Week 4: Information Management Flashcards
Defined as a system that incorporates all the processes needed for effectively managing data—both incoming and outgoing patient information.
Information Management
These people need to ensure that the laboratory has an effective information management system in place in order to achieve accessibility, accuracy, timeliness, security, confidentiality, and privacy of patient information.
Laboratory directors
Important Elements of Information Management?
- Unique identifiers for patients and samples
- Standardized test request forms
- Logs and worksheets
- Checking processes to ensure the accuracy of data recording and transmission
- Protection against loss of data
- Protection of patient confidentiality and privacy
- Effective reporting systems
- Effective and timely communication.
Logs and worksheets consists of?
- control logbooks
- calibration worksheets
- temperature monitoring worksheet
- result logbooks
Examples of control logbooks?
Westgard rule, control of reagents
Examples of calibration worksheets?
machine, automations, instruments
Examples of temperature monitoring worksheet?
waterbath, freezer
Examples of result logbooks?
laboratory tests compiled for DOH accreditation
When do we perform controls in the laboratory?
everyday
It is the process by which information is exchanged and understood by two or more people, usually with the intent to motivate or influence behavior.
Communication
The exchange of thoughts, messages, or information using speech, signals, writing, or behavior.
Communication
The art and technique of using words effectively to impart information or ideas.
Communication
A system, such as mail, telephone, television, or computer, for sending and receiving messages.
Communication
The exchange or transmission of ideas, attitudes, or beliefs between individuals or groups.
Communication
To select symbols with which to compose a message.
Encode
The tangible formulation of an idea to be sent to a receiver.
Message
The carrier of communication.
Channel
To translate the symbols used in a message for the purpose of interpreting its meaning.
Decode
A response by the receiver to the sender’s communication.
Feedback
The Model of Communication Process is created by?
Shannon-Weaver
Who said: “The First executive functions is to develop and maintain a system of communication.”
Chester Barnard
Who said: “Organizational interaction depends on communications.”
Hicks
Who said: “The nature and used of communications in excellent companies are remarkable.”
Peters and Waterman
According to the Communication and Information Flow Diagram, where does information flow to?
- Internal department
- External department
- External vendors
- Regulators
- Laboratory clients
a plan used by the laboratory for the dissemination of information
Management Communication Strategy
Elements of a Communication Plan?
- Define objectives and purpose of the plan.
- Use a concise message.
- Gear communication to education level of recipient.
- Identify the structure and format of written communication. Design a format and use it as a template for all written communications.
- List recipients of laboratory communication. Identify all stakeholders who should receive communication.
- Identify the method(s) of communication.
The appropriate utilization of Laboratory Services?
- test orders
- frequency of test orders
- specimen collection and transport
- testing turnaround times
- report formats
- additional report comments
- reference ranges
- consultation options
- test limitations
Regulations Concerning the Operation of the Laboratory?
- hours of operation
- performance of tests per shift
- STAT reporting, critical value reporting
- laboratory organization chart
3 methods of communication?
Written, Verbal & Visual
Method of communication: memo, newsletter, email, specimen collection manual, etc.
Written
Method of communication: phone call, intercom, etc.
Verbal
Method of communication: banner, poster, video, etc.
Visual
Cycle of Communication In Processing Laboratory Determination?
- Physician
- Patient/lab request
- Specimen collection
- Laboratory processing
- Releasing of results
A request form should contain at least the following information?
- Laboratory procedure
- Identification of the patient
- Name of the physician
- Date and time the specimen was collected
- Date and time the specimen was received
- Date, time and by whom the specimen was examined
- Condition of any unsatisfactory specimen
- Type of test or procedure performed
- Results and date of reporting
General Qualities of a Laboratory Report?
- Compactness
- Consistency of terminology, format and usage of understandability
- Clear and easy to understand
- Statement of date and time of collection
- Gross description and source of the specimen when pertinent
- Sharp differentiation of reference or normal and abnormal values
- The sequential order of multiple results on a single specimen
- Identification of patient, patient location and physician
- Assurance of accuracy of transcription of request
1 of the 12 essential elements of the quality system.
Documents and Records
True or false: The management system addresses both use and maintenance of documents and records.
True
A major goal of keeping documents and records is to?
find information whenever it is needed
provide written information about policies, processes and procedures (WHO)
Documents
are the collected information produced by the laboratory in the process of performing and reporting a laboratory test (WHO)
Records
Characteristics of Documents?
- Communicate information to all persons who need it
- 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 record information, they become records
Examples of Documents?
- Quality manual
- Reference material
- Standard Operating Procedure (SOP)
- Job aids
- Policy manual
Characteristics of Records?
- Need to be easily retrieved or accessed
- Contain information that is permanent, and does not require updating
Examples of Records?
- Patient information
- Test results
It is a document that describes the quality management system of an organization.
Quality Manual
Quality Manual should follow which ISO standard?
ISO 15189
Purposes of Quality Manual?
- clearly communicate information
- serve as a framework for meeting quality system requirements
- convey a managerial commitment to the quality system
This quality manual template is based on internationally-accepted standards, and provides guidance for public health and clinical laboratories on writing policies and procedures that support a quality management system.
Laboratory Quality Manual
It comprises a main document providing information and examples to assist with writing a laboratory-quality manual, and 24 appendices (examples of standard operating procedures, forms, and processes).
Laboratory Quality Manual
The 24 appendices of the Laboratory Quality Manual?
- Meeting management
- Safe manipulation
- Equipment installation process
- Equipment repair process
- Decontamination of laboratory equipment
- Equipment decommission
- General sampling conditions
- Sample labelling
- Sample rejection or acceptance
- Sample transport
- Results validation
- Critical results reporting
- Internal audit
- Orientation checklist form
- Internal training
- Competency assessment
- Customer survey
- Customer complaint
- Nonconforming event management
- Internal documents management
- SOP management
- Document management
- Short term archiving
- Document control
The key points to remember about the quality manual are?
- There is only one official version
- The quality manual is never finished—it is always being improved
- It should be read, understood, and accepted by everyone
- It should be written in clear, easily understood language
- The quality manual should be dated and signed by the management
The Laboratory Quality Manual contains the following?
- The quality policy of the laboratory
- Reference to all processes and procedures
- Table of contents: Description of the lab & Staff education and training
It states the laboratory and institutional policy for the guidance of those working in the laboratory.
Policy Manual
Should reflect the philosophy and overall goals of the organization.
Policy Manual
Should be dated and approved by the laboratory director.
Policy Manual
Policy Manual contains the following?
- Dress Codes
- Food and smoking rules
- Telephone use
- Laboratory organizations and reporting relationship
- Writing, review and authorization of procedures
- Vacation and holiday request
- Supply requisition
- Absences and late arrival notification
- Reporting and releasing of test results
- Specific statements about enforcement of safety rules
It contains written step-by-step instructions that laboratory staff should meticulously follow when performing a procedure.
Standard Operating Procedure (SOP)
Written SOPs ensure the following?
- Consistency
- Accuracy
- Quality
SOP should have the following?
- Title
- Purpose
- Instructions
- Name of Person preparing the SOP
- Signatures of approving officials and dates of approval
A good SOP should be?
- detailed, clear and concise
- easily understood by new personnel or students in training
- reviewed and approved by the laboratory
- updated on a regular basis
These are needed in order to find scientific and clinical information.
Reference Materials
Good reference materials are needed in order to find scientific and clinical information about?
- diseases
- laboratory methods
- procedures
These are laboratory information, either written by hand or computer-printed.
Records
They are permanent, and are not revised or modified.
Records
Laboratory records contain?
- Sample log book or register
- Workbooks, worksheets
- Instrument printouts
- Maintenance records
- Quality control data
- EQA/PT records
- Patient test reports
Benefits of Paper System in storing documents and records?
Permanence
Accessibility
Security
Traceability
Benefits of Electronic System in storing documents and records?
Permanence
Security
Traceability
Factors on Record Retention?
- The length of time the laboratory will need to have access to its records
- Government requirements or standards that dictate record retention times
- Whether the laboratory is engaged in ongoing research requiring many years of data
- The time interval between the laboratory’s assessments or audits
Record Retention: Requisition and Accession Logs
2 years
Record Retention: Maintenance and Instruments Logs
2 years
Record Retention: Quality Control Records
2 years
Record Retention: Blood Bank Donor/Receipt Records
10 years
Record Retention: Blood Bank Patient Records
10 years
Record Retention: Blood Bank Employees Signature
10 years
Record Retention: Blood Bank QC Records
5 years
Record Retention: Clinical Pathology Test Records
2 years
Record Retention: Reports (Cytology, Surgical, Non-Forensic)
10 years
Record Retention: Cytogenetic Reports and Images
20 years
Record Retention: Flow Cytometry plots and Histograms
10 years
Computer network of hardware and software for receiving, processing, and storing laboratory data and information.
Laboratory Information System (LIS)
Laboratory Information System (LIS) can interface with ______________ to transfer data into patient records, evaluate quality control data, and store preventive maintenance records.
laboratory instruments
LIS can interface with?
HIS, pathology information system, and other information systems
Components of LIS?
- The LIS software user interface determines how the user will interact with the system.
- Request entry: Requests for laboratory tests can be entered through clients in the nursing units or remote primary care practitioner’s office.
- Data (results) entry: Electronic data interface (EDI), Manual Data entry, Release patient results
- Data storage: Redundant arrays of independent disks (RAID), System backup
- System security
- Barcoding
- Interface
- Manual procedures
- System maintenance
- Disaster recovery
Information provided by a LIS?
- Patient demographics
- Worklists
- Data retrieval (inquiry)
- Quality control
- Quality assurance
- Management reports
- Encoding systems
An LIS can analyze quality control specimens and prepare charts and reports (Westgard rules, Levey-Jennings charts).
Quality control
Can provide reports on turnaround time, documentation of critical result reporting, and corrected reports.
Quality assurance
Cost per billable test calculations, test volume, turnaround time, employee hours, workload data, etc.
Management reports
Benefits of data retrieval (inquiry) as one of the information provided by a LIS?
- Generate patient results
- Perform Delta Checks
- Patient results can be retrieved electronically at a client or via the Internet with a Web browser
Flag critical values, and print reports if requested.
Generate patient results
The results of an analyte assay are compared to the most recent previously performed results on the same patient.
Delta Checking
Advantages of Computerized Systems?
- Error reduction
- Quality control management
- Provision of option for data searching
- Access to patient information
- Generate reports
- Ability to tracks reports
- Improved capacity for maintaining patient confidentiality
- Financial management
- Integration with site outside the lab
Disadvantages of Computerized Systems?
- Training
- Time to adapt to a new system
- Cost
- Physical restrictions
- Need for backup system
It is the exchange of ideas, attitudes, and information through the spoken word, written word, and visual images.
Communication
It is a critical skill that laboratorians need to ensure effective delivery of laboratory services.
Effective communication
These include written policies, processes and procedures, and provide a framework for the quality system. They need to be updated and maintained.
Documents
These include information captured in the process of performing and reporting a laboratory test.
Records
