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:
- Maintain indoor records in a standard proforma for 3 years from commencement of treatment (Section 1.3.1 and Appendix 3).
- Request for medical records by patient or authorized attendant should be acknowledged and documents issued within 72 hours (Section 1.3.2).
- 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).
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 aquiring 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:
- 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
- Road traffic accident cases under the MACT Act for deciding on the amount of compensation
- Labor courts in relation to the Workmen's Compensation Act
- Insurance claims to prove the duration of illness and the cause of death
- 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.[1] However, the Bombay High Court held that doctors cannot claim confidentiality when the patient or his relatives demand medical records.[2] 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.[3] 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.[4]
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.[5] 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.[6]
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.[7] 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.[8]
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.[9] 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 intraoperative death as the complainant could not prove the allegation.[10]
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.[11] The State Commission held negligence on the basis of the records, which seemed to be manipulated.[12] Issues of tampering of medical records need detailed examination in a civil court rather that in Consumer Court.[13] 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.[14]
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.[15]
REFERENCES
1. Poona Medical Foundation v Marutturao Tikare. 1995;1 CPR 661(NC)
2. Raghunath Raheja v The Maharashtra Medical Council and Ors AIR. Bombay: 1996. p. 198.
3. Kanaiyalal Ramanlal Trivedi v Dr. Satyanarayan Vishwakarma. 1996;3 CPR 24 (Guj); I (1997) CPJ 332 (Guj); 1998 CCJ 690 (Guj)
4. S.A.Quereshi v Padode memorial Hospital and Research Centre II. 2000. CPJ 463 (Bhopal)
5. Dr. Shyam Kumar v Rameshbhai, Harmanbhai Kachiya. 2002;1 CPR 320, I (2006) CPJ 16 (NC)
6. Force v. M Ganeswara Rao. 1998;3 CPR 251; 1998 (1) CPJ 413 (AP SCDRC)
7. V P Shanta v. Cosmopolitan Hospitals (P) Ltd. 1997;1 CPR 377 (Kerala SCDRC)
8. Devendra Kantilal Nayak v Dr. Kalyaniben Dhruv Shah. 1996;3 CPR 56; I (1997) CPJ 103; 1998 CCJ 544 (Guj)
9. C Anjani Kumar v Madras Medical Mission. 1998;2 CPR (Chennai); I (1998) CPJ 533 (Chennai); 1998 CTJ 504 (CP) (SCDRC); 1999 CCJ 915 (TN)
10. Sethuraman Subramaniam Iyer v Triveni Nursing Home. 1997;2 CPR 144 (NC); I (1998) CPJ 10 (NC); 1998 CTJ 7 (CP) (NCDRC); 1998 CCJ 1532 (NC)
11. P.P. Ismail v K.K. Radha. 1997;2 CPR 171 (NC); I(1998) CPJ 16 (NC); (1997) 5 CTJ 685 (CP) (NCRDC); 1999 CPJ 99 (NC)
12. Nihal Kaur v. Director, PGI, Chandigarh. 1996;3 CPJ 112 (Chandigarh (UT) CDRC)
13. Harenbalal Das v Dr. Ajay Paul. 2001;2 CPR 498.
14. Meenakshi Mission Hospital and Research Centre v. Samuraj and Anr., I(2005) CPJ (NC)
15. Dr. Tokugha Yeptomi V Appollo Hospital Enterprises Ltd and Anr III. 1998 CPJ 132 (SC)
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2779965/
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