Country Strategy for Blood Donation Screening of Transfusion Transmissible Infections WORKSHOP REPORT

Transcription

1 WORKSHOP REPORT COUNTRY STRATEGY FOR BLOOD DONATION SCREENING OF TRANSFUSION TRANSMISSIBLE INFECTIONS Islamabad, July 01, 2013 SAFE BLOOD TRANSFUSION PROGRAMME WORLD HEALTH ORGANIZATION Workshop Report Page 1

2 Table of Contents 1. Introduction Workshop Proceedings Results of the Working Group... 9 Group Group Group Group ANNEXES A: List of Participants B: Workshop Programme C: Group Photograph D: Newspaper Clipping Workshop Report Page 2

3 1. Introduction Health care systems of developing countries are continue to face the challenge of inadequate supply of safe blood and an increase in the prevalence of transfusion associated infections. The situation in Pakistan is not different and the quality of blood transfusion services has been adversely affected due to the imbalance in the supply and demand. According to a study 2.74 million donations are made annually and this huge amount of blood collected remains a key vector of transmitting infectious diseases, affecting about 7.4 percent of the population. Screening for transfusion-transmissible infections (TTIs) is a critical part of the process of ensuring that transfusion is as safe as possible. In a fragmented blood transfusion system and with an only incipient culture of voluntary donations, a strong reliance on replacement and paid donors, and the lack of systematic screening strategy, the infection risks are at the higher end. A large community of thalassaemic patients in the country (6% carrier rate) is facing an imminent risk with accumulating higher percentages of HBV (8.4%) and HCV (56.8%) as they receive multiple transfusions every year. In the current scenario, the blood transfusion safety cannot be ensured without stringent control mechanisms and highly trained staff. With limited regulatory oversight, the blood screening for TTIs is largely un-regulated. The newly developed guidelines will fill this knowledge gap and would be a great help for blood banking services. The Safe Blood Transfusion Programme, Pakistan through WHO/OFID Joint Project (OPEC Fund for International Development) on Prevention of Transfusion Transmitted HIV/AIDS and Hepatitis Infections, developed guidelines for blood screening of TTIs. These guidelines were subsequently reviewed by an international consultant and a group of national experts finalized the report. The subject consensus workshop was conducted to share the guidelines and algorithms with all stakeholders and experts in the field to get their inputs and feedback before finalization. The next step would be printing of these guidelines for use by blood bank officials and training of these professionals on the developed guidelines. This process would ensure consensus and buying in from the stakeholders and end users. The Programme is very grateful to the WHO and OFID for providing the vital support to develop these guidelines and algorithms. The implementation of these documents in the blood centers will go a long way in improving the blood transfusion safety standards in the country. Prof. Hasan Abbas Zaheer, PhD Incharge Blood Transfusion Services Project Director Pakistan Institute of Medical Sciences Safe Blood Transfusion Programme Islamabad, Pakistan Government of Pakistan Ph: Ph: hazaheer@gmail.com URL: Workshop Report Page 3

4 2. Workshop Proceedings The Safe Blood Transfusion Programme and World Health Organization conducted a national workshop on Country Strategy for Blood Donation Screening of Transfusion Transmissible Infections in Islamabad on July 1, The objective of the workshop was to share with experts, the newly developed National Testing Strategy and Algorithms TTI screening and take their inputs and feedback for any possible revision. The workshop was conducted in an interactive manner and consisted of groups work and presentations. Dr. Quaid Saeed Prof. HA Zaheer Prof. Tahir Shamsi Dr. Saeed Ahmed Mr. Usman Waheed The programmed started with the opening remarks by Dr. Quaid Saeed, Programme Officer World Health Organization. He informed that WHO has launched blood safety as one of its priorities and the World Health Day 2000 was dedicated to the theme of blood safety. He updated about the WHO/ OFID Joint Project (OPEC Fund for International Development) on Prevention of Transfusion Transmitted HIV/AIDS and Hepatitis Infections. The overall goal of the project is to prevent transfusion-transmitted HIV/AIDS and hepatitis infections in Bangladesh, Bhutan, Workshop Report Page 4

5 Nepal and Pakistan through universal coverage and quality-assured testing of all donated blood. The current document, developed through this Joint Project, is imperative to guide and support the establishment and implementation of an appropriate, effective and reliable blood screening strategies which are uniform and standardized across the country. He emphasized that there is a need to coordinate efforts at national, regional and global level and develop effective collaboration with experts, institutions, organizations and other partners working for blood safety at different levels. The ongoing blood safety reforms in the country were elaborated by Prof. Hasan Abbas Zaheer, Project Director Safe Blood Transfusion Programme. He introduced the participants to the new centralized model of blood banking which will be introduced through the support from the German Government. He informed that the SBT Programme is successfully progressing with the support and cooperation of all the partners. The procurement for the construction and equipment of the infrastructure has commenced and the construction work will be initiated in July 2013, and expected to be completed by mid In the meantime the technical work is proceeding ahead with its work to train a suitable trained work force to work in the new system and also in the existing centers. The various guidelines, manuals, SOPs etc have also been developed as part of the blood safety systems reforms process. The Programme has also interacted proactively with the international blood transfusion community and developed strong linkages with many international partners. The establishment and strengthening of the Pakistan Haemovigilance Network and the Blood Donor Organization Network are currently on the priority list of the Programme. Workshop Report Page 5

6 Dr. Saeed Ahmed, Head of Husaini Blood Bank Karachi, discussed various screening techniques for transfusion transmitted infections. He said that preventing the spread of these TTIs by blood transfusion is addressed in several ways. In many cases, the blood is tested for the pathogen, sometimes with several different methodologies. Donors of blood are also screened for signs and symptoms of disease and for activities that might put them at risk for infection. Most commonly employed methods are designed to detect antibodies, antigens or the nucleic acid of the infectious agent. No single test satisfies all conditions or objectives. Different objectives require specific strategies (combination and sequence of tests), while local conditions such as daily volume of tests, staff training levels and comparative costs influence the type of test chosen. The screening assays include rapid tests, Enzyme Linked Immunosorbent Assay (ELISA), Chemiluminescent immunoassays (CLIAs) and Nucleic Acid Testing (NAT). A number of simple, rapid assays are in use to meet the challenges in resourced limited countries for blood screening but there are many studies which have reported the shortcomings in these tests. The sensitivity and selectivity mentioned on the devices is not accurate and often false positive and false negative results are encountered. Enzyme and chemiluminescent immunoassays are currently the most commonly used assays for screening donated blood for TTIs. The design of EIAs and CLIAs is similar and they differ only in the mode of detection of immune complexes formed; colour generation in ELISAs and measuring light produced by a chemical reaction in CLIAs. The Nucleic Acid Testing is widely recommended and was originally intended to complement serological screening for detection of donations infectious for those viruses. It is costly but reduces the window period considerably. Dr. Saeed also outlined the WHO statement of having a national policy on blood screening that defines national Workshop Report Page 6

7 requirements for the screening of all whole blood and aphaeresis donations. Prof. Tahir S. Shamsi, Consultant Haematologist National Institute of Blood Disease & Bone Marrow Transplantation Karachi, summarized the National Strategy for Blood Donation Screening of Transfusion Transmissible Infections. He outlined the major concepts in the document and presented an in-depth analysis. He said these algorithms have been developed specially for use in Pakistan, according to the situation in blood banks locally. A screening algorithm which is a sequence of steps in the blood screening process to be followed in each facility to determine the suitability of each unit of donated blood and its components for clinical or manufacturing use. The algorithm will specify the actual tests to be employed and, based on each test result, directs the user to the next step. Mr. Usman Waheed, Technical Expert SBTP, said that the use of the proposed screening algorithms are intended to ensure consistency in screening tests and decisions regarding the release of screened blood and blood components, the discard of unsuitable units and the management of blood donors with confirmed positive screening results. Therefore, it is vital to discuss the document in detail to indicate any limitations which may have been overlooked during the drafting process. All participants were distributed in four groups and each group was assigned a facilitator and two chapters to discuss. Group 1, 2, 3 and 4 were facilitated by Dr. Ashraf Memon (Senior Pathologist, Sindh AIDS Control Programme), Dr. Saeed Ahmed (Head Husaini Blood Bank Karachi), Dr. Nisar Ahmed (Associate Professor Haematology, Children Hospital Lahore) and Dr. Shahtaj Khan (Assistant Professor Haematology, HMC Peshawar) respectively. The presentations made by the working group were very well received and followed by a detailed question and answer session. The document was formally endorsed with some minor editing and a few recommendations. The participants discouraged the use of sub-standard kits in most of the blood banks. The use of rapid Workshop Report Page 7

8 devices by the Punjab Health Department in all public sector blood banks across Punjab is not ideal and needs to be replaced by ELISA/CLIA. The use of rapid devices compromises the blood safety standards. A Medical Technology Council needs to be established to make a career path for the Medical Technologists. Concluding remarks were given by Dr. Quaid Saeed who hoped that this document will form a backbone to improve the overall screening for each TTI in Pakistan, and therefore each chapter has been written to be a stand-alone document in itself. He also thanked the participants for sparing time to attend this national event. He also appreciated the tireless efforts by the facilitators to make this even a huge success. All the recommendations/suggestions pointed out by the experts will be addressed and a final version will be shared with experts and after their approval, will be disseminated across Pakistan for implementation. At the conclusion of the successful workshop, certificates were distributed to the workshop participants which was followed by lunch. Workshop Report Page 8

9 3. Results of the Working Groups Group 1 discussed Introduction and Chapter 1 of the document. The group made many amendments in the document including changes in the references, in the text and grammar correction as well. The group presentation was made by Dr. Farrukh Hasan who highlighted following points: 1. Instead of names, reference number should be written in the text. 2. Data in Pakistan are not only scanty but incomprehensive and not up to date (page-7, line-10). 3. The percentage data of blood donation divided among volunteers and non-volunteers is not accurate as it not only depends on the pints of blood but on the sample size as well (page-7, line- 11). 4. It should be clearly mentioned that besides HBV, HCV, HIV and Syphilis, the screening for malarial is also mandatory in Pakistan (page-7, line-21). 5. Hepatitis not only leads to liver infection but chronic liver complication as well (page-8, line-7). 6. Instead of NWFP, KPK should be written as the name of the province has been changed (page- 10, line-2). 7. There is a discrepancy in the line, so it should be removed. (page-10, line-14-15) 8. About the prevalence of HIV infections, there should be additional information about the total percentage divided among MSW, Hijrah, IDUs and other high risk population (page-11, line-6). 9. Platelet concentrates present a significantly higher risk of transmitting Syphilis at room temperature rather than at higher temperatures (page-12, line-6). Group 2 discussed chapters 2 and 3 which were National testing strategies for Transfusion Transmitted Infections and Standards, quality assurance and controls of the system. The group presentation was made by Dr. Saeed Ahmed who proposed following recommendations: 1. There should be home based services for platelets donation like plasmaphaeresis. 2. PCR is not the method of confirmation for antibodies. So, it should be corrected in the document. 3. The Blood Transfusion Authorities need to be strengthened for the check and balance of the system so that no sub-standard equipment and kit enters the system. 4. Training and awareness should start from the laboratory technician who has to handle most of the processes of blood donation here in Pakistan. 5. In the screening of HCV and HBV, first HBV screening should be performed as screening tests for HCV are much costly. 6. RIBA test for HCV is not available in Pakistan so it should be removed from the document. 7. Tax free import of kits should be ensured. 8. Establishment of National Quality Department is ideal. 9. Allow only FDA approved kits. 10. A uniform training curriculum for Medical Technologists and Technicians (NIBD agreed to provide SBTP with the required documents in this regard). Workshop Report Page 9

10 Group 3 discussed chapters 4 and 5 which were Testing for TTIs and Management of Positive Blood Donations. The group presentation was made by Dr. Nisar Ahmed who gave following recommendations: 1. A uniform color coding system to be strictly implemented in three colors for waste disposal; white for general waste, green for infectious waste and red for sharps. 2. Stringent data recording practices to be maintained. 3. Use of those rapid devices which are approved by WHO. 4. WHO guidelines should be strictly followed for a quality assurance system. 5. Screened and un-screened bags should have color coding system. Red stickers should be pasted on un-screened while white stickers on screened blood bags. 6. There should be simple and easy to follow Standard Operating Procedures for all processes. 7. Traceability should be ensured and positive donors should be confirmed. 8. Alternatives to incinerators should be practiced like chemical disinfection and autoclaving. 9. Pre-donation screening can be practiced and will reduce the burden of infectious waste and is more efficient and less costly. 10. Blood should be used in emergencies only. Appropriate clinical use of blood should be practiced. 11. Blood components should be prepared and made available for use to clinicians. 12. Trained human resource should be developed that is the backbone of any system and in developing countries human resource is not costly as compared to western developed countries. Group 4 discussed chapters 6 and 7 which were Programmatic Systems in Blood Screening and Quality Systems in Blood Screening. The group work was presented by Dr. Shahtaj Khan and made following recommendations: 1. A National Blood Transfusion Advisory Council should be formed which includes Programme Managers, Health Departments, Transfusion Experts, Transfusion Authorities, Haematologists and Technologists. 2. Procurement should be done by the advisory committee. 3. BTAs should ensure that blood banks are run by a trained Pathologist. 4. Donor screening should be properly done during the interview. 5. Training sessions for the staff should be organized at-least after every six months. 6. The basics of transfusion science should be included in the curricula. Workshop Report Page 10

11 A N N E X E S Workshop Report Page 11

12 A: List of Participants S. No. Name Designation Hospital/Institute 1. Prof. Hasan A. Zaheer Project Director SBTP 2. Dr. Quaid Saeed Programme Officer WHO Pakistan 3. Dr. Saeed Ahmed Head/Consultant Husaini Blood Bank, Karachi 4. Prof. Khurshid Ahmed Scientist Emeritus National Institute of Health 5. Dr. Sher Zaman Programme Manager SBTP Baluchistan 6. Prof. Tahir Shamsi Consultant Haematologist NIBD, Karachi 7. Prof. Syed Irfan Consultant Haematologist LNH, Karachi 8. Dr. Nisar Ahmed Associate Professor Children Hospital, Lahore 9. Dr. Ashraf Memon Senior Pathologist Sindh AIDS Control Programme 10. Dr. Shah Muhammad Deputy Program Manager Sindh Blood Transfusion Authority 11. Dr. Tahir Khan Project Director KPK SBT Project 12. Dr. Naveed Ahmed Programme Manager SBTP AJK 13. Dr. Noaman Siddiqui Secretary Abbottonian Medical Association 14. Dr. Imtiaz Hasan Pathologist Federal Government Polyclinic Hospital 15. Dr. Farhat Abbas Infection Control Committee Benazir Bhutto Hospital, Rawalpindi 16. Dr. Sarfaraz H. Jaffri Administrator Husaini Blood Bank, Karachi 17. Dr. Saif-ur-Rehman Assistant Director PRCS Blood Donor Centre, Islamabad 18. Dr. Shahida Baloch QC Incharge Fatimid Foundation, Karachi 19. Mr. Zahid Mahmood Team Leader EPOS Health Management 20. Dr. Farrukh Hasan Vice President SAATM 21. Mr. Wasiq Paracha Vice President PWA, Karachi 22. Mr. Usman Waheed Technical Expert SBTP 23. Dr. Shahtaj Khan Assistant Professor HMC, Peshawar 24. Dr. Rubina Kamran Microbiologist PIMS, Islamabad 25. Dr. Jafar Saleem Secretary Punjab Blood Transfusion Authority 26. Dr. Suryya Hashmi Public Health Specialist Institute of Public Health 27. Mr. Bilal Tareen Medical Technologist PIMS, Islamabad 28. Dr. M. Aamir Mirza Associate Professor Dow University of Health Sciences 29. Dr. Sartaj Khan Deputy Director DHS, FATA 30. Dr. Rubina Moin Medical Superintendent Family Health International Hospital 31. Mr. Sajd Shah Admin Officer SBTP 32. Mr. Muhammad Fareed Managing Editor Medical Review 33. Ms. Tayyaba Komal Internee, BTS, PIMS Student, NUST Univ. 34. Ms. Isra Mahmood Internee, BTS, PIMS Student, NUST Univ. 35. Ms. Hafsa Inam Internee, BTS, PIMS Student, NUST Univ. 36. Ms. Kaenat Nasir Internee, BTS, PIMS Student, NUST Univ. 37. Ms. Ayesha Sajid Internee, BTS, PIMS Student, NUST Univ. 38. Ms. Fatima Darakhshan Internee, BTS, PIMS Student, NUST Univ. 39. Mr. Uzair Hashmi Internee, BTS, PIMS Student, NUST Univ. 40. Ms. Aqsa Abbasi Internee, BTS, PIMS Student, NUST Univ. 41. Ms. Sana Javed Internee, BTS, PIMS Student, NUST Univ. Workshop Report Page 12

13 B: Workshop Programme WORKSHOP ON COUNTRY STRATEGY FOR BLOOD DONATION SCREENING OF TRANSFUSION TRANSMISSIBLE INFECTIONS Monday, July 01, 2013 Hotel Hill View, Islamabad Time Subjects Format Actor 08:30 Registration Individual All participants 09:00 OPENING 09:05 Recitation from the Holy Quran 09:10-09:15 Introductory Remarks Speech Dr. Quaid Saeed 09:15-09:30 Blood Safety System Reforms in Pakistan Speech Prof. Hasan A. Zaheer 09:30-10:00 Screening Techniques for TTIs Presentation Dr. Saeed Ahmed (30 min) Group Photograph and Tea Break 10:30-11:00 Country Strategy for TTI Screening Presentation Prof. Tahir S. Shamsi Questions / Answers Discussion Forum 11:10 11:20 Introduction to Working Groups Speech Mr. Usman Waheed 11:20-13:00 WORKING GROUP ACTIVITY 1. Introduction and Chapter 1 2. Chapter 2 and 3 3. Chapter 4 and 5 4. Chapter 6 and 7 Group Work Group Work Group Work Group Work Dr. Ashraf /Dr. Farrukh Dr. Saeed Ahmed Dr. Nisar Ahmed Dr. Shahtaj Khan (1 hour) Lunch/Prayer Break 14:00-15:00 Results from Working Groups Presentations/ Discussion Forum Endorsement Forum 15:10-15:20 Closing Remarks/Certificates Distribution Prof. Hasan A. Zaheer / Dr. Quaid Saeed Workshop Report Page 13

14 C: Group Photograph Workshop Report Page 14

15 D: Newspaper Clipping Workshop Report Page 15