Friday, 25 March 2016

Is it obligatory for hospitals to provide copy of the case record to patient or his legal representative?

Is it obligatory for hospitals to provide copy of the case record to patient or his legal representative? Dr SS Agarwal, Dr KK Aggarwal, Ira Gupta, Rahul Gupta Yes, it is obligatory for doctors, hospitals to provide the copy of the case record or medical record to the patient or his legal representative. The preamble to the Constitution of India coupled with the Directive Principles of State Policy strives to provide a welfare State with socialist patterns of society. It enjoins the State to make the “improvement of public health” a primary responsibility. Furthermore, Articles 38, 42, 43 and 47 of the Constitution provide for promotion of health of individuals as well as health care. The Constitution of India also enumerates the separate and shared legislative powers of Parliament and State Legislatures in three separate lists: the Union List, the State List and the Concurrent List. The Parliament and State legislatures share authority over matters on the Concurrent List, which include criminal law and procedure. Health service includes securing citizen from medical negligence by punishing concerned for crime of medical negligence and compensating the damage caused by doctor or hospital through negligence under tort action or securing the enforcement of contractual obligation under law of contract. Consumer Protection Act is another legislation which is aimed at preventing negligence and deficient services besides assuring right to information about medical treatment given to the patient at the threat of imposing compensation. The Medical Council of India has imposed an obligation on Hospitals as per the regulations notified on 11th March 2002, amended up to December 2010 to maintain the medical record and provide patient access to it. These regulations were made in exercise of the powers conferred under section 20A to be read with section 33(m) of the Indian Medical Council Act, 1956 (102 of 1956), by the Medical Council of India, with the previous approval of the Central Government, relating to the Professional Conduct, Etiquette and Ethics for registered medical practitioners, namely: Maintenance of Medical Records: 1.3.1. Every physician shall maintain the medical records pertaining to his/her indoor patients for a period of three years from the date of commencement of the treatment in a standard proforma laid down by the Medical Council of India and attached as Appendix 3. 1.3.2. If any request is made for medical records either by the patients / authorised attendant or legal authorities involved, the same may be duly acknowledged and documents shall be issued within the period of 72 hours. MCI ethics regulations 7.2 further clarifies that not giving records can amount to professional misconduct. Misconduct: “7.2 If he/she does not maintain the medical records of his/her indoor patients for a period of three years as per regulation 1.3 and refuses to provide the same within 72 hours when the patient or his/her authorised representative makes a request for it as per the regulation 1.3.2.” With the enforcement of the MCI Regulations, 2002 it is made clear 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. In Kanaiyalal Ramanlal Trivedi v Dr. Satyanarayan Vishwakarma 1996; 3 CPR 24 (Guj); I (1997) CPJ 332 (Guj); 1998 CCJ 690 (Guj), the Hon’ble High Court of Gujarat has held that 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. In Raghunath Raheja v Maharashtra Medical Council, AIR 1996 Bom 198, Bombay High Court upheld the right of patient to medical record very emphatically. Judges M. Shah and A. Savanth stated: “We are of the view that when a patient or his near relative demands from the Hospital or the doctor the copies of the case papers, it is necessary for the Hospital authorities and the doctors concerned to furnish copies of such case papers to the patient or his near relative. In our view, it would be necessary for the Medical Council to ensure that necessary directions are given to all the Hospitals and the doctors calling upon them to furnish the copies of the case papers and all the relevant documents pertaining to the patient concerned. The hospitals and the doctors may be justified, in demanding necessary charges for supplying the copies of such documents to the patient or the near relative. We, therefore, direct the first respondent Maharashtra Medical Council to issue necessary circulars in this behalf to all the hospitals and doctors in the State of Maharashtra. We do not think that the hospitals or the doctors can claim any secrecy or any confidentiality in the matter of copies of the case papers relating to the patient. These must be made available to him on demand, subject to payment of usual charges. If necessary, the Medical Council may issue a press note in this behalf giving it wide publicity in all the media.” In the matter titled as 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), the Hon’ble National Commission for Consumer Dispute Redressal Forum held the hospital 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. In S. A. Quereshi v Padode Memorial Hospital and Research Centre II 2000. CPJ 463 (Bhopal), it was held that 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. In case of Dr. Shyam Kumar v Rameshbhai, Harmanbhai Kachiya 2002;1 CPR 320, I (2006) CPJ 16 (NC), the Hon’ble National Commission of Consumer Dispute Redressal Forum has held that not providing medical records to the patient prevents the complainant from seeking an expert opinion and 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 Hon’ble Kerala High Court in the matter titled as “Rajappan Vs. Sree Chitra Tirunal Institute for Medical Science and Technology [ILR 2004 (2) Kerala 150]” has held that: “It is also to be noticed that Regulations do not provide any immunity for any medical record to be retained by any medical practitioner of the hospital from being given to the patient. On the other hand it is expressly provided that a patient should be given medical records in Appendix 3 with supporting documents. Therefore in the absence of any immunity either under the Regulations or under any other law, the respondent Hospital is bound to give photocopies of the entire documents of the patient. Standing counsel for the respondent Hospital submitted that the documents once furnished will be used as evidence against the hospital and against the doctors concerned. I do not think this apprehension will justify for claiming immunity against furnishing the documents. If proper service was rendered in the course of treatment, I see no reason why the hospital, or staff, or doctors should be apprehensive of any litigation. A patient or victim's relative is entitled to know whether proper medical care was rendered to the patient entrusted with the hospital, which will be revealed from case sheet and medical records. There should be absolute transparency with regard to the treatment of a patient and a patient or victim’s relative is entitled to get copies of medical records. This is recognized by the Medical Council Regulations and therefore petitioner is entitled to have copies of the entire medical records of his daughter which should be furnished in full. The Hon’ble Central Information Commission has examined the issue of right of patient to have the medical records in the matter titled as Nisha Priya Bhatia v Institute of Human Behaviour and Allied Sciences GNCTD, bearing File No.CIC/AD/A/2013/001681SA vide order dated 23.07.2014 has held that “The Patient has a right to his/her medical record and Respondent Hospital Authorities have a duty to provide the same under Right to Information Act, 2005, Consumer Protection Act, 1986, The Medical Council Act as per world medical ethics. The Commission recommended the Public Authority to develop a timeframe mechanism of disclosure of medical records to patients or their relatives with safeguards for privacy and confidentiality of the patient”. In the matter titled as Shri Prabhat Kumar versus Directorate of Health Services, GNCTD, Delhi, the Hon’ble Central Information Commission vide order dated 07.04.2015 has held that: “The Commission recommends the Government of India, states and Union Territories, besides the respondent authority in this case, to take necessary steps to enforce the right to information, i.e., forcing the private hospitals to give medical records of the patients on day to day basis, because this daily disclosure will prevent undesirable practices of altering records after damage caused to patient. Forcing the private hospitals to provide daily wise medical records will also act as a check on some hospitals from resorting to CIC/SA/A/2014/000004 Page 30 extortionist, inhuman and ruthless business of prescribing unnecessary diagnostic tests, unnecessary surgical operations, caesarean deliveries, unwarranted angioplasties, inserting stents, without need, or of substandard nature, or putting low quality stent while collecting price of high quality stent, and several such malpractices amounting to medical terrorism, etc. They should not be allowed to such malpractices with all impunity and get away without any legal consequences as if there is an absolute immunity. The Government, Medical Council of India and the health regulatory has to see that licence to practice medicine will not become licence to kill and extort and come to the rescue of helpless patients.” A Bombay High Court ruled against Ruby Hall clinic and said that patient has a right over his record with the hospital and hospital should provide copy of it within a reasonable time (MMC says 3 days) and hospital is entitled to charge a reasonable amount for the same. A hospital should provide a copy of the patient's medical record when requested by the patient. But the above right cannot be enforced under the MCI, 2002, Regulations. The patient's indoor medical case sheet is a property of the hospital and the patient has only a right to get a copy, not the original record. In Medi. Supri. Loknayak Jaiprakash Narayan Hospital & Ors. V/s. K.M. Santosh. F.A. No. 244/2008, decided on 14/03/2016, the National Commission observed: “5. 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 hospital 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. It is the duty of doctor or hospital to preserve, maintain the medical record for certain specified period under different laws like Limitation Act, Consumer Protection Act and the Directorate General of Health Service (DGHS), Prenatal Diagnostic Test Act, 1994, the Clinical Establishments (Registration and Regulation) Act, 2010 (Central Act No. 23 of 2010). These records are required in medical negligence, accident, insurance claims and in criminal cases also in the Labour Courts. Hon’ble Supreme Court and the National Consumer Commission in various judgments held the hospitals/doctors liable for medical negligence for non-production of medical record.” 6. “Smart people learn from their mistakes. But the real sharp ones learn from the mistakes of others.” I have explained previously also about umpteen no of judgments which underlines the importance of keeping proper record & documentation and also the ill effects of failure. There is no escape for proper documentation. Always remember POOR RECORD IS POOR DEFENSE AND NO RECORD IS NO DEFENSE. For how long should the records of patients be maintained? • As per the proposed / draft “Clinical Establishments (Registration and Regulation) Rules, 2010, “Copies of all records and statistics shall be kept with the clinical establishment concerned for at least 3 or 5 years or in accordance with any other relevant Act in force at the time”. • As per Regulation 1.3.1 of the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002, “Every physician shall maintain the medical records pertaining to his / her indoor patients for a period of 3 years from the date of commencement of the treatment in a standard proforma laid down by the Medical Council of India and attached as Appendix 3”. • As per Rule 6F (3) of the Income Tax Rules, 1962, doctors in private practice are required to preserve the daily case register as per Form 3C for a period of six years from the end of the relevant assessment year. That would ordinarily mean for seven years from the close of the accounting year. • As per Punjab Medical Manual (1934), the medicolegal record is to be preserved for 12 years. • As per the DGHS vide letter No. 10-3/68-MH dated 31-8-68, records should be maintained as follows: For inpatient medical records (case sheets)……………….10 years For medico-legal registers…………………………………….10 years For outpatient records………………………………………….5 years The above requirement can be found in the “Hospital Manual” published in 2002 by the Directorate General of Health Services, MOHFW, GOI, in chapter 12 titled “Medical Record Services”. In summary, medical records belong to the medical professionals / entities but patients generally have a right to review them, demand copies of them, and to demand their confidentiality as per the MCI ethics regulations.

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