Country report ATMC 7 Guidance questionnaire
This will be presented orally (10mn for each part and
in the corresponding session

Session 1 (Day 1)

1. Do you have a nationally coordinated blood transfusion service (BTS)? Please indicate if it is defined by a legal text and when it has been promulgate?
   
2. Do you have a national policy? If yes, Please, indicate when it have been approved and by whom?
   
3. Is there any legal text which defined blood collection? Please indicate if it mentions that blood donation must be voluntary and non remunerated?
   
4. Is the BTS national coordinate and centralized?
   
5. Is the BTS has its own budget? Please indicate the total amount of the budget for the last year
   
6. Is there a guideline for the rational use of blood to reduce unnecessary transfusions and minimize the risks associated with transfusion?
   
7. Is there a national blood regulatory authority for inspection and licensing of blood transfusion facilities?

Session 2 (Day 2)

1. Is there a Heamovigilance system in place?
   
2. Is there any legal text which regulates the system? When it has been promulgate? And, by whom?
   
3. Is it mandatory to report incident linked to the blood transfusion?
   
4. To whom the incident must be reported?
   
5. Please indicate the number of incident reported last year
   
6. Do you think that a heamovigilance network for the Arab countries could be implemented?
   
7. If such a system could be implemented do you think that you can provide information linked to the blood transfusion?
   

Session 3 (Day 3)

1. Is there a national screening policy that defines national requirements for the screening of all whole blood and apheresis donations for transfusion-transmissible infections.
   
2. Are all whole blood and apheresis donations screened for evidence of infection prior to the release of blood and blood components for clinical or manufacturing use.
   
3. Is the screening of all blood donations mandatory for the following infections and using the following markers: HIV-1 and HIV-2: screening for either a combination of HIV antigen-antibody or HIV antibodies Hepatitis B: screening for hepatitis B surface antigen (HBsAg) Hepatitis C: screening for either a combination of HCV antigen-antibody or HCV antibodies Syphilis (Treponema pallidum): screening for specific treponemal antibodies
   
4. Is there a national programme for blood screening which defines the strategy for screening, with algorithms that define the actual testing processes?
   
5. Is there a national system for the evaluation, selection and validation of all assays used for blood screening?
   
6. Are all assays used for blood screening have a sensitivity and specificity that approach 100%?
   
7. Is a quality-assured serological screening of all donations in place?
   
8. Is there a national procurement policy and supply system to ensure the quality and continuity of test kits, reagents and other consumables required for the screening of all donations?