Laboratory Information Management · PDF fileLaboratory Information Management Systems ......
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Laboratory Information Management Systems Presented By: Happy Mashigo & Vuyiswa Kenke
Transcript of Laboratory Information Management · PDF fileLaboratory Information Management Systems ......
Laboratory Information Management Systems
Presented By: Happy Mashigo & Vuyiswa Kenke
Welcome
Welcome to the Laboratory Information Management Systems
Module
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Module Objectives
At the end of this module, participants will be able to: Describe important elements of an information management system; Discuss guidelines on standards, policies and best practice of
Information Management; Explain things to consider when developing a manual, paper-based
information system; Describe the advantages and disadvantages of a computerized
information management system; Discuss IT governance and best practice; Discuss IT standards and security.
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The Quality Management System
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Activity
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“You manage a laboratory for a 300 bed hospital and the administrator has just notified you that funds are available for the purchase of a computerised laboratory information system.” How do you assess the relevancy of such a system for your laboratory?
Information Management
Establish processes for managing data
Source: WHO – Training Toolkit 6
Presenter
Presentation Notes
A laboratory information system (LIS) is a series of computer-based or paper-based processes that store, process and manage data from all stages of medical processes and tests. Basic laboratory information systems commonly have features that manage specimen from check in, order entry, specimen processing, result entry and patient demographics. A LIS tracks and stores every detail about a patient sample from the minute it arrives until the results are issued and keeps the information stored in its database for future reference. Physicians and lab technicians use laboratory information systems to supervise many varieties of inpatient and outpatient medical testing.
Information Management Elements
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Effective communication
Confidential Checking processes
Standardised request forms
Important elements
Unique identifiers for
samples & patients
Logs, worksheets
Data protection
Effective reporting systems
Information Management Elements (continued…)
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Patient identifiers — Patients who are hospitalised must have a unique patient identifier, often bracelets are used. It is advisable that this unique patient identifier is used for the duration of the hospital stay.
Sample identifiers —Unique identifiers must be allocated to patient samples, so they can be tracked throughout the laboratory.
Forms: -- Standardise the test form—the form should indicate all information that needs to be provided when ordering and submitting a test request, and in the design there must be sufficient space for recording the information; make sure that it is completed correctly.
Logs and worksheets must be kept. Recording data at the time of arrival of the sample in the laboratory are kept in a log book, while a worksheet is used to record which patient samples are being tested during a certain procedure. In a paper-based system, this will be a written record, usually in a bound book. For an electronic system, logs and worksheets may be generated from the computer. One must decide as to what information should be recorded.
Information Management Elements (continued…)
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Processes: Errors can occur at any time when handling data. Put processes in place as precaution and protection against errors at these points. Implement formal checking processes to ensure the accuracy of data recording and transmission of handwritten or keyed information. Data Protection: Protect against loss of data. For paper-based systems, use safe materials for recording and storing the records properly. For computerized systems, regular backup processes are required. Confidentiality: Protect patient’s privacy by implementing security measures to guard the confidentiality of laboratory data. Policies and procedures to assure confidentiality of patient information must be put in place and this is the responsibility of the laboratory director.
Reporting systems: The test result, or the report is the final product of the laboratory. The test result must be issued timeously. It must also be accurate, legible, and easily understood. It should be verified and signed by the appropriate laboratory staff. Communication: When planning for paper-based or computer-based information systems, consider the need for a good communication system the enables a laboratory to connect both internally and externally.
Common problems
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COMMON PROBLEMS
Data incomplete
ID (patient/sample)
insufficient
Forms inadequate
Archiving poor
Data organized poorly
Transmission errors
Computer systems
incompatible
Presenter
Presentation Notes
Some of the most common problems that may occur when managing laboratory information: Incomplete data for test interpretation, or insufficient or illegible identification. Systems should be created to minimize this occurrence. Forms that are ineffectually designed to meet laboratory and client needs; Standardized forms prepared by laboratories may not be suitable for all laboratories; Inability to recover data due to poor archiving processes or insufficient backup of computerised information; Poor data organisation, which may delay later data analysis efforts to meet research or other needs; Incompatibility between computerised information systems and equipment or other electronic systems, resulting in problems with data transmission.
Developing a paper-based system
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Staff need to be informed that when using a paper system, the following points are important: All data entry must be complete. Handwritten logs must be checked. Emphasize to employees the importance of legibility. If issuing handwritten reports, the laboratory must always make a copy for its files
or archives. Not having an exact copy of the report can lead to later problems, if errors in transcription occur.
Storing paper-based materials
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Goals: Find results Trace samples Evaluate occurrences
Useful rules: Keep everything for a designated time Ensure easy access Use a logical system for filing Number in chronological order
Storing paper-based materials (continued…)
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Paper is brittle, and susceptible to water, fire, humidity, and vermin (rodents and insects). Use a storage area that will protect against these elements as much as possible.
X √
Developing a computer-based system (LIMS)
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A computerised system for laboratory data is known as a laboratory information management system and is referred to by the acronym LIMS or LIS. A well planned and installed LIMS brings accuracy and accessibility to the flow of samples and data in the clinical laboratory.
Laboratory Information Management System
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Advantages of LIMS
Presenter
Presentation Notes
The computerised system offers advantages over paper-based systems. Below are some of the advantages: Error reduction: By creating check systems for errors, the user of the system will be alerted of any inconsistencies and the number of errors and problems of poor / illegible hand writing will be reduced. Quality control management: Easier to keep good quality control records, perform analysis on QC data, and generate statistics automatically. Provision of options for data searching: Data retrieval is easier as the user can enter search parameters e.g. access data by name, by laboratory or patient number. Access to patient information: Most computer systems allow access to all recent laboratory data for a patient. This is very useful in the process of checking the most recent results against previous data to look for changes. Generate and track reports: Easy to generate detailed, legible reports quickly. A LIMS will provide standardised reports. It is also easier to track reports; to know when work was finished, who performed the work, when the data was reviewed, and when the report was sent. Ability to track and analyse trends: It will be possible to retrieve and use large amounts of data to track and analyse trends of various kinds by using the systems search facilities. Improved capability for maintaining patient confidentiality: By establishing computer user codes that control access to the data, patient’s confidentiality can be maintained. Financial management: Some systems will allow for financial management, for example, patient billing. Integration with sites outside the laboratory: If the system is set up correctly, data will be able to come into the laboratory system directly from a patient or client registration point. Results can be delivered directly to computers accessible to the health care provider or public health official. Computers can handle data entry into a national laboratory data base. Manufacturer-provided training: When a laboratory purchases a LIMS, the manufacturer’s often include on-site training for staff. Staff must be trained.
The Use of LIMS in Disease Management
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Pre Analytics Request Forms Patient demographics Patient History Test
Post Analysis Patient demographics Test Patient Results
Tools to be used Analysers Stats from the LIS
Lab Resources Pathologists, Scientists, Medical Technologists
Process: Path of Workflow
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Presenter
Presentation Notes
Doctor draws patient sample Completes a request form with Patient Demographics and Hospital# Request forms and Tubes are shipped to the lab. Data Clerk register or scans the request form LIS automatically assign a unique identifier
Application
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Referrals between Laboratories
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Laboratory Connectivity
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Data Centre
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A Data Centre is a facility or centralized repository used for storage and management of Data
This includes computer and server operations, data entry, data security, data quality control and management of services and applications used for data processing.
Management of Data Centre requires a number of tools, policies and strategies to create and maintain.
IT Governance and Best Practice
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ITIL®
COBIT5 (audited tool)
Prince 2
King III
Presenter
Presentation Notes
Our Organisation is in the process of Implementing ITIL® and COBIT Framework
ITIL v3 Life Cycle
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ITIL v3 (continued…)
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Presenter
Presentation Notes
Our Organisation is in the process of Implementing ITIL® and COBIT Framework
IT Service Management
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Key issues facing many of today’s senior Business Managers and IT Managers in Service Management includes:
IT and business strategic planning;
Integrating and aligning IT and business goals;
Implementing continual improvement;
Measuring IT organization effectiveness and efficiency.
ITIL® Service Management Cycle
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Organizations that use IT depend on IT to be successful. ITIL gives guiding processes to ensure that the business’s success can be achieved …. Service Strategy Service Design Service Transition Service Operation Continual Service Improvement
ITIL® Service Management Cycle (continued…)
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Service Strategy
For an organisation to be successful, the services provided must be perceived by the customer to deliver sufficient value in the form of outcomes that the customer wants to achieve.
Service Design
The design of appropriate and innovative IT services, including their architectures, processes, policies and documentation, to meet current and future agreed business requirements.
Service Transition
The role of Service Transition is to deliver services that are required by the business into operational use.
ITIL® Service Management Cycle (continued…)
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Service Operation
Is to deliver agreed levels of service to users and customers, and to manage the applications, technology and infrastructure that support delivery of the services.
Continual Improvement
Continual Service Improvement (CSI) is concerned with maintaining value for customers through the continual evaluation and improvement of the quality of services and the overall maturity of the ITSM service lifecycle and underlying processes.
COBIT5 Principles
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COBIT5 Principles (continued…)
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IT Governance through COBIT5
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IT Governance is the ability of senior management to direct, measure and evaluate the use of IT resources to achieve organisations strategic goals.
Cobit5 provides guidelines on adopting a formal approach to IT
governance by setting out standard procedures and processes to be implemented by IT departments in order to improve service delivery to customers and Risk management.
Presenter
Presentation Notes
Cobit IT governance framework that allows managers to bridge the gap between control requirements, technical issues and manage risks
COBIT5
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Cobit Framework is set out of 34 high level processes, grouped into 4 domains that cover all aspects of IT. Measurement scales 0-5 0 - Non-Existent 1 - Initial/ Ad-hoc 2 - Repeatable but intuitive 3 - Defined Process 4 - Managed And Measurable 5 - Optimised
Presenter
Presentation Notes
0 lack of recognisable processes( organisation have not recognised that there is an issue to be addressed) 1 There is evidence that the organisation recognised there issue exist and need to be addressed There are how ever no standards or processes instead its Ad hoc approaches and tend to be applied on an individual or case by case. 2 processes have been developed to the stage where similar procedures are followed by different people undertaking the same task No formal training or communication responsibility is left on individuals. There is a high degree of reliance on individuals and errors are likely 3 Procedures standardised and documented and communicated through training. How ever it is left to an individual to follow the processed and unlikely that deviation will occur. 4 It is possible to monitor and measure compliance with procedures and take action where processes appear not to be working effectively( process under continuous improvement and provide good practice 5 Processes refined to a level of best practice based on results of continuous improvement and maturity modelling with other organisations IT is used in an intergraded way to automate the workflow providing tools to improve quality and effectiveness
IT Standards / Security
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Data protection and security are critical components of routine pathology practice because laboratories are legally required to securely store and transmit electronic patient data
Computer equipment, data, information, and computer services should be protected from unintended or unauthorized access
Data should be made available to clients for years after release for research and legal purposes, dictated by law or governance.
IT Standards / Security (continued…)
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All electronic systems or devices that play a role in generating, capturing, storing, or modifying patient data require security review. This includes LIS hardware and software as well as devices that can access LIS data (i.e., mobile devices such as tablet computers or smart phones) or interfaced devices such as instruments or point of care testing devices.
Laboratories should establish audit programs to ensure that access to health information systems is appropriate and has not been compromised.
IT Standards / Security (continued…)
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Written policies are required to cover the mechanisms available to provide individuals with access to information systems.
Policies and procedures for terminating access, such as when staff leaves the health-care organization need to be implemented.
In addition, security awareness training should be provided to all staff members. Initial general training should be reinforced through periodic security reminders.
System Availability and Disaster Resiliency
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A major requirement of laboratory computer systems used to manage patient information is their reliability.
Laboratories should have procedures for both planned and unplanned system outages (i.e., down-time) which should address how the laboratory should function during the outage and the sequence in which all impacted software in the laboratory (LIS, middleware, instrument software, etc.) are brought back online once the outage has been resolved.
System Availability and Disaster Resiliency (continued…)
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For planned outages (i.e., down-time that occurs to perform system maintenance or an upgrade), the procedure should define the sequence as well as the process for shutting systems down. For unplanned events, procedures should assign responsibility for determination of the cause of the outage to defined individuals as well as the process and persons responsible for performing disaster recovery.
Down-time procedures should be logged /documented should specify the laboratory's response based on the type of system outage (e.g., LIS, instrument, network etc.) can be updated annually as systems or risks change.
System Availability and Disaster Resiliency (continued…)
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Any unplanned outage can result in data loss, it is critically important for the laboratory to develop robust data protection mechanisms that minimize loss and help speed up the recovery process.
Different Backup mechanisms can be used
Summary
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System for managing both incoming and outgoing data.
May be paper-based or computer-based.
Both require a similar framework, including unique identifiers, forms, logs and worksheets.
Cost is a major factor in using a computer-based system.
A good information management system will: Ensure all data—the final product of the laboratory—is well
managed Consider all the ways laboratory data will be used when
planning a system Assure the accessibility, accuracy, timeliness, and security of
data Ensure confidentiality and privacy of patient information
Summary (continued…)
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Disease management is made easy through the use of IT LIS.
Data can be accessed from a central storage centers Data in the LIS can be used for survey statistics Disease Hot spots or problem areas can be identified using
patient results. The results can be used in anonymity through the use of
Unique Identifiers. Historic data can be referred to, for future management of
pandemics. Security in Data centers and Lab Networks should be
trusted to restrict use to only authorised users.
References & Links
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WHO: Quality Management Toolkit ISO 15189:2012: Quality management in the clinical laboratory Guidance for Laboratory Quality Manuals (Ontario Laboratory Accreditation Division) ITIL_V3_Study_Guide (Taruu LLC)
References
http://www.techrepublic.com/blog/it-security/cobit-5-for-information-security-the-underlying-principles/
Links
Wrap Up for Module 5
Participants are now able to: Describe important elements of an information management system; Discuss guidelines on standards, policies and best practice of
Information Management; Explain things to consider when developing a manual, paper-based
information system; Describe the advantages and disadvantages of a computerized
information management system; Discuss IT governance and best practice; Discuss IT standards and security.
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Questions
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Presenter
Presentation Notes
Facilitator Notes: Ask participants if they have any final questions.
