The Truth about HCV spread due to the medical negligence of
Stanley Medical College
Aam Aadmi Party has been working on the issue from August 21 st ever since patients relatives approached us saying that they were being driven out of the hospital for no fault of theirs. While we have been successful in getting the treatment started for the 16 patients suffering from Hepatitis C, we have been fighting on our other demands including recalling of patients who underwent dialysis in the last 6 months in Stanley for HCV screening, compensation for HCV affected patients and action on people responsible for the HCV spread. First we were promised by the Director of Medical Education that the enquiry committee will finish its report within a week. Secondly, the health secretary promised us that he will let us meet the enquiry team to share our findings within last week. None of them happened. So we are sharing our findings with the public and the media on how the infection spread and the reasons behind our demands. Particularly, the health secretary and the hospital are not recalling earlier patients. In this document, we clearly show you how we have found a patient who underwent dialysis between May and July at Stanley hospital has been sent out of the hospital on July 16 th and found to have HCV after going back to their hometown. Their life and livelihood is at stake.
What happened ? Sequence of Events
1. An outbreak of HCV virus has come to light in the nephrology department of the Stanley Medical College over the past one month. On the 13th of Aug 2014, a patient named P was diagnosed as Heptatits C Virus positive in the ELISA Test. This patient was waiting for a kidney transplant. His blood sample was taken on the 9th of August. After the diagnosis, P was asked to leave Stanley without a proper counseling procedure. Since his dialysis was done on the 12th Aug, he was asked to leave solely based on the Elisa test result [Ref 1]
2. Subsequent to this, one of the patients relatives told us that a patient who came in for dialysis on the 15th Aug was sent back by the doctor, citing a HCV spread in the hospital dialysis ward. It should be noted that the dialysis, meanwhile, continued to happen for the other patients.
3. On the 18th of August, 15 patients were asked to take the HCV test (RNA by PCR), at the same time. It should be noted that this was not a routine test - it was taken for all the patients in the ward at that time. The usual routine test in the hospital is an Elisa test. Hitech Daignostics from Kilpauk visited the hospital and took the blood samples.
4. On the 20th of Aug, all 15 of these patients were informed, as they showed up for dialysis, or when the doctor visited them, that they had Hepatitis C Virus. It should be noted that these patients were not told how they could have contracted the virus. They were simply told that there is an infection for the patient and that the treatment cannot be continued in Stanley for the infection. They were asked to leave to other hospitals for treatment.
5. All these patients have been in the hospital for anywhere between 2 months to 1.5 years and all of them were awaiting kidney transplant and each of them had a donor. However, it was a huge shock for them that they were asked to leave the hospital for no fault of theirs.
6. Aam Aadmi Party got the information and visited the patients on 21 st August when they were all shocked and didnt know what to do. One patient L said that enough was enough and that he would like to end his life. He was then counseled by us.
7. Dr Edwin, Head of Nephrology refused to share the truth of how it spread with us and instead said that Hep C spreads through bedsheets, saliva and air.
8. AAP immediately had to resort to protest the very next day inside the hospital demanding that all patients be readmitted into the hospital and for the treatment for HCV to be started immediately and independent enquiry committee to be put up. The complete set of demands can be seen in Reference 2 [Ref 2]
9. Subsequent to the protests and push-back, it should be noted that even while an Enquiry Commission was being formed, the hospitals doctors, such as Dr.Edwin Fernando (Head of Nephrology) and Dr.A.L.Meenakshi Sundaram, Dean of Stanley Medical College, continued to misinform the media that the patients must have contracted the virus outside [Ref 3]
10. It should also be noted that subsequent to the protests and media, public attention, the doctors in Stanley did take the patients back; and also described a path for them to be treated. In other words, there was no sound clinical reason for the Stanley administration decision to send the patients away in the first place. If the hospital knew how to treat it and had the expertise, why did it cover up the whole thing and drive away patients initially??
11. Initially we were promised by DME that the enquiry committee will be set up, we could present our findings to them and it will be completed before end of August. The health secretary later promised us that we could meet the enquiry team before September 5, 2014. We waited patiently to share our findings with the enquiry committee. They didnt make us meet. We again requested him to make us meet atleast on or before Sep 10 th . Since that also lapsed, we are forced to take this to public domain. Will this enquiry committee be also another eyewash committee?? We have not even been informed about the members of enquiry committee yet.
HCV Virus spread because of Stanley Hospital
Why we think that the infection arose and spread because of medical negligence of Stanley Hospital?
1. Many of these 16 patients were undergoing dialysis in Stanley and nowhere else for most of the past 6 months
2. For most of them, the results went from negative to positive within a short time period, in which they were only treated by Stanley
3. Except for patient P, rest of them are ELISA negative for HCV but they were all positive in RNA by PCR taken on 18 th August suggesting that they have contracted it in the last 2 months. ELISA test generally takes 7 to 8 weeks to detect antibodies [Ref 4]
4. For patient P, who was the first to be tested for HCV positive, Hepatitis test was not done for the patient after May 9, 2014. Between May 9 and Aug 13 the patient has undergone 36 dialysis but ELISA HCV test was not conducted which was a clear violation of the procedure. On August 13 th , the patient tested HCV positive in ELISA test.
5. The behavior of the doctors in seeking a test on the same day for 15 of the patients shows that they themselves suspect an infection spread from their hospital
6. When 16 patients in the same ward turn positive (seroconversion) on the same narrow time period, logic and statistics dictate that we start with the specific ward for the origination of the infection.
7. According to patients and their relatives, the dialysis tubes were not sterilized properly. The tubes were all washed in the same bucket and reused many times. [Ref 5]
8. Doctor Edwin told us that they reuse dialyser tubes for 5 to 8 times which is standard practice. What we found out was that they have used it more than 10 times for many patients. Inorder to cover this up, they had rewritten the number of times dialyser tubes were reused in the patients notebook [Ref 6]
9. Almost all the literature on Hepatitis C outbreaks in Hemodialysis units mention that the causes are primarily not following proper infection control procedures. They can be prevented, particularly since the Indian government has mandated compulsory blood screening for HCV since 2002.
10. Without following proper procedures, dialysers were disposed. Immediately after this HCV spread, patients and AAP volunteers found that the hospital has thrown a dialyser out of the window and it fell on a loft. The picture is attached for reference [Ref 7]
11. Clearly it has happened due to the medical negligence of the procedures of sterilization and infection control mechanisms of Stanley hospital. Such a spread to 16 patients within a short time span has not happened anywhere in the world.
Recall Patients Immediately
Why we demand that all patients who underwent dialysis at Stanley over the last 6 months needs to be recalled?
1. References from the Center for Disease Control, United States, show that a window should be established to find out the earliest infection, and patients who underwent dialysis from two months before that to the present should be recalled for screening, counseling and treatment [Ref 8]
2. So far, there has not been any attempt by the hospital to recall earlier patients. Even some of the patients who were driven out came back after looking at the news of protest at Stanley by themselves.
3. Many a times, the dean and doctors have told the press that the incubation period is 2 weeks to 6 months [Ref 3]. If this is the case they need to call everyone who underwent dialysis over the last 6 months for screening HCV since the infection has spread from within the hospital
4. In this case, only the doctors exactly know who was the earliest patient to be detected with HCV positive. Available information with us initially suggested that patient P was the first patient to be detected on August 13 th as ELISA positive for HCV
5. However, with little more research we found out that there was one patient Ms R who was sent back last month itself by Stanley. The reason given to her was that she had some infection in lungs. She left to tuticorin general hospital and did a dialysis there. Doctors there then spoke to Stanley and then requested her to leave the hospital saying that she could not be treated there. She then left to Tirunelveli General hospital who found through a blood test that she has contracted HCV positive. They also asked her to leave citing HCV positive patients cannot be treated there. Finding no solution to her problems, she then went to a private hospital and did dialysis without informing them that she has HCV. She feared that she would not be given treatment here as well, They found out after a couple of dialysis and then have asked the family to take HCV Genotype test. Her husband could not afford the test and hence has not taken it. This family needs immediate recall and treatment by Stanley [Ref 9]
6. The above story could have happened to many others which we will only know if the hospital recalls all the patients who underwent dialysis in the last 6 months at stanley for screening. It is also scary as there is a possibility of this getting spread further in other hospitals as well if Stanley doesnt recall earlier patients.
7. We should note that most of these 16 patients still had ELISA HCV as negative when they were tested for RNA by PCR as HCV positive on August 18th. This is because RNA by PCR tests the presence of virus which could be detected in 2 weeks whereas ELISA tests the presence of antibodies and hence takes 7 to 8 weeks. People who went out from Stanley over the last 6 months could have gone elsewhere and started dialysis there after testing ELISA. This infact could have led to transfer of HCV to other patients over there if that hospital also doesnt follow proper infection control mechanisms
8. We demand that all patients who underwent dialysis at Stanley over the last 6 months be recalled immediately and a HCV RNA by PCR test to be run on them free of cost.
Take ownership and Compensate the victims
Why Aam Aadmi Party is demanding compensation for people affected by HCV ?
1. All the 16 patients + 1 patient (Patient R) were here for transplanting kidney and many were in their final stages. The fact that they have been given HCV by the hospital means that their transplantation has got shifted from anywhere between 6 months to 1 year depending on the level of viral load.
2. Secondly, many of these families are from out of station and their livelihood is at stake as both the husband and wife are here. Now without money, it is a huge burden for them to run their family in the coming months
3. Hepatitis C for dialysis patients are more severe than for normal patients. Researches clearly point out that there is lower survival for dialysis patients with Hepatitis C than non hepatitis C dialysis patients [Ref 10].This means that Stanley hospital is directly responsible for putting these patients life at more risk.
4. Hepatitis C is chronic for these patients as even after kidney transplantation, there is very high chance of Hepatitis C continuing for these patients. After kidney transplantation these patients will be continuously given immuno suppressors which means that it would be very tough for their body to fight Hepatitis C. The patients may also face further complications in future, given the nature of Hepatitis C [Ref 11]
5. Considering that all these families come from very poor background and that the hospital is completely responsible for making their life tougher and shorter due to their medical negligence, Aam Aadmi party strongly demands that the Government take up immediate responsibility and provide reasonable compensation for all these families
Demand strong action against Medical negligence
1. Clearly Medical journals suggest that HCV spread could be prevented if proper infection control procedures were followed.
2. By not following the infection control procedures, Stanley hospital doctors and staff failed in their duty. Moreover they tried covering up the whole episode by sending the patients to different hospitals
3. It is important that the guilty are punished both through department steps and legally
4. Only a strong action against erring officials will lead to better public health care services for the general public
References 1. ELISA test result of patient P taken on Aug 13 th
2. Our demands to the hospital on Aug 23 rd attached for reference (Attach1) 3. Press reports given by Dean and Head of Nephrology Stanley hospital http://www.thehindu.com/todays-paper/tp-national/tp-tamilnadu/special-team-to-treat- hepatitis-c-patients-at-stanley/article6345924.ece http://www.newindianexpress.com/cities/chennai/Doctors-Divided-on-Hepatitis-C- Spread-Among-Stanley-Patients/2014/08/25/article2396772.ece 4. ELISA test report for Patient B clearly shows that ELISA test taken on Aug 19 shows as negative and RNA PCR taken on the same date as positive suggesting that the virus was acquired within the hospital over the last 2 months 5. One of the patients relatives explaining how dialyser tubes were washed. Audio file in the link http://clyp.it/nex1c3uy 6. Patient notebook of Patient M clearly shows that dialyser tubes were used for more than 10 times and then struck off by end of August. 7. Picture of dialyser thrown on the sunshade of Stanley Hospital after the detection of HCV attached (Attach 2) 8. http://www.cdc.gov/hepatitis/outbreaks/healthcarehepoutbreaktable.htm 9. Video Evidence shown during press meet and evidence of HCV positive for patient R attached (Attach 3) 10. ISRN Nephrology, Vol 2013, Article ID 159760, Fabrizi et al Hepatitis C virus infection and dialysis: 2012 Update 11. http://www.nmji.in/archives/volume_19_4_Jul_Aug_2006/SPECIAL_SERIES/Spe cial_Series_19_4.htm
Attach - 1 Reference 2 AAPs demands submitted to DME on August 23 rd
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Attach 2 :
Dialyser part thrown on the sunshade of Stanley medical college
Attach 3
Both ELISA and RNA by PCR for patient R while coming into Stanley showing Negative
On August 2 nd after going back from Stanley, the patient R has HCV positive as can been seen from the private hospital report below
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