ARTICLE IN PRESS Transfusion and Apheresis Science ■■ (2015) ■■–■■
Contents lists available at ScienceDirect
Transfusion and Apheresis Science j o u r n a l h o m e p a g e : w w w. e l s e v i e r. c o m / l o c a t e / t r a n s c i
Letter to the Editor Donor notification: Streamlining the existing enigmatic process: An experience from a tertiary care hospital in central Delhi, India Blood has been an area of great fascination since ancient times. Enhanced sensitivity and better use of serologic testing, nucleic acid testing along with stringent scrutiny of donors has resulted in major reductions in risk of transfusion transmitted disease. Still donor notification which is an essential process whereby the otherwise asymptomatic donor is informed of the harboured transfusion transmissible infection (TTI) has been a matter of debate. As per guidelines of the Ministry of Health and Family Welfare (Government of India) under the Drug and Cosmetic Act,1945 amendments thereafter, all the blood donations are mandated to transfusion transmitted infections (TTI) testing for Hepatitis B (HBV), Hepatitis C (HCV), HIV 1 and 2, syphilis and malaria [1]. According to objective 4.16 of Indian Action Plan for blood safety, the donor is counselled about TTIs prior to donation and is offered the option of knowing his or her TTI status provided he/she has given written consent for the same [2]. In view of all the efforts in place for donor notification, we carried out a study at Department of Pathology and Blood Bank, Lady Hardinge Medical College and Associated Shrimati Sucheta Kriplani Hospital and Kalawati Saran Children Hospital, New Delhi for the period of 4.5 years i.e. from January 2010 to June 2014 in order to analyse how many of the seroreactive donors contacted by blood bank had responded back for notification and limitations associated with the process. Routinely, prior to blood donation, donors are provided with predonation counselling from a trained counsellor posted in blood bank who provides information about the facts and myths related to blood donation procedure and taking donor into confidence asks about any high risk behaviour activities in detail. Written informed consent about whether donor would like to be informed of their TTI status is taken. The medical history, brief physical examination and fitness of the donor are approved by the doctor on duty. A total of 46,172 donors had come for blood donation at our blood bank or outside blood donation camps during the study period and were screened according to the national guidelines as laid by Directorate General Health Services (DGHS) and National AIDS Control Organisation (NACO). A total of 41,000 (88.79%) were selected as fit for donation while 5172 (11.20%) donors were deferred due to
various medical reasons and preliminary blood tests. Majority of the blood donations (93.16%, 38,194) were done by family or relative donors and 2238 blood units (5.46%) were collected through outdoor voluntary blood donation camps and the in-house altruistic voluntary donors at our blood centre contributed only 1–2% (568). All the collected units were tested by fourth generation ELISA kits for Hepatitis C (Monolisa HCV Ag-Ab Ultra, BioRad, France) and HIV 1 and 2 (VironostikaHIVAg/Ab, Biomerieux, France) and third generation ELISA kits for Hepatitis B (Monolisa HBs Ag Ultra, BioRad, France). Treponema pallidum haemagglutination assay (TPHA, BioRad, France) testing was used as screening test for syphilis and rapid card test (Parabank, BioRad, France) for malaria. The total seroprevalence for all the five markers was found to be 5.13% (2105 blood units). Of all the collected blood units, 1218 (2.97%) units were found reactive for one of the HBV (1.79%), HCV (0.74%) or HIV (0.44%) infections as also observed by previous studies from Delhi [3–5]. All the reactive donors were replacement except one (HBsAg positive) male voluntary donor during the study period. The seroreactive units were quarantined and discarded as per institutional policy. The entry was made in reactive donor register and donor notification register and kept confidential. The reactive donors were referred to concerned speciality as per infectious marker such as HIV reactive donor to Integrated Counselling and Testing Centre (ICTC), HBV or HCV reactive donors to Medicine OPD and to Department of dermatology if TPHA reactive for syphilis, after repeat check of donor details on their revisit to blood bank. A special proforma was used for donor notification and referral to other specialities and a copy having donor’s signature and answers to post counselling questionnaire was kept as Blood Bank record in confidential state. However TPHA positive donors were started being notified in November 2013 onwards. The study period was divided into two phases according to the mode of communication to the seroreactive donors. The first phase was from January 2010 to May 2013 – contacted through letters only, writing that their blood tests are inconclusive and they should visit blood bank for retesting. The second phase was from June 2013 to June 2014 – contacted by hospital telephone first and if no response on first day, another call was made the following day or within a week with a maximum of three attempts. If the donor did not respond within 14 days of phone call, a letter was sent subsequently. If no response is observed to letter or telephone within 8–10 weeks, the donor was considered non-respondent.
http://dx.doi.org/10.1016/j.transci.2015.03.001 1473-0502/© 2015 Elsevier Ltd. All rights reserved.
Please cite this article in press as: Daljit Kaur, Sangeeta Pahuja, Manjula Jain, Rama Khaspuria, Donor notification: Streamlining the existing enigmatic process: An experience from a tertiary care hospital in central Delhi, India, Transfusion and Apheresis Science (2015), doi: 10.1016/j.transci.2015.03.001
ARTICLE IN PRESS 2 (6.67%) 13 (16.05%) 0 (0.00%) 25 (43.10%) 13 (52.00%) 53 (17.49%) 50 81 89 58 25 303 (0.74%) 13 (25.49%) 11 (23.40%) 5 (12.20%) 19 (54.29%) 6 (75.00%) 54 (29.67%) 51 47 41 35 8 182 (0.44%) 8 (5.10%) 24 (12.63%) 0 (0.00%) 95 (54.91%) 28 (38.36%) 155 (21.15%) Also the boldface indicates the higher response to donor notification in phase 2 of study. a Wrong address/information provided: HIV – 6, HBV – 08.
23 (9.83%) 48 (15.09%) 5 (1.85%) 139 (53.46%) 47 (46.08%) 262 (21.76%) 258 318 270 266 106 1218 2010 2011 2012 2013 2014 (until June 2014) Grand total
254a 318 270 260a 102a 1204
157 190 140 173 73 733 (1.79%)
HCV reactive HIV respondents HIV reactive HBV respondents HBV reactive Total respondents Total reactive donors notified through letters or telephonea Total sero-reactive donors (except TPHA and malaria) Year
A total of 1204 (98.85%) of the reactive donors were contacted through letters or telephone. Six and 8 of the HIV and HCV reactive donors respectively could not be contacted due to incomplete address mentioned in donor form. In year 2010 only 9.58% reactive donors responded out of 254 contacted (23/254), 15% (48/270) in 2011, 1.57% (05/318) in 2012, 54% (155/260) in 2013 and 46.07% (47/102) mid 2014 (Table 1). Only 1.85–15.09% of reactive donors turned back to blood bank during the years 2010–2012. It was observed that all the donors could not be contacted as letters kept bouncing back due to wrong/incomplete address mentioned by donors. During the first phase, commoner causes of poor donor notification response rate observed were distance, low educational status of donors, fright to know their TTI status, forcible donation, long absence of counsellor in blood bank, professional donors acting as patient’s relatives and resistance to show or lack of identity proof by the donors. Since donor disclosure methods keep getting updated by NACO from time to time considering the ongoing scenario of notification response in the region. Therefore we changed the mode of communication to telephonic calls first followed by letters noticing the limitation of low response rate in our reactive blood donors (2nd phase). We followed a policy of contacting the reactive donors at the earliest when their patients might be still admitted in the hospital so as to curtail the poor response due to long distance. Consequently, overall response rate increased to 54% and 46.07% in 2013 and mid 2014 respectively. Majority of the blood donors feel more comforted when they are contacted telephonically for the first time rather than directly receiving letters at their homes as observed by Choudhary et al. [6]. Moreover, they can raise their anxiety and can be reassured by the counsellor to visit blood bank at the earliest. When compared to other studies from India which were conducted for a period of 1–2 years, we had similar and/or higher response rate than others in the second phase of our study period [7,8]. The donors reactive for anti-HIV responded maximally in the second phase of study as 6 out of 8 (75%) in 2014 (until June) and 19 out of 35 (54.3%) responded in 2013 due to more stringent protocol followed for such donors. Similarly, respondents rose from 16.05% to 52% for anti-HCV and from 12.5% to 38.36% for HBsAg positive cases in the years 2010 to mid of 2014. We could get the feedback of all antiHIV 1 and 2 positive donors visiting ICTC for treatment with the referral numbers provided during notification. But not all anti-HBV or anti-HCV positive donors could be traced for their response to future management as majority wish to consult nearby physicians or private gastroenterologists after notification or were lost to follow up. Our blood centre collects maximum of replacement donors while voluntary non remunerated blood donors donating out of altruism accounts to only 5–10%. For safe blood supply more and more philanthropic donors need to be recruited. Moreover, it is worthwhile spending more time during predonation counselling especially in high prevalence areas by recruiting trained counsellors rather than exhausting resources on testing and retesting donated blood. The reactive donor should be referred with a referral slip mentioning the TTI test result as well as detailed address
HCV respondents
D. Kaur et al./Transfusion and Apheresis Science ■■ (2015) ■■–■■
Table 1 Data related to the donor notification for TTIs for the study period.
2
Please cite this article in press as: Daljit Kaur, Sangeeta Pahuja, Manjula Jain, Rama Khaspuria, Donor notification: Streamlining the existing enigmatic process: An experience from a tertiary care hospital in central Delhi, India, Transfusion and Apheresis Science (2015), doi: 10.1016/j.transci.2015.03.001
ARTICLE IN PRESS D. Kaur et al./Transfusion and Apheresis Science ■■ (2015) ■■–■■
of the concerned physician to get better response out of notification. Sustained efforts of a trained counsellor as well as integration with ICTC, gastroenterologists and dermatologists for HBV, HCV and TPHA positive cases for referral can bring in a lot of change in donor notification process which is a great societal concern of today’s time. References [1] Malik V. Drugs and cosmetics act, 1940. 16th ed. Lucknow: Eastern Book Company; 2003. p. 279–303. [2] An Action Plan for Blood Safety. National AIDS Control Organisation. Ministry of Health and Family Welfare. Government of India. Available from: ; 2007;34. [3] Pahuja S, Sharma M, Baitha B, Jain M. Prevalence and trends of markers of Hepatitis C infection, Hepatitis B infection and Human Immunodeficiency Virus in Delhi based blood donors-a hospital based study. Jpn J Infect Dis 2007;60:389–91. [4] Makroo RN, Walia RS, Chowdhry M, Bhatia A, Hegde V, Rosamma NL. Seroprevalence of anti-HCV antibodies among blood donors of north India. Indian J Med Res 2013; 138:125–8. [5] Singh B, Kataria SP, Gupta R. Infectious markers in blood donors of East Delhi: prevalence and trends. Indian J Pathol Microbiol 2004; 47(4):477–9. [6] Choudhury LP, Tetali S. Notification of transfusion transmitted infection. Indian J Med Ethics 2008;5:58–60. [7] Patel P, Patel S, Bhatt J, Bhatnagar N, Gajjar M, Shah M. Evaluation of response to donor notification of reactive transfusion transmitted infections (TTIs) result. NJIRM 2012; 3(2):20–5.
3
[8] Dontula S, Mathur A, Kamala Doss T, Adimurthy S, Jagannathan L. Donor disclosure – a donor’s right and blood bank’s responsibility. Transfus Altern Transfus Med 2012;12:44–50.
Daljit Kaur * Department of Pathology and Blood Bank, Lady Hardinge Medical College and Associated Hospitals, New Delhi 110001, India * Tel.: +8872932452; fax:+011 23340566. E-mail address: [email protected] Sangeeta Pahuja Department of Pathology and Blood Bank, Lady Hardinge Medical College and Associated Hospitals, New Delhi 110001, India Manjula Jain Department of Pathology and Blood Bank, Lady Hardinge Medical College and Associated Hospitals, New Delhi 110001, India Rama Khaspuria Department of Pathology and Blood Bank, Lady Hardinge Medical College and Associated Hospitals, New Delhi 110001, India
Please cite this article in press as: Daljit Kaur, Sangeeta Pahuja, Manjula Jain, Rama Khaspuria, Donor notification: Streamlining the existing enigmatic process: An experience from a tertiary care hospital in central Delhi, India, Transfusion and Apheresis Science (2015), doi: 10.1016/j.transci.2015.03.001
Contents lists available at ScienceDirect
Transfusion and Apheresis Science j o u r n a l h o m e p a g e : w w w. e l s e v i e r. c o m / l o c a t e / t r a n s c i
Letter to the Editor Donor notification: Streamlining the existing enigmatic process: An experience from a tertiary care hospital in central Delhi, India Blood has been an area of great fascination since ancient times. Enhanced sensitivity and better use of serologic testing, nucleic acid testing along with stringent scrutiny of donors has resulted in major reductions in risk of transfusion transmitted disease. Still donor notification which is an essential process whereby the otherwise asymptomatic donor is informed of the harboured transfusion transmissible infection (TTI) has been a matter of debate. As per guidelines of the Ministry of Health and Family Welfare (Government of India) under the Drug and Cosmetic Act,1945 amendments thereafter, all the blood donations are mandated to transfusion transmitted infections (TTI) testing for Hepatitis B (HBV), Hepatitis C (HCV), HIV 1 and 2, syphilis and malaria [1]. According to objective 4.16 of Indian Action Plan for blood safety, the donor is counselled about TTIs prior to donation and is offered the option of knowing his or her TTI status provided he/she has given written consent for the same [2]. In view of all the efforts in place for donor notification, we carried out a study at Department of Pathology and Blood Bank, Lady Hardinge Medical College and Associated Shrimati Sucheta Kriplani Hospital and Kalawati Saran Children Hospital, New Delhi for the period of 4.5 years i.e. from January 2010 to June 2014 in order to analyse how many of the seroreactive donors contacted by blood bank had responded back for notification and limitations associated with the process. Routinely, prior to blood donation, donors are provided with predonation counselling from a trained counsellor posted in blood bank who provides information about the facts and myths related to blood donation procedure and taking donor into confidence asks about any high risk behaviour activities in detail. Written informed consent about whether donor would like to be informed of their TTI status is taken. The medical history, brief physical examination and fitness of the donor are approved by the doctor on duty. A total of 46,172 donors had come for blood donation at our blood bank or outside blood donation camps during the study period and were screened according to the national guidelines as laid by Directorate General Health Services (DGHS) and National AIDS Control Organisation (NACO). A total of 41,000 (88.79%) were selected as fit for donation while 5172 (11.20%) donors were deferred due to
various medical reasons and preliminary blood tests. Majority of the blood donations (93.16%, 38,194) were done by family or relative donors and 2238 blood units (5.46%) were collected through outdoor voluntary blood donation camps and the in-house altruistic voluntary donors at our blood centre contributed only 1–2% (568). All the collected units were tested by fourth generation ELISA kits for Hepatitis C (Monolisa HCV Ag-Ab Ultra, BioRad, France) and HIV 1 and 2 (VironostikaHIVAg/Ab, Biomerieux, France) and third generation ELISA kits for Hepatitis B (Monolisa HBs Ag Ultra, BioRad, France). Treponema pallidum haemagglutination assay (TPHA, BioRad, France) testing was used as screening test for syphilis and rapid card test (Parabank, BioRad, France) for malaria. The total seroprevalence for all the five markers was found to be 5.13% (2105 blood units). Of all the collected blood units, 1218 (2.97%) units were found reactive for one of the HBV (1.79%), HCV (0.74%) or HIV (0.44%) infections as also observed by previous studies from Delhi [3–5]. All the reactive donors were replacement except one (HBsAg positive) male voluntary donor during the study period. The seroreactive units were quarantined and discarded as per institutional policy. The entry was made in reactive donor register and donor notification register and kept confidential. The reactive donors were referred to concerned speciality as per infectious marker such as HIV reactive donor to Integrated Counselling and Testing Centre (ICTC), HBV or HCV reactive donors to Medicine OPD and to Department of dermatology if TPHA reactive for syphilis, after repeat check of donor details on their revisit to blood bank. A special proforma was used for donor notification and referral to other specialities and a copy having donor’s signature and answers to post counselling questionnaire was kept as Blood Bank record in confidential state. However TPHA positive donors were started being notified in November 2013 onwards. The study period was divided into two phases according to the mode of communication to the seroreactive donors. The first phase was from January 2010 to May 2013 – contacted through letters only, writing that their blood tests are inconclusive and they should visit blood bank for retesting. The second phase was from June 2013 to June 2014 – contacted by hospital telephone first and if no response on first day, another call was made the following day or within a week with a maximum of three attempts. If the donor did not respond within 14 days of phone call, a letter was sent subsequently. If no response is observed to letter or telephone within 8–10 weeks, the donor was considered non-respondent.
http://dx.doi.org/10.1016/j.transci.2015.03.001 1473-0502/© 2015 Elsevier Ltd. All rights reserved.
Please cite this article in press as: Daljit Kaur, Sangeeta Pahuja, Manjula Jain, Rama Khaspuria, Donor notification: Streamlining the existing enigmatic process: An experience from a tertiary care hospital in central Delhi, India, Transfusion and Apheresis Science (2015), doi: 10.1016/j.transci.2015.03.001
ARTICLE IN PRESS 2 (6.67%) 13 (16.05%) 0 (0.00%) 25 (43.10%) 13 (52.00%) 53 (17.49%) 50 81 89 58 25 303 (0.74%) 13 (25.49%) 11 (23.40%) 5 (12.20%) 19 (54.29%) 6 (75.00%) 54 (29.67%) 51 47 41 35 8 182 (0.44%) 8 (5.10%) 24 (12.63%) 0 (0.00%) 95 (54.91%) 28 (38.36%) 155 (21.15%) Also the boldface indicates the higher response to donor notification in phase 2 of study. a Wrong address/information provided: HIV – 6, HBV – 08.
23 (9.83%) 48 (15.09%) 5 (1.85%) 139 (53.46%) 47 (46.08%) 262 (21.76%) 258 318 270 266 106 1218 2010 2011 2012 2013 2014 (until June 2014) Grand total
254a 318 270 260a 102a 1204
157 190 140 173 73 733 (1.79%)
HCV reactive HIV respondents HIV reactive HBV respondents HBV reactive Total respondents Total reactive donors notified through letters or telephonea Total sero-reactive donors (except TPHA and malaria) Year
A total of 1204 (98.85%) of the reactive donors were contacted through letters or telephone. Six and 8 of the HIV and HCV reactive donors respectively could not be contacted due to incomplete address mentioned in donor form. In year 2010 only 9.58% reactive donors responded out of 254 contacted (23/254), 15% (48/270) in 2011, 1.57% (05/318) in 2012, 54% (155/260) in 2013 and 46.07% (47/102) mid 2014 (Table 1). Only 1.85–15.09% of reactive donors turned back to blood bank during the years 2010–2012. It was observed that all the donors could not be contacted as letters kept bouncing back due to wrong/incomplete address mentioned by donors. During the first phase, commoner causes of poor donor notification response rate observed were distance, low educational status of donors, fright to know their TTI status, forcible donation, long absence of counsellor in blood bank, professional donors acting as patient’s relatives and resistance to show or lack of identity proof by the donors. Since donor disclosure methods keep getting updated by NACO from time to time considering the ongoing scenario of notification response in the region. Therefore we changed the mode of communication to telephonic calls first followed by letters noticing the limitation of low response rate in our reactive blood donors (2nd phase). We followed a policy of contacting the reactive donors at the earliest when their patients might be still admitted in the hospital so as to curtail the poor response due to long distance. Consequently, overall response rate increased to 54% and 46.07% in 2013 and mid 2014 respectively. Majority of the blood donors feel more comforted when they are contacted telephonically for the first time rather than directly receiving letters at their homes as observed by Choudhary et al. [6]. Moreover, they can raise their anxiety and can be reassured by the counsellor to visit blood bank at the earliest. When compared to other studies from India which were conducted for a period of 1–2 years, we had similar and/or higher response rate than others in the second phase of our study period [7,8]. The donors reactive for anti-HIV responded maximally in the second phase of study as 6 out of 8 (75%) in 2014 (until June) and 19 out of 35 (54.3%) responded in 2013 due to more stringent protocol followed for such donors. Similarly, respondents rose from 16.05% to 52% for anti-HCV and from 12.5% to 38.36% for HBsAg positive cases in the years 2010 to mid of 2014. We could get the feedback of all antiHIV 1 and 2 positive donors visiting ICTC for treatment with the referral numbers provided during notification. But not all anti-HBV or anti-HCV positive donors could be traced for their response to future management as majority wish to consult nearby physicians or private gastroenterologists after notification or were lost to follow up. Our blood centre collects maximum of replacement donors while voluntary non remunerated blood donors donating out of altruism accounts to only 5–10%. For safe blood supply more and more philanthropic donors need to be recruited. Moreover, it is worthwhile spending more time during predonation counselling especially in high prevalence areas by recruiting trained counsellors rather than exhausting resources on testing and retesting donated blood. The reactive donor should be referred with a referral slip mentioning the TTI test result as well as detailed address
HCV respondents
D. Kaur et al./Transfusion and Apheresis Science ■■ (2015) ■■–■■
Table 1 Data related to the donor notification for TTIs for the study period.
2
Please cite this article in press as: Daljit Kaur, Sangeeta Pahuja, Manjula Jain, Rama Khaspuria, Donor notification: Streamlining the existing enigmatic process: An experience from a tertiary care hospital in central Delhi, India, Transfusion and Apheresis Science (2015), doi: 10.1016/j.transci.2015.03.001
ARTICLE IN PRESS D. Kaur et al./Transfusion and Apheresis Science ■■ (2015) ■■–■■
of the concerned physician to get better response out of notification. Sustained efforts of a trained counsellor as well as integration with ICTC, gastroenterologists and dermatologists for HBV, HCV and TPHA positive cases for referral can bring in a lot of change in donor notification process which is a great societal concern of today’s time. References [1] Malik V. Drugs and cosmetics act, 1940. 16th ed. Lucknow: Eastern Book Company; 2003. p. 279–303. [2] An Action Plan for Blood Safety. National AIDS Control Organisation. Ministry of Health and Family Welfare. Government of India. Available from: ; 2007;34. [3] Pahuja S, Sharma M, Baitha B, Jain M. Prevalence and trends of markers of Hepatitis C infection, Hepatitis B infection and Human Immunodeficiency Virus in Delhi based blood donors-a hospital based study. Jpn J Infect Dis 2007;60:389–91. [4] Makroo RN, Walia RS, Chowdhry M, Bhatia A, Hegde V, Rosamma NL. Seroprevalence of anti-HCV antibodies among blood donors of north India. Indian J Med Res 2013; 138:125–8. [5] Singh B, Kataria SP, Gupta R. Infectious markers in blood donors of East Delhi: prevalence and trends. Indian J Pathol Microbiol 2004; 47(4):477–9. [6] Choudhury LP, Tetali S. Notification of transfusion transmitted infection. Indian J Med Ethics 2008;5:58–60. [7] Patel P, Patel S, Bhatt J, Bhatnagar N, Gajjar M, Shah M. Evaluation of response to donor notification of reactive transfusion transmitted infections (TTIs) result. NJIRM 2012; 3(2):20–5.
3
[8] Dontula S, Mathur A, Kamala Doss T, Adimurthy S, Jagannathan L. Donor disclosure – a donor’s right and blood bank’s responsibility. Transfus Altern Transfus Med 2012;12:44–50.
Daljit Kaur * Department of Pathology and Blood Bank, Lady Hardinge Medical College and Associated Hospitals, New Delhi 110001, India * Tel.: +8872932452; fax:+011 23340566. E-mail address: [email protected] Sangeeta Pahuja Department of Pathology and Blood Bank, Lady Hardinge Medical College and Associated Hospitals, New Delhi 110001, India Manjula Jain Department of Pathology and Blood Bank, Lady Hardinge Medical College and Associated Hospitals, New Delhi 110001, India Rama Khaspuria Department of Pathology and Blood Bank, Lady Hardinge Medical College and Associated Hospitals, New Delhi 110001, India
Please cite this article in press as: Daljit Kaur, Sangeeta Pahuja, Manjula Jain, Rama Khaspuria, Donor notification: Streamlining the existing enigmatic process: An experience from a tertiary care hospital in central Delhi, India, Transfusion and Apheresis Science (2015), doi: 10.1016/j.transci.2015.03.001
