MEDICAL TECHNOLOGY ASSESSMENT PROGRAM 2

IMMUNOHEMATOLOGY
LECTURE 13: MISCELLANEOUS TOPICS

Menissa S. Acierto, RMT, MEd

TOTAL QUALITY MANAGEMENT IN BLOOD
TRANSFUSION SERVICE
What is Quality?
Degree to which a set of inherent characteristics fulfills requirements
Customer satisfaction
Ability to satisfy stated or implied needs
A degree or grade of excellence or worth
A product or service free of deficiencies
Doing the right thing at the right time
Total Quality Management (TQM)
A management approach to long-term success through customer satisfaction.
All members of an organization participate in improving processes, products, services, and the culture
in which they work.
Quality can and must be managed
The first step in the TQM process is to realize there are problems and that problems can be controlled.
TOTAL QUALITY MANAGEMENT IN BLOOD
TRANSFUSION SERVICE
Principles of TQM
Customer Focused - the customer ultimately determines the level of quality
Total Employee Involvement - every employee is responsible for quality
Process-centered - the steps required to carry out the process are defined, and
performance measures are continuously monitored in order to detect unexpected
variation.
Integrated System - Although an organization may consist of many different
functional specialties often organized into vertically structured departments, it is
the horizontal processes interconnecting these functions that are the focus of TQM.
Strategic / Systematic Approach - A critical part of the management of quality is the
strategic and systematic approach to achieving an organization’s vision, mission, and
goals.
TOTAL QUALITY MANAGEMENT IN BLOOD
TRANSFUSION SERVICE
Principles of TQM
Quality improvements must be continuous - Improvements must occur frequently
and continually in order to increase customer satisfaction and loyalty.
Fact-based Decision Making - In order to know how well an organization is
performing, data on performance measures are necessary. TQM requires that an
organization continually collect and analyze data in order to improve decision
making accuracy, achieve consensus, and allow prediction based on past history.
Communications - Effective communications plays a large part in maintaining
morale and in motivating employees at all levels.
TOTAL QUALITY MANAGEMENT IN BLOOD
TRANSFUSION SERVICE
TOTAL QUALITY MANAGEMENT IN BLOOD
TRANSFUSION SERVICE
TOTAL QUALITY MANAGEMENT IN BLOOD
TRANSFUSION SERVICE
Quality Control
Reveals when a method, equipment or procedure is not working as expected
Testing reactivity of reagents, Calibration of equipment, Temperature monitoring
Quality Assurance
Determines how well a process, sequence of activities is working
Proficiency testing, Validation studies
TOTAL QUALITY MANAGEMENT IN BLOOD
TRANSFUSION SERVICE
Quality System
The organizational structure and resources needed to implement quality
requirements
Standards for Quality Systems
National
DOH-NVBSP, Blood Services Network
PBCC, PSHBT, PSP, PACQL
International
Good Manufacturing Practice (GMP)
International Organization for Standardization (ISO)
American Association of Blood Banks (AABB)
TOTAL QUALITY MANAGEMENT IN BLOOD
TRANSFUSION SERVICE
Quality System Essentials
Organization
Personnel
Documents / Records
Equipment
Purchasing / Inventory
Process control
Occurrence
management
Assessments
Process Improvement
Facilities and Safety
BLOOD SERVICE FACILITIES IN THE PHILIPPINES
RA 7719
National Blood Services Act of 1994
Promotes a voluntary blood donation, providing for an adequate supply of safe
blood and regulating blood banks
Bureau of Health Facilities and Services
Main regulatory body which is responsible in ensuring that blood service facilities
comply to requirements as defined in the AO 2008-008 and 2008-008-A
BLOOD SERVICE FACILITIES IN THE PHILIPPINES
Categories of Blood Service Facilities
Blood Station (BS)
Hospital based
Non-hospital based
Blood Collection Unit (BCU)
Category A
Hospital based
Non-hospital based
Category B
Hospital based
Non-hospital based
BLOOD SERVICE FACILITIES IN THE PHILIPPINES
Blood Station
Non-hospital based
storage and issuance of whole blood and PRBC
Hospital based
Storage and issuance of whole blood and PRBC
Compatibility testing (cross matching)
BLOOD SERVICE FACILITIES IN THE PHILIPPINES
Blood Collection Unit
Non-hospital based
Recruitment of voluntary blood donors
Health education and counseling
Donor screening and collection
Blood collection
Transport of blood to blood banks/blood centers
Hospital based
Recruitment of voluntary blood donors
Health education and counseling
Donor screening and collection
Blood collection
Transport of blood to blood banks/blood centers
Compatibility testing (cross matching)
BLOOD SERVICE FACILITIES IN THE PHILIPPINES
Blood Bank/Blood Center (Category A)
Non-Hospital based
Recruitment of voluntary blood donors
Health education and counseling
Donor screening and collection
Blood collection
Blood screening and testing of transmissible diseases
Provision of whole blood and PRBC
Storage of blood and blood products
Issuance, transport and distribution of whole blood and blood products
BLOOD SERVICE FACILITIES IN THE PHILIPPINES
Blood Bank/Blood Center (Category A)
Hospital based
Recruitment of voluntary blood donors
Health education and counseling
Donor screening and collection
Blood collection
Blood screening and testing of transmissible diseases
Provision of whole blood and PRBC
Storage of blood and blood products
Issuance, transport and distribution of whole blood and blood products
Compatibility testing
BLOOD SERVICE FACILITIES IN THE PHILIPPINES
Blood Bank/Blood Center (Category B)
Non-Hospital based
Recruitment of voluntary blood donors
Health education and counseling
Donor screening and collection
Blood collection
Blood screening and testing of transmissible diseases
Provision of whole blood and PRBC
Storage of blood and blood products
Issuance, transport and distribution of whole blood and blood products
BLOOD SERVICE FACILITIES IN THE PHILIPPINES
Blood Bank/Blood Center (Category B)
Hospital based
Same as blood bank/blood center (Category A)
Compatibility testing
Investigation of transfusion reaction
Resolution of incompatible crossmatch
BLOOD SERVICE FACILITIES IN THE PHILIPPINES
Manpower Requirements of Blood Collection Unit
Head 1
PRC registered physician with valid professional license with at least 4 months training in
Blood banking services
Voluntary donor recruitment and screening
Voluntary donor holding and motivation
Health education and counseling
Blood collection, handling and transport
Management of blood collection activities and problem
Compatibility testing
Attended continuing education seminar/workshop in Blood Transfusion medicine sufficient to
maintain competency
BLOOD SERVICE FACILITIES IN THE PHILIPPINES
Manpower Requirements of Blood Collection Unit
Head 2
PRC registered physician with at least one-year on the job experience as head or associate of a currently
licensed blood bank
Attended continuing education seminar/workshop in Blood Transfusion medicine sufficient to maintain
competency
BLOOD SERVICE FACILITIES IN THE PHILIPPINES
Manpower Requirements of Blood Collection Unit
Personnel
One trained Medical Technologist
PRC registered with valid professional license with at least one-year on-the-job
experience in a currently licensed blood bank
Attended continuing education seminar/workshop in blood transfusion medicine
sufficient to maintain competency
With at least one month training in compatibility testing
One Medical Technologist
PRC registered with valid professional license and shall be under the
responsibility of a trained Medical technologist
BLOOD SERVICE FACILITIES IN THE PHILIPPINES
Manpower Requirements of Blood Collection Unit
Personnel
One donor recruitment officer (MD/RMT/RN)
PRC registered with valid professional license with at least 6 months training on
Voluntary blood donor recruitment
Voluntary blood holding and motivation
Health education and counseling
Blood collection
Prevention and management of adverse reaction
WASTE MANAGEMENT
Classification of waste
Hazardous waste
Any waste that poses a substantial threat to human health or to the environment
Infectious waste – disposal equipment, utensils, articles or substances that have
come in contact with blood and other body fluids
Sharps – needles, syringes, scalpels, lancets, blades, broken glass
Pathological waste - blood samples, blood clots serum, and blood unit not fit for
transfusion
Chemical wastes – substances that are flammable, reactive, corrosive, toxic,
irritating or strongly sensitizing
WASTE MANAGEMENT
Methods of decontamination of waste
All infectious waste shall be decontaminated prior to packing by any of the following methods:
Chemical disinfections by soaking for hours in
Sodium hypochlorite solution with 0.1-0.5% available chlorine
70% ethanol
70% isopropanol
2.5% polyvidone iodine
4% formaldehyde
2% glutaraldehyde
6% hydrogen peroxide
All infectious waste shall be decontaminated prior to packing by any of the following methods:
Steam sterilization by autoclaving at 121oC for a minimum of 20 minutes
Sterilization by dry heat (oven) for 2 hours at 170oC
Autoclaving (for pathological waste)
WASTE MANAGEMENT
Color coding of Disposal bags
Red – sharps/needles
Yellow – for infectious waste
Yellow with black band – chemical waste
Green – non-infectious wet waste
Black – non infectious dry waste
QUALITY CONTROL OF REAGENTS
Hemoglobin determination (must be checked on day of use)
CuSO4 method
Cyanmet hemoglobin method
Drabkin’s reagent or
Cyanmethemoglobin method
Bloods typing (must be checked before each batch/run of test)
ABO grouping (forward and reverse slide method or tube method)
Anti-A
Anti-B
Anti-A1 lectin
NSS (0.9% NaCl)
Rh typing (tube method)
Anti-D
Known D negative cells
Control system (known D positive cells)
QUALITY CONTROL OF REAGENTS
Crossmatching (must be checked on each batch/run of test)
NSS (0.9% NaCl)
22% bovine serum albumin
Polyspecific anti-human globulin
QUALITY CONTROL OF EQUIPMENTS AND
INSTRUMENTS
To be checked daily
Thermometer
Donor’s weighing scale
Blood unit spring scale
Sphygmomanometer
BB refrigerator
To be checked on the day of use
Stethoscope
Spectrophotometer]serologic centrifuge
To be checked on each use
Autoclave
Computer hardware and software
PRINCIPLES OF BLOOD REPLACEMENT
Principle 1
The cause of the deficiency must be identified
The deficiency will recur unless the cause is identified and corrected
The transfusion of red cells into a patient with gastrointestinal bleeding will only
temporarily correct the anemia unless the cause of the bleeding is corrected
PRINCIPLES OF BLOOD REPLACEMENT
Principle 2
The deficient component only should be replaced
The product given to the patient must contain the maximum concentration of the deficient
component with minimal concentration of other product
A patient with hemophilia is best treated by administration of Factor VIII as cryoprecipitate or
Factor VIII concentrate rather than fresh whole blood or FFP
Estimating red cell requirement
Total blood volume is 7% body weight and the plasma volume is 4-5% of body weight
Total body weight
40% non-aqueous components
60% total body water
Intracellular fluid 40%
Extracellular fluid 20%
Interstitial fluid 15%
Plasma 5%
PRINCIPLES OF BLOOD REPLACEMENT
Principle 2
Estimating red cell requirement
Sample problem:
How many units of red cell concentrate are needed to raise a 72 kg person’s hematocrit from
12% to 30%?
Note:
One unit red cell concentrate contains about 200 ml red cells
As a rule of thumb, the transfusion of one unit of red cell concentrate into an adult raises the
haemoglobin 1 g/dl or hematocrit by 3%
PRINCIPLES OF BLOOD REPLACEMENT
Principle 2
Estimating Factor VIII requirements
Sample Problem:
How much cryoprecipitate does a 70 kg bleeding hemophiliac require?
Note:
One assumes the level of Factor VIII is 0%. To achieve hemostasis, we want to raise the Factor VIII
level to 50%. The infused Factor VIII distributes within his plasma volume (PV)
A clotting unit of a coagulation factor is the amount of that factor (arbitrarily set at 100%) in normal
plasma.
One bag cryoprecipitate contains approximately 80% clotting units of Factor VIII
PRINCIPLES OF BLOOD REPLACEMENT
Principle 3
The blood product should be safe as possible
Transfusion reactions can be minimized by crossmatching blood prior to
transfusion
Most immediate hemolytic transfusion reactions occur when ABO incompatible
blood is given. This is often caused by clerical mistakes such as an error in
identification of the recipient or the blood specimen
The risk of infection is reduced by ensuring that the donor is in good health using
aseptic techniques during collection and processing and storing blood at
appropriate temperature. (platelets must be stored at 22oC to maintain
hemostatic function)
Care should be taken not to overload a patient with fluid, particularly patients with
in whom heart or kidney function is already compromised
APHERESIS
Apheresis (hemapheresis) is derived from a Greek term that means to separate or
remove
It is a procedure whereby blood is withdrawn from a donor and separated into its
components. One or more of the component sis retained and the remaining
constituents are recombined and returned to the donor
APHERESIS
Types of Apheresis
Any component of blood can be removed and the procedures are specified by the
component collected
Plasmapheresis
removing plasma from the blood
Plateletpheresis/thrombocytapheresis
Removal of platelets
Erythrocytapheresis
Removal of red blood cells
Leukapheresis
Removal of leukocytes
APHERESIS
Automated Apheresis Instruments
The most commonly used instruments employ centrifugation method of separation.
Apheresis procedure by membrane filtration is occasionally used.
The centrifugation method is divided into two categories:
Intermittent-flow centrifugation(IFC)
Continuous flow centrifugation (CFC)
APHERESIS
Intermittent-flow centrifugation(IFC)
Requires only one venipuncture in which blood is drawn and reinfused through the same
needle
Once the desired component is separated, the remaining components are reinfused to the
donor and one cycle is complete
A plateletpheresis procedure usually takes 6 to 8 cycle to collect a therapeutic dose
Continuous flow centrifugation
Procedures withdraw, process and return to individual simultaneously
Two venipuncture sites are necessary
The process of phlebotomy, separation and reinfusion is uninterrupted
Membrane filtration technology
Uses membranes with specific pore sizes, allowing the passage of plasma through the
membrane while the cellular portion passes over it
APHERESIS
Apheresis procedure is completed in a range of 60 to 150 minutes
Granulocyte concentrates must contain a minimum of 1.0 x 1010 granulocytes in at
least 75% of units tested
Anticoagulant and Replacement fluids
The most common anticoagulant is ACD
In therapeutic plasmapheresis the replacement fluids used on the donor to maintain
appropriate intravascular volume and oncotic pressure include:
NSS
FFP
50% NSA
POLYAGGLUTINATION
Refers to the agglutination of altered red cells by a large proportion of ABO compatible
adult human sera caused by:
Microbial (bacterial and viral activity)
Certain forms of aberrant erythropoiesis
Inherited alterations in the red cell membrane
POLYAGGLUTINATION
Microbially Associated Polyagglutination
These include T, Th, Tx, Tk, acquired B Phenomenon and VA
In acquired B phenomenon, enzymes produced by E. coli, C. tertium and P. vulgaris cause
deacetylation of the Group A determinant on red cells (N-acetyl-d-galactosimide) to produce
a structure similar to the Group B determinant (D-galactose) which cross reacts with human
anti-B typing reagents
In T polyagglutination, the enzyme neuramidase produced by bacteria such as pneumococci
cleaves terminal N-acetyl neural minic acid residues from the red cell membrane exposing
the hidden T antigen
Tk polyagglutination may lead to decreased expression of the ABH, Ii, Lewis and P1 antigens
becasue of microbial enzymatic action on galactose present on the paragloboside structure
Non-Microbially Associated Polyagglutination
Include Th agglutination
POLYAGGLUTINATION
Inherited forms of polyagglutination
Include Cad, Hemoglobin M-Hyde Park, HEMPAS and NOR
HEMPAS (Hereditary Erythroblastic Multinuclearity with a positive acidified serum
test) red cells have increased amounts of I-antigen, decreased amounts of H antigen
and sialic acid and are susceptible to lysis by anti-I in the presence of complement
POLYAGGLUTINATION
Clinical Significance
Sepsis
Leukemia
Breast cancer

Investigated through the use of

Cord blood sera
Fresh group AB adult sera
An autocontrol
Enzymes
Lectin studies

Polyagglutinable cells are naturally occurring and react best at lower temperature via direct
agglutination
IMMUNE HEMOLYTIC ANEMIA (IHA)
Shortened red cell survival mediated by humoral antibody
Immune hemolysis represents the result of an acquired abormality of the red blood cell
membrane associated with demonstrable antibodies
Categories
Alloimmune HA
Autoimmune HA
Drug-induced HA
IMMUNE HEMOLYTIC ANEMIA (IHA)
Shortened red cell survival mediated by humoral antibody
Immune hemolysis represents the result of an acquired abormality of the red blood cell
membrane associated with demonstrable antibodies
Categories
Alloimmune HA
Autoimmune HA
Drug-induced HA
IMMUNE HEMOLYTIC ANEMIA (IHA)
Autoimmune Hemolytic Anemia (AIHA)
Patients produce antibodies against their own red cell antigens
AIHA may be classified as:
Cold reacting (18%)
Warm reacting (70%)
Drug-induced (12%)
Diagnostic tests include:
DAT
Characterization of the autoantibody in the serum and/or eluate
Common specificity in both benign and pathologic cold auto agglutinins is anti-I
IMMUNE HEMOLYTIC ANEMIA (IHA)
Pathologic Cold Agglutinins
Cold hemagglutinin disease or Idiopathic cold AIHA
DAT is positive because of the complement coating of the red cells
The antibody titer is greater than 1000
Paroxysmal Cold Hemoglobinuria
Classic antibody produced is Donath-Landsteiner antibody and has the specificity
of auto-anti-P
This antibody binds to patient’s red cells at low temperature and fixes complement
Hemolysis occurs when coated cells are warmed at 37oC and complement-
mediated intravascular lysis occurs
IMMUNE HEMOLYTIC ANEMIA (IHA)
Warm Reactive autoantibodies
Associated with:
Reticuloendothelial neoplasm (such as chronic lymphocytic leukemia)
Collagen disease such as SLE
Infectious disease such as viral syndromes
Immunologic disease such as hypogammaglobulinemia
IMMUNE HEMOLYTIC ANEMIA (IHA)
Alloimmune Hemolytic anemia
Patients produce antibodies to foreign red cell antigens introduced into their
circulation, most often through transfusion or pregnancy
Drug-induced Hemolytic anemia
Aldomer or alpha-methyldopa induces production of an autoantibody that
recognizes RBC antigens
ALTERNATIVE TECHNOLOGIES AND AUTOMATION
IN BLOOD BANKS
Alternative technologies/automation:
Gel test
Solid phase assay
Affinity column testing
Major advantages
Standardization
There is no tube shaking or resuspension of RBC button to cause subjectivity in the
interpretation of the test
Stability
There are well-defined endpoints of the reaction
Decreased sample volume needed for testing
Enhanced sensitivity and specificity
ALTERNATIVE TECHNOLOGIES AND AUTOMATION
IN BLOOD BANKS
Gel test
Principle is hemagglutination
RBCs and serum/plasma are allowed to incubate together in a reaction chamber
Following incubation, controlled centrifugation drives the RBCs through a specially designed
microtube filled with beads of dextran-acrylamide gel
Agglutinated cells remain at the top of the tube or are trapped in the gel, depending on the size of the
agglutinates
Unagglutinated cells move through the gel to the bottom of the tube
Reactions are stable for observation or review for 2-3 days
Gel technology is currently approved for ABO forward and reverse grouping, Rh typing, DAT, antibody
screening, antibody identification, and compatibility testing
Major disadvantage is the need to purchase special equipment: a centrifuge to accommodate the
microtube cards used for testing and a pipettor and pipettes for dispensing plasma or serum and RBC
suspension into the reaction chambers of the microtubes
ALTERNATIVE TECHNOLOGIES AND AUTOMATION
IN BLOOD BANKS
ALTERNATIVE TECHNOLOGIES AND AUTOMATION
IN BLOOD BANKS
Solid phase assay
Stable for observation or review for 2 days
Currently approved for antibody screening, antibody identification, and compatibility testing
Advantages include ease of use because of no predilution of reagents is required and the ability to test
hemolyzed, lipemic, or icteric samples. Enhanced sensitivity increases the detection of weak
alloantibodies
Major disadvantage is the need to purchase special equipment: a centrifuge that can spin microplates,
a 37oC incubator for microplates, and a light source for reading final results
Based on solid-phase red cell adherence (SPRCA)
The target antigen (RBCs) is affixed to the bottom of the microplate wells
If patient plasma contains antibodies to the antigen, the antibodies attach to the fixed antigen.
Indicator cells detect attached antibodies by forming a monolayer of RBCs
If patient plasma contains no antibodies to the antigen, there is no attachment, and the indicator cells
form a clearly delineated button at the center of the microplate well
ALTERNATIVE TECHNOLOGIES AND AUTOMATION
IN BLOOD BANKS
ALTERNATIVE TECHNOLOGIES AND AUTOMATION IN BLOOD BANKS
COMPARISON OF TRADITIONAL AND ALTERNATIVE METHODS
ALTERNATIVE TECHNOLOGIES AND AUTOMATION IN BLOOD BANKS
COMPARISON OF TRADITIONAL AND ALTERNATIVE METHODS
ALTERNATIVE TECHNOLOGIES AND AUTOMATION
IN BLOOD BANKS
Affinity column testing - Red Cell affinity-column
Based on the principle of affinity adherence of Ig sensitized erythrocytes to an
immunologically active matrix
Major advantage include pre-filled strips, no washing after incubation, ease of use,
stable and reproducible results, less than 3 minutes of centrifuge time, and clear
differentiation between positive and negative results
Major disadvantage is the need to purchase a special centrifuge and incubation to
accommodate the microcolumn strips used for testing