QUALITY MANAGEMENT IN SWEDISH FORENSIC MEDICINE

QUALITY MANAGEMENT IN SWEDISH FORENSIC MEDICINE
- AN INTERNATIONAL COMPARISON
by Lennart Rammer
Report from the Swedish National Board of Forensic Medicine, No 2011-02
SUMMARY
Background
The Swedish National Board of Forensic Medicine was established in 1991 and is a
government authority under the Ministry of Justice. According to its official mandate
the Board is responsible for forensic psychiatry, forensic toxicology, forensic genetics
and forensic medicine for the whole country (population 9.4 million). Furthermore the
Board has the duty of international cooperation within its field of activity as well as to
support research of importance for its commission. The annual letter of regulation from
the government demands the Board to report which measures have been undertaken for
quality development and quality assurance as well as the results of the follow up. The
present report has been produced on the commission of the director-general of the
National Board of Forensic Medicine elucidating how the Board responds to these
demands. More specifically the basis for the study is as follows:
To determine the quality of the work within Swedish forensic medicine
concerning structure, process and result,
To assess quality management within Swedish forensic medicine concerning
quality assurance, quality control, quality audit, quality development and
research, and
To compare the quality and the quality management within Swedish forensic
medicine with other countries.
Important statistics representing various parts of the activity of forensic medicine in
Sweden have been collected from the internal computer system for forensic
examinations. Interviews have been held with the heads of the six departments of
forensic medicine, a number of specialists in forensic medicine, physicians under
specialist training, physicians that have left forensic medicine and representatives for
forensic toxicology, forensic genetics, the health care system, universities and other
state authorities. Study visits have been made to the six departments of forensic
medicine in Sweden and a number of leading institutes of forensic medicine in
Scandinavia, Europe, USA and Australia. Information was also collected at
international conferences, from scientific reports and from Internet.
Structure
Sweden is divided into six districts with departments of forensic medicine in Umeå,
Uppsala, Stockholm, Linköping, Göteborg and Lund. The departments perform forensic
examinations of deceased, especially autopsies, and of living persons for the purpose of
issuing medico-legal certificates on demands by the police, prosecutors and courts.
For several decades a troublesome shortage of qualified staff has existed among
medico-legal experts in Sweden (at present 44 doctors, 22 specialists and 22 under
training). The main reason is that a great number of doctors have left forensic medicine.
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During the last 10 years 34 doctors have disappeared, 19 specialists and 15 doctors
under education have left for other duties. This corresponds to an annual loss of nearly
10 percent of the entire group. This shortage of staff is absolutely the most important
problem in Swedish forensic medicine at the present time.
The main reason for the problem is a feeling among many pathologists that the work is
tedious and too demanding and gives little possibility for professional development and
stimulation. The heads of the departments are responsible for organizing the workload
so that the situation can be improved. The National Board of Forensic Medicine has
created an ambitious plan with a 10-year perspective with major focus on recruitment
and education of doctors. The goal is that by 2018 there will be 71 pathologists within
Swedish forensic medicine. Creation of a stimulating intellectual environment at the
departments with seminars, case discussions and research projects as well as carrier
planning with sub specialization is probably of decisive importance in order to
encourage physicians to remain active in the field.
University affiliation exists at four of the six departments in form of professorships in
forensic medicine in Umeå and Uppsala and lectureship in Stockholm and Lund.
During a period in the 1990s all six heads of the departments were professors and
specialists in forensic medicine. The change reflects increasing competition for
permanent appointments within the university system and decreased activity in forensic
medicine with regard to basic research and scientific publications. The National Board
therefore should concentrate on financing adjunct university positions in forensic
medicine, in the same way as in forensic toxicology, genetics and psychiatry.
The current heads of the departments of forensic medicine have a somewhat different
educational background. Three of them are medico-legal experts, of whom one is a
medical doctor, and three of them are not. Of the three non-medically qualified
individuals, two have an education as laboratory technicians and one as a lawyer. At the
three departments where the heads are not qualified in medicine, a forensic pathologist
is made responsible for the medical activities as a medical head of the department. Two
departments lack an assistant head of the department, which is regrettable. A more
uniform and competence oriented solution of the management of the departments
would be desirable. At all departments the leadership should consist of two persons,
one head and one assistant and deputy head of the department, who together should
provide skills in leadership, administration, medicine and research. The main
alternative is that the head of the department should be a specialist in forensic medicine.
A new category of personnel recently introduced by the National Board of Forensic
Medicine is so-called medico-legal death investigators. These individuals are trained as
nurses or similar occupation and their task is to have a dialogue with relatives of the
deceased. This might entail an assessment of the medical and social background of the
deceased before the forensic autopsy is performed and on request to inform the relatives
about the results of the autopsy. This is an important professional category to maintain
and develop further.
The departments of forensic medicine generally have buildings and facilities well suited
for their intended purpose. The department in Göteborg will undergo reconstruction in
1912 to create more space for its morgue and autopsy work. During 2011 enlargement
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of the department in Stockholm has started. Also other departments will need larger
localities to house rooms for an increased number of medico-legal experts.
The departments are also well equipped for histopathological and other related
laboratory work. All departments should have access to a car for official duties.
One of the strongest operational areas of the National Board of Forensic Medicine is
the computerized data system. Shortly after the establishment of the Board in 1991 the
case management system “Rättsbase” was introduced for registration and follow up of
medico-legal examinations. The system was used both for case registration, typing of
reports, recording of diagnoses and producing statistics based on the case material. It
was also connected to the system “Toxbase” for the post-mortem toxicological results.
The computer activities now progress into a new generation with the introduction of the
“Portal” which is a module based case registration system built in JAVA-language, and
a management system for all IT-activities, LEDOK. The IT-system of the National
Board of Forensic Medicine has received attention internationally and is used by the
Institute of forensic medicine in Oslo, Norway. The organization with one state
authority for forensic medicine in Sweden has facilated the creation of a uniform
computer system for the whole forensic medicine and forensic toxicology organization
throughout the country, which is a unique situation.
Medico-legal examinations of deceased
The number of medico-legal autopsies has remained remarkably constant at about
5 500 cases a year since the establishment of the National Board in 1991. Of these cases
about 200 are so called “detailed medico-legal autopsies”, where the death is suspected
to have been the result of a violent crime. About 20 cases consist only of an external
post-mortem examination with samples taken for toxicological analysis. In about 50
cases a year, mostly when a criminal offence e.g. murder is suspected, the medico-legal
expert is instructed by the police to examine the body at the scene of death. Such cases
as well as the need to perform examinations of living persons at short notice motivate
creating an emergency service of doctors outside normal working-hours.
Forensic autopsies are quantitatively the dominating part of the workload of the
departments of forensic medicine, and the work is generally of good quality. The
autopsies are generally performed as complete autopsies and include a careful external
examination, removal and examination of all internal organs, extensive sampling of
body fluids for toxicology and any special analyses required. Microscopical
examination is performed in between 60 and 90 percent of all cases with an average of
75 percent. The equipment and methods used for microscopic examination is
approximately the same in all departments and in general the same staining methods are
used. The quality is good.
Forensic toxicological examination is the other main type of special investigation after
a forensic autopsy. Nearly all cases (95 percent) are subjected to the determination of
alcohol and prescription drugs and often the analysis of illicit drugs and other
substances of interest. The analyses are made at the Department of Forensic Genetics
and Forensic Toxicology in Linköping. The quality of sampling, handling, analyses of
biological fluids is well standardized and reports are issued in each case. The
Department of forensic toxicology has a database of normal, toxic and lethal
concentrations of drugs that has attracted attention internationally. Forensic toxicology
is perhaps the strongest aspects of Swedish forensic medicine. Important areas for
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future development include use of biochemical markers of disease and new methods for
determining new pharmaceutics and drugs of abuse. Another important area is regular
case seminars between toxicologists and medico-legal experts, possibly through videoconferences,
for discussion of results of forensic toxicological findings.
A new spectacular area in forensic autopsy work is computer tomography, CTexamination.
Three-dimensional X-ray pictures are taken of the whole body and are
examined and evaluated before the autopsy is performed. Through cooperation with a
radiological department at the university hospitals all the six departments of forensic
medicine during the last years have performed such examinations. Types of cases
subjected to examination are the specially detailed forensic autopsies when deaths were
the result of a violent crime, deaths in children, burn victims, traffic fatalities and
drowning. No department has so far purchased a CT-equipment for sole use in forensic
pathology. The National Board in 2009 set up a committee to investigate the need and
possibilities for such a technique in the country. The group has recommended that CTinstrumentation
should be purchased at all departments of forensic medicine, starting in
Stockholm and Uppsala. The director-general of the Board recently decided that the
first CT-apparatus would be placed in Uppsala. This is an important area of
development that should be given top priority. Equally important, however, is the
consideration of professional competence by those responsible for operating the
equipment. This will demand recruitment of X-ray technicians, diagnostic radiologists
and a team leader responsible for the whole CT-project.
In addition to forensic examinations of living and deceased persons the forensic
departments in accordance with the instructions are allowed to perform other
commissions within their field of competence if the workload permits, i.e. clinical
autopsies and procurement of tissues after donation. Such activities are performed at
some of the departments.
When writing forensic reports the contents and conclusions are the most important,
but the design and formulation of the language are also critical for the reader to grasp
the meaning and understand the results. In the 1990s a common uniform design of the
medico-legal reports was established, but the present survey shows that a great
variation in the layout and sentence structure still exists between different departments
and also between individual pathologists within the same department.
The turn-around-time from receipt of a body to reporting back the results of the autopsy
to the police authorities averages about two months with some small variation between
the six departments. This is an unacceptably long time. The explanation generally given
is shortage of pathologists, but the handling time is primarily a question of organization
and prioritizing of different activities. The National Board should set up time limits for
completion of forensic cases and strive to ensure that these limits are kept. Even the
time from the death to the autopsy is too long depending on a slow handling of the
cases by the police authorities and limited capacity at the mortuary at one department.
Forensic pathologists are often required to serve as medico-legal expert witnesses in
court in important cases. The formalities for this type of work are extremely variable,
apparently arbitrary, which hampers the appearance in court by the medico-legal expert.
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Judicial death investigation
The purpose of a medico-legal death investigation is to disclose, examine and exclude a
crime as a cause of death. A Swedish study has shown that eight percent of all murders
were detected at a forensic autopsy, which corresponds to up to ten cases a year in the
country. The measures of the society to fulfill this purpose are a police investigation
and a medico-legal examination of all suspected unnatural deaths, i.e. deaths by injury
and intoxication. Recent cause of death statistics from the National Board of Health and
Welfare show that only 55 percent of unnatural deaths are subjected to a forensic
examination. This means a considerable risk that deaths involving crime can pass
undetected. The National Board ought to raise the question with the National Board of
Health and Welfare of reporting deaths to the police.
On the other hand a considerable number of forensic autopsies are performed that more
correctly should have been completed within the normal medical service, either as a
clinical autopsy or without an autopsy. These cases ought to have been brought back to
the reporting doctor after consultation between the police and a medico-legal expert.
Other cases correctly reported to the police could have been completed with an external
medico-legal examination, being sufficient to answer questions about the cause of death
and the manner of death. If the medico-legal expert after making such an examination
considers there are remaining questions to answer then a complete forensic autopsy
should be performed. A survey of a number of forensic examinations shows that
approximately 5-10 percent of the cases could have been brought back to the health
services and 20 percent could have been completed with only an external medico-legal
examination.
The transports of bodies from a place of death to a department of forensic medicine and
back is arranged and paid for by the police authorities and carried out by various
undertaker companies. However, a number of problems exist in relation to these
transports, especially concerning security, and therefore it has been suggested that the
National Board of Forensic Medicine should take over this responsibility. However, at
longer distances it is difficult to arrange the transports directly from the departments of
forensic medicine and to achieve full covering of the costs. The main alternative,
therefore, should be that the police also in the future takes the responsibility for the
transports of bodies. The security questions should be considered after discussions with
the National Police Board.
Identification of bodies after mass disasters is regulated by the instruction for the IDcommission
and according to international regulations. Specific regulations, however,
are lacking for identification of single cases of death within the country and the police
decide in each specific case if the body can be considered identified with sufficient
certainty. There are examples of deaths in which the body has undergone severe
putrefaction and has been identified by belongings or by resemblance with a
photograph. Regulations should be formulated such that when there is any doubt about
identity, this should be established with full certainty by odontological, genetical or
fingerprint method. The question should be discussed further with representatives of the
National Police Board.
In deaths resulting from medical negligence or maltreatment, these should be reported
to the National Board of Health and Welfare, and also to the police authorities. Often
reporting to the police is omitted, and the number of forensic autopsies in such cases is
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only about 20 per year, while the number of deaths reported to the National Board of
Health and Welfare exceeds more than 100. The discrepancy in these numbers needs to
be discussed with the National Board of Health and Welfare, and appropriate measures
taken.
Medico-legal certificates
In 2006 a new law and a new order appeared concerning the issuing of judicial
certificates. The National Board of Forensic Medicine was made responsible for
providing these certificates and contracted about 50 doctors (forensic physicians) who,
together with the medico-legal experts at the departments of forensic medicine, would
issue the certificates. A follow up of this reform showed that the new order had resulted
in certain improvement in the quality of the certificates, but that a number of problems
still remained.
The number of certificates issued remains low at about 8 000 per year compared to
120 000 cases of physical and sexual assault reported to the police. The costs of the
examination have to be covered by the police budget, which might account for the low
number of victims actually examined. The majority of the certificates are opinions
about medical records and is not based on de facto medico-legal examination of the
person. Often the police demand only a copy of the medical record instead of a
certificate without cost for the police. The law about judicial certificates deals only with
issuing these certificates and not with the physical examination of the person.
Regulations are also lacking concerning when and how certificates should be ordered
by the police and prosecutors. These questions should be discussed with the National
Police Board and the Prosecutor-General.
The quality of the training of the forensic physicians needs to be improved. Presently,
the basic training includes two days of instructions, which has to be extended.
Instructions should also be given when the physicians come to the departments of
forensic medicine for individual review of cases. There is a need for internal quality
control of the certificates performed by a medico-legal expert prior expedition of the
reports. A question to consider in the long run is if the main part of the activity
involving clinical forensic medicine should be taken over by the medico-legal experts
within the departments of forensic medicine. Exceptions where forensic physicians still
have to be used would be when there are long distances to travel to the nearest
department of forensic medicine.
According to the previous presentation there is a number of areas concerning both death
investigations and clinical forensic medicine, where discussions with the National
Police Board, the Prosecutor-General and the National Board of Health and Welfare are
necessary. From an efficiency aspect these discussions ought to be conducted in form
of projects during short periods of time and not through regular annual meetings.
Quality management
Quality assurance was early instituted in Swedish forensic medicine. Already at the
beginning of the National Board in 1991 regulations about medico-legal examinations
of deceased were introduced. Before a Scandinavian conference about quality assurance
in forensic medicine and forensic toxicology in Göteborg in 1993 a “ Basis for national
guidelines in forensic medicine and forensic toxicology” was issued. The document
was promoted to internal guidelines in 1994 as a professional support in performing
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forensic autopsies. In 2003 a modernization of these guidelines was instituted, and in
2007 they were revised into a method manual. After a certain uncertainty about its
introduction this manual has constituted the basis for a new quality project within
Swedish forensic medicine. Apart from these documents a number of internal
guidelines exist regulating parts of the activity with medico-legal examinations. These
guidelines are not complete, were produced fairly long ago and are under revision. In
1998 a group was appointed responsible for the quality management in forensic
medicine, consisting of the heads of the departments, under the leadership of a senior
medico-legal expert. In 2001 this group was reorganized to a board for quality
development with representation from various categories of personnel.
In the beginning of 2009 one head of department was appointed as a quality coordinator
and convener of a project group “Quality in forensic medicine”. This project has the
purpose to result in a system for quality management and intended accreditation
according to ISO/IEC 17025 and 17020 through SWEDAC for medico-legal
examinations of deceased and living persons for the whole country. Representatives of
various categories of personnel cooperate in working groups. Medico-legal experts are
not particularly represented, which is a severe drawback that should be considered and
taken care of. A reference group consisting of the heads of the departments and the
medical heads are responsible for the medical part of the project.
The work with quality assurance within Swedish forensic medicine and introduction of
a system for quality management and intended accreditation through SWEDAC is
positive and of importance to generate a high and even quality of the medico-legal
examinations. When the project is finished a specialist physician in forensic medicine
should be appointed as a technical leader and responsible for the quality system of
medico-legal examinations.
External control of the quality management system will be done by SWEDAC in case
of an accreditation. External audit of the medico-legal examinations and reports have
on some occasions been performed by representatives from the National Board of
Health and Welfare and within forensic medicine through alternate inspection between
the departments. It is desirable that within the framework of the quality management of
forensic medicine a system of external audit is constructed concerning handling,
procedure, interpretation and documentation of single cases of examination. This could
be preformed by an external specialist in forensic medicine, e.g. from another
Scandinavian country or previously active in Swedish forensic medicine. Apart from
the description of methods within the accreditation documents, the selection of methods
for various types of cases should also be indicated in the system.
Internal quality control presently is performed according to “Guidelines for quality
assurance at the departments of forensic medicine”. Two doctors, one examining and
one controlling physician should perform the so-called ”Detailed forensic autopsy”.
Other cases of forensic autopsy should be performed by one doctor, and in these cases
the report should be controlled by another doctor. For the moment the National Board
considers after consultation with the National Police Board to abandon the type of
autopsy called “Detailed forensic autopsy”, as it is not mentioned in the Autopsy law.
In this case it is important to keep the procedure with two doctors in cases with
apparent or suspected crime in accordance with the recommendation of the European
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commission. The procedure with two doctors performing the autopsy should be used
more flexibly, also in other types of difficult cases after decision of the medical head.
According to its instruction the National Board of Forensic Medicine is expected to
support research of importance for its commission. This is done by administration of
funding for research projects, creation of contracts with universities, financing of
positions as adjunct professors and lecturers and allowing time for research work. The
amount of money allocated for research projects is decided annually and amounts to
about 1 million SEK (100 000 Euro). On a central level a director of research
administers the activities.
The total level of the research activities at the departments of forensic medicine is on
the whole fairly good, considering the limited size of the organization and extensive
routine work. Troublesome, however, is that some departments are almost totally
lacking research activities, that the research activity is declining and that with a few
exceptions no doctors within forensic medicine are registered as postgraduate students.
The National Board, however, has an ambitious research policy. Of importance is that
the research activity of the departments more clearly should be organized in research
groups with defined projects lead by a project leader and tutors. Connection to the local
universities is important to accomplish registration of postgraduate students and in the
long run elevation of the level of quality of the research of special importance for the
commission of forensic medicine.
Borttaget:
International comparison
As part of the present project a number of leading institutes of forensic medicine were
visited, both in Europe and previously also in USA and Australia. The purpose was to
document and learn about the organization and procedures used and to compare quality
and quality management of Swedish forensic medicine with other countries. Generally
the quality of forensic medicine in Sweden is high by international standards. Strong
areas are the core commission as forensic autopsies and forensic examinations of living
persons, histopathology and above all forensic toxicology, where a central accredited
laboratory is available. Even national efforts within specialist education and the
computerized system are strong areas of the current system. Ongoing projects including
CT-diagnostics and accreditation of forensic medicine will help to bring Swedish
forensic medicine on par with leading institutes in other countries. Problem areas are
the recruitment of the medico-legal experts and to encourage them to remain within the
organization, the quality of the reports by the contracted forensic physicians and the
low research activity of some departments.
In this report special attention has been given to legislation in other Scandinavian
countries in the way unnatural deaths are dealt with within the legal field. The
legislation is clear and coherent in Denmark and Finland, while it is less clear and
disparate in Norway and Sweden. The Danish Health law has a structure with three
levels 1) A medical external examination performed by a doctor in all out-of-hospital
deaths, 2) A forensic external examination performed by a county medical officer or a
medico-legal expert in all deaths reported to the police and 3) A forensic autopsy
performed by a medico-legal expert in special cases of death. The Law on investigation
of the cause of death in Finland separates 1) Medical investigation of the cause of death
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and 2) Forensic investigation of the cause of death, with the special types of
investigation, medical autopsy and forensic autopsy.
A new order for judicial investigation of death
There is reason to improve the Swedish system for investigation of deaths within the
legal field to guarantee that all deaths caused by crime shall be disclosed. Thus all
deaths resulting from injury or poisoning must be reported to the police for
investigation and forensic examination. At the present time only 55 percent of such
deaths are subjected to a medico-legal examination. In that way several deaths by crime
risk to pass undetected every year. Good examples of organizational solutions of this
question are the Danish system of forensic external examination, the American medical
examiner system and especially the system with preliminary examination used in
Victoria, Australia.
To meet this purpose the following changes of the routines should be considered:
Physicians should report to the police all deaths suspected to be caused by
injury or intoxication.
The police should decide that a forensic examination of the body should be
performed in all deaths properly reported to them.
Medico-legal experts at the National Board of Forensic Medicine should decide
whether an external examination of the body or a complete autopsy should be
performed.
Deaths in hospital with good medical documentation after accidents with known
course of events can be closed without further examination of the body after
consultation between the police and a medico-legal expert.
The above changes can be effected within the framework of the present legislation.
Reporting of deaths to the police by the health organization can be improved by a more
distinct formulation of the death certificate and by revision of the regulations by the
National Board of Health and Welfare. The decision by the police authorities to request
a forensic examination can be improved by a more stringent application of the internal
rules of the police. The choice of type of forensic examination is a question for the
National Board of Forensic Medicine, as this issue is not commented upon in the
Autopsy Law.
If the above suggested changes are made, one can expect an increase in the total
number of forensic examinations from about 5 500 per year to about 7 000 per year.
However, the number of forensic autopsies will decrease from about 5 500 cases to
about 4 000 cases a year. An addition of about 2 000 external forensic examinations
will follow, a type of examination which is not much used today. About 1 000 cases
can be closed by a medico-legal expert and the police using information from the
medical records. This is valid primarily for accidental deaths, such as falls, with welldocumented
course of events. These figures must be read as gross approximations.
Contact is needed between the National Board of Forensic Medicine, the National
Police Board and the National Board of Health and Welfare with the aim to initiate
changes in the routines for unnatural death investigations. If it turns out that these
changes cannot be realized or don’t give the expected result, changes in the legislation
should be considered. In an official letter from the National Board of Forensic
Medicine to the Ministry of Justice in 2003 the Board proposed a change in the Burial
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Law as follows: “The police authority shall inform the Taxation authority about the
case of death and after (the investigation that is needed) police investigation and a
forensic examination deliver the death certificate to the Taxation authority together
with permission to interment or cremation”. Such a change would ensure that a forensic
examination in any form, whether external examination or autopsy, would be
performed in all deaths reported to the police.
Finally it is worth considering the need for a more logical and coherent new “Law of
Death Investigation”. This should include the rules in the Burial Law about death
certificate, cause of death certificate and reporting of deaths to the police and in the
Autopsy Law about clinical autopsy, forensic external examination and forensic
autopsy. The further regulation about reporting to the police today to be found in the
regulations by the National Board of Health and Welfare should be elevated to the law.
A suggested disposition would be to have one section dealing with clinical death
investigation comprised of the external clinical examination and clinical autopsy and
one section about the forensic death investigation consisting of external forensic
examination and forensic autopsy. The suggested new disposition would then be similar
to the Danish and Finnish legislations.
Borttaget:
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