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IMHM 311
LABORATORY / SECOND SEMESTER
Earl Joseph D. Catampatan, RMT, MPH©

WEEK 2: BLOOD BANK QUALITY MANAGEMENT

 FACILITIES:
o BLOOD CENTER – stand-alone facility which cater donor
screening in line with the specimen collection, blood bag
processing, storing and issuance of different blood components
o HOSPITAL BLOOD BANKS – connected to the hospital, they are
some blood banks that are include in the main laboratory and some
are separated. They do the donor screening, blood processing and
also store and issue different blood components
❑COMPLIANCE PROGRAM- evaluate how effectively the facility meets
regulatory and accreditation a requirements by detecting errors, deficiencies, and
deviations.
❑COMPLIANCE INSPECTIONS- measure the state of the facility’s program with
respect to the applicable requirements and are usually conducted every 2 years.
 Also called as the SURVEY or ASSESSMENT
 Conducted every 2 years but every year in PH (surprise visit)

o TRANSFUSION SERVICES – only transfusion services itself
Blood banks must provide quality to their customers in many forms, including:
• Safe, satisfying donation experiences for blood donors.
❑QUALITY MANAGEMENT (QM)- is actively and continuously practiced by
blood bank leaders, managers, and staff throughout all blood bank operations.
 All of the staffs in the blood bank should be cooperative

 Donors = treasure
QUALITY CONTROL
• Accurately labeled and tested blood components provided to transfusion services.
❑All blood bank medical laboratory scientists and technicians are familiar with routine
• Timely, accurate transfusion services provided to physicians and other health-care blood bank QC procedures:
personnel.
 Daily testing the reactivity of blood typing reagents.
• Safe and efficacious blood transfusions to patients.  Before performing to an actual donor, take note the physical
appearance of blood typing sera
 Check if there is still a reaction or the reagent still work (time of
reaction)
The method for bringing this quality philosophy into all operations involves each
 Calibrating serologic centrifuges;
facility developing a foundation of quality:
 Timer checks
 Monitoring temperatures
❑Quality control (QC)
 Take note of the humidity, air flow, and the ventilation of the
 Set of activities in blood banking laboratory – also freezers and refrigerators
 Checking of equipment and reagents  Worksheet for temperature monitoring compiled on a monthly
basis
❑Quality assurance (QA)  Manufacturers’ package inserts,
 Intended for the test kits like rapid immunoassays used in blood
 Organized and systematized planned activities banks
 Rapid immunoassays are used to check some infectious diseases
❑Quality management system (QMS) in the blood bags such as STIs; HIV, Syphilis, Hepatitis B surface
Antigen Test (HBsAg) etc.
 Regular performance of QC
 In line with the schedule of a specific equipment takes place when
Blood bank compliance with federal regulations and accreditation standards is it comes to the QC
required by the following organizations:

❑ United States Food and Drug Administration (FDA)

 They check anticoagulant of blood bags when it comes to the

pharmaceutical aspect

❑ The Joint Commission

 Maintains physical facility of a facility

 They also provide the size of the donor screening area.

❑ College of American Pathologists (CAP)

 Head of the laboratory: PATHOLOGISTS

❑ AABB (formerly known as American Association of Blood Banks)

 Guidelines and standardization for blood transfusion

INDIVIDUALIZED QUALITY CONTROL PLAN (IQCP).

COMPLIANCE VS QUALITY MANAGEMENT ❑Laboratory’s Risk Assessment.

❑Pre-analytic, Analytic, and Post-Analytic Processes

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❑Customize its QC program  Microhematocrit instrument controls

 Hemoglobin instrument controls
 Apheresis equipment function check
 Blood-weighing scales accuracy
RISK ASSESSMENT (RA)
 Ideal amount blood in blood bags – 450 mL
SPECIMEN
BLOOD COMPONENTS
A. Patient Preparation
B. Specimen Collection  Red blood cell hematocrit
C. Specimen Labelling  Cryoprecipitated antihemophilic factor
 Platelet counts in platelet units
TEST SYSTEM  Take note the difference between Random donor platelet from a
Single donor platelet
A. Failure of System Checks  Residual leukocyte counts in leukocyte-reduced components
B. Detection of Clots, Hemolysis and Lipemia  Administered to patients with problems in Bone marrow,
C. Transmission of Data to LIS (Laboratory Information System) unresponsive to Antibiotic therapy
 Bacterial contamination of platelet units
REAGENT
 Blood component which is most prone for bacterial contamination is
A. Shipping and Receiving PLATELETE CONCENTRATE, because platelet is only stored at
B. Storage Condition room temperature (20-24C) w/ continuous agitation
C. Preparation
REAGENT CONTROLS
ENVIRONMENT
 Copper sulfate
A. Temperature  Determination of Hemoglobin (Hb)
B. Airflow/Ventilation  Floats = Qualified Hb
C. Humidity  Reagent red blood cells
 Reagent antisera Test kits for infectious disease testing
TESTING PERSONNEL
LABORATORY EQUIPMENT FUNCTION CHECKS
A. Training
B. Competency  Heating instruments
C. Staffing
 Water baths
 Thawing devices for blood components
 pH meters
QUALITY CONTROL PLAN (QCP)  Cell counters
 Centrifuges, refrigerated and serologic
❑The number and type of QC testing materials  Cell washers
 Blood irradiators
❑The frequency of testing  Refrigerators
 Freezers
❑The criteria for acceptable QC results  Platelet incubators
 Blood warmers
 For transfusion
 Shipping containers
 Blood bags are in vertical position
QUALITY ASSESSMENT
QA INDICATORS
❑Proficiency testing records and QC results
 Number of donor forms with incomplete or incorrect information
❑Turnaround time reports  Number and types of unusable units and blood components
 Number of blood typing discrepancies in donors and patients
 TURNAROUND TIME – How long will you release the results  Number of and reasons for invalid tests
 Number of and reasons for labeling check failures
❑Personnel competency record  Number and source of improper and incomplete requests for blood
components
❑Corrective action reports  Number and location of patients without proper identification at time of
specimen collection or transfusion
 Number of, source of, and reasons for unacceptable specimens
 Number of times wrong component or ABO was selected for crossmatch or
QUALITY ASSURANCE
use
 Number and type of transfusion complications
❑Performance of a test method
 Number of and reasons for turnaround time failures
 Goal is to provide them a satisfactory product or service

❑Performance of an equipment QUALITY MANAGEMENT SYSTEM

❑Provides a FRAMEWORK for applying quality principles and practices uniformly

across all blood bank operations, starting with donor selection and proceeding through
COMMON QC ACTIVITIES
transfusion outcomes.
DONOR COLLECTION

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QUALITY MANAGEMENT SYSTEM ESSENTIALS ❑Temperature Control

❑Physical Facilities ❑Electrical Safety

❑Hires Qualified Personnel ❑Fire Protection

❑Materials and Equipment  Emergency Preparedness

 Chemical Hygiene
❑Documents for Work Performance  Infection Control

PERSONNEL

❑Educational qualifications,

❑Experience, and federal state,

 Licensing in U.S would be the American Society for Clinical Pathologists

(ASCPi) but it’s not applicable in all states.

❑Local licensing requirements

Competence assessment must include:

1. Direct observation of patient test performance.

2. Monitoring the recording and reporting of test results.

3. Review of test results or worksheets, QC records, proficiency testing results, and

preventive maintenance records.

4. Direct observation of performance of instrument maintenance and function checks.

5. Assessment of test performance through testing previously analyzed specimens or

external proficiency testing samples.
 AUTOLOGOUS – referring with the donor client. You are the recipient of
your own donated the blood 6. Assessment of problem-solving skills.
 ALLOGENEIC – the usual type of donation. You don’t know who will
receive your donated blood. PURCHASING AND INVENTORY

❑Inventories of reagents, supplies and blood components

ORGANIZATION
 FIFO – First in, first out
❑Relationships among blood bank personnel by job title
❑Selecting vendors of equipment, supplies and services
❑The blood bank’s link to the laboratory
❑Blood centers must also have processes for receipt, inspection, and testing
❑The blood bank’s link to the hospital

❑How the blood bank links to the hospital’s quality function

EQUIPMENT

❑Installation qualification demonstrates that the equipment is correctly installed.

CUSTOMER FOCUS
❑Blood centers and transfusion services work on behalf of patients, the real customer
of these facilities is the entity or person who receives and must be satisfied with a
product or service.
❑Operational qualification ensures the equipment operates as intended.
❑Performance qualification evaluates the personnel, procedures, and supplies in the
facility work environment.

❑For BLOOD CENTERS the customers are the DONORS, who want a safe and ❑Schedules for calibration, preventive maintenance, RPM and timer checks, and
satisfying donation experience, and the transfusion services served by the blood monitoring of temperature-regulated equipment are required.
center, that want properly tested and labeled blood components of the appropriate types
on demand.

❑For TRANSFUSION SERVICES, customers are the PHYSICIANS, who want the
blood transfusions they order to occur in a timely manner.
❑The NURSES, who want the correctly issued blood components in a timely manner for
administration to patients.
PROCESS MANAGEMENT
❑PROCESS CONTROL- is a set of activities that ensures a given work process will
keep operating in a state that is continuously able to meet process goals without
compromising the process itself.

❑For all types of facilities, internal customers are the personnel. ❑TOTAL PROCESS CONTROL- is the evaluation of process performance,
comparison of actual performance to a goal, and action taken on any significant
difference.

FACILITIES AND SAFETY

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