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--------------- Print Magazine --------------
  May 2016
  April 2016
CASE STUDY - by Anoop K. Kaushal

Institutes should update Diagnostic and Screening Tests

Escorts Heart Institute & Research Centre v. Mrs. Harbans Kaur Chawla

First Appeal No. 155 of 2007 pronounced on 20 th September, 2012 by National Consumer Disputes Redressal Commission, New Delhi.

Facts: The patient had been admitted for Coronary Artery Bypass Grafting in the Appellant/Institute and on 30-1-1995 during the course of this surgery, four units of blood from the Appellant's blood bank were transfused into her. On 29-3-1995, it was noted that she had lost her appetite, could not take food and had developed fever along with drowsiness and giddiness, contacted one Dr. B.S. Bhatia at P.G.I. Hospital, Chandigarh who after conducting a series of tests including blood and urine tests, on 30-3-1995 informed that she had contracted Hepatitis B infection due to transfusion of blood at the time of surgery in Appellant/Institute and advised her to seek urgent admission in P.G.I. Hospital, Chandigarh for treatment. A viral marker test confirmed that Hepatitis B had been caused by transfusion of HBs Ag infected blood by Appellant/Institute's blood bank which according to Respondents was due to lack of proper screening of the blood which is an essential requirement. Despite treatment for damaged liver, faulty renal function, etc., the patient did not fully recover from the side effects of Hepatitis B as is confirmed from the report dated 8-9-1995 of specialists of P.G.I. Hospital, Chandigarh. Respondents filed a complaint before the State Commission on grounds of medical negligence and deficiency in service and requested that Appellant/Institute be directed to refund the amount of ` 1,65,250 spent on the Heart Bypass Surgery at the Appellant/Institute, ` 25,000 towards expenses incurred for treatment at PGI Hospital, Chandigarh and ` 5 lakhs towards permanent disability caused to the patient along with interest @ 24% per annum w.e.f. 17-4-1995 till the date of realization.

Defence: It was stated that all blood donated in the Appellant's blood bank is duly screened to ensure that it is HBs Ag negative, through a well acknowledged test i.e . ELISA test but the test does not have 100% accuracy because it cannot always detect virus in the blood particularly during the early stages of incubation; incidence of post-transfusion jaundice are known to occur. Blood received from the four donors was carefully screened and tested before transfusion. Nowhere did the doctors in P.G.I. Hospital, Chandigarh state that Hepatitis B that was contracted by the patient, was due to transfusion of infected blood from the Appellant/Institute.

Operative part of the order of the State Commission:

"The complainant was an old lady of 69 years age. She went through bypass surgery. The discharge summary issued by the OP-Escorts hospital shows that she was given transfusion of four units of blood and was not suffering from any ailment or any complication of any kind that could have resulted in the Hepatitis B virus. As per medical literature the incubation period is between 40 days to 180 days whereas the complainant suffered Hepatitis B virus after 60 days of transfusion and the only inference derivable is that it was because of the blood which was of sub-standard that the virus was caused. Since she was a resident of Chandigarh she got herself admitted in the PGI, Chandigarh as she faced this complication within 60 days of transfusion of blood. As per report of the PGI, Chandigarh, the problem faced by the complainant was only due to the transfusion of blood. In the Discharge summary and follow-up card of PGI, Chandigarh dated
31-3-1995 in the title 'Course Management' the patient was diagnosed as 'a case of post-transfusion Hepatitis with Grade I' and she was treated for Hepatitis B virus in the PGI itself and since it is a Government Institute and not a competitor of the OP, there is no room for doubling the authenticity of the diagnosis given by the doctors of the PGI."

(The doctors cannot be held responsible for any negligence and deficiency in service since it was the technicians in the Blood Bank who were negligent and therefore, the Appellant/Institute is directed to pay the Respondents a lump-sum compensation of ` 50,000.)

Findings: There is adequate evidence on record to establish that there is clear nexus between the blood transfusion on the patient during the course of her cardiac surgery at the Appellant/Institute and her contracting Hepatitis B 60 days later especially since the patient had not undergone any other blood transfusion except at the Appellant/Institute. The report from P.G.I. Hospital, Chandigarh which is a highly reputed independent institution with specialized healthcare facilities has confirmed this fact in writing. The Appellant/Institute has in its defence produced documentary evidence to show that there is proper screening of all blood donors as also the blood donated by them and the latter is done through the ELISA method. As per medical literature, it is internationally well-accepted that even after screening through a reliable test like the ELISA test, there is still a possibility of the Hepatitis virus not being detected in the blood if it is in the early stages of incubation which may have happened in the instant case. For screening of blood, two tests are in use: (i) ELISA test; and (ii) Radio Immunoassay test. Medical literature extracted from Wikipedia states that the Radio Immunoassay test vis-à-vis the ELISA test is considered to be more sensitive and specific and also less expensive method to screen blood for possible viruses and the American Red Cross routinely uses this test to screen blood. In this method, the antigen-antibody reaction is measured using radioactive signals whereas in the ELISA method it is measured by using colorimetric signals . ELISA test is not considered conclusive in detecting the HIV viruses and its results usually have to be confirmed by a subsequent test like the Western Blot Test. There is a case for Hospitals like the Appellant/Institute which conduct major surgeries to seriously consider whether the ELISA test can be replaced by a more reliable test.

Held : The State Commission has taken into account the fact that reasonable if not foolproof precautions were taken in screening the blood and therefore, it awarded a compensation of only ` 50,000 against the amount of ` 6.95 lakhs claimed by the Respondents. Appeal is dismissed and the Appellant/Institute is directed to pay the Respondents ` 50,000 within six weeks from the date of receipt of this order.

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