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Overview
Primary goal is transfusion of a safe unit of blood. To achieve quality one must have: Well constructed SOPs.
Well trained personnel who carefully adhere to the SOPs. Comprehensive guidelines in compliance with regulatory
agencies.
Failure in: the quality of blood collected; screening
of collected blood; or failure to follow procedures in transfusion protocols may result in fatal consequences.
Terms
Quality control is the management of the testing process itself. Monitoring of equipment and instruments Determining that reagents are reacting appropriately Quality Assurance includes the entire process of providing patient care,
from the time the physician orders the test until treatment of patient based on results of test. Were appropriate lab tests ordered to determine the need for transfusion? Did the transfusion service perform appropriate testing of patient specimen and preparation of the appropriate component? Was the transfusion administered properly? Did the patient obtain the anticipated benefit?
Utilization review is the process of monitoring the appropriateness of
transfusion.
Continuous quality improvement involves reviewing the process of
providing patient care with the goal of reducing rework, waste and inappropriate care.
regulators
These regulations specify what needs to be done without
organization
Ensures the quality of products and services offered Must include GMPs Activities must be planned and documented by written
Records
If it is not recorded then it NEVER happened.
components including individuals involved. Creates an audit trail necessary to investigate errors.
Original data CANNOT be obliterated, single line. Date and initial of changes required. NO white out or pencil ever allowed. Document control essential as it specifies and describes:
Audit Trail
A thorough record-keeping system recreates every step
related to:
Production Distribution of a unit of blood
This step is known as an audit trail An audit trail is important when investigating errors and
accidents
Ability to trace back to the original entry and make
Document Control
Regulatory and accrediting agencies expect
documentation to:
Be thorough Be well organized Be appropriately stored Be retrievable in a reasonable amount of time
Change Control
The blood industry is in a constant state of change Challenged routinely by new technologies and regulatory
Personnel Qualifications
Good employees are essential to the success of any
organization
Hiring unqualified individuals can add significant cost to the
organization
Selection process must be thorough, and minimal pre-
essential
Training
A critical aspect of compliance with GMPs Must define tasks performed and levels of competence
needed.
Must have a written training program and assessment to
Competency Assessment
When documented evidence exists that the employee is
competency for personnel testing, twice the first year of employment and annually thereafter e.g.:
AABB
Proficiency Testing
A required component of QA program Used to ensure that test methods and equipment are working
correctly Ensures that staff members are following procedures Assigning external proficiency testing samples on a rotating basis. Proficiency testing may be internal, external or both.
Observing employee performing assigned tasks. Reviewing documentation. Internal - unknown samples prepared in house
Supplier Qualifications
The quality of any given product is as good as the quality
of the raw materials Supplier qualification has become standard practice in blood banks Written agreements between blood banks and suppliers are common practice Specific terms of product expectations Course of action when criteria are not met
Error Management
Part of a QA plan must include mechanisms for the
Recalls
Regulators require that licensed and registered facilities
Validation
A process that establishes documented evidence providing
a high degree of assurance that a specific product meets its pre-established quality and performance specifications
Validation necessitates the commitment of time, resources,
and manpower
Must be planned and thoroughly documented
support of GMPs
Documentation must be made of routine maintenance, repairs and
testing performed on instruments from date of receipt to date instrument is permanently removed from service.
Temperature monitoring is critical for refrigerators, freezers,
24 hours a day. When temperature is out of range must have documentation of reason or corrective action taken. Alarms on refrigerators and freezers must be tested periodically to make sure they will sound at the appropriate temperature.
antihuman globulin serum blood grouping anti-sera lectins antibody screening cells reverse grouping cells Enzymes
each run:
hepatitis testing reagents HIV testing reagents HTLV-I/II reagents ALT testing reagents syphilis serology reagents.
expiration date
review of manufacturer's circular for changes leaking or damaged containers
tested for sensitivity and specificity. Daily testing is required to ensure the reagent has not lost potency or reactivity.
Can use a formand procedure created in-house or
utilize QC kit provided by a manufacturer. Lot numbers and expiration date of all reagents tested must be on the form. Graded reactions recorded. Special typing sera need only be QCd when used.
Final disposition of damaged or unsatisfactory
Other Issues
Lot release and label control to avoid product recall
resulting from mislabeling QA department to coordinate all activities related to QA Regulatory agencies include AABB and FDA; their compliance standards should be known International Standards Organization 9000 provides guidance in the development of standards; not specific for any product or industry
Commission
Assign responsibility Delineate the scope of care Identify the most important aspect of care Identify indicators Establish thresholds Collect and organize data Evaluate data Take corrective action Assess actions and document improvement Communicate.
Utilization Review
Used to assess the blood ordering and transfusion
number transfused. Used as an indicator that too much blood is being requested to be on hold. Could result in high outdate or waste.
Number of autologous transfusions.
Utilization Review
Number of emergency releases.
Haematocrit [less than 24%] Haemoglobin [less than 8 gm/dL] Symptoms due to anaemia Recent estimated blood loss of greater than 10% of total blood volume.