Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬

Ministry of Health ‫وزارة الصحة‬

Directorate of Health Affairs ‫المديرية العامة للشئون الصحية‬
Northern Border Region ‫بمنطقة الحدود الشمالية‬
Regional Laboratory & Blood Bank ‫المختبر أالقليمى وبنك الدم‬
Northern Border Regional Lab & Blood Bank
‫المختبرأألقليمى وبنك الدم بمنطقة الحدود الشمالية‬
BLOOD BANK INTERNAL AUDIT

COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD BANK

INSPECTION CHECKLIST

REGULATIONS Are records of all proficiency testing FM PM N/A Comment

PROFICIENCY results, including interpretations,
TESTING maintained?
Are proficiency testing results
periodically reviewed and evaluated by
the blood bank director?
QUALITY Does the blood bank have quality control √ Not updated as
MANAGEMENT and quality assurance programs which are per last update
in compliance with the rules to ensure that with reference
blood and blood components, reagents Saudi FDA
and equipment perform as expected?
Do the SOP manuals contain all policies √ √ Maintaince and
and procedures developed for use? biomedical
maintainence not
updated
Is there evidence of validation of all √
methods used by the blood bank?
Does the blood bank have a process for √ Architect HIV, no
qualifying critical equipment prior to regaent lot number
validation
initial use? Is there evidence of
qualification and validation for all critical
equipment including the FDA-cleared
devices?
Are new or changed SOPs validated √
before implementation?
Is there evidence of periodic evaluation of √
reagents and equipment including the date
of performance?

1
 Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
Ministry of Health ‫وزارة الصحة‬
Directorate of Health Affairs ‫المديرية العامة للشئون الصحية‬
Northern Border Region ‫بمنطقة الحدود الشمالية‬
Regional Laboratory & Blood Bank ‫المختبر أالقليمى وبنك الدم‬
Northern Border Regional Lab & Blood Bank
‫المختبرأألقليمى وبنك الدم بمنطقة الحدود الشمالية‬
Are QC results for reagents and √ Some QC for
equipment reviewed and documented? architect not
signed for
reviewal
Are equipment problems documented, √ IT maintenance
investigated and resolved? Is there a not present process
process for removing equipment from
service and reporting to manufacturer
when indicated?
Does the blood bank have a process √
for scheduled monitoring and
preventive maintenance for
equipment which includes: frequency
of checks, check methods, acceptance
criteria, and actions to be taken for
unsatisfactory results?
Is there evidence of periodic evaluation to √
determine that policies and
procedures are
appropriate and are followed?
√
Does the blood bank have a process for
reviewing and approving new and revised
SOPs?
√ Forms not present
Does the blood bank use only current
ÖVR”
SOPs, forms and valid documents?
Is there evidence of adequate and timely √ Maintainence
corrective action for malfunctions, failures process needs to
or adverse events? be revised
No enough data of
adverse events
could be retrieved
ERRORS AND When components are improperly tested, FM PM N/A
ACCIDENTS not tested, or tested properly but
improperly interpreted for ABO or
infectious diseases, is there evidence of
immediate effort to locate and quarantine
all components that is labeled and
released for transfusion, fractionation,
reagent production, research or other use
until satisfactory resolution?
Is the notification procedure for error or
accident occurrences resulting in a blood
transfusion that could result in infectious
disease or other harmful consequences
and are these actions documented
completely?

2
 Kingdom of Saudi Arabia ‫المملكة العربية السعودية‬
Ministry of Health ‫وزارة الصحة‬
Directorate of Health Affairs ‫المديرية العامة للشئون الصحية‬
Northern Border Region ‫بمنطقة الحدود الشمالية‬
Regional Laboratory & Blood Bank ‫المختبر أالقليمى وبنك الدم‬
Northern Border Regional Lab & Blood Bank
‫المختبرأألقليمى وبنك الدم بمنطقة الحدود الشمالية‬
Managerial review 1.3.1 Management Review Management √ No managerial
must review the system at regular intervals review evidence
to verify its effectiveness and introduce available
corrective measures if deemed necessary.
Complaint procedure 1.3.1 complaints about blood and blood √ No defined
components are examined, the causes of process for
quality defects investigated, and appropriate electronic
measures taken in respect of the defective complains
blood components to prevent reoccurrence. Complains for 937
not well
documented
Deviation recording 1.3.1 o any significant deviations are fully √ Not all staff know
recorded and investigated; process of OVR
recording

TOTAL SCORE