How Qualis LIMS helps Laboratories to fulfill ISO 15189 requirements
INTRODUCTION
About IS0 15189 Standard and its importance
ISO 15189 is an international standard, prepared the International Organization for Standardization (popularly referred to as ISO, which brings together a worldwide federation of national standardization bodies to formulate standards), that specifies requirements for competence and quality that are specific for medical laboratories to meet both the technical competence and management system requirements necessary for delivering consistent technically valid results.
It is based upon ISO/IEC 17025 and ISO 9001 and deals with the important aspects and processes in a medical laboratory such as arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, interpretation and reporting of results, etc.
Background
Medical Laboratories play an important role in the Health Care System. The results obtained from Medical Laboratories are critical for detection of disease in individuals and populations as well as for the proper treatment provided to the patients. Quality management has been around for long time and the quality management system (QMS) model has been adapted to the medical laboratory environment through the use of international standards such as ISO 15189.
Laboratory quality can be defined as accuracy, reliability, and timeliness of reported test results. To be useful, laboratory results must be as accurate as possible, all aspects of the laboratory operations must be reliable, and reporting must be timely. Some significant consequences of poor quality in the laboratory can include unnecessary treatment or treatment complications, failure to provide correct treatment, delayed diagnosis, and unnecessary follow-up diagnostic testing. These consequences result in increased cost in time and work, as well as poor patient outcomes.
All aspects of the laboratory operation—including the organizational structure, processes, and procedures— need to be attended to in a QMS. ISO 15189 is the international standard that sets the requirements for a quality management system in a medical laboratory environment.
How it will apply to Laboratories?
This standard is intended to be used in the most common disciplines of a medical laboratory for the purpose of providing information for the diagnosis, management, prevention and treatment of disease in, or assessment of the health of, human beings.
To understand what kind of laboratories will benefit by implementing ISO 151189 standards, we can look at the definition of medical and clinical laboratories as mentioned in ISO 15189 standards:
“… laboratory for biological, micro-biological, immunological, chemical, immuno- haematological, haematological, biophysical, cytological, pathological or other examination of materials derived from human body for the purpose of providing information for the diagnosis, prevention and treatment of disease in, or assessment of health of, human beings and which may provide a consultant advisory service covering all aspects of laboratory investigation including interpretation of results and advice on further appropriate investigation”.
A note further states:
“These examinations also include procedures for determining, measuring or otherwise describing the presence or absence of various substances or micro-organisms. Facilities which only collect or prepare specimens or act as mailing or distribution center, are not considered to be medical or clinical laboratories, although they may be part of a larger laboratory network or system”
The medical and clinical laboratory services need the following tasks to be considered as per the standard:
“…..arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work”
ISO 15189 Accreditation
The medical and clinical laboratories that perform the services as described above can be benefited by obtaining ISO 15189 accreditation. They can do so with the help of professional accreditation body that has a full understanding of ISO 15189 Standards and that can assist and verify the requirements of any specific medical laboratory.
It is also to be noted that ISO 15189 is not equivalent to ISO 9001 (though both have many similarities), which needs to be accredited separately if required. Of course, many of ISO 15189 and ISO 9001 standards overlap and mutually beneficial while implementation of the standards.
Another important standard that can be focussed on is ISO 17025 which are technical competence ones upon which a lot of ISO 15189 standards are based. The laboratories can be benefitted a lot by obtaining both ISO 15189 and ISO 17025. Same as in the case of ISO 9001, if required, ISO 17925 needs to be accredited separately.
A few of the benefits of accreditation for Medical Laboratories and users are:
- International recognition
- Techniques are up to date
- Reliable and trusted results
- Confidence in the competency of staff
- Commitment for continuous improvement
- Risk mitigation measures are applied
- Traceability of measurement
OVERVIEW OF AGARAM’S QUALIS LIMS
About Qualis LIMS
Agaram Technologies’ Qualis® LIMS (Laboratory Information Management System) is designed for use in manufacturing, Quality Control, R&D, analytical research and any testing laboratory. Qualis LIMS helps organization to manage the laboratory business process end- to-end, from sample receipt to COA generation, MIS and beyond.
It helps in streamlining the process with respect to laboratory investigations starting from tests and specifications management, ordering of tests, registration of samples, job allocation, results entry, approval, report generation, OOS, deviations recording, and document management. It provides a structured method to document the laboratory investigations besides handling the compliance requirements.
Qualis LIMS ensures that the laboratory organisation complies with regulations and standards namely 21 CFR Part 11, Eudralex Annex 11, ISO 17025, ISO 15189 and ALCOA data integrity. The advantages include paper-less record keeping system having high availability, easy access, accurate validation at various levels, easy tracking of records, data integrity, Audit trail information and authorised secured user access to data.
Qualis LIMS Core Product Features
- Sample Management – It helps the laboratory users to receive, register and manage samples within LIMS application including barcode labelling
- Results and Release Management – It helps the laboratory users to enter results and the details including inventory material usage using approval workflow and retest/recalculation features.
- Work Scheduling – It helps the laboratory users to allocate tasks to human resources and reschedule them
- Test Grouping and Specification Management – It helps the laboratory users to manage test and specification version and release controls, template-based hierarchy
- Instrument Management – It helps the laboratory users to maintain the instrument details along with calibration schedule (for validation) and instrument usage log
- Training and Certification Management – It helps the laboratory users to maintain training and competency records of human resources (to comply with GLP principles and ISO 17025 requirement)
- Inventory Management – It helps the laboratory users to maintain and record the usage of material inventory (consumables, reagents, etc) along with expiry data for validation and re-order level
- Workflow – Multi-level workflow configuration is used for better monitoring of the processes, approve the data, results (with electronic signature) and calculation and also to order re-test and re-calculation to achieve better quality and reliability.
- User Management – It helps the laboratory users to setup control role-based access with password policy setup
- Reports, Alerts and Dashboards – It helps the laboratory users to enable them to monitor the process and take pro-active action as required
- Audit Trail – It helps the laboratory users to keep track of what, when, who, why changes take place and maintain the record of changed values with date/time and electronic signature
Overview of Qualis LIMS Process Flow
This is the overview of the sequence of process flow carried out in a typical lab. It involves: Planning, Registering, Job Allocation, Analysis or Testing, QA Verification and Approval followed by Output Report generation.
In Planning process, the master data is collected and configured in the system. Masters namely Organisation hierarchy, Users, their roles and rights, tests and specifications, workflow setup, etc are configured.
In Sample registration process, samples are collected, pre-registered, registered, labelled, stored, divided into subsamples and tests are associated.
In work allocation, the tests are assigned to the right users (using validation of users for their competency), right instruments (using validation of instruments for their calibration and maintenance status) and job scheduling.
The results are captured during the sample analysis by the Analyst and the results entry is by direct method or using instrument integration with the help of ELN/SDMS (either in simple manner or using complex calculation and parsing logic).
The results of the tests are routed typically to verifiers from QA Department who after verification approve or reject or request for recalculation/re-entry or re-do tests. Once reviewed, the results are routed for final approver, who approves and releases the final results.
Finally, the Certificate of Analysis (COA) report along with other reports are generated in the system and despatched to whosoever requires it.
Qualis LIMS Features and their benefits to the users
ISO 15189 AND QUALIS LIMS SOLUTION
In this section, we shall see how Qualis LIMS helps laboratories to fulfil ISO 151189 requirements. We shall see the critical ISO 15189 clauses and the corresponding Qualis LIMS solution.
CONCLUSION
ISO 15189 standards help medical and clinical laboratories in various industries to streamline quality and competence. Switching to automated processes that associated with quality and compliance can make medical and clinical laboratories more efficient than ever and more prepared to compete in an increasingly competitive life-science and healthcare environment.