LAB1 - Blood Bank Quality Management Flashcards

1
Q

Rules in Blood Banking/ Factors to Consider in BBQM

A

a) Safe, satisfying donation experiences for blood donors
b) Accurately labeled and tested blood components provided to transfusion services
c) Timely, accurate transfusion services provided to physicians and other health-care personnel
d) Safe and efficacious blood transfusions to
patients

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2
Q

different foundation in BB

A

a) Quality control (QC)
b) Quality assurance (QA)
c) Quality management system (QMS

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3
Q

ensuring that each of the routine test w must manage the ____ in terms of the daily activities we need to perform

A

QUALITY CONTROL

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4
Q

main objective of QUALITY ASSURANCE

A

quality of the product or service

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5
Q

once the QC and QA are systemized, we’ll get

A

quality management system

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6
Q

Governing Agencies in relation to Blood Banking

A

United States Food and Drug Administration (FDA)
The Joint Commission
College of American Pathologists (CAP)
AABB (formerly known as American Association of Blood Banks)

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7
Q

the agency that make rules regarding anticoagulants, and certifies the machines we used

A

United States Food and Drug Administration (FDA)

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8
Q

The Joint Commission is known before as

A

JCAHO - joint commission on accreditation of healthcare organizations

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9
Q

this agency maintains the physical facilities a s well as the blood bank environment

A

The Joint Commission

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10
Q

__are the Head of Laboratory

A

Pathologists

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11
Q

Most followed governing agency when it comes
to BB standards/ guidelines/accreditation e

A

AABB - Association for the Advancement of Blood & Biotherapies

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12
Q

AABB old term

A

american association of blood banks

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13
Q

Most important one

A

AABB - association for the advancement of blood and biotherapies

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14
Q

Compliance VS Quality Management

evaluate how effectively facilities meet regulatory standards and accreditation

A

Compliance

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15
Q

Compliance VS Quality Management

a requirement by detecting errors deficiencies,
and deviations

A

Compliance program

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16
Q

Compliance inspection

A

Aka Service/ or Assessment

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17
Q

Compliance inspection is done every how many years `

A

2 yrs

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18
Q

measure the state of the facility’s program with
respect to the applicable requirements

A

Compliance inspections

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19
Q

what are the different governing agencies in pH setting

A

▪ PH Blood Coordinating Council
▪ DOH
▪ NVBSP - national voluntary blood services program

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20
Q

▪ PH Blood Coordinating Council
▪ DOH
▪ NVBSP - national voluntary blood services program

this provides ____

A

standardization in the field of transfusion medicine here in pH

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21
Q

the governing agency that provides training in blood bank and even seminars is the

A

Ph blood coordinating council

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22
Q

is actively and continuously practiced by
blood bank leaders, managers, and staff throughout all blood bank
operations.

A

Quality management

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23
Q

Routine blood bank QC procedure

A

✓Daily testing the reactivity of blood typing reagents.
✓Calibrating serologic centrifuges;
✓Timer checks
✓Monitoring temperatures
✓Manufacturers’ package inserts,
✓Regular performance of QC

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24
Q

how many phases we have in manual crossmatching

A

3 phases

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25
3 factors of Quality Management
Quality System Quality Assurance Quality Control
26
Organizational structure, procedures, processes, and resources needed to implement quality management
Quality System
27
Planned, systematic activities implemented within the quality system to provide confidence that requirements for quality will be fulfilled
Quality Assurance
28
Operational techniques and activities used to fulfill the requirements for quality
Quality Control
29
creating your own QC is called as
Individualized Quality Control Plan (IQCP)
30
owned QC plan
Individualized Quality Control Plan (IQCP)
31
factors in making Individualized Quality Control Plan (IQCP)
1. laboratory risk assessment 2. Pre-analytic, Analytic, and Post-Analytic Processes 3. Customize its QC program
32
factors that needs to undergo risk assessment
specimen reagent test system environment testing personnel competency staffing
33
In risk assessment, we are assessing the specimen. What are the things we need to consider in terms of the specimen
Patient Preparation Specimen Collection Specimen Labelling
34
In risk assessment, we are assessing the reagent. What are the things we need to consider in terms of the reagent
Shipping and receiving Storage Condition Preparation
35
In risk assessment, we are assessing the TEST SYSTEM. What are the things we need to consider in terms of the TEST SYSTEM
Failure of System Checks Detection of Clots, Hemolysis and Lipemia Transmission of Data to LIS
36
the easiest way for the medical practitioner to read the result
LIS - laboratory information system
37
In risk assessment, we are assessing the ENVIRONMENT What are the things we need to consider in terms of the ENVIRONMENT
a) Temperature b) Airflow/Ventilation c) Humidity
38
In risk assessment, we are assessing the TESTING PERSONNEL What are the things we need to consider in terms of the TESTING PERSONNEL
a) Training – Philippine Blood Coordinating Council (PH) b) Competency c) Staffing
39
Quality Control Plan (QCP) we mst consider the following
❑The number and type of QC testing materials ❑The frequency of testing ❑The criteria for acceptable QC results
40
Quality Assessment we must consider the following
❑Proficiency testing records and QC results ❑Turnaround time reports ❑Personnel competency record ❑Corrective action reports
41
Proficiency testing records and QC results (Monitor and assess effectiveness of Individualized Quality Control Plan – IQCP)
Quality Assessment
42
turn around time of crossmatching
3 hrs
43
it is about the o Incident Reports
Corrective action reports
44
Quality Assurance measures the performance of ____
❑Performance of a test method ❑Performance of an equipment
45
Set of planned actions that ensure that systems and elements will influence the quality of the product or service
Quality Assurance
46
Common QC Activities in donor collection, we have the following
o Microhematocrit instrument controls o Hemoglobin instrument controls o Apheresis equipment function check o Blood-weighing scales accuracy
47
special technique : only ONE blood component is given to blood ban
Apheresis
48
Common QC Activities in Blood Components , we have the following
a) Red blood cell hematocrit b) Cryoprecipitated antihemophilic factor c) Platelet counts in platelet units d) Residual leukocyte counts in leukocyte reduced components e) Bacterial contamination of platelet units (Prone to contamination → room temperature only)
49
ideal Blood Bag weight ( how many ml)
450mL
50
in a 450mL blood bag, how much anticoagulant is in there
63 ml
51
in a 400mL blood bag, how much anticoagulant is in there
70 ml
52
What blood component is the most prone to bacterial contamination?
Platelet concentrate because its stored in room temp
53
bacteria that will contaminate the platelet concentrate
staphylococcus epidermidis bacillus cereus
54
Common QC Activities in Reagent Controls , we have the following
o Copper sulfate o Reagent red blood cells o Reagent antisera o Test kits for infectious disease test
55
a reagent control that is Used in hemoglobin detection
Copper sulfate
56
the reagent control that Used in MBD (mobile blood donations) – like ones done in schools, covered courts to check patient Hg instead of machines
Copper sulfate
57
shelf life of platelet concentrate and the granulopheresis
5 days for platelet concentrate and 24 hrs for granulopheresis
58
Common QC Activities in ENVIRONMENT , we have the following
o Heating instruments o Water bath o Thawing devices for blood component o pH meters o Cell counter o Centrifuges o Cell washers o Blood irradiators o Refrigerators o Freezers o Platelet incubators o Blood warmers o Shipping containers
59
we used this to prevent graft vs host disease
Blood irradiators
60
Blood should be ___before release to nurses
warmed - we use blood warmers
61
Shipping containers ▪ ____is commonly used in PH
STYROFOAM
62
Shipping containers ▪ STYROFOAM is commonly used in PH ▪ Capacity is around only ___
2 bags
63
the transportation temperature is
1-10 * Celcius
64
QA Indicators
1. Number of donor forms with incomplete or incorrect information 2. Number and types of unusable units and blood components 3. Number of blood typing discrepancies in donor and patients 4. Number of and reasons for invalid tests ▪ Number of and reasons for labeling check failures 5. Number and source of improper and incomplete request for blood components 6. Number and location of patients without proper identification at time of specimen collection or transfusion 7. Number of, source of, and reasons for unacceptable specimens 8. Number of times wrong component or ABO was selected for crossmatch or use 9. Number and type of transfusion complications 10. Number of and reasons for turnaround time failures
65
preferred specimen for crossmatching
serum
66
we need to keep the sample in the laboratory for about how many days (free transfusion testing)
7 days
67
free transfusion testing samples has an expiration of how many days
3 days
68
Provides a framework for applying quality principles and practices uniformly across all blood bank operations,
Quality Management System
69
starting with donor selection and proceeding through transfusion outcomes.
Quality Management System
70
goal of transfusion services
0% error
71
Quality Management System Essentials
Physical Facilities Hires Qualified Personnel Materials and Equipment Documents for Work Performance
72
QMS Essentials
o Organization o Resources o Equipment o Suppler and customer issues o Process control o Documents and records o Deviations, nonconformances, and adverse events o Assessments: Internal and external o Process improvement through corrective and preventive action o Facilities and safety
73
Blood Bank Operations
o Donor qualification o Autologous donor qualification o Apheresis donor qualification o Blood collection o Cytapheresis collection o Preoaration of components o Testing of donor blood o Final labeling o Final inspection before distribution o Patient samples and request o Serologic confirmation of donor blood ABO/D o Pretransfusion testing of patient blood o Selection of compatible blood and components for transfusion o Crossmatch o Special considerations for neonates o Selection in special circumstances o Issue for transfusion o Blood administration o Rh-immune globulin
74
refer to those transfusions in which the blood donor and transfusion are the same (rare phenotypes, rare blood types)
AUTOLOGOUS DONATION
75
Donor donates their own blood in advance to be given to themselves in the future
AUTOLOGOUS DONATION
76
Usually done before surgeries (to avoid discrepancies in blood)
AUTOLOGOUS DONATION
77
AUTOLOGOUS DONATION is also known as
donor patient
78
AUTOLOGOUS DONATION how many days stable and replenishment
3 days stability and 45 days replenishment
79
refer to blood transfused to someone other than the donor
ALLOGENIC DONATION
80
Relationships among blood bank personnel by job title
Organization
81
Costumer Focus of Blood centers
donors
82
Costumer Focus of transfusion services
physician and nurses
83
customer focus of all types of facilities
internal customers = blood bank personnel
84
who want the correctly issued blood components in a timely manner for administration to patients.
Nurses
85
Facilities components
* Temperature Control * Electrical Safety * Fire Protection
86
Safety components
* Emergency Preparedness * Chemical Hygiene * Infection Control
87
What governing agency is in charge of mandating the physical facility management and maintenance of Blood Banks?
The Joint Commission
88
Personnel components
❑Educational qualifications, ❑Experience, and federal state, ❑Local licensing requirements
89
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. 6. Assessment of problem-solving skills.
90
Purchasing and Inventory components
❑Inventories of reagents, supplies and blood components ❑Selecting vendors of equipment, supplies and services ❑Blood centers must also have processes for receipt, inspection, and testing
91
Equipment components
❑Installation qualification demonstrates that the equipment is correctly installed. ❑Operational qualification ensures the equipment operates as intended. ❑Performance qualification evaluates the personnel, procedures, and supplies in the facility work environment. ❑Schedules for calibration, preventive maintenance, RPM and timer checks, and monitoring of temperature-regulated equipment are required
92
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.
Process control
93
is the evaluation of process performance, comparison of actual performance to a goal, and action taken on any significant difference
total process control
94
blood bank path of workflow
1. Component Collections 2. Preparation 3. Testing 4. Labeling 5. Distribution 6. Compatibility Testing 7. Issue 8. Administration
95
QUALITY SYSTEM ESSENTIAL BUILDING BLOCKS THE BLOOD BANK
* Organization (relationships) * Customer Focus * Facilities & Safety * Personnel * Purchasing & Inventory * Equipment
96
QUALITY SYSTEM ESSENTIAL BUILDING BLOCKS The Work
* Process Management * Documents & Records (keeping files) * Information Management
97
QUALITY SYSTEM ESSENTIAL BUILDING BLOCKS The Performance
* Nonconformance Management * Assessments * Continual Improvement