Blood Banking Test 1: Chapters 11, 23, 25, 26 Flashcards Preview

Med Lab Tech Fall 2016 > Blood Banking Test 1: Chapters 11, 23, 25, 26 > Flashcards

Flashcards in Blood Banking Test 1: Chapters 11, 23, 25, 26 Deck (160):
1

What is the regulating agency for Blood Banking?

Food and Drug Administration

2

Blood Banking seeks accreditation from...

American Association of Blood Banks (AABB)

3

Definition: a facility involved in the collection, storage, processing, and distribution of human blood and blood products for transfusion

A blood bank laboratory

4

After collection, _____ ______ is allowed to cool to room temperature if ________ are to be prepared from the unit.

-Whole blood
-platelets

5

After collection, ______ ______ is cooled between 1C-10C if the unit is to be processed for ______ ______

-Whole blood
-frozen plasma

6

What is the difference between FFP and FP24 regarding preparation?

FFP must be prepared within 8 hours of collection of the whole blood unit
FP24 may be prepared up to 24 hours following collection of the whole blood unit

7

What is the required temperature for storing blood products such as whole blood, RBCs, or thawed plasma, in a refrigerator?

1C to 6C

8

What is the required temperature for storing frozen plasma and cryo in freezers?

-18C or lower

9

What is the required temperature for storing frozen RBCs in freezers?

-65C or lower

10

What is the required temperature for platelet incubators?

20C - 24C

11

True or False:
Tests must be performed at each donation regardless of the number of times a donor has previously donated.

True

12

True or False:
Labeling of blood products occurs only after there have been no discrepancies in the ABO and Rh testing.

False, there should be no discrepancies in ABO and Rh testing as well as the absence of detectable antibodies in the plasma-containing components, nonreactive viral marker tests, and nonreactive syphilis test

13

When a blood bank receives a shipment what are they required to do to each RBC-containing product?

Reconfirm the labeled ABO

14

The Rh type of all Rh-_______ units must be reconfirmed when a shipment is received at a blood bank

Rh-negative

15

A minimum of ___ identifiers is required for patient samples used for blood bank testing.

2 identifiers; The patient's full name and 1 other unique identifier

16

This type of routine testing allows better utilization of blood supplies; ABO and Rh testing and antibody screening are performed; the patient's transfusion record is checked; and if an antibody is detected the antibody is identified, and compatible units are reserved for the patient.

Type and Screen

17

This type of routine testing reserves completely tested and crossmatched blood for the patient

Type and Crossmatch

18

This type of routine testing includes determination of the ABO group and Rh type of the mother and antibody screen for antibodies that have the potential to cause HDFN

Prenatal Evaluation

19

This type of routine testing requires that all women admitted for delivery be tested to determine their Rh status. If mom is Rh-negative and baby is Rh-positive, the maternal sample is further evaluated to detect a fetomaternal hemorrhage (FMH)

Postpartum Evaluation

20

What 3 tests are used to test for FMH >30 mL whole blood?

Kleihauer-Betke Test, flow cytometry, or enzyme-linked antiglobulin test

21

What is required in order for blood components to be released to the designated recipient after pretransfusion testing is complete?

Written request with proper patient identification (2 unique identifiers)

22

What can an immune reaction to a drug, a disease state, or a delayed hemolytic transfusion reaction cause?

Positive DAT

23

What may mask the presence of clinically significant alloantibodies and requires the removal of RBC-bound autoantibody followed by serum autoadsorption?

Warm autoantibodies

24

What may cause ABO discrepancies, a positive DAT, and may mask clinically significant alloantibodies?

Cold autoantibodies

25

What requires the removal of RBC-bound autoantibody using 37C saline?

Cold autoantibodies

26

These are manuals outlining the operations of the laboratory.

Standard Operating Procedures (SOPs)

27

These devices produce sterile welds between two pieces of compatible tubing.

Sterile connecting devices

28

This process renders donor lymphocytes nonfunctional and protects against graft-versus-host disease.

Irradiation

29

RBCs stored in freezers maintained at -65C or lower are frozen in what?

40% glycerol

30

Some tissues require storage in an ultralow freezer at what temperature?

-80C or lower

31

Name 3 tests required for donor blood

-ABO and Rh
-Antibody screen
-serologic test for syphilis
-Hep B surface antigen (BCsAg)
-Antibodies to HIV
-Antibodies to human T-cell lymphotropic virus
-Antibodies to Hep C virus
-Antibodies to Hep B core antigen
- Hep C virus (HCV RNA)
- Human immunodeficiency virus (HIV-1 RNA)
-West Nile virus (WNV) RNA

32

What is a reference laboratory's goal?

To ensure that any discrepancies detected in routine testing are resolved in an accurate and time-efficient manner.

33

What is the shipping temperature requirement for plasma?

-18 or lower

34

Antibody serial titration studies are most often associated with which of the following blood bank test groupings:
A. Prenatal evaluation
B. Type and screen
C. Type and crossmatch
D. Blood unit processing

Prenatal evaluation

35

The prewarm technique is most useful in investigating which types of blood bank problems?

Cold antibodies

36

It is most important to perform weak-D testing in which of the following blood bank test groupings:
a. Type and screen
b. type and crossmatch
c. cord blood evaluation
d. prenatal evaluation

C. Cord blood evaluation

37

Which of the following is a method for determining approximate volume of fetal-maternal bleed:
a. Kleihauer-Betke test
b. Eluate testing
c. Nucleic acid amplification testing
d. Antibody screening

a. Kleihauer-Betke test

38

Which of the following may not be used as a patient identifier:
a. Patient's full name
b. Patient's date of birth
c. Patient's medical record number
d. Patient's room number

d. Patient's room number

39

Which of the following is not an enhancement media that may be used in antibody screening and identification:
a. albumin
b. low ionic strength solution (LISS)
c. normal saline
d. polyethylene glycol

c. normal saline

40

Which of the following methods may be useful in investigating a positive DAT:
a. elution techniques
b. removal of cell-bound antibody using chloroquine
c. drug studies
d. all of the above

d. all of the above

41

What are the building blocks of quality? (3)

-Quality control (QC)
-Quality assurance (QA)
-Quality management systems (QMS)

42

Blood bank compliance with federal regulations and accreditation standards is required by what organizations? (4)

-FDA
-The Joint Commission
-CAP
-AABB

43

Definition:
these programs evaluate how effectively the facility meets the requirements by detecting errors, deficiencies, and deviations.

Compliance programs

44

Definition:
these measure the state of the facility's program with respect to the applicable requirements at a single point in time and are usually conducted every 1 to 2 years

Compliance inspections

45

Definition:
A set of planned actions that ensure that systems and elements that influence the quality of the product or service are working as expected, individually and collectively.

Quality assurance (QA)

46

Definition:
an active and continuous process so the blood bank is always ready for an inspection.

Quality management (QM)

47

Definition:
requires the correction of identified deviations and deficiencies and usually leaves the facility with the false sense that it has solved its problems and is in compliance.

Compliance

48

Definition:
operational activities used to fulfill quality requirements

Quality control (QC)

49

Definition:
the system that keeps it all organized- procedures, processes

Quality management systems (QMS)

50

What temperature are refrigerators maintained at?

1-6C

51

What temperature are freezers maintained at?

-18C

52

How often do you review a chart recorder for regularity?

weekly

53

How often do you check the alarms on refrigerators and freezers?

daily

54

How often do you activate the alarm on refrigerators and freezers?

quarterly

55

These are kept at temperatures between 20-24C

Platelet incubators

56

If platelets are stored at ambient temperature, you must record the temperature every ___ hours.

4

57

What must be checked on centrifuges/cell washers on the day of use?

-Tube fill level
-Reaction check

58

What must be checked weekly for centrifuges and cell washers?

-Decontamination
-Saline fill volume

59

What must be checked quarterly on centrifuges and cell washers?

-Tach (rpms) and timing
-Global parameters

60

What is done annually on centrifuges and cell washers?

Calibration

61

Who mandates an environmental control program that addresses all significant environmental issues for facility management and maintenance such as temperature control, electrical safety, fire protection, and so forth?

The Joint Commission

62

A ________ can be defined as a set of interrelated resources and activities that transforms inputs into outputs.

Process

63

Definition:
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

64

Definition:
the evaluation of the performance of a process, comparison of actual performance to a goal, and action taken on any significant difference.

Total process control

65

These are kept at 37C

heat blocks, waterbaths, and thawbaths

66

These require that you check the temperature on day of use and rotate the thermometer to all holes over a period of time

Heat blocks and waterbaths

67

What requires that facilities design their processes and procedures to ensure that blood components are manufactured consistently to meet the quality standards appropriate for their intended use?

current Good Manufacturing Practices (cGMP)

68

________ graphically represent the sequence of activities in a process and show how the inputs are converted into outputs

Flowcharts

69

These provide instructions for each activity in the larger process

Standard operating procedures (SOPs)

70

Proficiency testing is an example of what?

Process control

71

Definition:
approved information contained in a written or electronic format. They define the QMS for external inspectors and internal staff. Ex: written policies, process flowcharts, procedures and instructions, etc.

Documents

72

This links a facility's policies, processes, and procedures and ensures that only the latest approved copies of documents are available for use.

Document control system

73

Definition:
Specially designed documents- either paper or electronic- on which are recorded the results or outcomes of performing a given procedure.

Forms

74

Each blood bank must have a process for detecting, reporting, evaluating, and correcting deviations and any nonconformance with its own procedures, products, or services. This is known as what?

Nonconformance management
(aka occurrence, incident, or variation management)

75

Definition:
The immediate action, which is the initial quick-fix solution

Remedial action

76

_______ measure the state of a facility's quality program with respect to the applicable requirements at a single point in time.

Assessments

77

What are 2 types of external assessments?

-Proficiency testing
-External audit

78

What is a type of internal assessment?

Internal audit

79

What are 2 "good" quality costs?

-Prevention costs
-Appraisal costs

80

What are 2 "bad" quality costs?

-Internal failure costs
-External failure costs

81

A QMS is :
a. synonymous with compliance
b. active and continuous
c. part of quality control
d. an evaluation of efficiency

b. active and continuous

82

QSEs are applied to:
a. Just the blood bank's management staff
b. Blood bank quality control activities
c. Only blood component manufacturing
d. The blood bank's path of workflow

d. The blood bank's path of workflow

83

cGMP refers to:
a. regulations pertaining to laboratory safety
b. validation of testing
c. nonconformance reporting
d. manufacturing blood components

d. Manufacturing blood components

84

Internal and external failure costs are:
a. Readily identifiable in facility reports
b. Controlled through prevention and appraisal
c. Built into the facility's operating budget
d. Part of prevention and appraisal

b. Controlled through prevention and appraisal

85

Which one statement below is correct?:
a. A process describes how to perform a task
b. A procedure simply states what the facility will do
c. A procedure informs the reader how to perform a task
d. A policy can be flowcharted

c. A procedure informs the reader how to perform a task

86

A blank form is a:
a. record
b. procedure
c. flowchart
d. document

d. document

87

An example of a remedial action is:
a. Applying the problem-solving process
b. Starting a process improvement team
c. Resolving the immediate problem
d. performing an internal audit

c. Resolving the immediate problem

88

The PDCA cycle is used for:
a. problem resolution
b. process control
c. validation
d. auditing

a. Problem resolution

89

The difference between the blood bank and laboratory QMSs is that:
a. The laboratory has a different path of workflow
b. The blood bank does not include computer systems
c. The QSEs are different
d. The blood bank excludes testing

a. The laboratory has a different path of workflow

90

The QSEs for the blood bank QMS can be used for the laboratory because:
a. The paths of workflow are identical
b. Both the laboratory nd blood bank experience accreditation inspections
c. The QSEs are universal
d. The QSEs are required by international standards

c. The QSEs are universal

91

The United States government's principal health agency for protecting the health of all Americans

The Department of Health and Human Services (DHHS)

92

These 4 agencies are the primary agencies of the DHHS with responsibilities directly related to blood.

-CDC
-FDA
-CMS
-NIH

93

What agency promulgates and enforces regulations to ensure the safety and efficacy of biological products, drugs, and devices, which include human blood and blood components, blood collection supplies and instruments, blood establishment computer systems, blood bank reagents, and infectious disease tests?

The FDA

94

What are the five overlapping layers of blood transfusion safety?

-Donor screening
-Blood testing
-Donor lists
-Quarantine
-Problems and deficiencies

95

Definition:
any legal person or entity engaged in the manufacture of biological products

Biological product manufacturers

96

The Biologics Control Act of 1902 was passed following what incident?

The deaths of 13 children who received injections of diphtheria antitoxin contaminated with tetanus

97

A drug or device is ________ if its labeling is false or misleading.

Misbranded

98

A drug is _______ if the methods used in its manufacture do not conform with cGMP to ensure the drug is safe, and has the identity and strength, and meets the quality and purity characteristics which it is represented to possess

Adulterated

99

Definition:
"any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product or arsphenamine or derivative or arsphenamine (or other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or condition of human being" (42 USC 262(I)).

Biological products

100

Definition:
act passed by Congress and signed into law by the President to establish the FDA and to grant the agency authority to fulfill its mission.

Statutes

101

Definition:
An interpretation of the statutes and are legally binding on both the manufacturing industry and the government agencies charged with enforcing the laws

Regulations

102

Proposed and final regulations are published in the ______ _______

Federal Register (FR)

103

These describe the agency's interpretation of or policy on a regulatory issue.

Guidance documents

104

Regulates allergenic products, cellular and gene therapy products, human tissue and tissue products, vaccines, and blood and blood components.

CBER- Center for Biologics Evaluation and Research

105

Regulates blood components for transfusion, blood components for further manufacturing, and medical devices used for blood component collection and manufacturing

Office of Blood Research and Review (OBRR)

106

Who conducts pre-license and pre-approval inspections, routine cGMP inspections, and for-cause inspections?

The FDA

107

What are 3 types of FDA actions?

-Advisory
-Administrative
-Judicial

108

Class I, II, or III recall:
Situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

Class I

109

Class I, II, or III recall:
Situation in which use of the product may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote

Class II

110

Class I, II, or III recall:
Situation in which use of the product is not likely to cause adverse health consequences

Class III

111

Blood and blood component manufacturers should initially notify ____ of any transfusion-related fatalities or donation-related deaths.

CBER

112

CAP, AABB, and CLIA sanctioned are all _______ ______

Voluntary agencies

113

Which of the following is responsible for overseeing the safety of the nation's blood supply?
a. Joint Commission on Accreditation of Healthcare Organizations
b. Food and Drug Administration
c. College of American Pathologists (CAP)
d. Occupational Safety and Health Administration

b. FDA

114

Where are the regulations for blood and blood components published?
a. The AABB technical manual
b. CAP inspection checklist
c. The Code of Federal Regulations
d. State Inspectional Guidance Documents

c. The CFR

115

What was an important tragedy that prompted Congress the enact the Public Health Service Act?
a. 3 patients contracted Hep C following transfusion
b. A child died following transfusion of hemolyzed RBCs
c. A group O patient received group A blood
d. 13 children died after receiving diphtheria antitoxin contaminated with tetanus

d. 13 children died after receiving diphtheria antitoxin contaminated with tetanus

116

What is require to ship blood and blood components across state lines (interstate)?
a. AABB accreditation
b. State license
c. CMS certification
d. Approved Biologics License Application

d. Approved Biologics License Application

117

Which of the following government organizations inspect blood and blood component manufacturers?
a. CBER
b. ORA
c. CMS
d. all of the above

c. CMS

118

Which of the following is true about CGMP?
a. CGMP is the minimum current practice for methods and facilities used to manufacture a drug to ensure that it is safe, pure, and potent
b. The FDA will approve a Biologics License Application if the manufacturer does not have a quality control plan
c. The quality control unit must perform all the quality functions
d. Blood and blood components do not have to be in compliance with the drug CGMP regulations

a. CGMP is the minimum current practice for methods and facilities used to manufacture a drug to ensure that it is safe, pure, and potent

119

A donor calls the blood bank and informs them that within a year prior to his donation, he had intimate contact with a person diagnosed with HIV. Which of the following action is NOT required by the FDA?
a. Identify and quarantine all blood and blood components produced from the blood supplied by the donor
b. Report the biological product deviation to CBER if the product has already been distributed
c. Enter the donor in a record so that he can be identified and his product not be distributed while he is deferred
d. Notify the AABB

d. Notify the AABB

120

A patient dies following transfusion of ABO-incompatible blood. To whom should this event be reported?
a. CBER
b. CMS
c. AABB central office
d. OSHA

a. CBER

121

Which federal agency has the responsibility to routinely inspect an unregistered transfusion service that does not collect blood?
a. FDA
b. CMS
c. OSHA
d. State health department

b. CMS

122

Which of the following is NOT one of the FDA layers of safety?
a. Donor screening
b. Biologics License Application
c. Investigation of manufacturing problems
d. Infectious disease testing

b. Biologics License Application

123

What allows users to perform tasks that are specific to blood bank operations?

Application software

124

Definition:
An organized set of information divided into files and further subdivided into records

Database

125

What type of files contain records related to a specific donor, patient, or blood component?

Dynamic files

126

What type of files contain information that is updated infrequently, such as the list of blood products used in the facility?

Static files

127

Most systems are equipped with both a ____ or production database and a ____ database.

-Live
-Test

128

This database contains real information

Production (live)

129

This database contains fictitious records

Test

130

Definition:
Unique identification number, type of donation made, occurrence of a donor reaction, autologous or designated donation

Donation Data

131

Definition:
Donors with a specific ABO group, other RBC antigen type, or cytomegalovirus (CMV) seronegativity

Donor Recruitment

132

This system can aid in the selection of blood components that will satisfy special transfusion needs and are ABO/Rh compatible

Blood Component Reserve

133

Definition:
The series of exercises that will be used to validate the blood bank software
Should be created for each function or operation that the computer will perform

Test Plan

134

Definition:
Assess the system under normal operating conditions but must also offer challenges to the system

Test Cases

135

This type of testing uses typical blood bank inputs to produce normal, or routine, outputs

Normal Testing

136

This type of testing involves forcing the system to evaluate data that are slightly below or slightly above valid ranges

Boundary testing

137

This type of test case assess the system's ability to recognize and to reject incorrect inputs

Invalid testing

138

These types of tests cases are those that make the system ready to unusual inputs

Special Test Case

139

This testing pushes the system to its physical limits

Stress testing

140

This type of testing involves running 2 systems in parallel and comparing the outputs of both

Parallel testing

141

What are 2 reasons parallel testing may be done?

-A blood bank is switching from a manual to a computerized system
-When switching from a previous information system to a new system

142

What are the 3 main functions performed by hardware components?

-Processing
-Input and output
-Storage

143

What is the central hardware component of a computer system?

Central processing unit (CPU)

144

This type of memory contains the "start-up" instructions for the computer

Read-only memory (ROM)

145

This type of memory is an array of chips in which Dara are temporarily entered while they are being processed

Random access memory (RAM)

146

This type of memory is data saved on a medium from which they can later be retrieved, such as a hard disk.

Long-term memory

147

Definition:
An organized set of information divided into files and then further subdivided into records

Database

148

What do blood component modifications include? (5)

-Irradiation
-Leukocyte reduction
-Aliquoting (dividing)
-Washing
-Pooling

149

Definition:
Decisions made by the system without human intervention

Process control functions

150

These functions occur when the system displays information to the user, who then decides on the next course of action

Decision support control functions

151

Components of an information system consist of all the following except:
a. Hardware
b. Software
c. Validation
d. People

C. Validation

152

To be in compliance with regulatory and accreditation agency requirements will for blood bank information systems, blood banks must maintain SOPs for all of the following except:
A. Vendor validation testing
B. Computer downtime
C. System maintenance
D. Personnel training

A. Vendor validation testing

153

A validation t4est case that assesses the system's ability to recognize an erroneous input is called:
A. Normal
B. Boundary
C. Stress
D. Invalid

D. Invalid

154

An example of interface software functionality is:
A. The entry of blood components into the blood bank
B. The transmission of patient information from the HIS into the blood bank system
C. The printing of a workload report
D. Preventing access to the system by an unauthorized user

B, the transmission of patient information from the HIS into the blood bank system

155

Backup copies of the information system:
A. Can be used to restore the information system data and software if the production system is damaged
B. Are used to maintain hardware components
C. Are performed once a month
D. Are created any time changes are made to the system

A. Can be used to restore the information system data and software if the production system is damaged

156

User passwords should be:
A. Share with others
B. Kept confidential
C. Posted at each terminal
D. Never changed

B. Kept confidential

157

Preventing the issue of an incompatible blood component is an example of:
A. Inventory management
B. Utilization review
C. System security
D. Control function

D. Control function

158

Information is stored in a collection of many different files called the:
A. Database
B. Configuration
C. Hardware
D. Disk drive

A. Database

159

Application software communicates with this type of software to retrieve data from the system disks:
A. Interface
B. Operating system
C. Security
D. Program

B. Operating system

160

Validation testing for software should consider all of the following items except:
A. Data entry methods
B. Control functions
C. Performance of testing in production database
D. Invalid data

B. Control functions