ORDER Dr. P. D. Shenoy, Member— Case of the complainant: The original complainant Shri Suresh Pratap Singh was a retired Government servant and has been suffering from mild heart problems and was treated at the Escort Heart Institute and Research Centre (in short EHIRC) for several years. He was advised to undergo angiography for which he was admitted to the hospital on 17.7.1995. Blood test conducted prior to the angiography proved Hepatitis B negative (HBs Ag). After the angiography the complainant was advised to undergo by-pass surgery of the heart (CABG). As advised by the opposite party, the complainant was admitted to EHIRC on 4.12.1995 to undergo by-pass surgery. However, no surgery could be performed on the complainant till such time a boil on the leg of the complainant did not heal. Accordingly, the surgery was delayed till 13.12.1995. 2. Though the relatives were willing to donate the blood to the complainant, the EHIRC utilized the blood from the blood bank and took the blood given by the relatives for storage in the blood bank for future use. At around 10.30 p.m. on the same day, the relatives of the complainant were informed by the attending doctor that there was some internal bleeding hence, he was again taken to the operation theatre at 11 p.m. and the chest of the complainant was opened to detect the cause of internal bleeding. During the operation a large amount of blood was utilized for transfusion and the same was obtained from the blood bank in spite of availability of individual blood donors amongst the relatives of the complainant. 3. On 21.12.1995, the complainant was discharged from the hospital and was informed that the surgery was successful. The bill amount of Rs. 89,000, was paid by the CGHS, the complainant being a CGHS beneficiary, and the balance amount, was paid by the complainant. 4. On 10.3.1996 the complainant developed high fever and Dr. P.C. Bhalla examined the complainant and advised certain medicines. As the fever persisted the same doctor advised him to go for a detailed examination including blood test on 25.3.1996. On 26.3.1996 tests on the complainant indicated that Bilirubin is very high suspecting jaundice. On 30.3.1996 another blood test indicated that the complainant was suffering from Hepatitis B. On the same day the complainant, was examined by Dr. As the fever persisted the same doctor advised him to go for a detailed examination including blood test on 25.3.1996. On 26.3.1996 tests on the complainant indicated that Bilirubin is very high suspecting jaundice. On 30.3.1996 another blood test indicated that the complainant was suffering from Hepatitis B. On the same day the complainant, was examined by Dr. Vimal Nakra, of Deepak Memorial Hospital, who stated in his prescription that Hepatitis B was contracted during the blood transfusion during CABG in December 1995. The doctor opined that, Hepatitis B infected blood once given to a person has an incubation for a period of 8 to 12 weeks and the symptoms about the onset of hepatitis B would be discovered after that period. According to the doctor, as the by-pass surgery was done on 13.12.1995, Hepatitis B infection surfaced in March 1996 clearly indicated that the same was caused due to the infected blood given during blood transfusion. 5. The complainant was regularly examined for the level of Bilirubin test conducted from 1.4.1996 to 13.7.1996 and in all the tests it was seen that Bilirubin in the blood was very high. On 1.4.1996, the complainant was subjected to ultrasound test, which indicated that the liver of the complainant was mildly enlarged. On 31.3.1996, the son of the complainant who is an advocate practicing in the Supreme Court talked to Dr. Trehan on telephone informing about the hepatitis B infection caused to the complainant. Case of the opposite party (EHIRC) 6. It is submitted on behalf of the hospital that as a matter of practice and policy the attendants or relatives of every patient, who has to undergo by-pass surgery, are asked to arrange for 6 units of blood of the same group to which the patient belongs through donations by relatives and friends. If it is not possible for the patient’s attendants to bring all the donors of the same blood group, the blood donated by the other blood group donors is stored in the blood bank of the Institute after carrying out all the necessary and prescribed medical tests according to the international standards and later on it is utilized. No blood purchased from the market is transfused by the EHIRC. 7. No blood purchased from the market is transfused by the EHIRC. 7. Whenever the friends and relatives of the patient come to EHIRC for donation of blood, their past history is taken and blood of those donors is accepted who have no past history of jaundice and whose HBs Ag Test is negative. In this case also similar precautions were taken. Copy of the relevant pages from the ‘Donor Screening Register’ giving the details of the donors and the Lab Test Reports of the blood used in this case was produced by the EHIRC. It was also submitted that out of the donors brought by the complainant, blood of three donors was not taken as one of them had a history of diabetes, the second had history of jaundice and the third one was on some medicines. The well known HBs Ag. Test (ELISA) which is conducted for detection of jaundice infection in the blood donated has sensitivity range of 95% and there is still a possibility of 2.7% recipients developing jaundice. It is also submitted that that this is the only test for detection of jaundice which is carried allover the world and has the same incidence of post transfusion jaundice infection ranging from 4 to 44%. Therefore, the allegation of the complainant that he developed jaundice due to surgery at EHIRC is baseless. An extract from AABB Technical Manual, 1990 is as under: “Mandatory screening of all donors for HBs Ag and the use of volunteer donors have significantly decreased but not eliminated, the risk of HBV infection after transfusion.” 8. It is further contended that the patient was a known case of hyper-tension and attending to G.B. Pant Hospital prior to coming to EHIRC on 2.12.1989 and he was advised to undergo angiography. In view of the finding of the triple vessel disease which needed by-pass surgery (CABG), the complainant was advised early surgery on 18.7.95 as the complainant had already delayed the treatment by many years, but the patient chose to delay it further and got himself admitted on 4.12.95. The EHIRC has one of the best managed blood banks in the country and it carries out all the necessary and internationally prescribed tests like HBs Ag. HIV, VDRL, Malaria Parasite and thereafter all possible precautions are taken for test, preservation and surgery. The EHIRC has one of the best managed blood banks in the country and it carries out all the necessary and internationally prescribed tests like HBs Ag. HIV, VDRL, Malaria Parasite and thereafter all possible precautions are taken for test, preservation and surgery. The surgery related to 4.12.95 was postponed as during the pre-operative check up of the complainant it was found that he has a boil on his leg and till the boil healed no elective open heart surgery is performed in the presence of any septic focus in the body. They have quoted the Oxford Text Book of Clinical Hepatology edited by five professors wherein it is observed as under: “That hepatitis B from transfusion has become rare since introduction of screening of blood donors for HBs Ag. Isolated cases of post-transfusion hepatitis, however, still occur which may be due to the rare blood donor who is a low level carrier of hepatitis B, (undetectable HBs Ag) or which is in an incubation period.” 9. They have also quoted ‘Blood Transfusion in Clinical Medicine, 1987 Ed. Molison et al’ wherein it is observed as under: “Following the introduction of test in 14 prospective studies in the U.S.A. the overall frequency of hepatitis in patients is receiving HBs negative. Blood from volunteer donors was between 4 and 13 per cent.” 10 They have given details of the blood used. Further they have quoted a study made by Dasarathy, S. Misra S.C. Acharya, S.K. et al “Prospective controlled study of post transfusion Hepatitis after cardiac surgery in large referral hospital in India”, it has been observed that 15 out of 250 (6.9%) recipients who had undergone cardiac surgery, developed post transfusion hepatitis. EHIRC in their submissions also stated that prescription of Dr. Vimal Nakra no where states that hepatitis B virus was contracted during surgery. It is also submitted that the complainant got a new lease of life on account of specialized and successful treatment of his heart problem when his three arteries were blocked and without surgery he was at a risk to have a major heart attack and collapse any time and it was only due to the best medical care provided for it by the respondent EHIRC that the complainant is alive today. Hence, it was submitted that the patient’s developing jaundice was not on account of any deficiency, imperfection and negligence in the treatment given to the complainant by the EHIRC. Written Submissions of Dr. Naresh Trehan 11. In his written submissions, Dr. Naresh Trehan has admitted that there was a telephonic conversation with the son of the complainant but according to him the contents of the conversation have been misrepresented. He simply informed the complainant’s son of the practice which is followed by the respondent hospital of testing all blood samples received from donors by conducting all prescribed tests, including, Hbs. Ag. Test (ELISA). It is submitted that the said ELISA test is the most efficacious test for hepatitis, and only test relied upon world-wide which has sensitivity of 99.9%. Therefore, the blood which is transfused is only that which after screening, tests shows negative for hepatitis B virus. The allegation of the complainant is totally misconceived, as no statement was made as alleged in para 15 of the complaint, which is contrary to the established practice followed by the respondent hospital. 12. He further informed the complainant’s son that the hepatitis B virus has a window period of about 3 weeks from the date of infection when there is no serological evidence of its presence in the blood test. Therefore, in spite of every possible precaution, and tests being conducted on the samples of the donor blood, there is no medical test which yields 100% perfect results with regard to hepatitis B. 13. In this written submission, he has also stated that the laboratory test reports clearly show that Bag Nos. 10687' 10879, 10954, 11047, 11074, 10461, 11287, 10768, 10642 which were used for blood transfusion in the complainant’s case, tested negative in the ELISA (Hepatitis B) test. Hence, the record clearly reveals that all blood which was administered to the complainant was duly tested for Hepatitis B. Submission of the LD counsel for the complainant 14. When the matter was initially heard on 14.5.08, we have heard the submissions of Mr. Varun Aggarwal who reiterated the many of the points made in the complaint. Mr. Aggarwal submitted that the subsequent to the elective open heart surgery, the complainant was diagnosed for Hepatitis B and this has occurred due to blood transfusion as 20 units of blood were transfused from the stock of the EHIRC. Varun Aggarwal who reiterated the many of the points made in the complaint. Mr. Aggarwal submitted that the subsequent to the elective open heart surgery, the complainant was diagnosed for Hepatitis B and this has occurred due to blood transfusion as 20 units of blood were transfused from the stock of the EHIRC. Doctors of the Institute did not give Hepatitis B vaccination prior to the surgery to the patient. Even the patient was not advised to take vaccination from some other place. The learned counsel drew our attention to the affidavit filed by the complainant wherein he has stated that his son, an Advocate practicing in the Supreme Court on informing Dr. Trehan of the opposite party on 31.3.96 over the telephone about his Hepatitis B infection, was informed by Dr. Trehan that the infection could have been caused due to presence of the virus in the blood supplied by the EHIRC, as it was only an elective open heart surgery. He quoted from the letter dated 3.4.96 of Mr. Vikas Singh, Advocate Supreme Court to Dr. Naresh Trehan wherein it is stated as under: “More serious, after the operation my father developed jaundice. We have been professionally advised that the Hepatitis B which my father is affected with is entirely due to infected blood supplied by your hospital. When I talked to you on telephone on 31.3.96, you informed that the emphasis in your hospital is to test the blood only for HIV and Aids and there is a possibility of Hepatitis B infected blood being supplied by your hospital.” 15. The risk of occurrence of this disease due to blood transfusion during the surgery was not intimated to the patient before performing the elective open heart surgery. Submission of the LD Senior counsel of EHIRC 16. Mr. Sanjiv Puri, learned senior counsel submitted that surgery for triple vessel disease was successful. When the patient was brought to the EHIRC he was under serious condition and had diabetic block in his leg and therefore the surgery was postponed. After the surgery the patient was alive for 10 long years. Report of Dr. Vimal Nakra dated 30.3.96 reads as under: “Viral Hepatitis HBs Ag+ve. H/o Blood transfusion in December, 1995 while He undergone for CABG C/o Anorscia } Two weeks Nausea Detected Jaundice one week back” 17. He has not filed any ELISA report. After the surgery the patient was alive for 10 long years. Report of Dr. Vimal Nakra dated 30.3.96 reads as under: “Viral Hepatitis HBs Ag+ve. H/o Blood transfusion in December, 1995 while He undergone for CABG C/o Anorscia } Two weeks Nausea Detected Jaundice one week back” 17. He has not filed any ELISA report. The complainant had not requested to the Commission to cross-examine Dr. Nakra who had also not filed any affidavit. He was travelling to USA and other countries regularly. There was no question of giving Hepatitis vaccination before conducting CABG. As per the affidavit it takes about 9 months to develop immunity after vaccination for Hepatitis B. The consent was taken before surgery was conducted. The blood transfused to the patient was free from Hepatitis virus. Submission of the LD Counsel for the Opposite Party No. 2, Dr. Naresh Trehen 18. Ms Indu Malhotra, Sr advocate had made submissions on an earlier date of hearing. 19. There was no jaundice at the time of the discharge of the patient from the hospital after the performance of CABG. It is not a practice to give anti-hepatitis vaccination before performing the surgery CABG. The booster dose is spread over nine months and jaundice cannot be prevented by one dose of vaccination. Blood which was disinfected, preserved and tested was only administered to the patient. There is no complaint about negligence in surgery. Dr. Nakra has not filed any affidavit in support of the certificate given by him when he observed jaundice on 30.3.96. Evidence 20. In this case, the complainant has filed his own affidavit and on behalf of EHIRC, Dr. (Gen.) Tarsem Kumar, Medical Superintendent has filled affidavit. Dr. Naresh Trehan, opposite party No.2 has also filed an affidavit. In addition, Dr. R.C. Khurana who is the Head of Blood Bank of EHIRC has also filed affidavit. Findings 21. One of the issues to be decided is whether the blood which was transfused to the complainant during his stay in the hospital was tested for Hepatitis B. Detailed record of the blood transfused to the complainant filed by the EHIRC clearly shows that the blood which was administered to the patient complainant was tested for HIV, Aids, VDRL and Hbs. Ag. Last test Hbs. Ag. refers to Hepatitis B and the blood which was shown negative for Hbs. was only administered to the patient. Ag. Last test Hbs. Ag. refers to Hepatitis B and the blood which was shown negative for Hbs. was only administered to the patient. This has been stated by the affidavit filed by Dr. Khurana who is the Head of the Blood Bank of EHIRC. 22. The short point to be determined is whether even though Hbs Ag negative blood was transfused, can the patient have been afflicted by the Hepatitis B? The extract of medical text produced by the opposite parties and which have been quoted above in extenso clearly shows that there is a possibility of the patient contracting Hepatitis B even though blood which has been tested negative for Hbs. was administered to patient. This is because of prevalence of a window period between starting of the infection and it becoming a full flown disease so as to show its presence in the blood. 23. In this context, it is relevant to look into the examination of the patient conducted by Dr. Vimal Nakra. Dr. Nakra has examined the patient after about three months of the surgery and has observed in his prescription that the complainant suffered from Hbs. Ag. positive and has also observed about the blood transmission in December, 1995 when the patient underwent CABG. But Dr. Nakra has not filed an affidavit to support his prescription to enable the opposite parties to cross-examine him or to serve interrogatories upon him. On the other hand, the complainant was cross-examined extensively. An extract of the cross-examine is given hereunder: It is correct that in the event of infection in diabetics it takes longer to heel. I do not have any qualification in the field of medicine. The medical terms used in my complaint were written on the information/advised by my doctor son-in-law. I have not filed any document alongwith the complaint or the affidavit showing consultation of my doctor son-in-law, nor I have mentioned the fact of such consultation in the complaint or affidavit. It is correct that at the time of CART (Angiography) I was advised early operation. When I went to have surgery in December, 1995, I had a boil on my leg. The boil was not hurling me. I had noticed it on 4.12.95 but had ignored it. It is correct that at the time of CART (Angiography) I was advised early operation. When I went to have surgery in December, 1995, I had a boil on my leg. The boil was not hurling me. I had noticed it on 4.12.95 but had ignored it. I did not put any thing in writing in relation to the boil on my leg in writing to the doctor of Escorts Hospital (volunteers) my daughter. Dr. Sadhna Singh had informed the Escorts Hospital regarding this boil. It is correct that I have not mentioned in my complaint or affidavit that my daughter, Dr. Sadhna Singh had pointed out the boil to the doctors of Escorts Hospital. I think I was treated for this boil by the doctors of Escorts Hospital prior to the surgery. I do not recall the medical qualifications of Dr. Vimal Nakra. I cannot remember whether Dr. Nakra is a registered medical practitioner or not. I do not remember if Dr. Nakra had any expertise in Gastrology, I cannot say whether Dr. Nakra is a part of the team who had treated me in December, 1995 at Escorts. I do not recall having gone to Dr. Nakra before December, 1995. I have not filed any document showing any treatment given to me or examination by Dr. Nakra prior to March, 1996. In the photocopy of medical certificate of Dr. Nakra dated 30.3.96. I cannot say what the term C/O means at point X and then at point X1 what the term O/E means. At the point X2 the terms ADX means advise and at point X3 the term RX stands for what is being prescribed to me. At point Y the term H/O I do not know what the term H/O at point H/O at point Y stands for. I did not do the cutting of the words January, 1996 at point Y1 in Exhibit C/E. I am not aware who has scored the words at point Y1 in Exhibit C/E. The certificate Ex. C/E does not contain mention of surgery having taken place on 13.12.95. I do not recall what medical papers I had carried to Dr. Nakra at the time of examination on 30.3.96. I must have informed Dr. Nakra about the history of my treatment when I went to him on 30.3.96. In page 2 of Ex. C/E does not contain mention of surgery having taken place on 13.12.95. I do not recall what medical papers I had carried to Dr. Nakra at the time of examination on 30.3.96. I must have informed Dr. Nakra about the history of my treatment when I went to him on 30.3.96. In page 2 of Ex. C/E in the advice and prescription given by Dr. Nakra he has not given any finding in writing as to how infection of hepatitis has occurred. Along with the complaint I have not produced any tape recording of any conversation between my son Vikas Singh who is an advocate and Dr. Naresh Trehan. I was present at the time of conversion between Dr. Naresh Trehan and my son Vikas Singh. I do not recall the date of the conversion. 24. During the conversion, Dr. Trehan is alleged to have told that EHIRC gives importance during blood test to HIV Test and not to Hepatitis B. This allegation has been rebutted by Dr. Trehan in his statement, which has been elucidated above and also in his affidavit filed before this Commission. Informed consent was taken prior to the surgery in EHIRC. Affidavit has been filed by Dr. R.C. Khurana stating that the blood transfused was not infected. 25. The complainant, Suresh Pratap Singh was 62 years old at the time, he underwent the high risk surgery i.e. CABG. He has not complained against the surgery per se. The surgery was successful, wound got healed and the complainant went home after recovery. The complainant has not complained at all about the surgery as well as nursing care in the hospital. His only complaint is regarding the blood which was transfused to him. This Commission, in M Chinnaiyan v. Sri Gokulam Hospital and Anr.1 has held that respondents Sri Gokulam Hospital and Queens Mary’s Clinical Laboratory were responsible for medical negligence. Subsequent to the hysterectomy operation, in this case, two units of blood was transfused by the treating doctors of Sri Gokulam Hospital to the patient. This blood was supplied by Queen Mary’s Clinical Laboratory without conducting the mandatory test to satisfy that it was free from infection like HIV. 26. This reported case is distinguishable from the case under consideration in as much as EHIRC had conducted the mandatory test to check whether the blood was free from hepatitis infection. This blood was supplied by Queen Mary’s Clinical Laboratory without conducting the mandatory test to satisfy that it was free from infection like HIV. 26. This reported case is distinguishable from the case under consideration in as much as EHIRC had conducted the mandatory test to check whether the blood was free from hepatitis infection. Therefore, this reported case is not applicable to the case under consideration. 27. One of the issues raised by the complainant was that he should have been given anti-hepatitis B vaccination before performance of the surgery. This has been replied by the opposite parties stating that it is not a practice to give this vaccination prior to CABG. Moreover a boster dose spread over 9 months has to be given and jaundice cannot be prevented by a single dose of vaccination. The complainant lived for about 10 years after the surgery and has been able to travel extensively. The EHIRC has produced detailed medical records relating to the blood transfusion as well as the performance of surgery and post operative care. 28. In this connection, it is relevant to quote an extract of the celebrated judgment of the Hon’ble Supreme Court in Jacob Mathew v. State of Punjab and Anr.2 which is as under: “The fact that a defendant charged with negligence acted in accord with the general and approved practice is enough to clear him of the charge. It is not necessary for every professional to possess the highest level of expertise in that branch which he practices. Three things are pertinent to be noted. Firstly, the standard of care, when assessing the practice as adopted, is judged in the light of knowledge available at the time (of the incident), and not at the date of trial. Secondly, when the charge of negligence arises out of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that point of time (that is, the time of the incident) on which it is suggested as should have been used. Thirdly, when it comes to the failure of taking precautions, what has to be seen is whether those precautions were taken which the ordinary experience of men has found to be sufficient, a failure to use special or extraordinary precautions which might have prevented the particular happening cannot be the standard for judging the alleged negligence.* 29. Thirdly, when it comes to the failure of taking precautions, what has to be seen is whether those precautions were taken which the ordinary experience of men has found to be sufficient, a failure to use special or extraordinary precautions which might have prevented the particular happening cannot be the standard for judging the alleged negligence.* 29. A professional may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, with reasonable competence in the given case, the skill which he did possess. The standard to be applied for judging, whether the person charged has been negligent or not, would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities, but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence. 30. The test for determining medical negligence as laid down in Bolam case, WLR at p. 586 holds good in its applicability in India.” 31. This ratio of the above judgment is squarely applicable to the case on hand. Accordingly, we are not persuaded to accept the contention of the complainant that there was medical negligence in this case. Therefore, this complaint is dismissed. However, there shall be no orders as to cost. Complaint dismissed. *******