1. Method confirmation:
The laboratory should confirm the accuracy, sensitivity, specificity and precision of the detection methods used. This involves the performance verification, calibration and quality control procedures of test equipment. Method validation ensures that the detection methods used in the laboratory meet the international standards and quality control requirements.
2. Sample confirmation:
The laboratory needs to confirm whether the collection, preservation and transportation of specimens conform to the specifications. Different types of specimens (such as blood, urine, tissues, etc. ) special processing methods are needed to ensure the integrity and stability of the specimen, so as to ensure the reliability of the test results.
3. Quality control confirmation:
The laboratory should establish a quality control system, including internal quality control and external quality evaluation. Internal quality control includes daily quality control sample testing to monitor the daily operation of the laboratory. Inter-laboratory quality evaluation is to evaluate the overall level of the laboratory by participating in the inter-laboratory quality evaluation scheme and comparing with the results of other laboratories.
4. Equipment confirmation:
Laboratory equipment (such as analytical instruments, centrifuges, etc. ) requires regular performance verification and maintenance to ensure its normal work. Equipment verification includes equipment calibration, maintenance record management, equipment fault handling, etc. Ensure the stability and reliability of the equipment.
5. Environmental confirmation:
The environmental conditions of the laboratory (such as temperature and humidity) also affect the experimental results, so it is necessary to confirm the environment. The laboratory should regularly monitor and record the environmental conditions of the laboratory, and ensure that they meet the requirements of the standard to ensure the stability of the experimental results.
6. Personnel confirmation:
Laboratory staff need to receive relevant training, and regularly conduct skills training and assessment to ensure that their operations meet standards and norms. Personnel confirmation also includes confirming the organizational structure, division of responsibilities and staffing of the laboratory.
7. Confirmation of standards and reagents:
The standards and reagents used in the laboratory need to come from reliable suppliers and need to be verified. The laboratory shall establish a management system for receiving, storing and using records of standards and reagents to ensure their quality and stability.
8. Laws and regulations confirm that:
Laboratories need to comply with relevant laws, regulations and ethical requirements, including medical ethics and patient privacy protection. The laboratory should regularly carry out training on laws and regulations to ensure that the laboratory operation meets the requirements of laws and regulations.
Generally speaking, the laboratory should identify and manage all factors that may affect the test results, ensure that the operation of the laboratory conforms to standards and specifications, provide accurate and reliable test results, and ensure the safety and health of patients. Confirmation requires the joint efforts of all laboratory staff and the cooperation of relevant departments and institutions to form a scientific and efficient management system.