|Year : 2013 | Volume
| Issue : 3 | Page : 219-225
Universal screening versus universal precautions in the context of preoperative screening for HIV, HBV, HCV in India
R Ahmed, S Bhattacharya
Tata Medical Centre, Rajarhat, Kolkata , West Bengal, India
|Date of Submission||10-Dec-2012|
|Date of Acceptance||01-Jul-2013|
|Date of Web Publication||25-Jul-2013|
Tata Medical Centre, Rajarhat, Kolkata (RA, SB), West Bengal
Source of Support: None, Conflict of Interest: None
In the Indian context, there is a convention of doing pre-operative screening for HIV, hepatitis B virus and hepatitis C viruses for all patients as a routine pre-intervention investigation. This approach is justified in some instances in the best interest of the patient. However, as routine screening is not the standard care internationally and as there is a significant divergence of views about the merits and demerits of this practice, this issue needs to be debated in a rational manner with an evidence-based approach. The present article is authored by a surgeon and a microbiologist from a new cancer care centre in eastern India, who has attempted to address this contentious issue. The various available options have been explored, and advantages and disadvantages of the different approach have been discussed. An algorithm for infection prevention and control has been presented so that surgeons and medical microbiologists could manage infection control challenges satisfactorily.
Keywords: HBV, HCV, HIV, pre-operative screening, universal precautions
|How to cite this article:|
Ahmed R, Bhattacharya S. Universal screening versus universal precautions in the context of preoperative screening for HIV, HBV, HCV in India. Indian J Med Microbiol 2013;31:219-25
|How to cite this URL:|
Ahmed R, Bhattacharya S. Universal screening versus universal precautions in the context of preoperative screening for HIV, HBV, HCV in India. Indian J Med Microbiol [serial online] 2013 [cited 2019 Jun 20];31:219-25. Available from: http://www.ijmm.org/text.asp?2013/31/3/219/115623
| ~ Background|| |
Performance of non-essential and occasionally inappropriate pre-operative blood tests before elective surgery is an important health economic and clinical management issue. A retrospective observational study from Chelsea and Westminster hospital in London found that 31.3% of routine pre-operative blood tests were inappropriate, none of those tests changed management and about 11.2 million were spent on inappropriate tests in England and Wales.  Another retrospective review showed that adherence to the National Institute for Clinical Excellence UK guidelines (for the use of routine pre-operative tests for elective surgery) to be only 5% and the tests were ordered in excess of NICE guidelines in 17.8% of all cases. , Because of the low yield of positive results, low-positive predictive value due to low prevalence of many conditions being screened and the high aggregate costs of the practice in routine pre-operative blood tests is under close scrutiny. It has been suggested that a large number of investigations that are often expensive to pursue and rarely detect major abnormalities may cause unnecessary delay or cancellation of surgery and increase medico-legal liability. An approach of selective testing based on the history and physical examination reduces cost without sacrificing the safety or quality of surgical care.  Tests for blood-borne viruses including that for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) does not find mention in some of the reputed and authoritative pre-operative testing guidelines. , It has been argued that, in a significant proportion of cases, routine pre-operative testing is reduced to tick-box exercises and doctors fail to use their clinical judgement in deciding on the appropriateness of the requested investigations. 
| ~ Justification for universal screening|| |
However, the argument in favour of universal screening is equally strong. Universal or routine pre-operative HIV and other blood-borne virus (HBV, HCV) testing has been described to be a risk-reduction strategy from a staff health and infection prevention viewpoint (e.g. double gloving). Moreover, after a sharp injury, the surgeon would know to begin post-exposure prophylaxis immediately, without encountering the difficulties of patients' consent for subsequent HIV testing. Recently, it has been suggested that routine pre-operative HIV (and by implication HBV/HCV) testing may benefit patients allowing detection of unknown cases and management of cases before onset of AIDS/cirrhosis/liver carcinoma. 
Screening for HIV, HBV and HCV as a part of routine pre-operative investigations is a common practice in many centres. ,,, The investigations are done a) to prevent transmission from patient to healthcare workers, b) to take adequate precautions in the form of enhanced personal protective equipments (PPE) during surgical procedures, c) to decide on the sequence and placement of the patient in a surgical list, d) to decide on the nature of equipment and environmental decontamination following the procedure, e) to decide if the procedure is necessary or not, based on individual perceptions about safety of the operating and anaesthetic team and hospital management.
Although low in relative terms, in absolute terms, because of its large population, India has one of the largest reservoirs of HIV, HBV and HCV and many of its cases remain undetected. Data from India suggests that, about 0.36% of the population is HIV infected, 2.4% (extending to 15.9% in certain population groups) are HBV infected and 1.2% are HCV infected. ,, With a population of about 1.2 billion, this equates to about 2.5 million HIV cases, at least 29 million HBV cases and 12 million HCV cases within the country. It has been suggested that a minimum prevalence of 1 in 1000 (0.1%) in the general population justifies screening.  In the Indian context, although the screening of HIV, HBV and HCV may have epidemiological justification, what is debatable is the health economic justification and the subsequent clinical management of positive cases.
There are three main criticisms against the universal screening strategy. First, it may be suggested that many of the concerns with regard to infection transmission can be addressed through the practice of universal precautions rather than through universal screening. Second, in the emphasis on universal screening, the focus appears to be more on prevention of infection transmission from patient to staff (which is none-the-less very important) rather than case detection for HIV/HBV/HCV and subsequent care of the infected patients. Third, universal screening does not seem to give due attention to sensitivity and specificity issues in relation to screening tests and the concept of 'window period negativity', which does occur in some infections (especially in case of HCV). There is often disproportionate degree of importance given to a single test result, losing sight of the clinical context in which it may have been done.
| ~ Sensitivity and specificity issues in routine testing for HIV, HBV, HCV|| |
Reports from the AIDS Reference Laboratory in Delhi have shown that, in some HIV reactive samples, the second assay could be negative even in Western blot-confirmed cases.  On the other side, studies from the National JALMA Institute of Leprosy in Agra has shown that HIV test can be falsely reactive in patients with leprosy due to cross reactivity of HIV GP41, p55, p18 antigens with mycobacterial antigens.  With regard to HBV surface antigen reactivity, it was reported from Vellore, that 7% of low-reactive samples and 100% of grey-zone reactive samples could not be confirmed as HBsAg reactive by the confirmatory neutralisation tests. 
It may not be well appreciated by the non-specialists that a patient with negative serology may be in a sero-conversion window or be a occult carrier and that precautions, including the use of PPE might still need to be followed. A study reported on blood donors from New Delhi showed that several additional HBV, HCV and HIV infection could be detected using more sensitive nucleic acid amplification test (NAT) when conventional serology were non-reactive. ,
In order to save time and money, some laboratories resort to rapid tests for HIV, HBV and HCV. These rapid tests have limitations. In a study from the ICMR Virus Unit in Kolkata, it was revealed that, out of the 612 serum samples reported as non-reactive by rapid immuno-diagnostic tests, 15.7% were sero-positive by ELISA and 11% were RNA positive by RT-PCR test.  Significant variation in the performance of HCV kit efficiency has been reported from ICMR at Kolkata, along with relatively low sensitivity of HIV and HCV rapid test kits. 
In addition, not all anti-HCV antibody reactive patients are carriers of active HCV infection. In a community-based study in West Bengal, it was seen that HCV RNA was undetectable in 19.2% of the patients with antibody reactivity.  Another study of 140 HCV antibody reactive samples from blood donors in Nagpur showed positive NAT result in only 11.4% of the samples.  If HCV RNA testing and viral load were to be done on all HCV reactive patients before surgery, a notable proportion of so called 'HCV carriers' could then be excluded, and expensive PPEs and other preventative measures could be used more rationally.
| ~ Testing for HIV, HBV, HCV in pre-operative settings: A three-tier strategy|| |
Three distinct positions emerge [Table 1] out of the discussion and debate, as described earlier, about the merits and demerits of routine preoperative screening for HIV, HBsAg and anti-HCV: ,,,,,,,,
- Universal pre-operative testing in resource-rich settings
- Selective screening based on history and clinical examination in resource-limited settings
- No screening or screening only in exceptional circumstances in resource-poor settings.
This article intends to discuss the scientific evidence and rational arguments in relation to these approaches. The development of a national guideline with respect to routine pre-operative screening for HIV/HBV/HCV is important, and one of the aims of this article is to facilitate that process through further discussion. The pros and cons of the various screening options have been discussed.
Universal pre-operative testing in resource-rich settings for HIV, HBV and HCV
This approach is justifiable if:
- There is enough resource available for testing and management of reactive or positive cases. The adequacy of resource in this context signifies reliable screening, confirmation and follow-up services for treatment and monitoring.
- The idea behind screening is not just infection prevention but also case detection (HIV/HBV/HCV). The medical implications of a positive result should be clear to both the care giver and the patient before testing. A plan for management of patients with positive results should be in place.
- Patients should be given appropriate pre-test counselling. It is recommended that this be done as per the guidelines from the National AIDS Control Organisation. 
- Screened patients should be given appropriate post-test counselling. NACO guidelines states that 'HIV counselling can be provided by anyone who has a sympathetic ear, can give time to listen, has got knowledge of accurate scientific facts about HIV/AIDS and undergoes systematic and periodic training in counselling.' 
- Screened and reactive patients are followed-up with confirmatory assays. These may include further serology, complete serological markers for HBV, Western blot for HIV-1 and 2 and viral load for HIV/HBV/HCV.
- Screened patients are informed and referred to relevant treatment centres (in case of HIV) and specialist physicians experienced in the management of viral hepatitis (hepatology/medical gastroenterology for HBV and HCV).
- Other appropriate investigations are facilitated as and when required. This needs to be done as suggested by the NACO guidelines on anti-retroviral therapy (e.g. complete blood counts, CD4 count, urea/electrolytes, liver function tests, chest X-ray, anti-viral resistance). 
- Appropriate public health measures such as immunity and infection screening and counselling of contacts and immunisation of the risk groups should be conducted. Intra-familial non-sexual modes of transmission of HIV, HBV and HCV have been described both from India and internationally, hence efforts should be made to test family members of confirmed cases. ,,,
- Standard precautions are followed irrespective of the serological status and extra-precautions are taken if clinical risk assessment is suggestive of high-risk status.
Unfortunately, many of these essential steps may not be routinely done. Presumed reasons for non-conformity to guidelines may include need for additional resources. In a systematic review of HIV testing in resource rich settings, it was shown in 16 studies that the proportion of patients who received their HIV test result could be as low as 29%.  The issue of non-communication of HIV test result and incorrect assumptions about HIV test results in patients receiving routine pre-operative blood tests have been reported.  The threshold deemed cost-effective for routine HIV testing was suggested to be 1 infection per 1000 individuals screened. 
Selective screening based on history and clinical examination in resource-limited settings
This appears to be the most rational approach and is the norm in most developed countries (in the USA, however, universal admission screening for HIV is followed for all patients, irrespective of surgical intervention as the intention is to detect cases early). This approach seems to take care of the interest of both the patient as well as the care provider. The approach is dependent on and also emphasises the need for clinical risk assessment based on history and physical examination. The care provider can appreciate negative or positive report in light of the clinical assessment. This option is particularly relevant in resource-constraints situations in carrying out universal screening, although facilities of reliable testing may be available for a limited number of patients. This option reduces the number of tests, saves patient and institutional resources, reduces the chance of false positive tests (and unnecessary investigations, expenses and management delays) and increases the positive predictive value of a test. On the other hand, it is true that some cases would be missed by the approach, the care provider would not have the opportunity of knowing the serology status of all patients at the time of intervention (and take enhanced precautions if required), and, in case of exposure (sharps injury or splash), consent for or even the opportunity of HIV and other tests (HBsAg, HCV) may not be available. Moreover, the clinical assessment by one care provider may be different from that of another, depending of the experience, questionnaire or checklist used. Some care providers may feel that anyone living in or coming from a developing country is at increased risk, as unsafe situations or practices such as the use of recycled or unsterile syringes and needles, the use of less than adequately tested blood and blood products are rare, but not unheard of and incomplete clinical records or social and cultural issues make it impossible to do a proper clinical risk assessment. If this approach is used, it is necessary that the decision to test or not test HIV/HBV/HCV for an individual patient is left to clinical judgement of the consulting physician. This selective approach to testing would, however, miss a proportion of true positive cases, depending on the sensitivity and negative predictive value of the clinical judgement or the risk assessment algorithm or questionnaire used.
Clinically directed selective testing for HIV has been tried among specific cohorts. In a study from Mumbai, children with chronic diarrhoea, severe malnutrition, persistent cough, generalized lymphadenopathy, oral thrush, hepatomegaly, repeated common infections, generalized dermatitis, chronic parotid swelling, recurrent bacterial infection, disseminated tuberculosis and/or Pneumocystis carinii pneumonia were tested for HIV. Twenty-three (20%) of the 115 children enrolled tested positive for HIV. The seropositivity rate for various features ranged from 9.1% for chronic diarrhoea to 83.3% for chronic dermatitis.  In another study from the same city, children with severe malnutrition, serious pyogenic infections (pneumonia, pyogenic meningitis, septicaemia), disseminated tuberculosis, chronic diarrhoea and oral candidiasis, present either singly or in combination) when tested yielded a positivity in 11.8% of patients.  In a similar approach, serum aminotransferase measurement was used for selective screening against HCV.  However, in a study from Denmark, selective screening failed to pick up 1/3 rd of the antenatal women with HBV. 
No screening or screening only in exceptional circumstances in resource-poor settings.
This approach is followed, where serology is generally not done (either because of severe resource constraint or lack of reliable testing facilities) or performed only in exceptional cases, and universal precautions are followed for patients perceived to be at high risk. It is debatable if universal screening followed by directed use of enhanced PPE is more or less expensive than use of universal precautions. In a study from the USA in 1993, it was shown that the minimized estimate for routine testing (US$57) was greater than the maximized estimate for universal precautions (US$36) per procedure. The study concluded that routine HIV testing was not a valid economic alternative to universal precautions for elective surgery.  In our centre it was noted that the cost of a set of disposable PPE was between Rs. 3500-Rs. 4000 (Surgiware, Kimberley Clark). The comparative cost for HIV, HBsAg and anti-HCV testing was Rs. 1500 to Rs.3000 (based on concessional or private rate). The vital importance of clinical risk assessment and the need to take extra steps based on an enhanced risk perception requires intensive and continuous training for all staff.
| ~ Conclusion|| |
The issue of testing for HIV/HBV/HCV and treatment of these conditions are inextricably linked. Although recent years has seen significant improvements in the availability and access to anti-retroviral therapy, data from United Nations Program on HIV/AIDS suggests that a significant disparity exists between the number of persons needing antiretroviral therapy and those receiving it.  The problem is likely to be worse with respect to HBV and HCV, where national or international programs to support treatment and monitoring do not generally exist in the poorest parts of the world where the disease has relatively high prevalence. If healthcare systems are weak, the culture of health service utilization not strong and stigma and discrimination against those infected is rampant mandatory or universal testing could be producing more problems than solutions. For example, the Berger HIV Stigma scale was validated in south India to demonstrate its relevance in the Indian context.  The above argument has been put forward against the policy of routine HIV testing in some countries of the Sub-Saharan Africa, but may be equally applicable to certain regions of India whose socio-economic indices is comparable to if not worse, according to the Oxford Multi-dimensional Poverty Indices.  As per the figures from the World Bank, India falls under the category of lower-middle income economies with gross national income (GNI) per capita in the South Asian region being $1,176. 
On the other side of the argument, enhanced PPE used during interventions on suspected or confirmed HIV/HBV/HCV positive patients is not cheap (or easily available in resource-deficient settings), and indiscriminate use can be a drain on resources, besides generating an unnecessary amount of biomedical waste. This cost is either passed on to the patient as part of the intervention fee or has to be absorbed by the hospital administration as part of hospital infection-prevention expenditure. The use of enhanced PPE needs rationalisation and can be based on clinical risk assessment in resource-poor settings.
The option (universal screening, or universal precautions with enhanced PPE wherever necessary) that would be cost-effective in an organisation would depend on a number of factors, including prevalence of HIV/HBV/HCV in the area, the level of awareness and training of healthcare workers, availability of reliable testing facilities and the resources available for testing or enhanced PPE use.
An algorithm for the assessment of patients and management in the peri-operative period has been suggested [Figure 1].
|Figure 1: Infection prevention and PPE usage algorithm for the management of potentially sero-positive patients undergoing surgical intervention|
Click here to view
The interest and concern about infection transmission among healthcare workers is a positive development. But, it is desirable that this concern is not only restricted to infection transmission from patient to staff but also from staff to patient, environment to patient and patient to patient. Unfortunately, there could be instances of care givers doing an exposure-prone procedure on patients without themselves being tested for HIV/HBV/HCV. It is not uncommon to find healthcare workers (including doctors) not practising standard precautions and basic hand hygiene while dealing with patients. There is no doubt that adequate precautions should be taken while performing exposure prone interventions in patients, but, in an effort to be fair to ourselves, we should also take the necessary steps to ensure that we are fair to the system, so that limited resources are appropriately and judiciously utilised and to see to it that the patient also gets a fair deal. In the final analysis, there is no substitute for universal or standard precautions. Appropriate use of PPE is a part of universal or standard precautions, which also includes hand hygiene and appropriate measures for environmental cleaning, waste disposal and linen management in healthcare settings.  Universal precautions also help in protecting healthcare workers against untested and undiscovered pathogens that are not possible by universal testing strategies.
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