Implementing a quality management system in the laboratory can help ensure customer satisfaction, satisfy regulatory requirements, and create more efficient processes. Quality in Laboratories is as important as in any other organization and even more. Quality management systems in laboratories assure the reliability of all aspects of the operations. Therefore, QMS in medical laboratories requires quality in all practices including environment, quality procedures, record keeping, human resources, reagents, and equipment and instruments. The Quality System Essentials have been described by CLSI as 12 important elements that are required to act as building blocks for developing a QMS.
Compliance with the QMS will be checked by carrying out audits on each or all of these elements on a regular basis.
The Laboratory needs to be able to show a clear organizational structure, indicating who has overall responsibility for laboratory activities and who reports to who. An organogram or organizational chart is an important tool for this. The Lab also needs to show that there is planning and control in the day-to-day and periodic tasks to ensure a well-oiled system.
Facilities and safety
Despite the nature of work undertaken e.g. handling infectious material, laboratories should be a safe place for staff and visitors alike. The physical containment of the laboratory, worker safety, and ergonomics are key considerations. Procedures and standards should ensure a safe, secure, and clean environment.
Quality System Essentials: Personnel
The management of staff within the lab is paramount to a well-functioning lab. Although laboratory processes are becoming more automated, lab staff still make the ultimate decisions about methods and results. Staff must have the right qualifications for the job, and job descriptions must spell out what is expected of each position. Training and competency assessment at the beginning of employment and regularly thereafter will ensure staff remains competent to carry out tasks as expected. Motivated and engaged staff will perform at their best.
Quality System Essentials: Equipment
Decisions on the choice of equipment have to be evidence-based. The laboratory maintains an inventory of all the equipment and schedules maintenance activities to ensure optimum functionality.
Purchasing and inventory
Quality System Essentials: Purchasing and Inventory
Laboratory stocks and supplies provide the inputs for laboratory processes. ‘Garbage in, garbage out. The quality of supplies is dependent on choosing the right products and the right suppliers. A good inventory management system ensures uninterrupted service as supplies are available when required.
The laboratory testing process from the pre-analytical, and analytical to the post-analytical phase is controlled by having checks and balances along the way. Validation and verification of methods as well as Internal Quality Control are some of the measures in place to ensure that the processes deliver the best outcomes for the patient.
Quality System Essentials: Information Management
Laboratories receive and produce information that is highly sensitive and confidential. As one of the 12 Quality System Essentials, it is important to have measures in place to ensure that only the right people can access, edit and share that information.
Documents and records
A cornerstone of the QMS, documentation ensures standardization which is paramount to quality management. Policies, procedures, and instructional guides will define the QMS and give direction for the laboratory and supporting processes. They should be available for staff to use for reference and they should be current.
An “occurrence” is any error or non-conformance. All deviations from what is expected within a laboratory and affecting laboratory operations should be investigated. They pose a risk of harm to patients and staff. If root cause analysis is thorough, corrective action will be appropriate to address the error.
An important element of maintaining a QMS is constantly checking compliance with requirements. This is done through internal audits and external audits by regulatory and accreditation bodies. Audits are planned and systematic. Participation in External Quality Assessment/ Quality Assurance Programs is mandatory for all the tests that the lab performs.
The laboratory should have a way to continuously improve processes. Improvements may be triggered by something having gone wrong with correction resulting in the improvement of a process, but the laboratory should also have mechanisms in place to identify opportunities for improvement even before anything goes wrong. This proactive approach is preferred to a reactive approach for process improvement.
The laboratory needs to understand the customers and their needs and use customer feedback for improvement. There should be mechanisms in place to handle customer feedback and complaints.