Table of Contents - WHO | World Health Organization Syed Sajid Hussain Shah, Bilal Ahmed Tareen, Kamran Khan, and Usman Waheed, deserve special appreciation for their hard work and

0

1

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

2

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

3

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.

4

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

5

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.

6

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.

7

8

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.

9

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.

10

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.

11

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.

12

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)


0

20

40

60

80

100

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 32 33 34 35 36

Pre Post

0

20

40

60

80

100

1 2 3 4 5 6 7 8 9 10111213141516171819202122232425262728293031323334353637383940

Pre Post

13

4.3. Workshop 3 (Bahawalpur)


4.3. Workshop 4 (Peshawar)


0

20

40

60

80

100

1 2 3 4 5 6 7 8 9 10111213141516171819202122232425262728293031323334353637383940

Pre Post

0

20

40

60

80

100

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55

Pre Post

14

5. ANNEXES

15

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 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

16

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


02:00-03:00 Quality Control in Immunohaematology Practical


03:10 Conclusion of WS Day 2

Time Subjects Workshop Day 3 Format Actor


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



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

17

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

WHO/SBTP Workshop on Quality Management in Blood Transfusion Services

18

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


19

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


20

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


21

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


22

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


Document Title

Blood Bank Freezer Temperature Record Form

Document No. Revision No: 0 Effective Date: ___/___/2014 Page1 of 1


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


Document Title

Blood Bank Refrigerator Temperature Record Form

Document No. Revision No: 0 Effective Date: __/__/2014 Page1 of 1


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


Platelet Concentrate (PC-PRP)

Volume 45-65ml

Swirling Present

Platelet count >55x109/unit

RBC count <1x109/unit

pH 6.4-7.4

Sterility Sterile


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