DESCRIPTION OF MEDICOLEGAL CHARACTERISTICS IN INSTITUTIONAL HEALTH CARE

CASES 1999 – 2006

COLOMBIAN SOCIETY OF ANESTHESIOLOGY AND REANIMATION (SCARE) - SPECIAL

FUND TO AID SOLIDARITY LAWSUITS (FEPASDE), BOGOTA COLOMBIA

MAURICIO REY 1

ABSTRACT

41 medicolegal cases in health care institutions (IPS) were analyzed, carried out between 1999
and 2006, in order to describe their legal liability characteristics, socio-demographics, and
specifically in medicolegal responsibility. The main difficulties to demonstrate the medical act
were presented in the medical records and informed consent reflected in the grounds of the
legal process.

KEYS WORD

Liability, health institution, Mistake.

INTRODUCTION

In 1999, the report of the Institute of Medicine of the United States opened the discussion on
preventable medical errors, showing that between 44000 and 98000 people annually died at
hospitals in the country, as a result of medical errors, being the eighth leading cause of death in
the United States, beyond those produced by motor vehicle accidents, breast cancer and AIDS
(1). The World Health Organization (WHO) noted that in Canada and New Zealand, about 10%
of hospitalized patients suffered adverse consequences due to medical errors, while in
Australia, this figure was approximately 16.6%. Although the studies and data from developing
countries, experts believe that the situation is still worrying, WHO estimates that at least 50%
of medical equipment is not safe and that 77% of all reported cases occurs in developing
countries (2).

In turn, studies have been conducted seeking to determine the relationship between the
damage and accountability. An example is "Accountability sought by patients following adverse

1
Business Administrator. Scientific Support Unit. Colombian Society of Anesthesiology and Reanimation (SCARE) - Special Fund
To Aid Solidarity Lawsuits (FEPASDE).
events from medical care: the New Zealand experience" (3) where it was founded that 50% of
patients sought corrective actions to prevent future damage similar in patients, (change of
system in 45%, review the capacity of the health team involved in 6%) and 40% wanted more
effective communication, (an explanation in 34%, an apology within 10%). Similarly it is
concluded that the probability that a patient seeks compensation increased significantly if the
patient was in his early years working or suffered permanent disability as a result of the medical
act.

In Colombia information about this is limited and therefore the FEPASDE has conducted studies
in order to identify the relationship between the damage and accountability, in order to raise
awareness in the need of a safety culture at the country's health system.2

MATERIALS AND METHODS:

The investigation was conducted in all cases of responsibility for providing health institutions
(IPS) with in scientific-technical consultancies records3 carried out by professionals of the
scientific support unit at SCARE between 1999 and 2005, in order to analyze the socio-
demographic characteristics in medicolegal liability, the type of legal process and their
weaknesses, analyzing their relationship with the accountability presented. The variables were
analyzed through measures of central tendency, dispersion and position. For the qualitative
ones there was made an assessment of proportions.

RESULTS:

The results corresponded to 41 legal medical liability cases analyzed during 1999 to 2006; the
age range of patients provided with health services was characterized by a ratio of gender
1.05:1 male: female. The most frequent age of patients was between 21 to 60 years, age where
they are able to be economically active (Figure 1).

2
The Colombian Society of Anesthesiology SCARE, is a scientific organization, that owns FEPASDE, a solidarity fund to help cover
the medicolegal actions against health professionals in the country.
3
It is a concept on the technical characteristics of care, by assessing the medical act committed. It is the comparison of the act of
the institution with patterns of management. (13)
 Figure 1 Patient Age

14
12
12
10
10
8
8
6 6 6 6 Female
6 5 Male
4
4 3 3 3 3 Total
2 2
2 1 1 1

0
<20 years 21 to 30 31 to 40 41 to 50 51 to 60 > 60 years
years years years years

Source: 41 cases in Institutional health care CASES 1999 – 2006 SCARE-FEPASDE 1999-2006

The provision of health service was conducted in 37 public and 4 in private institutions with the
vast majority (N = 31) located at the capital cities in Colombia (Figure 2).

Figure 2 Institution Location

Municipalities 4

Intermediate cities 6

Capital Cities 31

0 5 10 15 20 25 30 35

Source: 41 cases in Institutional health care CASES 1999 – 2006 SCARE-FEPASDE 1999-2006

In relation to the level of complexity of the institution, it was noted that the attention was
presented in greater proportion in the third level with 18 cases, followed by level II with 15 and
6 in the level I. 4This attention was ambulatory in 41% of cases (N = 17) and in the

4
Levels of health care for Colombia have been classified according to compliance with the basic conditions of scientific and
technological capabilities. The first level addresses basic medicine and dentistry, the level II has specialized medical care and
hospitalization form with 59% (N = 24). On the other hand, it was noted that attention was
generated elective in 15 events and 26 by urgency and that depending from the level of IPS an
increase in cases was presented (Table 1).

Table 1 institution level, shape and type of care

Type level of the
Form of attention Elective Urgent Total
institution
I Ambulatory 2 2 4
Hospital 1 1 2
total 3 3 6
II Ambulatory 3 3 6
Hospital 3 6 9
total 6 9 15
III Ambulatory 4 2 6
Hospital 2 10 12
total 6 12 18
Without Data Ambulatory 1 1
Hospital 1 1
Without Data Total 2 2
Total 15 26 41

Source: 41 cases in Institutional health care CASES 1999 – 2006 SCARE-FEPASDE 1999-2006

For the location of the patient in the physical area of care, 18 cases were presented at the
surgery area, 6 outpatient, 6 in the emergency room, 5 at the hospitalization services, 4 in the
delivery room and 2 in the areas of diagnostic support.

Reviewing the attention made, it was found that in 66% of the service was performed involving
surgery and the other 34% was non-surgical. The faults presented in non-surgical interventions
were related to the control or surveillance; diagnostic, evaluation and treatment or therapy
were presented in equal proportions; there were found two that did not applied because they
were presented by their clinical condition. Related to the surgical interventions, the highest
proportion of faults in the postoperative was presented within 15 cases, followed by problems
during the surgery with 5 cases. This showed a classification does not apply in a case where an
anatomical anomaly generated the inconvenience. It is important to show that 38 of the cases
were a result or effect contrary to expectations, 2 in which the clinical condition did not gave a
good prognosis since before the intervention, and there was no harm in 1 case (Table 2).

hospitalization of basic specialties: Ginecobstetrics, internal medicine, pediatrics and surgery and the level III has in addition to the
above different subspecialties. The level IV is related to attention at university hospitals.
 Table 2 location of the problem in the medical act

Intervention Location of the problem in Total

the medical act
No surgical Control or clinical 4
surveillance
Diagnostic evaluation 4
Treatment or therapeutic 4
Not applicable 2
No surgical total 14
Surgical Control or clinical 2
surveillance
Diagnostic evaluation 2
Postoperative 15
Transoperative 5
Treatment or therapeutic 2
Not applicable 1
Surgical total 27
Total 41

Source: 41 cases in Institutional health care CASES 1999 – 2006 SCARE-FEPASDE 1999-2006

With regard to the damage that was submitted, it was found the death of patients in 21 cases
and 16 patients had a physiological or anatomical injury. In one case did not apply because
there was no damage (Figure 3). The origin of the damage was in 21 cases an inherent
complication5 in the act or by the medical condition; we must add an event because an
anatomical anomaly and 2 did not apply to be part of the clinical condition. Moreover, 9 were
an obvious failure of the institution or health system, in 8 cases there was fault of health
personnel (generated by possible: recklessness in 4, negligence n 3 and incompetence in 1)
(Table 3).

With regard to the 9 cases with institutional failure (Table 3), we found a case involving a blood
transfusion, in which a patient was contaminated with HIV. In two cases were presented a
nosocomial infection triggering injuries final in the lower limbs. In one case there was a delay in
authorizing the change of catheter to a patient with chronic renal failure, which generated an
infection that eventually led to the death. In another case there was delay in the authorization
to practice an appendectomy. It showed a case where the patient suffered loss of vision,
because the waiting in the authorization of the procedure until it was determined which
insurance health company assumed the costs of intervention. Three cases relate to obstetric
care, in one of them a maternal death was presented with 20 weeks of gestation, who in the

5
It is clear that although a complication is inherent, but at this part of the investigation was not evaluated whether or not was well
attended.
absence of authorization by the insurance health company to which she was affiliated, decided
to consult with another institution where she died. In another case, after 24 hours of difficulty
in referring a woman who was in labor, family members opt for voluntary departure and lead to
the patient to another institution where she died. Finally, 42 weeks pregnant woman who
enters labor to high-risk institution that did not have the conditions necessary for their care,
were not carried out the formalities for transferring the patient to a more complex level of the
neonates.

Figure 3 Damage presented to the patient

Death 16

Definitive physiological or anatomical

16
injuries

Neonatal death 3

Tempory physiological or anatomical

3
injuries

Fetal death 2

No appilicable 1

0 5 10 15 20

Source: 41 cases in Institutional health care CASES 1999 – 2006 SCARE-FEPASDE 1999-2006

Table 3 of Origin the result

Inherent complication to the medical act or 24

the pathology
Evident fault of the institution or the system 9
of health
Personnel of health by Recklessness 4
possible: Negligence 3
Incompetence 1

Source: 41 cases in Institutional health care CASES 1999 – 2006 SCARE-FEPASDE 1999-2006

The reasons why a patient or his family initiated a complaint against the health institutions
were diverse. It was noted that a lawsuit may be initiated nor only by submitting an injury such
as death or incapacity, but because of the perception of inappropriate care, inadequate or in
situations where there was no attention. It was found that the reasoning behind the patient or
his family to search accountability to the institution was: the perception of failure or deficiency
in service in 51% of cases (N = 21) and the damage caused in 41% (N = 17) (Figure 4).

Figure 4 what led to the legal process?

Failure or deficiency in the presentation 51%

of service 21

Damage 41%
17

Lack of hardware 2%
1

Another professional advocates legal 2%

process 1

Preventive* 2%
1

0 5 10 15 20 25

Source: 41 cases in Institutional health care CASES 1999 – 2006 SCARE-FEPASDE 1999-2006

Referring to the type of process for the medical-legal liability of the patient or family are
presented, in greater frequency of civil law proceedings with 66% (N = 27), followed by
administrative processes 20% (N = 8) (Figure 5).6

6
Types of processes (medicolegal actions): ethical process started with a complaint filed by patients, family members or entities,
and a judge of the Medical Ethics Court investigates performance in the light of the rules in force at Colombia. In a penal system, the
operator can be investigated in connection with the medical act for the crimes of personal injury, which was investigated after a
complaint to the “Fiscalia”, or manslaughter, which investigates and officers commonly practiced medico-legal autopsy. The civil law,
under the legal context, the doctor-patient relationship is seen as a "contract" between individuals. The process extended when the
applicant is seeking monetary damages presented before a civil court. For the administrative, in the event of lawsuits against state
entities, if the doctor is a civil servant, can be called by the institution to reply within two moments process: call security while occurs
during the process that courses in the Administrative Court or for a repeat action against the professional in the event of a
conviction. Doctors linked to the social enterprise of the State (ESE) are subject to the provisions of the Single Disciplinary Code
which houses government officials; disciplinary investigations are advanced by the Attorney General's Office or the internal audit
offices of the entities. * Preventive process: this means that the medical professional sought support in the assessment of the case
to the suspicion of a possible filing of a legal status, without a formal legal process has started
 Figure 5 type of legal processes in liability cases

1
5
2%
12%

Civil
8 Administrative
20%
Penal
Preventive*
27
66%

Source: 41 cases in Institutional health care CASES 1999 – 2006 SCARE-FEPASDE 1999-2006

In reviewing the available records (medical and informed consents) with the institution to
looked for an adequate provision of quality health care, protocols and comply with regulations
in force, it was observed an inadequate medical records, because in the 71% (N = 29) of cases
they were with medium or low quality7 (Figure 6). In 18 cases that was not needed of the
informed consent because an urgency. In the remaining 23 requiring, it was noted that in 12
were not found informed consent, 4 had no deficiencies, 3 were in a institutional form that was
no adequately to informed the procedure, nor the specific risks that could be presented by the
patient and there were 4 consent in which it was unable to determine their characteristics8
(Table 4). For this reason, the technical risk-scientist who came from the technical and scientific
advice, was determined as low: 32% (evidence of an adequate service, based on clinical records
and other documentary evidence), middle in 36% (There may be controversy in the proper
service, or does not have a clear support within the medical records, or does not have
authorization for the procedure) and high: 32% (The failure care with causal with damage are
presented with procedural weaknesses) (Figure 7).

7
Quality of medical record is discussed by the scientific support unit using the resolution 1995 of 1999, taking the classification:
High: fully compliant with the requirements of resolution 1995 of 1999 and provides information about the way it was conducted the
service.
Middle: is deficient in complying with requirements of resolution 1995 of 1999, but provides information about the way it was
conducted the service.
Low: is deficient in complying with requirements of resolution 1995 of 1999 and does not provide information about the way it was
conducted the service.
8
A proper informed consent is given when it is in medical record informing the diagnosis, procedure and risks with a detailed
planned for the event and shows how the acceptance by the patient and / or responsible.
 Figure 6 Quality of medical record

9
22%
12
29%

Low
Middle
High

20
49%

Source: 41 cases in Institutional health care CASES 1999 – 2006 SCARE-FEPASDE 1999-2006

Table 4 Informed consent

It does not require an informed consent 18

because a urgency
Informed consent was not 12
demonstrated
It requires It was not possible to be 4
informed determined it
consent characteristics
Informed consent adapted 4
Only institutional format 3

Source: 41 cases in Institutional health care CASES 1999 – 2006 SCARE-FEPASDE 1999-2006
 Figure 7 technical scientific Risk

13 13
32% 32%

High
Middle
Low

15
36%

Source: 41 cases in Institutional health care CASES 1999 – 2006 SCARE-FEPASDE 1999-2006

However, when it was making the comparison of variables in their technical risk-versus
scientific quality of the records , that it was observed an inverse relationship, where a higher
quality of the clinical record minor the technical risk (Figure 8). Behavior it was expected,
because as it mentioned above clinical records is the written evidence available of the
institution to demonstrate an adequate allowance, quality, use of protocols and comply with
regulations in force.

Figure 8 Risk vs. scientific technical quality of medical history

100%
1
90% 3
80% 5
70% 6
60%
8 Low
50%
Middle
40% 6
High
30%
20% 6
4
10% 2
0%
High Middle Low

Source: 41 cases in Institutional health care CASES 1999 – 2006 SCARE-FEPASDE 1999-2006
DISCUSSION

There is no doubt that the communication problems between the actors of the health system
and especially among the health team and patient generate complaints and demands. This was
evident in the reasons for the legal process, so as it was in the description of the facts by which
requires responsibility. Similarly channels of communication between the medical services,
such as administrative, are inefficient and generate confusion and delays that led accountability
by the patient or his family. It is important to conduct a study on the effectiveness and
efficiency in the communication of the health area.

18 poor medical records (71%) (Figure 6) and insufficient informed consent, 23 requiring this
act (Table 4) generated shortcomings in the records that did not prove an adequate attention.
This situation showed the importance of diligence and proper use of clinical records and
informed consent, that not only helps to have evidence in case of a legally answer, but also as
mechanisms that improve the medical-patient relationship and patient safety in their attention.

Moreover, the study noted that there were more demands on capital cities (75%) (Figure 2)
where the hospitals are of high complexity (N = 33 hospitals in Level II and III) and which have a
human resources and infrastructure in line, but had shortcomings in the care and patient
monitoring, coupled with the perceptions of failure in service and submitted to the damage
(51% of cases).

However, analyzing the medicolegal characteristics, medical institutions found that the highest
proportion occurred in civil suits (66%), followed by administrative (20%), and comparing with
the scientific-technical risk given by the advisor where he was high or middle in 28 cases (68%)
allowed difficulties in defending the institution for financial compensation of the legal process.

The study showed that most adverse events occurred in surgical rooms with (n = 18) and
emergency departments (n = 6), perceived shortcomings in the monitoring of patients:
insufficient, distance or the professional was not available.9 Which helped that in several cases
were detected in late complications, because complications were frequent in each procedure,
but unfortunately the attention of the same was deficient in 61%.

With regard to the 9 cases with institutional failure, it was found in 4 cases delays in the
necessary authorizations for care, which led to situations that aggravated the patient's clinical
condition. In three cases there were faults in the protocols and procedures in the laboratory or
in surgery rooms that led to the damage. In two inabilities to transfer favored the death.
Looking such situations, it is pertinent to reflect on the protocols and procedures with

9
For this study, the term availability is the time during which the employee is not working at his job site but is orders to an employer
who at any time can call for assistance.
administrative accounts in our health institutions. It is important to determine whether there
are protocols and procedures, whether these are clear, if the staff implements it is properly and
whether they understood the implications of their decisions, because as it is noted in the study
, they inside significantly the health status of patients.

CONCLUSIONS AND RECOMMENDATIONS

It is necessary to establish procedures, instructions and protocols in the health care more
common, but it is important to ensure that members of the institution know, understand and
apply them.

It is important to assess the costs that are carrying the institution because of the shortcomings
that they are generated in the service. Likewise, training the members of the institution, so they
can detect the faults, give an optimal response, informed the institution and the patient, and
lastly, that they can take steps for not repeat the mistakes.

A medical record properly processed as well as being a support for the diagnosis and treatment
constitutes the main element of proof to the defense of the institution in case of being doomed
to claim for the provision of health services. Therefore, the medical history should be recorded
as done for each member of the team who had contact with the patient, while the institution
and the medical health group must be aware about the importance of making records. For this
reason, the institution must take steps, in order to have a committee of medical records to
train, monitor and generate policies to improve the diligence, use and control of them and their
components. This not only helps to comply with laws and rules which govern them, but they
can be use as a mechanism to protect the patient and collaborating with reducing errors in
health.

You are invited to maintain constant supervision of staff and generate efficient and effective
communication between departments in real time. It also calls for the digitalization of medical
record and their components.
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