Laboratory Information Management Flashcards
Facts provided or learned about something or someone.
Information
The resolution of uncertainty.
Information
What is conveyed or represented by a particular arrangement or sequence of things
Information
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
Pathology Informatics
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
Information Management
Provide written information about policies, processes, and procedures
Documents
Documented statement of overall intentions and direction defined by organization
Policies
What to do?
Policies
Set of interrelated or interacting activities that transform inputs into outputs
Processes
How it happens?
Processes
Specific activities of a process
Procedures
How to do it?
Procedures
• 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
Characteristics of Documents
What makes a good document?
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
Documents inside the Laboratory
Laboratory Manual
Document that describes quality management system of an organization
Quality Manual
Describes how all related quality processes occur
Quality Manual
Purpose of Quality Manual
Clearly communicate information
Serve as framework for meeting quality system requirements
Convey managerial commitment to the quality system
Derived from operators manual
Standard Operating Procedures
Written step-by-step instructions one should follow when performing a procedure
Standard Operating Procedures
What SOP’s ensures?
Consistency
Accuracy
Quality
Shortened version of SOP; allows for easier access and reference for procedures
Job Aids
Allows for easier identification of pertinent information
SOP Header
Two types of Header
Complete Standardized Header
Reduced Standardized Header (Simplified Header)
What should be included in SOP?
Title
Purpose
Instructions
Name of the person preparing the SOP
Signature of approving officials and dates of approval
Uniform and standardized formatting system
Document Control
Process for format approvap, distribution and updating and revising laboratory documents
Document Control
Process to ensure availability of documents and for document archiving
Document Control
Texts, Articles, and books that are referenced in laboratory documents
Controlled Documents
It is based from SOP
Records
It involves continuous monitoring, data storage, tracking of samples, evaluating processes and management
Records
Type of Records
•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
Test Report Contents
• 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
Used in Document and Record Storage
Paper System
Electronic System
It involves manual method, logbooks and worksheets, copy of patient result, reagent/equipment inserts, posters
Paper System
Utilized computer system, laboratory information system and cloud storage
Electronic System
Proof that you have document
Record Retention
It includes:
• Time interval between laboratory assessments
• Involvement in ongoing research
• Government requirements
• Length of time required for access or audits
Record Retention
Most famous LIMS
Bizbox
Elements of LIMS
- 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
Assigned to patients for the duration of their hospital stay
Patient Identifiers
Assigned to each sample sent to the laboratory
Sample Identifiers
Proper Data Handling
•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
Common Problems in Data Handling
- 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
Manual, Paper Based Systems
ADVANTAGES
- Financially viable (Economical)
- Easily accessible
- Little learning curve
- Less prone to digital compromise
- Portable
Manual, Paper Based Systems
DISADVANTAGES
- Vulnerable to physical elements
- Handwriting concerns
- Storage and Space
Computerized Systems
ADVANTAGES
- 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
Computerized Systems
DISADVANTAGES
- Training
- Cost
- Adjustment Period
- Physical restrictions
- Need for backup systems
