Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Mercy CLS 4: Blood Bank > 12. QC & orientation > Flashcards

12. QC & orientation Flashcards

1
Q

enforces the code of federal regulations and federally established laws

A

Food and Drug Administration (FDA)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

performs lab-wide inspections to monitor compliance with quality performance standards

A

College of American Pathologists (CAP)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

emphasis on standardization and quality of technical aspects of blood banking

A

Association for the Advancement of Blood and Biotherapies (AABB)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

local professional organization with Mary as president

A

Heart of America Association of Blood Banks (HAABB)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

sets guidelines and rules for use of irradiators

A

Nuclear Regulatory Commission (NRC)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

emphasis on employee safety in the workplace

A

Occupational Safety and Health Administration (OSHA)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

a process intended to ensure that reagents and equipment function as expected

A

quality control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

a process intended to provide confidence that systems and elements that influence the quality of the product/service are working as expected

A

quality assurance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

organizational structure, responsibilities, policies, procedures and resources established by executive management to achieve quality

A

quality systems

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

a process intended to ensure that problems with processes and procedures can be identified, monitored and corrected

A

quality improvement

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

certification of CLS professionals

A

American Society of Clinical Pathologists (ASCP)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

accredits CLS programs

A

National Accreditation Agence of Clinical Laboratory Science (NAACLS)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

internal assessments covering the quality system and major operating systems of blood services

A

audits

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

structured evaluation of laboratory methods that assesses the suitability of processes, procedures, equipment, materials, and personnel

A

proficiency

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

evaluation of the ability of the coworker to perform a specific task according to procedures

A

competency

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

step by step directions used by an individual to perform a specific task

A

SOP

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

documents the way the facility conforms to federal, state, and local regulations

A

policies

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

testing to ensure equipment and processes are functioning as expected, required before implementation and after modifications

A

validation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

provides for immediate retrieval of information on a patient, blood product or donor

A

Lab Information System (LIS)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

set of regulations, codes and guidelines for the manufacture of drug substances and medical devices, diagnostic products and foods

A

current good manufacturing processes (cGMP)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

provides a worldwide standard to ID each blood component with a unique identifier

A

International Society of Blood Transfusion (ISBT)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

provides evidence that regulations and standards are met and that all coworkers are following the same procedures and policies

A

document control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

follow any unit of blood or component from its source to its final disposition

A

tracibility

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

used to prevent unauthorized persons from accessing information

A

password

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

alternative system to obtain previous record during downtime

A

backup

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

system performs an interpretation of results, prohibition of action, or provision of information that a tech uses to make decisions

A

critical point

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

critical point examples

A
  • forward and reverse types do not match
  • type does not match previous record
  • product doesn’t meet pt special needs
  • specimen or visit is not current
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

4 aspects of document control

A
  • procedures and forms verified for adequacy, reviewed and approved, then kept current with regulations and standards
  • versions are controlled and changes are identified
  • documents are protected from alteration, or unintended use or destruction
  • ensures all testing and processes are performed according to procedure the same way by each tech
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

good record keeping tips

A
  • concurrent documentation of each step
  • use non-water soluble pen
  • write clearly and neatly
  • proper method for making corrections
  • enter enough details so document can be understood in the future
30
Q

10 commandments of cGMP

A
  1. validation—design and construct facilities and equipment properly
  2. document control—write step by step operating procedures
  3. follow written procedures and instructions (no copies or cheat sheets)
  4. document work as performed
  5. validate work
  6. QC and PM—monitor facilities and equipment
  7. design, develop and maintain job confidence
  8. protect against contamination
  9. control components and product related processes
  10. conduct planned and periodic audits
31
Q

emphasis on safety/risk management; scheduled inspections monitor compliance

A

the Joint Commission (TJC)

32
Q

infectious disease reporting in the BB

A

state health department

33
Q

type of irradiation now used

A

x-ray

34
Q

unscheduled inspections

A

FDA

35
Q

may have dual —–/—– inspections

A

AABB/CAP

36
Q

scientific society which promotes science, research, and best practice in areas of transfusion medicine

A

ISBT

37
Q

CLIA

A

clinical laboratory improvement amendmends (1988)

38
Q

aims to improve the quality and safety of collecting, processing, testing, transfusion and distribution of blood products

voluntary and nongovernmental

A

accreditation

39
Q

force of law; ensures safety for the blood supply, blood donors, and blood product recipients

mandatory and federal

A

regulations

40
Q

CMS

A

center for medicare and medicaid services

41
Q

10 quality systems essentials

A
  • organization
  • resources (personnel)
  • equipment
  • supplies/customer issues
  • process control, final inspection, handling
  • documents and records
  • deviations, nonconformances, adverse events
  • assessments
  • process improvement
  • facilities and safety
42
Q

defines and documents the parties responsible for provision of blood, blood products, and services

A

organization

43
Q

products used in the collection, testing, processing, holding and distribution of blood that have the potential to affect the quality of blood

A

critical materials

44
Q

CAPA

A

corrective and preventive action

45
Q

uses a collaborative team effort to improve performance by systematically removing operational waste and reducing process variation

A

lean six sigma

46
Q

an action taken in response to identified problems

A

corrective action

47
Q

active planning for potential problems

A

preventive action

48
Q

documentation hierarchy

A
  1. policies (what to do)
  2. processes (how it happens)
  3. procedures (how to do it)
  4. forms, records, supporting docs, QC records, templates (tools to use)
49
Q

unknown samples received from a designated provider, tested as other samples

demonstrates that a facility provides comparable results to other facilities

A

proficiency testing (PT)

50
Q

direct observations of test performances, testing previously resulted speciments, and assessment of problem solving skills

A

competency assessment

51
Q

6 elements required by competency assessment

A
  • direct observation of test performance
  • monitoring of recording and reporting results
  • review of test results/worksheets/QC records
  • direct observation of instrument maintenance and function checks
  • testing previously resulted specimens
  • assessment of problem solving skills
52
Q

analysis of quality indicator data, complaint records, blood utilization

A

product audit

53
Q

useful to maintain inspection readiness

A

self-audit

54
Q

follow a product to the floor, observe the transfusion

A

process audit

55
Q

5 functional areas of blood bank

A
  • blood donor services (BDS)
  • component processing and storage
  • main BB lab
  • reference lab
  • component preparation and issue
56
Q

5 basic BB bench assignments

A
  • ordering
  • crossmatch
  • reference
  • hot seat
  • float
57
Q

reviews all orders that print in the blood bank, receives specimen and performs computer steps necessary for testing

A

ordering tech

58
Q

performs all routine pretransfusion testing

A

crossmatch tech

59
Q

serological problem solver

A

reference tech

60
Q

primary person assigned to preparation and issuing of blood products

A

hot seat tech

61
Q

second issuing tech, may also help in any area

A

float tech

62
Q

allows EXM
results and interpretations recorded

A

stand alone BBIS

63
Q

methods preventing unauthorized access to a computer system

A
  • passwords
  • program restrictions
  • terminal lockouts
64
Q

necessary before a computer system is used or if a change is made (5)

A
  • program development
  • installation of system
  • validation of functionality and date integrity
  • training of personnel
  • policies and procedures for system maintenance and operations
65
Q

HIPAA

A

health insurance portability and accountability act

66
Q

patient info kept so inadvertent —— does not occur

A

use or disclosure

67
Q

basic tenet of cGMP

A

quality cannot be tested into a product, but must be built into each product during all stages of manufacturing process

68
Q

access blood portion of code of federal regulations

A

title 21
chapter 1
subchapters F (biologics) and C (drugs)

69
Q

subchapter F concerned with…

A

safety, purity and potency

70
Q

subchapter C concerned with…

A

safety, purity and effectiveness

71
Q

revalidation may be necessary when…

A

changes or process deviations occur

72
Q

consequences of noncompliance

A
  • FDA warning letter
  • FDA licence suspension
  • FDA licence revocation
  • seizure
  • injunction
  • prosecution

Mercy CLS 4: Blood Bank (13 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions