Dr. Kai Shan of Beijing Tiantan Hospital Identifies Full Automation and Internet-Based Quality Control as Key Trends in POCT Development
POCT has gained increasing recognition for its convenience and ease of use in rapid diagnosis, dynamic monitoring, and treatment efficacy assessment of critically ill and emergency patients. However, it also faces urgent challenges related to non-standardized and inadequate quality management.
November 13–14, 2020 – The “2020 China POCT Annual Conference,” co-hosted by the Point-of-Care Testing (POCT) Branch of the China Association for Medical Device Industry and the People’s Government of Jiangbei District, Chongqing Municipality, was held in Chongqing. Under the slogan “BeiDou + 5G: Building the Dream of China’s POCT” and themed “Precision Epidemic Control, Health for All,” the conference featured discussions on topics including POCT applications, nanozymes and POCT, ultrasound testing, POCT and primary healthcare, and POCT and the Six Major Centers. The event comprised a plenary session, thirteen specialized academic forums, and an exhibition showcasing corporate products.
On the 14th, at the POCT and Six Major Centers Sub-Forum, Dr. Shan Kai, Associate Chief Physician of the Emergency Department at Beijing Tiantan Hospital, Capital Medical University, delivered a presentation titled “Quality Control and Management of POCT in Emergency Care.” VCBeat has compiled his key insights.
Shan Kai, M.D., is an Associate Chief Physician in the Department of Emergency Medicine at Beijing Tiantan Hospital, Capital Medical University. He currently serves as a Standing Committee Member of the Chinese Academy of Emergency Medicine Education, a Council Member of the Emergency Branch of the Chinese Medical Rescue Association, and a Committee Member of the Beijing Society for Emergency Anti-Infection, among other professional society roles. He has led and participated in several research projects, published more than 10 academic papers as the first author in domestic and international journals, including three articles indexed by SCI, and contributed to five professional books.
The Emergency Department is a unique specialty. While departments such as Pediatrics and Cardiology are named after specific disciplines or diseases, the Emergency Department is defined by time, emphasizing the critical nature of "urgency." Therefore, for emergency departments, minimizing patient wait times and delivering rapid, accurate laboratory test reports are key to ensuring patient satisfaction.
POCT systems perfectly align with the workflow demands of emergency departments, serving as critical equipment for enhancing efficiency in emergency care. Emergency medicine has diverse POCT testing needs, including assessments for acute chest pain, acute dyspnea, rapid blood glucose monitoring, and emergency drug or toxicology screening.
In 2012, quality construction standards for emergency departments and intensive care units (ICUs) were introduced, explicitly stating the need for rapid access to laboratory test results in these settings. For instance, for a patient presenting with acute chest pain, the emergency department is required to obtain blood gas analysis results within 3 minutes, complete an electrocardiogram (ECG) within 10 minutes, acquire cardiac troponin I (cTnI) and B-type natriuretic peptide (BNP) levels within 15 minutes, and finish medical history collection, ECG, and point-of-care testing (POCT) within 20 minutes.
However, point-of-care testing (POCT) still faces numerous limitations, such as operator-dependent variability in technical proficiency leading to testing errors, inadequate product quality control systems, unclear policies, regulations, and management frameworks, limited test menus, and constrained testing throughput. Data indicate that false results attributable to these limitations account for approximately 30% of all laboratory testing issues, posing significant challenges to emergency department operations.
Dr. Shan Kai believes that among the many issues mentioned above, an imperfect quality management system is a significant factor affecting the accuracy of POCT testing. Inaccurate test results not only fail to provide a basis for clinical diagnosis and treatment but may even lead to misleading conclusions.
Factors contributing to an unsound POCT quality management system include six major aspects: personnel (weak quality control awareness, lack of testing training, and unauthorized operation); instruments (widespread distribution, inadequate maintenance, and lack of calibration); materials (absence of inventory management for incoming and outgoing supplies, and lack of quality control materials); test reports (missing reference intervals, non-standardized formats, and lack of review); quality assurance (no method comparison, non-participation in External Quality Assessment [EQA], and no Internal Quality Control [IQC]); and management (absence of dedicated management and training bodies).
POCT Quality Management System Is Closely Related to the Improvement of Medical Quality and Safety, and Quality Management Is Imperative.
Dr. Shan Kai summarized the four major significances of POCT quality management: (1) Timely detection of potential malfunctions or issues with testing instruments or reagents to avoid erroneous test reports; (2) Regular monitoring of systematic and random errors of the instruments to prevent test reports with significant errors; (3) Continuous awareness of the operational status of instruments to effectively enhance the trust of physicians and laboratory personnel in issued reports, particularly abnormal ones; (4) The accuracy of test results directly impacts the emergency treatment of patients.
Internationally, a relatively robust documentation system has been established to guide the management of point-of-care testing (POCT). The Clinical and Laboratory Standards Institute (CLSI) in the United States has developed CLSI POCT guidelines, which provide detailed requirements ranging from the selection of POCT instruments to the establishment of POCT management systems. In the U.S., the Food and Drug Administration (FDA) classifies POCT into two categories: waived and non-waived tests. Many developed countries have also formulated relevant POCT management standards from both managerial and technical perspectives; for instance, organizations such as the Royal College of Pathologists of Australasia (RCPA) in Australia and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom have established POCT-related standards.
China has also been continuously strengthening and improving its POCT quality management system, issuing several key documents, including the Expert Consensus on Clinical Application and Quality Management of Handheld Point-of-Care Testing (POCT), Requirements for Quality and Competence of Point-of-Care Testing, Administrative Measures for Clinical Laboratories in Medical Institutions, and Specifications for the Management and Clinical Operation of Portable Blood Glucose Meters in Medical Institutions (Trial).
Dr. Shan Kai stated that emergency point-of-care testing (POCT) should minimize the operational burden and intensity for personnel, broadly expand the range of test items, and achieve high-throughput capabilities. Furthermore, establishing a networked management platform to enable more specialized information-based quality management can effectively reduce testing errors caused by manual operations, thereby ensuring the accuracy of results.
Full Automation and Internet-Based Quality Control Management Are the Two Major Development Directions for POCT in Emergency Departments.
Foreign surveys indicate that 19% of POCT operators are untrained, 25% do not operate in accordance with manufacturers’ specifications, 32% fail to perform quality control as required, and 6% use expired reagents. The management of POCT quality has long been challenging due to the wide variety of test items and platforms, significant variations in assigned values among different manufacturers, and substantial result errors associated with semi-automated instruments. There is an urgent need for standardized and networked management.
The internet platform features multiple functional modules, including quality control management, multi-dimensional access control, patient views, log management, and internal administration, thereby comprehensively and personalizedly meeting hospitals’ quality control management needs.
Beijing Tiantan Hospital, Capital Medical University, has made extensive practical advancements in internet-based quality control management systems. By leveraging the Getein uni-Q quality control management system, it has achieved interconnectivity across multiple departments, comprehensively enhancing quality management in clinical laboratory testing.
Under ideal conditions, Getein uni-Q can leverage an internet platform-style management system to implement a comprehensive tiered diagnosis and treatment framework, thereby maximizing the standardization of quality control for equipment and reagents across hospitals. In the future, Beijing Tiantan Hospital will progressively achieve interconnectivity among multiple hospitals (regional centers/medical consortia) as well as between the clinical laboratory center and multiple hospitals.
Another development direction for POCT is full automation. Automation can avoid human operational errors, achieve automatic identification, meet quality control requirements for different batches of reagents, and maximize the standardized management of reagent and instrument performance.
The Emergency Department of Beijing Tiantan Hospital has collaborated with the Information Center, the Laboratory Center, and vendors to implement a bidirectional LIS workflow. The bidirectional LIS workflow adopted by the Emergency Department of Beijing Tiantan Hospital is as follows: Sample verification of identification numbers and manual setup of test items are not required. Samples are loaded onto the analyzer for testing; the instrument automatically queries the test items for each sample; the LIS automatically acknowledges receipt based on the barcode number; the LIS system automatically responds to the instrument with the required test items for each sample; upon completion of testing, results are automatically retrieved and uploaded.
Complete all tests with a single click via bidirectional LIS integration, significantly reducing operator workload while greatly enhancing testing efficiency and stability. It facilitates POCT quality control management, making it an essential choice for hospital emergency departments.