Article

Dear Editor,

this editorial aims to tackle a relevant topic such as perinatal foetal autopsy. To this end, a few answers have been developed and summarised that we are often required to offer when specific questions are raised under urgent circumstances. Hence its title ‘Answers by phone’.

Preliminarily, it should be pointed out that foetal autopsy procedures are not yet fully established in all healthcare facilities. This is due to the small number of cases referred to them or the lack of interest in foeto-perinatal pathology as a whole by both too many pathologists and some gynaecologists.

Undeniably, foetal autopsy involves high costs in terms of time and resources; it needs to be integrated with other disciplines – i.e. forensic medicine, genetics, imaging, microbiology, for which quite a complex organization would be required. Also undeniably, disaffection of many pathologists with this type of autopsy is growing.

In fact, according to many pathologists, foetal autopsy requires a significant amount of (both medical and technical) time and energy for a diagnostic finding that falls outside the current trends not only, and no longer, of surgical pathology but, to a much greater extent, of immunohistochemistry and bio-molecular sciences.

In the above roughly sketched overview, there are a number of interpretation uncertainties, while erroneous beliefs have taken root, and inappropriate or even outright wrong behaviour is being consolidated.

On the other hand, some departments, belonging to general hospitals, are second level centres where numerous cases diagnosed in gynaecology units with ultra-specialist ultrasound equipment are referred to.

These two opposing situations contribute – in no small measure – to confusion and disorientation among operators as well as next of kins.

In other words, we could say – metaphorically – that the situation is the same as the one examined and investigated in relation to birth centres, where very different and sometimes critical circumstances arise depending on the number of performed deliveries.

In this paper, only the most common questions and the most general topics will be dealt with, in order to fill a gap and unify attitudes on a relevant public health issue that is often likely to hinder a proper implementation of a regular diagnostic plan in Italy.

For ease of reading and reference, to maintain the chosen approach, 15 bullet points will be summarised and proposed.

1) The Italian Mortuary Police Regulations, although very old (1990) ¹, are the applicable regulations in these cases.

Article 37. 1. Without prejudice to the powers of judicial authorities, the corpses of people who have died without medical assistance and have been taken to a hospital or to a waiting mortuary or morgue, as well as the corpses of people who have died in hospitals, university hospitals and private nursing homes, shall undergo an autopsy examination in compliance with the provisions of Law No. 83 dated 15 February 1961, when so decided by the respective directors, chief physicians or attending physicians, in order to confirm the diagnosis or clarify any clinical-scientific questions.

The above regulation, in a concise and straightforward manner, identifies the purpose of an Autopsy Examination (AE) and the individuals who may request it.

On this matter, it is worth mentioning that new long-awaited and hoped-for Mortuary Police Regulations, the text of which has already been drafted, agreed upon, amended and refined, has been awaiting approval by the Italian Parliament for many years.

2) A foetal autopsy is compulsory under the Prime Minister’s Decree dated 9 July 1999 ².

All foetal autopsies, irrespective of whether they are performed after a late miscarriage (LM) (Note: the Italian text improperly uses the term ‘abortion’. From a legal point of view, the expression ‘termination of pregnancy’ would be more correct, since the word abortion implies a felony), or following a voluntary termination of pregnancy, are regulated by the Prime Minister’s Decree dated 9 July 1999 ². The Decree is entitled: “Guidelines and Coordination to the Regions … on Investigations Useful for the Early Diagnosis of Malformations and for Mandatory Checks for the Detection and Timely Treatment of Congenital Hypothyroidism, Phenylketonuria and Cystic Fibrosis”. Article 2 of the Decree states: “ … (omissis) … In the case of stillbirths, autopsy examinations shall be performed, together with history taking as determined during the medical and, if deemed necessary, instrumental examinations, and the taking of photographs … (omissis)…”.

In other words, under the Prime Minister’s Decree, autopsies must be performed on the products of conception at any gestational age. It is a legal obligation and not a choice of the gynaecologist who, otherwise, would be violating a specific legal provision.

3) Autopsy under certain special circumstances

In 2006, a law was enforced entitled: “Provisions Regarding Autopsy Examinations on Victims of Sudden Infant Death (SID) and Unexpected Foetal Death” ³, which would finally address an important legislative void.

A particular category of autopsy examinations concerning sudden foetal and infant death is covered by this law.

As to the foetus, these post mortem investigations apply to intrauterine deaths, after the 25^th week of pregnancy, occurring without any warning signs, in a perfectly healthy mother, and despite a regular pregnancy. In this sense, it should be made clear that the term ‘sudden’ does not refer to time only.

Conversely, as to infants, they apply to the sudden death of apparently healthy babies within 12 months of age, in this case too, without any warning symptoms or signs of illness.

The operational protocols to be followed for this particular category of AE is defined by a Decree of the Ministry of Health dated 7/10/2014, published in the Official Gazette on 22 November 2014, entitled ‘Diagnostic Protocols in Cases of Sudden Infant Death and Unexpected Foetal Death’ ⁴.

In a note dated 19/12/2014, entitled: ‘Adoption of Diagnostic Protocols regarding the Law dated 2 February 2006’, the Ministry of Health – through the Directorate General for Health Prevention – drew attention to the Decree Law published on 22 November 2014 ⁴, emphasising the urgency and obligation to move to an implementation phase. The role of the Regional and Autonomous Provinces’ Health Departments was also better clarified.

Currently, a Pathway is defined that can be briefly outlined as follows: following the death, without apparent cause, of a foetus after the 25^th week of pregnancy or of an infant within their 12^th month of life, the gynaecologist or the doctor who establishes death initiates the following process (unless the body has been made available to the judicial authority or following the latter’s issue of a burial permit if there is no judicial involvement), namely they shall:

Request the parents’ consent to the autopsy examination as provided for by Law 31/2006 ³ using the relevant informed consent form, to which a copy of both parents’ ID must be attached.

Fill in the Form entitled ‘Request for Autopsy Examination for Foetuses > 25 weeks or Infants within the 12^th Month of Life Who Died without Apparent Cause’.

Fill in the ‘Medical Certificate’ for stillbirths or deaths in the first year of life.

As soon as possible, send the original documents mentioned above to the Health Directorate of the Health Unit to which the Pathological Anatomy Unit appointed as Regional Reference Centre belongs.

Procedure Identification and Description:

Under Article 1 of the Law dated 2 February 2006 ³, infants who suddenly die within one year of life without apparent cause and foetuses who die, also without apparent cause, after the 25^th week of pregnancy shall promptly undergo – with the consent of both parents – an Autopsy Examination.

The Autopsy Examination shall be performed in compliance with a protocol featuring a very long and thorough autopsy examination.

Upon autopsy completion, the doctor shall immediately release the body to the family and may still conduct further investigations in the following weeks.

The autopsy shall be carried out by specialists ensuring corpse integrity and a proper reassembly after post mortem examination.

Even if both parents refuse to give consent to an autopsy on their child according to the SIUD protocol, the obligation laid down by the mortuary regulations currently in force (the aforementioned Presidential Decree No. 285/1990) ¹, under which no corpse may be buried without a cause of death, shall apply. Therefore, even in this case, a standard autopsy shall be conducted, to which relatives cannot object.

4) The autopsy examination is usually requested

The above-mentioned Mortuary Police Regulations identify the place and people responsible for requesting the autopsy examination on all: “… people who have died in hospitals, university hospitals and private nursing homes, when the autopsy examination is ordered by the respective directors, chief physicians or attending physicians, in order to confirm the diagnosis or clarify any clinical-scientific questions”.

We believe that the key term is ‘attending’ physicians, i.e. doctors who have not only established a trustful relationship with the patient or the patient’s family, but who have undertaken a proposed, outlined, accepted, and shared course of treatment.

Autopsy, in this light, is an integral part of the care pathway.

“Art 37-3. The autopsy examination shall be conducted in the presence of the head physician or attending physician, and, if the latter deems it necessary, in university hospitals or hospitals, by the university or hospital pathologist, or by another expert medical officer in charge of the service.”

This further explanation clearly establishes the role of the post-mortem examination as a moment of care with the joint participation of pathologists and attending physicians.

The attending physician may participate either directly (i.e. by taking part in the autopsy) or indirectly, by providing the medical records, and later discussing the case with the pathologist.

The meetings provided for by Quality Systems on ‘Incident reporting’ or the different types of Audit required by the various healthcare organizations are designed to meet the above objectives.

5) Failure or omission to request an Autopsy Examination

Failure to request an autopsy examination deemed useful and, as mentioned, almost always mandatory, due to pressure by family members amounts to an omission proper and constitutes a breach of duty, involving multiple offences and ethical violations: omission of official acts, interruption of a public service, failure to comply with rules and regulations, etc.

On the other hand, the AE is a diagnostic tool at the service of patients and – more extensively – of their families. The usual practice of not requesting an AE must, therefore, be strongly condemned: while depriving the family of a diagnostic tool, it also exposes the healthcare facility, as well as all involved professional, to the risk of future litigation for failure to complete the care pathway, or even for raising the doubt that it was intended to silence and hide unacceptable or inappropriate behaviour.

Further, this conduct is likely to have repercussions in terms of professional liability, since a family is being deprived of the right to a diagnosis.

6) Can parents request an autopsy when not already requested by the doctor/hospital and can a doctor they trust attend it?

Law No. 24 of 8 March 2017 entitled “Provisions on the Safety of Care and Patients, as well as on Professional Liability of Healthcare Professionals” ⁵ – more commonly known as the Gelli-Bianco Law – in Art. 4 paragraph 4, provides for the addition to Article 37 of the Mortuary Police Regulations, referred to in Presidential Decree No. 285 dated 10 September 1990 ¹, of the following paragraph 2: “2-bis. The next of kins of the deceased or other entitled persons may agree with the medical or social-health director on performing an autopsy examination, whether the person died in a hospital or elsewhere, and may arrange for the attendance of a doctor they trust”. Hence, the answer to both questions is “Yes”.

7) Who can cancel the request for an autopsy examination?

The request can be cancelled only by the attending physician who had requested and signed the Autopsy Request Form in the first place.

The request for cancellation shall be substantiated by a well-reasoned and documented opinion. Since the autopsy is conducted for diagnostic purposes, i.e. “for clarifying clinical questions”, also laboratory tests or other types of diagnostics may actually provide explanations as to the causes of death or the course of the disease that were not known at the time the autopsy was first requested.

8) Who can object to the autopsy examination?

Under applicable law, no one can object to an autopsy examination, except for a Judge who may require the seizure of documents and place the corpse of the foetus or of the deceased infant under judicial authority. In particular, not even close relatives or any other next of kin may object to an autopsy being performed, nor may other public officials do so, including medical directors.

Much confusion on this specific issue was caused by the entry into force of the Law dated 2 February 2006 ³ on sudden infant death. In this law, as already mentioned, the parents’ consent to perform an autopsy is explicitly required (Art. 1 paragraph 1: “Infants who die suddenly within a year of life without apparent cause and foetuses that also die without apparent cause after the 25^th week of pregnancy must promptly undergo an autopsy examination, with the consent of both parents, which will be carried out in authorised centres, in accordance with the criteria identified in Article 2, and where the removed organs shall be sent”).

However, with a more careful interpretation of the rule, this authority clashes against the current mortuary regulations. As a matter of fact, parental consent does not refer to the performance of the autopsy per se, but rather to performing it according to the protocol established by the 2006 Law ³. This law provides for tissue and blood samples to be stored in a biobank, genetic testing and, above all, data management by a regional and national system.

In other words, while parents may object to the autopsy being performed on the foetus or newborn child according to the protocols published in 2014 (supplementing the 2006 Law)⁴, they cannot do so if the autopsy examination is conducted according to conventional procedures laid down in the operating instructions (so called Hospital’s Diagnostic-Therapeutic Pathways - PDTA) of the individual operating units.

9) Observation period

The Mortuary Police Regulation ¹, in Chapter II - Article 8 - states:

“No corpse shall be closed in a coffin, nor undergo autopsy, kept in cold storage, nor interred, buried, cremated, before 24 hours have elapsed from the time of death, except when the body is decapitated or mangled, and except when the necropsy doctor has ascertained death also with the aid of an ECG with minimum recordings of 20 minutes, without prejudice to the provisions of Law No. 644 dated 2 December 1975, as amended”.

Article 9 states: “In cases of sudden death and states of apparent death, the observation period shall be extended to 48 hours, unless death was ascertained by the necropsy doctor in the manner provided for in Article 8”.

Article 10 states: “Where death was due to an infectious-diffusive disease included in the special list published by the Ministry of Health, or the corpse shows signs of commencing putrefaction, or when so required by other special reasons, on the proposal of the Health Coordinator of the Local Health Unit, the Mayor may decrease the observation period to less than 24 hours”.

It is, thus, clear that a period of observation is necessary before proceeding with the autopsy examination. This rule applies to all individuals and, in the case of perinatal foetal pathology, to live births (with the caveat that, within the first year of life, the observation period shall be extended from 24 to 48 hours).

The debate on ‘stillborn’ is more intense. In these cases, an observation period before proceeding with the autopsy seems quite unreasonable, also considering that:

1. death was already ascertained with appropriate equipment before inducing labour (if it were not ascertained, it would be a miscarriage);
2. in many cases, initial phenomena of transformation are triggered by prolonged post mortem retention in uterus, all of them fully contemplated by the law (it is not putrefaction proper, since an intact amniotic environment is, by definition, sterile).

That being said, it is worth remembering that an ECG performed for 20 minutes obviates the need to wait, whenever a delay in performing an AE could hinder a diagnosis of the cause of death.

10) In order to overcome hostility and mistrust, communication and the physician-patient relationship are key to effective dialogue with relatives. At this stage, it is necessary to clearly and firmly explain to them that the autopsy is useful and mandatory. At the same time, its execution must be motivated with a view to ensuring continuity of care that will not end with the foetus or the newborn, but will be involving the rest of the family, and be particularly aimed at protecting the health of other children or of any future pregnancies.

11) Assumed criminal offence charges determined by AE

If, while carrying out the autopsy examination, the pathologist detects evidence raising a reasonable suspicion that the death was by unlawful means, or evidence of any traumatic injuries or complications of surgery, or of previous doubtful autopsy examinations, they shall immediately discontinue the autopsy and inform the healthcare facility’s manager accordingly, which in turn shall notify the judicial authority concerned (Mortuary Police Regulations “Art 39-3. When there is a reasonable suspicion that the death was by unlawful means, the doctor in charge shall stop all operations and immediately inform the judicial authority”).

In fact, in this case, the doctor is required to report and submit the finding to the judicial authorities. Failure to do so will result in criminal liability.

12) Requirements for foetal autopsy ^6,7

The autopsy examination shall always be complete (i.e. full autopsy) and entirely performed by the same medical examiner.

A codified and validated observational and diagnostic protocol shall be applied (detailed Diagnostic Therapeutic Care Pathway).

The placenta shall always be examined to get a complete view of the foetal-placental unit.

A benchmark network shall be available, and, in particular a Reference Centre for a Second Opinion shall be identified.

The aim of such path is to:

Establish a diagnosis.

Rule out any liability (litigation against operators, suspicions about the family, etc.).

Enable a care pathway.

Care pathway for the mother, the couple, the family

Monitoring future pregnancies.

Protecting the mother’s health.

Seeking the couple’s well-being.

13) A post-autoptical meeting (in Italian: Incontro post-autoptico) with parents shall be scheduled in order to explain the results of performed investigations and provide all the necessary information from a family health protection perspective.

This practice, or, rather, opportunity, called ‘post autoptical meeting’, was introduced in the United States many years ago.

Its Italian equivalent (Incontro post-autoptico) perhaps gives a better idea of a dialogue between people bound by a fiduciary relationship. Under this care contract with a hospital facility, patients entrust the latter with the body of the product of conception which will be handed over to the pathologist under a fiduciary bond. Its purpose is to understand what happened, and any likely consequences for the mother’s health; to better plan future pregnancies with successful births outcomes, and, last but not least, to possess accurate and useful information for coping with grief.

A parents’ meeting with clinicians (gynaecologists) is certainly due and important. However, the preliminary meeting with the pathologist, when, in simple terms, the events, the findings of the examinations, and the conclusion of the autopsy investigation will be explained, has a very strong and, in some ways, different value.

The pathologist is – indeed – the ultimate ‘super partes’ doctor deemed to be more objective and detached from the events in analysing what happened. This added value significantly reduces misunderstandings, mistrust, and suspicion. At the end of the day, it is key to containing further unmotivated disputes linked to the natural and inevitable feelings of despair and anger experienced after a grievous event.

Obviously enough, preparation for the meeting with the clinician is one of the topics of this meeting, which may also be attended by other specialists: geneticist, endocrinologist, nephrologist, etc.

Finally, the meeting with the pathologist marks the conclusion of a process that had ideally begun with a letter delivered to the relatives informing them of the need to perform an autopsy.

We generally deliver a letter where we basically state the purpose of the autopsy, and provide information on the medical examiner who will be carrying out the post mortem investigations and set the date for the autopsy to be performed.

The purpose of this letter is essentially to ‘give a face and a name’ to the ‘ultimate’ doctor, thus making the whole diagnostic procedure less impersonal, to set a timeframe, and also mention that a post-autoptical meeting will be held.

In other words, a post-mortem should not be seen as a mere imposition, but as a key contribution to a family’s health journey, also by tailoring it to the family’s needs.

14) Reassembly and Preparation of the body

Reassembling the body after a post-mortem examination is one of the least-explained issues, yet of great relevance to medical staff and next of kins alike.

Pathologists, assisted by autopsy technicians (with postgraduate master degrees in autopsy techniques) are required to prepare the body in the best possible way. Preparation means, first and foremost, returning the individual organs back to the corresponding body cavity and stitching up the incisions made during dissection. This is in accordance with the law. Pursuant to the aforementioned Mortuary Police Regulations ¹, Article 37, paragraphs 3 and 4: “… avoiding mutilations and resections that are not necessary to ascertain the cause of death” as well as “the corpse must be reassembled with the best care”.

Failure to comply with the above rules may constitute one of the crimes specified by the Criminal Code, in Book II - Title IV, such as crimes against the piety of the deceased. More specifically, it may involve the crime of vilification of the corpse – for example, in case of improperly sutured resection lines, or returning a poorly washed or reassembled body after post-mortem –, and unlawful use of a dead body.

It is, therefore, a carefully established and defined obligation guaranteeing a procedure that must be fully respectful of the body, the person, and what they represent.

For the next of kins, being assured that the body – whether foetus or newborn – is correctly laid out, it is part of the difficult process of accepting an autopsy and coping with grief. Banishing the idea of a destructive and bloody examination is one of the tasks of those who are in charge of carefully explaining to relatives what the autopsy to be performed is all about.

Under funeral or simple burial rituals, in most cases, the dressing of the body should be provided and, upon request, even the possibility to see it in the full dignity of the human person.

15) Finally, it must be remembered that, on request of parents, the burial of foetuses must be guaranteed at any gestational age ⁸.

This rule, contained in Article 7 of the Mortuary Police Regulations ¹, states: ‘On request of parents, products of conception of an alleged age of less than 20 weeks may also be buried in a cemetery under the same procedure’.

Hospital facilities must be aware of this provision and include it in the operating instructions as a supplement to grief support procedures.

References

1. Presidential Decree. “Approval of Mortuary Police Regulations”. 1990.
2. Prime Minister’s Decree. “Guidelines and Coordination to the Regions … On Investigations Useful for the Early Diagnosis of Malformations and for Mandatory Checks for the Detection and Timely Treatment of Congenital Hypothyroidism, Phenylketonuria and Cystic Fibrosis”. 1999.
3. “Provisions regarding Autopsy Examinations on Victims of Sudden Infant Death (SID) and Unexpected Foetal Death”. 2006.
4. Decree. “Diagnostic Protocols in Cases of Sudden Infant Death and Unexpected Foetal Death”. 2014.
5. “Provisions on the Safety of Care and Patients, as well as on Professional Liability of Healthcare Professionals”. 2017.
6. Facchinetti F, Monari F, Buffelli F. Mandatory examinations to understand causes of stillbirth: the key role of autopsy and placental analysis. Ital J Gynaecol Obstet. 2023; 35:4-7. DOI
7. Fulcheri E, Bulfamante G, Resta L. Embryo and fetal pathology in routine diagnostics: what has changed and what needs to be changed. Pathologica. 2006; 98:1-36.
8. Fulcheri E, Buffelli F, Fiore C, Izzotti A. Considerations about the burial of foetuses of less than 20-weeks gestational age. Pathologica. 2022; 114:238-420. DOI