Laboratory Information Management

Question 1

Facts provided or learned about something or someone.

Answer 1

Information

Question 2

The resolution of uncertainty.

Answer 2

Information

Question 3

What is conveyed or represented by a particular arrangement or sequence of things

Answer 3

Information

Question 4

collecting, examining, reporting, and storing large complex sets of data derived from tests performedin clinical laboratories, anatomic pathology laboratories,or research laboratories in order to improve patient care and enhance our understanding of disease-related processes

Answer 4

Pathology Informatics

Question 5

a cycle of processes that support the organization’slearning activities: identifying information needs,acquiring information, organizing and storinginformation,developing information products andservices, distributing information, and usinginformation

Answer 5

Information Management

Question 6

Provide written information about policies, processes, and procedures

Answer 6

Documents

Question 7

Documented statement of overall intentions and direction defined by organization

Answer 7

Policies

Question 8

What to do?

Answer 8

Policies

Question 9

Set of interrelated or interacting activities that transform inputs into outputs

Answer 9

Processes

Question 10

How it happens?

Answer 10

Processes

Question 11

Specific activities of a process

Answer 11

Procedures

Question 12

How to do it?

Answer 12

Procedures

Question 13

• communicate information to all persons who need it, including laboratory staff
• users and laboratory management personnel
• need to be updated or maintained
• must be changed when a policy, process or procedure changes
• establish formats for recording and reporting information by the use of standardized forms
• once the forms are used to store information, theybecome records

Answer 13

Characteristics of Documents

Question 14

What makes a good document?

Answer 14

Written clearly and concisely
Written in a user-friendly style
Written so as to be explicit and accurate
Maintained to ensure that it is always up to date

Question 15

Documents inside the Laboratory

Answer 15

Laboratory Manual

Question 16

Document that describes quality management system of an organization

Answer 16

Quality Manual

Question 17

Describes how all related quality processes occur

Answer 17

Quality Manual

Question 18

Purpose of Quality Manual

Answer 18

Clearly communicate information
Serve as framework for meeting quality system requirements
Convey managerial commitment to the quality system

Question 19

Derived from operators manual

Answer 19

Standard Operating Procedures

Question 20

Written step-by-step instructions one should follow when performing a procedure

Answer 20

Standard Operating Procedures

Question 21

What SOP’s ensures?

Answer 21

Consistency
Accuracy
Quality

Question 22

Shortened version of SOP; allows for easier access and reference for procedures

Answer 22

Job Aids

Question 23

Allows for easier identification of pertinent information

Answer 23

SOP Header

Question 24

Two types of Header

Answer 24

Complete Standardized Header
Reduced Standardized Header (Simplified Header)

Question 25

What should be included in SOP?

Answer 25

Title Purpose Instructions Name of the person preparing the SOP Signature of approving officials and dates of approval

Question 26

Uniform and standardized formatting system

Answer 26

Document Control

Question 27

Process for format approvap, distribution and updating and revising laboratory documents

Answer 27

Document Control

Question 28

Process to ensure availability of documents and for document archiving

Answer 28

Document Control

Question 29

Texts, Articles, and books that are referenced in laboratory documents

Answer 29

Controlled Documents

Question 30

It is based from SOP

Answer 30

Records

Question 31

It involves continuous monitoring, data storage, tracking of samples, evaluating processes and management

Answer 31

Records

Question 32

Type of Records

Answer 32

•Sample logbook • Internal and external audits • Laboratory worksheets • Instrument printouts • Quality control data • External quality assessment or proficiency testing • Continuouss improvement projects • Incident reports • User survey and customer feedback • Patient test records • Personnel records • Critical Communications

Question 33

Test Report Contents

Answer 33

• Test identification • ldentification of laboratory • Patient identification • Name of requestor • Date and time of collection • Time of receipt in laboratory • Primary sample type • Date and time of collection • Time of receipt in laboratory report • Results, in Sl units • Reference intervals • Interpretation of results • Comments about sample, methodology limitations, or other issues • ldentification and signature of releasing person • Original and corrected results

Question 34

Used in Document and Record Storage

Answer 34

Paper System Electronic System

Question 35

It involves manual method, logbooks and worksheets, copy of patient result, reagent/equipment inserts, posters

Answer 35

Paper System

Question 36

Utilized computer system, laboratory information system and cloud storage

Answer 36

Electronic System

Question 37

Proof that you have document

Answer 37

Record Retention

Question 38

It includes: • Time interval between laboratory assessments • Involvement in ongoing research • Government requirements • Length of time required for access or audits

Answer 38

Record Retention

Question 39

Most famous LIMS

Answer 39

Bizbox

Question 40

Elements of LIMS

Answer 40

- Unique identifiers for patients and sample - standardized test request forms (requisition) - log and worksheets - checking processes to assure accuracy of data recording and transmission - protection against lost of data - protection of patient confidentiality and privacy - effective reporting systems - effective and timely communication

Question 41

Assigned to patients for the duration of their hospital stay

Answer 41

Patient Identifiers

Question 42

Assigned to each sample sent to the laboratory

Answer 42

Sample Identifiers

Question 43

Proper Data Handling

Answer 43

•Test request forms must be standardized and completed • Presence of safeguarding processes -Review of data transcription by two people - Electronic checks requiring duplicate data entry •Usage of safe, durable materials and having routine backup processes ensure data security • Degree of access to data must be established to ensure patient privacy

Question 44

Common Problems in Data Handling

Answer 44

- Incomplete data for test interpretation or insufficient or illegible identification - inadequately designed forms - standardized forms not suitable for laboratory settin - poor archiving or back up processes - poor data organization - incompatibility between computerized information system and equipment

Question 45

Manual, Paper Based Systems ADVANTAGES

Answer 45

- Financially viable (Economical) - Easily accessible - Little learning curve - Less prone to digital compromise - Portable

Question 46

Manual, Paper Based Systems DISADVANTAGES

Answer 46

- Vulnerable to physical elements - Handwriting concerns - Storage and Space

Question 47

Computerized Systems ADVANTAGES

Answer 47

- Error reductio - Quality control management - Easier data searching - Easier patient data access - computerized reports - report tracking - analysis of trends - increase patient confidentiality - financial management - Offsite integration

Question 48

Computerized Systems DISADVANTAGES

Answer 48

- Training - Cost - Adjustment Period - Physical restrictions - Need for backup systems