MEDICAL RECORDS vis-a-vis MEDICAL NEGLIGENCE

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. It is very important for the treating doctor to properly document the management of a patient under his care. This will be the only way for the doctor to prove that the treatment was carried out properly. A properly obtained consent of the patient 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.

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.

Legal Provisions Regarding Medical Records :

Ordinarily, hospitals and nursing homes should preserve records of patients for not less than 3 years, so that when a case is filed :

(i) Under the CP Act, where the limitation for filing a complaint is 2 years;

(ii) Or under law of court, where the limitation is 3 years, record can be produced in defense of your case, or it may be required to be produced by the consumer forum or civil court but in new-born cases, medical records should be preserved for not less than 3 years after the child attaining majority age of 18 years, the reason being that such minor’s cause of action subsists upto 2 years after attaining majority under the C.P. Act and upto 3 years under the civil law.

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.

Criminal Negligence

As regards criminal liability of medical practitioners, Supreme Court in a recent judgment in the case of Dr. Suresh Gupta vs. Govt. of Delhi curtailed criminal proceedings against medical negligence to incidents of gross negligence. It held that a medical practitioner cannot be held punishable for every mishap or death during medical treatment. No criminal liability should be attached where a patient’s death results from error of judgment or an accident. Mere inadvertence or some degree of want of adequate care and caution might create civil liability but would not suffice to hold him criminally liable.

Even where gross negligence is alleged, a prima facie case must be established before a magistrate at the first instance as was pointed out in Dr. Anand R. Nerkar vs. Smt Rahimbi Shaikh Madar It is necessary to observe that in cases where a professional is involved and in cases where a complainant comes forward before a Criminal Court and levels accusations, the consequences of which are disastrous to the career and reputation of adverse party such as a doctor, the court should be slow in entertaining the complaint in the absence of the complete and adequate material before it.

In Jacob Matthew V State of Punjab the apex Court has also laid down guidelines for prosecuting doctors:

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

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

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

N.B. The limit of penalty imposed on opposite party, if the complaint made against medical practitioners is found to be frivolous or vexatious (as per the amendment in section 26 of the CPA in 1993) should be exceeded from present Rs. 10000/- to Rs. 50000/- so that frivolous complaints will be reduced.

Medical Practice and its Legal obligations

Medical Profession - Ethics and Legality in India

Query. Can a Medical Practitioner legally de-associate himself or refrain from treating a patient?

Ø  There are only a few or limited grounds on which medical professionals can refuse treatment to a patient. One is when the patient refuses to follow the treatment advised by the doctor.  Another is when a patient already under the care of one doctor approaches another for treatment. Such patients cannot be accepted unless they are referred by their first doctor, or they leave the care of the first doctor. Finally, a patient whose treatment is beyond the expertise of the doctor can be directed to an expert. Let us now discuss in detail.

INDIAN MEDICAL COUNCIL (PROFESSIONAL CONDUCT, ETIQUETTE AND ETHICS) REGULATIONS, 2002, provide as follows:

Regulation 2. DUTIES OF PHYSICIANS TO THEIR PATIENTS

Obligations to the Sick

2.1.1 Though a physician is not bound to treat each and every person asking his services, he should not only be ever ready to respond to the calls of the sick and the injured, but should be mindful of the high character of his mission and the responsibility he discharges in the course of his professional duties. In his treatment, he should never forget that the health and the lives of those entrusted to his care depend on his skill and attention. A physician should endeavour to add to the comfort of the sick by making his visits at the hour indicated to the patients. A physician advising a patient to seek service of another physician is acceptable, however, in case of emergency a physician must treat the patient. No physician shall arbitrarily refuse treatment to a patient. However for good reason, when a patient is suffering from an ailment which is not within the range of experience of the treating physician, the physician may refuse treatment and refer the patient to another physician.

2.1.2 Medical practitioner having any incapacity detrimental to the patient or which can affect his performance vis-à-vis the patient is not permitted to practice his profession.

The Patient must not be neglected

Again, as per Regulation 2.4: A physician is free to choose whom he will serve. He should, however, respond to any request for his assistance in an emergency. Once having undertaken a case, the physician should not neglect the patient, nor should he withdraw from the case without giving adequate notice to the patient and his family. Provisionally or fully registered medical practitioner shall not willfully commit an act of negligence that may deprive his patient or patients from necessary medical care.

However in case of serious illness and in doubtful or difficult conditions, the physician should request consultation, but under any circumstances such consultation should be justifiable and in the interest of the patient only and not for any other consideration.

In every consultation, the benefit to the patient is of foremost importance. All physicians engaged in the case should be frank with the patient and his attendants.

Patients Referred to Specialists

Regulation 3.6 : When a patient is referred to a specialist by the attending physician, a case summary of the patient should be given to the specialist, who should communicate his opinion in writing to the attending physician.

In the matter of medical referral, there is also another ethical consideration with medico- legal significance. It is the question of primary responsibility. This depends on the nature of the referral. If for instance, it is a consultation between general practitioner and specialist, the latter is mainly responsible for the continued care and concern for his patient. The general practitioner merely follows the advice of the consultant, reporting to him the progress of the patient so as to modify therapy or obtain further instructions with regard to continued care.

Act not intended to cause death, done by consent in good faith for person's benefit

As per Section 88 of the Indian Penal Code 1860:

Nothing which is not intended to cause death, is an offence by reason of any harm which it may cause, or be intended by the doer to cause, or be known by the doer to be likely to cause, to any person for whose benefit it is done in good faith, and who has given a consent, whether express or implied, to suffer that harm, or to take the risk of that harm.

Illustration

A, a surgeon, knowing that a particular operation is likely to cause the death of Z, who suffers under a painful complaint, but not intending to cause Z's death, and intending in good faith, Z's benefit performs that operation on Z, with Z's consent. A has committed no offence.

Scope

Consent is good defence to all offences in general. But if once it is proved in a case of rape that the girl in question was below 16 years, her consent becomes wholly irrelevant and the accused is liable for the offence as if no consent were obtained; Harpal Singh v. State of Himachal Pradesh, AIR 1981 SC 361.

Here it would also be expedient to refer the Law Commission of India (196^th Report) on ‘Medical Treatment to Terminally ill Patients (Protection of Patients and Medical Practitioners)’

Every medical practitioner who takes a decision to withhold or withdraw medical treatment must maintain a register giving details as to why he is or is not satisfied that a patient is competent and as to why he considers the patient has or has not taken an informed decision, as to the opinion of the experts from the panel; the age, sex, address of the patient and what is in the best interests of the patient and other particulars. The information will have to be kept confidential.

·         The medical practitioner has to inform the patient (if he is conscious) or parents or relatives about his decision to withhold or withdraw treatment and if they desire to move the High Court, he has to wait for 15 days and if no orders are received from the High Court, he can proceed.

·         A copy of the contents of the register relating to each such patient shall be lodged, as a matter of information, with the Director General of Health Services or Director of Medical Sciences, as the case may be, immediately on the taking of a decision to withhold or withdraw treatment and an acknowledgement therefore will have to be obtained. The above authorities will also have to keep the information confidential.

Conclusion : Being a professional in his own right, the doctor/ Medical Practitioner certainly has an ethical right to refuse to treat a patient, who will, in his view, not follow treatment directions to their logical ends. This right not to treat or accept for treatment also extends to those situations where a patient approaches a doctor insisting on a predetermined mode or line of treatment and to some other situations mentioned above. But all such actions must conform to the moral, ethical and legal values.