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Lab Man > U6.2: Information Management (LIMS, Documents, Records) > Flashcards

U6.2: Information Management (LIMS, Documents, Records) Flashcards

1
Q

brings accuracy and accessibility to the flow of samples and data in the clinical laboratory

A

Computerized laboratory information systems

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2
Q

T/F:
Computerized laboratory information systems may be an in-house computer network or locally developed systems based on commercially available database software.

A

T

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3
Q

3 Criteria for choosing the system

A
  1. flexibility, adaptability
  2. ease of evolution and support
  3. system speed will most benefit the laboratory
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4
Q

Advantages of LIMS:
a well-planned computer system, with check systems for errors, will help to alert the user of inconsistencies and reduce the number of errors

a. error reduction
b. quality control management
c. provision of options for data searching
d. ability to track reports

A

a. error reduction

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5
Q

Advantages of LIMS:
It will also provide information that is legible.

a. error reduction
b. quality control management
c. provision of options for data searching
d. ability to track reports

A

a. error reduction

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6
Q

Advantages of LIMS:
It becomes easy to keep good quality control records, perform analysis on quality control data and generate statistics automatically

a. access to patient information
b. quality control management
c. provision of options for data searching
d. ability to track reports

A

b. quality control management

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7
Q

Advantages of LIMS:
a variety of parameters can be used for data retrieval; it is usually possible to access data by name, by laboratory or patient number, and sometimes by test result or analysis performed

a. access to patient information
b. ability to track and analyze trends
c. provision of options for data searching
d. ability to track reports

A

c. provision of options for data searching

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8
Q

Advantages of LIMS:
this kind of data searching is almost impossible with paper-based systems

a. access to patient information
b. ability to track and analyze trends
c. provision of options for data searching
d. ability to track reports

A

c. provision of options for data searching

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9
Q

Advantages of LIMS:
most computer systems allow access to all recent laboratory data for a patient

a. access to patient information
b. ability to track and analyze trends
c. provision of options for data searching
d. ability to track reports

A

a. access to patient information

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10
Q

Advantages of LIMS:
very useful in the process of checking the most recent results against previous data to look for changes, which is a good practice and helps to detect errors

a. access to patient information
b. error reduction
c. provision of options for data searching
d. ability to track reports

A

a. access to patient information

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11
Q

Advantages of LIMS:
very useful in the process of it is easy to generate detailed, legible reports quickly

a. ability to track reports
b. access to patient information
c. provision of options for data searching
d. generate reports

A

d. generate reports

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12
Q

Advantages of LIMS:
A LIMS will provide standardized (or customized) reports.

a. ability to track reports
b. access to patient information
c. provision of options for data searching
d. generate reports

A

d. generate reports

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13
Q

Advantages of LIMS:
a computer system makes it much easier to __________, to know when work was finished, who performed the work, when the data was reviewed and when the report was sent

a. ability to track reports
b. access to patient information
c. ability to track and analyze trends
d. generate reports

A

a. ability to track reports

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14
Q

Advantages of LIMS:
the computer and its databases provide very strong search capabilities

a. ability to track reports
b. access to patient information
c. ability to track and analyze trends
d. generate reports

A

c. ability to track and analyze trends

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15
Q

Advantages of LIMS:
possible to retrieve and use large amounts of data effectively

a. ability to track reports
b. access to patient information
c. ability to track and analyze trends
d. generate reports

A

c. ability to track and analyze trends

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16
Q

Advantages of LIMS:
track and analyze trends of various kinds

a. ability to track reports
b. access to patient information
c. ability to track and analyze trends
d. generate reports

A

c. ability to track and analyze trends

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17
Q

Advantages of LIMS:
easier to maintain confidentiality of laboratory data than when dealing with a handwritten report form

a. ability to track reports
b. access to patient information
c. ability to track and analyze trends
d. improved capability for maintaining patient confidentiality

A

d. improved capability for maintaining patient confidentiality

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18
Q

Advantages of LIMS:
some systems will allow for _____________; for example, patient billing

a. manufacturer-provided training
b. integration with sites outside the laboratory
c. financial management
d. quality control management

A

c. financial management

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19
Q

Advantages of LIMS:
a LIMS can be set up so that data comes into the laboratory system directly from a patient or client registration point

a. manufacturer-provided training
b. integration with sites outside the laboratory
c. financial management
d. quality control management

A

b. integration with sites outside the laboratory

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20
Q

Advantages of LIMS:
Data can be transmitted to many sites or interfaces as needed

a. manufacturer-provided training
b. integration with sites outside the laboratory
c. financial management
d. quality control management

A

b. integration with sites outside the laboratory

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21
Q

Advantages of LIMS:
Results can be provided directly to computers accessible to the health care provider or public health official

a. manufacturer-provided training
b. integration with sites outside the laboratory
c. financial management
d. quality control management

A

b. integration with sites outside the laboratory

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22
Q

Advantages of LIMS:
Computers can handle data entry into a national laboratory database and almost any other data application that is needed

a. manufacturer-provided training
b. integration with sites outside the laboratory
c. financial management
d. quality control management

A

b. integration with sites outside the laboratory

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23
Q

Advantages of LIMS:
purchased LIMS often include on-site training for staff

a. manufacturer-provided training
b. integration with sites outside the laboratory
c. financial management
d. quality control management

A

a. manufacturer-provided training

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24
Q

Disadvantages of LIMS:
personnel _______ is required

a. training
b. time to adapt to a new system
c. cost
d. physical restrictions
e. need for backup system

A

a. training

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25
Disadvantages of LIMS: because of the complexity of LIMS, _________ can be time-consuming and expensive a. training b. time to adapt to a new system c. cost d. physical restrictions e. need for backup system
a. training
26
Disadvantages of LIMS: when starting up a computer system, it may seem inconvenient and unwieldy to laboratory staff a. training b. time to adapt to a new system c. cost d. physical restrictions e. need for backup system
b. time to adapt to a new system
27
Disadvantages of LIMS: Personnel accustomed to manual systems may be challenged by such tasks as correcting errors, and uncertain of how to proceed when encountering situations where a field must be filled in a. training b. time to adapt to a new system c. cost d. physical restrictions e. need for backup system
b. time to adapt to a new system
28
Disadvantages of LIMS: purchase and maintenance are the most expensive parts of a computerized system a. training b. time to adapt to a new system c. cost d. physical restrictions e. need for backup system
c. cost
29
Disadvantages of LIMS: can be prohibitive in some settings a. training b. time to adapt to a new system c. cost d. physical restrictions e. need for backup system
c. cost
30
Disadvantages of LIMS: some settings will not have good maintenance that is locally available a. training b. time to adapt to a new system c. cost d. physical restrictions e. need for backup system
c. cost
31
Disadvantages of LIMS: computers use lots of paper, and the _____ of materials must be planned for, as this can add up a. training b. time to adapt to a new system c. cost d. physical restrictions e. need for backup system
c. cost
32
Disadvantages of LIMS: technology changes rapidly, and the life of a computer may not be more than a few years a. training b. time to adapt to a new system c. cost d. physical restrictions e. need for backup system
c. cost
33
Disadvantages of LIMS: adequate space and dedicated electrical requirements are necessary a. training b. time to adapt to a new system c. cost d. physical restrictions e. need for backup system
d. physical restrictions
34
Disadvantages of LIMS: placement of the computer away from heat, humidity and dust a. training b. time to adapt to a new system c. cost d. physical restrictions e. need for backup system
d. physical restrictions
35
Disadvantages of LIMS: all computer information must be carefully backed up a. training b. time to adapt to a new system c. cost d. physical restrictions e. need for backup system
e. need for backup system
36
T/F: Reporting of Patient Results Key Elements compactness
T
37
T/F: Reporting of Patient Results Key Elements Consistency of terminology, format and usage of abbreviations and symbols
T
38
T/F: Reporting of Patient Results Key Elements Clearly understandable
T
39
T/F: Reporting of Patient Results Key Elements Logical and accessible location in medical chart
T
40
T/F: Reporting of Patient Results Key Elements No date and time of collection
F; Statement of date and time of collection
41
T/F: Reporting of Patient Results Key Elements Unknown source of specimen
F; Good description and source of specimen when pertinent
42
T/F: Reporting of Patient Results Key Elements Similar reference or normal and abnormal values
F; Sharp differentiation
43
T/F: Reporting of Patient Results Key Elements Random order of multiple results on single specimen
F; Sequential order
44
T/F: Reporting of Patient Results Key Elements Identification of patient, patient location and physician
T
45
T/F: Reporting of Patient Results Key Elements Assurance of accuracy of transcription of request
T
46
T/F: Reporting of Patient Results Key Elements Ease of preparation
T
47
T/F: Reporting of Patient Administration and record keeping value
T
48
provide written information about policies, processes and procedures a. documents b. records
a. documents
49
the collected information produced by the laboratory in the process of performing and reporting a laboratory test a. documents b. records
b. records
50
communicate information to all persons who need it, including laboratory staff, users and laboratory management personnel a. documents b. records
a. documents
51
need to be updated or maintained a. documents b. records
a. documents
52
must be changed when a policy, process or procedure changes a. documents b. records
a. documents
53
establish formats for recording and reporting information by the use of standardized forms a. documents b. records
a. documents
54
Once the forms are used to record information, they become ________. a. documents b. records
b. records
55
need to be easily retrieved or accessed a. documents b. records
b. records
56
contain information that is permanent, and does not require updating a. documents b. records
b. records
57
Documents: “a documented statement of overall intentions and direction defined by those in the organization and endorsed by management” a. policy b. processes c. procedures
a. policy
58
Documents: gives broad and general direction to the quality system a. policy b. processes c. procedures
a. policy
59
Documents: tell “what to do”, in a broad and general way a. policy b. processes c. procedures
a. policy
60
Documents: include a statement of the organizational mission, goals and purpose a. policy b. processes c. procedures
a. policy
61
Documents: serve as the framework for the quality system, and should always be specified in the quality manual a. policy b. processes c. procedures
a. policy
62
Documents: the steps involved in carrying out quality policies a. policy b. processes c. procedures
b. processes
63
Documents: set of interrelated or interacting activities that transform inputs into outputs a. policy b. processes c. procedures
b. processes
64
Documents (Processes): test requests, samples, requests for information a. inputs b. outputs
a. inputs
65
Documents (Processes): laboratory data, reports of results a. inputs b. outputs
b. outputs
66
Documents: “how it happens” a. policy b. processes c. procedures
b. processes
67
Documents: the specific activities of a process a. policy b. processes c. procedures
c. procedures
68
Documents: easily described as the performance of a test a. policy b. processes c. procedures
c. procedures
69
Documents: “how to do it”, and shows the step-by-step instructions that laboratory staff should meticulously follow for each activity a. policy b. processes c. procedures
c. procedures
70
Documents (Procedures): used to indicate the detailed instructions on how to do it
Standard operating procedure (SOP)
71
Document Hierarchy (top to bottom)
procedures processes policies
72
Documents: the overall guiding document for the quality system and provides the framework for its design and implementation a. quality manual b. SOPs c. reference materials
a. quality manual
73
Documents: contain step-by-step written instructions for each procedure performed in the laboratory a. quality manual b. SOPs c. reference materials
b. SOPs
74
Documents: essential to ensure that all procedures are performed consistently by everyone in the laboratory a. quality manual b. SOPs c. reference materials
b. SOPs
75
Documents: needed in order to find scientific and clinical information about diseases, laboratory methods, and procedures a. quality manual b. SOPs c. reference materials
c. reference materials
76
Documents: Ex: when examining samples microscopically for parasites, photographs and descriptive information can be very helpful a. quality manual b. SOPs c. reference materials
c. reference materials
77
T/F: Characteristics of a good document written clearly and concisely
T
78
T/F: Characteristics of a good document wordy, unnecessary explanations
F; better to avoid wordy, unnecessary explanations
79
T/F: Characteristics of a good document written in a user-friendly style
T
80
T/F: Characteristics of a good document use a standard outline so the general structure will be familiar to staff and easily used by new personnel
T
81
T/F: Characteristics of a good document written so as to be explicit and accurate, reflecting all implemented measures, responsibilities and programs
T
82
T/F: Characteristics of a good document maintained to ensure that it is always up to date
T
83
provides procedures for formatting and maintaining documents
document control system
84
system that should ensure that the most current version of any document is the one that is in use
document control system
85
system that should ensure availability and ease of use when a document is needed
document control system
86
system that should provide for the appropriate archiving of documents when they need to be replaced
document control system
87
T/F: Elements of a Document Control a uniform format that includes a numbering system, to include a method for identifying the version (date) of the document
T
88
T/F: Elements of a Document Control a process for formal approval of each new document, a distribution plan or list, and a procedure for updating and revising laboratory documents
T
89
T/F: Elements of a Document Control a master log or inventory of all documents of the laboratory
T
90
T/F: Elements of a Document Control a process to ensure that the documents are available to all who need them, excluding users outside the laboratory
F; including users outside the laboratory
91
T/F: Elements of a Document Control a method for archiving documents that become updated but need to be kept for future reference
F; outdated
92
Records' Importance: without access to all the data collected as a part of a quality system process, this cannot be accomplished a. continuous monitoring b. tracking of samples c. evaluating problems d. management
a. continuous monitoring
93
Records' Importance: well-kept records allow for this throughout the entire testing process; this is essential for troubleshooting, looking for sources of error in testing and investigating identified errors a. continuous monitoring b. tracking of samples c. evaluating problems d. management
b. tracking of samples
94
Records' Importance: well-kept equipment records will allow for thorough evaluation of any problems that arise a. continuous monitoring b. tracking of samples c. evaluating problems d. management
c. evaluating problems
95
Records' Importance: good records serve as a very important management tool a. continuous monitoring b. tracking of samples c. evaluating problems d. management
d. management
96
T/F: A method to record any information that must be kept should be established.
T
97
Odd one out: Types of records that could easily be forgotten a. Information on the management and handling of rejected samples b. Data needed on any sample referred to another laboratory c. laboratory workbooks or worksheets d. The sample should be able to be tracked throughout the referral process.
c. laboratory workbooks or worksheets
98
Information about adverse occurrences or problems (all information that is pertinent, such as the results of any investigation of the problem) a. documents b. records
b. records
99
Inventory and storage (help keep track of reagents and supplies) a. documents b. records
b. records
100
equipment ________ a. documents b. records
b. records
101
Test Report Contents (required by ISO _______)
ISO 15189
102
Storing documents and records: Considerations on a Paper System paper records must last for as long as needed a. permanence b. accessibility c. security d. traceability
a. permanence
103
Storing documents and records: Considerations on a Paper System should be ensured by binding pages together, or using a bound book (log register) a. permanence b. accessibility c. security d. traceability
a. permanence
104
Storing documents and records: Considerations on a Paper System Pages should be numbered for easy access, and permanent ink should be used. a. permanence b. accessibility c. security d. traceability
a. permanence
105
Storing documents and records: Considerations on a Paper System Paper systems should be designed so that information can be easily retrieved whenever needed. a. permanence b. accessibility c. security d. traceability
b. accessibility
106
Storing documents and records: Considerations on a Paper System documents and records must be kept in a secure place a. permanence b. accessibility c. security d. traceability
c. security
107
Storing documents and records: Considerations on a Paper System maintaining patient confidentiality a. permanence b. accessibility c. security d. traceability
c. security
108
Storing documents and records: Considerations on a Paper System safe from any environmental hazards such as spills a. permanence b. accessibility c. security d. traceability
c. security
109
Storing documents and records: Considerations on a Paper System protected in the event of fires, floods or other possibilities a. permanence b. accessibility c. security d. traceability
c. security
110
Storing documents and records: Considerations on a Paper System It should be possible to trace a sample throughout all processes in the laboratory. a. permanence b. accessibility c. security d. traceability
d. traceability
111
Storing documents and records: Considerations on a Paper System be able to see who collected the sample, who ran the test, and what the quality control results were for the test run, including issuing of the report a. permanence b. accessibility c. security d. traceability
d. traceability
112
Storing documents and records: Considerations on an Electronic System backup systems are essential in case the main system fails a. permanence b. security c. traceability
a. permanence
113
Storing documents and records: Considerations on an Electronic System regular maintenance of the computer system will help to reduce system failures and loss of data a. permanence b. security c. traceability
a. permanence
114
Storing documents and records: Considerations on an Electronic System it can be more difficult to assure confidentiality with a computer system, as many people may have access to the data a. permanence b. security c. traceability
b. security
115
Storing documents and records: Considerations on an Electronic System computer access codes can be established to protect the data a. permanence b. security c. traceability
b. security
116
Storing documents and records: Considerations on an Electronic System electronic record systems should be designed in a way that allows for tracing the specimen throughout the entire process in the laboratory a. permanence b. security c. traceability
c. traceability
117
Odd one out: Factors to consider on the retention of records a. the length of time the laboratory will need to have access to its records b. government requirements or standards that dictate record retention times c. whether the laboratory is engaged in ongoing research requiring many years of data d. the time interval between the laboratory’s assessments or audits e. the status of the person identified on the record
e. the status of the person identified on the record

Lab Man (12 decks)

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