Dear Experts,

There are 2 more questions from Ms. Keti Shermadini.

Please find it below:

1. There are no clear guidelines in the European blood directives regarding reporting SAR among donors unless this affects the quality and safety of the blood product. What rules exist in the Netherlands and Lithuania regarding SAR and SAE among donors?

2. What are the routes for reporting SAR and SAE? Does the hospital blood bank report SAE and SAR also to the blood establishment along with reports to the competent authority?

Best Regards,

Keti

Keti Khizanishvili

RTA Assistant

Twinning Project Strengthening Blood Safety System in Georgia

Mob: (+995) 599 155 002

On Tue, Jun 30, 2020 at 11:29 AM Keti Khizanishvili <keti.khizanishvili@gmail.com> wrote:

Dear Experts,

below are additional questions from NCDC representatives regarding NCA functioning in European countries, particularly, in Lithuania and the Netherlands:

1. Detailed information about the body which provides license and inspects blood establishments:

     - How many staff works in the mentioned body? 

     - Do the same people work on licensing and also perform inspections of BE?

     

2. Is the National Competent Authority in each country an independent body or the entity under the Minister of Health?

3. How many licensing decisions are taken a year by NCA? 

     - Does the NCA in your country have developed a main (framework) document based on which inspection is conducted?

    - what time is necessary for performing inspections of Blood Establishments? and how many people make inspection?

    - Which aspects are particularly inspected?

4. You mentioned that inspection is conducted once in 2 years. In the period between inspections are conducted, what are other duties/tasks of NCA inspectors? Do they inspect documents? particularly, what issues are focused on during document inspection?

5. In the transition period in the Netherlands, when 23 banks were operating and finally they were merged and united under the Saquin umbrella, what was specifically inspected and what was the frequency in inspection?

6.  Please share the Standards based on which the inspections are performed in the following areas:   

    - donor selection, 

     - blood collection, 

     - testing, 

     - processing, 

     - storage and distribution

Thank you and looking forward to meeting you online,

Best Regards,

Keti Khizanishvili

   

 

On Tue, Jun 30, 2020 at 7:08 AM Keti Khizanishvili <keti.khizanishvili@gmail.com> wrote:

ძვირფასო კოლეგებო,

დღეს, 30 ივნისს, 14:00 სთ-ზე ჩატარდება 4.1.1 აქტივობის (ევროპული რეგულაციების ანალიზი ეროვნული კომპეტენტური ორგანოს მოწყობის შესახებ) დასკნითი სესია კითხვა-პასუხის რეჟიმში. გთხოვთ, თქვენი კითხვები ექსპერტებთან გამოგვიგზავნოთ არაუგვიანეს 12:00 სთ-ზე. ონლაინ შეხვედრის ხანგრძლივობა იქნება დაახლოებით 1 საათი.

ონლაინ ჩართვისთვის გთხოვთ, გამოიყენოთ ეს ბმული

ttps://ncdcportal.3cx.net/open/3d32fe9ffa0a9aa51359beef8a3f2badc6c0ef37   

პატივისცემით,

ქეთი

---------- Forwarded message ---------
From: Keti Khizanishvili <keti.khizanishvili@gmail.com>
Date: Mon, Jun 29, 2020 at 12:45 PM
Subject: Closing session of Activity 4.1.1
To: Elene Godziashvili <e.godziashvili@ncdc.ge>, Anzor tchavtchavadze <atchavtchavadze@moh.gov.ge>, Ekaterine Adamia <eadamia@moh.gov.ge>, kuchuloria.tatia@gmail.com <kuchuloria.tatia@gmail.com>, turkia babilina <bturkia@yahoo.com>, Smid, Martin <M.Smid@sanquin.nl>, <agne.kaminskiene@kraujodonoryste.lt>, Algirdas Gri <algirdasgris@gmail.com>, Kakhaber Dvalidze <kakha99@gmail.com>

Dear Georgian experts,

Tomorrow a closing session of Activity 4.1.1 will be held. I would like to ask you all to prepare your questions for our experts and discuss them on-line.

The online meeting will be held on June 30, 2020, Tuesday at 14:00 (Georgian time). The meeting will include only questions and answers, that will last about 1 hour. 

Please, use the link below for the teleconference.

https://ncdcportal.3cx.net/open/3d32fe9ffa0a9aa51359beef8a3f2badc6c0ef37 

Best Regards,

Keti Khizanishvili

RTA Assistant

Twinning Project Strengthening Blood Safety System in Georgia

Mob: (+995) 599 155 002