6 Important Medico Legal Aspects in India Related to Safety of Patients in a Hospital

Important Medico legal Aspects Related to Safety of Patients in a Hospital are given below:

1. Protection of Rights of Patients:

In India, unlike in many other countries, the rights of the patients have not yet been spelt out in a legal form. Even the level of awareness among public as well as health care professionals is low.

However, the fundamental rights enshrined in the constitution and certain laws enacted from time to time, have spelt out the obligations of the health care providers towards patients and have, indirectly, conferred certain rights on the patients.

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Learning from the world wide movement and the emphasis by the JCAHO/JCI (USA) on the Rights of Patients in their Accreditation Standards, National Accreditation Board for Hospitals and Health Care Providers (NABH) (India) have also, for the first time, brought the subject to the fore.

With that the awareness about the rights (and responsibilities) of patients among patients/public as well as health care providers is on the increase.

Although, no charter of patient’s rights has been framed by the executive or the judiciary so far in India, it is likely to become a reality not far in future. A suggested charter containing essential rights and responsibilities of patients is given below.

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Charter of Patients’ Rights and Responsibilities:

This charter of Patients Rights and Responsibilities has been framed to ensure that in illness the patients are treated and nursed back to health in the manner that is safe, humane, dignified and acceptable and that they, willingly, fulfill certain obligations that will (along with their rights) uphold the rights of other patients, public and the health care providers, too.

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Rights:

1. Right of Access to Health Care

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2. Right to Emergency Life Saving Treatment

3. Right to be treated with Respect and Dignity

4. Right to Full Information

5. Right to Consent

6. Right to Choice of Care

7. Right to Privacy and Confidentiality

8. Right to Care of Acceptable (Quality) Standards

9. Right to Safety

10. Right to Healthy (clean, infection free, hazard free) Environment

11. Right to Education about the Health Care Needs

12. Right to Redressal of Grievances.

Responsibilities:

1. Knowing and understanding his/her rights and responsibilities and exercising them responsibly.

2. Providing accurate, complete and relevant information to the doctor.

3. Enquiring about the estimated cost of treatment and paying the bills in time.

4. Choosing the class of patient accommodation as per his/her paying capacity.

5. Making decisions after full information, and accepting their consequences.

6. Following the advice of the doctor primarily responsible for the care.

7. Respecting the rights of other patients, hospital staff, management

8. Protecting the hospital environment and not polluting it

9. Compliance with the hospital rules and regulations.

Actions to be taken by the Hospitals in R/O Patients’ Rights:

It is time, the health care providers (HCP) start thinking in terms of their obligation to implement these rights and the actions to be taken. Some of the actions that the hospitals (though not legally required right now) would be required to take, are:

1. Adopt a charter of the Rights (and responsibilities) of the patients.

2. Display the charter prominently in their hospital and even include it in the hospital information brochure for the patients/public to see.

3. Inform and educate their staff about the rights of the patients and the need to respect these rights.

4. Modify/adapt their infrastructure, policies/procedures/protocols in accordance with the requirements of these rights.

5. Establish a formal mechanism in the form of a Patients’ Grievance Redressal Committee to address the complaints/grievances of the patients/ attendants.

6. Include the information about the Grievance Committee and the procedure for grievance redressal in the Hospital Information Brochure for the information of all the patients/attendants.

7. Gear up the staff to fully brief the patients about their disease/diagnosis/treatment options/expenditure expected and the chances of recovery, etc. and enable them to take their informed decisions.

8. Establish a mechanism for ensuring the safety and security of patients, their attendants and their belongings.

9. Establish a mechanism for ensuring compliance with the rules and regulations;

10. Bring about an element of transparency by:

i. Informing the public and patient about the schedule of charges

ii. The doctors actually available in different specialties and their level of competence

iii. The services that the hospital has the services that are not available and the services that is outsourced.

It is very important that before the hospital formally accepts and announces a charter of patients’ rights, the hospital and its staff and system of functioning are adapted to it.

Otherwise, the hospital may not be able to live up to the expectations and the patients/ public may not appreciate that.

2. Protection of Rights of Research Subjects:

Hospitals carrying out any biomedical research or experimentation on the human subjects are obligated to ensure total protection of the rights of the research subjects as stipulated in the ICMR Guidelines on the subject and discussed below:

1. Informed Consent Process:

This includes the consent form, participant’s information sheet, obligations of investigators regarding informed consent and essential information for prospective research participants (the aims and methods of research, expected duration, benefits, alternative courses of treatment, any foreseeable risk/discomfort to the participant, right to withdraw from research, confidentiality of records with limitations).

2. The participants will be fully and honestly informed about the possibility of any genetic/ Teratogenic effects of the research and any possible ill effects, immediate or remote in the future.

3. Observance of all due precautions to ensure minimization of risk to the research subjects.

4. Compensation to be paid to the research subjects, including the compensation for accidental injury if any, will be reasonable and as per a prior written agreement.

5. It will be the responsibility of the principle researcher, the ethics committee and the hospital administration to ensure that the research subjects are not exploited in any manner.

6. Conflict of Interest: The conflict of interest, if any, will not be allowed to cause harm to research subjects or damage the scientific integrity of the project.

7. Privacy and Confidentiality of all information about the research subjects and the research data will be ensured except under the following circumstances:

i. In a court of law under the orders of the presiding judge

ii. If there is threat to a person’s life

iii. In cases of severe adverse reaction information may be required to be communicated to drug registration authority

iv. If there is risk to public health which takes precedence over personal right to privacy.

These limitations shall be communicated to appropriate individuals/authorities as the case may be.

8. Research will be carried out only by professionals with due competence in the field.

9. The research will be carried out in a transparent manner with full briefing to the subjects from time to time.

10. The hospital will ensure that they have adequate equipment and expertise to handle any adverse effects/complications.

11. The hospital will undertake to provide free and full treatment in case of any adverse effects during or after the course of research work.

12. Post-trial Access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care to be specified in the protocol.

13. The records of research work carried out will be preserved by the hospital for a period of at least 15 years (as per the ICMR Guidelines) after the termination of research work.

14. In drug trials there should be adequate arrangements for management of adverse reactions, including resuscitative measures as in intensive care.

15. In case of research involving radioactive materials/diagnostic agents the following precautions will be ensured:

i. Minimum possible exposure to radiation

ii. In the event of death of a participant with radiological implant, due precaution for protection of relatives or the close cohabitants from radiation, till safe

iii. Safety measures should be taken to protect research participants and others who may be exposed to radiation

iv. Avoidance of exposure of pregnant women to radiation

v. Information must be given to participants about possible genetic damage to offspring

vi. Ultrasound should be substituted wherever feasible to avoid any unnecessary exposure to radiation.

16. In Contraceptive trials on women:

i. Where implant has been used as a contraceptive for trial, a proper follow up for removal of the implant should be done, after the trial is over or the participant has withdrawn from the trial

ii. Children born due to failure of contraceptives under study should be followed up for any abnormalities if the woman does not opt for medical termination of pregnancy.

17. In vaccine trials:

i. Some vaccines that contain active or live-attenuated microorganisms may have a small risk of producing that particular infection. The participants to be vaccinated should be informed of the same and in such an event free treatment for the disease should be given, even if required for life long

ii. When a trial of HIV preventive vaccine is being conducted, positive serology may result after the vaccination. To avoid confusion, a certificate stating that the person is a trial participant in an HIV vaccine trial may be issued.

18. In case of research involving assisted reproductive technology, the best interests and safety of the pregnant lady should be the sole guiding principle for taking any decisions.

19. In cases of research involving Donation/Transplantation of Human Organs:

i. Donation from a live donor should be restricted to renewable tissues like bone marrow or to a paired organ whose removal will not greatly alter physiological functions, such as the kidney

ii. It is imperative that no risk be imposed on the donor beyond that inherent in surgery and the loss of a vital organ. Any manner of experimentation, should be prohibited if there is the slightest extra risk to the donor

iii. Legally valid, fully informed consent of the donor without any coercion. Children and mentally incompetent adults, as also individuals with restricted autonomy should not be used as organ donors or as subjects for such experiments

iv. The interests of the donor should always take priority over those of the recipient of the transplant.

20. The Institutional Ethics Committee has a very important role in safeguarding the rights of the research subjects.

The committee is expected to closely monitor the progress of research and ensure that the research work does not in any way, at any stage, compromise the interests or the safety of the research subjects or violate the rules.

To do full justice to their job the committee must acquire the latest information and expertise so as to be able to make the right decisions.

3. Mercy Killing/Euthanasia:

Euthanasia or Mercy killing has been a very sensitive subject, a real dilemma for the treating doctor. The pathetic condition of the brain dead patients being kept alive completely by mechanical support (withdrawal of which will mean certain and immediate death) is quite a familiar scene in intensive care units of every hospital.

The problem here is that this permanent vegetative state (PVS) or equipment-dependent existence after brain death can continue indefinitely, for days, weeks, months and sometimes, even years as seen in Aruna Shanbaug’s case.

It does not affect the treating doctors or the hospital as long as the bills are being paid, even though it may mean denial of valuable life support to another deserving patient who has potentially reversible illness with all the chances of survival.

Further, intensive care being very expensive (up to Rs 15 000 or even more per day) this artificial prolongation of life may be far beyond the means of any average family. The patient in any case is going to die; this huge expenditure can spell the doom for his survivors too.

Often, the relatives reach an emotional breaking point and beg the doctors to put an end to their misery (and that of the patient as well). In many cases, a stage comes when the relatives stop paying the bills and, sometimes, even stop visiting the patient.

These situations pose a real dilemma for the treating doctors as well as the hospitals that cannot stop the treatment as it would be not only unethical but be criminal as well.

Similarly, Situations of terminally ill and suffering patients begging for mercy (killing) are not unknown.

There may also be situations where the greedy unscrupulous relatives of a patient want to get rid of him or her and pressurize the doctor by emotional blackmail or inducements of various kinds to put an end to the patient’s life.

These are the situations where the doctor may sometimes succumb to the pressure and cause, aid or abet the death of a patient by an act of omission or commission and commit a crime.

In India, like in many other countries, mercy killing (euthanasia) has been a criminal offence. Voluntary euthanasia, conducted by one is treated as suicide. If unsuccessful, it would be treated as a criminal offence (attempted suicide) punishable under IPC Section 309.

Aiding or assisting in voluntary euthanasia is treated as abetting a crime under IPC Section 306. Euthanasia, through aggressive or non-aggressive means, will be treated as homicide (IPC section 304 or 302). In 1996, the Supreme Court of India ruled that “the right to life does not include the right to die or the right to be killed”.

As per Indian Medical Council Regulations, 2002, “practicing euthanasia shall constitute unethical conduct.”

The question of withdrawing life support devices even after the brain death could be decided only by a team of doctors and not by the treating physician alone. The team is to consist of the doctor in-charge case, CMO/MO in-charge hospital and a doctor nominated by the in charge hospital from the hospital staff or in accordance with the provisions of the Transplantation of Human Organs Act, 1994.

However, the recent landmark judgment by Supreme Court of India, in Aruna Ramchandra Shanbaug Vs Union of India and others has changed the situation. The salient aspects of the judgment are:

i. Passive euthanasia, in case of patients brain-dead or in permanent vegetative state, has been allowed, in the best interests of the patient and subject to approval of the high court of the state

ii. If a person consciously and voluntarily refuses to take life saving medical treatment it is not a crime

iii. Active euthanasia and physician assisted suicide continues to be criminal offences under IPC Sections 304/302 and 306 respectively

iv. A procedure to be followed by the High Court has been laid down for processing the application for euthanasia and taking a decision

v. The court will give a decision after considering the opinion of a panel of three doctors (a neurologist, a psychiatrist and a physician)

vi. The views of the near relatives and committee of doctors are to be given due weight by the High Court

vii. The court will be required to give the decision speedily.

In view of the above, it will be prudent and eminently important that in such situations the doctors take the right and rational decisions.

Passive euthanasia as defined by the Supreme Court, means withdrawing medical treatment with a deliberate intention of causing the patient’s death.

For example, if a patient requires kidney dialysis to survive, not giving dialysis although the machine is available, is passive euthanasia.

Similarly, if a patient is in coma or on a heart lung machine, withdrawing of the machine will ordinarily result in passive euthanasia.

Similarly, not giving life saving medicines like antibiotics in certain situations may result in passive euthanasia. Denying food to a person in coma or in permanent vegetative state may also amount to passive euthanasia.

However, the doctor must refrain from active euthanasia which is defined as the use of lethal substances or forces to kill a person, e.g. a lethal injection given to a person with terminal cancer who is in terrible agony. He/she must also refrain from aiding/abetting or assisting in euthanasia.

4. Pre Natal Sex Selection and Female Feticide:

Importance for the Hospitals/Clinics/Diagnostic Centers:

In view of the seriousness of the issue of fetal sex detection and female feticide, it is of utmost importance that every medical facility equipped to carry out such tests must ensure absolute compliance with the PNDT Act and the Rules, there under.

That would involve full understanding, commitment and cooperation of the medical/paramedical staff and a discrete vigil by the administrative authorities. In addition, it will also need actions as mentioned below:

1. Full understanding of the provisions of the Act and the Rules there under including the offences and punishments.

2. Ensuring registration of the ultrasonologists and the ultrasonography/imaging equipments with the appropriate Authority.

3. Ensuring that only the staff possessing the prescribed qualification is employed at such centers/laboratories/clinics.

4. Prominent display of the mandatory notices in the department informing public that “Preconceptual/prenatal sex determination is prohibited under the PNDT Act and no such tests are conducted at that department/center.

5. Full briefing to the pregnant ladies of the side effects/after effects of the test procedure to be conducted.

6. Written consent of the pregnant woman (see annexure 19) on whom the test is to be carried out.

7. Timely submission of reports as per the prescribed format and filled completely, in respect of the ultrasonography done on every pregnant woman.

8. Maintenance of records of all such procedures carried out by the hospital/center for the mandatory period of 2 years or more (as per the legal requirement).

5. Theft of Human Organs:

Illegal organ trade has become a cause of serious concern in India. There has been a spate of reports in the print and electronic media about a thriving human organ trade in India and the consequential exploitation of economically weaker sections of the society. Instances of “Kidney marriages”, “Kidney tours” by prospective donors/recipients are common knowledge.

Instances of illegal removal of kidneys without the consent or even knowledge of the victims are also happening.

Such criminal activities by a few unscrupulous medical professionals/others has eroded the public faith in the medical profession and opened the hospitals to greater public criticism.

The punishments under HOTA, 1994, are fairly stiff. Punishment for involvement in removal of human organs without authority is imprisonment up to 5 years and fine and penal erasure of the name of the doctor from State Register for 5 years (Section 18).

For commercial dealing in human organs the imprisonment is even stiffer-7 years (Section 19).

In order to ensure safety of patients as well as protection of own interests, the hospitals running a program of organ transplantation must ensure full compliance with the provisions of the Human Organs Transplantation Act and implement the following measures:

Safety Measures:

1. Removal / transplantation of human organs can be done only at a hospital duly registered by the appropriate Authority of the State concerned (Section 10, 14, 15 of HOTA).

However, the eyes or the ears (including ear drums and ear bones) may be removed at any place from the dead body of any donor, for therapeutic purposes, by a registered medical practitioner.

2. The hospital should ensure that removal of human organs is done only by a registered medical practitioner (Section 3.4 of HOTA)

3. Removal of any human organ for therapeutic purposes will be done before or after the death of the donor on valid authorization by the donor vide Section 3.1 or 3.2 or by the person lawfully in possession of the body (vide Section 3.3) in case no authorization was made by the donor but no objection was expressed either.

4. Before removal of the organ, the RMP shall ascertain fully, that life is extinct in that body or, where it appears to be a case of brain-stem death, that such death has been certified under Section 3.6.

By a Board of Medical Experts, approved by the appropriate authority and consisting of the following, namely:

i. The registered medical practitioner in charge of the hospital in which brain-stem death has occurred.

ii. An independent registered medical practitioner, being a specialist approved by the appropriate Authority.

iii. A neurologist or a neurosurgeon to be nominated by the registered medical practitioner specified in clause (i), from the panel of names approved by the appropriate Authority.

iv. The registered medical practitioner treating the person whose brain-stem death has occurred.

4. In brain-stem death of any minor, certified under Section 3.6, authority from any of the parents of the deceased person will be obtained before removal of any organ from the body of the deceased person (Section 3.7).

5. Removal of organs is not to be authorized in cases where inquest is likely to be held (Section 4).

6. Removal of human organs from unclaimed bodies or from the bodies sent for postmortem examination will be undertaken only after satisfying the provisions of Sections 5 and Section 6, respectively.

7. Preservation of human organs (Section 7). After removal of the human organs, the RMP shall ensure preservation of the organs as prescribed.

8. Organ removed before the death of the donor shall not be transplanted into a recipient unless the donor is a near relative of the recipient (Section 9).

9. The organ removed after the death of the donor, with prior valid authorization may be transplanted into the body of any recipient in need of such organ (Section 9).

10. Organ removed before death of the donor, duly authorized, cannot be transplanted in any recipient other than a near relative of the donor, without prior approval of the Authorization Committee.

11. Removal and transplantation of any human organ can be done only for therapeutic purposes. Removal/transplantation for any other purpose is prohibited (Section 11).

12. Explaining the effects, etc. to donor and recipient is mandatory before removal/ transplantation of organs (Section 12)

13. The doctor authorized to remove the organ for transplantation must satisfy himself (vide Rule 4, HOTA Rules, 1995) that:

a. Before removal of an organ from the body of a live donor-:

i. That the donor has given his authorization in Form 1

That the donor is in a proper state of health and is fit to donate the organ and shall sign a certificate in Form 2

That the donor is a near relative of the recipient and shall sign a certificate as specified in Form 3 after carrying out the serological tests on the donor and the recipient for antigenic products of the Human Major Histo­compatibility system HLA-A, HLA-B and HLA-DR.

If recipient is a spouse of the donor, statement of both to that effect is to be recorded and a certificate signed by them in Form 4.

b. Before removal of an organ from the body of a donor after his death, a registered medical practitioner shall, satisfy himself that the donor had given a valid authorization as specified in Form 5 and the person lawfully in possession of the dead body has signed a certificate as specified in Form 6 or Form 7.

c. Before removal of an organ from the body of a brain stem dead, a registered medical practitioner shall, satisfy himself that the certificate specified in Form 8 has been signed by all members of the board of medical experts vide Section 3 (6) of the Act and in case the brain stem dead person is less than 18 years of age, an authority as specified in Form 9 has been signed by either of the parents of such person.

14. Before removal of an organ from a live donor, the doctor authorized to do so will satisfy himself that the donor is medically fit to undergo surgery and donation of the organ will not in any manner impose on the donor, any risk beyond that inherent in surgery and the loss of a vital organ.

Any manner of experimentation should be prohibited if there is the slightest extra risk to the donor.

15. In case of live donor transplant, the following norms must be adhered to:

i. Donation from a live donor should be restricted to renewable tissues like bone marrow or to a paired organ only whose removal will not greatly alter physiological functions, such as the kidney

ii. The interests of the donor should always take priority over those of the recipient of the transplant

iii. Legally valid, fully informed consent of the donor, without any coercion, must be obtained prior to organ removal. Children and mentally incompetent adults, as also individuals with restricted autonomy should not be used as organ donors

iv. Legally valid, fully informed prior consent of the recipient without any coercion

v. It should be ensured that both the donor and the recipient are fully protected from all the complications such as infections.

16. In case of removal of organ after death (cadaver donor transplant) the following aspects must be adhered to:

i. Cadaver donor transplants must be undertaken after a valid and specific consent from the donor/NOK/person in charge of the body

ii. It is important that the medical team uses the body only for the purpose for which consent has been given

iii. Remaining tissue and organs should be treated with the respect due to a human body and will not be used for any purpose to which explicit consent had not been given

iv. Under no circumstances should financial gain be made from any such procedure

v. There shall be no coercion and no monetary inducements offered to the family of the prospective cadaver donor

vi. Confidentiality of the donation must be maintained on both sides.

Proposed Amendments to the HOTA, 1994:

The experience of the last 15 years of implementation of HOTA, 1994 has shown that the Act has many drawbacks because of which it has been rather ineffective in checking the illegal trade in organs or in streamlining the process and facilitating the genuine cases.

In order to make the law more effective, the Cabinet Committee has given approval to certain amendments to the law, as discussed below, which will have far reaching improvements once approved by the parliament:

1. The law will be amended to be called Transplantation of Human Organs and Tissues Act (THOTA) and will include donation of human tissues also.

2. The law will expand the definition of ‘Near Relatives’ to include grandparents and grandchildren also.

3. It will legalize swap donation to facilitate cross donation between two couples (with approval from Authorization Committee) who, though willing to donate the organ to the spouse, are unable to do so because of tissue mismatch.

4. It will have enhanced penalties for unauthorized removal or sale/purchase of human organs, up to 10 years of imprisonment and a fine of Rs 25 lakh.

5. The amendment also proposes creation of a central registry of those requiring organ transplants and a nationwide network of transplant centers and retrieval centers and a national database to facilitate the transplant process.

6. Medical Termination of Pregnancy:

(The MTP Act 1971 incorporating the MTP Amendment Act, 2002 and The MTP Regulations, 2003)

MTP Act was enacted to regulate the abortion clinics and to ensure safety of the procedure for the women undergoing it.

The Act, laid down the rules as to when and under what circumstances the abortion can be carried out, who can do it and where can it be carried out. It also stipulated the punishments for any violations of the Act or the Rules.

However, even after nearly forty years of its implementation, abortions are being carried out at ill- equipped places, by untrained hands and under unsafe circumstances, in violation of the rules and resulting into infections of the genital tract, septicemia, severe hemorrhage or perforation, endangering the life and safety of the women.

It is legally binding on the hospitals/clinics/medical professionals to ensure that termination of pregnancy is carried out only in full compliance with the provisions of the Act and ensuring absolute safety of the patient. Some of the important provisions are discussed below:

1. Termination of a pregnancy shall be carried out only by a registered medical practitioner (a qualified and registered allopathic doctor) (Section 3.1).

2. It can be carried out only up to 20 weeks of pregnancy, certified by the registered medical practitioner (s) that it is justified as per the rules (Section 3.2) (annexure 20)

3. No pregnancy will be terminated without the valid informed consent of the pregnant woman /her legal guardian (Section 3, 4).

4. Pregnancy can be terminated only at a hospital established/maintained/approved for MTP by government (Section 4).

5. Identity of the lady undergoing MTP is to be kept strictly confidential.

i. A separate register containing the details of admissions of women for MTP shall be maintained in Form III and preserved for a period of five years

ii. Admission register shall be a secret document and the name and other particulars of the pregnant woman shall not be disclosed to any person

iii. The admission register is not to be open to inspection by anyone except under the authority of law.

It is the responsibility of the healthcare provider to:

i. Ensure that the hospital / clinic is fully equipped to carry out the termination of pregnancy and also to handle any complications that may occur

ii. Fully inform and educate the woman about the procedure and the possible effects/ complications

iii. Obtain a valid informed consent from the patient

iv. Ensure that the rules are not violated in any manner

v. Ensure that the health and safety of the woman is not compromised in any manner

vi. Ensure that confidentiality of information is not breached in any manner.