- Email: [email protected]
The Law, Science and Art of Consent-A Gynaecologist's Approach
Quality in Health
THE LAW, SCIENCE AND ART OF CONSENT–A GYNAECOLOGIST’S APPROACH Urvashi Prasad Jha* and Swasti** *Gynaecological Laparoscopic & Gynae-Onco-Surgeon & Academic Co-ordinator, **Clinical Assistant and Research Fellow, Department of Obstetrics & Gynaecology, Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi 110 076, India. Correspondence to: Dr. Urvashi Prasad Jha, Senior Consultant Gynaecological Laparoscopic & Gynae-OncoSurgeon & Academic Co-ordinator, Department of Obstetrics & Gynaecology, Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi 110 076, India. e-mail: [email protected], [email protected]
COUNSELING of patients and obtaining valid consent is mandatory before any therapy is instituted. In keeping with the changing times, fortunately utilization of health services, medical awareness and right to information have become a way to life today. The medical profession needs to keep abreast.
physically handling or interfering with the patient’s body constitutes assault. This may lead to disciplinary procedures, civil claim or even criminal prosecution. The law regarding consent
Sadly, and perhaps justifiably, in some instances the public at large views doctors with suspicion. It is imperative that patients comprehend all aspects of their health care and get involved in medical decision making to leave no or little room for doubt. Providing adequate and appropriate medical information in proper perspective to each and every patient is a duty of the doctors and a right of the patient or client. Doing so avoids unnecessary doubts, prevents possible litigation and forms the basis of obtaining a fully informed valid written consent from most patients. There will still be those, who despite all clarifications verbal and written, will fail to fully comprehend the implications of all that has been discussed with them. Failure of adequate bilateral communication and of being in denial are equally important valid reasons for this. The science of obtaining consent is discussed in this chapter. The art needs to be developed individually with experience. The law must be understood to protect both the patient and the doctor. Even the Hippocratic oath has metamorphosized to become contemporary as instituted by many visionary medical schools [1-3]. Counseling and consent form an integral part of medical practice today and must be included in part of medical education programmes.
Mandatory components of legal consent [5] The patient must fulfill all the following criteria in order to give valid legal consent: (a) Have capacity – This implies that the patient must have sufficient mental competence to make an independent choice (b) Have voluntariness – For this consent must be without duress, fraud, coercion, mistake, undue influence or misrepresentation (c) Have knowledge – The patient must also have the necessary and sufficient information provided with regards to transactions regarding the disease and available treatment options before giving consent. In addition to these the physician must ascertain any unusual stress, anxiety, fear or depression the patient may have for the consent to be legal. Certain terminology in relation to finding deficiency with medical services by the law is given below. This is critical when judging whether or not there was deficiency in the service provided by a doctor.
DEFINITION OF CONSENT [4]
The Human Rights Act requires the patient to receive sufficient information prior to consenting. With regards to that a ‘reasonable physician standard’ is level of information which is provided by a typical physician.
Under common law, every person has the right to protect their bodily integrity against invasion by others including by doctors. A failure to obtain patient’s consent prior to Apollo Medicine, Vol. 5, No. 1, March 2008
For consent to be legal the patient must fulfill certain criteria, the doctor must abide by certain guidelines and the documentation be methodical and comprehensive and follow specific norms.
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This is mostly inconsistent and for the most part inadequate in India today – international standards, however, are available.
patient's actions. As an example – it is presumed that the patient understands commonly known procedures such as agreeing to have a blood pressure recorded when she puts forward her arm for getting her BP measured.
A ‘reasonable patient standard’ is the information required by an average patient to be able to give consent to any medical intervention. Based on both these facts, judgments are made as to whether there was deficiency in obtaining an appropriate informed consent or not.
3. Expressed consent (oral or written) is by patient’s sounds and actions or is written. Consent for obtaining personal sensitive history and performing an examination must be rechecked by the doctor as by asking “Is it alright with you if I ask you details of your sexual history?”Another example is as in asking the patient to expose her breasts for clinical examination. If she undresses and does so, it implies expressed consent for a breast examination. Hence, the importance in current times of a chaperone even in an out patient clinic when examining a patient of the same or the opposite sex.
Subjective standard is used to assess whether tailoring of information to an individual patient or to the relevant disease, procedure or co-morbid condition is legally and ethically debatable. The law requires that basic information be provided to a patient even if that patient requests a doctor to take a decision on his or her behalf and refuses to receive the information. If stressed, the patient may decline to receive any information. If this is the case, it is essential to document it especially in a high risk patient. Even so, basic information has to be provided to the patient. Beware of not informing a cancer patient of her condition prior to operating at the request of her sympathetic relatives! Post surgery she has every right to sue you, if you have done so.
4. Presumed consent is one that is presumed or is applicable in emergency situations. What is immediately necessary should only be done in emergency conditions. A ‘second opinion’ may be seeked before performing any additional procedure not discussed or not lifesaving but mandatory. For the most part an unconsented procedure may be performed at a later date after obtaining a fully informed consent. The “Principle of beneficence may require health professionals to act for the patient’s benefit on her behalf only when her life is at stake”. In fact delaying unnecessarily in these circumstances in order to obtain consent may constitute negligence. It is best if the second opinion is taken in writing from a colleague who has concurred with performing the procedure in emergency or unexpected situations.
Medical negligence can come under the following: (i) In cases of appeal for deficient services compensation is payable (the case is then that of an appellant vs respondent). (ii) Under law of Torts – Torts implies conduct that is twisted or wrongful as in civil cases (the case would be that of a petitioner vs defendant or respondent).
Goals of informed consent
(iii) Under criminal law when any hazardous act is undertaken, the punishment for which is usually imprisonment. (The case would then be filed by the complainant vs the accused.)
Obtaining a valid consent must be a lawful act and not be against morality. An informed consent is “an ethical & moral obligation of doctors to patients” [1]. In the social and cultural scenario in our country, providing of all of the above information should ideally include close relatives or friends. This inclusion ofcourse, should be with the consent of the patient. In the unfortunate event of a death or a subsequent mental incapacitation of the patient, this is always helpful. Their inclusion in the discussion must be documented in the out patient or inpatient records as happened.
Terminology of different types of consent 1. Informed consent is one that is taken after giving complete information of relevant medical facts, benefits and risks to the patient and subsequent implications of both positive and negative results of the intervention. This may be for a diagnostic test even as in obtaining consent for cancer screening. It may be oral or written. Written informed consent is mandatory in most situations particularly for performing invasive procedures or surgical operations. 2. Implied consent – Consent may be ‘implied’ by a
The goals of taking an informed consent are to:
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Provide clarification or explanation to the patient.
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Relieve stress of the unknown to the patient. Apollo Medicine, Vol. 5, No. 1, March 2008
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help patient participate in the health care decision making.
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External medical examination of new prisoners (to exclude infectious disease)
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enhance communication of the patient with all the members of the health-care team.
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External medical examination of members of the armed forces.
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minimize problems with unnecessary litigation for both the patient and the doctor involved.
Process of obtaining consent For assessment, treatment, intervention, operation or screening of any patient, consent should be obtained after providing complete explanation and information. An assessment should be made as to how much information has been clearly understood by the patient. He or she should be given time to think over the issues and reach a decision. Consent should be not rushed unless it is a life threatening situation. It has to be ascertained that all the implications explained have been clearly understood. Any questions or issues raised by the patient should be answered and the patient encouraged, and not discouraged, from asking questions.
An expressed consent [6] is to be obtained for: (i) All major diagnostic procedures. (ii) General anaesthesia. (iii) Surgical and interventional procedures. (iv) Intimate examinations. (v) Examination for determining age, potency and virginity. (vi) In medico-legal cases. An obligatory expressed written consent is essential under the MTP Act, PNDT Act, transplantation of human organs act and for all operative procedures.
The treating physician should document, with dates, in the outpatient notes all the above as discussed on each consultation when the information is being provided to the patient and obtain written consent from the patient, parent or legal guardian. Where relevant the interpreter must sign the form. A witness’s signature should be obtained at the time of obtaining a formal consent from the patient. The doctor obtaining the consent should also sign the consent form. This will make the consent more valid. Remember any consent is invalid if it is unilaterally executed.
There are certain other situations where written consent is mandatory. Written consent is mandatory [4] where the treatment or procedure is complex involving significant risks or side effects, where provision of clinical care is not the primary purpose of the investigation or examination, where the anticipated consequences are significant to the patient’s employment, social or personal life, where the treatment is part of a research programme and for fertility treatment as per local guidelines. Even on patient refusal, consent is not essential under the following circumstances [4]: •
Medical emergencies that are life threatening
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For immigrants-Medical examination of immigrants by port or airport medical staff on entry to the country
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Psychiatric examination or treatment order by court (under section 2, 3, 35 & 3b of mental health act 1983)
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Examination or treatment of patient suffering from a notifiable disease (but this must have a magistrate’s order)
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Approach to providing information A proper manner should be used to provide information to patients. Patient dignity and privacy should be maintained at all times. The information should be provided at a proper time, in presence of a friend, relative or other as desired by patient, by the doctor who intends to supervise or perform the procedure or by an adequately trained fully informed specialist using ‘lay terminology’ in the language that the patient fully understands whether simple English, Hindi or other. Pictures, diagrams, tapes, leaflets or interpreters should be used for clarification where necessary. Structured methodology of obtaining a fully informed consent [4,5] Obtaining a valid consent is an art based on scientific methodology, keeping the law in mind. Consent should be obtained in a systematic manner using dedicated and updated patient information leaflets or tapes.
Examination of dairy men, food handlers (if an outbreak of salmonella or staphylococcus is suspected.)
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8.
The following protocol should be explained, followed and documented:
Ascertain patient’s attitude and explain rescheduling of procedures under such circumstances
1. Nature of disease or illness.
Check regards ‘proxy decision’ making (proxy consent as to who will provide the substitute consent) and document it
2. Name and nature of procedure / course of action. 3. Available alternative treatments with risks and benefits should be discussed. Medical, surgical or less invasive procedures (e.g., uterine artery embolisation, Mirena in patients with menorhagia and fibroids) should be included in the discussion
Beware of “blanket consent” ! – it does not hold any substance in a court of law. 9.
Statement of patient with regards to special requests, if any, should be taken (i) Ascertain and document any procedure which the patient particularly wishes and has expressed should not be performed till further discussion is conducted by the patient. If this involves threat to life and the patient is unwilling to give such a consent, do not perform the primary procedure. In the rare event of a mishap requiring the very procedure to be performed that has been refused pre-operativley, the court will not support your decision to have operated inspite of a clear refusal of such a consent.
4. Explain outcome if no treatment is undertaken and how it will affect future life or natural history or course of disease 5. After this relevant issues about the procedure including benefits of the procedure should be discussed systematically. These should include: (a) Chances of success (include International, national and personal data where available) (b) Uncertainties of diagnosis, options and of the procedure
(ii) Obtain consent for necessary blood transfusion and blood products
(c) Associated risks and outcomes, harms, discomforts, inconvenience
(iii) Document special concerns of patient - medical, religious or cultural.
(d) Serious and frequently occurring risks
10. Explain the following post-operative issues:
(i) Define these separately
(a) About pain intra- or post-operatively and planned analgesic options
(ii) Provide national and personal data (e) Document any likely psychological or social impact
(b) Recovery (c) Expected length of hospitalization
6. Description of steps of the procedures – these should include information about
(d) Likely impact on daily or personal life, time off work, sexual activity, on driving, regards limits of weight that can be lifted
(a) use of lines / catheter / drains,
11. Tissues / organs be removed–Regarding tissues obtained for examination, the storage and disposal should be documented and the possible broad use for education, training and research, especially if no anonymity can be ensured. The patient needs an explanation about this and appropriate consent must be taken.
(b) anaesthesia, (c) need for vaginal examination during procedure specify if someone other than the operating surgeon like medical students or residents are going to perform these, (d) Do check for known allergies with all drugs to be normally used pre-, intra- and post-operatively and document it clearly on all relevant in and out patients records. 7.
Discuss unexpected pathology or procedures.
12. Obtain consent for recording of videos, photographs for education, training and publishing. 13. Take reasonable steps to exclude unexpected pregnancy before any surgical procedures (LMP cycles, etc).
Extra procedures likely or probable for preventing compromise to life or quality of life. 51
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metriosis, suspected cancer, pregnancy, abdominopelvic tuberculosis it is generally unwise to proceed with any additional surgical procedures without discussing them with the woman, even if this means a second operation” [5] if not already explained to the patient preoperatively.
Reschedule surgery in case pregnancy is unexpectedly discovered at the start of surgery. 14. Make the patient recall and summarize salient features discussed and obtain the general consent. 15. Make a “closure” at end. Explanation of serious risks [5]
“Where complications of the surgery occur, for example – trauma to a viscus that in itself is life threatening, then corrective surgery must proceed and full explanation given as soon as practical during the woman’s recovery” [5].
These must be specifically explained to the patient even if the chances of these are very miniscule. Risks that are general and as specific to a procedure, situation, person must be clarified in addition to the following:
Record findings, procedures and decision or reasons for doing them.
(a) Death
Obtain and record a second opinion from an expert colleague at the time after providing the information he/ she requires before giving that opinion. If this is not done the person providing the second opinion may later say that the opinion was given on insufficient information provided. Infact it is advisable to get the expert to document that the opinion is given after receiving the appropriate information at the outset itself.
(b) Venous thrombosis / pulmonary embolism (c) Return to theatre (d) Trauma to bowel, bladder, ureter (e) Severe glycine overload in operative hysteroscopies. Explanation of frequently occurring risks [5]
Inform the patient and relative or attendant of events that have taken place, the reasons and implications as soon as practical.
General risks of undergoing any procedure such as infection, bleeding, scarring, urinary frequency or loss of control, bruising, adhesions, anemia and fatigue must be explained to the patients. Frequently occurring consequences specific to a particular procedure must also be explained in addition to the general risks.
Consent to screening For debilitating or life threatening conditions the consent to screening should be obtained after explaining the uncertainties – false positive or negative results and the medical, social, personal and financial implications of action that may be required after obtaining the results of screening that may affect the patient, family or relatives – as in screening for cancer, cancer risks and HIV / hepatitis B screening.
Examples of additional procedures that may be required Consent for these unlikely but remotely possible procedures should have specific pre-operative counseling [5]. – Oophorectomy during hysterectomy.
COURT CASES EXEMPLIFYING CONSENT ISSUES
– Appendicectomy and adhesiolysis involving vital organs during laparoscopy for pain.
Case Summary 1
– Hysterectomy during myomectomy.
A surgical procedure was performed in 1993. The case was filed in the National Consumer Disputes Redressal Commission, New Delhi in 1996 and decided on 9th July 2007.
– Laparoscopy proceeding to laparotomy. – Laparoscopy / laparotomy during hysteroscopy and or D&C or surgical termination of pregnancy. – Removal of lump during tissue sampling.
Appellants A vs Respondent B
Special circumstances: Unexpected pathology and procedures
The doctor’s story: As claimed by the expert consultant gynaecologist after a consultation, a hysterectomy with bilateral oophorectomy was mutually agreed upon; the
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possibility of a vaginal route for the hysterectomy was discussed.
(v) When the complainant had agreed for general anesthesia, why was (LEA)-Lumbar epidural anaesthesia administered without her written consent?
However, no notes of this were made in the outpatient file.
Relevant excerpts from the judgment as given in this case are quoted with reference to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Chapter 7 ‘Misconduct’
The patient after admission in hospital signed consent for “TAH” only. The consent was obtained by the resident on call. Before surgery – the consent was not checked by the consultant. A vaginal hysterectomy with BSO was performed. During the procedure a pelvic varicocele of the right infundibulopelvic ligament bled from possible inadvertent puncture or avulsion of vessels. To control bleeding conversion to laparotomy was undertaken with the help of surgical and urological senior colleagues. To control massive hemorrhage with retracted ovarian vessels and possible para-aortic retroperitoneal hematoma formation, the right renal vessels possibly got tied during ligation of the right ovarian vessels. A nephrectomy was performed. The patient recovered uneventfully and was discharged home but after a heavy bill. The patient appeared grateful at her recovery and distributed sweets to the consultant, doctors and staff on discharge.
“The followings acts of commission or omission on the part of the physician shall constitute professional misconduct rendering him/her liable for disciplinary action. 7.16: Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be ……”. “Even if oral consent was obtained before two days of the operation, at least some notes would have been made and that is not produced on record”. “It cannot be said that the operating surgeon can carry out the surgery of his/her choice, because he/she may be an expert in the field. If he/she does so, he/she does it at his/her risk and mishap”.
One year later, to the doctor’s horror – summons was sent from the consumer court on the same patient’s petition.
“No doubt, in case of emergency there can be deviation in the mode of surgery, but not in a planned surgery where express consent for a particular mode is taken from the patient, particularly, when there is no emergency”.
Question raised in the court by the appellant (i) Whether a doctor who is an expert gynecologist, was justified in carrying out operation of a hysterectomy via the vaginal route even though specific written consent was obtained only for “Total Abdominal Hysterectomy (TAH)”?
“A consent form only provides that ‘during the course of the operation’, if it is found that the abdominal hysterectomy is risky because of some reasons, the doctor can switch over to an alternative route. But before starting of the operation, switching over to an alternative operative measure cannot be said to have been consented, even as per the aforesaid consent form”.
(ii) Secondly, whether the doctor was justified in removing healthy ovaries while performing the operation for hysterectomy, that too, without the written consent of the complainant? (iii) Thirdly, whether the ovarian vein can avulse to such an extent that the kidney is required to be removed?
“Thirdly, there is no justifiable ground for not carrying out D&C (dilatation and curettage) on the earlier day, before carrying out the hysterectomy operation. Admittedly it was carried out at the time of hysterectomy that too without consent”.
(iv) Since there was no explanation in the records as to how the vein had avulsed to such an extent that it could not be traced and clamped, whether the principle of ‘res ispa loquitor’ (facts speak for themselves) could be applied as observed in the case of Savita Garg (Smt.) vs. Director, National Heart Institute MANU/SC/0882/2004.
“In medical literature, for BSO, i.e., bilateral salpingo-oophorectomy is a separate surgical procedure and also requires the specific consent of the patient”. “Since the respondent is an experienced gynaeco53
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A careless consent was taken for one EUA. A short form EVA was used in that consent form. Husband’s signature was obtained in the place allocated for the witness’s signature.
logist, hence she was expected to take expressed informed consent to perform hysterectomy via the vaginal route. Further, it is difficult to accept her contention that because the general consent is taken, she can perform the operation in the way she likes.
There was no name of surgeon, procedure, witness, patient explanation or consent for LA / GA on the form.
General consent is – while operating – if some difficulty or any contemplated difficulty arises, then she can adopt such further or alternative operative measures or treatment to save the life of the patient or for patient’s benefit”.
The relatives also denied being told verbally or of being aware of these procedures being conducted on their patient.
“But, that would not give her any discretion to do whatever she chooses. This would also be against the medical ethics, as quoted above and the purpose for which expressed consent is obtained”.
To top it – the respondent pleaded ‘Not necessary to take consent’ – since they acted in the patient’s interest!!
“The Senior Consultant, Gynaecologist and Obstetrician, has carried out large number of operations.
“The doctor’s name who was performing the procedure or surgery had not been filled in the consent form and the signature of the husband of the complainant is taken on the witness column which means that there is no separate witness who signed this form on 23.8.1995.
Excerpts of the final judgment
She, being an expert, was required to act more skillfully and her superiority ought not to have given her over confidence which finally resulted in a number of complications and endangered the life of the patient.
If forceps were handled carefully and episiotomy was performed with due care it would not have resulted in a tear of the anus and loss of sphincter muscle.
As an expert doctor, she is expected to be more careful and skillful and that has not been done. Hence, there has been deficiency in service.
Adjudged ‘Res ispa loquitor’ doctrine (the thing speaks for itself).
For finding deficiency in service, motive is not a relevant ingredient”.
This is a clear cut deficiency of service on the part of the respondent.”
The gynaecologist was deemed guilty in the judgment and was ordered to pay compensation.
The doctor was pronounced guilty and fined heavily.
Case Summary 2 A surgical procedure was performed in 1993. The case was filed in the National Consumer Disputes Redressal Commission, New Delhi in 1998.
Case Summary 3 A surgical procedure was performed in 1993. The case was filed in the National Consumer Disputes Redressal Commission, New Delhi in 1997.
Appellants C vs Respondent D A mediolateral episiotomy was made whilst applying an outlet forceps for an occipitoposterior position resulting in a 3rd degree perineal tear, loss of function of anal sphincter with a low rectovaginal fistula. An examination under anaesthesia and resuturing of episiotomy was performed twice. A colostomy followed by repair of the rectovaginal fistula was unsuccessfully also performed twice. The patient continued to leak faeces.
Appellants E vs Respondent F The doctor was accused of a fabricated written consent for performing a vaginal hysterectomy and bilateral salpingo-oophorectomy (VH BSO) at the time of a breast lumpectomy. The complaint was dismissed since a proper signed consent was produced in the court. A previous referral letter from the general practitioner regards VH BSO was also produced in court to support the fact that the written consent was not fabricated. This just goes to show the strength and value of the “written word” and getting your documentation airtight.
The summarized relevant contents of the complaints are: There was no consent obtained from the patient. Consent was not taken for examination under anaesthesia, episiotomy or all other procedures. Apollo Medicine, Vol. 5, No. 1, March 2008
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Case Summary 4
CONCLUSION
A surgical procedure was performed in 1993. The case was decided in the National Consumer Disputes Redressal Commission, New Delhi on 14th February 2007.
According to the law consent should be exhaustive, complete and specific. Methodologically must include the name of the patient, date and time, diagnosis, details of proposed procedure, name of the surgeon, type of anaesthesia, signature of the patient, signature of the guardian in case of minors and signature of the witness. Refusal of giving consent by a patient should also be documented and why the surgery was performed despite no consent being taken should also be written down along with a second expert’s concurring opinion if unusual circumstance or emergency situations.
Appellants G vs Respondent H The patient had a rectal injury at an abdominal hysterectomy for a ‘cystic’ / minimally enlarged ovary in a patient operated for a previous rectal cancer about 9 years ago. The histopathology report was normal ovaries but the cysts as seen were described in the OT notes. Multiple operations including dense adhesiolysis, stapling rectosigmoid anastamosis, colostomy repair and appendicectomy were performed. No consent had been obtained for an appendicectomy. She had an ongoing recto-vaginal fistula with a poorly maintained colostomy with leak.
A valid consent cannot be obtained from minors, patients with an unsound mind, unconscious patients or warrant the performance of such a procedure those under the influence of intoxicants. Reluctance to follow these rules of obtaining consent may result in serious consequences. Obtaining consent in apprehensive, scared, difficult or demanding patients is an art which develops with experience and time if the science of doing so is rigorously followed in each and every case - without exception and prevents litigation.
“The surgeons were adjudged negligent and deficient in discharge of duties on the basis of: –
No valid indication for hysterectomy was given.
–
Appropriate consents were not obtained for each of the procedures performed.
–
When the general surgeon was called into OT- he was not given complete priming
–
Improper post-operative care was provided to the patient
–
Conflicting report was given by an expert witness who attended from a second hospital”.
REFERENCES 1. Definition of Hippocratic oath http://www.mdterms.com/ script/main/art.asp?articlekey=20908 (accessed on November 1, 2007) 2. The Hippocratic Oath Today: Meaningless Relic or Invaluable Moral Guide?http://www.pbs.org/wgbh/nova/ doctors/oath_today.html (accessed on November 1, 2007) 3. Melissa Hantman. From antiquity to eternity: Revised Hippocratic Oath resonates with graduates; http://www.news.cornell.edu/stories/June05/Hippo cratic –oath.mh.html (accessed on November 1, 2007)
Rupees 10 lac damages were ordered in this case! Comments: Despite the fact that the complication of rectal injury during hysterectomy in a patient with previous rectal cancer surgery and adhesions is possible the fact that a comprehensive written consent was not taken explaining the risk of the complication and possible poor outcome and the indication for surgery and discussed options not documented in the OPD notes - in this case went against the doctors. Ten extra minutes spent pre-operatively on counseling would have saved those 10 extra lacs and all the heartache!
4. Obtaining valid consent- Clinical Governance Advice No 6, October 2004, Royal College of Obstetricians and Gynaecologists (RCOG) 5. Sinha Prabha. Consent issues and complications in obstetrics and gynaecology-University of Sheffield, UK, published by Rosewell Publishing 2005 6. Jagdish Singh and Vishwa Bhushan. “Medical Negligence and Compensation” by Bharat Law Publications, Jaipur 1999.
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Appendix A An example of a comprehensive consent form from Apollo Hospitals
Patient Label
CONSENT FORM FOR PROCEDURE, TREATMEET, ANESTHESIA, HIGH RISK CONSENT INSTRUCTIONS: This consent form should be signed by patient if an adult (18 years of older) : by a parent/ guardian if the patient is a minor: by the spouse or adult children or parents or adult brothers or sisters or other family member or significant other (in this order or priority) if the patient lacks the ability to make an informed decision. The physician or his designee doctors are responsible for obtaining informed consent. 1. I hereby authorise the performance of the following operation(s), procedures, or treatment(s) {hereafter referred to as procedures} : (Use no abbreviation I Avoid Technical Terms).
Upon
(Name of Patient)
2. I have been advised of the benefits and reason the procedure(s) as indicated by the clinical observations and OR diagnostics performed. I recognize that the practice of medicine is a much an art as a science and therefore acknowledge that no guarantees have been or can be made regarding the likelihood of success or outcomes. Benefits & Reason listed as follows:
See Progress Note. 3. I have been advised that major risks involved in the above procedure(s) are Listed as follows: .
See Progress Note 4. I have been advised of the following existing alternatives in treatment and prognosis if the procedure(s) is not done. Listed as follows :
See Progress Note 5. I authorise Dr. and such assistants and associates as may be selected by him/ her to perform any part of the above procedure(s) upon myself/the patient. I have been advised and agree that any member of this team may perform any part of my procedure(s) according to his/her stage of training and ability, if in the opinion of the above named physician the experience and capability of the assistant surgeon justifies such a decision.
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6. As with any procedure. I am aware that risks such as blood, infection heart failure change in blood pressure, anaesthetic allergic reactions, paralysis etc. May arise necessitating attention. Therefore, in addition to consenting to the performance of the particulars procedure(s). I also consent and authorise the rendering of such other care and treatment as my physician or his designee reasonably believes necessary should one or more of these and or other unforeseeable events occur. 7. BLOOD OR BLOOD PRODUCT TRANSFUSIONS: This consent includes the administration of blood or product transfusion during this procedure and immediate post-operative period. I have been informed that despite careful screening in accordance with national and international regulations. there are rare instances of life threating infections such as AIDS. Hepatitis and other viruses or diseases as yet unknown for which screening tests do not exits. I also understand that unpredictable reactions may occur which include but are not limited to fever, rash and shortness of breath, shock and in rare occasions death. Expected benefits of the transfusion may include minimizing shock, brain and other organ damage, hastening recovery and limiting blood loss, however, I understand that there are no guarantees offered as to the expected benefits of the transfusion. 8. PHOTOGRAPHY: I consent to the photography or televising of the procedure(s) to be performed for the purpose of advancing medical education; or its publication in scientific journals providing my I the patient identity is not revealed by the pictures or description in the accompanying texts. In an effort to further medical science and education. I consent to and authorize the presence of and observation of this procedure by qualified observers as may be authorized the Indraprastha Apollo Hospital and its regulatory laws and agencies. AUTHORIZATION OF PATIENT I acknowledge that I have had and opportunity to discuss this procedure, as stated above, with my physician or physician designee, and hereby consent to this procedure. Patient
Date
Witness
Date
Doctor
Date
PATIENT REPRESENTATIVE I SURROGATE The patient is unable of consent because:
and I (name I relationship to the patient), therefore consent for the
patient I acknowledge that I have had an opportunity to discus this procedure, as stated above, with my physician or physician designee, and hereby consent to this procedure. Patient representative
Date
Witness
Date
Doctor
Date
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CONSENT FOR ANESTHESIA / OBSTETRICS ANALGESIA I SEDATION I consent to the use of anesthesia by my anaesthetist and his I her assistants. I understand that the use of anesthetic or placement of intra - vascular lines for invasive monitoring may, despite all appropriate measures to prevent pose certain risks including but not limited to temporary impairment of judgement and motor coordination; temporary decrease in attention span: nausea or vomiting; headache; sore throat; muscle aches; bruises or tenderness at the site or intravenous infusions: and may result in paralysis. cardiac arrest or brain damage. In this regard; I have been fully informed as to the nature and to the purpose of the anesthesia, the possible risks and complications and possible alternative methods and I understand the explanation, I have received. Furthermore, I have been specifically advised that there is a possibility of damage to my I the patient’s teeth during the procedure (s) and administration of anesthesia, particularly if the teeth are loose, weak, decayed or artificial, and I hereby waive any claim to damage to my I the patient’s teeth as a result therefore. AUTHORIZATION OF PATIENT I acknowledge that I have had an opportunity to discuss this procedure, as stated above, with my anesthetist or his / her designee, and hereby consent to the use of the anesthesia discussed. Patient
Date
Witness
Date
Doctor
Date
PATIENT REPRESENTATIVE I SURROGATE The patient is ‘unable of consent because:
and I,
(name l relationship to the patient), therefore consent for the patient I acknowledge that I have had an opportunity to discuss this procedure, as stated above, with my anesthetist or his I her designee, and here by consent to the use of the anesthesia discussed. Patient attendant
Date
Witness
Date
Doctor
Date
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HIGH RISK CONSENT INDEMNITY STATEMENT I ............................................................................................................................... have been explained about my surgery, I have been explained by the doctors that the causes of my being High Risk are due to following:
(PATIENT/REPRESENTATIVE) Reason for High Risk 1. 2. 3. I also state that I or my family shall not hold Apollo Hospital or its doctors for any consequences whatsoever. It has also been explained to me that the PACKAGE TARIFF FOR THE HIGH RISK CASES IS SUBSTANTIALY HIGHER THAN NON-HIGH RISK CASES. Name of relative authorising the surgeon to carry out the operation: Relationship to the patient: Signature of relative: Time & Date: Signed in the presence of witness 1. 2. Signature of doctor who has explained the risk: Name of Doctor: Date: Time: NOTE: PLEASE ENTER HIGH RISK STATUS ON THE ACTIVITY CARD
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Appendix B Rules for doctors: An obituary to the mutual trust between doctors and patients 1. Once a doctor has chosen to go into this “honourable profession” he/she forgoes all human rights – and has only the right to play God with only good results.
12. If a doctor has the expertise to figure out a problem in minutes he is a cheat for charging the patient any consultation. It matters not the hours of toil and trauma in the wards and hospital, the rigorous self discipline to put work before pleasure most of his life, the reams of books read, re-read and re-read since the age of 18, the sleepless nights on-call and endless ward rounds he has to put in to obtain that experience which enables him to perform most procedures and take most decisions at the spinal level (as on automatic pilot). Only a plumber or lawyer is allowed to charge money for a two minute consultation because he chose a profession that is not called “honorable”.
2. If a doctor cannot provide 100% results to 100% of his patients 100% of the time he must pay for the correction of the compromised result from his own pocket and with disgrace. 3. A hypocritical mockery is made quoting the Hippocratic oath taken by doctors by having double standards of life when it comes to a doctor’s life. 4. All doctors are out to get a patient’s money, are careless, are unconcerned if they cannot make a patient well, have no conscience, are inhuman-unless proved otherwise.
13. It is unreasonable for a doctor to earn enough money, to expect to educate his children, provide functional necessities for his family and ensure a self earned pension for his old age. It is only honorable for the rest of the society to do so since they did not choose this “honorable” profession – the doctors can honorably suffer penury in their old age.
5. The onus is on the doctor to prove himself innocent by continuously, simultaneously recording his innocence and magically managing patient care simultaneously. 6. A doctor must always clinically remind himself that the written word is stronger than any presumed ‘word of honour’ made by a patient to his/her doctor or that of a doctor to his patient. That is history.
14. If the doctor does not market himself above others and does not network he is not good enough since his clinic is not bursting at its seams. On the other hand if he does so blatantly he is unethical.
7. The doctor despite the elevated humble nature of his profession has to also be a legal expert document all explanations made and any questions discussed in his/her notes in order for people, judge and jury to believe him/her.
15. If a doctor makes a patient wait in his clinic he is unprofessional even if he has to spend 10 extra minutes for repeating the same explanations to patients multitudes of times for juggling supervision of other sick or operated patients whilst attending to patients in the clinic for attending to his personal unavoidable calls from home for stopping to have a sandwich for having his car repaired for allowing his patients to weep inside his office when bad news is broken and not hurry for not having that ‘military regime’ in his clinic and most of all for being human – he must pay the price.
8. The extra time, money and energy spent in doing so are to come from the doctors pocket-because if the patient is charged for this extra service the doctor is “greedy”. 9. If things go well-the doctor has only done what he/she was paid to do. 10. If things go wrong and are not a 100% correct or optimum, the doctor has not fulfilled his part of the unwritten contract of what he was paid to do.
16. Only a human being who is under the influence of alcohol, deranged mentally or subnormal would therefore choose to be a doctor given the above rules and hence must be continued to be treated so in his lifetime.
11. Laws of nature, circumstantial variabilities, and acceptable human error factors are not applicable to the practice of medicine or to a doctor.
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This obituary only clarifies the doctors dilemmas!
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THE LAW, SCIENCE AND ART OF CONSENT–A GYNAECOLOGIST’S APPROACH Urvashi Prasad Jha* and Swasti** *Gynaecological Laparoscopic & Gynae-Onco-Surgeon & Academic Co-ordinator, **Clinical Assistant and Research Fellow, Department of Obstetrics & Gynaecology, Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi 110 076, India. Correspondence to: Dr. Urvashi Prasad Jha, Senior Consultant Gynaecological Laparoscopic & Gynae-OncoSurgeon & Academic Co-ordinator, Department of Obstetrics & Gynaecology, Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi 110 076, India. e-mail: [email protected], [email protected]
COUNSELING of patients and obtaining valid consent is mandatory before any therapy is instituted. In keeping with the changing times, fortunately utilization of health services, medical awareness and right to information have become a way to life today. The medical profession needs to keep abreast.
physically handling or interfering with the patient’s body constitutes assault. This may lead to disciplinary procedures, civil claim or even criminal prosecution. The law regarding consent
Sadly, and perhaps justifiably, in some instances the public at large views doctors with suspicion. It is imperative that patients comprehend all aspects of their health care and get involved in medical decision making to leave no or little room for doubt. Providing adequate and appropriate medical information in proper perspective to each and every patient is a duty of the doctors and a right of the patient or client. Doing so avoids unnecessary doubts, prevents possible litigation and forms the basis of obtaining a fully informed valid written consent from most patients. There will still be those, who despite all clarifications verbal and written, will fail to fully comprehend the implications of all that has been discussed with them. Failure of adequate bilateral communication and of being in denial are equally important valid reasons for this. The science of obtaining consent is discussed in this chapter. The art needs to be developed individually with experience. The law must be understood to protect both the patient and the doctor. Even the Hippocratic oath has metamorphosized to become contemporary as instituted by many visionary medical schools [1-3]. Counseling and consent form an integral part of medical practice today and must be included in part of medical education programmes.
Mandatory components of legal consent [5] The patient must fulfill all the following criteria in order to give valid legal consent: (a) Have capacity – This implies that the patient must have sufficient mental competence to make an independent choice (b) Have voluntariness – For this consent must be without duress, fraud, coercion, mistake, undue influence or misrepresentation (c) Have knowledge – The patient must also have the necessary and sufficient information provided with regards to transactions regarding the disease and available treatment options before giving consent. In addition to these the physician must ascertain any unusual stress, anxiety, fear or depression the patient may have for the consent to be legal. Certain terminology in relation to finding deficiency with medical services by the law is given below. This is critical when judging whether or not there was deficiency in the service provided by a doctor.
DEFINITION OF CONSENT [4]
The Human Rights Act requires the patient to receive sufficient information prior to consenting. With regards to that a ‘reasonable physician standard’ is level of information which is provided by a typical physician.
Under common law, every person has the right to protect their bodily integrity against invasion by others including by doctors. A failure to obtain patient’s consent prior to Apollo Medicine, Vol. 5, No. 1, March 2008
For consent to be legal the patient must fulfill certain criteria, the doctor must abide by certain guidelines and the documentation be methodical and comprehensive and follow specific norms.
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This is mostly inconsistent and for the most part inadequate in India today – international standards, however, are available.
patient's actions. As an example – it is presumed that the patient understands commonly known procedures such as agreeing to have a blood pressure recorded when she puts forward her arm for getting her BP measured.
A ‘reasonable patient standard’ is the information required by an average patient to be able to give consent to any medical intervention. Based on both these facts, judgments are made as to whether there was deficiency in obtaining an appropriate informed consent or not.
3. Expressed consent (oral or written) is by patient’s sounds and actions or is written. Consent for obtaining personal sensitive history and performing an examination must be rechecked by the doctor as by asking “Is it alright with you if I ask you details of your sexual history?”Another example is as in asking the patient to expose her breasts for clinical examination. If she undresses and does so, it implies expressed consent for a breast examination. Hence, the importance in current times of a chaperone even in an out patient clinic when examining a patient of the same or the opposite sex.
Subjective standard is used to assess whether tailoring of information to an individual patient or to the relevant disease, procedure or co-morbid condition is legally and ethically debatable. The law requires that basic information be provided to a patient even if that patient requests a doctor to take a decision on his or her behalf and refuses to receive the information. If stressed, the patient may decline to receive any information. If this is the case, it is essential to document it especially in a high risk patient. Even so, basic information has to be provided to the patient. Beware of not informing a cancer patient of her condition prior to operating at the request of her sympathetic relatives! Post surgery she has every right to sue you, if you have done so.
4. Presumed consent is one that is presumed or is applicable in emergency situations. What is immediately necessary should only be done in emergency conditions. A ‘second opinion’ may be seeked before performing any additional procedure not discussed or not lifesaving but mandatory. For the most part an unconsented procedure may be performed at a later date after obtaining a fully informed consent. The “Principle of beneficence may require health professionals to act for the patient’s benefit on her behalf only when her life is at stake”. In fact delaying unnecessarily in these circumstances in order to obtain consent may constitute negligence. It is best if the second opinion is taken in writing from a colleague who has concurred with performing the procedure in emergency or unexpected situations.
Medical negligence can come under the following: (i) In cases of appeal for deficient services compensation is payable (the case is then that of an appellant vs respondent). (ii) Under law of Torts – Torts implies conduct that is twisted or wrongful as in civil cases (the case would be that of a petitioner vs defendant or respondent).
Goals of informed consent
(iii) Under criminal law when any hazardous act is undertaken, the punishment for which is usually imprisonment. (The case would then be filed by the complainant vs the accused.)
Obtaining a valid consent must be a lawful act and not be against morality. An informed consent is “an ethical & moral obligation of doctors to patients” [1]. In the social and cultural scenario in our country, providing of all of the above information should ideally include close relatives or friends. This inclusion ofcourse, should be with the consent of the patient. In the unfortunate event of a death or a subsequent mental incapacitation of the patient, this is always helpful. Their inclusion in the discussion must be documented in the out patient or inpatient records as happened.
Terminology of different types of consent 1. Informed consent is one that is taken after giving complete information of relevant medical facts, benefits and risks to the patient and subsequent implications of both positive and negative results of the intervention. This may be for a diagnostic test even as in obtaining consent for cancer screening. It may be oral or written. Written informed consent is mandatory in most situations particularly for performing invasive procedures or surgical operations. 2. Implied consent – Consent may be ‘implied’ by a
The goals of taking an informed consent are to:
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•
Provide clarification or explanation to the patient.
•
Relieve stress of the unknown to the patient. Apollo Medicine, Vol. 5, No. 1, March 2008
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•
help patient participate in the health care decision making.
•
External medical examination of new prisoners (to exclude infectious disease)
•
enhance communication of the patient with all the members of the health-care team.
•
External medical examination of members of the armed forces.
•
minimize problems with unnecessary litigation for both the patient and the doctor involved.
Process of obtaining consent For assessment, treatment, intervention, operation or screening of any patient, consent should be obtained after providing complete explanation and information. An assessment should be made as to how much information has been clearly understood by the patient. He or she should be given time to think over the issues and reach a decision. Consent should be not rushed unless it is a life threatening situation. It has to be ascertained that all the implications explained have been clearly understood. Any questions or issues raised by the patient should be answered and the patient encouraged, and not discouraged, from asking questions.
An expressed consent [6] is to be obtained for: (i) All major diagnostic procedures. (ii) General anaesthesia. (iii) Surgical and interventional procedures. (iv) Intimate examinations. (v) Examination for determining age, potency and virginity. (vi) In medico-legal cases. An obligatory expressed written consent is essential under the MTP Act, PNDT Act, transplantation of human organs act and for all operative procedures.
The treating physician should document, with dates, in the outpatient notes all the above as discussed on each consultation when the information is being provided to the patient and obtain written consent from the patient, parent or legal guardian. Where relevant the interpreter must sign the form. A witness’s signature should be obtained at the time of obtaining a formal consent from the patient. The doctor obtaining the consent should also sign the consent form. This will make the consent more valid. Remember any consent is invalid if it is unilaterally executed.
There are certain other situations where written consent is mandatory. Written consent is mandatory [4] where the treatment or procedure is complex involving significant risks or side effects, where provision of clinical care is not the primary purpose of the investigation or examination, where the anticipated consequences are significant to the patient’s employment, social or personal life, where the treatment is part of a research programme and for fertility treatment as per local guidelines. Even on patient refusal, consent is not essential under the following circumstances [4]: •
Medical emergencies that are life threatening
•
For immigrants-Medical examination of immigrants by port or airport medical staff on entry to the country
•
Psychiatric examination or treatment order by court (under section 2, 3, 35 & 3b of mental health act 1983)
•
Examination or treatment of patient suffering from a notifiable disease (but this must have a magistrate’s order)
•
Approach to providing information A proper manner should be used to provide information to patients. Patient dignity and privacy should be maintained at all times. The information should be provided at a proper time, in presence of a friend, relative or other as desired by patient, by the doctor who intends to supervise or perform the procedure or by an adequately trained fully informed specialist using ‘lay terminology’ in the language that the patient fully understands whether simple English, Hindi or other. Pictures, diagrams, tapes, leaflets or interpreters should be used for clarification where necessary. Structured methodology of obtaining a fully informed consent [4,5] Obtaining a valid consent is an art based on scientific methodology, keeping the law in mind. Consent should be obtained in a systematic manner using dedicated and updated patient information leaflets or tapes.
Examination of dairy men, food handlers (if an outbreak of salmonella or staphylococcus is suspected.)
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8.
The following protocol should be explained, followed and documented:
Ascertain patient’s attitude and explain rescheduling of procedures under such circumstances
1. Nature of disease or illness.
Check regards ‘proxy decision’ making (proxy consent as to who will provide the substitute consent) and document it
2. Name and nature of procedure / course of action. 3. Available alternative treatments with risks and benefits should be discussed. Medical, surgical or less invasive procedures (e.g., uterine artery embolisation, Mirena in patients with menorhagia and fibroids) should be included in the discussion
Beware of “blanket consent” ! – it does not hold any substance in a court of law. 9.
Statement of patient with regards to special requests, if any, should be taken (i) Ascertain and document any procedure which the patient particularly wishes and has expressed should not be performed till further discussion is conducted by the patient. If this involves threat to life and the patient is unwilling to give such a consent, do not perform the primary procedure. In the rare event of a mishap requiring the very procedure to be performed that has been refused pre-operativley, the court will not support your decision to have operated inspite of a clear refusal of such a consent.
4. Explain outcome if no treatment is undertaken and how it will affect future life or natural history or course of disease 5. After this relevant issues about the procedure including benefits of the procedure should be discussed systematically. These should include: (a) Chances of success (include International, national and personal data where available) (b) Uncertainties of diagnosis, options and of the procedure
(ii) Obtain consent for necessary blood transfusion and blood products
(c) Associated risks and outcomes, harms, discomforts, inconvenience
(iii) Document special concerns of patient - medical, religious or cultural.
(d) Serious and frequently occurring risks
10. Explain the following post-operative issues:
(i) Define these separately
(a) About pain intra- or post-operatively and planned analgesic options
(ii) Provide national and personal data (e) Document any likely psychological or social impact
(b) Recovery (c) Expected length of hospitalization
6. Description of steps of the procedures – these should include information about
(d) Likely impact on daily or personal life, time off work, sexual activity, on driving, regards limits of weight that can be lifted
(a) use of lines / catheter / drains,
11. Tissues / organs be removed–Regarding tissues obtained for examination, the storage and disposal should be documented and the possible broad use for education, training and research, especially if no anonymity can be ensured. The patient needs an explanation about this and appropriate consent must be taken.
(b) anaesthesia, (c) need for vaginal examination during procedure specify if someone other than the operating surgeon like medical students or residents are going to perform these, (d) Do check for known allergies with all drugs to be normally used pre-, intra- and post-operatively and document it clearly on all relevant in and out patients records. 7.
Discuss unexpected pathology or procedures.
12. Obtain consent for recording of videos, photographs for education, training and publishing. 13. Take reasonable steps to exclude unexpected pregnancy before any surgical procedures (LMP cycles, etc).
Extra procedures likely or probable for preventing compromise to life or quality of life. 51
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metriosis, suspected cancer, pregnancy, abdominopelvic tuberculosis it is generally unwise to proceed with any additional surgical procedures without discussing them with the woman, even if this means a second operation” [5] if not already explained to the patient preoperatively.
Reschedule surgery in case pregnancy is unexpectedly discovered at the start of surgery. 14. Make the patient recall and summarize salient features discussed and obtain the general consent. 15. Make a “closure” at end. Explanation of serious risks [5]
“Where complications of the surgery occur, for example – trauma to a viscus that in itself is life threatening, then corrective surgery must proceed and full explanation given as soon as practical during the woman’s recovery” [5].
These must be specifically explained to the patient even if the chances of these are very miniscule. Risks that are general and as specific to a procedure, situation, person must be clarified in addition to the following:
Record findings, procedures and decision or reasons for doing them.
(a) Death
Obtain and record a second opinion from an expert colleague at the time after providing the information he/ she requires before giving that opinion. If this is not done the person providing the second opinion may later say that the opinion was given on insufficient information provided. Infact it is advisable to get the expert to document that the opinion is given after receiving the appropriate information at the outset itself.
(b) Venous thrombosis / pulmonary embolism (c) Return to theatre (d) Trauma to bowel, bladder, ureter (e) Severe glycine overload in operative hysteroscopies. Explanation of frequently occurring risks [5]
Inform the patient and relative or attendant of events that have taken place, the reasons and implications as soon as practical.
General risks of undergoing any procedure such as infection, bleeding, scarring, urinary frequency or loss of control, bruising, adhesions, anemia and fatigue must be explained to the patients. Frequently occurring consequences specific to a particular procedure must also be explained in addition to the general risks.
Consent to screening For debilitating or life threatening conditions the consent to screening should be obtained after explaining the uncertainties – false positive or negative results and the medical, social, personal and financial implications of action that may be required after obtaining the results of screening that may affect the patient, family or relatives – as in screening for cancer, cancer risks and HIV / hepatitis B screening.
Examples of additional procedures that may be required Consent for these unlikely but remotely possible procedures should have specific pre-operative counseling [5]. – Oophorectomy during hysterectomy.
COURT CASES EXEMPLIFYING CONSENT ISSUES
– Appendicectomy and adhesiolysis involving vital organs during laparoscopy for pain.
Case Summary 1
– Hysterectomy during myomectomy.
A surgical procedure was performed in 1993. The case was filed in the National Consumer Disputes Redressal Commission, New Delhi in 1996 and decided on 9th July 2007.
– Laparoscopy proceeding to laparotomy. – Laparoscopy / laparotomy during hysteroscopy and or D&C or surgical termination of pregnancy. – Removal of lump during tissue sampling.
Appellants A vs Respondent B
Special circumstances: Unexpected pathology and procedures
The doctor’s story: As claimed by the expert consultant gynaecologist after a consultation, a hysterectomy with bilateral oophorectomy was mutually agreed upon; the
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possibility of a vaginal route for the hysterectomy was discussed.
(v) When the complainant had agreed for general anesthesia, why was (LEA)-Lumbar epidural anaesthesia administered without her written consent?
However, no notes of this were made in the outpatient file.
Relevant excerpts from the judgment as given in this case are quoted with reference to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Chapter 7 ‘Misconduct’
The patient after admission in hospital signed consent for “TAH” only. The consent was obtained by the resident on call. Before surgery – the consent was not checked by the consultant. A vaginal hysterectomy with BSO was performed. During the procedure a pelvic varicocele of the right infundibulopelvic ligament bled from possible inadvertent puncture or avulsion of vessels. To control bleeding conversion to laparotomy was undertaken with the help of surgical and urological senior colleagues. To control massive hemorrhage with retracted ovarian vessels and possible para-aortic retroperitoneal hematoma formation, the right renal vessels possibly got tied during ligation of the right ovarian vessels. A nephrectomy was performed. The patient recovered uneventfully and was discharged home but after a heavy bill. The patient appeared grateful at her recovery and distributed sweets to the consultant, doctors and staff on discharge.
“The followings acts of commission or omission on the part of the physician shall constitute professional misconduct rendering him/her liable for disciplinary action. 7.16: Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be ……”. “Even if oral consent was obtained before two days of the operation, at least some notes would have been made and that is not produced on record”. “It cannot be said that the operating surgeon can carry out the surgery of his/her choice, because he/she may be an expert in the field. If he/she does so, he/she does it at his/her risk and mishap”.
One year later, to the doctor’s horror – summons was sent from the consumer court on the same patient’s petition.
“No doubt, in case of emergency there can be deviation in the mode of surgery, but not in a planned surgery where express consent for a particular mode is taken from the patient, particularly, when there is no emergency”.
Question raised in the court by the appellant (i) Whether a doctor who is an expert gynecologist, was justified in carrying out operation of a hysterectomy via the vaginal route even though specific written consent was obtained only for “Total Abdominal Hysterectomy (TAH)”?
“A consent form only provides that ‘during the course of the operation’, if it is found that the abdominal hysterectomy is risky because of some reasons, the doctor can switch over to an alternative route. But before starting of the operation, switching over to an alternative operative measure cannot be said to have been consented, even as per the aforesaid consent form”.
(ii) Secondly, whether the doctor was justified in removing healthy ovaries while performing the operation for hysterectomy, that too, without the written consent of the complainant? (iii) Thirdly, whether the ovarian vein can avulse to such an extent that the kidney is required to be removed?
“Thirdly, there is no justifiable ground for not carrying out D&C (dilatation and curettage) on the earlier day, before carrying out the hysterectomy operation. Admittedly it was carried out at the time of hysterectomy that too without consent”.
(iv) Since there was no explanation in the records as to how the vein had avulsed to such an extent that it could not be traced and clamped, whether the principle of ‘res ispa loquitor’ (facts speak for themselves) could be applied as observed in the case of Savita Garg (Smt.) vs. Director, National Heart Institute MANU/SC/0882/2004.
“In medical literature, for BSO, i.e., bilateral salpingo-oophorectomy is a separate surgical procedure and also requires the specific consent of the patient”. “Since the respondent is an experienced gynaeco53
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A careless consent was taken for one EUA. A short form EVA was used in that consent form. Husband’s signature was obtained in the place allocated for the witness’s signature.
logist, hence she was expected to take expressed informed consent to perform hysterectomy via the vaginal route. Further, it is difficult to accept her contention that because the general consent is taken, she can perform the operation in the way she likes.
There was no name of surgeon, procedure, witness, patient explanation or consent for LA / GA on the form.
General consent is – while operating – if some difficulty or any contemplated difficulty arises, then she can adopt such further or alternative operative measures or treatment to save the life of the patient or for patient’s benefit”.
The relatives also denied being told verbally or of being aware of these procedures being conducted on their patient.
“But, that would not give her any discretion to do whatever she chooses. This would also be against the medical ethics, as quoted above and the purpose for which expressed consent is obtained”.
To top it – the respondent pleaded ‘Not necessary to take consent’ – since they acted in the patient’s interest!!
“The Senior Consultant, Gynaecologist and Obstetrician, has carried out large number of operations.
“The doctor’s name who was performing the procedure or surgery had not been filled in the consent form and the signature of the husband of the complainant is taken on the witness column which means that there is no separate witness who signed this form on 23.8.1995.
Excerpts of the final judgment
She, being an expert, was required to act more skillfully and her superiority ought not to have given her over confidence which finally resulted in a number of complications and endangered the life of the patient.
If forceps were handled carefully and episiotomy was performed with due care it would not have resulted in a tear of the anus and loss of sphincter muscle.
As an expert doctor, she is expected to be more careful and skillful and that has not been done. Hence, there has been deficiency in service.
Adjudged ‘Res ispa loquitor’ doctrine (the thing speaks for itself).
For finding deficiency in service, motive is not a relevant ingredient”.
This is a clear cut deficiency of service on the part of the respondent.”
The gynaecologist was deemed guilty in the judgment and was ordered to pay compensation.
The doctor was pronounced guilty and fined heavily.
Case Summary 2 A surgical procedure was performed in 1993. The case was filed in the National Consumer Disputes Redressal Commission, New Delhi in 1998.
Case Summary 3 A surgical procedure was performed in 1993. The case was filed in the National Consumer Disputes Redressal Commission, New Delhi in 1997.
Appellants C vs Respondent D A mediolateral episiotomy was made whilst applying an outlet forceps for an occipitoposterior position resulting in a 3rd degree perineal tear, loss of function of anal sphincter with a low rectovaginal fistula. An examination under anaesthesia and resuturing of episiotomy was performed twice. A colostomy followed by repair of the rectovaginal fistula was unsuccessfully also performed twice. The patient continued to leak faeces.
Appellants E vs Respondent F The doctor was accused of a fabricated written consent for performing a vaginal hysterectomy and bilateral salpingo-oophorectomy (VH BSO) at the time of a breast lumpectomy. The complaint was dismissed since a proper signed consent was produced in the court. A previous referral letter from the general practitioner regards VH BSO was also produced in court to support the fact that the written consent was not fabricated. This just goes to show the strength and value of the “written word” and getting your documentation airtight.
The summarized relevant contents of the complaints are: There was no consent obtained from the patient. Consent was not taken for examination under anaesthesia, episiotomy or all other procedures. Apollo Medicine, Vol. 5, No. 1, March 2008
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Case Summary 4
CONCLUSION
A surgical procedure was performed in 1993. The case was decided in the National Consumer Disputes Redressal Commission, New Delhi on 14th February 2007.
According to the law consent should be exhaustive, complete and specific. Methodologically must include the name of the patient, date and time, diagnosis, details of proposed procedure, name of the surgeon, type of anaesthesia, signature of the patient, signature of the guardian in case of minors and signature of the witness. Refusal of giving consent by a patient should also be documented and why the surgery was performed despite no consent being taken should also be written down along with a second expert’s concurring opinion if unusual circumstance or emergency situations.
Appellants G vs Respondent H The patient had a rectal injury at an abdominal hysterectomy for a ‘cystic’ / minimally enlarged ovary in a patient operated for a previous rectal cancer about 9 years ago. The histopathology report was normal ovaries but the cysts as seen were described in the OT notes. Multiple operations including dense adhesiolysis, stapling rectosigmoid anastamosis, colostomy repair and appendicectomy were performed. No consent had been obtained for an appendicectomy. She had an ongoing recto-vaginal fistula with a poorly maintained colostomy with leak.
A valid consent cannot be obtained from minors, patients with an unsound mind, unconscious patients or warrant the performance of such a procedure those under the influence of intoxicants. Reluctance to follow these rules of obtaining consent may result in serious consequences. Obtaining consent in apprehensive, scared, difficult or demanding patients is an art which develops with experience and time if the science of doing so is rigorously followed in each and every case - without exception and prevents litigation.
“The surgeons were adjudged negligent and deficient in discharge of duties on the basis of: –
No valid indication for hysterectomy was given.
–
Appropriate consents were not obtained for each of the procedures performed.
–
When the general surgeon was called into OT- he was not given complete priming
–
Improper post-operative care was provided to the patient
–
Conflicting report was given by an expert witness who attended from a second hospital”.
REFERENCES 1. Definition of Hippocratic oath http://www.mdterms.com/ script/main/art.asp?articlekey=20908 (accessed on November 1, 2007) 2. The Hippocratic Oath Today: Meaningless Relic or Invaluable Moral Guide?http://www.pbs.org/wgbh/nova/ doctors/oath_today.html (accessed on November 1, 2007) 3. Melissa Hantman. From antiquity to eternity: Revised Hippocratic Oath resonates with graduates; http://www.news.cornell.edu/stories/June05/Hippo cratic –oath.mh.html (accessed on November 1, 2007)
Rupees 10 lac damages were ordered in this case! Comments: Despite the fact that the complication of rectal injury during hysterectomy in a patient with previous rectal cancer surgery and adhesions is possible the fact that a comprehensive written consent was not taken explaining the risk of the complication and possible poor outcome and the indication for surgery and discussed options not documented in the OPD notes - in this case went against the doctors. Ten extra minutes spent pre-operatively on counseling would have saved those 10 extra lacs and all the heartache!
4. Obtaining valid consent- Clinical Governance Advice No 6, October 2004, Royal College of Obstetricians and Gynaecologists (RCOG) 5. Sinha Prabha. Consent issues and complications in obstetrics and gynaecology-University of Sheffield, UK, published by Rosewell Publishing 2005 6. Jagdish Singh and Vishwa Bhushan. “Medical Negligence and Compensation” by Bharat Law Publications, Jaipur 1999.
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Appendix A An example of a comprehensive consent form from Apollo Hospitals
Patient Label
CONSENT FORM FOR PROCEDURE, TREATMEET, ANESTHESIA, HIGH RISK CONSENT INSTRUCTIONS: This consent form should be signed by patient if an adult (18 years of older) : by a parent/ guardian if the patient is a minor: by the spouse or adult children or parents or adult brothers or sisters or other family member or significant other (in this order or priority) if the patient lacks the ability to make an informed decision. The physician or his designee doctors are responsible for obtaining informed consent. 1. I hereby authorise the performance of the following operation(s), procedures, or treatment(s) {hereafter referred to as procedures} : (Use no abbreviation I Avoid Technical Terms).
Upon
(Name of Patient)
2. I have been advised of the benefits and reason the procedure(s) as indicated by the clinical observations and OR diagnostics performed. I recognize that the practice of medicine is a much an art as a science and therefore acknowledge that no guarantees have been or can be made regarding the likelihood of success or outcomes. Benefits & Reason listed as follows:
See Progress Note. 3. I have been advised that major risks involved in the above procedure(s) are Listed as follows: .
See Progress Note 4. I have been advised of the following existing alternatives in treatment and prognosis if the procedure(s) is not done. Listed as follows :
See Progress Note 5. I authorise Dr. and such assistants and associates as may be selected by him/ her to perform any part of the above procedure(s) upon myself/the patient. I have been advised and agree that any member of this team may perform any part of my procedure(s) according to his/her stage of training and ability, if in the opinion of the above named physician the experience and capability of the assistant surgeon justifies such a decision.
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6. As with any procedure. I am aware that risks such as blood, infection heart failure change in blood pressure, anaesthetic allergic reactions, paralysis etc. May arise necessitating attention. Therefore, in addition to consenting to the performance of the particulars procedure(s). I also consent and authorise the rendering of such other care and treatment as my physician or his designee reasonably believes necessary should one or more of these and or other unforeseeable events occur. 7. BLOOD OR BLOOD PRODUCT TRANSFUSIONS: This consent includes the administration of blood or product transfusion during this procedure and immediate post-operative period. I have been informed that despite careful screening in accordance with national and international regulations. there are rare instances of life threating infections such as AIDS. Hepatitis and other viruses or diseases as yet unknown for which screening tests do not exits. I also understand that unpredictable reactions may occur which include but are not limited to fever, rash and shortness of breath, shock and in rare occasions death. Expected benefits of the transfusion may include minimizing shock, brain and other organ damage, hastening recovery and limiting blood loss, however, I understand that there are no guarantees offered as to the expected benefits of the transfusion. 8. PHOTOGRAPHY: I consent to the photography or televising of the procedure(s) to be performed for the purpose of advancing medical education; or its publication in scientific journals providing my I the patient identity is not revealed by the pictures or description in the accompanying texts. In an effort to further medical science and education. I consent to and authorize the presence of and observation of this procedure by qualified observers as may be authorized the Indraprastha Apollo Hospital and its regulatory laws and agencies. AUTHORIZATION OF PATIENT I acknowledge that I have had and opportunity to discuss this procedure, as stated above, with my physician or physician designee, and hereby consent to this procedure. Patient
Date
Witness
Date
Doctor
Date
PATIENT REPRESENTATIVE I SURROGATE The patient is unable of consent because:
and I (name I relationship to the patient), therefore consent for the
patient I acknowledge that I have had an opportunity to discus this procedure, as stated above, with my physician or physician designee, and hereby consent to this procedure. Patient representative
Date
Witness
Date
Doctor
Date
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CONSENT FOR ANESTHESIA / OBSTETRICS ANALGESIA I SEDATION I consent to the use of anesthesia by my anaesthetist and his I her assistants. I understand that the use of anesthetic or placement of intra - vascular lines for invasive monitoring may, despite all appropriate measures to prevent pose certain risks including but not limited to temporary impairment of judgement and motor coordination; temporary decrease in attention span: nausea or vomiting; headache; sore throat; muscle aches; bruises or tenderness at the site or intravenous infusions: and may result in paralysis. cardiac arrest or brain damage. In this regard; I have been fully informed as to the nature and to the purpose of the anesthesia, the possible risks and complications and possible alternative methods and I understand the explanation, I have received. Furthermore, I have been specifically advised that there is a possibility of damage to my I the patient’s teeth during the procedure (s) and administration of anesthesia, particularly if the teeth are loose, weak, decayed or artificial, and I hereby waive any claim to damage to my I the patient’s teeth as a result therefore. AUTHORIZATION OF PATIENT I acknowledge that I have had an opportunity to discuss this procedure, as stated above, with my anesthetist or his / her designee, and hereby consent to the use of the anesthesia discussed. Patient
Date
Witness
Date
Doctor
Date
PATIENT REPRESENTATIVE I SURROGATE The patient is ‘unable of consent because:
and I,
(name l relationship to the patient), therefore consent for the patient I acknowledge that I have had an opportunity to discuss this procedure, as stated above, with my anesthetist or his I her designee, and here by consent to the use of the anesthesia discussed. Patient attendant
Date
Witness
Date
Doctor
Date
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HIGH RISK CONSENT INDEMNITY STATEMENT I ............................................................................................................................... have been explained about my surgery, I have been explained by the doctors that the causes of my being High Risk are due to following:
(PATIENT/REPRESENTATIVE) Reason for High Risk 1. 2. 3. I also state that I or my family shall not hold Apollo Hospital or its doctors for any consequences whatsoever. It has also been explained to me that the PACKAGE TARIFF FOR THE HIGH RISK CASES IS SUBSTANTIALY HIGHER THAN NON-HIGH RISK CASES. Name of relative authorising the surgeon to carry out the operation: Relationship to the patient: Signature of relative: Time & Date: Signed in the presence of witness 1. 2. Signature of doctor who has explained the risk: Name of Doctor: Date: Time: NOTE: PLEASE ENTER HIGH RISK STATUS ON THE ACTIVITY CARD
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Appendix B Rules for doctors: An obituary to the mutual trust between doctors and patients 1. Once a doctor has chosen to go into this “honourable profession” he/she forgoes all human rights – and has only the right to play God with only good results.
12. If a doctor has the expertise to figure out a problem in minutes he is a cheat for charging the patient any consultation. It matters not the hours of toil and trauma in the wards and hospital, the rigorous self discipline to put work before pleasure most of his life, the reams of books read, re-read and re-read since the age of 18, the sleepless nights on-call and endless ward rounds he has to put in to obtain that experience which enables him to perform most procedures and take most decisions at the spinal level (as on automatic pilot). Only a plumber or lawyer is allowed to charge money for a two minute consultation because he chose a profession that is not called “honorable”.
2. If a doctor cannot provide 100% results to 100% of his patients 100% of the time he must pay for the correction of the compromised result from his own pocket and with disgrace. 3. A hypocritical mockery is made quoting the Hippocratic oath taken by doctors by having double standards of life when it comes to a doctor’s life. 4. All doctors are out to get a patient’s money, are careless, are unconcerned if they cannot make a patient well, have no conscience, are inhuman-unless proved otherwise.
13. It is unreasonable for a doctor to earn enough money, to expect to educate his children, provide functional necessities for his family and ensure a self earned pension for his old age. It is only honorable for the rest of the society to do so since they did not choose this “honorable” profession – the doctors can honorably suffer penury in their old age.
5. The onus is on the doctor to prove himself innocent by continuously, simultaneously recording his innocence and magically managing patient care simultaneously. 6. A doctor must always clinically remind himself that the written word is stronger than any presumed ‘word of honour’ made by a patient to his/her doctor or that of a doctor to his patient. That is history.
14. If the doctor does not market himself above others and does not network he is not good enough since his clinic is not bursting at its seams. On the other hand if he does so blatantly he is unethical.
7. The doctor despite the elevated humble nature of his profession has to also be a legal expert document all explanations made and any questions discussed in his/her notes in order for people, judge and jury to believe him/her.
15. If a doctor makes a patient wait in his clinic he is unprofessional even if he has to spend 10 extra minutes for repeating the same explanations to patients multitudes of times for juggling supervision of other sick or operated patients whilst attending to patients in the clinic for attending to his personal unavoidable calls from home for stopping to have a sandwich for having his car repaired for allowing his patients to weep inside his office when bad news is broken and not hurry for not having that ‘military regime’ in his clinic and most of all for being human – he must pay the price.
8. The extra time, money and energy spent in doing so are to come from the doctors pocket-because if the patient is charged for this extra service the doctor is “greedy”. 9. If things go well-the doctor has only done what he/she was paid to do. 10. If things go wrong and are not a 100% correct or optimum, the doctor has not fulfilled his part of the unwritten contract of what he was paid to do.
16. Only a human being who is under the influence of alcohol, deranged mentally or subnormal would therefore choose to be a doctor given the above rules and hence must be continued to be treated so in his lifetime.
11. Laws of nature, circumstantial variabilities, and acceptable human error factors are not applicable to the practice of medicine or to a doctor.
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This obituary only clarifies the doctors dilemmas!
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