To Err is Human: Post Mortem of the recent Max controversy

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“A premature (22 weeks) newborn was allegedly declared dead. While being taken for the funeral, the newborn was discovered to be alive, put on life support system, and died after 5 days. His twin was stillborn.”

This was a ‘medical error’ caused due to wrong diagnosis and declaring a newborn dead in the presence of hypothermia. This amounts to professional incompetency and it is for the MCI or State Medical Council to take necessary action against the concerned doctors.

Clinical death vs permanent death is a concept that started after the introduction of CPR in the country. A similar mistake occurred in Safdarjung hospital in June 2017, that of terming clinical death as brain death. In clinical death, the person may have no signs of life, but the brain remains alive for 10 minutes in routine deaths and for few hours in hypothermia. CPR during this period can revive the heart.

There is always opportunity in adversity and the same is true for this incident as well. Measuring rectal temperature in newborn is not currently the practice. However, in view of this incident, measuring rectal temperature should now become part of the protocol adopted before declaring a newborn dead. This will ensure that no patient is declared dead under conditions of hypothermia.

Mistakes or errors are a part of clinical practice. They should be accepted as there is always a lesson in them. However, with knowledge, we can learn more about how to avoid them.

This was, however, not a case of criminal negligence.

For this incidence to be called criminal negligence and to apply Section 308, there should have been an intention to declare an living baby dead or the knowledge that the baby was alive. According to me, the doctor on duty was unaware that the baby was alive.

Even today, not everyone knows that in hypothermia, the brain can remain alive for few hours.

I personally feel such mistakes will continue to happen until widespread dissemination of this knowledge is undertaken.

Are medical errors common?

The Institute of Medicine released their landmark report To Err Is Human in 1999 according to which 98,000 people die in US hospitals every year from preventable medical errors.

In 2013, there were about 400,000 deaths from preventable medical errors. Today, 1.7 million Americans are victims of preventable medical errors, which lead to as many as 440,000 deaths annually. In India, the number is likely to be higher.

Was this mistake avoidable?

I feel mistakes occurred at every level. The first one was by the first junior doctor, second by nurse, third by the senior nurse, and lastly by the consultant. If the child was alive, at least one of them could have noticed.

It’s clear that the child had no heart beat and hence the error in judgment.

Also, the very fact that all concerned missed the diagnosis of alive brain indicates the level of ignorance and absence of established protocols in the medical society.

IMA has since issued an advisory to make sure that all practitioners are aware of this fact. It is also creating guidelines regarding declaring death in hypothermia cases.

Doctors and nurses also make mistakes as a part of their learning curve. Only bad doctors sexually molesting patients, stealing drugs, or making a wrong diagnosis with no insight need to be punished.

Definition of abortion

As per the Medical Termination of Pregnancy Act, termination of a pregnancy at 20 weeks is an abortion and delivery after 20 weeks and before 37 weeks is a premature delivery.

What is prematurity?

Prematurity is defined as a birth that occurs before the completion of 37 weeks (less than 259 days) of gestation. It is associated with approximately one-third of all infant deaths and accounts for about 45% of children with cerebral palsy, 35% of children with vision impairment, and 25% of children with cognitive or hearing impairment.

The risk of complications increases with increasing immaturity. Thus, infants who are extremely preterm (EPT), born at or before 25 weeks of gestation, have the highest mortality rate (approximately 50%) and if they survive, they are at the greatest risk for severe impairment.

What is fetal viability?

A fetus delivered after 28 weeks or one with a weight > 900 gram is a viable fetus; no consent is required for active resuscitation (surfactant and ventilator if required)

What about 20-28 weeks?

Today 20-28 weeks means extreme prematurity. The fetus must be put on warmer and symptomatic therapy. It is a norm to not put the fetus on ventilator. However, if the parents insist on placing the 22-week-old baby on ventilator, the doctors can find it extremely hard to refuse. The process should then be carried out only after informed consent. In cases the patient cannot afford, he or she must be transferred by the private hospital under supervision to a government hospital with nursery facility.

Classification of prematurity

Preterm infants can be classified according to gestational age (GA) as follows.

  • Late preterm birth: GA between 34 and 37 weeks
  • Very preterm birth: GA less than 32 weeks
  • Extremely preterm birth: GA at or below 28 weeks

Preterm infants are also classified by birth weight.

  • Low birth weight (LBW): Less than 2500 g
  • Very low birth weight (VLBW): Less than 1500 g
  • Extremely low birth weight (ELBW): Less than 1000 g

When to declare death?

No death to be declared in presence of hypothermia.

What is hypothermia?

A core body temperature of 90-95°F (32 to 35°C) is mild hypothermia, 82 to 90°F (28 to 32°C) is moderate hypothermia, and below 82°F (28°C) is severe hypothermia.

In about 14% of premature babies, core body temperature below 35°C is common.

Can a fetus appear dead when it is not?

In severe hypothermia, cold slows or stops the metabolic machinery underlying body function. The metabolism slows by approximately 6% for each 1°C (1.8°F) decrease in body temperature, such that at 28°C (82°F), the basal metabolic rate is approximately half of normal. At this temperature, all body systems begin to fail including circulation, ventilation, and the central nervous system. Patients often lose consciousness and vital signs may be absent. Muscle rigidity without shivering can be mistaken for rigor mortis. The absence of shivering and presence of stupor, skin flushing, muscle rigidity, hypoventilation, and circulatory failure means very cold patients often appear dead rather than hypothermic. This may partly explain why many severely cold patients are pronounced dead without consideration of hypothermia.

However, in this stage of severe hypothermia (core temperature <28°C or 82°F), a suspended metabolism may protect against hypoxia. There have been cases of patients surviving anoxia for 12 to 18 minutes at 28°C (82°F) and up to 60 minutes or more at 20°C (68°F). Intact recovery has been reported after submersion for up to 66 minutes, after hours of arrest without cardiopulmonary resuscitation (CPR), after CPR for as long as six and a half hours, and with total resuscitation times up to nine hours.

Thus, recognition of hypothermia in such patients may sometimes permit successful recovery despite prolonged arrest. Only with such recognition can the patient benefit from rapid, effective rewarming, and vigorous support.

How a doctor from Oxford, ‘Dr Amit Gupta’, would have managed a 22-week-old baby?

A 22-week preterm birth is not viable for life

Firstly, as a neonatologist, I would not expect to be called in to attend the delivery of babies that are preterm.

To put it in context, when a mother carries her baby for 9 months, it is a 40-week gestation period. Survival at 22 weeks gestation is only about 3% in the UK and 5% in the US.

These babies, weighing anywhere between 250 grams and 500 grams, are extremely fragile and have such severely immature organ systems that current technology struggles to transition them to full maturity. It is accepted practice to not offer resuscitation at 22 weeks. This may change in the future, but for now, the prognosis is grim for babies born at 22 weeks.

I would talk to parents and explain.

Before delivery, however, our obstetric staff would counsel the parents on the abysmal outcome of babies born so prematurely. Many would not even survive the process of labor. However, if they did, parents would be offered support and may choose to hold the babies, to stay with them, and take their time to say their prayers and goodbyes.

For a baby born alive, the parents would be explained that the babies might continue to show signs of life for several minutes or even hours.

Though it may sound shocking, we do come across cases where the heart rate is so faint after birth, the breathing so shallow and intermittent, that the doctor attending the delivery presumed that the baby is dead.

So, while it is crucial that the healthcare professional is 100% sure before death is pronounced, there have been cases where death has been falsely presumed.

Should babies be handed over in a plastic bag?

No. This reflects a poor attitude towards human dignity and the lack of empathy towards the enormous tragedy befalling the parents. Even if parents consider the death of a baby at 22 weeks as a miscarriage and choose to not carry out final rites, the body should be handed over respectfully. However, in this case, the plastic bag probably provided the warmth needed to revive the baby.

What is the answer?

The answer to such situations is: Fix the culture.

  • Communicate, communicate, and communicate
  • Compassion should be demonstrated in practice as much as in feeling. Health care is compassion and everything else stems from it. A compassionate attitude of staff in clinical medicine is more important than all the brilliant CVs, flashing monitors, and state-of-the-art equipment put together. The poor/inconsiderate/uncompassionate communication is at the core of why patients sue. A programme, which embeds a culture of transparency, openness and compassionate communication, makes both moral and financial sense.
  • Call relatives, meet them if they are willing, and then listen to them. When you think you have listened enough, listen some more (and switch your mobile phone off when you do!). Apologize for the pain they have undergone. Dont indulge in non-apology. An apology is not an admission of guilt, but an acknowledgment of the pain they have been through. And tell them what you would do so that other parents dont go through this experience.

Dr KK Aggarwal

National President IMA

Who can give consent?

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Dr KK Aggarwal

Informed consent is an integral and crucial part of medical treatment today. It is not only a procedural requirement, but also a legal requirement. Not taking consent is gross negligence. Consent has to be taken before starting a treatment or a procedure.

For consent to be valid, it should be voluntary i.e. given without coercion, informed and the patient should be competent to understand the information given.

Consent indicates a respect for patient autonomy, a very important principle of medical ethics. This means that patients have the decision making capacity and doctors need to respect their right to make decision regarding their care. And, no doctor treats a patient without informed consent.

Who can give the consent?

Informed consent must ideally be taken from the patient himself/herself.

In a traditional Indian setting, if the husband is hospitalized, the wife, at times, may not be taken into confidence by the relatives about the gravity of the situation or otherwise. Most often, it is one of the family members who usually sign the consent in such cases.

If the patient is unconscious, then the spouse should authorize one person as a legal heir to take legal decisions, in case the spouse does not want to take decisions or is not informed.

In an emergency situation when the patient is not able to give consent, then treatment may be given without consent, if there is no other person available to give consent. But, the onus lies on the doctor to prove that the treatment given was lifesaving. The facts of the case must be documented.

The Medical Council of India (regulation 7.16) states that “Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed”.

The MCI should revisit the regulation 7.16 and come out with a clause of “next of kin” consent or “surrogacy” consent, which should also include “all legal heirs” and not just one as part of the consent.

Disclaimer: The views expressed in this write up are entirely my own

Can NRI doctors barred abroad work in India? IMA writes to MCI

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At Delhi High Court, a bench of Acting Chief Justice Gita Mittal and Justice VK Rao, took a suo moto note to examine the issue whether Indian-origin doctors, barred from practicing by a foreign country, can practice in India?

Based on news reports that an Indian-origin doctor, who has been barred from practicing by a US court, is now treating patients in Delhi and Gurgaon, the court directed the member secretary of Delhi State Legal Services Authority, Sanjeev Jain, to verify the name and address of this doctor, carry out an immediate probe and file a report within four days; issued notice to the MCI to file a report on the mechanism, statutory regime as well as rules and regulations in place to scrutinize and check such practices and also made Ministry of Health and Family Welfare a party. The next date of hearing was on May 15.

As per the US court, the doctor has been ordered “not practice medicine in any form within the United States or any other country”

IMA Response: IMA is for a defined policy in such cases. IMA wrote to the MCI on 9th in this regard.

To
The President
Medical Council of India
New Delhi

Sub: imposing the condition of Good Standing Certificate for those who are Registered with registering authorities in other countries

Respected Madam

Greetings from Indian Medical Association!

We deem it fit to bring it to your kind notice that any Graduate or Post Graduate from our country whenever intends to register with registering authorities for practicing modern medicine in the concerned countries, he/she is required to furnish a Good Standing Certificate for their verification issued by the Medical Council of India.

This is solely to ensure that the concerned registered medical practitioner has a good track record and there is nothing against him/her, especially with reference to ethical breach and/or violation. In the same breath and vein, it is necessary that a similar condition needs to be imposed for Indian doctors who are practicing in other countries after getting registered in that country and intend to come back to India.

Imposition of similar conditions would be required for Indian students getting their MBBS or equivalent course outside India and coming back for registration in India; foreigners to India and asking for temporary license to practice and also for Indian doctors seeking multiple registrations in different states.

This would mean that before they are registered or re-registered with the registering authorities in India, they will have to furnish the similar Good Standing Certificate as a condition precedent.

This will serve the similar purpose as the Good Standing Certificate issued by the MCI serves in respect of Indian Doctors seeking registration to the competent registering authority practicing modern medicine in foreign countries.

Hence the suggestion. We are sure that the required decision will be taken, in this regard for the enforcement by all concerned.

With kind regards

Dr KK Aggarwal
National President, IMA
Padma Shri Awardee

Dr RN Tandon
Hony Secy General, IMA

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