State Consumer Disputes Redressal Commission
Shaik Haseena W/O Shaik Nissar vs 1. Indian Red Cross Society And Others on 25 November, 2013
BEFORE THE A.P.STATE CONSUMER DISPUTES REDRESSAL COMMISSION: AT HYDERABAD C.C.NO.137 OF 2012 Between Shaik Haseena W/o Shaik Nissar Occ: Daily Labour, Age 20 years R/o Venkateshwarapuram Nellore Town, Nellore-003 Complainant A N D 1. Indian Red Cross Society 1, Red-Cross Road, New Delhi-001 Rep. by its Secretary General 2. Indian Red Cross Society Andhra Pradesh State Branch H.No.3-6-212, Street No.15 Himayatnagar, Hyderabad-029 rep. by its Honorary Secretary 3. Indian Red Cross Society blood Bank, Red-Cross Road Nellore-003 rep. by its Honorary Secretary Opposite parties Counsel for the complainant M/s P.Subhash Counsel for the opposite parties M/s V.Basavaraju (Ops No.1&2) M/s S.Subramanyam Reddy(OP3) QUORUM: SRI R.LAKSHMINARSIMHA RAO, I/C PRESIDENT HONBLE SRI THOTA ASHOK KUMAR, HONBLE MEMBER
& SRI S.BHUJANGA RAO, HONBLE MEMBER MONDAY THE TWENTY FIFTH DAY OF NOVEMBER TWO THOUSAND THIRTEEN Oral Order ( As per R.Lakshminarsimha Rao, Member) ***
1. The complaint is filed claiming compensation of `95,00,000/- towards loss of health, loss of family, loss of companionship and mental agony and costs.
2. The averments of the complaint are that the complainant after conceiving was taken to Triveni Hospital for medical checkup and on the advice of the doctors, she was admitted in the hospital for delivery. As per advice of doctors of the Triveni Hospital on 1.11.2011 the complainant agreed to undergo cesarean section. After conducting several tests the doctors advised her to make arrangement for two units of B Positive blood for cesarean operation as the complainant was not having sufficient blood. The complainants parents purchased two units of B+ blood bearing packet No.A-75001 and A-74949 from opposite party no.3 for `1,000/- on 2.11.2011. On 3.11.2011 and the doctor has advised for one more unit of blood to the complainant and as such her parents purchased B+ blood from opposite party no.2 vide bag No.A-75097 for `700/- and the same was handed over to the doctor in the hospital.
3. The complainant has submitted that the doctors transfused the blood to the complainant after cesarean and were discharged from the hospital after one week from the hospital. After discharge the complainant started suffering with high temperature with severe body pains and itching over the body and the complainant was taken to Triveni Hospital and got examined by the doctors and prescribed medicines. Thereafter when the condition of the complainant was deteriorating she was admitted in Narayana Hospital on 3.12.2011 and the doctors in the hospital after conducting medical tests found that she was infected with HIV Positive. The complainant was sent to Andhra Pradesh Aids Control Society at Hyderabad and confirmed that the complainant was infected with HIV+.
4. The complainant further submitted that after their being infected with HIV she and her baby were thrown out of the house by her husband. The relatives and friends of the complainant had demanded the explanation from the Secretary Mr.Dr.A.V.Subramanyam of Red Cross Society, Nellore for which he has denied the supply of blood to the complainant. The District Collector, Nellore has intervened into the matter and constituted High Level Committee on the issue which after enquiry they came to the opinion that HIV infected blood was supplied to the complainant.
5. The complainant has submitted that the report establishes the negligence on the part of the opposite party no.3 in supplying infected blood to the parents of the complainant. The negligence of the opposite party no.3 was published in all the newspapers. The blood banks needs to take proper care and needs to conduct necessary pre-requisite test after obtaining the blood from the donor.
6. Due to negligent manner of the opposite party no.3 the complainant and their infant baby are infected with HIV+ and they lost the health, family and companionship and they were thrown out from society and hence prayed for grant of compensation of `95 lakhs.
7. The opposite partyno.2 filed counter affidavit in the shape of written version which was adopted by the opposite party no.1 and contended that the opposite parties no.1 and 2 are not responsible for the day to day affairs of the opposite party no.3 and each district has its own entity. The opposite party no.2 only issues guidelines to the district offices and is not involved in the day to day affairs of entities at the district level. The Indian Red Cross Society is a voluntary humanitarian organization having a network of over 700 branches throughout the country providing relief in times of disasters/emergencies and promoting health care of the vulnerable people and communities. It is a leading member of the largest independent humanitarian organization in the work. The Indian Red Cross society follows 7 principles i.e., Humanity, Impartiality, Neutrality, Independence, Voluntary Service, Unity and Universality. The dispute is in between the complainant and the opposite party no.3 and not against the opposite parties no.1 and 2.
These opposite parties are in no way concerned or involved in the issue. The Indian Red Cross Society works for the public and supplies several blood packs to poor and needy free of cost and hence prayed for dismissal of the complaint.
8. The opposite party no.3 resisted the case contending that the blood packets supplied to the complainant were tested at the time of collection from the donors and found to be free of HIV.
After the blood was tested for other parameters such as HBsAG, HCV, MP apart from HIV, the details of the packets so collected are entered in a Master Register and on issue are entered in an Issue Register. The technique used in testing the blood for HIV was ELISA technique which is used worldwide for testing HIV. On being questioned by the relatives and the friends of the complainant, the Secretary of the Red Cross Society informed them the blood from the donors was tested as per international standards and was found to be negative for HIV and even otherwise if the blood were contaminated as alleged there is no scope for HIV to express itself because of the window or incubation period which may be as long as 10 to 15 years.
9. The opposite party no.3 submitted that the High Level Committee on enquiry also confirmed that the complainant had CD4 count of 189 which is suggestive of full blown up case of AIDS. On enquiry conducted at different levels the High Level Committee come to the conclusion that the same was due to human error and not due to wilful negligence of the Red Cross Blood Bank. It is also not brought to the notice of the committee that no test of HIV was ever conducted on the complainant. Out 1000 test results done using ELISA technique, among healthy individuals, about 3 may be false negatives and therefore the very high predictive value of the test is the reason why it is recommended and that is the reason why a negative test result can be taken as conclusive evidence that the individual does not have HIV. The opposite party no.3 further submitted that as per the ELISA test done on the donors, they were proved to be negative for HIV. The incubation period or window period for HIV infection to mature into AIDS is anywhere from 10-15 years depending on the immune response of the individual concerned and that it may not possible for an individual to be affected by AIDS within a period of 1 to 4 weeks from the date of the alleged infection through blood transfusion. There is no chance of HIV infection maturing into full blown AIDS as indicated by CD4 count within such a short time.
10. The opposite partyno.3 submits that T lymphocytes are responsible for the immune response of the body. CD4 is a receptor present on the T lymphocytes. In a normal person CD4 count is between 500 to 1500. HiV virus which is RNA virus enters the cytoplasm of T lymphocytes, becomes double stranded DNA and enters the nucleus of the cell and integrates itself into the host cell. It then starts replicating very rapidly. As the T lymphocytes over by HIV the body loses its immune response to various diseases which would not affect a normal person. The immune suppression is indicated by CD4 count which is considerably reduced in case of full blown AIDS to below 200. The whole process from infection to maturing into full blown AIDS takes about 10 to 15 years. The said period is called window or incubation period. The report of the Committee cannot be said to be conclusive or clinchingly establish the alleged negligence on the part of the opposite party no.3 and hence the opposite party no.3 prays for dismissal of the complaint.
11. The complainant filed her affidavit and the documents, Exs.A1 to A30. On behalf of the opposite parties, Dr.C.Umamaheswara Rao, General Secretary of the opposite partyno.2 and B.Lakshmikantham, the Joint Collector and Vice President of the opposite party no.3 filed their respective affidavits and the documents, Exs.B1 and B2.
12. The point for consideration is whether the opposite parties supplied infected blood to the hospital and whether the hospital transfused the blood supplied by the opposite parties to the complainant?
13. The facts beyond any dispute are that the complainant was admitted in Triveni Hospital to undergo caesarean section on 1.11.2011 and she was transfused with blood supplied by the opposite party no.3. The complainant delivered female baby by caesarean section and she was discharged on 5.12.2011 from the hospital.
14. The complainant was admitted in Narayana Hospital where she had undergone medical tests and found her infected with HIV positive. The learned counsel for the complainant has submitted that Andhra Pradesh AIDS Control Society subjected the complainant to medical tests and it found that the complainant was infected with HIV positive. The learned counsel for the opposite parties has contended that the complainant was not subjected to medical tests before transfusing the blood to find whether she was already infected with HIV positive and that the opposite party no.3 had taken all precautionary measures by subjecting the donor and the blood to the screening test and there was no deficiency in service on the part of the opposite parties. He has contended that it was not brought to the notice of the committee constituted by the District Collector Nellore that the complainant was not subject to HIV test.
15. The learned counsel for the opposite parties has submitted literature pertaining to various stages adopted in collection and preservation of blood and the literature would also provide several precautions on broad spectrum which read as under:
Terminology The window period is the time from infection until a test can detect any change. The average window period with HIV-1 antibody tests is 25 days for subtype B. Antigen testing cuts the window period to approximately 16 days and NAT (Nucleic Acid Testing) further reduces this period to 12 days.
Performance of medical tests is often described in terms of:
sensitivity: The percentage of the results that will be positive when HIV is present specificity: The percentage of the results that will be negative when HIV is not present.
All diagnostic tests have limitations, and sometimes their use may produce erroneous or questionable results.
False positive: The test incorrectly indicates that HIV is present in a non-infected person.
False negative: The test incorrectly indicates that HIV is absent in an infected person.
Nonspecific reactions, hypergammaglobulinemia, or the presence of antibodies directed to other infectious agents that may be antigenically similar to HIV can produce false positive results. Autoimmune diseases, such as systemic lupus erythematosus, have also rarely caused false positive results. Most false negative results are due to the window period.
Principles Screening donor blood and cellular products Tests selected to screen donor blood and tissue must provide a high degree of confidence that HIV will be detected if present (that is, a high sensitivity is required). A combination of antibody, antigen and nucleic acid tests are used by blood banks in Western countries. The World Health Organization estimated that, as of 2000[update], inadequate blood screening had resulted in 1 million new HIV infections worldwide.[citation needed] In the US, the Food and Drug Administration requires that all donated blood be screened for several infectious diseases, including HIV-1 and HIV-2, using a combination of antibody testing (EIA) and more expeditious nucleic acid testing (NAT). These diagnostic tests are combined with careful donor selection. As of 2001[update], the risk of transfusion-acquired HIV in the US was approximately one in 2.5 million for each transfusion.
Diagnosis of HIV infection Tests used for the diagnosis of HIV infection in a particular person require a high degree of both sensitivity and specificity. In the United States, this is achieved using an algorithm combining two tests for HIV antibodies. If antibodies are detected by an initial test based on the ELISA method, then a second test using the Western blot procedure determines the size of the antigens in the test kit binding to the antibodies. The combination of these two methods is highly accurate (see below).
Human rights The UNAIDS/WHO policy statement on HIV Testing states that conditions under which people undergo HIV testing must be anchored in a human rights approach that pays due respect to ethical principles. According to these principles, the conduct of HIV testing of individuals must be Confidential;
Accompanied by counseling (for those who test positive);
Conducted with the informed consent of the person being tested.
Confidentiality Considerable controversy exists over the ethical obligations of health care providers to inform the sexual partners of individuals infected with HIV that they are at risk of contracting the virus. Some legal jurisdictions permit such disclosure, while others do not. More state funded testing sites are now using confidential forms of testing. This allows for monitoring of infected individuals easily, compared to anonymous testing that has a number attached to the positive test results. Controversy exists over privacy issues.
In developing countries, home-based HIV testing and counseling (HBHTC) is an emerging approach for addressing confidentiality issues. HBHTC allows individuals, couples, and families to learn their HIV status in the convenience and privacy of their home environment. Rapid HIV tests are most often used, so results are available for the client between 15 and 30 minutes. Furthermore, when an HIV positive result is communicated, the HTC provider can offer appropriate linkages for prevention, care, and treatment.
Anonymous testing Testing that has only a number attached to the specimen that will be delivered for testing. Items that are confirmed positive will not have the HIV infected individual's name attached to the specimen. Sites that offer this service advertise this testing option.
Routine testing recommendation In the United States, one emerging standard of care is to screen all patients for HIV in all health care settings. [ In 2006, the Centers for Disease Control announced an initiative for voluntary, routine testing of all Americans aged 1364 during health care encounters. An estimated 25% of infected individuals were unaware of their status; If successful the effort was expected to reduce new infections by 30% per year. The CDC recommends elimination of requirements for written consent or extensive pre-test counseling as barriers to widespread routine testing. [ In 2006, the National Association of Community Health Centers implemented a model for offering free, rapid HIV testing to all patients between the ages of 13 and 64 during routine primary medical and dental care visits. The program increased testing rates, with 66% of the 17,237 patients involved in the study agreeing to testing (56% were tested for the first time) In September 2010, New York became the first state to require that hospitals and primary care providers offer an HIV test to all patients between the ages of 13 and 64 years. A mandatory evaluation of the law's impact found that it increased testing significantly throughout the state.
Antibody tests HIV antibody tests are specifically designed for routine diagnostic testing of adults; these tests are inexpensive and extremely accurate.
Window period Antibody tests may give false negative (no antibodies were detected despite the presence of HIV) results during the window period, an interval of three weeks to six months between the time of HIV infection and the production of measurable antibodies to HIV seroconversion. Most people develop detectable antibodies approximately 30 days after infection, although some seroconvert later. The vast majority of people (97%) have detectable antibodies by three months after HIV infection; a six-month window is extremely rare with modern antibody testing. During the window period, an infected person can transmit HIV to others although their HIV infection may not be detectable with an antibody test. Antiretroviral therapy during the window period can delay the formation of antibodies and extend the window period beyond 12 months. This was not the case with patients that underwent treatment with post-exposure prophylaxis (PEP). Those patients must take ELISA tests at various intervals after the usual 28 day course of treatment, sometimes extending outside of the conservative window period of 6 months. Antibody tests may also yield false negative results in patients with X-linked agammaglobulinemia; other diagnostic tests should be used in such patients.
Three instances of delayed HIV seroconversion occurring in health-care workers have been reported; in these instances, the health-care workers tested negative for HIV antibodies greater than 6 months postexposure but were seropositive within 12 months after the exposure. DNA sequencing confirmed the source of infection in one instance. Two of the delayed seroconversions were associated with simultaneous exposure to hepatitis C virus (HCV). In one case, co-infection was associated with a rapidly fatal HCV disease course; however, it is not known whether HCV directly influences the risk for or course of HIV infection or is a marker for other exposure-related factors.
ELISA The enzyme-linked immunosorbent assay (ELISA), or enzyme immunoassay (EIA), was the first screening test commonly employed for HIV. It has a high sensitivity.
In an ELISA test, a person's serum is diluted 400-fold and applied to a plate to which HIV antigens have been attached. If antibodies to HIV are present in the serum, they may bind to these HIV antigens. The plate is then washed to remove all other components of the serum. A specially prepared "secondary antibody" an antibody that binds to human antibodies is then applied to the plate, followed by another wash. This secondary antibody is chemically linked in advance to an enzyme. Thus the plate will contain enzyme in proportion to the amount of secondary antibody bound to the plate. A substrate for the enzyme is applied, and catalysis by the enzyme leads to a change in color or fluorescence. ELISA results are reported as a number; the most controversial aspect of this test is determining the "cut-off" point between a positive and negative result.
Western blot Western blot test results. The first two strips are a negative and a positive control, respectively. The others are actual tests.
Like the ELISA procedure, the western blot is an antibody detection test. However, unlike the ELISA method, the viral proteins are separated first and immobilized. In subsequent steps, the binding of serum antibodies to specific HIV proteins is visualized.
Specifically, cells that may be HIV-infected are opened and the proteins within are placed into a slab of gel, to which an electrical current is applied. Different proteins will move with different velocities in this field, depending on their size, while their electrical charge is leveled by a surfactant called sodium lauryl sulfate. Some commercially prepared Western blot test kits contain the HIV proteins already on a cellulose acetate strip. Once the proteins are well-separated, they are transferred to a membrane and the procedure continues similar to an ELISA: the person's diluted serum is applied to the membrane and antibodies in the serum may attach to some of the HIV proteins. Antibodies that do not attach are washed away, and enzyme-linked antibodies with the capability to attach to the person's antibodies determine to which HIV proteins the person has antibodies.
There are no universal criteria for interpreting the western blot test: The number of viral bands that must be present may vary. If no viral bands are detected, the result is negative. If at least one viral band for each of the GAG, POL, and ENV gene-product groups are present, the result is positive. The three-gene-product approach to western blot interpretation has not been adopted for public health or clinical practice. Tests in which less than the required number of viral bands are detected are reported as indeterminate: a person who has an indeterminate result should be retested, as later tests may be more conclusive. Almost all HIV-infected persons with indeterminate western blot results will develop a positive result when tested in one month; persistently indeterminate results over a period of six months suggests the results are not due to HIV infection. In a generally healthy low-risk population, indeterminate results on western blot occur on the order of 1 in 5,000 patients.: However for those individuals that have had high-risk exposures to individuals where HIV-2 is most prevalent, Western Africa, an inconclusive western blot test may prove infection with HIV-2 The HIV proteins used in western blotting can be produced by recombinant DNA in a technique called recombinant immunoblot assay (RIBA).
Rapid or point-of-care tests A woman demonstrates the use of the OraQuick rapid HIV test Blood being taken for HIV rapid test Rapid antibody tests are qualitative immunoassays intended for use as a point-of-care test to aid in the diagnosis of HIV infection. These tests should be used in conjunction with the clinical status, history, and risk factors of the person being tested. The positive predictive value of Rapid Antibody Tests in low-risk populations has not been evaluated. These tests should be used in appropriate multi-test algorithms designed for statistical validation of rapid HIV test results.
If no antibodies to HIV are detected, this does not mean the person has not been infected with HIV. It may take several months after HIV infection for the antibody response to reach detectable levels, during which time rapid testing for antibodies to HIV will not be indicative of true infection status. For most people, HIV antibodies reach a detectable level after two to six weeks.
Although these tests have high specificity, false positives do occur. Any positive test result should be confirmed by a lab using the western blot.
Interpreting antibody tests ELISA testing alone cannot be used to diagnose HIV, even if the test suggests a high probability that antibody to HIV-1 is present. In the United States, such ELISA results are not reported as "positive" unless confirmed by a Western Blot.
The ELISA antibody tests were developed to provide a high level of confidence that donated blood was NOT infected with HIV. It is therefore not possible to conclude that blood rejected for transfusion because of a positive ELISA antibody test is in fact infected with HIV. Sometimes, retesting the donor in several months will produce a negative ELISA antibody test. This is why a confirmatory Western Blot is always used before reporting a "positive" HIV test result.
Rare false positive results due to factors unrelated to HIV exposure are found more often with the ELISA test than with the Western Blot. False positives may be associated with medical conditions such as recent acute illnesses and allergies. A rash of false positive tests in the fall of 1991 was initially blamed on the influenza vaccines used during that flu season, but further investigation traced the cross-reactivity to several relatively non-specific test kits. A false positive result does not indicate a condition of significant risk to health. When the ELISA test is combined with Western Blot, the rate of false positives is extremely low, and diagnostic accuracy is very high (see below).
HIV antibody tests are highly sensitive, meaning they react preferentially with HIV antibodies, but not all positive or inconclusive HIV ELISA tests mean the person is infected by HIV. Risk history, and clinical judgement should be included in the assessment, and a confirmation test (Western blot) should be administered. An individual with an inconclusive test should be re-tested at a later date.
Accuracy of HIV testing Modern HIV testing is highly accurate. The evidence regarding the risks and benefits of HIV screening was reviewed in July 2005 by the U.S. Preventive Services Task Force. The authors concluded that:
...the use of repeatedly reactive enzyme immunoassay followed by confirmatory Western blot or immunofluorescent assay remains the standard method for diagnosing HIV-1 infection. A large study of HIV testing in 752 U.S. laboratories reported a sensitivity of 99.7% and specificity of 98.5% for enzyme immunoassay, and studies in U.S. blood donors reported specificities of 99.8% and greater than 99.99%. With confirmatory Western blot, the chance of a false-positive identification in a low-prevalence setting is about 1 in 250 000 (95% CI, 1 in 173 000 to 1 in 379 000).
The specificity rate given here for the inexpensive enzyme immunoassay screening tests indicates that, in 1,000 HIV test results of healthy individuals, about 15 of these results will be a false positive. Confirming the test result (i.e., by repeating the test, if this option is available) could reduce the ultimate likelihood of a false positive to about 1 result in 250,000 tests given. The sensitivity rating, likewise, indicates that, in 1,000 test results of HIV infected people, 3 will actually be a false negative result (the McGovern-Tirgari anomaly). However, based upon the HIV prevalence rates at most testing centers within the United States, the negative predictive value of these tests is extremely high, meaning that a negative test result will be correct more than 9,997 times in 10,000 (99.97% of the time). The very high negative predictive value of these tests is why the CDC recommends that a negative test result be considered conclusive evidence that an individual does not have HIV.
Of course, the actual numbers vary depending on the testing population. This is because interpreting of the results of any medical test (assuming no test is 100% accurate) depends upon the initial degree of belief, or the prior probability that an individual has, or does not have a disease. Generally the prior probability is estimated using the prevalence of a disease within a population or at a given testing location. The positive predictive value and negative predictive value of all tests, including HIV tests, take into account the prior probability of having a disease along with the accuracy of the testing method to determine a new degree of belief that an individual has or does not have a disease (also known as the posterior probability). The chance that a positive test accurately indicates an HIV infection increases as the prevalence or rate of HIV infection increases in the population. Conversely, the negative predictive value will decrease as the HIV prevalence rises. Thus a positive test in a high-risk population, such as people who frequently engage in unprotected anal intercourse with unknown partners, is more likely to correctly represent HIV infection than a positive test in a very low-risk population, such as unpaid blood donors.
Many studies have confirmed the accuracy of current methods of HIV testing in the United States, reporting false-positive rates of 0.0004 to 0.0007 and false-negative rates of 0.003 in the general population.
Antigen tests The p24 antigen test detects the presence of the p24 protein of HIV (also known as CA), the capsid protein of the virus. Monoclonal antibodies specific to the p24 protein are mixed with the person's blood. Any p24 protein in the person's blood will stick to the monoclonal antibody and an enzyme-linked antibody to the monoclonal antibodies to p24 causes a color change if p24 was present in the sample.
This test is no longer used routinely in the US or the EU to screen blood donations since the objective was to reduce the risk of false negatives in the window period. Nucleic acid testing (NAT) is more effective for this purpose, and p24 antigen testing is no longer indicated if a NAT test is performed. The p24 antigen test is not useful for general diagnostics, as it has very low sensitivity and only works during a certain time period after infection before the body produces antibodies to the p24 protein.
Nucleic acid-based tests (NAT) Nucleic-acid-based tests amplify and detect one or more of several target sequences located in specific HIV genes, such as HIV-I GAG, HIV-II GAG, HIV-env, or the HIV-pol. Since these tests are relatively expensive, the blood is screened by first pooling some 8-24 samples and testing these together; if the pool tests positive, each sample is retested individually. Although this results in a dramatic decrease in cost, the dilution of the virus in the pooled samples decreases the effective sensitivity of the test, lengthening the window period by 4 days (assuming a 20-fold dilution, ~20hr virus doubling time, detection limit 50 copies/ml, making limit of detection 1,000 copies/ml). Since 2001, donated blood in the United States has been screened with nucleic-acid-based tests, shortening the window period between infection and detectability of disease to a median of 17 days (95% CI, 13-28 Days, assumes pooling of samples). A different version of this test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the management of HIV-1-infected patients.
In the RT-PCR test, viral RNA is extracted from the patient's plasma and is treated with reverse transcriptase (RT) to convert the viral RNA into cDNA. The polymerase chain reaction (PCR) process is then applied, using two primers unique to the virus's genome. After PCR amplification is complete, the resulting DNA products are hybridized to specific oligonucleotides bound to the vessel wall, and are then made visible with a probe bound to an enzyme. The amount of virus in the sample can be quantified with sufficient accuracy to detect threefold changes.
In the Quantiplex bDNA or branched DNA test, plasma is centrifugated to concentrate the virus, which is then opened to release its RNA. Special oligonucleotides that bind to viral RNA and to certain oligonucleotides bound to the wall of the vessel are added. In this way, viral RNA is fastened to the wall. Then new oligonucleotides that bind at several locations to this RNA are added, and other oligonucelotides that bind at several locations to those oligonucleotides. This is done to amplify the signal. Finally, oligonucleotides that bind to the last set of oligonucleotides and that are bound to an enzyme are added; the enzyme action causes a color reaction, which allows quantification of the viral RNA in the original sample. Monitoring the effects of antiretroviral therapy by serial measurements of plasma HIV-1 RNA with this test has been validated for patients with viral loads greater than 25,000 copies per milliliter.[36] Screening The South African government announced a plan to start screening for HIV in secondary schools by March 2011. This plan was cancelled due to concerns it would invade pupil's privacy, schools typically don't have the facilities to securely store such information, and schools generally do not have the capacity to provide counseling for HIV positive pupils. In South Africa, anyone over the age of 12 may request an HIV test without parental knowledge or consent. Some 80,000 pupils in three provinces were tested under this programme before it ended.
Other tests used in HIV treatment The CD4 T-cell count is not an HIV test, but rather a procedure where the number of CD4 T-cells in the blood is determined.
A CD4 count does not check for the presence of HIV. It is used to monitor immune system function in HIV-positive people. Declining CD4 T-cell counts are considered to be a marker of progression of HIV infection. A normal CD4 count can range from 500 cells/mm3 to 1000 cells/mm3. In HIV-positive people, AIDS is officially diagnosed when the count drops below 200 cells/μL or when certain opportunistic infections occur. This use of a CD4 count as an AIDS criterion was introduced in 1992; the value of 200 was chosen because it corresponded with a greatly increased likelihood of opportunistic infection. Lower CD4 counts in people with AIDS are indicators that prophylaxis against certain types of opportunistic infections should be instituted.
Low CD4 T-cell counts are associated with a variety of conditions, including many viral infections, bacterial infections, parasitic infections, sepsis, tuberculosis, coccidioidomycosis, burns, trauma, intravenous injections of foreign proteins, malnutrition, over-exercising, pregnancy, normal daily variation, psychological stress, and social isolation. This test is also used occasionally to estimate immune system function for people whose CD4 T cells are impaired for reasons other than HIV infection, which include several blood diseases, several genetic disorders, and the side effects of many chemotherapy drugs.
In general, the lower the number of T cells the lower the immune system's function will be. Normal CD4 counts are between 500 and 1500 CD4+ T cells/microliter, and the counts may fluctuate in healthy people, depending on recent infection status, nutrition, exercise, and other factors. Women tend to have somewhat lower counts than men.
Criticisms Oral tests As a result of an increase in false positive rates with rapid oral HIV testing in 2005, New York City's Department of Health and Mental Hygiene added the option of testing finger-stick whole blood after any reactive result, before using a Western Blot test to confirm the positive result. Following a further increase of false positives in NYC DOHMH STD Clinics during the end of 2007 and beginning of 2008, their clinics opted to forgo further oral screenings, and instead reinsituted testing using finger-stick whole blood. Despite the increase in false positives in NYC DOHMH, the CDC still continues to support the use of noninvasive oral fluid specimens due to their popularity in health clinics and convenience of use. The director of the HIV control program for public health at Seattle King county, reported OraQuick failed to spot at least 8 percent of 133 people found to be infected with a comparable diagnostic test. Strategies implemented to determine quality control and false positive rates were implemented. It is to be understood that any reactive OraQuick test result is a preliminary positive result and will always require a confirmatory test, regardless of the mean of testing (venipuncture whole blood, fingerstick whole blood or oral mucosal transudate fluid) Several other testing sites who did not experience a spike in false positive rates continue to use OraSure's OraQuick HIV Anti-body Testing.
AIDS denialism HIV tests have been criticized by AIDS denialists (a fringe group that believes that HIV either does not exist or is harmless). The accuracy of serologic testing has been verified by isolation and culture of HIV and by detection of HIV RNA by PCR, which are widely accepted "gold standards" in microbiology.[25][26] While AIDS denialists focus on individual components of HIV testing, the combination of ELISA and Western blot used for the diagnosis of HIV is remarkably accurate, with very low false-positive and -negative rates as described above. The views of AIDS denialists are based on highly selective analysis of mostly outdated scientific papers; there is broad scientific consensus that HIV is the cause of AIDS.
Fraudulent testing There have been a number of cases of fraudulent tests being sold via mail order or the Internet to the general public. In 1997, a California man was indicted on mail fraud and wire charges for selling supposed home test kits. In 2004, the US Federal Trade Commission asked Federal Express and US Customs to confiscate shipments of the Discreet home HIV test kits, produced by Gregory Stephen Wong of Vancouver, BC. In February 2005, the US FDA issued a warning against using the rapid HIV test kits and other home use kits marketed by Globus Media of Montreal, Canada.
16. The learned counsel for the opposite party no.3 has relied upon the following decisions:
1. Dr.C.P.Sreekumar vs S.Ramanujam reported in 2009(5) ALD 93(SC)
2. NIMS Vs Prashant S Dhanaka and others reported in 2009(4) ALD 42 (SC)
3. Gulshan Kumar Vs Dr.Rajan and Others reported in 2012(5) ALD (Cons) 9 NC
4. Shashi Prabha Singh and Others Vs Escort Heard Institute and Research Centre, reported in 2009 (4) ALD (Cons) 9NC
5. V.Narayana Vs Sri Venkateswara Institute of Medical Services and another reported in 2012 (6) ALD (Cons) 12 NC
17. Dr. Sreekumars is a case where the Supreme Court had an occasion to consider the difference modes of treatment and the options left to the doctor to proceed with in the administration of treatment to the patient.
It is also relevant that though the respondent had sought the opinion of Dr. Ajit Yadav of the Tamil Nadu Hospitals on 30th May 1992, he produced no evidence to off.set the appellant's evidence as to why he had chosen hemiarthroplasty over internal fixation. It is qually significant that the respondent had taken the advice of several renowned doctors including Dr. Mohan Das and Dr. Nand Kumar, but none of them in their treatment notes observed adversely about the choice of treatment nor any negligence in the actual operation. In the light of the fact that there is some divergence of opinion as to the proper procedure to be adopted, it cannot be said with certainty that the appellant, Dr. Sreekumar was grossly remiss in going in for hemiarthroplasty. In Jacob Mathew case (supra) it has observed as under:
(2) Negligence in the context of the medical profession necessarily calls for a treatment with a difference. To infer rashness or negligence on the part of a professional, in particular a doctor, additional considerations apply. A case of occupational negligence is different from one of professional negligence. A simple lack of care, an error of judgment or an accident, is not proof of negligence on the part of a medical professional. So long as a doctor follows a practice acceptable to the medical profession of that day, he cannot be held liable for negligence merely because a better alternative course or method of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure which the accused followed;
21. It would, thus, be seen that the appellant's decision in choosing hemiarthroplasty with respect to a patient of 42 years of age was not so palpably erroneous or unacceptable as to dub it as a case of professional negligence
18. The learned counsel for the complainant has submitted that the high level committee constituted by the District Collector, Nellore submitted its report casting negligence on the part of the opposite party no.3. He has relied upon the decision of the Honble Supreme Court in Common Cause v. Union of India AIR 1996 SC to contend that the program and activities of the National Council and State Council would cover the range of services related to operation and requirement of blood bank.
19. The Apex Court in the matter of Common Cause v. Union of India reported in AIR 1996 SC 929 laid the following guidelines:
1. The Union Government shall take steps to establish forthwith a National Council of Blood Transfusion as a society registered under the Societies Registration Act. It would be a representative body having in it representation from the Directorate General of Health Services of the Government of India, the Drug Controller of India, Ministry of Finance in the Government of India, Indian Red Cross Society, private blood banks including the Indian Association of the Blood Banks, major medical and health institutions of the country and non-Government organisations active in the field of securing voluntary blood donations. In order to ensure coordination with the activities of the National Aids Control Organisation, the Additional Secretary in the Ministry of Health, who is incharge of the operations of the programme of National Aids, Control Organisation for strengthening the blood banking system could be the President of the National Council.
2. The National Council shall have a secretariat at Delhi under the charge of a Director.
3. The basic requirements of the funds for the functioning of the National Council shall be provided by the Government of India but the National Council shall be empowered to raise funds from various other sources including contributions from trade, industry and individuals.
4. In consultation with the National Council, the State Governments/ Union Territory administration shall establish a State Council in each State/ Union Territory which shall be registered as a society under the Societies Registration Act. The State Council should be a representative body having in it representation from Directorate of Health Services in the State, State Drug Controller, Department of Finance of the State Government/Union Territory Administration, important medical institutions in the State/Union p Territory, Indian Red Cross Society, private blood banks, Non- Governmental Organisations active in the field of securing voluntary blood donations. The Secretary to the Government in charge of the Department of Health could be the President of the State Council.
5. The State Council should have its headquarters at the premises of the premier medical institution or hospital in the State/Union Territory and should function under the charge of a Director.
6. The funds for the State Council shall be provided by the Union of India as well as the State Government/Union Territory Administration. The State Council shall also be empowered to collect funds in shape of contributions from trade, industry and individuals.
7. The programmes and activities of the National Council and the State Councils shall cover the entire range of services related to operation and requirements of blood banks including the launching of effective motivation campaigns through utilisation of all media for stimulating voluntary blood donations, launching programmes of blood donation in educational institutions, among the labour, industry and trade, establishments and organisations of various services including civic bodies, training of personnel in relation to all operations of blood collection, storage and utilisation, separation of blood groups, proper labelling, proper storage and transport, quality control and archiving system, cross-matching of blood between donors and recipients, separation and storage of components of blood, and all the basic essentials of the operations of blood banking.
8. The National Council shall undertake training programmes for training of technical personnel in various fields connected with the operation of blood banks.
9. The National Council shall establish an institution for conducting research in collection, processing, storage, distribution and transfusion of whole human blood and human blood components, manufacture of blood products and other allied fields.
10. The National Council shall take steps for starting special postgraduate courses in blood collection, processing, storage and transfusion and allied fields in various medical colleges and institutions in the country.
11. In order to facilitate the collection of funds for the National Council and the State Councils, the Government of India (Ministry of Health and Ministry of Finance) should find out ways and means to secure grant of 100% exemption from income tax to the donor in respect of donations made to the National Council and the State Councils.
12. The Union Government and the Governments of the States and Union Territories should ensure that within a period of not more than one year all blood banks operating in the country are duly licensed and if a blood bank is found ill equipped for being licensed, and remains unlicensed after the expiry of the period of one year, its operations should be rendered impossible through suitable legal action.
13. The Union Government and the Governments of the States and Union Territories shall take steps to discourage the prevalent system of professional donors so that the system of professional donors is completely eliminated within a period of not more than two years.
14. The existing machinery for the enforcement of the provisions of the Act and the Rules should be strengthened and suitable action be taken in that regard on the basis of the Scheme submitted by the Drugs Controller (I) to the Union Government for upgradation of the Drugs Control Organisation in the Centre and the States (Annexure - II to the affidavit of Shri R. Narayansawami, Assistant Drug Controller, dated September 16, 1994.)
15. Necessary steps be taken to ensure that Drugs Inspectors duly trained in blood banking operations are posted in adequate numbers so as to ensure periodical checking of the operations of the blood banks throughout the country.
16. The Union Government should consider the advisability of enacting a separate legislation for regulating the collection, processing, storage, distribution and transportation of blood and the operation of the blood banks in the country.
17. The Director General of Health Services in the Government of India, Ministry of Health shall submit a report by July 15, 1996 about the action taken in pursuance of these directions.
18. It will be open to the Director General of Health Services, Government of India as well as the National Council to seek clarification/modification of these directions or further directions in this matter.
20. The High Level Committee was constituted by the District Collector Nellore submitted its report on 31.12.2011. The High Level Committee comprised of five doctors, Dr.K.Padmavathi, Additional District Medical & Health Officer (Aids & Leprosy), Nellore,
2. Dr.Ramanaiah, medical Superintendent, DSR Govt. Hqrs Hospital, Kavali, 3. Dr.K.Subba Rao, Physician medical Superintendent, Area Hospital, Kavali, 4. Dr.Vasundhara, Professor of Micro biology, Narayana Medical College, Nellore and 5. Dr.G.Ashok Kumar formerly State President, A.P. Indian Medical Association. The High Level Committee in its report referred to the role of the opposite party no.3 in supplying the infected blood to the complainant. The material portion of the report reads as under:
As per the enquiry conducted in different levels we are of the opinion that HIV+ infected blood was issued to the patient, through IRCS Blood Bank, Nellore, as the CD4 count of the patient is 189 that is suggestive of a full blowup case. We have come to a conclusion that it is a human error and not the willful negligence of IrCS Blood Bank, Nellore. It may be given permission to work as usual in the interest of public health and private doctors of Nellore and other nearby Districts.
21. The High Level Committee found negligence on the part of the opposite party n o.3. However, it has referred to the negligence of the opposite party no.3 in supplying the infected blood to the complainant as not wilful negligence and only a human error and recommended for continuance of the service to be rendered by the opposite party no.3. We find substance in the contention of the learned counsel for the opposite party no.3 that the doctors at Triveni Hospital did not conduct diagnostic tests as to find out whether the complainant was found with HIV + prior to transfusion of the blood supplied by the opposite party no.3. It is also pertinent to note that during window period any blood collected from the donor would not reveal that the donor contacted HIV.
However, we are unable to disagree with the opinion expressed by the high level committee that the opposite party no.3 has supplied HIV infected blood that was transfused to the complainant at Triveni Hospital.
22. Having found the deficiency in service on the part of the opposite party no.3, now we proceed to assess the quantum of compensation to be awarded to the complainants. On receiving the recommendation of High Level Committee the State Government awarded exgratia of Rs.2 lakhs and released the amount from the opposite partyno.3 on 1.2.2012 and the State Government provided house site measuring 648 sft to the complainant as also it has sanctioned a house under Indiramma program and the house is stated to have been under construction through departmental execution. It is also stated in the report of the high level committee that the complainant has been provided the job of sub-staff at IRCS Cancer Hospital at Nellore. The State Government also issued AAy card under Anthyodaya Scheme to the complainant for the supply of 35 kgs of rice per month at Rs.1/- per kg and the State Government has undertaken continuous monitoring health of the complainant and her daughter besides supplying of nutrition regularly t the complainant. Such being the relief granted to the complainant, we have taken into consideration of the compensation awarded by the State Government of which a sum of `2 lakhs had already been paid by the opposite party no.3.
23. The State Government has taken all required steps to come to rescue of the complainant. The complainant has been awarded adequate relief by the State Government as also arranged for payment of a sum of rupees not less than `2 lakhs by the opposite party no.3. Taking into consideration of the amount paid by the opposite party no.3 and other reliefs provided by the State Government as also in the light of the finding of the High Power Committee there was no wilful negligence on the part of the opposite party no.3 in the matter of supply of the blood to the complainant, this Commission is of the considered view that if a further sum of `50,000/- awarded as compensation on all counts, it would meet the ends of justice.
24. The Honble Supreme Court in State of Gujarath vs Shantilal Mangaldas AIR 1969 SC 634, held the compensation to mean.. in ordinary parlance the expression compensation means anything given to make things equivalent; a thing given to or to make amends for loss recompense, remuneration or pay, it need not therefore necessarily in terms of money. The phraseology of the Constitutional provision also indicates that compensation need not necessarily be in terms of money because it expressly provides that the law may specify the principles on which, and the manner in which , compensation is to be determined and given . If it were to be in terms of money along, the expression paid would have been more appropriate.
25. The Supreme Court held that the compensation to be awarded is to be fair and reasonable. In Charan Singh vs Healing Touch Hospital and others 2000SAR(Civil) 935 the Apex Court stressed the need of balancing between the compensation awarded recompensing the consumer l and the change it brings in the attitude of the service provider.
26. The Court held While quantifying damages , consumer forums are required to make an attempt to serve ends of justice so that compensation is awarded, in an established case, which not only serves the purpose of recompensing the individual, but which also at the same time aims to bring about a qualitative change in the attitude of the service provider. Indeed calculation of damages depends on the facts and circumstances of each case. No hard and fast rule can be laid down for universal application. While awarding compensation, a Consumer Forum has to take into account all relevant factors and assess compensation on the basis of accepted legal principles, on moderation. It is for the Consumer Forum to grant compensation to the extent it finds it reasonable, fair and proper in the facts and circumstances of a given case according to established judicial standards where the claimant is able to establish his charge.
27. The opposite parties no.1 and 2 had taken a plea that it is a voluntary humanitarian organisation and their mission of Indian Red Cross is to inspire, encourage and initiate at all times all forms of humanitarian activities so as to minimize human suffering and to prevent it to a possible extent and contribute creating more congenial climate for peace. It is not disputed that the opposite parties no.1 and 2 have no control over day to day affairs of the opposite party no.3 and they have no concern or involved in the issue of the supply of the blood by the opposite party no.3 to Triveni Hospital. As such the complaint is liable to be dismissed against the opposite parties no.1 and 2.
28. In the result the complaint is allowed directing the opposite party no.3 to pay a sum of `50,000/- together with costs of `5,000/-. The complaint is dismissed against the opposite parties no.1 and 2. No costs. Time for compliance four weeks.
I/C PRESIDENT MEMBER MEMBER Dt.25.11.2013 కె.ఎం.కె.* APPENDIX OF EVIDENCE WITNESSES EXAMINED NIL EXHIBITS MARKED For complainant Ex.A1 Scanning Report, dated 29.03.2011 Ex.A2 Prescription Copy, dated 05.05.2011 Ex.A3 Prescription Copy, dated 23.05.2011 Ex.A4 Blood Report, dated 10.05.2011.
Ex.A5 Prescription Copy, dated 09.06.2011 Ex.A6 Prescription Copy, dated 07.07.2011 Ex.A7 Prescription Copy, dated 03.09.2011 Ex.A8 Receipt No. 6355 issued by Blood Bank for purchase of Blood Bag No. A75001, dated 02.11.2011 Ex.A9 Receipt No. 6340 issued by Blood Bank for purchase of Blood Bag No. A74949, dated 02.11.2011 Ex.A10 Receipt No. 6373 issued by Blood Bank for purchase of Blood Bag No. A75097, dated 03.11.2011 Ex.A11 Lab Report, dated 01.11.2011 Ex.A12 Discharge Summary, dated 07.11.2011 Ex.A13 Prescription Copy, dated 10.10.2011 Ex.A14 Scanning Report, dated 10.10.2011 Ex.A15 Ultra Sound Report, dated 07.07.2011 Ex.A16 Urine Examination Report, dated 18.11.2011 Ex.A17 Lab Report, dated 01.12.2011 Ex.A18 Urine Culture and Sensitivity Report, dated 20.11.2011 Ex.A19 Lab Report, dated 10.10.2011 Ex.A20 Lab Report, dated 15.11.2011 Ex.A21 Lab Report, dated 30.11.2011 Ex.A22 Bio-Chemistry Report, dated 01.12.2011 Ex.A23 Central Clinical Laboratory Report of Clinical Micro Biology Report, dated 03.12.2011.
Ex.A24 Central Clinical Laboratory Report of Clinical Bio Chemistry Report, dated 03.12.2011.
Ex.A25 Central Clinical Laboratory Report of Clinical Pathology Report, dated 03.12.2011 Ex.A26 Central Clinical Laboratory Report of Clinical Bio Chemistry Report, dated 03.12.2011.
Ex.A27 Laboratory Report Form issued by A.P. State Aids Control Society, Hyd, dated 07.12.2011.
Ex.A28 Laboratory Report Form issued by A.P. State Aids Control Society, Hyd, dated 07.12.2011 Ex.A29 Report submitted by High level Committee, dated 31.12.2011 Ex.A30 Newspapers Cuttings (Colly) For Opposite parties Ex.B1 T/C. of Master Record, dated 30. 09.2011.
Ex.B2 T/C. of issue register, dated 02.11.2011 I/C PRESIDENT MEMBER MEMBER