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برنامج إدارة جودة المختبرات

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date_gregorian=2023-06-20 date_hijri=1444-12-02 document_type=guide entity=language:ar entity=format:application/pdf language=en taxonomy_l1=health taxonomy_l2=healthcare_system taxonomy_l3=health_infrastructure validity_confidence=0.0
5497-313-36-Wh1wYqyR6Z66k9yaEP+ylg==-6/20/2023 50:28:35-AG4Wh1wYqyR6Z66k9yaEP+ylg==-6/20/2023 10:28:35 AM
اداره الخدوات الطبيه
Medical Services Administration
رؤيه جامعه جده
الجامعه السعوديه الحديثه
NEW SAUDI UNIVERSITY VISION
2014
جامعه جده
University of Jeddah
(059)
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<table><tr><td colspan="3">Policy Title: Lab Quality Management Program.</td></tr><tr><td>Department/Unite: Laboratory Unit.</td><td>Policy Number: UOJ-MSA-LB-P/01</td><td>Replaces No.:</td></tr><tr><td>Creation Date: 10/11/2022</td><td>Effective Date:</td><td>Review Date:</td></tr></table>
Revision History
<table><tr><td>Subject</td><td>Changes made</td><td>Done by</td><td>Revision date</td></tr><tr><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td></tr><tr><td></td><td></td><td></td><td></td></tr><tr><td colspan="4">5497-313-36-Wh1wYqyR6Z66k9yaEP+ylg==-6/20/2023 10:28:35 AM</td></tr><tr><td></td><td></td><td></td><td></td></tr></table>
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Page 1 of 4
Enc:
المرافقان
Date:
اللات بن
Ref.: [UOJ-
-MSA-LB-P/01]
العربيه السعوديه - الجزاير
@Uoifjeddah
www.uj.edu.sa
+966 12 2334444
identity@uj.edu.sa
Kingdom of Saudi Arabia - Ministry of Education
P.O. Box 80327 Jeddah 21589 21589 80327
5497-313-36-Wh1wYqyR6Z66k9yaEP+ylg==-6/20/2023 5497833-A64Wh1wYqyR6Z66k9yaEP+ylg==-6/20/2023 10:28:35 AM

5497-313-36-Wh1wYqyR6Z66k9yaEP+ylg==-6/20/2023 50:28:35 AM
اداره الخدمات الطبيه
Medical Services Administration
رؤيه جامعه جده
الجامعه السعوديه الحديثه
NEW SAUDI UNIVERSITY VISION
2014
جامعه جده
University of Jeddah (059)
1. CONDITIONS: 1.1 All Lab Staff.
2. PURPOSE: 2.1 Ensure conformance to the requirements of patients and physicians who are the ultimate laboratory users or customers.
2.2 Ensure implementation of all quality laboratory processes, their assessment, improving and planning.
3. DEFINITIONS: 3.1 Conformance: means commitment of all laboratory personnel to the requirements and elements of quality assurance program.
3.2 Organization: The laboratory is a department in the center organization system that is headed by lab director and lab technicians running all laboratory processes constitute the skeleton of laboratory chart.
3.3 IPT: Internal Proficiency Testing.
4. Related 54 N/A-36-Wh1wYqyR6Z66k9yaEP+ylg==-6/20/2023 10:28:35 AM
Documents:
5. POLICY: 5.1 All quality laboratory processes should be documented.
5.2 This includes all processes and sub-processes that take place from time of initial
laboratory request for a test to the time of its final interpretation. lg==-6/20/2023 10:28:35 AM
5.3 must give attention to the most procedures susceptible to error.
5.4 Any error in specimen's acquisition, processing, analysis and reporting will invalidate the lab results and allow the lab to fall short of its quality.
5.5 The Laboratory must have adequate space for equipment, materials, supplies, stuffing, supervision and budgetary resources.
5.6 All personal in the laboratory must be committed to and be key person in enforcing quality.
5.7 All line workers in the processes and sub-processes must be technically competent for high quality services.
5.8 All members of the lab must have educational background and experience in all laboratory processes.
Page 2 of 4
Enc: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
Kingdom of Saudi Arabia - Ministry of Education
P.O. Box 80327 Jeddah 21589 21589 80327
P.O. Box 80327 Jeddah 21589 21589 80327

5497-313-36-Wh1wYqyR6Z66k9yaEP+ylg==-6/20/2023 50:28:35 AM
اداره الخدوات الطبيه
Medical Services Administration
رؤيه جامعه جده
الجامعه السعوديه الحديثه
NEW SAUDI UNIVERSITY VISION
[Non-Text]
2014
جامعه جده
University of Jeddah
(059)
5.9 Problem solving mechanisms must be implemented to have a feedback loop that responds to an error signal, reduce its size and prevent its recurrence.
5.10 Pre-analytical variables should be controlled.
5.11 Quality control programs must be enforced and followed strictly.
6. PROCEDURES:
6.1 control of pre-analytical variables:
6.1.1 Test requests and samples are monitored according to patient file in the medical data management system.
6.1.2 Patients are prepared before specimen collection according to the test requested by the physician.
6.1.3 Patients should identify by phlebotomist before specimen collection.
6.1.4 Specimen acquisition (collection, transport and TAT) is documented and monitored periodically to ensure compliance.
6.2 Control of analytical process:
6.2.1 Instrument daily, weekly, monthly and biannually maintenance should have followed strictly.
6.2.2 Records of maintenance should have filled.
6.2.3 Daily calibration if required or as requested to monitor machine performance and to ensure good standard curve.
6.2.4 Avoid specimen mix-up and incorrect volume of specimens.
6.2.5 Run QCs daily to monitor the reagents and kits used as in IPT policy.
6.3 Control of post-analytical:
6.3.1 Refer to result reporting policy.
7. RESPONSIBILITIES:
7.1 All members of the laboratory are responsible for implementation of the program each one in his site of work.
8. Appendix:
N/A
9. REFERENCES:
9.1 Tietze clinical chemistry 2008.
Page 3 of 4
Enc:
المرافقان
Date:
اللات
Ref.:
UOJ-MSA-LB-P/01
العربيه السعوديه - الجزاير
©
©
@uofjeddah
©
www.uj.edu.sa
©
+966 12 2334444
©
identity@uj.edu.sa
العربيه السعوديه - الجزاير
Kingdom of Saudi Arabia - Ministry of Education
P.O. Box 80327 Jeddah 21589 21589 80327 80327
5497-313-36-Wh1wYqyR6Z66k9yaEP+ylg==-6/20/2023 5497833-A64Wh1wYqyR6Z66k9yaEP+ylg==-6/20/2023 10:28:35 AM

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اداره الخدمات الطبيه
Medical Services Administration
رؤيه جامعه جده
الجامعه السعوديه الحديثه
NEW SAUDI UNIVERSITY VISION
2014
جامعه جده
University of Jeddah (059)
Prepared By: yR6Z66k9yaEP+ylg==-6/20/2023 549783 Recommended By: 66k9yaEP+ylg==-6/20/2023 10:28:35 AM
Name: Mrs. Noura AlSattami
Position: Quality Representative, laboratory Unit
Date: 10/12/2022
Signature:
Name: Mrs. Ahlam Alrefai
Position: Supervisor, Quality&Patient Safety Unit
Date:
Signature:

Reviewed By:
Name: Dr. ALmonther Hershan
Position: Supervisor, laboratory Unit
Date:
Signature:

Approved By:
Name: Dr. Mansour Tobaigy
Position: Supervisor, Medical Services Administration
Date:
Signature:
Reviewed By:
Name: Dr. Eman Balbaid
Position: Supervisor, General Clinics
Date:
Signature:

5497-3 Signature: WYqyR6Z66k9yaEP+ylg==-6/20/2023 5497833-A64WH1wYqyR6Z66k9yaEP+ylg==-6/20/2023 10:28:35 AM
5497
Page 4 of 4
Enc:
المرققات:
Date:
الترجمه
Ref.: [UOJ-
J-MSA-LB-P/01]
العربيه - ارسه- سوريه - واراثه- الممالكه
Kingdom of Saudi Arabia - Ministry of Education
P.O. Box 80327 Jeddah 21589 21589 80327
©
0
@uofjeddah
[Non-Text]
www.uj.edu.sa
[Non-Text]
+966 12 2334444
[Non-Text]
identity@uj.edu.sa
الاملكه العربيه السعوديه - الجزاير الحالي
Kingdom of Saudi Arabia - Ministry of Education
P.O. Box 80327 Jeddah 21589 21589 80327
(1) 2017年1月1日，公司召开2017年第一次临时股东大会，并通知全体董事。
(1) 2017年1月1日，公司召开2017年第二次临时股东大会，并通知全体董事。