventable, including thosecaused by misconduct) for the best interest of patients.
the laboratory professional acting as afiduciary
A fiduciary is entrusted with power and responsibility toact with another’s rights and interests in mind. Thefiduciary relationship is the modern basis for professionalethics, and specifically a model of the modern patient-physician relationship. Fundamental to the fiduciary re-lationship are these principles: autonomy, beneficence,nonmaleficence, and justice
Autonomy (from the Greek “autonomos”meaning “self rule”) is the freedom of individuals to maketheir own decisions, recognizing their capability for self-control, deliberation, and carrying out their own plans.An autonomous patient is able to give fully informedconsent when he has an awareness of all relevant medicalconcerns. When medical errors are not disclosed, hisability to understand the rationale or risks of an addi-tional or alternative procedure or longer hospital stay isimpeded, i.e., he is no longer capable of giving informedconsent.
Beneficence (from the Latin, “bene” and “fa-cio,meaning “to do well”) is a healthcare provider’sobligation to help his patients. Allowing a patient to believe his disease is responsible for an event (a pro-longed treatment time or additional testing), when inactuality the event is the result of a medical error, wouldnot be fair or kind. A reassurance including a full expla-nation by a beneficent physician allows the patient toanticipate and understand what may occur in the future
Crone et al.: Disclosing Medical Errors
Nonmaleficence (from the Latin “male”and “ficus,” meaning “to do no harm”) is a passiveobligation. It is encapsulated in the motto,
Primum nonnocere
, first do no harm. Healthcare providers must pre-vent patients from making bad decisions based on incom-plete information. If an error has harmed a patient, thephysician should do whatever is necessary to preventfurther harm. Doing otherwise only makes the problemworse
Justice (from the Latin “jus” meaning “law” or“right”) dictates that patients should receive what theydeserve. They may be owed compensation (for increasedhospital costs, or lost wages) and an apology. Moststudies indicate that nearly all patients demand, at aminimum, an apology
(11, 12)
. Most physicians want toapologize but may not do so in fear that the apology mayimply legal liability
(10, 13)
.From the application of these principles comes veracity(truth telling) and fidelity (promise keeping)
. It isimplied that a fiduciary will not deceive his or herpatients. Without this premise, the privilege of being apatient’s healthcare provider would likely not have beenentrusted to the healthcare provider.
error disclosure
As a fiduciary, a healthcare professional strives to main-tain a reputation of honesty, integrity, and reliability, i.e.,the fiduciary relationship in medicine is based on trust.Therefore, when medical errors are discovered, theyshould be disclosed. Ethicists, patient safety experts, andpatients agree that once serious errors occur they should be disclosed to the patient as soon as possible
.Although most physicians agree, citing their responsibil-ities as the patient’s healthcare fiduciary (Table 1), theliterature suggests they carry out this practice in less thanhalf of instances when a serious error has occurred
. Infact, many physicians admit that they have used decep-tion when forced to make a difficult ethical decision
.Interestingly, one third of polled physicians report they(or a family member) have been a victim of medical error,and in those cases they desire full disclosure of errors
.When and how to disclose a colleague’s error is evenmore poorly defined. Medical tradition tends to empha-size the loyal brotherhood of physicians
. Medicaltraining reinforces respect for teachers and colleagues andthus discourages whistle blowing
. Moreover, in thereal world, whistleblowers face discrimination
. Al-though error disclosure is difficult to approach, it is anessential component of our profession. It is not a surprisethat errors occur in medicine. How we choose to respondto them defines us, ethically, as professionals.The medical profession generally supports the disclo-sure of error, even when the error is not one’s own. Nodefinitive procedure or document outlines how a healthprofessional should disclose the errors of another healthprofessional, because vastly different circumstances canexist. In general, once the facts are known, the person whocommitted an error should be given the opportunity todisclose it. If that person is unwilling, another person whois aware of the error must act on his or her primaryresponsibility to the patient and disclose the error. Ap-propriate hospital patient safety mechanisms must then be followed.Many medical associations have adopted codes of ethics that address the issue of disclosing incompetenceand errors. For instance, the American Medical Associa-tion’s
Principles of Medical Ethics
A physician shall uphold the standards of the profession, behonest in all professional interactions, and strive to reportphysicians deficient in character or competence, or engaging infraud or deception, to appropriate entities
The American College of Physicians’
Ethics Manual
. . . physicians should disclose to patients information aboutprocedural or judgment errors made in the course of care if suchinformation is material to the patient’s well being. Errors do not
Table 1. Comparison of patient and physician attitudes about medical error disclosure.
Focus Group Themes Patient Attitudes Physician Attitudes
Definition of error Broad; includes deviations from standard care,some nonpreventable adverse events, poorservice quality, and practitioner’s deficientinterpersonal skillsNarrow; deviations from accepted standard careonly What errors to disclose All errors that cause harm Errors that cause harm, except when harm istrivial, patient cannot understand error, orpatient does not want to know about errorDisclose near misses? Mixed NoWhat information to disclose about error? Tell everything Choose words carefullHow to disclose error Truthfully and compassionately Truthfully, objectively, and professionallRole of apology Desirable Concerned that apology creates a legal liabilitEmotional impact of error Upset, angry, scared Upset that patient was harmed and about howerror could impact career
JAMA (2003)289:1001 Reprinted with permission from the American Medical Association.
Clinical Chemistry
52, No. 9, 2006

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