Laboratory managers aim to ensure the efficient running of their facilities while also ensuring the quality and dependability of the examination results they produce for patients.
To maintain a high-quality operation, medical laboratories have quality management systems and, through laboratory accreditation, establish their competence.
Quality management systems are based on international laboratory standards ISO/IEC 17025 and ISO 15189 and/or recommendations of good practices in different disciplines.
Many European countries started the process of accrediting medical laboratories around 20–25 years ago, while others are only getting started.
ISO/IEC 17025 is a generic standard for all types of laboratories, however, ISO 15189 is intended solely for medical laboratories and outlines how a medical laboratory should work.
The initial emphasis of accrediting examinations was on the technical operation of laboratories, but later assessments also placed greater emphasis on laboratory management.
Medical laboratories have utilized their quality management systems and accreditation quite well, by improving operations in several ways. Nevertheless, there remain certain areas for development.
Management must be responsible for strategic planning of the entire laboratory and close monitoring of both operations and customer service. These are all areas where medical labs still need to advance.
Management reviews and internal audits are effective methods to monitor the performance of a laboratory and are extensively employed. Unfortunately, not every lab has the resources to create the instruments necessary to learn as much as possible about its own operation and to investigate ways to enhance it.
Cooperation with healthcare providers is crucial to a laboratory’s success since this ensures that patients benefit from the most appropriate testing procedures and technology.
This collaboration has been organized in many ways by laboratories, but it needs better management to ensure that it is effectively planned and that the laboratory management learns what it needs to know about the demands and feedback of its clients.
Labs monitor for operational nonconformities and take corrective measures as needed. The procedures, however, are not always clear enough for employees to know what nonconformities should be recorded and reported to management or a responsible person.
A well-documented set of steps is also necessary for the efficient management of customer comments.
Skilled workers are crucial to the success of any laboratory. Scientists and technicians in labs receive ongoing education and instruction.
Laboratories, however, need to pay more attention to the quality and efficiency of their training programs. New doctors, chemists, physicists, and head nurses may be left out of a training plan, and the success of training is not always rigorously evaluated.
It is important for laboratories to use validated/verified examination methods to provide accurate patient findings; yet, there is room for improvement in both the design of validation and the documentation of validation results.
Exam results need to be traceable so that they can be compared and used for long-term patient monitoring. While there has been an uptick in awareness of the value of traceability, some laboratories may still be unfamiliar with the concept.
Internal and external quality assurance programs help laboratories ensure the accuracy and reliability of patient examination results, however, there is often a lack of clarity regarding the objectives for quality assurance and no universal criteria for accepting quality assurance results.
Examination results are reported promptly by laboratories, and clinicians are notified immediately of any results that are deemed to be critical or urgent.
To ensure that staff consistently adhere to stated procedures, labs should document these reporting processes more precisely.
Although laboratories provide all the information healthcare facilities need to help patients in the correct preparation for examination, patients often do not follow these directions, which is a major problem. Instructing patients on how to get ready still necessitates more collaborative effort.
The protocols in a lab and the adherence to those protocols by workers can be evaluated via proficiency testing. Participants in PT programs in the UK, Europe, and the US will follow different protocols and have their data handled in different ways.
Yet, they will each have a central office where samples with known levels of contamination will be prepared. In order to analyze PT samples, the administration center receives reports from collaborating labs.
The data is compiled by the administration and users are ranked according to their performance. Any and all participating laboratories will remain nameless. The anonymity ensures that all participating labs can detect patterns in their own testing results and compare with other labs.
Lab managers can use the information gathered during PT to determine who among their employees would benefit from additional training. Therefore, this results in uniform procedures being used across the laboratory.
The team stays focused on the proper execution of standard operating procedures thanks in large part to the frequent testing that is performed.
Employees can learn more about the ‘risk’ areas of testing that PT can expose them to. Staff members who have received training are better able to recognize their individual contributions to the high quality of their lab’s final products.
When employees realize how important they are to the success of their employers, everyone wins.
The data gleaned through PT can also be used by lab management to fine-tune procedures. In the case of a laboratory, this could mean that results suffer from a sudden spike in the number of samples being processed.
This could simply be an adjustment time, or it could be a sign of a more serious problem with the way things are being done.
If lab managers notice a consistent decline in success rates throughout testing cycles, they can take this as an opportunity to reevaluate methods and figure out how to reduce procedures.
In conclusion, healthcare facilities look to medical laboratories for guidance in selecting appropriate patient examinations and in employing appropriate patient sample procedures; cutting-edge examination techniques; transparently provided examination results; and consultation to interpret results.