MANAGEMENT OF NEONATAL INTENSIVE CARE UNIT (NICU)

& ACCOUNTABILITY UNDER THE

LAW

Dr. Rajneesh Kumar Patel Associate Professor Faculty

of Law, B.H.U.

WHAT IS THE

NEONATAL INTENSIVE CARE UNIT (N.I.C.U.)

?

The NICU is life saving unit of the Hospital, any newly born babies who needs a very special type of care or intensive medical attention and admitted into a special area of the hospital called the Neonatal Intensive Care Unit (NICU). In this unit one can find advanced technology and trained healthcare professionals to provide specialized care to the babies.

WHICH BABIES NEED N.I.C.U. ?

generally, premature babies requirs NICU or low birth weight babies or any other medical condition which requires special care and attentions by medical professionals.

Reasons for NICU

◦ If mother is younger than 16 or older than 40 years, or◦ Alcohol user, or◦ Diabetic patient, or◦ Hypertension, or◦ any Bleeding, or◦ Suffering from sexually transmitted diseases.◦ In case of multiple pregnancy, or◦ Inadequate amniotic fluid.

◦ In case of changes in organ systems due to lack of oxygen.◦ Breech delivery presentation or other abnormal

presentation.◦ The Baby's First Stool Passed during pregnancy into the

Amniotic Fluid, known as Meconium.◦ Cord around the Baby's Neck.

◦ Birth at Gestational Age less than 37 Weeks or More than 42 Weeks◦ Birth weight less than 2,500 Grams (5 Pounds, 8 Ounces)

or Over 4,000 Grams (8 Pounds, 13 Ounces)◦ Small for Gestational Age.◦ Medication or Resuscitation in the Delivery Room◦ Birth Defects.◦ Respiratory Distress including Rapid Breathing, Grunting,

or Stopping Breathing.◦ Infection . ◦ Hypoglycemia (Low Blood Sugar)

WHO WILL CARE FOR BABY IN THE NICU

It is a team work and this groups includes, Neonatologist , Neonatal nurses and other staffs.

Member of this group should be a man of special training, skill, and knowledge in the care of newborn babies.

In advance system the members of the NICU team are also working together with parents to develop a plan of care for high-risk newborns.

STRUCTURE OF N.I.C.U.

This unit should be well organized and advance unit in comparison with other wings of the hospital. It should contain all necessary equipments and proper facilities.

It includes adequate number of following equipments: Resuscitation set. Open care system. Incubators. Infusion pumps. Positive pressure ventilators. Oxygen hoods, oxygen analyzers. Heart rate – apnea monitors with scope. Phototherapy unit.

Cont………

Electronic Weighting Scale. Pulse Oxymeters. End tidal CO2 monitor .

Transcutaneous PO2 & PCO2.

Noninvasive B.P. monitors. Invasive B.P. monitors. ECG monitor with defibrillator. Intra cranial pressure monitor. Portable radiographic machine. Portable ultrasound machine. Blood gas analyzer.

•IV Catheters•IV Sets•Micro Burette Sets•Bacterial Filters•Feeding Tubes•Endotracheal Tubes•Suction Catheters•Three-way Stopcocks•Extension Tubing•Umbilical Arterial And Venous Catheters•Syringes, Needles•Trocar And Cannula

Cont………

ESTABLISHMENT AND CONDITION OF N.I.C.U.

The N.I.C.U. should be established closer to the labour

rooms and operation theatre.

There should be proper sunlight and ventilation of fresh air.

There should be proper space for concerning of patient,

keeping the essential equipment and for movement of

doctors, nurses, other staff.

Cont………………

There should be proper arrangement of uniform and shadow-free lighting .

The temperature should be adequate inside the unit. The unit should also have an intercom & a direct outside

telephone line . There should be round-the-clock power back up including

provision of UPS system.

NURSES

Nurse : patient ratio of 1:1 must be maintained 24 hours.

In addition to basic nursing, staff nurse need to be trained in handling equipment, use of ventilators and initiation of life-support like use of bag and mask resuscitation, endotracheal intubations, arterial sampling and so-on.

The staff must have a minimum of 3 years work experience in special care neonatal unit.

STAFF

A full time neonatologist. (One neonatal physician is required for every 6-10 patients)

At least two resident doctors should be present in the unit round-the-clock.

Pediatric Surgeon, Pediatric Pathologist and Respiratory Therapist, Laboratory Technician, Public Health Nurse or Social Worker, Biomedical Engineer are very much essential persons in establishment of a admirable quality of NICU.

RIGHTS OF THE PATIENT

Right to considerate and respectful care.Right to information on diagnosis, treatment and medicines.Right to obtain all the relevant information about the professionals involved in the patient care.Right to expect that all the communications and records pertaining to his/her case be treated as confidentialRight to every consideration of his/her privacy concerning his/her medical care programme.Right to expect prompt treatment in an emergencyRight to refuse to participate in human experimentation, research, project affecting his/her care or treatment.

GENERAL DUTIES OF MEDICO PERSONALS

Every doctor has some basic things to do :

1. He must listen to the patient and take proper history. 2. Examine him carefully. He must attend him or her personally and give diligent care. 3. He must explain the relevant facts related to the illness.4.He must advice proper medicines. 5.He must have average, recent knowledge and equipments in possession, as per their specialty. 6.He must be able to foresee the complications and refer the patient at proper time. 7.He must also maintain a proper record of their patients.

There are three types of law which may be applicable to the medical staff : 1.Statutory law, which are creation of legislators.2.Regulatory law or administrative law which are created by administrative bodies and it consists of rules and regulations.3.Judicial law , which are the decisions of mainly High Courts or Apex Court of India.

RESULT OF FAILURE

STATUTORY LAWS

1. INDIAN CONTRACT ACT, 1872.2. INDIAN PENAL CODE, 1860.3. CONSUMER PROTECTION ACT,1986.4. INDIAN MEDICAL COUNCIL ACT,1956.5. PRE- NATAL DIAGNOSTIC ACT, 1994.

REGULATORY LAWS

•Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002•Hippocratic Oath.•Declaration of Geneva.•Declaration of Helsinki.•International Code of Medical Ethics.•Govt. of India Guidelines for Sterilization.

JUDICIAL LAW

Decision of High Courts and Supreme Court.

REMEDIES AVAILABLE UNDER THE INDIAN LAW IN CASE OF MEDICAL NEGLIGENCE

(1) CIVIL SUIT BEFORE CIVIL COURT. (2) CIVIL SUIT BEFORE CONSUMER

COURT. (3) COMPLAINT BEFORE MEDICAL

COUNCIL. (4) CASE BEFORE CRIMINAL COURT.

WHEN DOES ACCOUNTABILITY ARISE?

It is well known that a doctor owes a duty of care to his patient. This duty can either be a contractual duty or a duty arising out of tort or civil law. This may be a criminal breach of duty for which penal action may be taken. In some cases, however, though a doctor-patient relationship is not established, the courts have imposed a duty upon the doctor. In the words of the Supreme Court “every doctor, at the governmental hospital or elsewhere, has a professional obligation to extend his services with due expertise for protecting life” (Parmanand Katra vs. Union of India).

LIABILITY UNDER CIVIL LAWS

1. Under Contract Act :

According to Sec. 70 of Indian Contract Act, when a patient goes to a doctor for medical treatment, he enters into an implied contract with the doctor that he will use reasonable professional skill and care in treating the patient. If the doctor doesn’t give complete or proper treatment or fail to fulfill this contractual obligation the patient can claim damage under Sec. 73 of the Act. Similarly, if the patient doesn’t pay the fees, doctors can file a civil suit. Doctors can take advances or deposits before starting treatment, but they can’t keep the patient in confinement on the ground of nonpayment of fees.

LIABILITY UNDER CIVIL LAWS

2 . Under Tort Law : If a doctor does not take reasonable degree of

care, which he is required to take under law and thereby causes injury to his patient, he can be sued under the law of Tort.

LIABILITY UNDER CIVIL LAWS

3. Under C. P. Act:

After 1995, the medical profession comes within the ambit of a 'service' as defined in the Consumer Protection Act, 1986.This defined the relationship between patients and medical professionals as contractual. Patients who had sustained injuries in the course of treatment could now sue doctors in 'procedure-free' consumer protection courts for compensation, even though services rendered by medical practitioners are of a personal nature they cannot be treated as contracts of personal service They are contracts for service, under which a doctor too can be sued….. Indian Medical Association v VP Shantha.

LIABILITY UNDER CRIMINAL LAW

If negligence is so blatant then it invites criminal proceedingsand on proof of negligence penal action may be taken against doctors. A doctor can be punished under Section 304A of the Indian Penal Code for causing death by a rash or negligent act, for example : where death of a patient is caused during operation by a doctor not qualified to operate. Some of the common sections of Indian Penal Code which are applicable to doctors include: Sec. 312-316 related to causing abortions or miscarriage without proper consent; Sec. 319-322 deals with causing grievous hurt, or disfigurement endangering the life; Sec. 340-342 related to wrongful confinement of patient; and Sec. 499 is related to defamation.

LIABILITY UNDER MEDICAL COUNCIL ACT

This Act provide for the constitution of a Medical Council of India. Under section 33 this council can set norms to regulate the conduct and behaviour for the medical practitioners.

The norms set by the council are mandatory and also followed by the State Medical Council.

WHAT IS THE DUTY OWED?

The duty owed by a doctor towards his patient, in the words of the Supreme Court is to “bring to his task a reasonable degree of skill and knowledge” and to exercise “a reasonable degree of care” (Laxman vs. Trimback).

The doctor, in other words, does not have to adhere to the highest or sink to the lowest degree of care and competence in the light of the circumstance. A doctor, therefore, does not have to ensure that every patient who comes to him is cured. He has to only ensure that he confers a reasonable degree of care and competence.

MEDICAL NEGLIGENCE

Under Indian law; medical negligence may be two types, civil wrong or criminal offence. For civil wrong compensation may be awarded and for criminal offence a doctor can be imprisoned.

NEGLIGENCE

In its general sense negligence means lack of proper care and attention or it is a carless behaviour.

It contain three things:1. A legal duty.2. Breach of this duty.3. Damage caused by breach.

WHAT IS MEDICAL NEGLIGENCE

There are three essential of medical negligence: The existence of a duty to take care, which is

owed by the doctor to the complainant. The failure to attain that standard of care,

prescribed by the law or administrative bodies or by judiciary.

Damage, which is both causally connected with such breach and recognized by the law, has been suffered by the complainant.

The court’s view:

BOLAM VS. FRIERN HOSPITAL MANAGEMENT COMMITTEE the Queen’s Bench Division of the British Court held that:

A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.

Cont………

Jacob Mathew vs. State of Punjab :

The standard of care, when assessing the practice as adopted is judged in the light of the knowledge available at the time (of the incident), and not at the date of trial. When the charge of negligence arises out of a failure to use some particular equipment, the charge would fail if the equipment was not generally available at that point of time on which it is suggested as should have been used. So long as a doctor follows a practice acceptable to the medical profession of that day, he cannot be held liable for negligence merely because a better alternative course or method of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure which the accused followed.

Cont…….

Therefore, a professional may be held liable for negligence when

a) He was not possessed of the essential skill which he professed to have possessed; [and/ or]

b) He did not exercise, with reasonable competence in the given case, the skill, which he did possess.

Dr. Suresh Gupta vs. Govt. of Delhi

a medical practitioner cannot be held punishable for every mishap or death during medical treatment. No criminal liability should be attached where a patient’s death results from error of judgment or an accident. Mere inadvertence or some degree of want of adequate care and caution might create civil liability but would not suffice to hold him criminally liable. The degree of medical negligence must be such that it shows complete apathy for the life and safety of the patient as to amount to a crime against the state.

Dr. Anand R. Nerkar vs. Smt Rahimbi Shaikh Madar

In this case the Supreme Court laid down following guidelines for prosecuting doctors:

1. A private criminal complaint should not be entertained unless the complainant has produced prima facie evidence in the court in the form of a credible opinion given by another competent doctor to support the charge of rashness or negligence.

2. The investigating officer, before proceeding against a doctor, should obtain an independent medical opinion preferably from a doctor in government service qualified in that branch of medical practice.

3. The accused doctor should not be arrested in a routine manner unless his arrest is necessary for furthering investigation or for collecting evidence or unless the investigating officer feels satisfied that the doctor will escape.

However ……………………………..

CONCLUSION

In ancient days, medical profession was considered to be a noble field. The patient’s faith and trust in doctors was so much that a doctor was equated to lord Vishnu. Gradually, this relationship is turning into a love and hate phenomenon. In this era, the focus of medical profession is progressing from a noble one to a commercial one. The cost of medical education, equipments, construction of clinics and hospitals are to some extent responsible for the commercial approach on part of doctors. Patients now are also more interested in facilities and good looking hospital rather then quality of care and competency of doctors. In this scenario, litigations related to medical practice are on the rise.

HOW TO AVOID COURTS?

If you wish to avoid such situation, attend all patients personally and carefully. Behave humanely, avoid rough, rude or inhuman behavior with the patients or their relatives. Communicate with the patient and take proper consent after explaining the condition. Documents related to a particular case should be maintained properly. Be efficient and have proper expert opinion especially in serious illnesses. Keep your knowledge updated and keep latest instruments , if possible.

MESSAGE TO MEDICO-PERSON

PLEASE DOCTORS, think twice litigations against medical practitioners are rising as the relationship between doctor and patient is deteriorating.

Don’t forget your duties with your rights as a medical practitioner.

Take a valid consent and maintain perfect records of your patients.

Don't get upset if there is case against you in consumer forum.

Have a respect for law, God and of course for human beings.

THANK

YOU