Медицинская ошибка это определение

План:

На
сегодняшний день проблема ненадлежащего
оказания медицинской помощи является
более чем актуальной. Часть 1 ст. 41
Конституции Р. Ф.провозглашает право
каждого человека на охрану его здоровья
и на медицинскую помощь. В соответствии
со ст. 10 Закона об основах охраны здоровья
граждан одним из основных принципов
охраны здоровья в России является
доступность и качество медицинской
помощи. Качественная медицинская помощь
характеризуется своевременностью ее
оказания, правильностью выбора методов
профилактики, диагностики,лечения и
реабилитации, степенью достижения
запланированного результата (п. 21 ст. 2
Закона об основах охраны здоровья
граждан). Однако в силу разных обстоятельств,
как объективных, так и субъективных,
врачами совершается немало медицинских
ошибок

Понятие «Врачебная ошибка»

Мы
глубоко осознаем, что врачи всех поколений
не были и не будут застрахованы от своих
ошибок, чаще именуемых «врачебными
ошибками»
Враче́бная
оши́бка
— ошибка врача при исполнении своих
профессиональных обязанностей, которая
явилась следствием добросовестного
заблуждения, не могла быть им предусмотрена
и предотвращена, т. е. не являлась
следствием халатного отношения врача
к своим обязанностям, его невежества
или злоумышленного действия; В. о. не
влечет за собой дисциплинарного,
административного или уголовного
наказания.

Можно
услышать, что врачебная ошибка – это
не преступная халатность, а погрешность
в профессиональных действиях врача,
совершаемых во благо больного. Ряд
судебных медиков (М.И. Авдеев, Н.В. Попов,
В.М. Смольянинов и др.) указывает, что
под врачебной
ошибкой
следует понимать
добросовестное заблуждение врача в его
профессиональной деятельности,
если исключены небрежность, халатность,
недозволенное экспериментирование на
больных. В противном случае будет уже
не врачебная ошибка, а преступление, за
которое врач несет предусмотренную
нашим законодательством судебную
ответственность.

Врачебные
ошибки подразделяются на три группы:

1)
ошибки диагностические — нераспознавание
или ошибоч­ное распознавание болезни;

2)
ошибки тактические — неправильное
определение показа­ний к операции,
ошибочный выбор времени проведения
опера­ции, ее объема и т.п.;

3)
ошибки технические — неправильное
использование ме­дицинской техники,
применение несоответствующих медика­ментов
и диагностических средств и т.д.
Клава
Б., 1 года 3 месяцев, умерла во время
дневного сна в яслях 29 января 1998 г. С 5
по 17 января она перенесла острую
респираторную инфекцию, по поводу
которой ясли не посещала. Врач яслей
принял ребен­ка 18 января с остаточными
явлениями после перенесенного катара
верхних дыхательных путей (обильные
слизистые выделения из носа, прослушива­лись
единичные сухие хрипы в легких), в
последующем ребенок был ос­мотрен
врачом лишь 26 января. Диагноз пневмонии
установлен не был, но было отмечено, что
явления катара верхних дыхательных
путей держатся, но температура у ребенка
была нормальная. Лечение продолжалось
в яслях (микстура — от кашля, капли в
нос — от насморка). Ребенок выглядел
плохо, был вялым, сонливым, ел без
аппетита, кашлял.

29
января 1998 г. в 13 ч Клаву Б. вместе с другими
детьми в спаль­ной комнате уложили
спать. Ребенок спал спокойно, не кричал.
При подъ­еме детей в 15 ч Клава Б. не
подавала признаков жизни, но была еще
теп­лой. Старшая сестра яслей немедленно
стала делать ей искусственное ды­хание,
сделала два укола кофеина, тело ребенка
согревалось грелками. Прибывшим врачом
скорой медицинской помощи производились
искусст­венное дыхание рот в рот и
непрямой массаж сердца. Однако оживить
ре­бенка не удалось.

При
судебно-медицинской экспертизе трупа
Клавы Б. были обнару­жены: катаральный
бронхит, распространенная серозно-катаральная
пнев­мония, интерстициальная пневмония,
множественные фокусы кровоизлия­ний
в легочную ткань, что и послужило причиной
смерти ребенка.

По
мнению экспертной комиссии, ошибочность
действий врачей в дан­ном случае
заключалась в том, что ребенок был
выписан в ясли не выздо­ровевшим, с
остаточными явлениями респираторной
инфекции. Врач яслей должен был обеспечить
активное наблюдение за ребенком, провести
допол­нительные исследования
(рентгеноскопию, анализ крови). Это дало
бы возможность более правильно оценить
состояние больного ребенка и актив­нее
проводить лечебные мероприятия. Более
правильным было бы лечение ребенка
производить не в условиях здорового
коллектива детей в яслях, а в лечебном
учреждении.

Отвечая
на вопросы органов следствия, экспертная
комиссия указала, что дефекты ведения
больного ребенка обусловлены в
значительной степени трудностью
диагностики интерстициальной пневмонии,
которая протекала при малонарушенном
общем состоянии ребенка и нормальной
температуре тела. Пневмония могла
развиться и в последние дни жизни
ребенка. Смерть детей при пневмонии
может наступать и во сне без каких-либо
вы­раженных признаков заболевания.

Экспертная
комиссия рекомендовала данный случай
атипичного течения пневмонии обсудить
в детских медицинских учреждениях,
обратив внимание на терапевтическую
тактику врача при ведении такого рода
больных детей.

Практика
показывает, что большинство врачебных
ошибок связано с недостаточным уровнем
знаний и небольшим опытом врача. Вместе
с тем ошибки, например диагностические,
встре­чаются не только у начинающих,
но и у опытных врачей.

Реже
ошибки обусловлены несовершенством
применяемых методов исследования,
отсутствием необходимой аппаратуры
или техническими недочетами в процессе
ее использования.

Классификация
врачебных ошибок
Классификациям
врачебных ошибок посвящены многочисленные
работы, что само по себе свидетельствует
о чрезвычайной сложности настоящей
проблемы. Наиболее популярны следующие
классификации.

Профессор
Ю.Я. Грицман (1981) предложил делить ошибки
на:

• диагностические

• лечебные

• лечебно-тактические

• лечебно-технические

• организационные

• ошибки,
  связанные с неправильным ведением
  документации и с поведением медицинского
  персонала.

Нам
импонирует классификация причин ошибок
по академику-онкологу Н.Н. Петрову:

1)
зависящие от несовершенства наших
знаний на современном этапе – 19%;

2)
зависящие от несоблюдения правил
клинического обследования – 50%;

3)
зависящие от состояния больного – 30%
(1956).

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В архив ФГБУ «Российский центр судебно-медицинской экспертизы» (далее РЦСМЭ) Минздрава России, начиная с 50-х годов прошлого века, поступают материалы уголовных и гражданских дел, касающиеся недостатков оказания медицинской помощи. В структуре поступающих материалов наибольшее количество составляет традиционная судебно-медицинская травматология и лишь некоторую часть — так называемые врачебные дела. Уже в 50-х годах «врачебным делам» уделялось значительное внимание. Так, в их производстве всегда участвовали главные специалисты, в РЦСМЭ это проф. Виктор Ильич Прозоровский (в то время главный эксперт Минздрава СССР, директор НИИ судебной медицины), Вячеслав Кириллович Дербоглав (тогда главный эксперт Минздрава РСФСР, начальник БГСМЭ МЗ РСФСР) и др.

Однако именно в последние годы наметилась четкая тенденция к увеличению поступления в РЦСМЭ материалов уголовных и гражданских дел, а также материалов проверок, связанных с недостатками в оказании медицинской помощи. Количество материалов по «врачебным делам» постепенно начинает превалировать над остальными, касающимися, например, нанесения телесных повреждений, т. е. находящихся в компетенции только судебно-медицинского эксперта. Так, в период с 2012 по 2016 г. ежегодно поступало около 350 материалов по «врачебным делам». Среди материалов гражданских дел подавляющее большинство представляли дела, связанные с исками к лечебным учреждениям в связи с недостатками в оказании медицинской помощи. В 2016 г. их было около 90% от всех поступивших гражданских дел (205 из 231). Во всех гражданских делах о недостатках в оказании медицинской помощи фигурирует понятие медицинской ошибки, которая может привести к наступлению гражданско-правовой ответственности.

Прежде всего необходимо определиться с понятием медицинской ошибки, которая приводит или может привести к наступлению гражданско-правовой или уголовной ответственности. Следует выявить те существенные признаки, которые помогут отнести или не отнести то или иное событие к медицинской ошибке.

Понятие — это форма мышления, которая отражает существенные свойства объектов и отношения между ними [1]. Понятия выражаются в виде отдельных слов («экспертиза») или словосочетаний («медицинская ошибка», «судебно-медицинская экспертиза»). Отечественный логик Е.К. Войшвилло так характеризует эту форму мышления: «понятие как форма (вид) мысли или как мысленное образование есть результат обобщения предметов некоторого класса, и мысленного выделения самого этого класса по определенной совокупности общих для предметов этого класса — и в совокупности отличительных для них — признаков» [2]. Таким образом, четкое определение понятия «медицинская ошибка» связано прежде всего с необходимостью представления, что в данное понятие входит, а что нет. Таким образом, необходимо выделить те существенные признаки понятия «медицинская ошибка», которые позволят охарактеризовать его как определенное понятие, имеющее ясное содержание и резкий объем.

В юридической и медицинской литературе встречаются два понятия, часто смешиваемые, а именно: «медицинская ошибка» и «врачебная ошибка». Законодательно эти понятия никак не закреплены, что дает повод для их вольной трактовки.

А.А. Андреев в 2006 г. справедливо писал о некорректности смешения этих понятий. Он указывает, что врачебная ошибка — это не только и не столько клиническое заблуждение, это социальный факт, обусловленный зачастую психологическими, экономическими, эргономическими и прочими факторами. Особое место среди этих случаев занимают те, которые принято называть «врачебными ошибками». Термина «врачебная ошибка» нет в законодательных актах, это значит, что ошибка не является проступком, правонарушением или преступлением. В общественном сознании принято считать врачебной ошибкой любое нанесение вреда пациенту, что абсолютно неверно. Более того, такую трактовку поддерживают средства массовой информации и даже некоторые медицинские работники [3].

Е.О. Костикова [4] в научной работе, посвященной ошибкам, использовала термин «медицинская ошибка» и определяла ее, как непреднамеренное ненадлежащее действие (бездействие) медицинского работника, повлекшее причинение вреда жизни или здоровью пациента, наступление которого медицинский работник имел реальную возможность избежать, действуя иначе. В данном случае автор определяет медицинскую ошибку через причинение вреда здоровью ненадлежащим действием или бездействием, с чем можно согласиться. Автор в определение медицинской ошибки включил и понятие причинно-следственной связи, которая должна быть между ошибкой и неблагоприятными последствиями (в данном случае причинение вреда жизни или здоровью пациента), и само наступление неблагоприятного исхода.

Следует указать, что к числу общих условий гражданско-правовой ответственности относятся следующие: 1) противоправный характер поведения (действие или бездействие) лица, на которое предполагается возложить ответственность (либо наступление иных, специально предусмотренных законом или договором обстоятельств); 2) наличие у потерпевшего лица вреда или убытков; 3) причинная связь между противоправным поведением нарушителя и наступившими вредоносными последствиями; 4) вина правонарушителя [5].

Е.О. Костикова дает чрезмерное определение, так как наличие причинно-следственной связи, которая должна быть между медицинской ошибкой и неблагоприятным исходом, и наличие у потерпевшего вреда являются частью условий наступления гражданско-правовой ответственности. Вернее сами по себе причинно-следственная связь и вред, являясь условиями наступления гражданско-правовой ответственности, не могут являться частью медицинской ошибки.

Н.А. Иванова [6] в диссертационной работе указывает, что с позиции гражданского права врачебная ошибка — это действие (бездействие) медицинского работника лечебно-профилактического учреждения, являющееся результатом заблуждения в процессе осуществляемой медицинской деятельности из-за недостатка врачебного опыта либо медицинского оборудования, неполноты собранной истории болезни, редкости заболевания, анатомических особенностей организма, способное повлечь неверное диагностирование заболевания, определение методов и средств лечения. В остальных случаях врачебную ошибку следует квалифицировать — как уголовно наказуемое деяние. Данное пространное определение врачебной ошибки включает, скорее, объективные причины возникновения этой ошибки, чем собственно само ее определение. Непонятно, в каких «остальных случаях» врачебная ошибка будет уголовно наказуема. С другой стороны, отсутствие упоминания вреда, который повлекла или могла повлечь изучаемая автором врачебная ошибка, является положительной стороной данного определения.

Согласно определению А.А. Старченко, «врачебная ошибка — это такое действие или бездействие врача, которое способствовало или могло способствовать увеличению риска прогрессирования имеющегося у пациента заболевания, возникновению нового патологического процесса или осложнений имеющегося заболевания» [7]. Приведенное определение отчасти совпадает с мнением Е.О. Костиковой, в том числе с точки зрения чрезмерности определения. По мнению А.А. Старченко, субъектом, допустившим ошибку, является врач (поэтому и ошибка врачебная). По мнению Е.О. Костиковой — это медицинский работник, следовательно, не обязательно врач.

А.А. Понкина в очень интересной и обстоятельной работе указывает, что «врачебная (медицинская) ошибка — это случившееся или эвентуальное (возможное при определенных условиях) событие (вид ятрогенного дефекта медицинской помощи), вызванное и характеризующееся невиновными действиями, бездействием или несвоевременными действиями врача (или в ряде случаев — младшего медицинского персонала) при оказании им пациенту медицинской помощи или медицинских услуг, результативно повлекшее по крайней мере одно из неблагоприятных для пациента событий» [8]. В данном определении автором совмещены два понятия: «врачебная ошибка» и «медицинская ошибка», при этом из буквального прочтения определения следует, что врачебные ошибки допускают врачи (что очевидно), а вот медицинские ошибки — младший медицинский персонал, с чем нельзя согласиться, так как понятие «врач» является видовым по отношению к понятию «медицинский работник», которое включает и понятие «младший медицинский персонал». Автором использован малопонятный термин «ятрогенный дефект медицинской помощи», что не добавляет ясности к указанной дефиниции. В данное определение также внесены множественные понятия, которые вместе с собственно медицинской ошибкой составляют состав гражданско-правового правонарушения (вина, причинно-следственная связь, последствия), что вносит излишнюю путаницу в понимание термина. Не совсем ясен смысл упоминания «по крайней мере, одного из неблагоприятных для пациента событий». Очевидно, что их меньше одного быть не может (при их наличии), а их количество никак не влияет на факт наличия или отсутствия медицинской ошибки. Иначе говоря, медицинская ошибка — это часть состава гражданско-правового правонарушения, его частью являются также вина, причинно-следственная связь, последствия. Внесение их в понятие медицинской ошибки ставит знак тождества между понятиями «медицинская ошибка», являющейся частью состава и «состав гражданско-правового правонарушения», включающий медицинскую ошибку, что логически противоречиво.

В доступной иностранной литературе при характеристике ошибок используется термин «medical error», который можно перевести и как «медицинская ошибка», и как «врачебная ошибка». Так, например, Л.Т. Кон, Дж.М. Корригэн и М.С. Дональдсон считают, что медицинская ошибка («medical error») возникает, когда «не удалось выполнить запланированные действия, направленные на достижение определенной цели терапии, или был сделан неверный выбор плана для достижения указанной цели» (цит. по [8]). В данном определении авторы справедливо ограничились констатацией собственной ошибочности действий, не изменяя определение.

Близкое к приведенному определение медицинской ошибки дал американский ученый Б.А. Лайен: «неудачное совершение спланированного действия не таким образом, как это изначально было задумано, либо использование неверного плана действий для достижения поставленной цели, которое не включает умышленные или неосторожные действия, наносящие вред пациенту» (цит. по [8]).

В приведенных примерах зарубежные авторы определяют медицинскую ошибку через неудачу в выполнении запланированных действий или составление неверного плана действий. Сама по себе неудача в выполнении запланированных действий вряд ли является синонимом медицинской ошибки.

По мнению бразильского исследователя Л.М. Мартина, медицинской ошибкой (он использовал термин «erro médico», который с португальского переводится именно как медицинская ошибка в отличие от врачебной ошибки, которую можно перевести, как «extra-territoriais erro») являются неудачи, которые возникают в результате человеческого бессилия перед лицом природных явлений в ситуациях, не зависящих от любых медицинских действий, которые находятся в ведении врача, в том смысле, что ошибок можно было бы избежать, если бы фактические обстоятельства были иными» (цит. по [8]). С данным определением бразильского автора трудно согласиться, так как в данном контексте не фигурирует собственно ошибка, а наоборот, говорится о некой непреодолимой силе, приведшей к «неудаче» в оказании медицинской помощи. Именно эта непреодолимая сила «обеляет» врача даже при неблагоприятном исходе, так как именно объективные факторы, перечисленные автором, практически исключают возникновение вины за совершение медицинской ошибки.

Другие бразильские авторы — Ж.С. Мейреллеш Гомеш и Ж. Велосо де Франса определяют медицинскую ошибку как совершаемое медицинским работником некорректное действие (действие ненадлежащим образом) или бездействие (несовершение тех действий, которые следовало совершить) при исполнении им его профессиональных обязанностей, результатом которого является несоблюдение технических стандартов такой деятельности, которое может повлечь за собой причинение вреда жизни или здоровью пациента при отсутствии у медицинского работника намерения причинить вред (цит. по [8]). При всей похожести данного определения с определениями отечественных исследователей оно имеет одно кардинальное отличие, а именно: российские исследователи говорят о наступлении некоего неблагоприятного исхода, то бразильские — о возможности его наступления. С точки зрения Ж.С. Мейреллеш Гомеш и Ж. Веласо де Франса, ошибкой является отход от стандарта, который лишь гипотетически может привести к вреду пациенту. Очевидно, подобный подход к трактовке медицинской ошибки в нашей стране неприемлем хотя бы с точки зрения не обязательности, а лишь рекомендуемости стандартов оказания медицинской помощи, что закреплено в п. 1 ст. 37 Федерального закона № 323-ФЗ «Об основах охраны здоровья граждан в Российской Федерации» (далее 323-ФЗ) от 21.11.11 [9]. В нем сказано, что медицинская помощь организуется и оказывается в соответствии с порядками оказания медицинской помощи, обязательными для исполнения на территории Российской Федерации всеми медицинскими организациями, а также на основе стандартов медицинской помощи и методических рекомендаций.

Таким образом, приведенные даже несколько определений понятий «медицинская ошибка» и «врачебная ошибка» показывают неоднозначный подход к их толкованию. В связи с этим целесообразно определить, какой термин более приемлем. Исходя из буквального прочтения указанных терминов, можно утверждать, что «медицинская ошибка» охватывает ошибки, допускаемые при оказании медицинской помощи, которая в соответствии с п. 3 ст. 323-ФЗ представляет собой «комплекс мероприятий, направленных на поддержание и (или) восстановление здоровья и включающих в себя предоставление медицинских услуг». Далее, раскрывая в пп. 4—8, 10 ст. 323-ФЗ понятия «медицинская услуга», «медицинское вмешательство», «профилактика», «диагностика», «лечение», «медицинская деятельность», законодатель нигде не оговаривает, что субъектом указанных мероприятий является именно врач, т. е. лицо, имеющее высшее медицинское образование и прошедшее соответствующую специальную подготовку, подтвержденную действующим сертификатом. Таким образом, медицинскую помощь может оказывать врач, средний медицинский персонал (медицинская сестра, фельдшер), лицо, обязанное ее оказывать в соответствии со специальным правилом (например, работник МЧС при работе на месте происшествия, кроме медицинского вмешательства, оказываемого именно медицинским работником).

Таким образом, «медицинская ошибка» относится ко всем субъектам, оказывающим медицинскую помощь, а «врачебная ошибка» — к имеющим высшее медицинское образование и прошедшим соответствующую специальную подготовку, подтвержденную действующим сертификатом. Понятие «медицинская ошибка» является более широким, чем понятие «врачебная ошибка», и первое включает второе. Именно поэтому правильнее говорить именно о «медицинской ошибке», а не о «врачебной», так как применяя термин «медицинская ошибка», мы не ограничиваем себя ошибками, допускаемыми именно врачами, но учитываем ошибки, допускаемые иными субъектами, за которые они также могут нести в том числе уголовную и гражданско-правовую ответственность.

Необходимо остановиться на содержании понятия «медицинская ошибка». Исходя из самого понятия, наиболее значимое в нем — ошибка, т. е. действие или бездействие, не соответствующее состоянию здоровья пациента, а также не соответствующее утвержденным правилам оказания медицинской помощи, стандартам оказания медицинской помощи и методическим рекомендациям, т. е. неправомочное.

В русском языке существует множество трактовок слова «ошибка». С.И. Ожегов и Н.Ю. Шведова указывают, что ошибка — это неправильность в действиях, мыслях [10], а В.И. Даль определяет ошибку как погрешность, промах, огрех, обмолвка, неумышленный проступок, невольное искажение чего-либо [11]. По мнению составителей толковых словарей русского языка, существенное в ошибке — это неправильность действий, при этом исход их неправильности никак не определяется и не изменяет суть ошибки.

Анализируя приведенные определения понятия «медицинская ошибка», можно выделить несколько составляющих, встречающихся в части из них:

— действие или бездействие;

— непреднамеренность;

— наличие неблагоприятного исхода;

— наличие причинно-следственной связи.

Медицинская ошибка, допускаемая при оказании медицинской помощи, может выражаться лишь в двух формах — в виде действия или в виде бездействия и никак иначе. В связи с этим в определении понятия «медицинская ошибка» они обязательно должны быть упомянуты.

Ошибка вообще и медицинская ошибка в частности не могут быть преднамеренным действием. Преднамеренность действия лишает его свойства именно ошибки, т. е. неумышленности. Таким образом, непреднамеренность является признаком медицинской ошибки.

Далее, медицинская ошибка не существует сама по себе, она объективно существует лишь применительно к последствиям, которые вызывает или может вызвать. Необходимо учитывать, что медицинская ошибка не всегда вызывает негативные последствия. Иногда ошибочные действия медицинских работников могут привести и к положительным результатам (например, диагноз поставлен неверно, неправильно проведено обследование, назначенное лечение лишь случайно оказалось соответствующим реальному состоянию здоровья и в этой связи оказало некоторое положительное воздействие и привело к улучшению состояния здоровья). Таким образом, наличие неких неблагоприятных последствий не является бесспорным атрибутом медицинской ошибки. Неблагоприятные последствия могут наступить и при правильно, без ошибок, оказанной медицинской помощи [12]. Существенный, по мнению многих авторов, признак медицинской ошибки — наступление неких неблагоприятных последствий таковым не является.

Третьим признаком медицинской ошибки, упоминаемым некоторыми авторами, является наличие причинно-следственной связи между действием или бездействием при оказании медицинской помощи и наступлением неблагоприятных последствий. Как отмечалось, неправильные действия (бездействие) при оказании медицинской помощи не всегда приводят к неблагоприятным последствиям. Далее — причинно-следственная связь наряду с противоправным действием или бездействием (которым собственно и является медицинская ошибка) – это условия наступления гражданско-правовой ответственности. В связи с этим включение в понятие «медицинская ошибка» причинно-следственной связи является нецелесообразным.

Приведенные соображения относительно содержания понятия «медицинская ошибка» во многом очевидны и объяснимы, однако отнесение того или иного действия или бездействия именно к медицинской ошибке требует осторожного подхода. В настоящее время существует великое множество медицинских школ и направлений, которые в ряде случаев подходят с совершенно различных позиций к диагностике и лечению тех или иных патологических состояний. Так, если с точки зрения одного медицинского направления совершенные медицинским работником действия будут верными, то с точки зрения представителей другого направления — неверными. Например, в каком-то конкретном клиническом случае выздоровление пациента не подвигнет оппонентов на признание медицинской помощи правильной, а будет констатировано лишь случайное наступление благоприятного исхода. Необходимо определить, по какому именно критерию можно отнести те или иные действия или бездействие именно к ошибке, нарушение чего будет расценено как ошибка. В соответствии со ст. 37 ФЗ-323 в Российской Федерации «медицинская помощь организуется и оказывается в соответствии с порядками оказания медицинской помощи, обязательными для исполнения на территории Российской Федерации всеми медицинскими организациями, а также на основе стандартов медицинской помощи», т. е. порядки обязательны для исполнения, стандарты носят рекомендательный характер. Кроме указанных нормативно-правовых актов, общепризнанными и рекомендуемыми к применению являются «Национальные руководства», выпускаемые под редакцией главных специалистов Министерства здравоохранения Российской Федерации по соответствующему профилю. По диагностике, лечению, реабилитации и профилактике тех или иных заболеваний также имеются соответствующие методические рекомендации. Таким образом медицинский работник, а также лицо, обязанное оказывать медицинскую помощь в соответствии с законом или со специальным правилом, должны руководствоваться, кроме имеющихся у них специальных познаний, порядками, стандартами, соответствующими руководствами и методическими рекомендациями.

Следовательно, можно выделить существенные признаки медицинской ошибки:

— медицинская ошибка является действием или бездействием;

— медицинская ошибка является неумышленным действием или бездействием;

— медицинская ошибка допускается медицинским работником (как с высшим медицинским, так и со средним медицинским образованием и соответствующей специальной подготовкой, подтвержденной действующим сертификатом) или лицом, обязанным оказывать медицинскую помощь в соответствии с законом или специальным правилом;

— медицинская ошибка не всегда приводит к наступлению неблагоприятных последствий в виде ухудшения состояния здоровья, отсутствия улучшения состояния здоровья или смерти; иногда она может привести к случайному улучшению состояния здоровья;

— медицинская ошибка не включает понятие причинно-следственной связи;

— является отходом от порядков, стандартов, руководств и методических рекомендаций.

Таким образом, медицинская ошибка — это действие или бездействие медицинского работника или лица, обязанного оказывать медицинскую помощь в соответствии с законом или специальным правилом, не соответствующее реальному состоянию здоровья гражданина, нуждающегося в оказании медицинской помощи, а также порядкам, стандартам, руководствам и методическим рекомендациям.

Причин возникновения медицинских ошибок может быть огромное количество, но все их можно разделить на несколько групп:

— субъективные (связанные с оказывающим медицинскую помощь);

— объективные (связанные с тем, кому оказывают медицинскую помощь).

Наличие как субъективных, так и объективных причин возникновения медицинских ошибок или их отсутствие не меняет факта наличия медицинской ошибки и может учитываться лишь при оценке наличия или отсутствия состава гражданско-правового правонарушения.

Автор заявляет об отсутствии конфликта интересов.

A medical error is a preventable adverse effect of care («iatrogenesis»), whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete diagnosis or treatment of a disease, injury, syndrome, behavior, infection, or other ailment.

Definitions[edit]

The word error in medicine is used as a label for nearly all of the clinical incidents that harm patients. Medical errors are often described as human errors in healthcare.^[1] Whether the label is a medical error or human error, one definition used in medicine says that it occurs when a healthcare provider chooses an inappropriate method of care, improperly executes an appropriate method of care, or reads the wrong CT scan. It has been said that the definition should be the subject of more debate. For instance, studies of hand hygiene compliance of physicians in an ICU show that compliance varied from 19% to 85%.^{[2][needs update]} The deaths that result from infections caught as a result of treatment providers improperly executing an appropriate method of care by not complying with known safety standards for hand hygiene are difficult to regard as innocent accidents or mistakes.

There are many types of medical error, from minor to major,^[3] and causality is often poorly determined.^{[4][needs update]}

There are many taxonomies for classifying medical errors.^[5]

Definitions of diagnostic error[edit]

There is no single definition of diagnostic error, reflecting in part the dual nature of the word diagnosis, which is both a noun (the name of the assigned disease; diagnosis is a label) and a verb (the act of arriving at a diagnosis; diagnosis is a process). At the present time, there are at least 4 definitions of diagnostic error in active use:

Graber et al. defined diagnostic error as a diagnosis that is wrong, egregiously delayed, or missed altogether.^[6] This is a ‘label’ definition, and can only be applied in retrospect, using some gold standard (for example, autopsy findings or a definitive laboratory test) to confirm the correct diagnosis. Many diagnostic errors fit several of these criteria; the categories overlap.

There are two process-related definitions: Schiff et al. defined diagnostic error as any breakdown in the diagnostic process, including both errors of omission and errors of commission.^[7] Similarly, Singh et al. defined diagnostic error as a ‘missed opportunity’ in the diagnostic process, based on retrospective review.^[8]

In its landmark report, Improving Diagnosis in Health Care, The National Academy of Medicine proposed a new, hybrid definition that includes both label- and process-related aspects: «A diagnostic error is failure to establish an accurate and timely explanation of the patient’s health problem(s) or to communicate that explanation to the patient.»^[9] This is the only definition that specifically includes the patient in the definition wording.

Impact[edit]

A 2000 Institute of Medicine report estimated that medical errors result in between 44,000 and 98,000 preventable deaths and 1,000,000 excess injuries each year in U.S. hospitals.^[10][11][12] In the UK, a 2000 study found that an estimated 850,000 medical errors occur each year, costing over £2 billion.^[13]

Some researchers questioned the accuracy of the IOM study, criticizing the statistical handling of measurement errors in the report,^[14] significant subjectivity in determining which deaths were «avoidable» or due to medical error, and an erroneous assumption that 100% of patients would have survived if optimal care had been provided.^[15] A 2001 study in the Journal of the American Medical Association of seven Department of Veterans Affairs medical centers estimated that for roughly every 10,000 patients admitted to the select hospitals, one patient died who would have lived for three months or more in good cognitive health had «optimal» care been provided.^[15]

A 2006 follow-up to the IOM study found that medication errors are among the most common medical mistakes, harming at least 1.5 million people every year. According to the study, 400,000 preventable drug-related injuries occur each year in hospitals, 800,000 in long-term care settings, and roughly 530,000 among Medicare recipients in outpatient clinics. The report stated that these are likely to be conservative estimates. In 2000 alone, the extra medical costs incurred by preventable drug-related injuries approximated $887 million—and the study looked only at injuries sustained by Medicare recipients, a subset of clinic visitors. None of these figures take into account lost wages and productivity or other costs.^[16]

According to a 2002 Agency for Healthcare Research and Quality report, about 7,000 people were estimated to die each year from medication errors – about 16 percent more deaths than the number attributable to work-related injuries (6,000 deaths).^{[citation needed]} Medical errors affect one in 10 patients worldwide. One extrapolation suggests that 180,000 people die each year partly as a result of iatrogenic injury.^[17] One in five Americans (22%) report that they or a family member have experienced a medical error of some kind.^[18]

The World Health Organization registered 14 million new cases and 8.2 million cancer-related deaths in 2012. It estimated that the number of cases could increase by 70% through 2032. As the number of cancer patients receiving treatment increases, hospitals around the world are seeking ways to improve patient safety, to emphasize traceability and raise efficiency in their cancer treatment processes.^[19]

Difficulties in measuring frequency of errors[edit]

About 1% of hospital admissions result in an adverse event due to negligence.^[20] However, mistakes are likely much more common, as these studies identify only mistakes that led to measurable adverse events occurring soon after the errors. Independent review of doctors’ treatment plans suggests that decision-making could be improved in 14% of admissions; many of the benefits would have delayed manifestations.^[21] Even this number may be an underestimate. One study suggests that adults in the United States receive only 55% of recommended care.^[22] At the same time, a second study found that 30% of care in the United States may be unnecessary.^[23] For example, if a doctor fails to order a mammogram that is past due, this mistake will not show up in the first type of study.^[20] In addition, because no adverse event occurred during the short follow-up of the study, the mistake also would not show up in the second type of study^[21] because only the principal treatment plans were critiqued. However, the mistake would be recorded in the third type of study. If a doctor recommends an unnecessary treatment or test, it may not show in any of these types of studies.

Cause of death on United States death certificates, statistically compiled by the Centers for Disease Control and Prevention (CDC), are coded in the International Classification of Disease (ICD), which does not include codes for human and system factors.^[24][25]

Causes[edit]

The research literature showed that medical errors are caused by errors of commission and errors of omission.^[26] Errors of omission are made when providers did not take action when they should have, while errors of commission occur when decisions and action are delayed.^[26] Commission and omission errors have also been attributed with communication failures.^[27][28]

Medical errors can be associated with inexperienced physicians and nurses, new procedures, extremes of age, and complex or urgent care.^[29] Poor communication (whether in one’s own language or, as may be the case for medical tourists, another language), improper documentation, illegible handwriting, spelling errors, inadequate nurse-to-patient ratios, and similarly named medications are also known to contribute to the problem.^[30][31] Misdiagnosis may be associated with individual characteristics of the patient or due to the patient multimorbidity.^[32][33] Patient actions or inactions may also contribute significantly to medical errors.^[28][27]

Healthcare complexity[edit]

Complicated technologies,^[34][35] powerful drugs, intensive care, rare and multiple diseases,^[36] and prolonged hospital stay can contribute to medical errors.^[37]

Complexity makes diagnosis especially challenging. There are less than 200 symptoms listed in Wikipedia,^[38] but there are probably more than 10,000 known diseases. The World Health Organization’s system for the International Classification of Disease, 9th Edition from 1979 listed over 14,000 diagnosis codes.^[39] Textbooks of medicine often describe the most typical presentations of a disease, but in many conditions patients may have variable presentations instead of the classical signs and symptoms. To add complexity, the signs and symptoms of a given condition change over time; in the early stages the signs and symptoms may be absent or minimal, and then these evolve as the condition progresses. Diagnosis is often challenging in infants and children who can’t clearly communicate their symptoms, and in the elderly, where signs and symptoms may be muted or absent.^[40]

There are more than 7000 rare diseases alone, and in aggregate these are not uncommon: Roughly 1 in 17 patients will be diagnosed with a rare disease over their lifetime.^[41] Physicians may have only learned a handful of these during their education and training.

System and process design[edit]

In 2000, The Institute of Medicine released «To Err is Human,» which asserted that the problem in medical errors is not bad people in health care—it is that good people are working in bad systems that need to be made safer.^[10]

Poor communication and unclear lines of authority of physicians, nurses, and other care providers are also contributing factors.^[42] Disconnected reporting systems within a hospital can result in fragmented systems in which numerous hand-offs of patients results in lack of coordination and errors.^[43]

Other factors include the impression that action is being taken by other groups within the institution, reliance on automated systems to prevent error.,^[44] and inadequate systems to share information about errors, which hampers analysis of contributory causes and improvement strategies.^[45]
Cost-cutting measures by hospitals in response to reimbursement cutbacks can compromise patient safety.^[46]
In emergencies, patient care may be rendered in areas poorly suited for safe monitoring. The American Institute of Architects has identified concerns for the safe design and construction of health care facilities.^[47]
Infrastructure failure is also a concern. According to the WHO, 50% of medical equipment in developing countries is only partly usable due to lack of skilled operators or parts. As a result, diagnostic procedures or treatments cannot be performed, leading to substandard treatment.

The Joint Commission’s Annual Report on Quality and Safety 2007 found that inadequate communication between healthcare providers, or between providers and the patient and family members, was the root cause of over half the serious adverse events in accredited hospitals.^[48] Other leading causes included inadequate assessment of the patient’s condition, and poor leadership or training.

Competency, education, and training[edit]

Variations in healthcare provider training & experience^[42][49] and failure to acknowledge the prevalence and seriousness of medical errors also increase the risk.^[50][51] The so-called July effect occurs when new residents arrive at teaching hospitals, causing an increase in medication errors according to a study of data from 1979 to 2006.^[52][53]

Human factors and ergonomics[edit]

Cognitive errors commonly encountered in medicine were initially identified by psychologists Amos Tversky and Daniel Kahneman in the early 1970s. Jerome Groopman, author of How Doctors Think, says these are «cognitive pitfalls», biases which cloud our logic. For example, a practitioner may overvalue the first data encountered, skewing their thinking. Another example may be where the practitioner recalls a recent or dramatic case that quickly comes to mind, coloring the practitioner’s judgement. Another pitfall is where stereotypes may prejudice thinking.^[54] Pat Croskerry describes clinical reasoning as an interplay between intuitive, subconscious thought (System 1) and deliberate, conscious rational consideration (System 2). In this framework, many cognitive errors reflect over-reliance on System 1 processing, although cognitive errors may also sometimes involve System 2.^[55]

Sleep deprivation has also been cited as a contributing factor in medical errors.^[13] One study found that being awake for over 24 hours caused medical interns to double or triple the number of preventable medical errors, including those that resulted in injury or death.^[56] The risk of car crash after these shifts increased by 168%, and the risk of near miss by 460%.^[57] Interns admitted falling asleep during lectures, during rounds, and even during surgeries.^[57] Night shifts are associated with worse surgeon performance during laparoscopic surgeries.^[13]

Practitioner risk factors include fatigue,^[58][59][60]
depression,^[61] and burnout.^[62]
Factors related to the clinical setting include diverse patients, unfamiliar settings, time pressures, and increased patient-to-nurse staffing ratio increases.^[63]
Drug names that look alike or sound alike are also a problem.^[64]

Errors in interpreting medical images are often perceptual instead of «fact-based»; these errors are often caused by failures of attention or vision.^[65] For example, visual illusions can cause radiologists to misperceive images.^[66]

A number of Information Technology (IT) systems have been developed to detect and prevent medication errors, the most common type of medical errors.^[67] These systems screen data such as ICD-9 codes, pharmacy and laboratory data. Rules are used to look for changes in medication orders, and abnormal laboratory results that may be indicative of medication errors and/or adverse drug events.^[68]

Examples[edit]

Errors can include misdiagnosis or delayed diagnosis, administration of the wrong drug to the wrong patient or in the wrong way, giving multiple drugs that interact negatively, surgery on an incorrect site, failure to remove all surgical instruments, failure to take the correct blood type into account, or incorrect record-keeping. A 10th type of error is ones which are not watched for by researchers, such as RNs failing to program an IV pump to give a full dose of IV antibiotics or other medication.

Errors in diagnosis[edit]

According to a 2016 study from Johns Hopkins Medicine, medical errors are the third-leading cause of death in the United States.^[69] The projected cost of these errors to the U.S. economy is approximately $20 billion, 87% of which are direct increases in medical costs of providing services to patient affected by medical errors.^[70] Medical errors can increase average hospital costs by as much as $4,769 per patient.^[71] One common type of medical error stems from x-rays and medical imaging: failing to see or notice signs of disease on an image.^[65] The retrospective «miss» rate among abnormal imaging studies is reported to be as high as 30% (the real-life error rate is much lower, around 4-5%, because not all images are abnormal),^[72] and up to 20% of missed findings result in long-term adverse effects.^[73][74]

A large study reported several cases where patients were wrongly told that they were HIV-negative when the physicians erroneously ordered and interpreted HTLV (a closely related virus) testing rather than HIV testing. In the same study, >90% of HTLV tests were ordered erroneously.^[75]
It is estimated^{[by whom?]} that between 10 and 15% of physician diagnoses are erroneous.^[76]

Misdiagnosis of lower extremity cellulitis is estimated to occur in 30% of patients, leading to unnecessary hospitalizations in 85% and unnecessary antibiotic use in 92%. Collectively, these errors lead to between 50,000 and 130,000 unnecessary hospitalizations and between $195 and $515 million in avoidable health care spending annually in the United States.^[77]

Misdiagnosis of psychological disorders[edit]

Female sexual desire sometimes used to be diagnosed as female hysteria.^{[citation needed]}

Sensitivities to foods and food allergies risk being misdiagnosed as the anxiety disorder orthorexia.

Studies have found that bipolar disorder has often been misdiagnosed as major depression. Its early diagnosis necessitates that clinicians pay attention to the features of the patient’s depression and also look for present or prior hypomanic or manic symptomatology.^[78]

The misdiagnosis of schizophrenia is also a common problem. There may be long delays of patients getting a correct diagnosis of this disorder.^[79]

Delayed sleep phase disorder is often confused with: psychophysiological insomnia; depression; psychiatric disorders such as schizophrenia, ADHD or ADD; other sleep disorders; or school refusal. Practitioners of sleep medicine point out the dismally low rate of accurate diagnosis of the disorder, and have often asked for better physician education on sleep disorders.^[80]

Cluster headaches are often misdiagnosed, mismanaged, or undiagnosed for many years; they may be confused with migraine, «cluster-like» headache (or mimics), CH subtypes, other TACs ( trigeminal autonomic cephalalgias), or other types of primary or secondary headache syndrome.^[81] Cluster-like head pain may be diagnosed as secondary headache rather than cluster headache.^[82] Under-recognition of CH by health care professionals is reflected in consistent findings in Europe and the United States that the average time to diagnosis is around seven years.^[83]

Asperger syndrome and autism tend to get undiagnosed or delayed recognition and delayed diagnosis^[84][85] or misdiagnosed.^[86] Delayed or mistaken diagnosis can be traumatic for individuals and families; for example, misdiagnosis can lead to medications that worsen behavior.^[87][88]

The DSM-5 field trials included «test-retest reliability» which involved different clinicians doing independent evaluations of the same patient—a new approach to the study of diagnostic reliability.^[89]

Outpatient vs. inpatient[edit]

Misdiagnosis is the leading cause of medical error in outpatient facilities.
Since the National Institute of Medicine’s 1999 report, «To Err is Human,» found up to 98,000 hospital patients die from preventable medical errors in the U.S. each year, government and private sector efforts have focused on inpatient safety.

Medical prescriptions[edit]

While in 2000 the Committee on Quality of Health Care in America affirmed medical mistakes are an «unavoidable outcome of learning to practice medicine»,^[90] at 2019 the commonly accepted link between prescribing skills and clinical clerkships was not yet demonstrated by the available data^[91] and in the U.S. legibility of handwritten prescriptions has been indirectly responsible for at least 7,000 deaths annually.^[92]

Prescription errors concern ambiguous abbreviations, the right spelling of the full name of drugs: improper use of the nomenclature, of decimal points, unit or rate expressions; legibility and proper instructions; miscalculations of the posology (quantity, route and frequency of administration, duration of the treatment, dosage form and dosage strength); lack of information about patients (e.g. allergy, declining renal function) or reported in the medical document.^[91] There were an estimated 66 million clinically significant medication errors in the British NHS in 2018. The resulting adverse drug reactions are estimated to cause around 700 deaths a year in England and to contribute to around 22,000 deaths a year. The British researchers did not find any evidence that error rates were lower in other countries, and the global cost was estimated at $42 billion per year.^[93]

Medication errors in hospital include omissions, delayed dosing and incorrect medication administrations. Medication errors are not always readily identified, but can be reported using case note reviews or incident reporting systems.^[94] There are pharmacist-led interventions that can reduce the incident of medication error.^[95] Electronic prescribing has been shown to reduce prescribing errors by up to 30%.^[96]

After an error has occurred[edit]

Mistakes can have a strongly negative emotional impact on the doctors who commit them.^{[97][98][99][100]}

Recognizing that mistakes are not isolated events[edit]

Some physicians recognize that adverse outcomes from errors usually do not happen because of an isolated error and actually reflect system problems.^[49] This concept is often referred to as the Swiss Cheese Model.^[101] This is the concept that there are layers of protection for clinicians and patients to prevent mistakes from occurring. Therefore, even if a doctor or nurse makes a small error (e.g. incorrect dose of drug written on a drug chart by doctor), this is picked up before it actually affects patient care (e.g. pharmacist checks the drug chart and rectifies the error).^[101] Such mechanisms include:
Practical alterations (e.g.-medications that cannot be given through IV, are fitted with tubing which means they cannot be linked to an IV even if a clinician makes a mistake and tries to),^[102] systematic safety processes (e.g. all patients must have a Waterlow score assessment and falls assessment completed on admission),^[102] and training programmes/continuing professional development courses^[102] are measures that may be put in place.

There may be several breakdowns in processes to allow one adverse outcome.^[103] In addition, errors are more common when other demands compete for a physician’s attention.^{[104][105][106]} However, placing too much blame on the system may not be constructive.^[49]

Placing the practice of medicine in perspective[edit]

Essayists imply that the potential to make mistakes is part of what makes being a physician rewarding and without this potential the rewards of medical practice would be diminished. Laurence states that «Everybody dies, you and all of your patients. All relationships end. Would you want it any other way? […] Don’t take it personally»^[107]
Seder states «[…] if I left medicine, I would mourn its loss as I’ve mourned the passage of my poetry. On a daily basis, it is both a privilege and a joy to have the trust of patients and their families and the camaraderie of peers. There is no challenge to make your blood race like that of a difficult case, no mind game as rigorous as the challenging differential diagnosis, and though the stakes are high, so are the rewards.»^[108]

Disclosing mistakes[edit]

Forgiveness, which is part of many cultural traditions, may be important in coping with medical mistakes.^[109] Among other healing processes, it can be accomplished through the use of communicative disclosure guidelines.^[110]

To oneself[edit]

Inability to forgive oneself may create a cycle of distress and increased likelihood of a future error.^[111]

However, Wu et al. suggest «…those who coped by accepting responsibility were more likely to make constructive changes in practice, but [also] to experience more emotional distress.»^[112] It may be helpful to consider the much larger number of patients who are not exposed to mistakes and are helped by medical care.^[108]

To patients[edit]

Gallagher et al. state that patients want «information about what happened, why the error happened, how the error’s consequences will be mitigated, and how recurrences will be prevented.»^[113] Interviews with patients and families reported in a 2003 book by Rosemary Gibson and Janardan Prasad Singh, put forward that those who have been harmed by medical errors face a «wall of silence» and «want an acknowledgement» of the harm.^[114] With honesty, «healing can begin not just for the patients and their families but also the doctors, nurses and others involved.» In a line of experimental investigations, Annegret Hannawa et al. developed evidence-based disclosure guidelines under the scientific «Medical Error Disclosure Competence (MEDC)» framework.^[110][115]

A 2005 study by Wendy Levinson of the University of Toronto showed surgeons discussing medical errors used the word «error» or «mistake» in only 57 percent of disclosure conversations and offered a verbal apology only 47 percent of the time.^[116]

Patient disclosure is important in the medical error process. The current standard of practice at many hospitals is to disclose errors to patients when they occur. In the past, it was a common fear that disclosure to the patient would incite a malpractice lawsuit. Many physicians would not explain that an error had taken place, causing a lack of trust toward the healthcare community. In 2007, 34 states passed legislation that precludes any information from a physician’s apology for a medical error from being used in malpractice court (even a full admission of fault).^[117] This encourages physicians to acknowledge and explain mistakes to patients, keeping an open line of communication.

The American Medical Association’s Council on Ethical and Judicial Affairs states in its ethics code:

«Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all facts necessary to ensure understanding of what has occurred. Concern regarding legal liability which might result following truthful disclosure should not affect the physician’s honesty with a patient.»

From the American College of Physicians Ethics Manual:^[118]

«In addition, physicians should disclose to patients information about procedural or judgment errors made in the course of care if such information is material to the patient’s well-being. Errors do not necessarily constitute improper, negligent, or unethical behavior, but failure to disclose them may.»

However, «there appears to be a gap between physicians’ attitudes and practices regarding error disclosure. Willingness to disclose errors was associated with higher training level and a variety of patient-centered attitudes, and it was not lessened by previous exposure to malpractice litigation».^[119] Hospital administrators may share these concerns.^[120]

Consequently, in the United States, many states have enacted laws excluding expressions of sympathy after accidents as proof of liability.

Disclosure may actually reduce malpractice payments.^[121][122]

To non-physicians[edit]

In a study of physicians who reported having made a mistake, it was offered that disclosing to non-physician sources of support may reduce stress more than disclosing to physician colleagues.^[123] This may be due to the finding that of the physicians in the same study, when presented with a hypothetical scenario of a mistake made by another colleague, only 32% of them would have unconditionally offered support. It is possible that greater benefit occurs when spouses are physicians.^[124]

To other physicians[edit]

Discussing mistakes with other physicians is beneficial.^[49] However, medical providers may be less forgiving of one another.^[124] The reason is not clear, but one essayist has admonished, «Don’t Take Too Much Joy in the Mistakes of Other Doctors.»^[125]

To the physician’s institution[edit]

Disclosure of errors, especially ‘near misses’ may be able to reduce subsequent errors in institutions that are capable of reviewing near misses.^[126] However, doctors report that institutions may not be supportive of the doctor.^[49]

Use of rationalization to cover up medical errors[edit]

Based on anecdotal and survey evidence, Banja^[127] states that rationalization (making excuses) is very common among the medical profession to cover up medical errors.

By potential for harm to the patient[edit]

In a survey of more than 10,000 physicians in the United States, when asked the question, «Are there times when it’s acceptable to cover up or avoid revealing a mistake if that mistake would not cause harm to the patient?», 19% answered yes, 60% answered no and 21% answered it depends. On the question, «Are there times when it is acceptable to cover up or avoid revealing a mistake if that mistake would potentially or likely harm the patient?», 2% answered yes, 95% answered no and 3% answered it depends.^[128]

Cause-specific preventive measures[edit]

Traditionally, errors are attributed to mistakes made by individuals, who then may be penalized. A common approach to respond to and prevent specific errors is requiring additional checks at particular points in the system, whose findings and detail of execution must be recorded. As an example, an error of free flow IV administration of heparin is approached by teaching staff how to use the IV systems and to use special care in setting the IV pump. While overall errors become less likely, the checks add to workload and may in themselves be a cause of additional errors. In some hospitals, a regular morbidity and mortality conference meeting is scheduled to discuss complications or deaths and learn from or improve the overall processes.

A newer model for improvement in medical care takes its origin from the work of W. Edwards Deming in a model of Total Quality Management. In this model, there is an attempt to identify the underlying system defect that allowed the error to occur. As an example, in such a system the error of free flow IV administration of heparin is dealt with by not using IV heparin and substituting subcutaneous administration of heparin, obviating the entire problem. However, such an approach presupposes available research showing that subcutaneous heparin is as effective as IV. Thus, most systems use a combination of approaches to the problem.

In specific specialties[edit]

The field of medicine that has taken the lead in systems approaches to safety is anaesthesiology.^[129] Steps such as standardization of IV medications to 1 ml doses, national and international color-coding standards, and development of improved airway support devices has the field a model of systems improvement in care.

Pharmacy professionals have extensively studied the causes of errors in the prescribing, preparation, dispensing and administration of medications. As far back as the 1930s, pharmacists worked with physicians to select, from many options, the safest and most effective drugs available for use in hospitals.^[130] The process is known as the Formulary System and the list of drugs is known as the Formulary. In the 1960s, hospitals implemented unit dose packaging and unit dose drug distribution systems to reduce the risk of wrong drug and wrong dose errors in hospitalized patients;^[131] centralized sterile admixture services were shown to decrease the risks of contaminated and infected intravenous medications;^[132][133] and pharmacists provided drug information and clinical decision support directly to physicians to improve the safe and effective use of medications.^[134] Pharmacists are recognized experts in medication safety and have made many contributions that reduce error and improve patient care over the last 50 years. More recently, governments have attempted to address issues like patient-pharmacist communication and consumer knowledge through measures like the Australian Government’s Quality Use of Medicines policy.

Legal procedure[edit]

Standards and regulations for medical malpractice vary by country and jurisdiction within countries. Medical professionals may obtain professional liability insurances to offset the risk and costs of lawsuits based on medical malpractice.

Prevention[edit]

Medical care is frequently compared adversely to aviation; while many of the factors that lead to errors in both fields are similar, aviation’s error management protocols are regarded as much more effective.^[135] Safety measures include informed consent, the availability of a second practitioner’s opinion, voluntary reporting of errors, root cause analysis, reminders to improve patient medication adherence, hospital accreditation, and systems to ensure review by experienced or specialist practitioners.^[136]

A template has been developed for the design (both structure and operation) of hospital medication safety programmes, particularly for acute tertiary settings,^[137] which emphasizes safety culture, infrastructure, data (error detection and analysis), communication and training.

Particularly to prevent the medication errors in the perspective of the intrathecal administration of local anaesthetics, there is a proposal to change the presentation and packaging of the appliances and agents used for this purpose. One spinal needle with a syringe prefilled with the local anaesthetic agents may be marketed in a single blister pack, which will be peeled open and presented before the anaesthesiologist conducting the procedure.^[138]

Physician well-being has also been recommended as an indicator of healthcare quality given its association with patient safety outcomes.^[139] A meta-analysis involving 21517 participants found that physicians with depressive symptoms had a 95% higher risk of reporting medical errors and that the association between physician depressive symptoms and medical errors is bidirectional ^[61]

Reporting requirements[edit]

In the United States, adverse medical event reporting systems were mandated in just over half (27) of the states as of 2014, a figure unchanged since 2007.^[140][141] In U.S. hospitals error reporting is a condition of payment by Medicare.^[142] An investigation by the Office of Inspector General, Department of Health and Human Services released January 6, 2012 found that most errors are not reported and even in the case of errors that are reported and investigated changes are seldom made which would prevent them in the future. The investigation revealed that there was often lack of knowledge regarding which events were reportable and recommended that lists of reportable events be developed.^[143]

Misconceptions[edit]

Some common misconceptions about medical error include:

• Medical error is the «third leading cause of death» in the United States. This canard stems from an erroneous 2016 study which, according to David Gorski, «has taken on a life of its own» and fuelled «a myth promulgated by both quacks and academics».^[144]
• «Bad apples» or incompetent health care providers are a common cause. (Although human error is commonly an initiating event, the faulty care delivery process invariably permits or compounds the harm and so is the focus of improvement.)^[12]
• High-risk procedures or medical specialties are responsible for most avoidable adverse events. (Although some mistakes, such as in surgery, are harder to conceal, errors occur in all levels of care.^[12] Even though complex procedures entail more risk, adverse outcomes are not usually due to error, but to the severity of the condition being treated.)^[42][145] However, United States Pharmacopeia has reported that medication errors during the course of a surgical procedure are three times more likely to cause harm to a patient than those occurring in other types of hospital care.^[43]
• If a patient experiences an adverse event during the process of care, an error has occurred. (Most medical care entails some level of risk, and there can be complications or side effects, even unforeseen ones, from the underlying condition or from the treatment itself.)^[10]

See also[edit]

References[edit]

Further reading[edit]

• Gawande, Atul (2002). Complications: A Surgeon’s Notes on an Imperfect Science. New York: Metropolitan Books. ISBN 978-0-8050-6319-6.
• Wachter, Robert; Shojania, Kaveh (2004). Internal Bleeding: The Truth Behind America’s Terrifying Epidemic of Medical Mistakes. New York: Rugged Land. ISBN 978-1-59071-016-6.
• Banja, John (2005). Medical Errors and Medical Narcissism. Boston: Jones and Bartlett. ISBN 978-0-7637-8361-7.
• Porter, Michael E.; Olmsted Teisberg, Elizabeth (2006). Redefining Health Care: Creating Value-Based Competition on Results. Boston: Harvard Business School Press. ISBN 978-1-59139-778-6.
• Gibson, Rosemary; Prasad Singh, Janardan (2003). Wall of Silence: The Untold Story of the Medical Mistakes That Kill and Injure Millions of Americans. Washington D.C.: Regnery. ISBN 978-0-89526-112-0.
• Alldred D.P.; Standage C.; Zermansky A.G.; Jesson B.; Savage I.; Franklin B.D.; Barber N.; Raynor D.K. (2008). «Development and validation of criteria to identify medication-monitoring errors in care home residents». International Journal of Pharmacy Practice. 16 (5): 317–323. doi:10.1211/ijpp.16.5.0007. S2CID 71701489.
• Committee on Identifying and Preventing Medication Errors; Board on Health Care Services (2007). Preventing medication errors. National Academies Press. ISBN 978-0-309-10147-9.
• Tewari, A.; Palm, B.; Hines, T.; Royer, T.; Alexander, E. (2014). «VEINROM: A possible solution for erroneous intravenous drug administration». Journal of Anaesthesiology Clinical Pharmacology. 30 (2): 263–266. doi:10.4103/0970-9185.130055. PMC 4009652. PMID 24803770.

A medical error is a preventable adverse effect of care («iatrogenesis»), whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete diagnosis or treatment of a disease, injury, syndrome, behavior, infection, or other ailment.

Definitions[edit]

The word error in medicine is used as a label for nearly all of the clinical incidents that harm patients. Medical errors are often described as human errors in healthcare.^[1] Whether the label is a medical error or human error, one definition used in medicine says that it occurs when a healthcare provider chooses an inappropriate method of care, improperly executes an appropriate method of care, or reads the wrong CT scan. It has been said that the definition should be the subject of more debate. For instance, studies of hand hygiene compliance of physicians in an ICU show that compliance varied from 19% to 85%.^{[2][needs update]} The deaths that result from infections caught as a result of treatment providers improperly executing an appropriate method of care by not complying with known safety standards for hand hygiene are difficult to regard as innocent accidents or mistakes.

There are many types of medical error, from minor to major,^[3] and causality is often poorly determined.^{[4][needs update]}

There are many taxonomies for classifying medical errors.^[5]

Definitions of diagnostic error[edit]

There is no single definition of diagnostic error, reflecting in part the dual nature of the word diagnosis, which is both a noun (the name of the assigned disease; diagnosis is a label) and a verb (the act of arriving at a diagnosis; diagnosis is a process). At the present time, there are at least 4 definitions of diagnostic error in active use:

Graber et al. defined diagnostic error as a diagnosis that is wrong, egregiously delayed, or missed altogether.^[6] This is a ‘label’ definition, and can only be applied in retrospect, using some gold standard (for example, autopsy findings or a definitive laboratory test) to confirm the correct diagnosis. Many diagnostic errors fit several of these criteria; the categories overlap.

There are two process-related definitions: Schiff et al. defined diagnostic error as any breakdown in the diagnostic process, including both errors of omission and errors of commission.^[7] Similarly, Singh et al. defined diagnostic error as a ‘missed opportunity’ in the diagnostic process, based on retrospective review.^[8]

In its landmark report, Improving Diagnosis in Health Care, The National Academy of Medicine proposed a new, hybrid definition that includes both label- and process-related aspects: «A diagnostic error is failure to establish an accurate and timely explanation of the patient’s health problem(s) or to communicate that explanation to the patient.»^[9] This is the only definition that specifically includes the patient in the definition wording.

Impact[edit]

A 2000 Institute of Medicine report estimated that medical errors result in between 44,000 and 98,000 preventable deaths and 1,000,000 excess injuries each year in U.S. hospitals.^[10][11][12] In the UK, a 2000 study found that an estimated 850,000 medical errors occur each year, costing over £2 billion.^[13]

Some researchers questioned the accuracy of the IOM study, criticizing the statistical handling of measurement errors in the report,^[14] significant subjectivity in determining which deaths were «avoidable» or due to medical error, and an erroneous assumption that 100% of patients would have survived if optimal care had been provided.^[15] A 2001 study in the Journal of the American Medical Association of seven Department of Veterans Affairs medical centers estimated that for roughly every 10,000 patients admitted to the select hospitals, one patient died who would have lived for three months or more in good cognitive health had «optimal» care been provided.^[15]

A 2006 follow-up to the IOM study found that medication errors are among the most common medical mistakes, harming at least 1.5 million people every year. According to the study, 400,000 preventable drug-related injuries occur each year in hospitals, 800,000 in long-term care settings, and roughly 530,000 among Medicare recipients in outpatient clinics. The report stated that these are likely to be conservative estimates. In 2000 alone, the extra medical costs incurred by preventable drug-related injuries approximated $887 million—and the study looked only at injuries sustained by Medicare recipients, a subset of clinic visitors. None of these figures take into account lost wages and productivity or other costs.^[16]

According to a 2002 Agency for Healthcare Research and Quality report, about 7,000 people were estimated to die each year from medication errors – about 16 percent more deaths than the number attributable to work-related injuries (6,000 deaths).^{[citation needed]} Medical errors affect one in 10 patients worldwide. One extrapolation suggests that 180,000 people die each year partly as a result of iatrogenic injury.^[17] One in five Americans (22%) report that they or a family member have experienced a medical error of some kind.^[18]

The World Health Organization registered 14 million new cases and 8.2 million cancer-related deaths in 2012. It estimated that the number of cases could increase by 70% through 2032. As the number of cancer patients receiving treatment increases, hospitals around the world are seeking ways to improve patient safety, to emphasize traceability and raise efficiency in their cancer treatment processes.^[19]

Difficulties in measuring frequency of errors[edit]

About 1% of hospital admissions result in an adverse event due to negligence.^[20] However, mistakes are likely much more common, as these studies identify only mistakes that led to measurable adverse events occurring soon after the errors. Independent review of doctors’ treatment plans suggests that decision-making could be improved in 14% of admissions; many of the benefits would have delayed manifestations.^[21] Even this number may be an underestimate. One study suggests that adults in the United States receive only 55% of recommended care.^[22] At the same time, a second study found that 30% of care in the United States may be unnecessary.^[23] For example, if a doctor fails to order a mammogram that is past due, this mistake will not show up in the first type of study.^[20] In addition, because no adverse event occurred during the short follow-up of the study, the mistake also would not show up in the second type of study^[21] because only the principal treatment plans were critiqued. However, the mistake would be recorded in the third type of study. If a doctor recommends an unnecessary treatment or test, it may not show in any of these types of studies.

Cause of death on United States death certificates, statistically compiled by the Centers for Disease Control and Prevention (CDC), are coded in the International Classification of Disease (ICD), which does not include codes for human and system factors.^[24][25]

Causes[edit]

The research literature showed that medical errors are caused by errors of commission and errors of omission.^[26] Errors of omission are made when providers did not take action when they should have, while errors of commission occur when decisions and action are delayed.^[26] Commission and omission errors have also been attributed with communication failures.^[27][28]

Medical errors can be associated with inexperienced physicians and nurses, new procedures, extremes of age, and complex or urgent care.^[29] Poor communication (whether in one’s own language or, as may be the case for medical tourists, another language), improper documentation, illegible handwriting, spelling errors, inadequate nurse-to-patient ratios, and similarly named medications are also known to contribute to the problem.^[30][31] Misdiagnosis may be associated with individual characteristics of the patient or due to the patient multimorbidity.^[32][33] Patient actions or inactions may also contribute significantly to medical errors.^[28][27]

Healthcare complexity[edit]

Complicated technologies,^[34][35] powerful drugs, intensive care, rare and multiple diseases,^[36] and prolonged hospital stay can contribute to medical errors.^[37]

Complexity makes diagnosis especially challenging. There are less than 200 symptoms listed in Wikipedia,^[38] but there are probably more than 10,000 known diseases. The World Health Organization’s system for the International Classification of Disease, 9th Edition from 1979 listed over 14,000 diagnosis codes.^[39] Textbooks of medicine often describe the most typical presentations of a disease, but in many conditions patients may have variable presentations instead of the classical signs and symptoms. To add complexity, the signs and symptoms of a given condition change over time; in the early stages the signs and symptoms may be absent or minimal, and then these evolve as the condition progresses. Diagnosis is often challenging in infants and children who can’t clearly communicate their symptoms, and in the elderly, where signs and symptoms may be muted or absent.^[40]

There are more than 7000 rare diseases alone, and in aggregate these are not uncommon: Roughly 1 in 17 patients will be diagnosed with a rare disease over their lifetime.^[41] Physicians may have only learned a handful of these during their education and training.

System and process design[edit]

In 2000, The Institute of Medicine released «To Err is Human,» which asserted that the problem in medical errors is not bad people in health care—it is that good people are working in bad systems that need to be made safer.^[10]

Poor communication and unclear lines of authority of physicians, nurses, and other care providers are also contributing factors.^[42] Disconnected reporting systems within a hospital can result in fragmented systems in which numerous hand-offs of patients results in lack of coordination and errors.^[43]

Other factors include the impression that action is being taken by other groups within the institution, reliance on automated systems to prevent error.,^[44] and inadequate systems to share information about errors, which hampers analysis of contributory causes and improvement strategies.^[45]
Cost-cutting measures by hospitals in response to reimbursement cutbacks can compromise patient safety.^[46]
In emergencies, patient care may be rendered in areas poorly suited for safe monitoring. The American Institute of Architects has identified concerns for the safe design and construction of health care facilities.^[47]
Infrastructure failure is also a concern. According to the WHO, 50% of medical equipment in developing countries is only partly usable due to lack of skilled operators or parts. As a result, diagnostic procedures or treatments cannot be performed, leading to substandard treatment.

The Joint Commission’s Annual Report on Quality and Safety 2007 found that inadequate communication between healthcare providers, or between providers and the patient and family members, was the root cause of over half the serious adverse events in accredited hospitals.^[48] Other leading causes included inadequate assessment of the patient’s condition, and poor leadership or training.

Competency, education, and training[edit]

Variations in healthcare provider training & experience^[42][49] and failure to acknowledge the prevalence and seriousness of medical errors also increase the risk.^[50][51] The so-called July effect occurs when new residents arrive at teaching hospitals, causing an increase in medication errors according to a study of data from 1979 to 2006.^[52][53]

Human factors and ergonomics[edit]

Cognitive errors commonly encountered in medicine were initially identified by psychologists Amos Tversky and Daniel Kahneman in the early 1970s. Jerome Groopman, author of How Doctors Think, says these are «cognitive pitfalls», biases which cloud our logic. For example, a practitioner may overvalue the first data encountered, skewing their thinking. Another example may be where the practitioner recalls a recent or dramatic case that quickly comes to mind, coloring the practitioner’s judgement. Another pitfall is where stereotypes may prejudice thinking.^[54] Pat Croskerry describes clinical reasoning as an interplay between intuitive, subconscious thought (System 1) and deliberate, conscious rational consideration (System 2). In this framework, many cognitive errors reflect over-reliance on System 1 processing, although cognitive errors may also sometimes involve System 2.^[55]

Sleep deprivation has also been cited as a contributing factor in medical errors.^[13] One study found that being awake for over 24 hours caused medical interns to double or triple the number of preventable medical errors, including those that resulted in injury or death.^[56] The risk of car crash after these shifts increased by 168%, and the risk of near miss by 460%.^[57] Interns admitted falling asleep during lectures, during rounds, and even during surgeries.^[57] Night shifts are associated with worse surgeon performance during laparoscopic surgeries.^[13]

Practitioner risk factors include fatigue,^[58][59][60]
depression,^[61] and burnout.^[62]
Factors related to the clinical setting include diverse patients, unfamiliar settings, time pressures, and increased patient-to-nurse staffing ratio increases.^[63]
Drug names that look alike or sound alike are also a problem.^[64]

Errors in interpreting medical images are often perceptual instead of «fact-based»; these errors are often caused by failures of attention or vision.^[65] For example, visual illusions can cause radiologists to misperceive images.^[66]

A number of Information Technology (IT) systems have been developed to detect and prevent medication errors, the most common type of medical errors.^[67] These systems screen data such as ICD-9 codes, pharmacy and laboratory data. Rules are used to look for changes in medication orders, and abnormal laboratory results that may be indicative of medication errors and/or adverse drug events.^[68]

Examples[edit]

Errors can include misdiagnosis or delayed diagnosis, administration of the wrong drug to the wrong patient or in the wrong way, giving multiple drugs that interact negatively, surgery on an incorrect site, failure to remove all surgical instruments, failure to take the correct blood type into account, or incorrect record-keeping. A 10th type of error is ones which are not watched for by researchers, such as RNs failing to program an IV pump to give a full dose of IV antibiotics or other medication.

Errors in diagnosis[edit]

According to a 2016 study from Johns Hopkins Medicine, medical errors are the third-leading cause of death in the United States.^[69] The projected cost of these errors to the U.S. economy is approximately $20 billion, 87% of which are direct increases in medical costs of providing services to patient affected by medical errors.^[70] Medical errors can increase average hospital costs by as much as $4,769 per patient.^[71] One common type of medical error stems from x-rays and medical imaging: failing to see or notice signs of disease on an image.^[65] The retrospective «miss» rate among abnormal imaging studies is reported to be as high as 30% (the real-life error rate is much lower, around 4-5%, because not all images are abnormal),^[72] and up to 20% of missed findings result in long-term adverse effects.^[73][74]

A large study reported several cases where patients were wrongly told that they were HIV-negative when the physicians erroneously ordered and interpreted HTLV (a closely related virus) testing rather than HIV testing. In the same study, >90% of HTLV tests were ordered erroneously.^[75]
It is estimated^{[by whom?]} that between 10 and 15% of physician diagnoses are erroneous.^[76]

Misdiagnosis of lower extremity cellulitis is estimated to occur in 30% of patients, leading to unnecessary hospitalizations in 85% and unnecessary antibiotic use in 92%. Collectively, these errors lead to between 50,000 and 130,000 unnecessary hospitalizations and between $195 and $515 million in avoidable health care spending annually in the United States.^[77]

Misdiagnosis of psychological disorders[edit]

Female sexual desire sometimes used to be diagnosed as female hysteria.^{[citation needed]}

Sensitivities to foods and food allergies risk being misdiagnosed as the anxiety disorder orthorexia.

Studies have found that bipolar disorder has often been misdiagnosed as major depression. Its early diagnosis necessitates that clinicians pay attention to the features of the patient’s depression and also look for present or prior hypomanic or manic symptomatology.^[78]

The misdiagnosis of schizophrenia is also a common problem. There may be long delays of patients getting a correct diagnosis of this disorder.^[79]

Delayed sleep phase disorder is often confused with: psychophysiological insomnia; depression; psychiatric disorders such as schizophrenia, ADHD or ADD; other sleep disorders; or school refusal. Practitioners of sleep medicine point out the dismally low rate of accurate diagnosis of the disorder, and have often asked for better physician education on sleep disorders.^[80]

Cluster headaches are often misdiagnosed, mismanaged, or undiagnosed for many years; they may be confused with migraine, «cluster-like» headache (or mimics), CH subtypes, other TACs ( trigeminal autonomic cephalalgias), or other types of primary or secondary headache syndrome.^[81] Cluster-like head pain may be diagnosed as secondary headache rather than cluster headache.^[82] Under-recognition of CH by health care professionals is reflected in consistent findings in Europe and the United States that the average time to diagnosis is around seven years.^[83]

Asperger syndrome and autism tend to get undiagnosed or delayed recognition and delayed diagnosis^[84][85] or misdiagnosed.^[86] Delayed or mistaken diagnosis can be traumatic for individuals and families; for example, misdiagnosis can lead to medications that worsen behavior.^[87][88]

The DSM-5 field trials included «test-retest reliability» which involved different clinicians doing independent evaluations of the same patient—a new approach to the study of diagnostic reliability.^[89]

Outpatient vs. inpatient[edit]

Misdiagnosis is the leading cause of medical error in outpatient facilities.
Since the National Institute of Medicine’s 1999 report, «To Err is Human,» found up to 98,000 hospital patients die from preventable medical errors in the U.S. each year, government and private sector efforts have focused on inpatient safety.

Medical prescriptions[edit]

While in 2000 the Committee on Quality of Health Care in America affirmed medical mistakes are an «unavoidable outcome of learning to practice medicine»,^[90] at 2019 the commonly accepted link between prescribing skills and clinical clerkships was not yet demonstrated by the available data^[91] and in the U.S. legibility of handwritten prescriptions has been indirectly responsible for at least 7,000 deaths annually.^[92]

Prescription errors concern ambiguous abbreviations, the right spelling of the full name of drugs: improper use of the nomenclature, of decimal points, unit or rate expressions; legibility and proper instructions; miscalculations of the posology (quantity, route and frequency of administration, duration of the treatment, dosage form and dosage strength); lack of information about patients (e.g. allergy, declining renal function) or reported in the medical document.^[91] There were an estimated 66 million clinically significant medication errors in the British NHS in 2018. The resulting adverse drug reactions are estimated to cause around 700 deaths a year in England and to contribute to around 22,000 deaths a year. The British researchers did not find any evidence that error rates were lower in other countries, and the global cost was estimated at $42 billion per year.^[93]

Medication errors in hospital include omissions, delayed dosing and incorrect medication administrations. Medication errors are not always readily identified, but can be reported using case note reviews or incident reporting systems.^[94] There are pharmacist-led interventions that can reduce the incident of medication error.^[95] Electronic prescribing has been shown to reduce prescribing errors by up to 30%.^[96]

After an error has occurred[edit]

Mistakes can have a strongly negative emotional impact on the doctors who commit them.^{[97][98][99][100]}

Recognizing that mistakes are not isolated events[edit]

Some physicians recognize that adverse outcomes from errors usually do not happen because of an isolated error and actually reflect system problems.^[49] This concept is often referred to as the Swiss Cheese Model.^[101] This is the concept that there are layers of protection for clinicians and patients to prevent mistakes from occurring. Therefore, even if a doctor or nurse makes a small error (e.g. incorrect dose of drug written on a drug chart by doctor), this is picked up before it actually affects patient care (e.g. pharmacist checks the drug chart and rectifies the error).^[101] Such mechanisms include:
Practical alterations (e.g.-medications that cannot be given through IV, are fitted with tubing which means they cannot be linked to an IV even if a clinician makes a mistake and tries to),^[102] systematic safety processes (e.g. all patients must have a Waterlow score assessment and falls assessment completed on admission),^[102] and training programmes/continuing professional development courses^[102] are measures that may be put in place.

There may be several breakdowns in processes to allow one adverse outcome.^[103] In addition, errors are more common when other demands compete for a physician’s attention.^{[104][105][106]} However, placing too much blame on the system may not be constructive.^[49]

Placing the practice of medicine in perspective[edit]

Essayists imply that the potential to make mistakes is part of what makes being a physician rewarding and without this potential the rewards of medical practice would be diminished. Laurence states that «Everybody dies, you and all of your patients. All relationships end. Would you want it any other way? […] Don’t take it personally»^[107]
Seder states «[…] if I left medicine, I would mourn its loss as I’ve mourned the passage of my poetry. On a daily basis, it is both a privilege and a joy to have the trust of patients and their families and the camaraderie of peers. There is no challenge to make your blood race like that of a difficult case, no mind game as rigorous as the challenging differential diagnosis, and though the stakes are high, so are the rewards.»^[108]

Disclosing mistakes[edit]

Forgiveness, which is part of many cultural traditions, may be important in coping with medical mistakes.^[109] Among other healing processes, it can be accomplished through the use of communicative disclosure guidelines.^[110]

To oneself[edit]

Inability to forgive oneself may create a cycle of distress and increased likelihood of a future error.^[111]

However, Wu et al. suggest «…those who coped by accepting responsibility were more likely to make constructive changes in practice, but [also] to experience more emotional distress.»^[112] It may be helpful to consider the much larger number of patients who are not exposed to mistakes and are helped by medical care.^[108]

To patients[edit]

Gallagher et al. state that patients want «information about what happened, why the error happened, how the error’s consequences will be mitigated, and how recurrences will be prevented.»^[113] Interviews with patients and families reported in a 2003 book by Rosemary Gibson and Janardan Prasad Singh, put forward that those who have been harmed by medical errors face a «wall of silence» and «want an acknowledgement» of the harm.^[114] With honesty, «healing can begin not just for the patients and their families but also the doctors, nurses and others involved.» In a line of experimental investigations, Annegret Hannawa et al. developed evidence-based disclosure guidelines under the scientific «Medical Error Disclosure Competence (MEDC)» framework.^[110][115]

A 2005 study by Wendy Levinson of the University of Toronto showed surgeons discussing medical errors used the word «error» or «mistake» in only 57 percent of disclosure conversations and offered a verbal apology only 47 percent of the time.^[116]

Patient disclosure is important in the medical error process. The current standard of practice at many hospitals is to disclose errors to patients when they occur. In the past, it was a common fear that disclosure to the patient would incite a malpractice lawsuit. Many physicians would not explain that an error had taken place, causing a lack of trust toward the healthcare community. In 2007, 34 states passed legislation that precludes any information from a physician’s apology for a medical error from being used in malpractice court (even a full admission of fault).^[117] This encourages physicians to acknowledge and explain mistakes to patients, keeping an open line of communication.

The American Medical Association’s Council on Ethical and Judicial Affairs states in its ethics code:

«Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all facts necessary to ensure understanding of what has occurred. Concern regarding legal liability which might result following truthful disclosure should not affect the physician’s honesty with a patient.»

From the American College of Physicians Ethics Manual:^[118]

«In addition, physicians should disclose to patients information about procedural or judgment errors made in the course of care if such information is material to the patient’s well-being. Errors do not necessarily constitute improper, negligent, or unethical behavior, but failure to disclose them may.»

However, «there appears to be a gap between physicians’ attitudes and practices regarding error disclosure. Willingness to disclose errors was associated with higher training level and a variety of patient-centered attitudes, and it was not lessened by previous exposure to malpractice litigation».^[119] Hospital administrators may share these concerns.^[120]

Consequently, in the United States, many states have enacted laws excluding expressions of sympathy after accidents as proof of liability.

Disclosure may actually reduce malpractice payments.^[121][122]

To non-physicians[edit]

In a study of physicians who reported having made a mistake, it was offered that disclosing to non-physician sources of support may reduce stress more than disclosing to physician colleagues.^[123] This may be due to the finding that of the physicians in the same study, when presented with a hypothetical scenario of a mistake made by another colleague, only 32% of them would have unconditionally offered support. It is possible that greater benefit occurs when spouses are physicians.^[124]

To other physicians[edit]

Discussing mistakes with other physicians is beneficial.^[49] However, medical providers may be less forgiving of one another.^[124] The reason is not clear, but one essayist has admonished, «Don’t Take Too Much Joy in the Mistakes of Other Doctors.»^[125]

To the physician’s institution[edit]

Disclosure of errors, especially ‘near misses’ may be able to reduce subsequent errors in institutions that are capable of reviewing near misses.^[126] However, doctors report that institutions may not be supportive of the doctor.^[49]

Use of rationalization to cover up medical errors[edit]

Based on anecdotal and survey evidence, Banja^[127] states that rationalization (making excuses) is very common among the medical profession to cover up medical errors.

By potential for harm to the patient[edit]

In a survey of more than 10,000 physicians in the United States, when asked the question, «Are there times when it’s acceptable to cover up or avoid revealing a mistake if that mistake would not cause harm to the patient?», 19% answered yes, 60% answered no and 21% answered it depends. On the question, «Are there times when it is acceptable to cover up or avoid revealing a mistake if that mistake would potentially or likely harm the patient?», 2% answered yes, 95% answered no and 3% answered it depends.^[128]

Cause-specific preventive measures[edit]

Traditionally, errors are attributed to mistakes made by individuals, who then may be penalized. A common approach to respond to and prevent specific errors is requiring additional checks at particular points in the system, whose findings and detail of execution must be recorded. As an example, an error of free flow IV administration of heparin is approached by teaching staff how to use the IV systems and to use special care in setting the IV pump. While overall errors become less likely, the checks add to workload and may in themselves be a cause of additional errors. In some hospitals, a regular morbidity and mortality conference meeting is scheduled to discuss complications or deaths and learn from or improve the overall processes.

A newer model for improvement in medical care takes its origin from the work of W. Edwards Deming in a model of Total Quality Management. In this model, there is an attempt to identify the underlying system defect that allowed the error to occur. As an example, in such a system the error of free flow IV administration of heparin is dealt with by not using IV heparin and substituting subcutaneous administration of heparin, obviating the entire problem. However, such an approach presupposes available research showing that subcutaneous heparin is as effective as IV. Thus, most systems use a combination of approaches to the problem.

In specific specialties[edit]

The field of medicine that has taken the lead in systems approaches to safety is anaesthesiology.^[129] Steps such as standardization of IV medications to 1 ml doses, national and international color-coding standards, and development of improved airway support devices has the field a model of systems improvement in care.

Pharmacy professionals have extensively studied the causes of errors in the prescribing, preparation, dispensing and administration of medications. As far back as the 1930s, pharmacists worked with physicians to select, from many options, the safest and most effective drugs available for use in hospitals.^[130] The process is known as the Formulary System and the list of drugs is known as the Formulary. In the 1960s, hospitals implemented unit dose packaging and unit dose drug distribution systems to reduce the risk of wrong drug and wrong dose errors in hospitalized patients;^[131] centralized sterile admixture services were shown to decrease the risks of contaminated and infected intravenous medications;^[132][133] and pharmacists provided drug information and clinical decision support directly to physicians to improve the safe and effective use of medications.^[134] Pharmacists are recognized experts in medication safety and have made many contributions that reduce error and improve patient care over the last 50 years. More recently, governments have attempted to address issues like patient-pharmacist communication and consumer knowledge through measures like the Australian Government’s Quality Use of Medicines policy.

Legal procedure[edit]

Standards and regulations for medical malpractice vary by country and jurisdiction within countries. Medical professionals may obtain professional liability insurances to offset the risk and costs of lawsuits based on medical malpractice.

Prevention[edit]

Medical care is frequently compared adversely to aviation; while many of the factors that lead to errors in both fields are similar, aviation’s error management protocols are regarded as much more effective.^[135] Safety measures include informed consent, the availability of a second practitioner’s opinion, voluntary reporting of errors, root cause analysis, reminders to improve patient medication adherence, hospital accreditation, and systems to ensure review by experienced or specialist practitioners.^[136]

A template has been developed for the design (both structure and operation) of hospital medication safety programmes, particularly for acute tertiary settings,^[137] which emphasizes safety culture, infrastructure, data (error detection and analysis), communication and training.

Particularly to prevent the medication errors in the perspective of the intrathecal administration of local anaesthetics, there is a proposal to change the presentation and packaging of the appliances and agents used for this purpose. One spinal needle with a syringe prefilled with the local anaesthetic agents may be marketed in a single blister pack, which will be peeled open and presented before the anaesthesiologist conducting the procedure.^[138]

Physician well-being has also been recommended as an indicator of healthcare quality given its association with patient safety outcomes.^[139] A meta-analysis involving 21517 participants found that physicians with depressive symptoms had a 95% higher risk of reporting medical errors and that the association between physician depressive symptoms and medical errors is bidirectional ^[61]

Reporting requirements[edit]

In the United States, adverse medical event reporting systems were mandated in just over half (27) of the states as of 2014, a figure unchanged since 2007.^[140][141] In U.S. hospitals error reporting is a condition of payment by Medicare.^[142] An investigation by the Office of Inspector General, Department of Health and Human Services released January 6, 2012 found that most errors are not reported and even in the case of errors that are reported and investigated changes are seldom made which would prevent them in the future. The investigation revealed that there was often lack of knowledge regarding which events were reportable and recommended that lists of reportable events be developed.^[143]

Misconceptions[edit]

Some common misconceptions about medical error include:

• Medical error is the «third leading cause of death» in the United States. This canard stems from an erroneous 2016 study which, according to David Gorski, «has taken on a life of its own» and fuelled «a myth promulgated by both quacks and academics».^[144]
• «Bad apples» or incompetent health care providers are a common cause. (Although human error is commonly an initiating event, the faulty care delivery process invariably permits or compounds the harm and so is the focus of improvement.)^[12]
• High-risk procedures or medical specialties are responsible for most avoidable adverse events. (Although some mistakes, such as in surgery, are harder to conceal, errors occur in all levels of care.^[12] Even though complex procedures entail more risk, adverse outcomes are not usually due to error, but to the severity of the condition being treated.)^[42][145] However, United States Pharmacopeia has reported that medication errors during the course of a surgical procedure are three times more likely to cause harm to a patient than those occurring in other types of hospital care.^[43]
• If a patient experiences an adverse event during the process of care, an error has occurred. (Most medical care entails some level of risk, and there can be complications or side effects, even unforeseen ones, from the underlying condition or from the treatment itself.)^[10]

See also[edit]

References[edit]

Further reading[edit]

• Gawande, Atul (2002). Complications: A Surgeon’s Notes on an Imperfect Science. New York: Metropolitan Books. ISBN 978-0-8050-6319-6.
• Wachter, Robert; Shojania, Kaveh (2004). Internal Bleeding: The Truth Behind America’s Terrifying Epidemic of Medical Mistakes. New York: Rugged Land. ISBN 978-1-59071-016-6.
• Banja, John (2005). Medical Errors and Medical Narcissism. Boston: Jones and Bartlett. ISBN 978-0-7637-8361-7.
• Porter, Michael E.; Olmsted Teisberg, Elizabeth (2006). Redefining Health Care: Creating Value-Based Competition on Results. Boston: Harvard Business School Press. ISBN 978-1-59139-778-6.
• Gibson, Rosemary; Prasad Singh, Janardan (2003). Wall of Silence: The Untold Story of the Medical Mistakes That Kill and Injure Millions of Americans. Washington D.C.: Regnery. ISBN 978-0-89526-112-0.
• Alldred D.P.; Standage C.; Zermansky A.G.; Jesson B.; Savage I.; Franklin B.D.; Barber N.; Raynor D.K. (2008). «Development and validation of criteria to identify medication-monitoring errors in care home residents». International Journal of Pharmacy Practice. 16 (5): 317–323. doi:10.1211/ijpp.16.5.0007. S2CID 71701489.
• Committee on Identifying and Preventing Medication Errors; Board on Health Care Services (2007). Preventing medication errors. National Academies Press. ISBN 978-0-309-10147-9.
• Tewari, A.; Palm, B.; Hines, T.; Royer, T.; Alexander, E. (2014). «VEINROM: A possible solution for erroneous intravenous drug administration». Journal of Anaesthesiology Clinical Pharmacology. 30 (2): 263–266. doi:10.4103/0970-9185.130055. PMC 4009652. PMID 24803770.