Immediate testing is the use of portable instruments to directly complete the entire process of specimen collection, testing and result reporting at the place closest to the patient. It provides the necessary basis for patient immediate testing or diagnosis and treatment. It has the characteristics of shortening the inspection cycle and is the future development of laboratory medicine. direction. However, in recent years, the organization and management of POCT has not been perfect, the quality control system is imperfect, and it is susceptible to problems such as the operator's technical level. The resulting inaccurate test results may affect clinical decision-making and treatment effects.

The establishment of the quality management system of the clinical POCT testing project in the tertiary hospital is demonstrated as follows:

01 Method

The hospital established a POCT management team to formulate a POCT testing project management system. The POCT management team is composed of the medical business department, the equipment department, the price management office, the nursing department, the inspection department and other departments, and collaboratively builds a comprehensive quality management system.

02 Project Evaluation (Approval)

The medical business department conducts a comprehensive evaluation of the POCT testing projects that have been carried out, including: 1. Necessity of development: projects within the discipline that urgently need to know the results immediately, and the clinical laboratory's return to the project (full TAT) time cannot meet the clinical Requirements; 2. Project standardization: must comply with relevant laws, policies, standards and ethics of the country and the region; 3. Comply with the principles of evidence-based medicine; 4. Practicality: the application level and scope do not overlap with the laboratory of our hospital ( If Glu is only for testing, not for diagnosis basis)

03Implementation of admission system and archival management

1. The POCT equipment and test items that have passed the project evaluation are required to undergo performance verification of precision, accuracy and linear range. Instruments and projects that meet the relevant standards can only be put into use, and those that have not reached the standard for maintenance and overhaul should be eliminated and replaced.

2. The equipment department will number and archive the above POCT equipment.

04 Formulate standard operating procedures

The clinical department assists each clinical department with reference to various standards and the relevant requirements in the expert guide and the instrument manual as guidelines to prepare standard operating procedures, covering the entire process before, during and after the inspection, and executed by the POCT management team after review. 

Among them, the storage and use conditions of POCT equipment and cleaning requirements, storage and use of reagents, specimen collection specifications, intra-department transfer and handover specifications, etc. are included in the test; the test includes indoor quality control and standard sample operation before the daily test ( If the sample addition tool is required), the standard operation of the project test, the re-inspection rules and the critical value registration, etc.; after the test, the content and method of the test report, the storage location, the storage period, the sample storage requirements for the completed test and the treatment of medical waste, etc. , Each department appoints a special person to be responsible for the maintenance, use and quality control of the instrument.

05POCT operator qualification, regular training, assessment and award

It is stipulated that the personnel engaged in POCT operations should be professional technicians, nurses or doctors in clinical laboratories with professional health professional titles and who have passed POCT training and passed the assessment.

06 Unified Report Format

The POCT result report refers to the requirements of the report form in the "Administrative Measures for Clinical Experiments in Medical Institutions", and follows the principles of protecting patient privacy, conforming to the case writing regulations and preservation regulations. The POCT result report form uses the POCT test form printed by the hospital uniformly; if there is a critical value, it shall be processed in accordance with the hospital's "critical value reporting system".

07 Regular comprehensive evaluation

The Medical Business Department organizes monthly operation specifications and indoor quality control inspections to standardize daily operations and indoor quality control.

The inspection department conducts a comparison test between POCT test items and large-scale instrument test results every six months to evaluate the accuracy of the results.

The medical business department conducts a full TAT time evaluation of the POCT testing projects carried out every year.

The Equipment Section conducts benefit evaluation of POCT testing projects once a year.

08 Indoor Quality Control

There are inspection departments to assist clinical departments to formulate indoor quality control rules with reference to various standards and relevant requirements in expert guides and instrument manuals.

It is stipulated that each POCT equipment must have an indoor quality control test and record the results in a unified quality control record book when there is a sample for 24 hours.

Under the guidance of the inspection department, the target value of the quality control substance of each POCT test item is set with the target value provided by the manufacturer as a reference and combined with the actual test result. Various quality control rules only set 1-3s out-of-control rules, and 3s for NT-proBNP, cTn and other projects is 30% of the quality control target value.

The results of indoor quality control can only be used for daily sample testing when it is under control. After losing control, the cause and treatment measures must be analyzed and recorded in detail.

Indoor quality control materials need to be archived and kept for more than 3 years.

09 Room Quality Evaluation

All POCT projects participate in at least one EQA/PT event organized by relevant domestic institutions every year.

The fluorescent quantitative immunoassay analyzer FA120 has the advantages of high sensitivity, short TAT and low cost. At the same time, it is simple to operate and easy to use. The reagents are single-served, samples are available for inspection, and a wide range of test items include myocardial series of markers , A series of inflammation markers, thyroid and sex hormone markers. There is no doubt that FA120 is a very ideal POCT analysis system for clinical departments such as hospital laboratory, emergency department, and chest pain center.