Philippine Blood Coordinating Council TOTAL QUALITY MANAGEMENT in Blood Service Facilities

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Philippine Blood Coordinating Council

TOTAL QUALITY MANAGEMENT in Blood Service Facilities

TOPICS:

1. Introductions to Quality in Blood Banking- Dr. Gary U. Ong


2. Quality systems in Blood Donor Management- Dr. Gary U. Ong
3. Donor Recruitment, Selection - Dr. Gary U. Ong
4. Blood Safety – Dr. Francis Dematera
5. Immunohematology and Pretransfusion Testing- Dr. Francis Dematera
6. Transfusion Transmitted Diseases - Dr. Francis Dematera
7. Universal Precautions in Laboratory Practices - Dr. Gary U. Ong
8. Critical points in Blood Collection - Salvador Aydante Jr.,RMT
9. Critical Points in Unit Processing- Salvador Aydante Jr.,RMT
10. Release and Transport of Blood Units- Lurdel Y. Posadas, RMT
11. Pre and Post Donation Counselling - Dr. Gary U. Ong
12. Hemovigilance- Dr. Gary U. Ong
13. Unit Selection and Assessing Quality in Transfusion- Kathyrine Pascual,RMT
14. Leukoreduction and Irradiation- Kathyrine Pascual,RMT
15. SOP documentation- Lurdel Y. Posadas, RMT
16. Audits –Aldrin L. Bigay ,RMT
17. Inventory Management- Lurdel Y. Posadas, RMT
18. Error Management- Aldrin L. Bigay ,RMT
19. Resource Management - Aldrin L. Bigay ,RMT

Objectives:

 To develop capabilities of donor recruitment officers on public education, motivation,


recruitment, and retention of voluntary, non-remunerated blood donors.
 To improve the clinical effectiveness of blood products and services in Blood service
facilities through quality laboratory and blood banking practices.

1. Introductions to Quality in Blood Banking- Dr. Gary U. Ong

Blood Safety is a global concern set by the World Health Organization in this region. WHO has
given much priority in promotion of voluntary, non-remunerated blood donation, laboratory
practices and blood transfusion aspects in our country.
The training has given strong importance on the Hierarchy of Quality wherein Total Quality
Management is the highest point to achieve.
Total Quality
Management

Quality System

Quality Assurance

Quality Control

Elements of Quality System (WHO)

Organizational Standards
Management

PROCESS
Training Assesment

DOCUMENTATION

Lesson Learned: Here in the Philippines RA 7719 known as National Blood Service Act of 1994
supports the advocacy of the WHO in which paid donors are transformed into voluntary blood
donors in order to provide safe blood to the people.

2. Quality systems in Blood Donor Management- Dr. Gary U. Ong


We want SAFE BLOOD..ONLY
This topic focused on how to provide quality products in blood banks which is safe and adequate
blood supply. Applying such quality system in blood donor managent will be a great help to
attain this goal.
1) Organizational Management
Policies on blood donor management
Identification of specific staff requirements
2) Quality Standards
Guidelines on Blood Donor Recruitment
Donor selection criteria
Blood collection
3) Training of staff in blood donor management
4) Documentation on donor management
In all activities
5) Assessment
Validation of equipment, materials procedures and software.
Monitoring and evaluation of donor management activities
Analyse the data.

Lesson Learned: A well-organized blood transfusion service, with quality systems in all areas is a
prerequisite for the safe and effective use of blood and blood products.

3. Donor Recruitment, Selection and Retention- Dr. Gary U. Ong


Donor recruitment officers play a vital role in every blood service facilities. It must be well
trained staffs that are in charge in the selection and retention of voluntary donors. Also,
assessment and outcomes of the donor selection process must be fully documented.
Here, are some of the indicators for success of donor recruitment selection and
retention policies and strategies:
 Increase in overall donors number
 Increase in number of voluntary non-remunerated donors
 Increase in number of times donors return to donate(retention rate)
 Decrease in seroprevalence of TTIs in the donor base

Blood service facilities are also required to have a Donor Counselling and Care program.
That includes the following:

 Pre-donation information – increase donor awareness of the Blood Service


Facility responsibility to ensure donors health and safety and confidentiality,
explain the rationale of each blood process and the importance of the safety of
donated bloods for transfusion recipients which can be achieve through donor
adherence to donor selection criteria relating to their health and risk for
transfusion transmitted infections.
 Counselling during donation process- ensure that donors feel comfortable
during blood donation and reduce donors anxiety that minimizes the risk of any
adverse donor reaction.
 Post donation counselling- explains the test results, the health implications for
the donor and the donated blood and the suitability of the donor for future
blood donation. Also, to secure donors cooperation in the confidential unit
exclusion or post donation process.
 Donor’s retention- it is said to be more cost effective than donor recruitment
for it is the key to a sustainable blood supply. Regular donors are “safer “than
new.

Lesson Learned: In order to deliver quality outcomes every BSF must achieve a high
donor satisfaction; they must feel valued, respected and acknowledged.

4.Blood Safety – Dr. Francis Dematera

A well-organized blood transfusion service with quality systems in all areas is a


prerequisite for the safe and effective use of blood and blood products.

So these are some of the activities a BTS must focus on:

 Training of staff in the blood donor unit


 Identification of donor populations at low risk for TTI’s
 Develop educational materials
 Establish a registry of voluntary non-remunerated blood donors
 Appointment of quality assurance officer
 Development of protocols and teams for the testing, selection and evaluation of
appropriate screening assays
 Systematic procurement, supply ,storage and distribution of reagents and materials
 Maintenance of effective distribution (cold chain) for the transport of blood products.

Lesson Learned: In order to adhere to these here are the overall strategies every
country needs:

 Establishment of a nationally-coordinated blood transfusion service.


 Collection of blood only from voluntary donors.
 Testing of all donated bloods.
 Reduction of unnecessary transfusion through the effective clinical use of blood.

5. Immunohematology and Pretransfusion Testing- Dr. Francis Dematera


In serologic testing, hemaglutination is the single most important in vitro immunologic
reaction in blood banking which is designed to detect RBC antigens and antibodies. Currently
there are 3 methods for evaluating visual hemaglutination reactions:
1. Tube testing
2. Column agglutination (gel technology)
3. Solid-phase technology

Lesson Learned: Pre-transfusion testing is a vital process in selecting blood components that will not
cause harm to the recipient and will have acceptable survival when transfused. Confirming ABO
compatibility between the component and the recipient and detect most clinically significant
unexpected antibodies is the main concern of pre-transfusion testing.

6. Transfusion Transmitted Diseases - Dr. Francis Dematera

Currently, here are the common TTI’s being screened in most countries:

1. Hepatitis B virus
3 clinical useful test to identify infection
 HBsag-antigen ,anti-HBs-antibody
 HBcAg- antigen, anti-HBc IgM, anti-HBc IgG-antibody
 HBeAg-antigen, anti HBeAg-antibody
2. Hepatitis C virus
 Anti- HCV-antibody
 Nucleic acid Testing-confirmatory test.
3. HIV
 Nucleic acid-based tests amplify and detect one or more of several target sequences
located in specific HIV genes.
4. Syphilis
 Non-treponemal- measure Ab to cardiolipin.
e.gRPR,VDRL
 Treponemal
e.g T.pallidum enzyme immuneassay test

5. Malaria

 Lab diagnosis:
 Giemsa stained blood film-gold standard
 Rapid Diagnostic Tests

Other TTI’s

1. Human T-cell Lymphotropic Virus


2. Cytomegalovirus
3. Parvoviris B19
4. West Nile Virus
5. Babesiosis
6. Chagas Disease

 PCR.
Lesson Learned:

WHO has set key recommendation to all countries around the world to prevent the spread of
transfusion transmitted infections.
 Screening of all blood donations should be mandatory
 There should be national system for the evaluation and validation of all assays used for
blood screening
 The minimum sensitivity and specificity level for screening preferably not less than
99.5%.
 All reactive components should be stored separately for confirmatory testing
counselling and referral for treatment.

7. Universal Precautions in Laboratory Practices - Dr. Gary U. Ong


This assessment includes a review of the practices and procedures that are appropriate to
promote laboratory safety. Here are the core topics:
 Orderliness and labelling
 Fire safety
 Emergency preparedness plan
 Entry restrictions
 Personal protective equipment
 Steps in glove removal and disposal
 Waste management
 Color coding scheme
 Sharps disposal
 Needle stick injury
 Spills
 Treatment and disposal of blood units
 Hand hygiene

The 5S Steps
Sort – Determine what is needed and what is not needed. Remove unnecessary items and dispose them
properly.
Set in Order – “A place for everything and everything in its place” – Control at glance.Arrange necessary
items in good order
Shine – Structured cleaning roster performed routinely. Clean your work place and equipment.
Standardise – Maintain a high standard of housekeeping and workplace at all times.
Self discipline- Do things spontaneously without being told or ordered

Lesson Learned: “Routine Practices,” also known as “Universal Precautions” or “Infection


Control Procedures,” refer to practices that help prevent the spread of infections between
service providers and their clients, usually in healthcare settings. These precautions protect both
the healthcare worker and the client during times when body fluids may be present.

8. Critical points in Blood Collection - Salvador Aydante Jr.,RMT


It is the point where failure of standard operation procedure could cause harm to products,
customers and to the facility.
The discussion focuses on these core topics:
 Pre-donation checks of equipment and materials
 Donor identification
 Donor arm cleansing
 Venipuncture and blood collection
 Care of the donor
 Handling of samples
 Quality issues at mobile blood donation

Lesson Learned: A failure at any of these points will potentially affect the quality and safety of
the final blood product no matter how controlled the manufacturing process.

9. Critical Points in Unit Processing- Salvador Aydante Jr.,RMT


In this phase we discussed about the:

Facilities and equipment


Component processing area
Pre-processing check
Selection of methodology

Lesson Learned: All activities associated with the processing of blood components
must be well-controlled and documented.

10. Release and Transport of Blood Units- Lurdel Y. Posadas, RMT


Blood is a perishable commodity. Therefore, it must be stored and transported at a proper
temperature
In here, we tackled carefully the transport and storage of blood components, Air circulation,
Cold chain, paper test returned and reissued blood

Lesson Learned: The blood cold-chain is a process that begins at the time of collection and continues
until the unit is transfused.
11. Pre and Post Donation Counselling - Dr. Gary U. Ong
Here are the principles of Pre and Post Donation Counselling:
To maintain the safety of blood supply
To protect the health of the VNRBD
To fullfill the ethical requirements

Lesson Learned: Those found to have and HIV infection are referred to the HIV Action Core
Team. (HACT).If reactive to hepatitis B and C, they encouraged to enrol in the Liver Study Group.

12. Hemovigilance- Dr. Gary U. Ong


From the word “hemo”-blood
“Vigilance”- watchfulness
A surveillance system for detecting, reporting and investigating adverse events and near
misses related to all blood transfusion activities in order to correct their cause and prevent
recurrence. It also aims to improve the quality and safety of transfusion, motivate clinicians to
pay more attention to improving practices, aid in formulation of guidelines and improve public
confidence.

Lesson Learned: To be effective, hemovigilance requires open, honest reporting and


investigation and depends upon the traceability in the hospital and the blood service.

13. Unit Selection and Assessing Quality in Transfusion- Kathyrine Pascual,RMT


We discussed here about the uses of different blood components such as:
Whole blood- > 50% of blood loss in less tha 3 hours
Packed RBC-symptomatic anemia, acute blood loss
Leukocyte reduced-immunocompromised patients
Irradiated RBC- direct donations for rare blood type. Prevents GVH
Platelet concentrate-thrombocytopenia
FFP- coagulation factor deficiencies
Cryoprecipitate- Haemophilia A

14. Leukoreduction and Irradiation- Kathyrine Pascual,RMT

Any production, method, or process that derease the amount of WBC in the blood component.
Here are the benefits of luekoreduction:
 Prevention of febrile non-hemolytic transfusion reaction
 Prevention of HLA alloimmunization and platelet refractoriness
 Prevention of leukocyte transmitted infections.

15. Lesson Learned: pre-storage LR can be considered equivalent to serologically negative CMV
allogeneic transfusion.

SOP documentation- Lurdel Y. Posadas, RMT


SOP’s are written instructions for the performance of a specific procedure.
It should be written by the process owner.
This topic focuses on the format of these documentations:
 Standard template and elements
 Coding sample
 Document controls
 Flowcharts

Lesson Learned: Having a system of retention and disposition of records consistent with the National
Archives of the Philippine guidelines.

16. Audits –Aldrin L. Bigay ,RMT


An audit collects information about current practice, analyses the information according to the
standard practice.
Types:
 Internal audit(first party)-by staff from the same organization
 External audit (second party)-audit of supplier
 External audit (third party)audit by regulatory body(DOH)

Benefits:

 Continuous improvement
 Independent view
 Communication
 A means of discussing problems
 Increase staff confidence
 Improve understanding of the use and value of standards
 Focuses minds on quality

Lesson Learned: Audit outcomes must continue quality improvement, the organizations operation
becomes more efficient, staff motivation improves and everyone is happy.
17. Inventory Management- Lurdel Y. Posadas, RMT
Inventory is the number of blood units of any one type that are in the blood bank on a given
day.
Minimal inventory levels; Method of estimating:
 Average weekly use
 Average daily use
 Moving average

Lesson Learned: The greater the number of units, the higher the potential of outdating.
The fewer the units in the inventory, the more frequent the shortages and the greater the need for
emergency blood units.

18. Error Management- Aldrin L. Bigay ,RMT

RECOMMENDATIONS:

Blood service facilities must focus on retention of low risk blood donors because voluntary blood donors
from low risk populations who give blood regular are the foundation of a safe and adequate blood
supply.
More training for blood service facility staffs

Cold chain must be practice properly by purchasing good transport containers for the distribution of safe
and quality blood supplies.

Elective Transfusions must only do by night for most technical errors happens at night time.

Systematic procurement, supply, storage and distribution of reagents and materials.

Commitment to the prevention, early diagnosis and treatment of conditions that could result in the
need of transfusions. (Obstetrical, complications and traumas)

Hospital Blood transfusion committee must monitor and evaluate the clinical use of blood to reduce
unnecessary transfusion and use of blood products.

Nucleic acid testing

LAB

1. In releasing blood, 3 witnesses are requires 2MT 1 Nurse/NA


2.

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