Quality
Assurance
Mam Aneeba
Reporting of
Results
Presented by
Kiran Amanat
Reporting of Results
• The laboratory is responsible for ensuring that the requester
receives the results of laboratory testing correctly, completely
and timely.
• Recording and reporting of results needs to be done
meticulously; if the recording/reporting system of the
laboratory is of inadequate quality this can affect the correct
transmission of results to the requester.
Rules
1. Recording of results
Ensuring correct recording of all the data needed in all the registers, forms and
reports necessary.
2. Reviewing and authorizing results for release
Including checking of correct transcription of results between registers, reports and
work forms, and checking completeness of final report by authorized personnel .
3. Normal procedure for reporting of results
Results must always be reported in a final, authorized official report to the
requester, not the patient, by authorized staff members. The results, reference
intervals and descriptions must be reported using accepted vocabulary/syntaxes
and nomenclature.
Rules…..
4. Immediate notification of the requester of results of urgent samples .
5. Immediate notification of the requester in case results fall in critical intervals (this procedure
was developed earlier ... Include the Immediate Notification Form developed earlier in as appendix to the
SOP.
This procedure must ensure that if no contact was made with the requester, the laboratory keeps trying to
get into contact until contact is made.
6. Reporting via telephone or other electronic means
Paying attention to proper verification that the correct clinician is called and that the clinician records the
correct results for the correct patient.
7. Reporting of results of samples of inadequate quality but that were still tested
Notifying the clinician of this and explaining that the results should be interpreted with caution as they are
less reliable.
Rules…..
8. Alteration of reports
When it is detected, after reporting of the result, that an examination might have been flawed (for
example due to the use a bad quality reagent) the requester needs to be notified of the fact that the
result is less reliable or may even be incorrect, so that he/she can undertake action with regard to
correct diagnosis and treatment of the patient. The changes to the original report need to be clearly
visible and need to be supplied with a date, time and name of the person who made the changes. In
electronic reporting systems a track and trace function is needed, which records all modifications.
9. Archiving of results
Copies of official Result Reports are stored by the laboratory for a specific period of time. When
reports are altered, the original report is also archived, together with the revised reports. When
results were immediately notified to the requester, the completed Immediate Notification Form must
be added to the official Result Report to enable later verification if needed.
Computer
process with
Laboratory
Computer process
• Today, laboratories use computers to manage test
requests and specimen collection, control
instruments, collect data from instruments,
translate that data into meaningful results, collate
all analyses on an individual patient, and generate
reports for physician information and inclusion in
patients medical ...
• The role of the computer in minimizing
transcription errors, reducing turn-around time of
Clinical Computing System
• Clinical computing systems—defined
computing systems used in direct patient
care—are common place in healthcare
organizations and growing dramatically in
importance …
Clinical Information System
• Clinical Information System (CIS) is a
computer-based system that is meant to
gather, store, and alter clinical data on
patients.
Components of Computer Lab
• Computers . Mouse
• Monitors . Cameras
• Keyboards
• Disk drives
• Modems for network
• Printers
• Scanners
Computer Base Lab
• A microcomputer based laboratory (MBL)
is one in which a microcomputer is used to
collect, store, process, and analyze data.
There are a large number of data collection
sensors available today that are inexpensive
and also easily connect to microcomputers
Requirements
1.Standard and Enough furniture.
2.Good ventilation.
3.Reliable & Enough source of power supply.
4.Free from Dust and Moisture.
Rules
1. Each person may only use one computer at a
time.
2. Computers and peripherals are not to be moved
or reconfigured without approval of Lab and
Classrooms staff.
3. Students may not install software on lab
computers. ...
4. The use of tobacco products is not allowed in
computer classrooms and labs.
CDM
• Clinical trial data management (CDM) is the
process of a program or study collecting,
cleaning, and managing subject and study
data in a way that complies with internal
protocols and regulatory requirements.
Clinical Lab Departments
1. Chemistry: Chemistry performs a wide variety of tests using the most
current technology. ...
2. Hematology: Hematology is the study of blood, blood morphology and
blood diseases. ...
3. Microbiology: ...
4. Transfusion Services/Immunology: ...
5. Immunology: ...
6. Surgical Pathology: ...
7. Cytology:
Computer in Medical
Technology
• Word processing
• Compiling databases
• Scheduling
• Maintaining financial records
• Monitoring patients
• Performing diagnostic tests
Software use
in Laboratory
Software
• Software refers to computer programs or applications
that are designed to perform specific tasks or
functions. It consists of instructions and code that tell
the computer what to do. Software can be categorized
into different types, such as operating systems,
productivity software, entertainment software, and
more. It's what allows us to use computers and other
electronic devices to perform various activities.
Softwares of Clinical Lab
1. Laboratory Information System (LIS)
2. Electronic Medical Record (EMR) Systems
3. Laboratory Information Management System (LIMS)
4. Data Analysis Software (SPSS, SAS, R)
5. Instrument Control Software (PCR analysis software,
spectrophotometer software, chromatography software)
6. Quality Control Software
7. Reporting and Documentation Software.
Laboratory Information System
• Laboratory Information System (LIS):
LIS is used to manage patient information,
test orders, and results in a clinical
laboratory. It helps streamline workflows,
track samples, and ensure accurate and
timely reporting.
Electronic Medical Record
• Electronic Medical Record (EMR)
Systems: EMR systems store and manage
patient health records electronically. They
include medical history, diagnoses,
medications, and test results, making it
easier for healthcare providers to access and
share patient information.
Lab Information
Management System
• Laboratory Information Management
System (LIMS): LIMS manages laboratory
operations, including sample tracking, data
management, and workflow automation. It
ensures efficient data collection, analysis, and
reporting, making it easier for researchers to
manage experiments and results.
Components
• Customers Collection sites . Employees
• Preservatives . Analysis method
• Passwords
• Tests & test results
• Bottle types
• Sample matrix
• Parameters
• Control limits
Functions
• Additional functions
• Audit management
• Barcode handling
• Chain of custody
• Compliance
• Customer relationship management
• Document management
Functions
• Manual and electronic data entry
• Method management
• Personnel and workload management
• Quality assurance and control
• Reports
• Time tracking
• Traceability
• Workflows
Data Analysis Software
• Data Analysis Software (SPSS, SAS, R):
These software tools are used for statistical
analysis and data modeling. They provide
various statistical methods and visualization
techniques to analyze research data and
draw meaningful insights.
Instrumental Control Software
• Instrument Control Software: Instrument
control software is used to operate and
control specific laboratory instruments like
PCR analyzers, spectrophotometers, and
chromatography systems. It allows
researchers to control instrument settings,
collect data, and analyze results.
Quality Control Software
• Quality Control Software: Quality control
software helps monitor and maintain the
quality of laboratory processes and results. It
includes features like quality control sample
tracking, data validation, and performance
monitoring to ensure accurate and reliable
results.
Reporting Software
• Reporting and Documentation Software:
This software helps generate reports and
documents related to laboratory tests and
research findings. It allows researchers to
create professional reports, customize
templates, and efficiently document their
work.
Central Computer Memory
• Central computer memory, also known as computer
RAM (Random Access Memory), is a type of
computer memory that is used to store data and
instructions that are actively being accessed by the
computer's processor. It is a temporary storage
location that allows the processor to quickly retrieve
and manipulate data. RAM is volatile, meaning that
its contents are lost when the computer is powered
off or restarted. It plays a crucial role in determining
the overall performance and speed of a computer
Thank
You
