QUALITY MANUAL POLICY # PAGE

SECTION : ASSESSMENT SUBJECT : INTERNAL AUDIT

PREPARED BY:
APPROVED BY:

REQUIREMENT EXPECTED MET NOT MET REMARKS

I. ORGANIZATION / TRAINING AND TRAINING RECORDS

The laboratory shall define its organizational An organizational chart for the
and management structure in the form of an department
organizational chart.
The facility shall evaluate staff skills to perform Up to date training records and
assigned tasks following training and performance evaluation has been done
periodically thereafter. Records shall be within the last 12 months.
maintained

The laboratory shall provide training for Check new staff records
personnel prior to the performance of duties
without direct supervision
II. QUALITY MANAGEMENT SYSTEM & DOCUMENT CONTROL
The policies, processes, and procedures Evidence of staff awareness
pertaining to the quality management system
shall be documented, communicated to and
understood by all personnel
Laboratory management shall implement QI team, Lab area LOC minutes of
quality indicators to monitor and evaluate the indicator review. QI team reports
laboratory's standards of performance,
contribution to patient care, and quality
improvement of service offered.
Document control processes shall ensure that Observe work areas for uncontrolled or
obsolete documents are removed and only

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currently authorized versions of appropriate out of date versions of documents.
documents are available for active use at
relevant locations. Check for abridged documents
III. FACILITIES
Work surfaces shall be chemical resistant, Note location of any bench tops that
impermeable, durable and readily cleanable. are in suboptimal condition
The laboratory shall monitor and record Review document where laboratory
environmental conditions (as appropriate) to management determined its criteria for
ensure they do not adversely affect the quality the monitoring of environmental
of examination results (e.g. dust, humidity, conditions and how criteria were
temperature, sound levels, vibration levels, arrived at e.g. humidity affects
ventilation. instrument in manufacturer’s manual.
Check for review to ensure that the
criteria are met.
The laboratory shall control access to areas Look for biohazards signs on door
posing a hazard, areas requiring special leading into the lab., on fridges,
conditions, or areas with a controlled incubators and freezers. Look for
environment appropriate chemical signs.
Note where missing if observed.
IV. EQUIPMENT, REAGENTS AND SUPPLIES
Laboratory management or the facility shall Review inventory logs for indication of
define a process and/or procedure and records acceptance/rejection.
for inspection, acceptance/rejection and
storage of consumable materials. The Ask how they would indicate that the
inspection, acceptance, rejection and storage shipment was fine or was damaged?
of inventory control system shall ensure Where is it recorded?
continuity of supply and minimize shortages.
Records of actions taken shall be maintained

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There shall be an inventory control system for
supplies that includes the recording of lot
numbers of all relevant reagents, control
materials and calibrators ,the date of receipt
in the laboratory, and the date the material is
placed in service
All reagents, standards and solutions shall be Check reagents, working solutions and
marked with the expiry date, and supplies for appropriate dates.
reconstitution date and time if applicable

All reagents shall be stored according to Check storage requirements for several
manufacturer's requirements and discarded reagents and confirm compliance.
when the expiry date is reached, unless
exceptions are confirmed by the manufacturer, Note reagents reviewed.
or controls indicate adequate performance.
There shall be a written procedure to outline
exceptions and authorization of the use of
outdated reagents.
Calibration policies, process(es) and/or Review calibration records and that
procedures for instruments, reagents, and equipment has a calibration sticker.
analytical systems shall be documented. Ask staff how they know when
Equipment calibration shall be performed as a something needs to be calibrated again
minimum with the frequency described by the or when the next calibration cycle will
manufacturer. be.
Manufacturer's performance claims shall be Review records of verification for
verified before equipment is placed in to several pieces of equipment.
service. Is there evidence that manufacturers'
performance claims have been verified? Note equipment reviewed.
All calibration material and devices shall be Review evidence of traceability, e.g.
traceable to an accepted reference standard calibrators traceable to an accepted
that is expressed in SI units whenever

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applicable .The laboratory shall have a reference range.
mechanism to ensure accuracy if the
information is not available from the
manufacturer. Review calibration certificates for
weights or thermometers.
Each piece of equipment shall be labelled to Check for labelling
indicate status of calibration, and when
recalibration is due, or a log shall be kept
There shall be records of each item of Review equipment logs for several
equipment. These shall be readily available at pieces of equipment.
minimum for the life span of the equipment.
Note equipment reviewed.
There shall be records of malfunction and
trouble-shooting.
Temperature dependent equipment shall be Review fridge and freezer monitoring
equipped with thermometers and the logs
temperature shall be read and documented at
the beginning of each testing day, or more
frequently, as required.
All refrigerators and freezers, equipped with
independent temperature-monitoring systems
should have alarms that do not derive their
power from the same circuit breakers as the
monitored devices.
Defective equipment shall be clearly labelled Check any equipment that is out of
and stored appropriately until it has been service for labelling
repaired and meets specified acceptance
criteria
The laboratory shall have processes and/or procedures Review procedures and observe staff.
for the safe handling, transport, storage and use of
reagents and supplies to prevent contamination and

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deterioration.
Water of suitable quality for testing performed shall be Review procedures for type of water used and
available. criteria used to determine type. Check for
compliance with type determined

V. BLOOD SCREENING
There are policies and procedures to ensure Review donation records.
proper donor identification through definition
of acceptable forms of Identification and
linking the donor identification information to
existing donor history.
There are policies and procedures that donors Review policy on pre donation
receive appropriate information/education information/education
materials including
1. Educational materials regarding
infectious disease transmitted by blood
transfusion.
2. Importance of accurate information
3. Importance of withdrawing themselves
from donation process if they believe
that their blood is not suitable for
transfusion.
4. Donors acknowledge that the
educational materials have been read
and understood.
The Blood Bank shall develop acceptance Review policy on donor selection
criteria for blood donors. criteria.
The Laboratory shall implement a process for
consenting blood donors to ensure;
1. Receiving explanation of donation
procedure
2. Being informed about the risks of the

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 procedure.
3. Being informed about the tests
performed and the risks of transmission
of infectious diseases.
4. Being informed that there are
circumstances in which blood/blood
components are released for
transfusion before the completion of
infectious disease testing.
5. Having read and understood the
information presented to him/her/
6. Having the opportunity to ask questions
and having them answered.
The blood bank must have a system for donor Review policy and procedure on donor
notification of significant findings detected notification of significant findings. The
during donor screening or after performing policy and procedure defines events
laboratory testing. The policy and procedure requiring official donor notification and
mandates the proper provision of proper describe the notification process.
education, counseling, referral for donors with
significant findings.

The Blood Bank must have a system for Review policy and venipuncture on
providing the necessary care for blood donors venipuncture site preparation
before, during and after the procedure.
Review policy on donor care. The policy
and procedure contain detailed
instruction for the provision of care
during and after the collection of
blood/blood component.

The Blood Bank must have a process for Review the policy and procedure on self

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confidential self unit exclusion and handling exclusion and third party information.
post donation information.

.
The Blood Bank must have a system for Review adverse donation evet reports
managing adverse donation events that covers:
1. Recognition and handling of adverse
donation events.
Reporting and monitoring of adverse donation
events.
The Blood bank must have a process for the Review policy and procedure on
collection of donor specimen to ensure that collection labeling and handling of
blood donor specimen are: donor specimen.
1. Collected during donation
2. Properly labeled and crosschecked with
collected product label
3. Stored under appropriate and
controlled conditions.

VI. STORAGE AND TRANSPORTATION OF BLOOD PRODUCTS AND REAGENTS

The Blood Bank must have a system for
preparation, storage, transportation, and
quality control of Red Blood Cells (RBC )
components. which includes:
1. Policy and procedure on handling RBC
components
2. RBC components are transported in
properly insulated container between 1
and 10 ºC
3. RBC components are assigned an
expiration date according to the

Malaz , Farazdak Street, PO Box 3484, Riyadh 11471, KSA ● Tel: (011)476-7222 Ext.515 ● Fax: (011) 476-7222 Ext.516 ● [email protected]
 manufacturer’s recommendations.
4. Policy and Procedure ensures that 1%
of the monthly production- but not less
than 4 units every month are subjected
to quality control testing. All tested RBC
units have a hematocrit of less than
80%

The Blood Bank must have a system for the

preparation, storage, transportation, and
quality control of Platelet Concentrates ( PC)
components which includes:
1. PC components are stored under
properly controlled conditions between
20 and 24°C with continuous agitation
2. PC components are transported in
properly insulated container as close as
possible to 20 and 24°C
3. PC components are assigned an
expiration date of twenty four hours to
five days from the day of whole blood
collection according to the
manufacturer’s recommendations or
four hours of opening PC unit
Policies and procedures ensure that 1%
of the monthly production but not less
than four units every month are
subjected to quality control testing. On
the expiration date or at issue, 90% of
the subjected units have a platelet
count of 5.5X1010 platelets/unit or

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 more and a minimum pH of 6.
The blood bank develops a system for the The policy and procedure should cover
preparation, storage, transportation, and the following:
quality control of Fresh Frozen Plasma
1. FFP components are prepared
by separating and freezing the
plasma from the whole blood
within eight hours of collection
2. FFP components are stored
under properly controlled
conditions below -18°C
3. During transportation, FFP units
are maintained at frozen state in
properly insulated container
4. FFP components are assigned an
expiration date of one year from
the day of whole blood
collection
5. If cryoprecipitate is not
prepared, 1% of the quarterly
production- but not less than
twelve units every three
months- are subjected to quality
control testing. 75% of the
tested units must have
minimum factor VIII level of 700
IU/L

The blood bank develops a system for the The Policy and procedure covers the
preparation, storage, transportation, and following:

Malaz , Farazdak Street, PO Box 3484, Riyadh 11471, KSA ● Tel: (011)476-7222 Ext.515 ● Fax: (011) 476-7222 Ext.516 ● [email protected]
quality control of Cryoprecipitate (CRYO). 1. CRYO components are prepared
by separating cold insoluble
proteins from Fresh Frozen
Plasma and re-freezing of the
product within one hour of
preparation
2. CRYO components are stored
under properly controlled
conditions below -18°C
3. During transportation, the CRYO
units are maintained at frozen
state in properly insulated
container
4. CRYO components are assigned
an expiration date of one year
from the day of whole blood
collection
5. Policies and procedures ensure
that 1% of the quarterly
production- but not less than
twelve units every three
months- are subjected to quality
control testing. 75% of the
tested units must have
minimum factor VIII level of 80
IU/unit and 150mg of
fibrinogen/bag.
The blood bank and transfusion services Policies and procedures ensure that LR-
develop policies and procedures to ensure that RBC units are prepared by a method
the prepared and/or transfused Leukocyte- known to retain 85% of the RBC in the

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Reduced Red Blood Cells (LR-RBC) units are original product and a residual WBC
handled in an appropriate manner count of less than 5X106 WBC/ unit
Policies and procedures ensure that 1%
of the quarterly production -but not
less than 12 units every three months-
are subjected to quality control testing.
All tested LR-RBC units have a RBC
recovery rate of more than 85% and a
residual WBC count of less than 5X106
WBC/unit in all subjected units

The blood bank and transfusion services Policies and procedures ensure that LR-
develop policies and procedures to ensure that PC units are prepared by a method
the prepared and/or transfused Leukocyte- known to retain 85% of the platelets in
Reduced Platelet concentrates (LR-PC) units the original product and a residual WBC
are handled in an appropriate manner. count of less than 8.3X105 WBC/ unit or
5X106 WBC/pool of six units

Policies and procedures ensure that 1%

of the quarterly production -but not
less than twelve units every three
months- are subjected to quality
control testing. All tested LR-PC units
have a platelets recovery rate of more
than 85% and a residual WBC count of
less than 8.3X105 WBC/unit or 5X106
WBC/pool of six units

Malaz , Farazdak Street, PO Box 3484, Riyadh 11471, KSA ● Tel: (011)476-7222 Ext.515 ● Fax: (011) 476-7222 Ext.516 ● [email protected]
The blood bank develops a process for initial There are policies and procedures
immune-hematological testing of blood donor mandating that a sample of blood
samples obtained from the donor during blood/
blood component collection is
subjected to the following testing:
1. Determination of the donor’s
forward ABO group (RBC
grouping).
2.  Determination of the donor’s
reverse ABO group (serum
grouping).
3.  Determination of the donor’s
Rh-D type (including a test for
weak-D).
4. Detection of unexpected
antibodies to red cell antigens
(antibody screening)
5.  There is a confirmation of
agreement between donor’s
current and historical
group/type

The blood bank develops a process to prevent There are policies and procedures
disease transmission by blood/platelet mandating that a sample of blood
transfusion obtained from the donor during blood/
blood component collection is
subjected to the following infectious

Malaz , Farazdak Street, PO Box 3484, Riyadh 11471, KSA ● Tel: (011)476-7222 Ext.515 ● Fax: (011) 476-7222 Ext.516 ● [email protected]
 diseases testing:
1. HBsAg.
2. Anti-HBc.
3. Anti-HCV
4.  Anti-HIV-1/2
5.  Anti-HTLV-I/II
6. HIV-1 RNA
7. HCV RNA
8. HBV DNA
9.  Serological test for syphilis.

The blood bank must have process to limit The process describes the blood bank
and detect bacterial contamination in platelet approach to limit bacterial
components. contamination and the investigations of
positive cases.
 Ensures the employed detection
method is sensitive enough to detect
significant bacterial contamination.
The blood bank establishes a process for the The process mandates two qualified
identification and discard of unacceptable staff members to perform and
blood/blood product document this activity and performing
this task before the initial labeling of
the units.
The process mandates discarding
unacceptable components before the
initial labeling of blood and blood
components

Malaz , Farazdak Street, PO Box 3484, Riyadh 11471, KSA ● Tel: (011)476-7222 Ext.515 ● Fax: (011) 476-7222 Ext.516 ● [email protected]
The blood bank develops a process for initial The policy and procedures mandate
labeling of blood and blood components. labeling the units only after completing
the testing and discarding the
unsuitable units.
The blood bank has a process to confirm the There is a process to confirm the
ABO/Rh-D of donated blood ABO/Rh-D of donated blood which
mandates that segment from RBC
components is subjected to the
following testing:
1.  Determination of the donor’s
forward ABO group (RBC
grouping)
2. Determination of the donor’s
Rh-D type.
3. ABO/Rh-D conformation is
performed after initial labeling.

The blood bank establishes a process to Clear policy and detailed procedure on
prevent the release of units that are not performing the critical task of releasing
suitable for transfusion to the available the suitable blood units to the available
inventory. inventory.

The transfusion services establish a process for There are implemented policies,
the release of incompletely tested blood/blood processes and procedures to ensure
components that incompletely tested blood/blood
components can be released under the
following circumstances:
1. For urgent need only.

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 2.  Upon the discretion of the
medical director of the
transfusion medicine, the
agreement of the attending
physician and the consent of the
patient or next of kin, when
applicable.
3.  Approved only for a particular
patient and one transfusion
event.

4.  The released blood products

are conspicuously labeled to this
effect.

The blood bank has a process for request, The implemented system describe the
approval, and execution of therapeutic ordering, approving and execution of
procedures. therapeutic phlebotomy and apheresis.
The process ensures all therapeutic procedures
are ordered and justified by an authorized
physician
The blood bank and transfusion services use
The blood and blood components
appropriate blood and blood components storage devices are:
storage devices. 1.  Designed for the intended use.
2.  Equipped with continuous
temperature monitoring system
(temperature recording).
3.  Equipped with audio/visual
alarm systems
The blood bank and transfusion services The implemented policy and procedure

Malaz , Farazdak Street, PO Box 3484, Riyadh 11471, KSA ● Tel: (011)476-7222 Ext.515 ● Fax: (011) 476-7222 Ext.516 ● [email protected]
develop policies and procedures to ensure that covers thawing, storage transportation
the thawed Fresh Frozen Plasma (FFP) units are and expiration of thawed FFP units.
handled in an appropriate manner.

The blood bank and transfusion services The implemented policy and procedure
develop policies and procedures to ensure that covers thawing, storage transportation
the thawed CRYO units are handled in an and expiration of thawed CRYO units.
appropriate manner.

The Blood bank and transfusion services Policies and procedures ensure
develop a system for reagents quality control. performance of reagents quality control
on each day of use

The implemented policy and procedure

covers frequency, extent of testing,
review and corrective action.
There are written blood supply/exchange Signed blood supply/exchange
agreements with outside facilities covering the agreements or any other form of
following: agreement with all outside facilities
sending to or receiving blood from. The
1.  Agreement conditions (including agreement must satisfy all of the
accreditation status). standard elements.
2. Agreement on adequate blood/blood
components inventory.
3. Role of the involved parties in look back
and transfusion transmitted diseases
investigation.
4.  Release of blood, blood components or
information to a third party.
5.  Validity of agreement and agreement

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 review schedule.
6.  Resolving disputes.

VII. CLINICAL USE OF BLOOD

The blood bank and transfusion services Clear policy and detailed procedures on
implement a system for pre-transfusion testing pre-transfusion testing covering
of the recipient. specimen requirements, history check
and immune-hematological testing.
There are policies and procedures for the The implemented policy addresses the
selection of blood/blood product for considerations for ABO groups, Rh
transfusion to ensure the following: types and clinically significant
1. The selected red blood cells component antibodies
is ABO group-specific or ABO group-
compatible with the recipient’s plasm
2. Only Rh-D negative red blood cell
components are transfused to Rh-D
negative patients.
3.  Identification of the conditions for the
release of Rh-D positive red blood cells
components to Rh-D negative patient
4.  If the patient has current or previous
history of clinically significant
antibodies in the patient serum, the
selected red cells must lack the
corresponding antigen(s
The transfusion services establish a process for Clear policy and detailed procedure on
compatibility testing. performing compatibility testing,
labeling of the crossmatched product
and documentation.

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The transfusion services develop a process for The prepared policy and procedures
intra-uterine and neonatal testing and addresses determination of the
transfusion neonate ABO/Rh, repeat of ABO/Rh
testing, DAT testing, clinically significant
antibodies of maternal origin and
selection of blood components for top-
ups and exchange transfusion
The transfusion services develop a process for The implemented policy and procedure
the issue of blood/blood component for ensure identification of the intended
transfusion recipient, identification of the required
blood components and proper
documentation of the event
The transfusion services develop a process for There is a process for emergency release
emergency release of uncross-matched or of uncross-matched or incompletely
incompletely cross-matched blood. cross-matched blood that ensures a
proper ordering, selection of component,
documentation and subsequent
compatibility testing.
There is a process for the management of Hospital or transfusion committee
adverse transfusion events which covers: approved policy and procedure on
1.  Recognition and handling of adverse recognizing, handling and reporting
transfusion events. adverse transfusion events.
2.  Reporting and monitoring of adverse
transfusion events.

Malaz , Farazdak Street, PO Box 3484, Riyadh 11471, KSA ● Tel: (011)476-7222 Ext.515 ● Fax: (011) 476-7222 Ext.516 ● [email protected]