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Table of Contents Preface
Introduction
Workshop Proceedings
3.1 Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
3.2 Husaini Blood Bank, Karachi
3.3 Islamia University of Bahawalpur, Bahawalpur
3.4 Hayatabad Medical Complex, Peshawar
Pre and Post Course Assessment
4.1 Workshop 1 (Islamabad)
4.2 Workshop 2 (Karachi)
4.3 Workshop 3 (Bahawalpur)
4.4 Workshop 4 (Peshawar)
Annexes
5.1 Annex-A Workshop Programme
5.2 Annex-B Pre- and Post-Course Assessment Questionnaire
5.3 Annex C Speaker’s Profile
5.4 Annex D News Cuttings
5.5 Annex E Quality Control Documents
5.6 Annex F Certificate Design
5.7 Annex G Shield Design
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1. Preface
Blood safety has been identified as one of the seven priority areas
of WHO and quality management is the most significant factors to
achieve safety. Transfusion Medicine is not only considered a
medical discipline; it can also be considered a manufacturing
process. Adherence to current Good Manufacturing Practices
(cGMP) ensures that each blood product meets the quality
standards for that product’s intended use.
There are many definitions of the term ‘quality’. One of the
simplest and most appropriate is ‘fit for the purpose’, in this case the purpose being safe
transfusion. Quality systems and quality management are designed to ensure the consistent
and reliable performance of services or products against given sets of standards. For blood
transfusion services (BTS), this means continual quality improvement to ensure the adequacy,
availability, efficacy and safety of blood and blood products. Quality management aims at
ensuring the highest possible standards in all aspects of blood transfusion – from ‘vein to vein’ –
and the prevention of errors, which may be fatal.
WHO/OFID Joint Since the last three years, Pakistan has been the recipient of support from
Project (OPEC Fund for International Development). Through this Programme training activities and
studies have been conducted throughout the country with an objective to improve the standard
of QM in the blood centers. According to WHO recommendations, a quality system should cover
all aspects of its activities and ensure traceability, from the recruitment and selection of blood
donors to the transfusion of blood and blood products to patients. It should also reflect the
structure, needs and capabilities of the blood transfusion service, as well as the needs of the
hospitals and patients that it serves. Similarly, all staff involved in blood screening should be
trained to perform their functions to nationally required standards. The subject training
workshops were thus organized in four provinces of Pakistan with this objective in mind.
The organization of the workshops would not have been possible without the cooperation of the
respective Provincial Blood Programmes and the key partners in the private sector. The
Programme would also like to appreciate the coordination role of Dr. Quaid Saeed from the
It is pertinent also to acknowledge the support WHO country office. of facilitators who spared
their valuable time to impart training in these workshops. The SBTP Team including Zain
Tareen, Syed Sajid Hussain Shah, Bilal Ahmed Tareen, Kamran Khan, and Usman Waheed,
deserve special appreciation for their hard work and commitment in conducting these
workshops in a very professional manner.
Prof. Hasan Abbas Zaheer Project Director Safe Blood Transfusion Programme Government of Pakistan Ph: 0092 51 926 32 36 Fax: 0092 51 926 32 38 Email: [email protected], [email protected] Website: http://www.sbtp.gov.pk
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2. Introduction
Lack of appropriate manpower is one of the major constraints in the development and
strengthening of blood transfusion services in Pakistan. Appropriate trainings require planning of
training programmes and refresher courses for the staff working in the blood banks. To train the
SBTP in existing BT manpower in Quality Management in Blood Transfusion Services,
collaboration with WHO/OFID, conducted a series of 3-day Training Workshops in Karachi,
Islamabad, Bahawalpur and Peshawar during March-May 2014. To organize the workshops in
each of the four provinces, SBTP coordinated with the four respective provincial blood
transfusion programmes. The objective of these workshops was to establish the status of quality
management in blood transfusion services and to improve the skills of participants in the
planning, management and implementation of quality systems, including preparation of SOPs
and assuring quality implementation.
The training modules for the QMT workshops were designed in accordance with the WHO
guidelines. The participants staff selected for the workshop were primarily experienced blood
bank laboratory staff who are actively involved in the daily routine of work in their blood banks.
As detailed in the Report, the workshops helped create a learning environment for this target
The training dealt with theoretical and practical aspects of quality management in blood group.
banking. The workshops also identified future training needs in quality management training.
Participants’ knowledge and understanding of quality concepts were assessed at the beginning,
during and at the end of each course and were assisted to prepare a plan of action for the
establishment of a quality system in their own blood transfusion service. Their performance was
formally evaluated by the course facilitators. Based on the assessment results it can be
concluded that the trainings were very successful in terms of knowledge dissemination and
knowledge retention as indicated by the Pre- and post-course assessments.
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Prof. Hasan Abbas Zaheer Dr. Arshad Malik Mr. Usman Waheed Dr. Masooma Raza Dr. Afrosa Liaquat Mr. Asim Ansari
3. Workshop Proceedings
3.1 Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad March 26-28, 2014
The Quality Management Training workshop in Islamabad was held from March 26-28, 2014, at the Shahed Zulfiqar Ali Bhutto Medical University with the support of WHO/OFID. Inaugurating the training course, Prof. Hasan Abbas Zaheer, Project Director, Safe Blood Transfusion Programme briefed all the participants about the various components of Quality Management Programme and the importance of quality management in improving blood safety. Thirty six participants (laboratory technicians and technologists) from public and private sector blood banks of Islamabad attended the workshop. University students (BS to MS level) from Biological and Medical Science Faculties also attended the workshop.
The workshop was facilitated by Dr. Arshad Malik, Assistant Professor, IIU, Dr. Afrose Liaquat, PhD Scholar Quaid-i-Azam University, Dr. Masooma Raza, Consultant Haematologist PAEC Hospital, Mr. Usman Waheed, Technical Expert SBTP and Mr. Asim Ansari, Incharge Blood Bank, KIH. The workshop included lectures and practical training on various aspects of Quality Management in Blood Transfusion Services.
Every participant performed practical on quality management procedures. Quality assurance aspects of BT along with discrepancies in the performance were discussed in detail. The topics of the workshop included V2V Transfusion
Chain, Quality Assurance in Blood Banking, Quality Control in Donor Management, Quality Control in Component Preparation, Standard Operating Procedures (SOPs), Quality Control in
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Immunohaematology, Minor Blood Group Systems, Adverse Transfusion Reactions, Quality Control in TTI Screening, Data Management in Blood Transfusion Services Haemovigilance as a Quality Management Tool.
The workshop concluded with a certificate distribution ceremony among the participants by Prof. Hasan A. Zaheer. He urged the students to become quality ambassadors at their place of work and spread the message of quality in vein to vein transfusion chain.
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Prof. Hasan Abbas Zaheer Dr. Zahid Hasan Ansari Dr. Quaid Saeed Dr. Sarfraz H. Jafari Dr. Qamar Abbas Dr. Saeed Ahmed
3.2 Husaini Blood Bank, Karachi March 24-26, 2014
The Quality Management Workshop for the province of Sindh was held on March 24-26, 2014 at the Husaini Blood Bank in Karachi. Forty participants attended the workshop. The facilitators of the workshop included Prof. Hasan Abbas Zaheer, Project Director, SBTP, Dr. Zahid Hasan Ansari, Programme Manager, Sindh Blood Transfusion Programme, Dr Qamar Abbas, Sindh AIDS Control Programme, Dr. Sarfraz H. Jafri, Administrator, Husaini Blood Bank and Dr. Saeed Ahmed, Head/Consultant, Husaini Blood Bank.
The Workshop started with the recitation of the Holy Quran. In his opening remarks, Prof. Zaheer welcomed all the participants and acknowledged the efforts of Husaini Blood Bank in successfully organizing the workshop in Karachi for the participants from all over Sindh. He emphasized the significance of QM in BTS and gave an overview about the role of WHO in promoting blood safety in Pakistan. Dr. Zahid Hasan Ansari, Programme Manager, Sindh Blood Transfusion Programme, informed the participants on the provincial blood transfusion authority recent activities. The participants appreciated this method of training and thanked WHO/OFID and the Safe Blood Transfusion Programme for providing them with an opportunity to improve their laboratory skills.
On the closing ceremony, Mr. Asad Ali, CEO, Husaini Blood Bank distributed shields and certificates among the facilitators and the workshop participants. In his address, he appreciated the facilitators expertise and participants interest in the training, highlighted the importance of quality management in blood transfusion. He advised all the participants to apply the training knowledge in their blood banks and ensure QM at all levels. He offered his gratitude to Dr. Quaid Saeed, National Programme Officer WHO, Prof. Hasan Abbas Zaheer, Project Director SBTP, Dr. Zahid H. Ansari, and all facilitators for arrangement, facilitation and active participation.
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Prof. Muhammad Mukhtar Dr. Jafar Saleem Dr. Saeed Ahmed Mr. Usman Waheed Mr. Asim Ansari
3.3 Islamia University, Bahawalpur April 10-12, 2014
The workshop for the province of Punjab was conducted from April 10-12, 2014 at the Islamia University of Bahawalpur. This activity was the third among the series of workshops conducted nationwide by SBTP in collaboration with WHO-OFID. Prof. Dr. Muhammad Mukhtar, Vice Chancellor IUB was the guest of honour. During his opening remarks, he appreciated the efforts of SBTP in addressing the needs of South Punjab and developing the capacity of technical personnel from public and private sector blood banks. He also announced to initiate diploma/degree courses in transfusion medicine and medical technology.
Other notable speakers included Dr. Jafar Saleem, Director, IBTS, Punjab, Dr. Saeed Ahmed, Head Husaini Blood Bank, Mr. Asim Ansari, In charge Blood Bank KIH and Mr. Usman Waheed, Technical Expert SBTP. The Workshop was conducted in an interactive manner and consisted of presentations, discussions, group activities and practical sessions. Dr. Qaiser Jabeen, Associate Professor IUB and Dr. Usman Cheema, Senior Medical Officer were also among the facilitators.
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At the end of the 3rd day, certificates were distributed among the participants and shields were also awarded to the presenters and facilitators by the Vice Chancellor, IUB. He also expressed his profound thanks to the facilitators and SBTP for this academic activity. He also wished to make this exercise regular as part of CME.
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Prof. Tahir Khan Prof. Fazl e Raziq Mr. Usman Waheed Dr. Rashid Azeem Dr. Muhammad Khalid Dr. Shahtaj Khan Dr. Zarmina Hussainn
3.4 Hayatabad Medical Complex, Peshawar May 5-7, 2014
The fourth 3-day workshop on “Quality Management in Blood Transfusion Services” was conducted for the province of KPK and AJK at Peshawar from May 5-7, 2014. Fifty six participants attended the workshop. The workshop participants included laboratory technicians and technologists from public and private sector blood banks of Khyber Pakhtunkhwa and Azad Jammu Kashmir. The workshop was facilitated by Prof. Fazl e Raziq, Head of Pathology Department, RMI, Peshawar, Dr. Shahtaj Khan, Head of Pathology Department, HMC, Peshawar, Mr. Usman Waheed, Technical Expert SBTP, Dr. Muhammad Khalid, Secretary, KP BTA, Dr. Rashid Azeem, Inspector, KP BTA and Dr. Zarmina Hussain, Inspector, KP BTA.
The training program started with the recitation of Holy Quran. Dr. Muhammad Tahir Khan, Project Director, KP SBTP, inaugurated the training workshop in which he briefed the participants about the importance of quality in blood transfusion services and its operations. He emphasized that quality management is essential in transfusion medicine practice as it helps to ensure that the patient receives a safe transfusion whether this is of red cells or another blood component.
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The objective of the workshop was to equip the blood bank staff with a better understanding of the quality management system, ensuring of full traceability (hemovigilance), mobilization and selection of
. The participants thanked SBTP, blood donors to the transfusion of blood and blood products to patientsProvincial Health Department and WHO for inviting them and urged to include them in future capacity building workshops as they needed such trainings to support their in comparison remote area of Safe Blood Transfusion.
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4. PRE- & POST- COURSE ASSESSMENT RESULTS
The pre- and post-course assessment is an effective method to assess the learning effectiveness and continue improving the instructor’s teaching ability. Pre- and post-course assessment was done for every workshop to have a systematic collection and analysis of information to improve participants’ learning. Participants were given a questionnaire with 50 multiple-choice questions at the beginning and at the end of training to assess their pre- and post-course knowledge. Twenty-three of the questions related to pure quality issues, while the remaining pertained to quality as applied to BTS. Participants were given 30 minutes to provide answers to these questions. The results of the analyses provided valuable inside information regarding the participants’ learning and effectiveness of teaching. Furthermore, the results will be used to continue improving teaching efforts since the results have shown which topics students had difficulty learning and where the instructor should pay closer attentions in the classroom. Overall, the knowledge after the post-course assessment has been raised.
4.1. Workshop 1 (Islamabad)
The participants scored 78.1% on an average in the post-course assessment as compared with 50.7% in the pre-course assessment.
4.2. Workshop 2 (Karachi)
The participants scored 73.8% on an average in the post-course assessment as compared with 53.9% in the pre-course assessment.
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4.3. Workshop 3 (Bahawalpur)
The participants scored 73.7% on an average in the post-course assessment as compared with 44.6% in the pre-course assessment.
4.3. Workshop 4 (Peshawar)
The participants scored 75.7% on an average in the post-course assessment as compared with 49.7% in the pre-course assessment.
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5. ANNEXES
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5.1. Annex-A Workshop Programme
Time Subjects Workshop Day 1 Format Presenter
08:30 Inscription Individual All participants
08:50 OPENING
09:00-09:05 Quotation from the Holy Quran Recitation
09:05-09:15 Introduction Forum
09:15-09:20 Introductory Remarks-WHO/OFID Speech
09:20-09:25 Objectives of the QM Training Presentation
09:25-09:50 Pre-Course Assessment Joint Activity
09:50-10:10 Vein-to-Vein Transfusion Chain Presentation
10:10-10:30 Quality Assurance in Blood Banking Presentation
10:30-11:00 Quality Control in Donor Management Presentation
11:00-11:30 Group Photograph and Tea Break
11:30-12:00 Quality Control in Component Preparation Presentation
12:00-12:30 Standard Operating Procedures (SOPs) Presentation
12:30-01:00 Group Activity - Writing a SOP Discussion
01:00-01:30 Presentation of the Group Work Presentation
01:30-02:20 Lunch and Prayer Break
02:20-03:20 Quality Control in Donor Management and Component Preparation
Practical
03:20-03:30 Questions and Answers
03:30 Conclusion of WS Day 1
Time Subjects Workshop Day 2 Format Actor
08:30 Inscription Individual All participants
08:30 OPENING
08:30-08:50 Wrap-up of Day 1 Speech
08:50-09:20 ABO-Rh System: Ag, Ab and Blood Typing Presentation
09:20-09:50 X-match and Coombs Test Presentation
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09:50-10-20 Minor Blood Group Systems Presentation
10:20-10:50 Quality Control in Immunohaematology Presentation
10:50-11:10 Tea Break
11:10-11:30 Problem Solving: Case Studies Pres./Discuss.
11:30-11:50 Adverse Transfusion Reactions Presentation
11:50-12:10 Investigation of Adverse Transfusion Reaction Presentation
12:10-12:40 Group Activity on Developing QC Charts Discussion
12:40-01:10 Presentation of the Group Work Presentation
01:10-02:00 Lunch and Prayer Break
02:00-03:00 Quality Control in Immunohaematology Practical
03:00-03:10 Questions and Answers
03:10 Conclusion of WS Day 2
Time Subjects Workshop Day 3 Format Actor
08:30 Inscription Individual All participants
08:30 OPENING
08:30-08:50 Wrap-up of Day 2 Speech
08:50-09:20 Quality Control in TTI Screening Presentation
09:20-09:50 Storage and Transportation (Cold Chain) in Transfusion Services
Presentation
09:50-10-20 Data Management in Blood Transfusion Services Presentation
10:20-10:50 Haemovigilance as a Quality Management Tool Presentation
10:50-11:20 Tea Break
11:20-11:50 Group Activity: Develop Haemovigilance Forms Presentation
11:50-12:50 Review of Quality Systems Presentation
12:50-01:00 Questions and Answers
01:00-01:40 Lunch and Prayer Break
01:40-02-00 Post-course Assessment
02:00-02:10 Remarks from the Participants (any 3)
02:10-02:20 Concluding Remarks
02:20-02:30 Certificates Distribution
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Name: ______________________________ 1. The donor questionnaire is:
a) not needed because testing for infectious agents is performed
b) important for the health of donor and patient c) needed for registration of the telephone number
of the donor d) will be proof of a successful donation
2. Syphilis screening: a) is not mandatory for Pakistan b) is always performed with an EIA technique c) is only performed in man d) is performed in order to prove existence of
Treponema Antigens
3. HBsAg: a) is not found in Hepatitis B reactive donors b) is found first in central Africa c) is a test to determine the presence of HBV core
molecules d) is an acronym for Hepatitis B Surface Antigen
4. Inadequate washing of microtest plate wells: a) will result in dirty plates during the test procedure b) is not often found with automated plate washers c) is the result of using demineralized water (distilled
water must be used) d) will result in false positive results
5. A PCR has the following steps: a) extraction, amplification & detection of DNA b) extraction, amplification & detection of RNA c) pooling, amplification & detection of DNA d) pooling, amplification & detection of RNA
6. Malaria is caused by: a) Plasmodium species b) Trypanosomes c) Leishmania species d) None of the above
7. RPR is used for the diagnosis of: a) Dengue Fever b) Malaria c) HCV d) Syphilis
8. Red Cell Concentrates in CPDA-1 (anticoagulant) can: a) be stored in a refrigerator up to 14 days b) be stored in a refrigerator up to 21 days c) be stored in a refrigerator up to 28 days d) be stored in a refrigerator up to 35 days
9. Platelet concentrates will be stored: a) in an incubator of 22-24
oC on an agitator
b) in an incubator of 22-24 oC only
c) can be stored up to 12 days d) must be used directly after production
10. p24 antigen testing is used for the diagnosis of: a) HBV chronic infection b) Plasmodium infection c) HIV/AIDS d) None of the above
11. Nucleic Acid Testing (NAT) a) is more specific than ELISA b) is out-dated c) results in high false positive results d) None of the above
12. In emergency situations: a) Blood can be issued without screening b) Blood should only be issued after screening with
ELISA/CLIA c) Blood can be issued after screening with rapid
devices (WHO approved) d) None of the above
12. A couple comes to your fertility clinic to discuss having a child. If both potential parents are group O, what blood type could their child be?
a) O b) A c) B d) AB
13. If two parents are Rh-negative, what are the possibilities for the Rh typing of their children?
a) All children will be Rh-positive b) All children will be Rh-negative c) Half of their children will be Rh-positive, half will be
Rh-negative d) 75% of their children will be Rh-positive, 25% will be
Rh-negative
5.2. Annex-B Pre- and Post-Course Assessment Questionnaire
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14. All of the following should be irradiated before they are given to an immunocompromised patient EXCEPT:
a) Whole Blood. b) Peripheral stem cell reinfusions. c) Granulocyte transfusions. d) Apheresis platelets.
15. A 14 year old boy needs a red cell transfusion. He has a documented history of IgA deficiency with a vague history of a "serious" reaction to a previous transfusion. Assuming that you have all of the following readily available in your Blood Bank, which is the best choice?
a) Irradiated RBCs b) Leukocyte-reduced RBCs c) negative whole blood d) Washed Red Cells
16. A 40 year old female loses 15% of her blood volume as a result of an accidental arterial laceration during a hysterectomy. The most appropriate immediate therapy is:
a) Crystalloids b) Colloids c) Crystalloids and packed red cells d) FFP and packed red cells
17. The reactivity of blood group A is confirmed by detecting the presence of which immunodominant sugar molecule?
a) N-acetyl-D-neuraminic acid b) L-fucose c) N-acetyl-D-galactosamine d) N-acetyl-D-glucosamine
18. Immune A and B alloantibodies differ from non-red cell stimulated (naturally occurring) A and B alloantibodies in that the immune antibodies:
a) Are generally IgG b) Are unable to cross the placenta c) Can be enhanced in reactivity by incubation at 4C d) Cause direct agglutination at room temperature
19. The ABO system is the most important blood group system in transfusion safety. Why?
a) ABO is the only blood group system in which reciprocal antibodies are normally produced for the antigens an individual lacks AND the ABO antibodies are capable of causing rapid, intravascular hemolysis
b) Reactions with ABO antibodies are the most common cause of transfusion-related death
c) Regardless of maternal and fetal ABO type, ABO antibodies are implicated in hemolytic disease of the fetus and newborn (HDFN)
d) Routine ABO forward and reverse grouping is difficult to interpret and fraught with error
20. Of the following choices, the most common source of ABO discrepancies is:
a) Bombay phenotype b) An individual who is not a secretor c) Clerical errors or a sample mix-up d) Use of an uncalibrated centrifuge
21. An ABO discrepancy between forward and reverse grouping owing to weak-reacting or missing antibodies could be BEST explained by which of the following:
a) Subgroups of blood group A b) Patients with extreme ages (the very old or the very
young) c) Acquired B phenomenon d) Antibodies to low incidence antigens or diluents
present in reagent A or B cells
22. Approximately what percentage of group A individuals could be further classified as subgroup A1?
a) 20% b) 40% c) 60% d) 80%
23. All of the following statements are TRUE regarding Hemolytic Disease of the Fetus/Newborn (HDFN) caused by ABO antibodies EXCEPT:
a) It is generally mild b) It may occur during the first pregnancy c) It is usually seen with group O mothers d) It is second in frequency to Rh HDFN
24. The minimum acceptable hemoglobin level for homologous blood donors is:
a) 11.0 g/dl b) 11.5 g/dl c) 13.5 g/dl d) 12.5 g/dl
25. It is acceptable to test a potential blood donor's hemoglobin or hematocrit by using an earlobe puncture. True False
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26. Which of the following methods for testing predonation hemoglobin levels in blood donors is MOST LIKELY to give falsely acceptable results in a donor with hyperviscosity?
a) Copper sulfate method b) Point-of-care hematology analyzers c) Spun microhematocrit d) Spectrophotometric measurement (e.g.,
"HemoCue")
27. A 20 year old female triathlete is a potential blood donor and has the following vital signs: Pulse 45, BP 100/60, respirations 14. Her hematocrit is 38%, and she weighs 112 pounds. According to current standards, which of the following is correct?
a) She should be deferred because of her hematocrit b) She should be deferred because of her pulse rate c) She should be deferred because of her weight d) She is an acceptable donor
28. What is the upper age limit for blood donation in Pakistan?
a) 60 b) 65 c) 70 d) 75
29. A regular apheresis platelet donor decides to donate whole blood on a blood drive at the mall. When is he eligible to resume platelet donation again?
a) Immediately b) Two days after the whole blood donation c) Seven days after the whole blood donation d) Eight weeks (56 days) after the whole blood donation
30. What three genes are responsible for the production of Rh antigens?
a) RHAG, RH1, and RH2 b) RHAG, DCE, and dce c) RHAG, RHD, and RHCE d) RHD, RHCc, and RHEe
31. Which of the following is TRUE regarding the weak D phenotype?
a) It usually occurs as a result of missing external parts of the D antigen
b) It may result when an allele coding for the C antigen is present on the same chromosome as one coding for D
c) It is serologically identified by a direct antiglobulin test
d) None of the above are true 32. In which of the following groups is Weak D testing required?
a) Whole Blood Donors b) Apheresis Platelet Donors c) Sickle cell anemia patients d) Cardiac surgery patients e) Answers A and B are correct f) Answers A, B, and C are correct
33. Which of the following is not a characteristic of Anti-D? a) IgG isotype b) Binds complement c) Causes Hemolytic Disease of the Fetus/Newborn
(HDFN) d) Reacts with D positive cells that have been treated
with ficin
33. Which of the following is CORRECT regarding D testing when investigating a case of HDFN and initial testing for the D antigen is negative?
a) Mother: Do not perform Weak D test; Baby: Perform Weak D test
b) Mother: Perform Weak D test; Baby: Do not perform Weak D test
c) Mother: Do not perform Weak D test; Baby: Do not perform Weak D test
d) Mother: Perform Weak D test; Baby: Perform Weak D test
34. If a patient had a positive direct antiglobulin test (DAT) with Anti-IgG, what would happen if you performed a Weak D test on the patient cells?
a) A false-positive result b) A false-negative result c) An indeterminate test result d) A valid test result
35. Leukocyte reduction is indicated for prevention of all of the following EXCEPT:
a) Febrile nonhemolytic transfusion reactions b) Transfusion-associated Graft vs Host Disease c) HLA alloimmunization d) Transmission of Cytomegalovirus (CMV) e) All of the above are prevented by leukocyte
reduction
35. The term used when blood is collected from a patient for medical reasons:
a) directed donor b) therapeutic bleeding c) recipient specific designated donation d) autologous donation
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36. Which criteria disqualifies this person from blood donation?
a) 110 lbs b) pulse = 73 bpm c) BP = 125/75 mmHg d) Hct = 35%
37. If a donor has received blood products within 12 months, why are the disqualified from donation?
a) HBV, HCV, HIV b) two cell populations c) cannot tolerate blood loss d) Hemoglobin too low
38. Which virus resides exclusively in leukocytes? a) CMV b) HIV c) HBV d) (d) HCV
39. A donor has taken 2 tablets of aspirin a day for 36 hours, which applies to his unit of blood?
a) may not be used for pooled platelet prep b) should not be collected until 36hrs after last dose c) may be used for pooled platelet prep d) RBC and FFP use is okay, but platelets need to be
discarded
40. Which does FFP not provide? a) F5 b) F8 c) F9 d) Platelets
41. Before intrauterine transfusion, what prep does the unit need to go through before transfusion?
a) Add FFP and pool-ed plasma b) Check that the RBC group in consistent with the
fathers group c) irradiate the RBCs d) Test the RBCs with neonatal eluate
42. If insufficient yield is recorded while preparing platelets and the second spin produced drastically less percent yield (60%), the best course of action would be to modify centrifugation by
a) increase time and/or rpm for first spin b) increase time and/or rpm for second spin c) decrease time and/or rpm for first spin d) decrease time and/or rpm for second spin
43. What is the result of a decrease in 2,3-BPG levels in stored blood?
a) RBC K+ increase b) RBC ability to release O2 decreases c) Plasma hgb is stabilized d) ATP synthesis increases
44. What virus is associated with a high asymptomatic carrier rate, 10% of which develop cirrhosis or hepatocellular carcinoma?
a) HAV b) HBV c) HCV d) HEV
45. The temperatre required for RBC and WB transport is: a) 0-4 b) 1-6 c) 1-10 d) -15
46. How many platelets must one unit of WB derived platelets contain?
a) 5.5e6 b) 5e8 c) 5.5e10 d) 5e10
47. The following platelet concentrations/volumes are measured: pH 6.0, 45mL; 5.5, 38; 5.8, 40, and 5.7, 41. What corrective action is needed?
a) No corrective action b) recalibrate pH meter c) increase plasma volume d) decrease plasma volume
48. A 70 kg male with a plt count of 15,000 was given 6 units of pooled platelets, what would you expect the post-transfusion platelet count to be?
a) 21-27,000/uL b) 25-35,000/uL c) 45-75,000/uL d) 75-125,000/uL
49. What is the shelf life of thawed FFP? a) 24hrs b) 5 days c) 35 days d) 1 yr
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50. What is the allowable shelf life for EDTA preserved blood products?
a) 21 days b) 35 days c) 42 days d) not approved anticoagulant
51. What is the process of removing an antibody from the RBC membrane?
a) absorption b) adsorption c) elution d) immunization
52. False negative at AHG phase of antibody screening are most likely due to:
a) excessive RBC washing b) inadequate washing of RBCs c) warm autoantibody present in patient serum d) failure to allow blood to clot properly
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5.3. Annex C Speakers’ Profile
Dr. Hasan Abbas Zaheer is Professor and Incharge Blood Transfusion Services, Pakistan Institute of
Medical Sciences. He is also the Project Director of the Blood Transfusion Programme. He has a wide
experience in Public Health Projects and Transfusion Services. He was instrumental in developing the
National Blood Policy and Strategic Framework. Earlier he has also worked as the National Programme
Manager of the National AIDS Programme formulating the National HIV/AIDS Policy. More than 20 years
of experience of teaching (pathology, hematology, transfusion medicine and public health) to
postgraduate medical students, medical technicians and public health professionals in diploma, degrees,
MPhil and Ph.D. programmes. As a researcher, he has to his credit a number of research publications on
topics of hematology, HIV/AIDS, blood transfusion and public health published in international and
national indexed journals. He is also one of the Editors of an indexed medical journal Annals of PIMS,
BMJ Open Journal, Journal of Public Health & Epidemiology and Journal of AIDS and HIV Research.
Dr. Jafar Saleem is a public health specialist. He is currently the Director, Institute of Blood Transfusion
Services, Lahore and Secretary Punjab Blood Transfusion Authority.
Dr. Zahid Hasan Ansari is Chief Pathologist at the Department of Health, Government of Sindh. He is
serving as the Secretary, Sindh Blood Transfusion Authority. Under his command, the authority has been
working considerably well covering all province. The authority has initiated registration and licensing
process and is the only authority in the country which is activated. Dr. Ansari is also heading the Blood
Transfusion Programme of the province and is working towards the system reform through his
programme. He has been active in initiating the construction work of Regional Blood Centres in his
province which are now near completion.
Dr. Muhammad Tahir Khan is Professor of Pathology at the Khyber Medical University. He is also the
Project Director of Safe Blood Transfusion Project in Khyber Pakhtunkhwa.
Dr. Saeed Ahmed is Head of the Husaini Blood Bank in Karachi, the largest NGO sector blood bank in
Pakistan with more than 150,000 donations per year. He did his MBBS from Quaid-i-Azam Medical
College, Bahawalpur and MS in Transfusion Medicine from Baqai Institute of Haematology. He is also a
certified Quality Professional from PIQC Institute of Quality, NED University of Engineering &
Technology. Dr. Saeed has a wide experience in teaching and training and has conducted several
workshops related to immuno-haematology, basic blood bank processes, TTI screening, and quality
management. He is also a Faculty Member of Husaini Institute of Haematology.
Mr. Usman Waheed is working as Technical Expert in the Safe Blood Transfusion Programme Pakistan,
which is co-funded by the governments of Pakistan and Germany. Mr. Waheed is a medical laboratory
graduate with an extensive experience in teaching and training of transfusion medicine. He has
completed a Fellowship in Transfusion Medicine from Sri Lanka and has also received post graduate
diplomas in Public Health (Pak) and Epidemiology (Lon). Mr. Waheed acquired additional trainings in
Transfusion Medicine and Quality Management from German Red Cross, Germany and Sanquin Blood
Foundation, Netherlands. He has published around 20 research papers in national and international
Journals besides authoring three handbooks related to Laboratory Sciences. He supervised the team
23
formulating the National HIV testing strategy for Pakistan and currently investigating the molecular and
genetic features of HIV in disease pathogenesis. A member of many professional bodies and
international expert working groups, Mr. Waheed is serving on Advisory Board of American Society for
Clinical Pathology and South Asian Association of Medical Laboratory Scientists.
Dr. Muhammad Arshad Malik received his PhD in Life Sciences from Tsinghua University Beijing, China
in July 2011. He has been affiliated with Microbiology & Immunology Department at University of Health
Sciences Lahore prior to going for his PhD. Dr. Arshad Malik is currently serving as an assistant professor
at Department of Bioinformatics & Biotechnology, Faculty of Basic and Applied Sciences, International
Islamic University Islamabad, Pakistan. He has a number of publications in the area of infectious diseases
and been involved in teaching Immunology, Microbiology and Cell Biology at graduate level in addition
to teaching various courses of Biotechnology to Post-graduate students. Moreover, Dr. Arshad Malik is
the Co-Author of a book entitled “Serological Techniques in Immunology” published by a US publishing
company. Main areas of interest of Dr. Arshad Malik include Emerging Infectious Diseases and their
Immunological aspects.
Mr. Muhammad Asim Ansari is a Medical Laboratory Technology graduate with Masters in Biochemistry
& Molecular Biology. He has received a number of professional diplomas/certificates during his carrier
along with the immense and diverse experience starting from a bench worker to a Manager. His core
competencies include Laboratory/Healthcare Management, LIS/HMIS domain expert, ISO Quality
Management, Infection Control and Personnel Capacity Building in Laboratory Sciences. He is a certified
ISO-15189:2007 Technical Assessor by Pakistan National Accreditation Council (PNAC) and Norwegian
Accreditation (NA). His interest in Infection Control & Health Informatics took him to the International
Federation of Infection Control (IFIC) and e-Health Association of Pakistan (eHAP) respectively as
associate member. He has written multiple manuscripts in local and international journals and was also
the co-author, with Usman Waheed, of two handbooks ‘Histotechniques’ and Clinical Microbiology for
laboratory professionals. He remained affiliated with well-reputed and known quality diagnostic
facilities and currently serving as a Manager, Pathology Laboratory and Blood Bank at a private hospital
in Islamabad.
Dr. Afrose Liaquat is graduate from Army Medical College and currently pursuing her PhD from the
Quaid-i-Azam University in Molecular Biology.
Dr. Masooma Raza, a haematologist by training is working as a Consultant Haematologist at the
Department of Pathology, PAEC General Hospital, Islamabad.
Dr. Sarfraz H. Jaffri is a Medical graduate with an immense experience in the field of transfusion
medicine. He has been working with the Husaini Blood Bank since its inception. Dr. Jaffri has remained
the Project Director of the Global Fund Blood Safety Programme and currently working as
Administrator/Consultant at the Husaini Blood Bank Karachi. He has been presenting and publishing his
research work at national and international fora. He has also contributed to the SOP Manual published
by the Safe Blood Transfusion Programme.
24
Dr. Muhammad Anwar, is Assistant Professor and Incharge Blood Transfusion Services at the largest
public sector hospital in Karachi, Jinnah Postgraduate Medical Centre.
Dr. Muhammad Saboor has done his PhD in Haematology and currently working as Assistant Professor
Haematology, Baqai Institute of Haematology, Baqai Medical University, Karachi.
Dr. Shahtaj Khan is a Haematologist by training and Head of the Department of Pathology at Hayatabad
Medical Complex, Peshawar.
Dr. Ashraf Memon is a Senior Pathologist at the Sindh AIDS Control Programme, Government of Sindh.
He got his MBBS in 1983 from University Of Sindh. He followed with a Masters in Infectious Diseases
from University of London, and MCPS in Clinical Pathology from College of Physicians and Surgeons
Pakistan. He currently supervise the laboratory work of Referral Lab at Provincial Implementation Unit
of Sindh AIDS Control Programme which is also providing pre and posttest counseling to all clients for
HIV and STDs Testing. He has to his credit more than 25 research publications in international and
national journals on virology, chemical pathology and epidemiology.
Prof. Fazle Raziq is among the senior haematologists in Peshawar. He remained affiliated with the HMC
Pathology Department as HOD and now serving as HOD Pathology at the Rehman Medical Institute.
Prof. Syed Muhammad Irfan is a senior Hematologist working as Professor and Head of Hematology at
Liaquat National Hospital, a 750 bed tertiary care hospital in Karachi. He is also the visiting Faculty at
Dow University of Health Sciences (DUHS), Karachi, Pakistan. He was trained at Aga Khan University
Hospital and holds fellowship in hematology from Pakistan and is also a fellow of American College of
Physicians. He has also worked at King Faisal Specialist Hospital, Riyadh, Saudi Arabia. Dr. Irfan is
member of American Society of Hematology (ASH), European Hematology Association (EHA) and
International Society of Blood Transfusion (ISBT). He has been member CIBMTR (USA), working party on
non-malignant hematological disorders and EMBMT working party on chronic leukemia. He is supervisor
and examiner for FCPS and MRCGP. He has more than 20 publications in National and International
Journals. He made numerous presentations at different at different forums. He writes regularly on
health issues in National News papers. His professional interests are Chronic Leukaemias, Immune
thrombocytopenic purpura (ITP), Thalassaemia management and Clinical blood transfusion.
Dr. Muhammad Usman has done his PhD in Haematology and currently working as Associate Professor
Haematology, Baqai Institute of Haematology, Baqai Medical University, Karachi.
Mr. Muhammad Khalid is working as Secretary of the Blood Transfusion Authority in Khyber
Pakhtunkhwa.
Dr. Zarmina Hussain is working as Inspector of the Blood Transfusion Authority in Khyber Pakhtunkhwa.
She has completed FCPS in Haematology.
Dr. Rashid Azeem is working as Inspector of the Blood Transfusion Authority in Khyber Pakhtunkhwa. He
has completed FCPS in Haematology.
25
5.4. Annex D News Cuttings
26
5.5. Annex E Quality Control Documents
Quality Control of Anti Sera
A1 Cells B Cells O Cells A1 Cells B Cells O Cells
Lot No:
Date of Manufacture
Date of Expiry
Date of Receiving
Date of Testing
Parameter Specification A1 Cells B Cells O Cells A1 Cells B Cells O Cells
Colour Red
Supernatant Clear
Mac. Clumps Negative
Mic. Agglutinations
Negative
Rouleaux Negative
PCV 2-5%
Reactivity
A1 Cells B Cells O Cells A1 Cells B Cells O Cells
Anti A Expected Results >/=2 Negative Negative >/=2 Negative Negative
Observed Results
Anti A1 Expected Results >/=2 Negative Negative >/=2 Negative Negative
Observed Results
Anti B Expected Results Negative >/=2 Negative Negative >/=2 Negative
Observed Results
AB Serum Expected Results Negative Negative Negative Negative Negative Negative
Observed Results
Performed by
Remarks
Authorized by
27
Quality Control of Blood Bag Shaker
Blood bag shakers are used to mix the incoming blood from the blood donor with the anticoagulant
CPDA1. The speed of the shaker varies from 10 rpm to 40 rpm. There should be homogenous mixing /
color of the blood. Normally 400-550 ml blood is collected (depending on the bag) within 8-12 minutes.
If whole blood is collected in more than 15 minutes then fresh plasma should not be separated for
making FFP, in such cases only packed red cells and platelets should be separated from collected whole
blood.
Date Shaker Speed Proper mixing of blood Yes / No
(homogenous color)
Alarm (optional)
Sign.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
Corrective and preventive action: _______________________________________________________ ___________________________________________________________________________________ Supervised By: ____________________________ Date: _________________
28
Safe Blood Transfusion Programme
Document Title
Blood Bank Agitator Temperature Record Form
Document No. Revision No: 0 Effective Date: __/__/2014 Page1 of 1
Equipment Brand/Model: Location:
Equipment Code no: Month:
Acceptable Temperature range: 200C - 240C Correction Factor (if any): Digital ……………Manual …………… (Add this value to the reading, before recording)
*In case of temperature deviations, inform quality manager.
Date 9 am 3 pm 9 pm Remarks
Digital Temp.
Manual Temp.
Sign Digital Temp.
Manual Temp.
Sign Digital Temp.
Manual Temp.
Sign
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
29
Safe Blood Transfusion Programme
Document Title
Blood Bank Freezer Temperature Record Form
Document No. Revision No: 0 Effective Date: ___/___/2014 Page1 of 1
Equipment Brand/Model: Location:
Equipment Code No: Month:
Acceptable Temperature range: < - 20O C < - 30O C < - 60O C other ____________ Correction Factors (if any): ………………………. (Add this value to the reading before recording)
Date 9 am 3 pm 9 pm Remarks/Action*
Digital Temp
Sign Digital Temp
Sign Digital Temp
Sign
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31 *In case of Temperature deviations, inform quality manager.
30
Safe Blood Transfusion Programme
Document Title
Blood Bank Refrigerator Temperature Record Form
Document No. Revision No: 0 Effective Date: __/__/2014 Page1 of 1
Equipment Brand/Model: Location:
Equipment Code no: Month:
Acceptable Temperature range: 020C - 060C Correction Factor (if any): Digital ……………Manual …………… (Add this value to the reading, before recording)
*In case of temperature deviations, inform quality manager.
Date 9 am 3 pm 9 pm Remarks
Digital Temp.
Manual Temp.
Sign Digital Temp.
Manual Temp.
Sign Digital Temp.
Manual Temp.
Sign
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
31
Blood Components Quality Control
Blood Component Parameter Specification Result
Red Cell Concentrate (RCC)
Volume 230-330ml
%Hct 55-75%
Hb >45g/unit
pH 6.4-7.4
Haemolysis at EOS <0.8%
Sterility Sterile
Blood Component Parameter Specification Result
Platelet Concentrate (PC-PRP)
Volume 45-65ml
Swirling Present
Platelet count >55x109/unit
RBC count <1x109/unit
pH 6.4-7.4
Sterility Sterile
Blood Component Parameter Specification Result
Platelet Concentrate (PC-AP)
Volume 150-300ml
Swirling Present
Platelet count >1000x109/L
RBC count <1x109/unit
WBC count <1x109 / unit
pH 6.4-7.4
Sterility Sterile
Blood Component Parameter Specification
Fresh Frozen Plasma (FFP)
Volume 150-250 ml
F VIII >0.7/ml
Fibrinogen >300mg/unit
Cryo precipitate (Single Donor Pack)
Volume 45-55ml
F VIII >240 IU
Fibrinogen >450mg/unit
32
Copper Sulphate Working Solution Quality Control Preparation of CuSO4.
1. Stock Solution: Take 17 grams of CuSO4 (blue) and gradually mix in 1000 ml distilled water. 2. Working Solution: Take 51 ml of stock solution and mix in 49 ml distilled water. Adjust specific gravity to 1.053 by adding stock solution or distilled water. Q-C of CuSO4. Physical quality: Check the copper sulphate solution against a light source for the presence of any precipitate/cloudiness. If it is cloudy/have precipitates then discard the solution. Specific gravity & working quality. Check specific gravity of the working solution by refractometer. It should be 1.053 which corresponds to haemoglobin of 12.5gm/dl.
Volume of CuSO4 working solution should be sufficient i.e. at least 50-60 ml to allow the drop to fall approximately 3 inches down. The drop of blood will sink to the bottom within 15 seconds if the donor haemoglobin value is more then 12.5gm/dl. If the donor value is less then 12.5gm/dl then the drop of blood will not sink to the bottom. Note: Change the solution after every 25 tests or if it is grossly turbid. The solution should be kept tightly in a container to prevent it from evaporation. The solution should be kept at room temperature or brought to room temperature before use. Used solution should consider as bio-hazard and discarded as per our policy. Working solution should be prepared on daily basis.
Q-C Date Technician
Name
Date of CuSO4
Preparation
Specific Gravity
(1.053)
Control / Known Hb
level
Drop of blood Sink (Pass) Float (Fail) Pass / Fail
Supervised by_________________ Date____________
33
Donor History Questionnaire
Have you donated blood before? If yes, when? •Yes •No
Have you received blood before? If yes, when? •Yes •No
Any history of recent travel abroad? If yes, specify country. •Yes •No
Present medication history? If yes, specify name? •Yes •No
Any history of jaundice? •Yes •No
Any history of high blood pressure or heart disease? •Yes •No
Any history of tuberculosis in the past? •Yes •No
Any history of unexplained prolonged fever? •Yes •No
Any history of unexplained weight loss? •Yes •No
Any history of dental treatment? •Yes •No
Any history of recent vaccination? •Yes •No
Any history of kidney, liver disease or epilepsy? •Yes •No
Any history of blood disorder or other illness (specify)? •Yes •No
Any history of surgery? •Yes •No
Any history of medical or surgical diagnostic procedure? •Yes •No
Any history of shaving from the barber? •Yes •No
Any history of treatment from Hakeem, homeopath or a
paramedic? •Yes •No
Are you feeling well today? •Yes •No
Do you know the patient? •Yes •No
34
Quality Control of Empty Blood Bags
Single, double and triple blood bags are used for collection of whole blood from the blood donor. JMS
company blood bags contains 70 ml CPDA1 anticoagulant which is sufficient for collection of 500 ml +
10% whole blood while Terumo bags contains 63 ml CPDA1 which is sufficient for collection of 450 ml +
10% whole blood. After opening the aluminum foil the blood bags should be used within 14 days (or
follow manufactures advice). Before issuance of blood bag, each bag should be looked for its quality.
The blood bag needle should be properly sealed, there should be no leakage and they should be within
expiry date. QC of atleast one bag should be checked in each shift.
__________ Month _____ Year
Date Company Name
Bag Type
Needle seal
(Yes / No)
Leakage
(Yes No)
Anticoagulant Transparency
Yes / No
Lot # Expiry Date
Sign.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
Technician: ____________________________ Date: ________________
Supervised By: _________________________ Date: ________________
35
Gel Card Centrifuge Machine Quality Control
Quarterly the centrifuge time and speed should be checked by the company.
Further for Negative control the gel column should contain no red cells and all cells should be
settled down clearly.
Positive control the agglutinate should entrap on the top of the gel column.
Centrifuge time is fixed for 10 minutes and alarm should buzzer after 10 minutes of
centrifugation.
Negative Control: Take 50 ul of 1% O Positive red cell suspension and centrifuge at machine
fixed speed (910 rpm OR 1030 rpm) and time (10 minutes). After centrifugation all the red cells
should settled down clearly.
Positive Control: Take 50 ul of 3% Check Cells and centrifuge at machine fixed speed (910
rpm OR 1030 rpm) and time (10 minutes). After centrifugation all the red cells should entrapped
at the top of the gel column clearly.
Year __________
1. 1st January: ______________
2. 1st April: _________________
3. 1st August: _______________
4. 1st December: ____________
Sr. No. Date Negative Control Positive Control Technologist 1. 2. 3. 4.
Date Corrective & Preventive Action Technologist
Supervised By: ____________________
36
Hospital Transfusion Committee Terms of Reference
Background: Blood should be transfused only when the clinical benefits are more important
than the potential risks, i.e. adverse transfusion reactions. The main purpose of establishing a
Hospital Transfusion Committee is to promote rational use of blood and blood safety in
hospitals.
Terms of Reference:
1. To ensure safe procedures in V2V transfusion chain. 2. To develop policies for the use of blood and blood products. 3. To ensure the dissemination and implementation of national guidelines on Clinical Use
of Blood to avoid unnecessary transfusions and rational use of blood. 4. To promote best practice through local protocols based on national guidelines. 5. To set up a surgical blood ordering schedule and also regularly review it. 6. To ensure that adverse transfusion events/reactions are investigated and corrective
actions are taken. 7. To ensure that adverse transfusion events/reactions are reported to the haemovigilance
system. 8. To support training and education in Clinical Use of Blood. 9. To promote audits of the use of blood components. 10. To consider the legal implications of clinical transfusion practice. 11. To address issues relating to patients’ religious and cultural choices. 12. To be aware of factors which might affect short and long term demands for blood. 13. To promote techniques such as Autologus Transfusion for preventing the use of donor
blood. 14. To support the blood bank to optimize stock management. 15. To communicate with internal and external quality assurance bodies (if necessary)
regarding transfusion quality assurance matters. 16. To monitor the blood transfusion budget and maintain a cost effective service.
Frequency of Meetings: Meetings may be held on quarterly or bi-annual basis.
Membership:
Medical Superintendent
Haematologist
Clinician from major specialties consuming blood products
Nursing Head
Pharmacist
Blood Bank Incharge
37
Date PT INR aPTT PT 1 9.4 0.89
Mean 9.71 Mini 8.00
Electrolytes QC Values
2 9.3 0.88
SD 0.57 Max 11.42
QC Test Mean Ranges (2SD)
3 9.3 0.88
3SD 1.71
PNU
Na 128 120 - 136 4 9.3 0.88
K 3.70 3.1 - 4.3
5 9.4 0.89
Cl 88 80 - 96 6 9.4 0.89
Calcium
7 10.2 0.96 26.8
PPU
Na 150 144 - 156 8 9.4 0.89
K 6.90 6.30 - 7.50
9 9.3 0.88
Cl 115 109 - 121 10 9.4 0.89
Calcium
11 10.4 0.98 12 10.5 0.99 13 10.9 1.03 Mean 9.71 0.92 SD 0.57 0.05
38
BLOOD DONOR VIGILANCE FORM
Name:_________________________________ Age/Sex:_______________ DV No: _________________
Donation Date:___________________________ Donation type: Replacement Voluntary
Donor Hb(g/dl): ____________Donor Weight (kg): ___________ Donor Height (cm):_________________
Frequency of Donation: First time No. of earlier donations ____________________________
Reaction began at:___________Reaction ended at:___________ Reaction recovery time: ____________
Type of Reaction (Mark all sign and symptoms)
1. Vasovagal 2. Systemic Allergic Reaction/Anaphylaxis
Cold extremities/Chills Anxiousness, restlessness
Convulsions Arrhythmia
Feeling of warmth Cyanosis
Hypotension Generalized hives
Lightheadedness/Dizziness Generalized rash
Urination/Loss of bladder/bowel control High blood pressure
LOC < 60 seconds Laryngeal edema with stridor (noisy breathing)
LOC > 60 seconds Low blood pressure
Nausea/Vomiting Pulmonary edema
Pallor (pale skin or lips) Rapid pulse
Rapid pulse Slow pulse
Slow pulse Scratchy feeling in throat
Sweating Shortness of breath
Tetany Sneezing and nasal congestion
Twitching Swollen throat, tongue, eyes, and face
Weakness Wheezing
3. Hyperventilation 4. Medical Emergency
Cardiac 5. Local Site Reaction Respiratory
Itching at insertion or bandage site Stroke
Rash/hives at insertion or bandage site
Redness at insertion or bandage site
Single prick Double prick
Bruising
Haematoma
Vital Signs (VS)
Time BP Pulse Position
Pre-donation Lying down
Post-donation Lying down
Vital signs are required in Vasovagal, Anaphylaxis, Hyperventilation, and Medical Emergencies
Deferral Yes No if Yes, Temporary Permanent
Donation taken by: _____________ Reaction reported by: _____________________ Date:
_____________
39
Hepatitis B: Reactive/Non-Reactive Hepatitis C: Reactive/Non-Reactive HIV:
Reactive/Non-Reactive
Reported by: Date:
Transfusion - related Adverse Reaction Notification Form
Patient Details
Patient PCN: Age: Gender:
Name: City:
Father Name:
Hospital:
Ward:
Physician:
Date of transfusion / / Time transfusion started am / pm
Time adverse reaction noticed am / pm Volume transfused mL
Blood Components Red Cells Platelets Fresh Frozen Plasma Cryoprecipitate
Washed Red Cells
Transfused Blood Bag number.
Patient’s diagnosis & other
relevant medical/surgical
history
No of earlier transfusions
Affected Siblings (write number) Cousin Marriage Yes / No
Pre transfusion: Temp: Pulse: BP:
Post transfusion: Temp: Pulse: BP:
Please circle relevant symptoms listed below & provide details
Febrile: Chills / Rigors / Flushing Temperature rise: oC
Allergic: Urticaria Isolated / Extensive Non-urticarial rash
Respiratory: Dyspnoea / Wheeze / Stridor / Cough / Hypoxaemia
Circulatory: Hypertension / Arrhythmia / Hypotension / Bradycardia / Tachycardia
Pain: Chest / Abdominal / Infusion site / delayed Pain in Arm / Other:
Restlessness / Anxiety Red urine: Yes / No / Unknown
Pricks Single Double Multiple Haematoma Yes No
Cannula blockage Yes No Bruising Yes No
Comments/other signs and symptoms::
Outcome
Un-eventful transfusion Mild complications Severe complication Transfusion incomplete
40
Blood Bank Centrifuge / Serofuge Quality Control Centrifuge No. ______________ Six monthly speed and time of the centrifuge should be checked with respect to cell button which should be round in immediate spin, supernatant fluid clear, no free cells and cell button should be easily be dispersed. In washing phase cell trailing should be present, smooth settlement of the cells and supernatant fluid should be clear.
Date Speed
3200
RPM
Time
Immediate
Spin 15 sec.
Washing
Phase 120
Sec.
Cell Button:
Round /
Irregular
Immediate
Spin / DAT
Phase)
Supernatant
Fluid:
Clear / Turbid
(Immediate
Spin / DAT
Phase)
Cell Button Easily
Dispersed:
Yes / No
(Immediate Spin
/ DAT Phase)
Cell Trailing:
Present /
Absent
(Washing
Phase)
Tech:
Corrective & Preventive action: ______________________________________________
Supervised By: _______________ Date: ____________
41
5.6. Annex F Certificates Design
42
5.7. Annex G Shield Design
43