Informed Consent and Medical Record
Informed Consent and Medical Record
Informed Consent and Medical Record
Standard
(Konsil Kedokteran Indonesia, 2007)
Competency areas:
1.
2.
3.
4.
5.
6.
7.
Effective communication
Clinical Skill
Scientific based medical sciences
Health problem management
Information management
Self evaluation and development
Ethics, Moral, Medicolegal,
Proffesionalism and Patients safety
Informed consent
Informed consent is a legal condition whereby a
person can be said to have given consent based upon
an appreciation and understanding of the facts and
implications of an action. The individual needs to be in
possession of relevant facts and also of his or her
reasoning faculties, such as not being mentally
retarded or mentally ill and without an impairment of
judgment at the time of consenting. Such impairments
might include illness, intoxication, insufficient sleep,
and other health problems.
INFORMED CONSENT/CHOICE
Persetujuan yang diberikan
seseorang yang kompeten sesudah
menerima dan memahami penjelasan
yang diberikan oleh dokter (dlm
konteks profesi), dan membuat
keputusan tanpa paksaan atau
dipengaruhi secara berlebihan,
dibujuk, dipaksa, atau diintimidasi
Dibuat secara tertulis dengan
diperkuat oleh paling sedikit seorang
saksi
ISI PENJELASAN :
1. Pertimbangan, penilaian, maksud dan tujuan dokter
2. Keadaan yang menyangkut diri pasien
3. Risiko dari prosedur tindakan medis
4. Alternatif lain, bila ada
5. Konsekuensi bila tindakan medis itu tidak dilakukan
Yang berhak menandatangani?
Dalam keadaan darurat?
Surgery
The doctrine of informed consent relates to
professional negligence and establishes a breach of the
duty of care owed to the patient.
In the United Kingdom and countries such as Malaysia
and Singapore, informed consent requires proof as to
the standard of care to be expected as a recognised
standard of acceptable professional practice (the
Bolam Test), that is, what risks would a medical
professional usually disclose in the circumstances.
Arguably, this is "sufficient consent" rather than
"informed consent."
GAWAT DARURAT
PERMENKES No. 585/1989 ps.11: Seorang pasien yg
tdk sadar atau pingsan dan tdk didampingi keluarga
terdekat yang secara medis berada dlm keadaan gawat
darurat dan perlu tindakan medis segera untuk
kepentingannya, tidak diperlukan persetujuan dari
siapapun
Bahwa untuk menyelamatkan nyawa atau anggota
tubuh pasien (life or limb saving) dan tidak ada waktu
lagi untuk menunggu atau menghubungi keluarganya,
maka kpd dokter tsb diberi wewenang untuk segera dan
secara langsung melakukan tindakan operasinya
Bahkan jika tdk diberi pertolongan dan atau tindakan
operasi, dokter tsb bisa dituntut berdasarkan kelalaian
(negligence) atau penelantaran (abandonment), kalau
sampai mengakibatkan meninggalnya pasien tersebut.
Competency
The ability to give informed consent will be governed by
a general requirement of competency. In common law
jurisdictions, adults are presumed competent to consent.
This presumption can be rebutted, for instance, in
circumstances of mental illness or other incompetence.
This may be prescribed in legislation or based on a
common-law standard of inability to understand the
nature of the procedure. In cases of incompetent adults,
informed consent--from the patients or from their
families--is not required. Rather, the medical practitioner
must simply act in the patient's best interests in order to
avoid negligence liability.
Abortion
In some U.S. States, informed consent laws (sometimes
called "Right To Know" laws) require that a woman
seeking an elective abortion be given factual information
by the abortion provider about her legal rights,
alternatives to abortion (such as adoption), available
public and private assistance, and medical facts (some
of which are disputed - see fetal pain), before the
abortion is performed (usually 24 hours in advance of the
abortion). Other countries with such laws (e.g. Germany)
require that the information giver not be affiliated with the
abortion provider, to avoid giving an economic incentive
for handing out faulty information.
Sex
The question of whether informed consent needs to be
formally given before sexual intercourse or other sexual
activity, and whether this consent can (and must be able to)
be withdrawn at any time during the act, is an issue which
is currently being discussed in the United States in regard
to rape and sexual assault legislation. For example, people
who perform sexual acts on sleeping people are not given
consent unless the initiator have given prior informed
consent to the act within a reasonable recency, and are
assumed to be consenting during the act and to not
prosecute for it when waking up. This is also an issue in
rape fantasy enaction which is often discussed by a
"ravishment community" of participants (a subset of the
BDSM community) who advocate extensive prior
negotiation and planning. The issue of prior informed
consent may also come up if the legality behind consensual
necrophilia is ever further explored.
No-victim laws
It may not be legally possible to give consent to
certain activities in certain jurisdictions; see the
Operation Spanner case for an example of this
in the UK which involved sadomasochistic
activities such as branding. There are currently
several legal challenges underway to address
these issues of legality in several nations.
Research
Informed consent is also important in
social research. For example in
survey research, people need to give
informed consent before they participate in
the survey. In medical research the
Nuremberg Code has set a base standard
since 1947, and most research proposals
are reviewed by ethics committees in the
21st century.
REKAM MEDIS
(Medical Records)
Pesatnya perkembangan sains dan teknologi memberi
dampak pada hubungan dokter-pasien, yg dulu bersifat
paternalistik, kini impersonal (autonomi)
Pasien tak segan-segan menuntut dokternya karena
ada dugaan bhw dokter itu telah berbuat kelalaian
Permenkes No. 749a/1989 : Pelaksanaan Rekam Medis
dengan membuat catatan-catatan sdh merupakan suatu
keharusan, sdh menjadi kewajiban hukum
Medical record
A medical record, health record, or medical chart is a
systematic documentation of a patients medical history
and care. The term 'Medical record' is used both for the
physical folder for each individual patient and for the
body of information which comprises the total of each
patient's health history. Medical records are intensely
personal documents and there are many ethical and
legal issues surrounding them such as the degree of
third-party access and appropriate storage and disposal.
Although medical records are traditionally compiled and
stored by health care providers, personal health records
maintained by individual patients have become more
popular in recent years.
Purpose
The information contained in the medical record allows
health care providers to provide continuity of care to
individual patients. The medical record also serves as a
basis for planning patient care, documenting communication
between the health care provider and any other health
professional contributing to the patient's care, assisting in
protecting the legal interest of the patient and the health
care providers responsible for the patient's care, and
documenting the care and services provided to the patient.
In addition, the medical record may serve as a document to
educate medical students/resident physicians, to provide
data for internal hospital auditing and quality assurance, and
to provide data for medical research.
Personal health records combine many of the above
features with portability, thus allowing a patient to share
medical records across providers and health care systems.
Format
Traditionally, medical records have been written
on paper and kept in folders. These folders are
typically divided into useful sections, with new
information added to each section
chronologically as the patient experiences new
medical issues. Active records are usually
housed at the clinical site, but older records
(e.g., those of the deceased) are often kept in
separate facilities.
The advent of electronic medical records has not
only changed the format of medical records but
has increased accessibility of files.
Contents
Although the specific content of the medical record may
vary depending upon specialty and location, it usually
contains the patient's identification information, the
patient's health history (what the patient tells the healthcare providers about his or her past and present health
status), and the patient's medical examination findings
(what the health-care providers observe when the patient
is examined). Other information may include lab test
results; medications prescribed; referrals ordered to
health-care providers; educational materials provided;
and what plans there are for further care, including
patient instruction for self-care and return visits. In some
places, billing information is considered to be part of the
medical record.
Demographics
Demographics include patient information that is
not medical in nature. It is often information to
locate the patient, including identifying numbers,
addresses, and contact numbers. It may contain
information about race and religion as well as
workplace and type of occupational information.
It may also contain information regarding the
patient's health insurance. It is common to also
find emergency contacts located in this section
of the medical chart.
Medical history
The medical history is a longitudinal record
of what has happened to the patient since
birth. It chronicles diseases, major and
minor illnesses, as well as growth
landmarks It gives the clinician a feel for
what has happened before to the patient.
As a result, it may often give clues to
current disease states. It includes several
subsets detailed below.
Surgical history
The surgical history is a chronicle of surgery for the
patient. It may have dates of operations, operative
reports, and/or the detailed narrative of what the
surgeon did.
Obstetric history
The obstetric history lists prior pregnancies and
their outcomes. It also includes any complications
of these pregnancies.
Social history
The social history is a chronicle of human
interactions. It tells of the relationships of the
patient, his/her careers and trainings, schooling
and religious training. It is helpful for the
physician to know what sorts of community
support the patient might expect during a major
illness. It may explain the behavior of the patient
in relation to illness or loss. It may also give clues
as to the cause of an illness (i.e., occupational
exposure to asbestos).
Habits
Various habits which impact health, such as
tobacco use, alcohol intake, recreational drug use,
exercise, and diet are chronicled, often as part of
the social history. This section may also include
more intimate details such as sexual habits and
sexual preferences
Immunization history
The history of vaccination is included. Any blood
tests proving immunity will also be included in this
section.
Medical encounters
Within the medical record, individual medical encounters
are marked by discrete summations of a patient's
medical history by a physician, nurse practitioner, or
physician assistant and can take several forms. Hospital
admission documentation (i.e., when a patient requires
hospitalization) or consultation by a specialist often take
an exhaustive form, detailing the entirety of prior health
and health care. Routine visits by a provider familiar to
the patient, however, may take a shorter form such as
the problem-oriented medical record (POMR), which
includes a problem list of diagnoses or a "SOAP" method
of documentation for each visit. Each encounter will
generally contain the aspects below:
Chief complaint
This is the problem that has brought the
patient to see the doctor. Information on
the nature and duration of the problem will
be explored.
History of the present illness
A detailed exploration of the symptoms the
patient is experiencing that have caused
the patient to seek medical attention.
Physical examination
The physical examination is the recording of
observations of the patient. This includes the vital
signs and examination of the different organ systems,
especially ones that might directly be responsible for
the symptoms the patient is experiencing.
Assessment and plan
The assessment is a written summation of what are
the most likely causes of the patient's current set of
symptoms. The plan documents the expected course
of action to address the symptoms (diagnosis,
treatment, etc.).
Orders
Written orders by medical providers are
included in the medical record. These
detail the instructions given to other
members of the health care team by the
primary providers.
Progress notes
When a patient is hospitalized, daily updates are
entered into the medical record documenting
clinical changes, new information, etc. These
often take the form of a SOAP note and are
entered by all members of the health-care team
(doctors, nurses, dietitians, clinical pharmacists,
respiratory therapists, etc). They are kept in
chronological order and document the sequence
of events leading to the current state of health.
Test results
The results of testing, such as blood tests
(e.g., complete blood count) radiology
examinations (e.g., X-rays), pathology (e.g.,
biopsy results), or specialized testing (e.g.,
pulmonary function testing) are included.
Often, as in the case of X-rays, a written
report of the findings is included in lieu of the
actual film.
Other information
Many other items are variably kept within the medical
record. Digital images of the patient, flowsheets from
operations/intensive care units, informed consent
forms, EKG tracings, outputs from medical devices
(such as pacemakers), chemotherapy protocols, and
numerous other important pieces of information form
part of the record depending on the patient and his or
her set of illnesses/treatments.
Administrative issues
Medical records are legal documents and
are subject to the laws of the country/state
in which they are produced. As such, there
is great variability in rule governing
production, ownership, accessibility, and
destruction.
Production
In the United States, written records must
be marked with the date and time and
scribed with indelible pens without use of
corrective paper. Errors in the record
should be struck out with a single line and
initialed by the author. Orders and notes
must be signed by the author. Electronic
versions require an electronic signature.
Ownership
In the United States, the data contained within
the medical record belongs to the patient,
whereas the physical form the data takes
belongs to the entity responsible for maintaining
the record. Therefore, patients have the right to
ensure that the information contained in their
record is accurate. Patients can petition their
health care provider to remedy factually
incorrect information in their records.
Accessibility
In the United States, the most basic rules governing
access to a medical record dictate that only the patient
and the health-care providers directly involved in
delivering care have the right to view the record. The
patient, however, may grant consent for any person or
entity to evaluate the record. The full rules regarding
access and security for medical records are set forth
under the guidelines of the Health Insurance Portability
and Accountability Act (HIPAA). The rules become more
complicated in special situations.
Capacity
When a patient does not have capacity (is not
legally able) to make decisions regarding his or
her own care, a legal guardian is designated
(either through next of kin or by action of a court
of law if no kin exists). Legal guardians have the
ability to access the medical record in order to
make medical decisions on the patients behalf.
Those without capacity include the comatose,
minors (unless emancipated), and patients with
incapacitating psychiatric illness or intoxication.
Medical emergency
In the event of a medical emergency involving a
non-communicative patient, consent to access
medical records is assumed unless written
documentation has been previously drafted (such
as an advance directive)
Research, auditing, and evaluation
Individuals involved in medical research, financial
or management audits, or program evaluation
have access to the medical record. They are not
allowed access to any identifying information,
however.
Destruction
. In general, entities in possession of medical
records are required to maintain those records
for a given period. In the United Kingdom,
medical records are required for the lifetime of a
patient and legally for as long as that complaint
action can be brought. Generally in the UK, any
recorded information should be kept legally for 7
years, but for medical records additional time
must be allowed for any child to reach the age of
responsibility (20 years). Medical records are
required many years after a patients death to
investigate illnesses within a community (e.g.,
industrial or environmental disease or even
deaths at the hands of doctors committing
murders).
Abuses
The outsourcing of medical record transcription
and storage has the potential to violate patientphysician confidentiality by possibly allowing
unaccountable persons access to patient data.
Falsification of a medical record by a medical
professional is a felony in most United States
jurisdictions.
Governments have often refused to disclose
medical records of military personnel who have
been used as experimental subjects.