Clinical laboratory quality assurance requirements

Release date: 2010-06-11

Source: Internet Foreword This standard is equivalent to the "Jia Chapter - moderate or highly complex test (or both) patients in the "Clinical Laboratory Improvement Amendments 88" (Clina 88). Chapter 2 of the “Inspection Management” and “P Sub-Chapter – Medium or Highly Complex Inspection (or both) Quality Assurance” has only changed in the format of the writing. The scientific and feasibility of the original standard has been recognized through many years of practice. This standard is a technical guidance document for improving the management of clinical laboratories in China, improving the inspection level, carrying out laboratory accreditation, and achieving international standards.
This standard is part of the “Clinical Laboratory Quality Requirements” standard. There are also: requirements for quality control in clinical laboratories, requirements for comparison of clinical laboratory capabilities, requirements for clinical laboratory staff, and so on.
This standard is equivalent for the first time.
This standard was proposed by the Ministry of Health of the People's Republic
This standard is drafted by the Clinical Testing Center of the Ministry of Health.
The main drafters of this standard: Guo Jian, Zhang Kejian, Yang Zhenhua This standard is entrusted by the Ministry of Health to the Clinical Inspection Center of the Ministry of Health.
1. Scope: This standard specifies the requirements for quality assurance in clinical laboratories. This standard applies to all clinical laboratories engaged in medical activities.
2. Definitions: (1) Quality: The sum of the characteristics that reflect the ability of an entity to meet explicit and implicit needs. (2) Quality Assurance (QA): In order to provide sufficient trust, the entity can meet the quality requirements, and implement in the quality system, and verify all the planned and systematic activities as needed. (3) Quality Control (QC): The work technology and activities adopted to meet the quality requirements. 1 Quality control includes operational techniques and activities, the purpose of which is to monitor the process and eliminate all causes of dissatisfaction in the quality link to achieve economic benefits; 2 certain activities of quality control and quality assurance are interrelated. (4) Internal Quality Control (IQC): Operational techniques and activities performed in the laboratory to meet quality requirements.
Note 1: In medical laboratories, indoor quality control aims to monitor the process to assess whether the test results are reliable, can be issued, and eliminate the causes of dissatisfaction in all stages of the quality link.
Note 2: In a broad sense, indoor quality control is applicable to the activities of all steps of the test results, from the consideration of clinical needs, by collecting specimens, detecting the measurable amount to report the results. 3. Quality Assurance Requirements 3.1. General: Clinical laboratories must establish and adhere to quality assurance (QA) policies and procedures, and use the established QA policies and procedures to monitor and evaluate the entire inspection process (pre-analysis, analysis, analysis). After) the quality. The QA program of the laboratory must be able to evaluate the effectiveness of its policies and procedures: identify and correct problems, ensure that the results of the report are accurate and timely, and ensure that the staff is appropriate and capable. If required, the laboratory can review QA policies and procedures based on the results of the assessment. When the laboratory applies for inspection services, sample inspections, and inspection reports, the requirements specified in this document must be met. All QA activities must be documented.
3.2. Management of patient testing: Each clinical laboratory must take steps to provide: appropriate patient preparation, proper specimen collection, labeling, storage, shipping and handling, and correct reporting of results. These measures must ensure the complete and unique identification of the specimens before, during and after the analysis, as well as the requirements of 3.3 to 3.7 of this standard.
3.3. Specimen submission and processing procedures 3.3.1. The laboratory must have and perform written documentation of the following: patient preparation methods; specimen collection methods; specimen identification methods; specimen delivery conditions and methods. These documents must ensure the complete and unique identification of the specimen from the time the specimen is collected until the test is completed and the results are reported.
3.3.2. If the laboratory accepts the transferred specimen, the customer should be able to obtain a written explanation, which must include the information specified in 3.3.1.
3.3.3. As a written supplement, the laboratory staff can verbally explain to the patient how to collect the specimen including how the patient is prepared.
3.4. Application for inspection: The laboratory may only carry out specimen inspection when it receives written or electronic application from the responsible person. Oral application is acceptable only if the laboratory can receive a written application within the next 10 days. The inspection application form shall be kept for at least 2 years. If the patient form or medical record is used as the basis for the test, it should be kept for at least 2 years. The laboratory shall be able to provide the above materials when necessary. The laboratory must ensure that the information on the application form includes:
3.4.1. Patient name or other specific identification number;
3.4.2. Name, address or other identification number of the person in charge of the application for inspection. If appropriate, it can be the person responsible for the test results or the name and address of the specimen laboratory. It is also possible to add the name and address of the contact person who should report the life or emergency of the patient.
3.4.3. Items requiring testing.
3.4.4. Date of specimen collection.
3.4.5. Other relevant interest rates required to ensure accurate and timely reporting of results.
3.5. Inspection records: When performing specimen processing or testing, the laboratory must have measures to ensure that patient specimens can be reliably identified to ensure that the reported results are accurate. Records must identify the staff performing the test. The records of patient tests, including the printed results of the instrument, must be kept for at least 2 years. The inspection records must provide information from 3.4.1 to 3.4.5 and include:
3.5.1. The patient's identification number, the specific unique number of the specimen;
3.5.2. The date and time the laboratory accepted the specimen;
3.5.3. Description of specimens that have not met the specimen acceptance criteria;
3.5.4. The staff performing the test.
3.6. Inspection report: The laboratory report must be promptly sent to the responsible person who applied for the specimen inspection, or the person responsible for the test results or the laboratory that originally applied for the inspection. The inspection laboratory shall keep the inspection report or its copy (including final and preliminary reports) at least 2 years after the report is sent. This information may also be stored as part of the patient form or medical record. The laboratory shall provide the laboratory if necessary. .
3.6.1. The laboratory must have measures to report results in a timely, accurate, reliable and confidential manner and to ensure that the entire process is under confidentiality and laboratory control.
3.6.2. The inspection report must have the name and address of the testing laboratory, the items tested, the results of the inspection, and, if required, the unit of measurement.
3.6.3. The laboratory must describe in the report a message that the laboratory specimen acceptance criteria have not been met.
3.6.4. The “reference range” corresponding to the test result shall be provided by the laboratory conducting the inspection to the person in charge of the application for inspection or the person responsible for the use of the inspection result.
3.6.5. The results or copies of the laboratory test must be given only to the person responsible for the test or the person responsible for the test results.
3.6.6. The laboratory must establish and follow written procedures for reporting life-threatening laboratory results or urgency values. In addition, when the test results indicate a life-threatening emergency, the laboratory must warn the person or unit applying for the test or the person responsible for using the test results.
3.6.7. When required, the laboratory shall provide the customer with a methodological list for laboratory testing and the performance of the method for testing patient specimens. In addition, relevant information that may affect the interpretation of the test results, such as interference from the test, should be provided when required. When the test condition changes significantly affect the test results or the interpretation of the test results, the updated information must be provided to the customer in a timely manner.
3.6.8. The laboratory must keep the original or photocopy in order to ensure timely access and confirmation if necessary.
3.7. Subcontracting: When the laboratory must transfer the specimen to other laboratories for inspection, the specimen can only be transferred to a professional or sub-professional laboratory with high authority for testing, such as a reference laboratory.
3.7.1. The reference laboratory cannot correct the results of the inspection laboratory or information directly related to the interpretation results.
3.7.2. The reference laboratory may have the inspection laboratory send the inspection report directly to the person in charge of the application for inspection. The reference laboratory must keep a copy of the inspection report.
3.7.3. The reference laboratory must inform the person in charge of the application for the name of the laboratory and the address.
3.8. Assessment of patient testing management: The laboratory must have regular measures to monitor and evaluate the operation of the various standards in 3.3 to 3.7. If necessary, assessments can be made based on the feedback below: (1) compliance with and implementation of established patient preparation, specimen collection, identification, storage, and shipping requirements; and (2) information obtained from inspection applications related to application testing; The completeness and relevance of the application for the inspection project, and whether the project to be inspected is required; (3) the application and conformity of the established rejection specimen standard; (4) the interpretation of the inspection result, whether the information of the inspection report is complete, useful and (5) Whether the inspection results are reported in a timely manner according to the priority of the inspection (emergency, routine, etc.); (6) Whether there is an accurate and reliable reporting system that properly records, stores and accurately and reliably corrects the inspection results.
3.9. Quality Control (QC) Assessment: The laboratory must have regular measures to assess the effectiveness of the corrective actions taken. Based on the results of the assessment, invalid QC policies and procedures must be reviewed. These measures must be able to assess the effectiveness of the work performed to correct the following problems: (1) problems found in the evaluation of method calibration and quality control data; (2) problems found in the evaluation method reference range; (3) errors detected in the results report .
3.10 Inter-room quality assessment (EQA) assessment: The effectiveness of corrective actions for “failed” inter-room quality assessments must be assessed.
3.11 Comparison of test results: If different methods or instruments are used for the same test item, or the same test is performed at different locations, the laboratory must establish a system that evaluates and determines different methods, instruments, or different tests twice a year. The relationship between the results of the inspections at the site, the same test project in a laboratory must have similar results. In addition, if the laboratory's inspection program does not participate in the inter-room quality assessment activities or the inter-room quality assessment activities can participate, the laboratory must establish a system to confirm the accuracy and reliability of the inspection results twice a year. A possible method is to compare the test results of this laboratory with the results of the reference laboratory.
3.12 Relationship between patient test results and patient information: In order to perform indoor quality control, the laboratory must have measures to identify and evaluate whether the patient's test results do not match the following factors, such as: (1) patient age; (2) patient gender; (3) clinical provision Diagnosis and other relevant information; (4) distribution of patient test results; and (5) relationship with other test results.
3.13 Personnel assessment: The laboratory must have regular measures to assess the effectiveness of laboratory personnel policies and procedures. This effectiveness is reflected in the ability to ensure the ability and use of staff, including the ability to provide advisory services.
3.14 Communication: The laboratory must have measures to ensure that the laboratory effectively contacts the individuals and organizations that apply for or undergo testing and records the problems found. The measures taken to solve the problem and reduce communication failure must be documented and documented.
3.15 Complaint investigation: The laboratory must have measures to ensure that all complaints and problems with the laboratory are recorded. Investigate the complaint if necessary. Corrective measures should be developed if appropriate and needed.
3.16 Joint Quality Assurance (QA) with staff: The laboratory must have the means to discuss the issues identified in the QA activities with the staff and document the activity. To prevent similar problems from occurring again, the laboratory must take corrective action.
3.17 Quality Assurance Record: The laboratory must document and document all quality assurance (QA) activities, including identified problems and actions taken. All QA records can be provided to the relevant regulatory agencies as necessary. Preparation Notes 1. Task Source: This project is based on the documents of the Ministry of Health (Wei Jian Jian Fa [2003] No. 329), aiming to put forward corresponding requirements for each quality link in clinical laboratory testing to ensure clinical trials. The reliability of the test results.
2. Determination of requirements: The requirements for quality assurance include multiple links before, during and after analysis. Due to the requirements of the analysis, special standards (such as quality control requirements) will be established. In this paper, only The various links after the analysis were regulated. Including the management of patients, the application of inspection, the submission and processing of samples, inspection records, inspection reports, inspection subcontracting and other elements.
3. Citation standards and references: This standard is mainly based on the relevant chapters of the US Clinical Laboratory Improvement Amendments 88.

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