Summary of the LAW of CONSENT

(ref.:Indian J Radiol Imaging. Aug 2008;18(3): 195–97)

Extracts from the Supreme Court's Judgment:

i. A doctor has to seek and secure the consent of the patient before commencing a ‘treatment’.

The consent so obtained should be real and valid, which means that: the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what he is consenting to.

ii. The ‘adequate information’ to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit to the particular treatment or not. This means that the doctor should disclose
(a) the nature and procedure of the treatment and its purpose, benefits, and effect; (b) alternatives, if any, available;
(c) an outline of the substantial risks; and
(d) adverse consequences of refusing treatment. 

But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment, which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.

iii. Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the unauthorized additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defense in an action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure, though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until patient regains consciousness and takes a decision.

iv. There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery.

v. The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment.’

Book reviewed by Dr. VP Singh (MD,LLB)

http://www.anilaggrawal.com/ij/vol_014_no_002/reviews/tb/page001.html

Major surgery done without ensuring availability of Life-saving equipment (ventilator) to manage complications – Medical negligence

M. Rajavadivelu v. Janamma Hospital

Date of Judgment 4.3.2013 by National Consumer Disputes Redressal Commission, New Delhi.

Facts: In his complaint to the State Commission, Appellant had contended that his late wife Mrs. Vijayalakshmi had been admitted to Respondent No.1/ Hospital on 2-1-1998 for undergoing Hysterectomy, which was done on 3-1-1998 by Respondent No.2 under general anaesthesia administered by Respondent No.3. It was informed that surgery was successful and the patient would recover within one hour.

However, at 9.45 a.m. Appellant was told by the Respondents that the Patient had developed breathing problems and would need to be shifted to the nearby Chennai Kaliappa Hosp. for ventilator support. Ambulance was sent from that Hospital. Shifting the Patient to ambulance took about 10 minutes, no doctor accompanied the Patient in the ambulance and only a nurse was present. During the transit period in ambulance Patient was again deprived of oxygen since the oxygen was not pumped to the Patient through an ambu bag. This delay proved to be fatal.

In the admission sheet of Chennai Kaliappa Hospital it was found - Patient was not conscious and the pulse rate and heart sounds were not heard. She was shifted to ICCU and connected to the ventilator with a diagnosis of Hypoxic Encephalopathy due to lack of oxygen to the brain. Tracheotomy was done on 4-1-1998. Patient shifted to Ramachandran Medical College Hosp However, Patient passed away on 3-4-1998.

It was contended that Patient expired due to medical negligence and deficiency in service. After the surgery was over when there was breathing problem, life-saving equipments like a ventilator were not available in the Respondent No.1/Hospital. If Patient had been put on a ventilator and sufficient oxygen to the brain had been ensured she would not have suffered Hypoxic Encephalopathy, which caused her death. Time taken to shift the Patient to the Chennai Kaliappa Hospital took about an hour, which proved fatal.

Order of State Commission: “There is nothing on record to show that the opposite parties had committed anything wrong in the performance of the surgery and administration of anesthesia. Opposite party-3 deposed that the patient regained consciousness after surgery and that there was no Hypoxia during surgery and there was no reintubation after surgery. Oxygen cylinder was available in the ambulance which carried the patient to Chennai Kaliappa Hospital. A well trained nurse accompanied the patient. No medical code expects that the patient must be accompanied by the surgeon and anaesthetist when she is being shifted to another hospital.

The first charge relating to negligence falls to the ground.

As regards the allegation regarding the non-pre- assessment tests before administering anaesthesia, the witness examined by the complainant viz., P.W.II expert has clearly admitted that he had no occasion to peruse the discharge summary as well as pre-assessment chart.          

There are no allegations with regard to the administration of the anaesthesia by the complainants. It is not the case of the complainants that the death occurred due to administration of anaesthesia. The patient died only after a period of three months. The expert P.W.II has not been able to give the cause for the death. His evidence is an interested one.

The opposite party-3 is a Senior Anesthetist and having rich experience for several decades. There is no legal evidence to prove the negligence on the part of the opposite parties.”

National Commission Held: It is admitted by the Respondents that soon after the surgery the Patient developed breathing problems, that there was no ventilator facility in the Respondent No.1/Hospital, which necessitated Patient being shifted to a nearby Hospital.

Had a ventilator been available and the required oxygen administered to the Patient by Respondents, she would not have suffered from Hypoxic Encephalopathy which led to her death some weeks later.

It is medically well established that Hypoxic Encephalopathy occurs when the brain does not receive enough supply of oxygen which can be fatal because as little as within 5 minutes of oxygen deprivation, brain cells can begin dying. In the instant case, Respondents have themselves admitted that they took 10 to 15 minutes to transfer the Patient to the ambulance and thereafter some more time to the Hospital, which was undoubtedly fatal in this case.

The Respondents should not have conducted a major surgery like Hysterectomy under general anaesthesia without ensuring that such life saving facilities were available in their Hospital. Further, they should have ensured that oxygen through ambu bag was available in the ambulance because a Patient with breathing problems cannot breathe the required oxygen through the oxygen tube/catheter attached to the oxygen cylinder.

Medical negligence and deficiency in service is established. Respondents are jointly and severally directed to pay the Appellant 3 lakhs within a period of 3 months, failing which it will carry interest @ 9% per annum for the period of default. 

Patient given first aid / treatment but not hospitalized – No need to maintain medical records

Shri Mahesh Prasad Aggarwal v/s M/s. Kamayani Patients Care India Ltd

The National Consumer Commission held that a doctor / hospital treating a patient or giving first aid does not have to maintain medical records of that patient if the patient is not hospitalized. 

The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 lays down that “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”.

Thus Hospitals or nursing homes are bound to prepare, preserve and provide medical records of only those patients who are hospitalized and none else.

In Shri Mahesh Prasad Aggarwal v/s M/s. Kamayani Patients Care India Ltd., the patient was on his way to Agra when his vehicle overturned. He was rushed to a nearby hospital where he was examined by doctors, CT scan and x-ray were done, and his hand was plastered. In the meantime the patient’s father and younger brother, a doctor having his own nursing home in Agra, arrived and the patient was taken away to his home. The family then decided to shift the patient to Delhi, but he died in the ambulance in transit.Patient’s family alleged negligence in treating and also in failure to give proper documents at discharge.

Hospital stated that the statutory provisions regarding maintaining medical records or giving documents at discharge were applicable only for indoor patients. In this case the patient was merely given first aid. It was further pointed that the patient was advised hospitalization but his family took him away.

National Consumer Commission held that the patient was never admitted in the hospital and hence the relevant regulations did not apply. The Commission held that there was nothing wrong if the hospital did not maintain record of the patient who was given first aid but never hospitalized.

Workshop on MLR Writing held at DMC&Hospital, Ludhiana.

 

Workshop-on-medico-legal-report-writing

Detailshttp://112.196.11.34/dailypost/Details.aspx?id=26445&boxid=57979&uid=&dat=2012-03-19

http://epaper.bhaskar.com/detail.php?id=127327&boxid=31924010171&ch=cph&map&currentTab=tabs-1&pagedate=03%2F19%2F2012&editioncode=84&pageno=5 

DMC & Hosp., Ludhiana organized a “workshop on MedicoLegal Report Writing” on 17^th March, 2012. Theme of the workshop was to improve the Quality of MedicoLegal Reports being prepared by the doctors. More than 60 delegates from North India actively participated in ‘Hands on Training program’. The workshop provided in depth knowledge about medical and legal aspects of MLR writing. Punjab Medical Council awarded two credit hours to the event. Dr. Arun Mitra, Member PMC, was the ‘Guest of Honor’. He informed about CME credit hours mandatory for all the registered medical practitioners. Dr. Daljit Singh Principal, DMCH, inaugurated the workshop and  also informed that similar training programs will be regularly organized every year to train fresh post graduate residents of the institute. Dr. Gautam Biswas (Org. Chairperson) welcomed the delegates and emphasized the importance of MLR preparation on a structured format. He delivered a lecture on medicolegal issues related to structured format of MLR.

Dr. V. P. Singh (Org. Secretary) informed that, “Role of good quality medicolegal documents in administration of justice is very crucial. DMCH has pioneered, by organizing this ‘Hands on Training program’ on MLR writing. This is an endeavor to improve the quality of medicolegal documentation in Indian healthcare system”. He also delivered a lecture on ‘Procedure of MLR Writing’ and emphasized the importance of standards and checklist in MLR writing. He further said that such medicolegal training programs are extremely essential for doctors handling medicolegal cases.

Resource Faculty from eminent Medical colleges of North India, delivered guest lectures during the workshop. Dr. Sandeep Puri (MS, DMCH) and Dr. Anju Gupta (Prof & Head , Forensic Medicine, PIMS, Jalandhar) chaired the scientific session. Dr. D. Harish from GMCH, Chandigarh, delivered a guest lecture on procedure of MLR preparation in firearm injury cases. Dr. Anil Kohli from UCMS, New Delhi, discussed medicolegal issues related to expert opinion on nature of injuries.

IMA opposes Rural Health Course

Continuing its protest against the government's decision to introduce a three-and-a-half-year-long Bachelor of Rural Health Course (BRHC) in the country, the Indian Medical Association has now called upon medical students and young doctors from across the country to join their agitation. The Association has also threatened to intensify its agitation by wearing black bands and going on an hour-long token strike in case the government does not pay heed to their demand of withdrawing the proposed course.
“It is unfortunate that the government has decided to go ahead with its plan to start the BRHC despite strong opposition. We have now called upon young doctors from across the country to be a part of the protest movement to ensure that the government has a chance to listen to the grievances of those who are going to be adversely affected by the introduction of this new course,” said IMA joint secretary Dr. Narendra Saini.
He said it is not just young doctors who would be adversely hit but the course would also affect the health of rural India as the course would “produce half-baked doctors”.
“Next month, doctors across the country will protest by wearing black bands on one day and the next month we will participate in a token strike. This is to drive home the point that doctors are unhappy with the introduction of the course. There is also a general consensus among medical students and young doctors on the ill effects of such a move. These doctors have joined under the banner Young Doctors' Federation to highlight their problems and to ensure that there is sustained pressure on the government to take back the course,” added a senior IMA official.
In a statement, the Association noted that through the introduction of the course, the government will produce “semi-qualified quacks” which will further expose the patients to several problems.
Source: The Hindu, 24, Feb, 2011. http://www.thehindu.com/news/cities/Delhi/article1487057.ece

Driving licence to indicate desire to donate organ

If the Union Health Ministry has its way, driver’s licences will indicate if the holder wants to donate organs after death.
In an ambitious plan to decrease the gap between the demand and supply of organs, the government is considering earmarking a designated space, indicating “donor”, on the driving licence.
The idea, officials say, will soon be communicated to the Ministry of Road Transport and Highways.
The ministry has got a sample driving licence from the US so that the same design and matter could be replicated here.
“At least, the intention of a dying person will be known to doctors, who can thereafter convince the family,” said a senior ministry official.
In a bid to streamline organ donation, the government also proposes to allow swap donation, tissue donation and expand the definition of near relatives to include grandparents and grandchildren in the Transplantation of Human Organs (Amendment) Bill 2009, which is likely to see light of the day soon.
With the amendments ready, the ministry proposes to table the final draft of the Bill, which may be called “Transplantation of Human Organs and Tissues Act” (THOTA), during the budget session.
The amendments were recommended by the Standing Committee on Health and Family Welfare last year. Tissue donation will include heart valves, bones transplantation, cornea, skin and vessels.
Once passed by Parliament, a pair of donor and recipient who are near relatives but whose organs do not medically match for transplantation will now be permitted to “swap organs” with another pair of such persons.
However, the approval of an authorization committee that will be constituted by the state governments and Union Territories will be required. The composition of the committee will be prescribed by the Centre.
The Health Ministry accepted about 43-odd recommendations of the Standing Committee to widen the scope of organ donation.
After the Cabinet passes it, the proposed Bill will be sent to the Law Ministry and then tabled in Parliament during the Budget Session.
Earlier, near-relatives included spouse, son, mother, daughter, father, brother, sister. Now, it adds grandparents and grandchildren.
The Bill enhances the penalty for unauthorised removal of human organs and for receiving or making payment for human organs up to 10 years of imprisonment and Rs. 25 lakh fine.
In case the donor or recipient is a foreign national, prior approval of the authorisation committee will be mandatory.
“In case the recipient is a foreigner and the donor is Indian, donation will be allowed only if they are relatives,” said a senior official in the ministry.
The government is also considering “required request” for patients dying in the intensive care unit (ICU). “If the patient is brain dead, the incharge of the ICU can give the option of donation to the family,” added the official.

http://www.indianexpress.com/news/health-ministry-for-driving-licence-to-indicate-desire-to-donate-organ/746991/0

“How to prevent litigation in Medical Practice? Do’s and Don’ts for a doctor.”
In ancient times, Medical Practice was more of an art than anything else. At that time healers were considered God. Then the medical profession evolved as a science. Still the doctors were considered next to God. The relationship between doctor and patient was of faith and trust. But now it has become more of a Business. Modern Medical Science has ignored the healing of soul or psyche of a patient leading to patient dissatisfaction. Recently there has been marked development in the medical profession and the concept of Quality Care has emerged. Expectation of the patient has grown tremendously. In today’s world of consumerism the patient is very intelligent. He has a lot of medical information even before consulting the doctor. For him there is no difference between buying a car or getting the medical services. To add to the insult, our doctor colleagues are no less. Doctors generally criticize their colleagues without realizing the consequences. Patient becomes aware of the deficiencies in health sector, ultimately leading to increased litigation.
The nature of our profession is such that it is prone to litigation. We are dealing with life and death of humans and cannot get 2nd chance to rectify the mistake. We must take some active steps so as to prevent the litigation. Every doctor must be aware towards his legal duties and should take the following precautions in the medical practice: Don’t assure 100% results. Take informed written consent. In cases of medico-legal implications do inform the police and keep documentary proof of the same. Avoid giving prescription on phone. Give extra time to potential litigants. Get the necessary investigations done and keep the record. Full record of the patient should be maintained. Keep a photocopy of the certificate issued. Put a stamp on every prescription/certificate mentioning your name, qualifications, registration number. Write legible and complete prescription. Give proper instructions regarding dosage, duration and likely effect and side effect of the medicine. Take extra caution in case of emergencies. Always ensure that the drug to be administered is properly identified. If a serious patient is to be referred, do it fast and explain everything to the relatives. Keep track of the patient and show your concern. Do not delay the treatment particularly in serious patients.
In Malpractice Litigation, medical records are most important. Extra care should be taken in preparation handling and storage of the records. Always remember 5Cs in relation to medical records. They should be clean (legible), comprehensive, clear, correct and in chronological order. Take written, informed consent in a standard format. Informed refusal must also be documented. History in detail must be recorded. Date and Time are extremely important. All nursing care record (Temp charts, diet charts etc) must be maintained with date & time. Investigations ordered and their results must be maintained with date & time. Name & Signature of the treating doctor must be identifiable. Avoid Overwriting, white fluid. Cutting of any word should be done by putting a single line. Medical notes carry confidential information. It should not be left by the bedside of the patient and should be in the custody of responsible staff on duty. Photocopy is to be supplied within 72 hrs of written request. Hand over after verifying identity of the demanding person. Each page must be numbered and carry name of the patient.

A good prescription is one which is legibly written and includes the following:
1. Name, age and address of the Patient.
2. Date and Time of Prescription.
3. Name of the Drug, Strength.
4. Dosage form, Total amount.
5. Instructions, Warnings.
6. Signature, Name, Qualification and Registration No. of the doctor.

Analysis of 45 malpractice cases showed that most of the doctors who were sued, delivered information poorly and devalued the patient’s views. Doctors who can’t communicate well are more likely to end up in court. Good Communication a golden key. It Improves Physician – Patient relationship. A good communication is also likely to reduce the clinical errors and improve patient satisfaction. Research shows that 70% of communication efforts are not heard or rejected or misunderstood. Then how to communicate? Spoken Words, Body Language, Eye Messages, Written Words are various means of communication and all are equally important and must be taken care of while dealing with the patients or their relatives.
We doctors must take these active steps so as to improve the physician – patient relationship and thus preventing the litigation in medical practice. It is a well known principle of science that for every action there is equal and opposite reaction. And it is only the reaction, which is coming from the patients. If we can control/modify the action, definitely there will be no litigation against us.
Dr.V.P.Singh MD, LLB, PGDMLS. Medico-Legal Consultant

Medical Records do not fall under RTI unless public interest is attached

New Delhi, Jan 12 (IANS) The Delhi High Court Tuesday ruled that income tax returns and medical records do not fall under the purview of Right To Information (RTI) Act 'unless public interest is attached' holding in its landmark judgment that the Chief Justice of India (CJI) came under the ambit of the transparency law.
Quoting an American writer that 'one man's freedom of information is another man's invasion of privacy', a full bench of Chief Justice Ajit Prakash Shah and Justices S. Muralidhar and Vikramjit Sen said: 'Personal information including tax returns, medical records etc. cannot be disclosed in view of Section 8(1)(j) of the act.'
'If, however, the applicant can show sufficient public interest in disclosure, the bar (preventing disclosure) is lifted and after duly notifying the third party (the individual concerned with the information or whose records are sought) and after considering his views, the authority can disclose it,' they said.
Highlighting how the right to information often clashes with the right to privacy, the court noted that the government stores a lot of information about individuals, supplied by the individuals themselves in applications made for obtaining various licences, permissions including passports, or through disclosures such as income tax returns or for census data.
'When an applicant seeks access to government records containing personal information concerning identifiable individuals, it is obvious that these two rights are capable of generating conflict,' the court said, adding that 'in some cases, this will involve disclosure of information pertaining to public officials. In others, it will involve disclosure of information concerning ordinary citizens. In each instance, the subject of the information can plausibly raise a privacy protection concern.'
However, the court ruled that notes made by the judges do not come under the RTI act, the court said the notes taken by judges while hearing a case cannot be treated as final views expressed by them on the case. 'They are meant only for the use of the judges and cannot be held to be a part of a record 'held' by the public authority. However, if the judge turns in notes along with the rest of his files to be maintained as a part of the record, the same may be disclosed.'
Maintaining that the right to information may not always have a linkage with the freedom of speech, the court said: 'If a citizen gets information, certainly his capacity to speak will be enhanced.'
'But many a time, he needs information which may have nothing to do with his desire to speak. He may wish to know how an administrative authority has used its discretionary powers. He may need information as to whom the petrol pumps have been allotted. The right to information is required to make the exercise of discretionary powers by the executive transparent and, therefore, accountable because such transparency will act as a deterrent against unequal treatment,' the court said.

Clinical Establishments (Registration and Regulation) Bill, 2010

The government has approved a Clinical Establishments (Registration and Regulation) Bill, 2010 for bringing all clinics in the country under one law that would go towards creation of a "national registry" and boost health services in the country.
The bill was cleared at a cabinet meeting here presided over by Prime Minister Manmohan Singh. It is likely to be introduced in the budget session of Parliament, beginning Feb 22.