Doctors

Since the ancient times, certain duties and responsibilities have been cast on persons who adopt the sacred profession as exemplified by Charka’s Oath ( 1000 B.C.) and Hippocratic Oath ( 460 B.C.). In order to understand the complexities of the doctor-patient relationship it is necessary to know about the Duties and Obligations of a Doctor, Doctor-Patient contract and what constitutes Professional Negligence.

Prerequisites of Medical Practice: A duly qualified medical professional, i.e. a doctor has a right to seek to practice medicine, surgery and dentistry by registering himself with the Medical Council of the State of which he is a resident, by following the procedure as prescribed under the Medical Act of the State.
The State Medical Council has the power to warn, refuse to register / remove from register the name of the doctor who has been sentenced by any court for any non-bailable offence or found to be guilty of infamous conduct in any professional respect. The State Medical Council has also the power to re-enter the name of the doctor in the register.
The provisions regarding offences and professional misconduct which may be brought before the appropriate Medical Council (State/Medical Council of India ) have been stated in the Code of Medical Ethics formulated by the Medical Council of India.
The appropriate Medical Councils are empowered to award such punishment as deemed necessary or direct the removal of the name of the delinquent registered practitioner from the register either permanently or for a specified period, if he has been found guilty of serious professional misconduct. No action against a medical practitioner can be taken unless an opportunity has been given to him to be heard in person or through an advocate.
Duties and Obligations of a Doctor : Duties and obligations of doctors are enlisted in ordinary laws of the land and various Codes of Medical Ethics and Declarations - Indian and International, which are :

• (i) Code of Medical Ethics of Medical Council of India ;
• (ii) Hippocratic Oath ;
• (iii) Declaration of Geneva ;
• (iv) Declaration of Helsinki;
• (v) International Code of Medical Ethics ;
• (vi) Government of India Guidelines for Sterilization.

These Codes and Declarations are being printed in the Appendices. On the basis of these various Codes of Ethics and Declarations, the duties can be summarised as under -

• 1. Duties to Patient.
• 2. Duties to Public.
• 3. Duties towards Law Enforcers.
• 4. Duties not to violate Professional Ethics.
• 5. Duties not to do anything illegal or hide illegal acts.
• 6. Duties to each other.

1. Duties to Patient - These are : Standard Care, Providing Information to the Patient /Attendant , Consent for Treatment, and Emergency Care.

(A) Standard Care - This means application of the principles of standard care which an average person takes while doing similar job in a similar situation:

• 1. Due care and diligence of a prudent Doctor.
• 2. Standard, suitable, equipment in good repair.
• 3. Standard assistants : Where a senior doctor delegates a task to a junior doctor or paramedical staff, he must assure himself that the assistant is sufficiently competent and experienced to do the job, and fulfills the prescribed qualifications.
• 4. Non-standard drug is a poison by definition.
• 5. Standard procedure and indicated treatment and surgery.
• 6. Standard premises, e.g. Nursing Home, Hospital , must comply with all laws applicable as imposed by the State and these must be registered wherever required.
• 7. Standard proper reference to appropriate specialist.
• 8. Standard proper record keeping for treatment given, surgery done, X-ray and pathological reports.
• 9. Standard of not to experiment with patient ( See Declaration of Helsinki in Appendix IV).
• 10. Anticipation of standard risks of complications and preventive actions taken in time.
• 11. Observe punctuality in consultation.

(B) Duty to provide information to patient / attendant

• 1. Regarding necessity of treatment.
• 2. Alternative modalities of treatment.
• 3. Risks of pursuing the treatment, including inherent complications of drugs, investigations, procedure, surgery etc.
• 4. Regarding duration of treatment.
• 5. Regarding prognosis. Do not exaggerate nor minimize the gravity of patient’s condition.
• 6. Regarding expenses and break-up thereof.

(C) Consent for treatment - Various types of consent and implications thereof are discussed in Chapter 5.

(D) Emergency Care - A doctor is bound to provide emergency care on humanitarian grounds, unless he is assured that others are willing and able to give such care. It may be noted that prior consent is not necessary for giving emergency / first-aid treatment. In emergency medico-legal cases, condition of first being seen by medical jurist is not essential.

2. Duties to the Public

• > Health Education
• > Medical help when natural calamities like drought, flood, earth-quakes, etc. occur.
• > Medical help during train accidents.
• > Compulsory notification of births, deaths, infectious diseases, food poisoning etc.
• > To help victims of house collapse, road accidents, fire, etc.

3. Duty towards Law Enforcers, Police, Courts, etc.

• > To inform the police all cases of poisoning, burns, injury, illegal abortion, suicide, homicide, manslaughter, grievous hurt and its natural complications like tetanus, gas-gangrene , etc. This includes vehicular accidents, fractures, etc.
• > To call a Magistrate for recording dying declaration.
• > To inform about bride burning and battered child cases.

4. Duty not to violate Professional Ethics ( Only important few given)

• > Not to associate with unregistered medical practitioner and not allow him to practice what he is not qualified for.
• > Not to indulge in self-advertisement except such as is expressly authorized by the M.C.I. Code of Medical Ethics.
• > Not to issue false certificates and bills.
• > Not to run a medical store / open shop for sale of medical and surgical instruments.
• > Not to write secret formulations.
• > Not to refuse professional service on grounds of religion, nationality, race, party politics or social status.
• > Not to attend patient when under the effect of alcohol
• > No fee sharing ( Dichotomy).
• > Not to talk loose about colleagues.
• > Information given by patient /attendant to be kept as secret. Not to be divulged to employer, insurance company, parents of major son/daughter without consent of patient. Even in court this information is given only if ordered by the Court.
• > Recovering any money ( in cash or kind) in connection with services rendered to a patient other than a proper professional fee, even with the knowledge of the patient.

5. Duty not to do anything illegal or hide illegal acts

• 1. Perform illegal abortions / sterilization’s
• 2. Issue death certificates where cause of death is not known.
• 3. Not informing police a case of accident, burns, poisoning, suicide, grievous hurt, gas gangrene.
• 4. Not calling Magistrate for recording dying declaration.
• 5. Unauthorized, unnecessary, uninformed treatment and surgery or procedure.
• 6. Sex determination (in certain States).

6. Duty to each other

• 1. A doctor must give to his teachers respect and gratitude.
• 2. A doctor ought to behave to his colleagues as he would like them to behave to him.
• 3. A doctor must not entice patients from his colleagues, even when he has been called as a specialist.
• 4. When a patient is referred to another doctor, a statement of the case should be given. The second doctor should communicate his opinion in writing /over telephone/fax direct to the first doctor.
• 5. Differences of opinion should not be divulged in public.
• 6. A doctor must observe the principles enunciated in ‘The Declaration of Geneva’ approved by the World Medical Association. (See Appendix III).

Duties of the Patient / Attendant
When a patient ( consumer ) hires or avails of services of a doctor for treatment, he has the following duties :-

• 1. He must disclose all information that may be necessary for proper diagnosis and treatment.
• 2. He must co-operate with the doctor for any relevant investigations required to diagnose and treat him.
• 3. He must carry out all the instructions as regards drugs, food, rest, exercise or any other relevant /necessary aspect.
• 4. In the case of a private medical practitioner, he must compensate the doctor in terms of money and money alone. Moral considerations apart, failure on the part of the patient / attendant to do his duty : (
• a) will enable the doctor to terminate patient -physician contract and that would free him from his legal responsibilities,
• (b) will be construed as contributory negligence and weaken the case of the patient for compensation.

Doctor - Patient Contract

Contract is defined as an agreement between two or more persons which creates an obligation to do or not to do a particular thing. Contract may be implied or express.
An implied contract is one inferred from conduct of parties and arises where one person renders services under circumstances indicating that he expects to be paid therefor, and the other person knowing such circumstances, avails himself of benefit of those services.
An express contract is an actual agreement of the parties, the terms of which are openly uttered or declared at the time of making it, being stated in distinct and explicit language, either orally (oral agreement ) or in writing (written agreement).
The doctor-patient contract is almost always of the implied type, except where a written informed consent is obtained.
While a doctor cannot be forced to treat any person, he has certain possibilities for those whom he accepts as patients. It is an implied contract. Implied contract is not established when :

• (i) the doctor renders first-aid in an emergency ;
• (ii) he makes a pre-employment medical examination for a prospective employer;
• (iii) he performs an examination for life insurance purpose ;
• (iv) he is appointed by the trial court to examine the accused for any reason ; and
• (v) when he makes an examination at the request of an attorney for last suit purposes. A doctor-patient contract requires that the doctor must :
• (1) continue to treat such a person ;
• (2) with reasonable care ;
• (3) reasonable skill ;
• (4) not undertake any procedure/ treatment beyond his skill and
• (5) must not divulge professional secrets.

These various requirements will now be discussed in the succeeding paragraphs.
(i) Continue to Treat - Responsibility towards a patient begins the moment a doctor agrees to examine the case. He must not, therefore, abandon his patient except under the following circumstances -

• 1. The patient has recovered from the illness, for which treatment was initiated.
• 2. The patient / attendant does not pay the doctor’s fees (in case of a private practitioner).
• 3. The patient / attendant consults another doctor ( of any branch of medicine ) without the knowledge of the first attending doctor.
• 4. The patient / attendants do not co-operate and follow the doctor’s instructions.
• 5. The patient is under some other responsible care, e.g., the patient, after admission in a hospital, comes under care of senior doctors / unit head.
• 6. The doctor has given due notice (orally or written ) for discontinuing treatment.
• 7. The doctor is convinced that the illness is a fictious one.

(ii) Reasonable Care - A doctor must use clean and proper instruments and provide his patients with proper and suitable medicines if he dispenses them himself. If not, he should write the prescriptions legibly, using standard abbreviations and mention instructions for the pharmacist in full. He should give full directions to his patients as regards administration of drugs and other measures, preferably in local written language. He must suggest / insist on consultation with a specialist in the following circumstances:

• 1. When the case is complicated.
• 2. When the question arises about performing an operation which may be dangerous to life or requiring amputation.
• 3. Operating on a case in which there has been a criminal assault.
• 4. Performing an operation which may affect the intellectual or reproductive functions of a patient.
• 5. In cases where there is suspicion of poisoning or other criminal act.
• 6. When desired by the patient / attendants.
• 7. When it appears that the quality of medical service is required to be enhanced.
• 8. When there is no one from whom informed consent can be obtained.

(iii) Reasonable Skill - The degree of skill a doctor undertakes is the average degree of skill possessed by his professional brethren of the same standing as himself. The best form of treatment may differ when different choices are available. There is an implied contract between the doctor and the patient when the patient is told in effect : "Medicine is not an exact science. I shall use my experience and best judgement and you take the risk that I may be wrong. I guarantee nothing."

(iv) Not to undertake any procedure beyond his skill - This depends upon his qualifications, special training and experience. The doctor must always ensure that he is reasonably skilled before undertaking any special procedure / treating a complicated case. To quote an example, a doctor who is not sufficiently trained or qualified should not administer anesthesia.

(v) Professional Secrets - A professional secret is one which a doctor comes to learn in confidence from his patients, on examination, investigations or which is noticed in the ordinary privacies of domestic life. A doctor is under a moral and legal obligation not to divulge any such secret except under certain circumstances. This is known as privileged communication which is defined as a communication made by a doctor to a proper authority who has corresponding legal, social and moral duties to protect the public. In must be bonafide and without malice, e.g., as a witness in a court of law; warning partners or spouses of AIDS patients and those found infected with HIV; informing public health authorities of food poisoning from a hotel etc; assisting apprehension of a person who has committed a serious crime ;informing law enforcers about medico-legal cases, etc.

Professional Negligence ( Malpractice, Malpraxis)
Professional negligence is defined as the breach of a duty caused by the omission to do something which a reasonable man guided by those considerations which ordinarily regulate the conduct of human affairs would do or doing something which a prudent and reasonable man would not do.
Medical negligence or malpractice is defined as lack of reasonable care and skill or willful negligence on the part of a doctor in the treatment of a patient whereby the health or life of a patient is endangered.
The term ‘damage’ means physical, mental or functional injury to the patient, while ‘damages ‘ are assessed in terms of money by the court on the basis of loss of concurrent and future earnings, treatment costs, reduction in quality of life ,etc.
In order to achieve success in an action for negligence, the consumer must be able to establish to the satisfaction of the court that :

• (i) the doctor (defendant) owed him a duty to conform to a particular standard of professional conduct ;
• (ii) the doctor was derelict and breached that duty ;
• (iii) the patient suffered actual damage ; and
• (iv) the doctor’s conduct was the direct or proximate cause of the damage.

The burden of establishing all four elements is upon the patient / consumer. Failure to provide substantiative evidence on any one element may result in no compensation.

Criminal Negligence. Here the negligence is so great as to go beyond matter of mere compensation. Not only has the doctor made a wrong diagnosis and treatment, but also that he has shown such gross ignorance, gross carelessness or gross neglect for the life and safety of the patient that a criminal charge is brought against him. For this he may be prosecuted in a criminal court for having caused injury to or the death of his patient by a rash and negligent act amounting to culpable homicide under Section 304-A of the Indian Penal Code. Some examples are as follows :

• 1. Injecting anesthetic in fatal dosage or in wrong tissues.
• 2. Amputation of wrong finger, operation on wrong limb, removal of wrong organ, or errors in legation of ducts.
• 3. Operation on wrong patient.
• 4. Leaving instruments or sponges inside the part of body operated upon.
• 5. Leaving tourniquets too long, resulting in gangrene.
• 6. Transfusing wrong blood.
• 7. Applying too tight plaster or splints which may cause gangrene or paralysis.
• 8. Performing a criminal abortion.

Maintenance of records.

(1) All records, charts, forms, reports, consent letters and all other documents required to be maintained under this Act and the rules shall be preserved for a period of two years or for such period as may be prescribed:
Provided that, if any criminal or other proceedings are instituted against any Genetic Councelling Centre, Genetic Laboratory or Genetic Clinic, the records and all other documents of such Centre, Laboratory or Clinic shall be preserved till the final disposal of such proceedings.
(2) All such records shall, at all reasonable times, be made available for inspection to the Appropriate Authority or to any other person authorised by the Appropriate Authority in this behalf.
Power to search and seize records, -
(1) If the Appropriate Authority has reason to believe that an offence under this Act has been or is being committed at any Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, such Authority or any officer authorised thereof in this behalf may, subject to such rules as may be prescribed, enter and search at all reasonable times with such assistance, if any, as such authority or officer considers necessary, such Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic and examine any record, register, document, book, pamphlet, advertisement or any other material object found therein and seize the same if such Authority or officer has reason to believe that it may furnish evidence of the commission of an office punishable under this Act.
(2) The provisions of the Code of Criminal Procedure, 1973 (2 of 1974) relating to searches and seizures shall, so far as may be, apply to every search or seizure made under this Act.
Protection of action taken in good faith.- No suit, prosecution or other legal proceeding shall lie against the Central or the State Government or the Appropriate Authority or any officer authorised by the Central or State Government or by the Authority for anything which is in good faith done or intended to be done in pursuance of the provisions of this Act.

Power to make rules:

• (1) The Central Government may make rules for carrying out the provisions of this Act.
• (2) In particular and without prejudice to the generality of the foregoing power, such rules may provide for--
• (i) the minimum qualifications for persons employed at a registered Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic under clause (1) of section 3;
• (ii) the form in which consent of a pregnant woman has to be obtained under section 5;
• (iii) the procedure to be followed by the members of the Central Supervisory Board in the discharge of their functions under sub-section (4) of section 8;
• (iv) allowances for members other than ex officio members admissible under sub-section (5) of section 9;
• (v) the period intervening between any two meetings of the Advisory Committee under the proviso to sub-section (8) of section 17;
• (vi) the terms and conditions subject to which a person may be appointed to the Advisory Committee and the procedure to be followed by such Committee under sub-section (9) of section 17;
• (vii) the form and manner in which an application shall be made for registration and the fee payable thereof under sub-section (2) of section 18;
• (viii) the facilities to be provided, equipment and other standards to be maintained by the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic under sub-section (5) of section 18;
• (ix) the form in which a certificate of registration shall be issued under sub-section (1) of section 19;
• (x) the manner in which and the period after which a certificate of registration shall be renewed and the fee payable for such renewal under sub-section (3) of section 19;
• (xi) the manner in which an appeal may be preferred under section 21;
• (xii) the period up to which records, charts, etc., shall be preserved under sub-section (1) of section 29;
• (xiii) the manner in which the seizure of documents, records, objects, etc., shall be made and the manner in which seizure list shall be prepared and delivered to the person from whose custody such documents, records or objects were seized under sub-section (1) of section 30;
• (xiv) any other matter that is required to be, or may be, prescribed.

Power to make regulations.- The Board may, with the previous sanction of the Central Government, by notification in the Official Gazette, make regulations not inconsistent with the provisions of this Act and the rules made thereunder to provide for-
(a) the time and place of the meetings of the Board and the procedure to be followed for the transaction of business at such meetings and the number of members which shall form the quorum under sub-section (1) of section 9; (b) the manner in which a person may be temporarily associated with the Board under sub-section (1) of section 11;
(c) the method of appointment, the conditions of service and the scales of pay and allowances of the officer and other employees of the Board appointed under section 12;
(d) generally for the efficient conduct of the affairs of the Board.

Rules and regulations to be laid before Parliament. – Every rule and every regulation made under this Act shall be laid, as soon as may be after it is made, before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or regulation or both Houses agree that the rule or regulation should not be made, the rule or regulation shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule or regulation.

Preventive Steps Against Litigation
It is not as if this aspect has not crossed the minds of doctors before the application of Consumer Protection Act (CPA) to medics. Complaints have been lodged with State Medical Councils, and M.C.I.., and there have been instances of action taken against doctors. More frequently patients have been suing & prosecuting doctors in Civil and Criminal Courts. The medical professionals have been exercising due caution while dealing with patients. With the coming into existence of compensation oriented Consumer Forums, the medical profession has been suddenly made to sit-up. What they were doing till the other day in mutual trust could land them into trouble, if they do not exercise extra precautions.
Where the doctor feels that the patient is suffering from some major illness in which complications are pre-existing or are likely to occur, he should take proper precautions. The precautions desired to be taken may be summarised as "Do’s and Don’ts" which are as follows :-

Some Do's

• 1. Mention your qualifications on the prescription. Qualifications mean recognized degrees / diplomas as regulated by the Indian Medical Degrees Act, 1916 as amended from time to time.
• 2. Mention of scholarships/training / membership/awards which are not qualifications should be avoided.
• 3. Always mention date and timing of the consultation.
• 4. Mention age, sex, weight (if child).
• 5. In complicated cases record precisely history of illness and substantial physical findings about the patient on your prescription.
• 6. If the patient/attendants are erring on any count ( history not reliable, refusing investigations, refusing admission ) make a note of it or seek written refusal preferably in local language with proper witness.
• 7. Mention the condition of patient in specific /objective terms. Avoid vague / non-specific terminology.
• 8. Record history of drug allergy.
• 9. Write name of drugs clearly. Use correct dosage (by revising knowledge periodically) and mention clearly method and interval of administration. Here one must use local or sign language. Do not forget writing precautions like Ast./p.c./a.c./locally/with milk/h.s. etc.
• 10. If a drug is a poison ( e.g., certain local applications ), warn in writing.
• 11. Mention additional precautions e.g., food, rest, avoidance of certain drugs, allergens, alcohol, smoking etc. if indicated.
• 12. Mention whether prognosis explained. If necessary take a signature of patient /attendant, after explaining the prognosis in written local language.
• 13. In case of any deviation from standard care, mention reasons.
• 14. Specifically mention review, SOS/or follow-up schedule.
• 15. Mention if patient /attendant are/is under effect of alcohol/drugs.
• 16. In case a particular drug/equipment is not available, make a note.
• 17. Mention where the patient should contact in case of your non-availability /emergency.
• 18. Keep updating your knowledge. Read again what you think you already know. You will be in for surprises.
• 19. Routinely advise X-rays in injury to bones/joints.

Some Dont's

• 1. Do not hesitate to discuss the case with your colleagues.
• 2. Do not hesitate to discuss the case with patients /attendants.
• 3. Do not write Ayurvedic formulations.
• 4. Do not allow substitutions.
• 5. For goodness sake do not examine a patient if you are sick, exhausted, under effect of alcohol.
• 6. Never talk loose of your colleagues, despite intense professional rivalry. Never criticize your brother in profession.
• 7. The patient /attendants may incite you to say/do something. They may seek your comments on the other doctor’s treatment. There is always a polite way to set aside their queries.
• 8. Remember if you had seen the case from start you would done the same. If your colleague has made error of judgement regarding diagnosis or treatment, you never know under what circumstances this happened.
• 9. Do not adopt experimental method in treatment. If there is some rationale do it only after informed consent.
• 10. If you to back and read the Duties and Obligations of doctors carefully and apply them religiously in your day to day practice, you are safe

It is very important for the treating doctor to properly document the management of a patient under his care. Medical record keeping has evolved into a science of itself. This will be the only way for the doctor to prove that the treatment was carried out properly. Moreover, it will also be of immense help in the scientific evaluation and review of patient management issues. Medical records form an important part of the management of a patient. It is important for the doctors and medical establishments to properly maintain the records of patients for two important reasons. The first one is that it will help them in the scientific evaluation of their patient profile, helping in analyzing the treatment results, and to plan treatment protocols. It also helps in planning governmental strategies for future medical care. But of equal importance in the present setting is in the issue of alleged medical negligence. The legal system relies mainly on documentary evidence in a situation where medical negligence is alleged by the patient or the relatives. In an accusation of negligence, this is very often the most important evidence deciding on the sentencing or acquittal of the doctor. With the increasing use of medical insurance for treatment, the insurance companies also require proper record keeping to prove the patient's demand for medical expenses. Improper record keeping can result in declining medical claims. It is disheartening to note that inspite of knowing the importance of proper record keeping it is still in a nascent stage in India. It is wise to remember that "Poor records mean poor defense, no records mean no defense". Medical records include a variety of documentation of patient's history, clinical findings, diagnostic test results, preoperative care, operation notes, post operative care, and daily notes of a patient's progress and medications. A properly obtained consent will go a long way in proving that the procedures were conducted with the concurrence of the patient. A properly written operative note can protect a surgeon in case of alleged negligence due to operative complications. It is important that the prescription for drugs should be legible with the name of the patient, date, and the signature of the doctor. An undated prescription can land a doctor in trouble if the patient misuses it. There are also many records that are indirectly related to patient management such as accounts records, service records of the staff, and administrative records, which are also useful as evidences for litigation purposes. Medical recording needs the concerted effort of a number of people involved in patient care. The doctor is the prime person who has to oversee this process and is primarily responsible for history, physical examination, treatment plans, operative records, consent forms, medications used, referral papers, discharge records, and medical certificates. There should be proper recording of nursing care, laboratory data, reports of diagnostic evaluations, pharmacy records, and billing processes. This means that the paramedical and nursing staff also should be trained in proper maintenance of patient records. The medical scene in India extends from smaller clinics to large hospitals. Medical record keeping is a specialized area in bigger teaching and corporate hospitals with separate medical records officers handling these issues. However, it is yet to develop into a proper process in the large number of smaller clinics and hospitals that cater to a large section of the people in India.

METHOD O F RECOD KEEPING :
The traditional method of keeping records that is followed in most of the hospitals across India is the manual method involving papers and books. There are serious limitations of manual record keeping including the need for large storage areas and difficulties in the retrieval of records. However, it is legally more acceptable as a documentary evidence as it is difficult to tamper with the records without detection. The present era has seen the computerization of medical records that are neat and tidy, and can be easily stored and retrieved. However, the possibility of easy manipulation without detection is a serious concern; hence, they may not be universally accepted at face value as a documentary evidence. If it is demanded during court proceedings, it is the duty of the hospital and the doctor to prove that these computer documents were not altered. Another major concern is maintaining confidentiality of the patient records as the patient can hold the doctor and the hospital negligent for breaking confidentiality of his medical records. Video tapes of endoscopic procedures, electronic fetal heart monitor charts, continuous ECG or Pulse oximeter charts could become important evidence in a court of law. Electronic medical recording is in the process of evolution and is being increasingly used. Though the total avoidance of paper records is the ideal aim, there are many areas that need to be sorted out. For example, an important issue is the electronic signature of the patient, doctors, and witnesses on informed consent forms.

Discharge notes:
This is a crucial piece of evidence regarding the inpatient treatment of a patient. It is important to give due importance to making a proper discharge summary as this is the summary document that will be kept by the patient which reflects the treatment received. The discharge summary should mirror the case notes of the patient records with a brief summary, relevant investigations, and operative procedures. The dates of admission, discharge, and surgery are useful when the sequence of events is an important issue in litigation later. It is also important to include instructions to be followed by the patient after discharge including dietary advice and date of next follow-up. The doctor can be held negligent if proper instructions are not given regarding the medications to be taken after discharge, physical care that is required, and the need for urgent reporting if an untoward complication happens before the advised time of review. As a urologist, it is common to see patients who are not aware of stents that should have been removed at its appropriate time, though mentioned properly in the discharge summary. The discharge summary should be signed or countersigned by the consultant. A copy of this must be preserved in the case file for future use if required. Discrepancies in the summary given to the patient and what is kept in the hospital records can cause suspicion about tampering with the medical records. These discrepancies should be avoided at all costs as the benefit of this usually goes in favor of the patient.
It is not uncommon to have patients who gets discharged against the advice of the doctor. These patients are also entitled to have a discharge summary about the course of treatment. It is imperative to record the fact that the doctor has advised a course of action with all its implications if not followed. The fact that the patient has understood this and has refused it on his volition should be recorded. This should be signed by the doctor, patient, or relative and duly witnessed. This document has to be retained along with the patient records. It will help the doctor in situations where the patient alleges negligence later.

Referral Notes
Referral notes are an important component of patient records. They should include the date and time of issue, the patient's general condition, cause of reference, and the course of action to be taken. It is wise to keep a duplicate copy of the referral note with the patient's signature. The fact that the patient did not go immediately on reference as advised could be proved by the duplicate copy of the referral note kept by the doctor. This could save a doctor who could be sued for alleged late referral after the patient's condition deteriorated.

Confidentiality of Record Keeping
Medical records can be used as a personal or impersonal document. 1) Personal document - this information is confidential and should not be released without the consent of the patient except in some specific situations. 2) Impersonal document - the record looses its identity as a personal document and patient permission is not required. These records could be used for research purposes. Confidentiality is an important component of the rights of the patient. The hospital is legally bound to maintain the confidentiality of the personal medical records. The patient can claim negligence against the hospital or the doctor for a breach of confidentiality. However, there are certain situations where it is legal for the authorities to give patient information. They are as follows: 1) during referral, 2) when demanded by the court or by the police on a written requisition, 3) when demanded by insurance companies as provided by the Insurance Act when the patient has relinquished his rights on taking the insurance, and 4) when required for specific provisions of Workmen's Compensation cases, Consumer Protection cases, or for Income tax authorities. The maintenance of confidentiality is an important issue in the era of electronic data storage. There should be checks in place so that only those who are authorized can access the patient data.
The impersonal documents have been used for research purposes as the identity of the patient is not revealed. Though the identity of the patient is not revealed, the research team is privy to patient records and a cause of concern about the confidentiality of information. Historically, such research has been exempt from an ethics review and researchers have not been required to obtain informed consent from patients before using their records. Recently, a need has been felt to regulate the use of medical records in research, effectively restricting the manner in which this type of research is conducted. An ethics review is required for using the patient data. However this is not widely followed all over India.

The different categories of medical records are as follows:

• 1. Certain records must be given to the patient as a matter of right. Discharge summary, referral notes, and death summary in case of natural death are important documents for the patient. Hence, these have to be given without charge for all including patients who leave against medical advice. The hospital bill cannot be tied up with these sensitive documents that are necessary for continuing patient care. Thus, the above documents cannot be legally refused even when the hospital bill has not been paid.
• 2. Certain records may be issued after the patient or authorized attendant fulfills the due requirements as stipulated by a hospital. This requires a formal application to the hospital requesting for the records. It is necessary that the hospital bills are cleared and the necessary processing fee has been paid. The documents in this group include copies of inpatient files, records of diagnostic tests, operation notes, videos, medical certificates, and duplicate copies for lost documents. It is important that the duplicate copies should be marked appropriately. It is not unusual for an unscrupulous patient to use it for multiple insurance claims without the knowledge of the doctor.
• 3. Certain records cannot be given to patients without the direction of the Court. The outpatient file, inpatient file, and files of medico-legal cases including autopsy reports cannot be handed over to the patient or relatives without the direction of the Court. But if these medico-legal cases are being referred to another center for management, copies of records could be given. However, X-rays are given only after a written undertaking by the patient or relatives that these will be produced in the Court as and when required.

Medical Council of India Guidelines on Medical Records:
The issue of medical record keeping has been addressed in the Medical Council of India Regulations 2002 guidelines answering many questions regarding medical records. The important issues that have been addressed are as follows:

• 1. Maintain indoor records in a standard proforma for 3 years from commencement of treatment (Section 1.3.1 and Appendix 3).
• 2. Request for medical records by patient or authorized attendant should be acknowledged and documents issued within 72 hours (Section 1.3.2).
• 3. Maintain a register of certificates with the full details of medical certificates issued with at least one identification mark of the patient and his signature (Section 1.3.3).
• 4. Efforts should be made to computerize medical records for quick retrieval (Section 1.3.4).

How long should Medical Records be Preserved?
There are no definite guidelines in India regarding how long to retain medical records. The hospitals follow their own pattern retaining the records for varied periods of time. Under the provisions of the Limitation Act 1963 and Section 24A of the Consumer Protection Act 1986, which dictates the time within which a complaint has to be filed, it is advisable to maintain records for 2 years for outpatient records and 3 years for inpatient and surgical cases. However the provisions of the Consumer Protection Act allows for condoning the delay in appropriate cases. This means that the records may be needed even after 3 years. It is important to note that in pediatric cases a medical negligence case can be filed by the child after acquiring the age of majority. The Medical Council of India guidelines also insist on preserving the inpatient records in a standard proforma for 3 years from the commencement of treatment. The records that are the subject of medico-legal cases should be maintained until the final disposal of the case even though only a complaint or notice is received. It is necessary that the Government frames guidelines for the duration for which medical records are preserved by the hospitals so that hospitals are protected from unnecessary litigation in issues of medical records.
The provisions of specific Acts like the Pre Conception Prenatal Diagnostic Test Act, 1994 (PNDT), Environmental Protection Act, etc. necessitate proper maintenance of records that have to be retained for periods as specified in the Act. Section 29 of the PNDT Act, 1994 requires that all the documents be maintained for a period of 2 years or until the disposal of the proceedings. The PNDT Rules, 1996 requires that when the records are maintained on a computer, a printed copy of the record should be preserved after authentication by the person responsible for such record.

Ownership of Medical Records:
An important issue of dispute between the patient and the treating hospital is about the ownership of the medical records. By and large medical records are the property of the hospitals and it is the responsibility of the hospitals to maintain it properly. The hospitals and the doctors have to be careful with medical records as these can be stolen, manipulated, and misused for malafide reasons by any interested parties. Hence, the records should be in safe custody. It is the primary responsibility of the hospital to maintain and produce patient records on demand by the patient or appropriate judicial bodies. However, it is the primary duty of the treating doctor to see that all the documents with regard to management are written properly and signed. An unsigned medical record has no legal validity. The patient or their legal heirs can ask for copies of the treatment records that have to be provided within 72 hours. The hospitals can charge a reasonable amount for the administrative purposes including photocopying the documents. Failure to provide medical records to patients on proper demand will amount to deficiency in service and negligence.

Summoning Medical Records by Courts:
Medical records are acceptable as per Section 3 of the Indian Evidence Act, 1872 amended in 1961 in a court of law. These are considered useful evidence by the courts as it is accepted that documentation of facts during the course of treatment of a patient is genuine and unbiased. Medical Records that are written after the discharge or death of a patient do not have any legal value. Erasing of entries is not permitted and is questionable in Court. In the event of correction, the entire line should be scored and rewritten with the date and time.
Medical records are usually summoned in a court of law in the following cases:

• 1. Criminal cases for proving the nature, timing, and gravity of the injuries. It is considered important evidence to corroborate the nature of the weapon used and the cause of death
• 2. Road traffic accident cases under the MACT Act for deciding on the amount of compensation
• 3. Labor courts in relation to the Workmen's Compensation Act
• 4. Insurance claims to prove the duration of illness and the cause of death
• 5. Medical negligence cases- these can be in criminal courts when the charge against the doctor is for criminal negligence or under the Consumer Protection Act for deficiency in the doctor's or hospital's care

It is usual to summon a doctor to appear in court to testify and to bring all the medical documents. When the court issues summons for medical records, it has to be honored and respected as it is a constitutional obligation to assist in the administration of justice. The records can also be produced in court by the medical records officer of the hospital. If the doctor is required to be present for giving evidence based on the medical records, he has to be present in the court to give evidence. The court may require these documents to be submitted for which a record is issued by the court. However, if the records are required for continuation of the medical treatment of the patient, copies can be kept by the hospital.

Judicial Decisions in India on Issues of Medical Records:

There have been many judicial decisions pertaining to medical records from various courts in India and a review of some of the important ones is given in this section.
The National Commission had held that there was no question of negligence for failure to supply the medical records to patients unless there is a legal duty on the hospital to give the records. The alleged hospital had provided a detailed discharge summary to the patient. However, the Bombay High Court held that doctors cannot claim confidentiality when the patient or his relatives demand medical records. With the enforcement of the MCI Regulations, 2002 it has been held without confusion that the patient has a right to claim medical records pertaining to his treatment and the hospitals are under obligation to maintain them and provide them to the patient on request.
The hospital and doctor were guilty of deficiency in service as case records were not produced before the court to refute the allegation of a lack of standard care. The plea of destroying the case sheet as per the general practice of the hospitals appeared to the court as an attempt to suppress certain facts that are likely to be revealed from the case sheet. The opposite party was found negligent as he should have retained the case records until the disposal of the complaint.
Not producing medical records to the patient prevents the complainant from seeking an expert opinion. It is the duty of the person in possession of the medical records to produce it in the court and adverse inference could be drawn for not producing the records. The State Commission held that there was negligence as the case sheet did not contain a proper history, history of prior treatment and investigations, and even the consent papers were missing.
The State Commission held that failure to deliver X-ray films is deficient service. The patient and his attendants were deprived of their right to be informed of the nature of injury sustained. The State Commission disbelieved the evidence of the surgeon because only photocopies were produced to substantiate the evidence without any plausible explanation regarding the absence of the original.
The allegation of not informing the possibility of vocal cord palsy was negated by the detailed written consent that showed that it was explained properly and consented. The allegation of the patient regarding negligence of the doctor was rejected.
The allegation of tampering with the operation notes was negated by the State Commission in a case of intra-operative death as the complainant could not prove the allegation.
The hospital was held vicariously liable for the negligent action of the doctor on the basis of the bill showing the professional fees of the doctor and the discharge certificate under the letterhead of the hospital signed by the doctor. The State Commission held negligence on the basis of the records, which seemed to be manipulated. Issues of tampering of medical records need detailed examination in a civil court rather that in Consumer Court. The National Commission in another case held that the hospital was guilty of negligence on the ground that the name of the anesthetist was not mentioned in the operation notes though anesthesia was administered by two anesthetists. There were two progress cards about the same patient on two separate papers that were produced in court.
Not maintaining confidentiality of patient information can be an issue of medical negligence. The HIV status of a patient was known to others without the consent of the patient.

Consent

Another major and important thing to do for a doctor is to obtain proper consent of the patient / attendant / relative.
The term ‘consent ‘ is defined thus : When two or more persons agree upon the same thing in the same sense they are said to consent as per the definition of ‘consent ‘ given in section 13 of Indian Contract Act, 1872.
Who can given consent : For the purpose of clinical examination diagnosis and treatment consent can be given by any person who is conscious, mentally sound and is of and above twelve years of age as provided under sections 88 and 90 of the Indian Penal Code, 1860.
Doctors are reminded that consent is taken under section 13 of the Indian Contract Act, 1872. This Act, however also provides under Section 11 that only those persons who are of and above 18 years of age are competent to enter into a contract. Since doctor-patient relationship amounts to entering into a contract, it is advisable that consent should be obtained, specially written consent, from parents / guardian of a patient who is below 18 years so that validity of the contract is not challengeable.
When a consent is not valid: Consent given under fear, fraud or misrepresentation of facts, or by a person who is ignorant of the implications of the consent, or who is under 12 years of age is invalid ( Sec. 90 I.P.C.).
In most of the cases filed against the doctors it is alleged that no consent was obtained. Obtaining of a consent will thus be a cornerstone of protection against litigation. Depending upon the circumstances in each case consent may be implied, express or informed.

Implied consent ( Tacit consent )
This is by far the most common variety of consent in both general practice and hospital practice. The fact that a patient comes to a doctor for an ailment implies that he is agreeable to medical examination in the general sense. This, however, does not imply consent to procedures more complex that inspection, palpation, percussion, auscultation and routine sonography. For other examinations, notably rectal and vaginal and withdrawal of blood for diagnostic purpose, express consent ( oral or written ) should be obtained. For more complicated diagnostic procedures, e.g., lumbar puncture, radiology, endoscopy, C.T. Scan, etc. express written consent should be obtained.

Express consent
Anything other than the implied consent is express consent. This may be either oral or written. Express oral consent is obtained for relatively minor examinations or therapeutic procedures, preferably in the presence of a disinterested third party. Express written consent is to be obtained for : (i) all major diagnostic procedures, (ii) general anesthesia, (iii) for surgical operations,(iv) intimate examinations, (v) examination for determining age, potency and virginity, and in medico-legal cases.

INTRODUCTION
There has been a definite increase in the number of suits that have arisen because of lack of consent or inadequate consent from the patients for various procedures. This is due to significant changes in the doctor patient relationship with the impact of technology in day-to-day practice. More and more patients are aware of their rights and are keen to make free choice and decision on their treatment A lot of remedial work needs to be done to minimize future litigation, as many doctors misunderstand their legal obligations and haven’t caught up with the change in judge’s thinking It is seen that there is lack of knowledge and not enough awareness of the legal and ethical requirements and clinical aspects of consent in Medicine in India. This paper discusses the ethical, legal and clinical aspects of informed consent.

INITIAL APPROACH TOWARDS CONSENT
The traditional doctor-patient relationship and its medical ethical principle required that the physician do what he thought would benefit the patient. Traditional doctor-patient relationship was one in which the doctor and the patient were unequal bargaining partners in a contract for services with the doctors special knowledge creating the advantage. The principle of mutual trust protected these decisions. The medical profession even refused to recognize the wishes of the patient and felt that he knows what is best for the patient – a paternalistic attitude. The physicians failed to accept that the patient is entitled to make his own free choice and decision the principle of autonomy.

CHANGE IN APPROACH The change in environment and awareness of rights of patients has eroded the old model. The emerging model prefers to treat a doctor as a service provider for hire, governed by negotiation and a commercial relationship. The patient today, chooses to have the ability to select and dismiss their doctors. They have the resources and can express their preferences about making decisions on general or even specific treatments. They prefer to ask questions, reject proposals offered by the doctors based on their own personal opinion. The clinical-ethical process of shared decision-making is mirrored by the legal doctrine of Informed Consent.(IC) Informed consent is meant to force the doctor to give the patient the knowledge that will make him an equal bargaining partner. Thus informed consent is meant to transform the essence of the doctor-patient relationship to a contractual one as contractual relationships are thought to promote individual autonomy and freedom of choice.

MEANING OF INFORMED CONSENT Informed consent is defined as voluntary acceptance by a competent patient of a plan for medical care after the doctor adequately discloses the proposed plan, its risks and benefits, and alternative approaches and options that the patient has. Informed consent needs to meet two essential requirements, firstly it needs to be free and voluntary and secondly it needs to be based on adequate reasonable information and disclosure made by the doctor.
Consent is said to be free when it is not caused by coercion, undue influence, fraud, misinterpretation or mistake. The consent must be to do a lawful act and it must not disobey any provision of the law. A Consent would be referred to as informed if it is given by a person after receipt of the following information: the nature and purpose of the proposed procedure or treatment; the expected outcome and the likelihood of success; the risks; the alternatives to the procedure and supporting information regarding those alternatives; and the effect of no treatment or procedure, including the effect on the prognosis and the material risks associated with no treatment. Also included are instructions concerning what should be done if the procedure turns out to be harmful or unsuccessful.
Common meaning of consent is permission whereas the law perceives it as a contract i.e. an agreement enforceable by law. In consent there are four separate but correlated elements that are: voluntary ness, capacity, knowledge and decision-making. Voluntary ness suggests willingness of patient to undergo treatment. Capacity means a degree of ability of the patient to understand the nature and consequences of the treatment offered. Knowledge means that sufficient amount of information about the nature and consequence of the treatment has been disclosed to the patient. Decision-making means the ability to take decisions regarding consent. To be legally valid all these elements must be present in the consent.

TYPES OF CONSENT Consent can be three types namely implied, expressed or presumed.
When a patient approaches a doctor, an implied consent is there for taking history, general physical examination etc which would enable the doctor to treat the patient.
An expressed consent can be written or oral. This type of consent is taken if there is no implied consent or when any material risk is involved. Expressed consent includes informed consent, which is the ideal form of consent because it includes all aspects of meaningful decision-making. Expressed consent can be oral and verbal.
Oral consent is generally taken for some specific medical procedures like injecting medication, drawing blood for pathological examination, gynecological examinations etc. Oral consent can be proved in court if it was taken in the presence of witnesses or if the doctor records in the case record of the patient that oral consent was taken.
Written consent is taken for major medical procedures and surgery. Written consent to undergo medical treatment and forms the best defence for a doctor to evade criminal liability.
Further, the code of medical ethics laid down by the Medical Council of India (approved by the Central Government under section 33 of Indian Medical Council Act, 1956) contains a chapter relating to disciplinary action which enumerates a list of responsibilities, violation of which will be professional misconduct. Clause 13 of the said chapter places the following responsibility on a doctor to obtain expressed consent (in writing). “13. Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of a 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.”
Presumed consent is important in cases of emergency when consent cannot be taken. Another example of presumed consent as practiced in some countries (U.S.A., Spain and France) is in postmortem cases where unless there is a pre-recorded objection or an intimation of objection from the next of kin of deceased prior to death, corneas can be removed for transplantation. Presumed consent allows the removal of organs, unless the decedent has opted out or the family objects i.e. unless there is a pre-recorded objection or an intimation of objection from the next of the kin of the deceased.

LEGAL ISSUES INVOLVED WITH CONSENT
AGE AT WHICH VALID CONSENT CAN BE GIVEN
Unlike India, many countries have legislated age for giving valid consent for medical examination and procedures.
S.90 of the Indian Penal Code provides ‘Consent by intoxicated person, person of unsound mind or a person below twelve years of age is invalid’. By implication from Section 90 IPC, one can say that in general a boy or girl can consent to medical or surgical treatment if he or she is above twelve years of age provided the treatment is intended for his or her benefit and is undertaken in good faith. Thus going by this school of thought a doctor cannot be held criminally liable if a person above 12 yrs has consented to undergo the treatment suggested by him.
Another school of thought however feels that valid consent can only be given at or above eighteen years of age. They feel that consent is a contract between two parties and as the Indian Contract Act states that to enter into a contract both parties must be at least eighteen years of age, this should be the age for giving valid consent in medicine. However the Indian Contract Act does not specifically applies to medicine.
In the absence of clear cut legislation in this regard majority of doctors consider the consent of a person above twelve and less than eighteen years valid for medical examination only and for medical procedures prefer to take the consent of the parents/guardians. They feel this will be of benefit in cases involving civil liability. To resolve this matter legislation should be passed specifying age for giving valid medical consent, as has been done in other countries, so that arbitrariness can be done away with and legal problems avoided.

COMPETENCE
Capacity to give valid consent is an essential consent is an essential element of Informed Consent. The aspect of age at which valid consent can be given to undergo a specific medical treatment has been discussed above. However there are several other factors that determine the competence of a person.
The ethical dimension of informed consent encourages respect for individual autonomy in medical decision-making. There are however conditions that substantially limit autonomy and therefore also autonomous choice. People with a learning disability or a mental or physical illness may be temporarily incapacitated to make autonomous choices due to their condition. In these cases the concepts of capacity and competence become paramount in determining the extent to which a person’s autonomy is restricted and whether that person can give a valid consent.
Competence is a legal term, and courts decide on the competence of a person based on the inputs provided to it by the doctors who give an opinion on the capacity of the patient The disability should materially incapacitate the person to comprehend facts and make independent decisions.
Some psychiatric disorders can impair decision-making functions to some extent, but not to the point where patients would be considered legally incompetent. In such cases, clinicians can make disclosure in a manner that takes patients’ limitations into account which may include simplifying elements of the disclosure, offering information in smaller amounts stretched out over time, and repeating disclosure several times.

EXCEPTION TO CONSENT a. Doctrine of Emergency: In medical emergencies consent need not be obtained if circumstances are such that it is impossible for that person to give consent.
Under section 92 of Indian Penal Code (IPC) treating without consent of patient is permissible if patient is unconscious, mentally ill or gravely sick. When the time required for disclosure would create a substantial risk of harm to the patient or third parties, full disclosure requirements may not apply. It is implied that the procedure / surgery is done to save the life or limb of the patient. If possible, surrogate/proxy consent should be taken.
b. Waiver: Patients may waive their rights to receive information. This should be a knowledgeable and informed waiver, i.e. patients should be made aware that they have a right to receive the information, to designate a surrogate to receive the information, or to be informed at a later date.
In emotionally disturbed patients the doctor should request a specialist consultation to establish that the patient is emotionally disturbed. The procedure requires the doctor to make a note of their withholding the information and the reason for doing so.
d. Incompetence: This exception to informed consent had been discussed in detail above. Incompetent patients may not, as a matter of law, give an informed consent as they do not possess the capacity to fully understand and comprehend the situation so as to enable them to make a reasonable decision. State law generally provides alternative mechanisms by which consent can be obtained, and requires disclosure to a substitute decision-maker. Procedure requires that when a person is incapable of giving expressed consent a substituted consent can be taken from the next of kin. Generally accepted order is spouse, adult child, parents, siblings, and lawful guardian.
e. Involuntary treatment: Psychiatric treatment is allowed to be carried on without patients’ informed consent. This occurs most commonly when patients’ refusals of treatment are specifically overridden following clinical, administrative, or judicial review.
f. It is important to appreciate that in a particular situation such as court ordered evaluations for competency to stand trial, consent is not required. In such a case a psychiatrist should inform the subject and explain that the evaluation is legally required and if the subject refuses to participate in the evaluation this fact will be included in any report or testimony. An arrested person can be examined without consent if requested to do so by a police officer not below the rank of a Sub-Inspector (Section 53 IPC).
g. Consent of one spouse is not necessary for an operation (including MTP) or treatment of another. For contraceptive sterilization consent of both husband and wife should be taken.
The concept of informed consent has comes to the fore in recent years and many actions have been brought by patients who alleged that they did not understand the nature of the medical procedure to which they gave consent. All information must be explained in comprehensible non-medical terms preferably in local language about the (a) diagnosis, (b) nature of treatment,(c) risks involved, (d) prospects of success, ( e) prognosis if the procedure is not performed, and (f) alternative methods of treatment. The physician’s duty to disclosure is subject to the exceptions : (a) if the patient prefers not be informed and (b) if the doctor believes in the exercise of coming to a sound medical judgement, that the patient is so disturbed or anxious that the information provided would not be processed rationally or that it would probably cause significant psychological harm. This is known as Therapeutic Privilege. In such a case it is advisable that the doctor should consult the patient’s family physician. Revelation of risk is always a compromise between reasonable information and the danger of frightening off the patient from beneficial treatment. The three important components of such consent are information, voluntariness and capacity. ( See Model Form of Informed Consent at the end of this Chapter).

Proxy Consent ( Substitute consent )
All the above types of consent can take the shape of Proxy Consent. Parent for child, close relative for mentally unsound /unconscious patient, etc. Situations where consent may not be obtained

• 1. Medical Emergencies. - The well being of the patient is paramount and medical rather than legal considerations come first.
• 2. In case of person suffering from a notifiable disease. - In case of AIDS/HIV positive patients, the position in India regarding its being a notifiable disease or not is not yet clear. However, in England the Public Health ( Infectious Diseases) Regulations, 1988 extend the provisions of notifiable diseases to AIDS but not to persons who are HIV positive.
• 3. Immigrants.
• 4. Members of Armed Forces.
• 5. Handlers of food and dairymen.
• 6. New admission to Prisons.
• 7. In case of a person where a court may order for psychiatric examination or treatment.
• 8. Under Section 53 (1) of the Code of Criminal Procedure, a person can be examined at request of the police, by use of force. Section 53 (2) lays down that whenever a female is to be examined, it shall be made only by, or under the supervision of a female doctor.

Situations Requiring Extra Caution
Doctors should keep in mind certain high-risk situations which are common causes for medical negligence actions, and require extra caution.

• 1. Failure to attend - These are particularly frequent where children are concerned, especially in relation to acute abdominal emergencies, meningitis and chest infections.
• 2. Retention of objects in operations sites - Swabs, packs, instruments or towels may be left behind in the field of operation. The responsibility remains with the surgeon.
• 3. Accident & Emergency Departments - This is the most hazardous part of the hospital and senior staff must be readily available to supervise the work.
• 4. Amputation of the wrong limb, digit or operation of wrong eye/tooth - This is a common mishap. Carelessness in hospital notes, errors in pre-operative skin marking and failure to check notes against the patient in the operating theater are the common reasons for the misadventure.
• 5. Emergency, Orthopedics and obstetrics - Surgery, Orthopedics, obstetrics, plastic-surgery, and gynaecology are ‘high-risk specialties. Missed fractures (especially the scaphoid) tight plaster casts and poor results from spinal procedures are common complaints in orthopedics. In obstetrics, damage to the newborn from anoxia or forceps procedures major damage claims. Failed sterilization / Vasectomy is again a common cause for litigation.
• 6. Anesthesia - Anesthetists along with surgeons, present a common target for litigation ; the actual administration of the anesthetic is not usually the cause of complaint, but the many ancillary responsibilities such as transfusions, injections, airways, i.e. catheters, diathermy, and hot water bottle burns may form grounds for allegations of negligence. One of the serious mishaps is the production of cerebral damage from hypoxia due to failure to maintain oxygenation during the operation. Inattention rather than failure to maintain oxygenation is the more common cause, and recent surveys have shown that inexperienced junior anesthetists are a major cause of problems.
• 7. Therapeutic hazards - These can be avoided by :
  • 1. Administering the right drug, the right dose, via the right route, e.g., in case of potassium chloride, insulin, antibiotics, spinal anesthesia.
  • 2. Informing patients / attendants of the potential risks of treatment.
  • 3. taking all possible steps to avoid undesirable consequences.
• 8. Failure of Communication - A doctor should inform about the patient’s medical condition in comprehensible language. IN case of reference to another doctor, it is his responsibility to communicate directly with the second doctor and not rely on the patient to carry any informal message.

What should a doctor do in the event of a medical mishap ?
When something untoward happens following a diagnostic or therapeutic procedure, or when a patient or relative makes a complaint, the doctor must take appropriate steps, some of which may be :

• 1. Complete the patient’s record and recheck the written notes.
• 2. Be frank enough and inform clearly of the mishap. Show that you were genuinely concerned about the unfortunate mishap. Answer all the queries of patient / relative and do not mind their repeated questioning, harsh attitude and at times even abusive language. Keep in mind the mental state of the close relatives / friends. Be compassionate. Try to remain on the scene as long as possible. Try to engage less excited attendants into discussion on the mishap and indirectly try to bring into focus the circumstances under which the mishap occurred. Doctors who are open-minded and communicative are much less likely to be complained against as patients / attendants are extremely forgiving of errors made by a friendly and concerned medical attendant.A high proportion of complaints are precipitated or escalated into legal action by a progressive breakdown of the doctor-patient communication.
• 3. After these initial responses, the doctor should contact some other doctor / protection organization to seek advice. The Medical Associations, Medical Practitioners’ Society, Hospitals and Nursing Homes’ Associations, etc. could form groups / cells to advise and assist in such situations. In future Medical defense organizations could be formed to take up cases of defence on behalf of doctors against alleged medical negligence.

I ..................................... son of ............................... aged ................ resident of ........................................... being under the treatment of ....................................... (state here name of doctor/hospital/nursing home) do hereby give consent to the performance of medical /surgical /anesthesia/ diagnostic procedure of ....................................................... (mention nature of procedure / treatment to be performed, etc.) upon myself/upon ................................................... aged ............. who is related to me as ................................... (mention here relationship, e.g. son, daughter, father, mother, wife, etc.).

I declare that I am more than 18 years of age. I have been informed that there are inherent risks involved in the treatment / procedure. I have signed this consent voluntarily out of my free will without any pressure and in my fell senses.

Place :

Date : SIGNATURE

Time : ( To be signed by parent /guardian in case of minor)

NOTES :

• 1. This Consent Form should be signed BEFORE the treatment is started. These formats may be modified as per individual requirements or experiences of Hospitals / Nursing Homes.
• 2. These formats should be in local language and in certain cases it would be prudent to record a proper witness to signature consent.
• 3. Informed consent forms for various situations can be made for Nursing Homes / Hospitals. Help of lawyers may have to be taken. Detailed forms on Medical history can also be maintained. Keep all records in order and safely.
• 4. It is important to note that written consent should refer to one specific procedure. Obtaining a ‘blanket’ consent on admission does not have legal validity

FORMAT OF GENERAL CONSENT FORM
(to be filled & signed by the patient / relative of patient while admitting the patient in Hospital for treatment)

I HEREBY CERTIFY THE FOLLOWING FACTS :

• That I want to get myself / my patient admitted and treated at …………………. …………………………, ………….(Name of Hospital and address of Hospital/nursing home). The decision of coming here is purely on my discretion. Nobody has forcibly motivated me/my patient from any other Medical Institute / Establishment.
• 2. That I am fully aware and satisfied with the facilities available for the care of myself/ my patient viz. Beds, Power Supply, Manpower & other infrastructures.
• 3. That I have full faith in the staff of this Hospital/Medical Establishment and I am ready to undergo any type of Surgery or Medication, major or minor as decided in emergency by staff or concerned doctors attending the patient at that time.
• 4. That I promise to clear all the dues of myself / my patient regardless of the end result of the illness treatment of me / my patient.
• 5. That I fully understand and agree that the fees charged by the Doctor / Hospital is for the professional service rendered to me / my patient during the illness regardless of the end result of the illness.
• 6. That I have been explained that there is no guarantee for the “Cure” of the disease seeing the vast unpredictability of Medical Science, this is an effort for the treatment.
• 7. That I have been explained that the Doctor will visit the patient according to the schedule even in emergency exist. Engagements with other patient, natural calamities, his/her personal engagement, and busy schedule, etc., I will abide his schedule.
• 8. That I have been explained that if too many low general condition patients are lying at one time, Doctor will focus the attention to the most deserved one according to his/her criteria, I fully agree with this schedule.
• 9. That I promise to not misbehave either with the Doctor or the staff of Hospital; I know that indecency on my part will demoralize the staff. Also I promise to follow all the regulations ordered by the staff in emergency situations.
• 10. That I have been thoroughly explained about the type & severity of the disease and complications of anesthesia and surgery and the risk of life involve in Medication and drug allergies, too.
• 11. That I give consent for ……………………………….operation of my patient, at my own risk.
  
  • a. I know there is unpredictable risk in Surgery and Anesthesia.
  • b. My / My patient’s condition is critical and there is risk of life during or after the operation.
  • c. I know that my patient’s condition is such that the surgery is the only alternative to save his/her life and the Surgeon is not willing to operate but as a last resort request, the surgeon to do surgery at my own risk.
  • d. I give consent for any change of plan during operation, in need.
  • e. I have been told that the operation will be done under general / local anesthesia. I have read / been explained (in Hindi & English) the above contents of form and fully understand the text of matter. I will abide, by the regulations of the hospital and also everything written in this form.
  • f. All type of Hospital & procedural changes have been explained to me and I give the consent to change the same as per requirement.

Signature & Thump Impression Of Relative/Friend of the patient With name & address & Phone No.

Signature & Thump Impression of the Patient or Gaurdian with name & address & phone No.

Witness
1. ………………………………………………………………………………………(Signature, Name & Address)
2. ………………………………………………………………………………………(Signature, Name & Address)

On 7th August 2009, the Supreme Court of India (SC) passed the final verdict in the “Anuradha Saha” wrongful death case. The Supreme Court has held four eminent Kolkata doctors (Sukumar Mukherjee, Abani Roychowdhury, Baidyanath Halder and Balaram Prasad) and Advanced Medicare Research Institute (AMRI), a premier private hospital in Kolkata, responsible for causing death of Anuradha Saha from medical negligence. The SC has sent the case back to the National Consumer Disputes Redressal Commission (NCDRC) solely to determine the quantum of compensation (out of a claim of Rs. 77.7 crore plus interests for the past 11 years) that these doctors and hospital must now pay for causing death of Anuradha Saha. In addition, the SC has also imposed a penalty of Rs. 5 lakh and Rs. 1 lakh against AMRI hospital and Dr. Sukumar Mukherjee, respectively, for their stance.

The Apex Court has made numerous observations in this historic judgment that will have far-reaching consequences for deciding cases against doctors and hospitals in India. The SC has also set categorical rules about “patients’ rights” and duty of the doctors/hospitals toward their patients in this judgment. Failure of any of the new rules, as established by the Apex Court in the Anuradha death case, would amount to “medical negligence” in India. Article 141 of the Indian Constitution mandates that the law declared by the Supreme Court shall be binding on all courts within the territory. All future cases of “medical negligence” must be decided after considering the views expressed by the SC in the “Anuradha Saha” death case. The members of the medical community are also urged to learn the specific new laws for medical negligence in view of this historic judgment.

To view the most important points that have emerged from this judgment and its possible significance for “medical negligence”

Recent SC Judgment has no bearing on the future cases against the medical negligent doctors

The Supreme Court (SC) on February 10, 2010 passed a judgment dismissing an appeal for compensation against the Batra Hospital in Delhi. There is absolutely no new observation in this judgment that could even remotely affect future cases of “medical negligence”. The two-judge bench depended on several past judgments by the Apex Court and foreign courts to come to the decision in this particular case.

Ironically, the bench did not cite the two most recent and historic judgments on “medical negligence”, i.e. Anuradha Saha judgment passed on August 7, 2009 (see below) and the Rs. 1 crore verdict against the NIMS hospital passed by the SC on May 14, 2009 (NIMS vs. Prasanth Dhananka). The laws about “medical negligence” as settled in these two momentous judgments still prevail across India. Unfortunately, the influential medical lobby and a section of the media have blown this inconsequential judgment out of proportion. They have tried to paint this as a major victory for all errant medicos and a blow for all victims of medical negligence who are fighting to find justice. There is absolutely no merit to these boisterous claims, which would be evident from a simple reading of the new judgment (click here for the complete judgment).

NEW DELHI: The Delhi Consumer Commission has upheld a lower forum order, directing a city-based hospital and its doctor to pay Rs five lakh compensation to the family of a victim of medical negligence.

"Negligence becomes actionable on account of injury resulting from the act or omission amounting to negligence attributable to the person sued. In the present case, all the three ingredients-- duty, breach and resulting damage, of negligence are satisfied," the Commission Bench headed by president Justice Barkat Ali Zaidi said.

Appellants Vimhans hospital and Dr A K Banerji approached the Commission, challenging the order of the Delhi District Forum which awarded Rs five lakh as compensation to the heirs of the patient, who died after being operated there in 2004.

The commission noted that the neck movement and blood pressure of the patient was found to be normal before the operation but developed complications soon after the surgery.

The appellants contended that the family members were told about the risk associated with the operation and there were no negligence on their part as she died due to cardiac arrest.

The commission said that from the medical tests of the deceased before the operation, it was clear that the patient was not suffering from any heart-related disease.

Deceased Meera, suffering from neck pain, was hospitalised in 2004 on doctor's advice. Her condition deteriorated post-surgery and she died later.

Chandigarh, December 26, 2007 The District Consumer Disputes Redressal Forum-I has directed Dr NS Bhambra of Chuttani Medical Centre to pay Rs 1 lakh as compensation for medical negligence of a patient.

It is the second time in less than ten days that Dr Bhambra has been asked to pay compensation of Rs 1 lakh for medical negligence

The forum has also asked Dr Bhambra to pay Rs 2,100 as litigation cost to the petitioner, Kusum Lata, a resident of Kullu.

According to the patient, she had approached Dr Bhambra for medical examination and the doctor had advised her to undergo Laparoscopic Surgery of gall bladder at the centre. She was operated upon in December 2003. After the surgery, however, Kusum suffered from high temperature and was tested positive for tuberculosis. Kusum alleged that she had no symptoms of the disease before she was operated upon.
She asserted that the equipment used for the operation were not sterilised, and the medical centre was responsible for the infection.

Dr Bhambra in his reply, however, denied that Kusum contracted tuberculosis after the surgery. He further stated that the complainant was not healthy as she was already suffering from back problem. The hospital said that equipment used for the operation were sterilised and no glands could appear on the body of the complainant on account of the said surgery.

ACTION AGAINST A DOCTOR:

A doctor in Hyderabad has been disqualified from practising for three months by the Medical Council of India (MCI) for his role in the death of an Indian diplomat's pregnant wife due negligence.
In March 2003, Indian diplomat K. Srikar Reddy, posted in Germany, lost his wife Srilatha and his unborn baby during labour in a Hyderabad hospital due to medical negligence.
Consumer court awarded compensation of Rs 15 lakh to widow for medical negligence of doctors
Dec 6, 2009
Mumbai: The State Consumer Disputes Redressal Commission has awarded a Thane widow a hefty compensation of Rs 15 lakh—one of the highest given in the state in the recent past—after penalising three doctors for medical negligence that led to her husband’s death.

Kalyani Raut’s husband, Bharat, died in April 2003, allegedly because of lack of facilities at a Thane hospital. He was admitted there for an operation of a tumour on his shoulder. While the surgery was being performed Bharat’s condition deteriorated and he died on the operation table. With his death, the family—Kalyani and her three children—was left with no earning member. “I was left with the huge responsibility of bringing up the kids,’’ she said.

Soon after, the Rauts lodged a complaint against the hospital and the three doctors with the directorate of health services, which appointed a committee to probe the incident. Kalyani also moved the apex consumer court in the state in 2004, demanding compensation from the doctors. The government team found negligence on the part of the doctors who operated on Bharat and the report submitted was used as an evidence in court. After hearing the matter and examining the report, state commission presiding judicial member P N Kashalkar ordered the doctors to pay a compensation as well as an interest of 6% on the amount, to be calculated from the date when the complaint was lodged.

When Kalyani was suddenly rendered a widow, she was too old to get employed to any place; so she has been doing odd jobs since 2003 to support her family. “I sold saris in Thane slums and middle-class housing colonies,’’ she said on Saturday. She also runs a small tiffin service but it depends on the number of lunch or dinner orders she gets in a day. Her entire family has been living on a monthly income of Rs 6,000. Her lawyers, Rajiv Thakur and Shilpa Ovalekar, did not charge her a single penny to contest her case. “We hope that the Medical Council of India and the local administration debar these doctors from practising as mentioned in the order,’’ Thakur said.