What Does a Medical Laboratory Technician Do?

This document was developed by the China National Accreditation Service for Conformity Assessment (CNAS). It is a further explanation of CNAS-CL02: 2012 "Quality and Competence Accreditation Guidelines for Medical Laboratories" made by CNAS based on the characteristics of histopathological examination, without increasing or decreasing. The requirements of the guidelines.

Application of CNAS-CL37 Medical Laboratory Quality and Competence Accreditation Criteria in the Field of Histopathology

This document was developed by the China National Accreditation Service for Conformity Assessment (CNAS). It is a further explanation of CNAS-CL02: 2012 "Quality and Competence Accreditation Guidelines for Medical Laboratories" made by CNAS based on the characteristics of histopathological examination, without increasing or decreasing. The requirements of the guidelines.

Chinese name

Application of CNAS-CL37 Medical Laboratory Quality and Competence Accreditation Criteria in the Field of Histopathology

release time

September 13, 2012

Release agency

China National Accreditation Service for Conformity Assessment

Implementation time

November 01, 2014

Application note text ^[1]

Foreword

This document is used in conjunction with CNAS-CL02: 2012 Guidelines for the Accreditation of Quality and Competence of Medical Laboratories. In terms of structure, the chapter numbers and clause names of the chapters and sections of this document adopt the chapter numbers and names of the CNAS-CL02: 2012 chapters. The specific contents of the CNAS-CL02: 2012 application note are given after the corresponding clauses. Appendix A and B of this document are normative appendices. The serial number and content of the appendix do not correspond to CNAS-CL02: 2012.

This document was developed in 2012, and this is the first revision.

range

This document specifies CNAS's accreditation requirements for the field of medical laboratory histopathology. Histopathological examination areas include surgical pathology, intraoperative freezing, special staining, immunohistochemistry, flow cytometry, molecular pathology, ultramicropathology, and more. The requirements of molecular pathology examination should conform to the relevant professional application instructions. Note: "Histopathology examination" is the customary usage in the field of pathology. In other professions, "test" is used, corresponding to the definition 3.7 in CNAS-CL02: 2012.

Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest version (including the amendment list) applies to this document.

Guide to Construction and Management of Pathology (Trial), Weiban Yizhengfa [2009] No. 31

Clinical Technical Practice and Pathology Volume, People's Military Medical Publishing House, 2004 CNAS-RL02 Proficiency Test Rules CNAS-CL 31 Internal Calibration Requirements

Management requirements

4.1 Organization and management responsibility

4.1.1.1 The pathological examination laboratory (hereinafter referred to as "laboratory") shall be set up in accordance with the requirements of the "Guidelines for the Construction and Management of Pathology (Trial)".

4.1.1.2 If the laboratory is an independent legal entity, it shall have a medical institution practice license; if the laboratory is a non-independent legal entity, the pathology department shall be included in the diagnosis and treatment subjects of the medical license of the medical institution to which the laboratory belongs, starting from the date of approval , Conduct pathological examination for at least 2 years.

4.1.2.5 At least one person with intermediate and above professional and technical qualifications and at least 5 years of pathological examination work shall be responsible for technical management.

4.2 Quality management system

4.3 Document Control

4.4 Service Agreement

4.4.1 Inspection items, inspection methods, sample requirements, pathological examination application form, pathological report, inspection period, unexpected results and special cases (such as infectious diseases that must be reported by the state as required), informed consent, etc. shall be used as service agreements Content.

4.5 Inspection by Entrusted Laboratory

4.5.1 Consultations requested by the patient or clinician are not applicable.

4.6 External services and supplies

4.7 Consulting services

4.8 Settlement of complaints

4.9 Identification and control of nonconformities

4.10 Corrective Action

4.11 precautionary measures

4.12 Continuous improvement

4.13 Record Control

4.14 Evaluation and audit

4.14.7 The laboratory shall establish quality indicators such as the rate of non-conformity, the rate of excellent films, the rate of compliance with the diagnosis of frozen and paraffin sections, the reporting period, and the rate of complaint handling.

4.15 Management review

5 Technical requirements

5.1 personnel

5.1.2 The person in charge of the laboratory shall be a pathologist with the qualifications of a professional and technical post of associate high and above, and have been engaged in clinical pathological diagnosis for at least 10 years. Physicians who independently issue histopathology reports should have the qualifications of intermediate and above pathology professional and technical positions, and have more than 5 years of pathological diagnosis experience. The accredited authorized signatory should be a pathologist with the qualifications of intermediate and above professional and technical positions, and have been engaged in pathological diagnosis in the field of applying for accreditation and authorized signature for at least 5 years.

5.1.3 The laboratory's staffing and post settings should meet the needs of a complete histopathological diagnosis process and quality assurance, and the number of personnel should be based on the number of pathological examinations. The proportion of doctors and technicians at all levels should be set reasonably, and the corresponding business requirements and job responsibilities should be formulated. Support staff should meet job requirements.

5.1.6 The content and methods of employee competency assessment shall be formulated to evaluate the employee's working ability every year; for new employees, competency assessment shall be conducted at least twice within the first 6 months. When responsibilities change, or after leaving the job for more than 6 months, or when there are changes in policies, procedures, and technologies, employees should be retrained and re-evaluated. Only after passing the qualification can they continue to work and record.

5.2 Facilities and environmental conditions

5.2.1 The laboratory shall provide corresponding functional areas, including at least areas for sample reception, material collection, tissue processing, film making, staining, immunohistochemistry, pathological diagnosis, pathological archives, and sample storage. A safety risk assessment should be implemented, and protective measures and appropriate warnings should be developed for biological, chemical, radiological and physical hazards. Measures should be taken to restrict patients and unauthorized visitors from entering or contacting areas and information that affect the quality of the test, such as sample receiving areas, sample collection rooms, production rooms, and pathological information systems.

5.2.2 Specimen receiving, material taking, storage and other areas shall be managed and set according to the biological safety level two (BSL-2).

5.2.3 Facilities used to store clinical samples and reagents shall set target temperatures and allowable ranges and record them. The laboratory shall have records and measures for temperature out of control.

5.2.6 The concentration of harmful gases such as formaldehyde and xylene should be tested in the work area every year to ensure that the harmful gas concentration is within the permitted range. The environmental temperature and humidity control requirements shall be formulated and recorded according to the requirements of the analysis equipment and experimental process used. Measures and records should be taken when temperature and humidity are out of control. Appropriate water quality standards should be developed based on the specific requirements for the use of instruments and / or reagents, and regularly tested and recorded. There should be out-of-control measures and records. When necessary, the laboratory should be equipped with uninterruptible power supply (UPS) and / or dual power supplies to ensure the normal operation of key equipment (such as analyzers, tissue dehydrators, incubators, refrigerators, etc. that require temperature control and continuous monitoring). There should be enough space in the microscope reading area, and the working environment is quiet and undisturbed.

5.3 Laboratory equipment, reagents and consumables

5.3.1.4 The strong inspection equipment performs verification / calibration according to relevant national requirements, such as balances, pipettes, thermometers, etc. Equipment that should be externally calibrated can be performed according to the manufacturer's calibration procedures. The internal calibration of analytical equipment and auxiliary equipment should comply with CNAS-CL31 "Internal Calibration Requirements".

5.4 Pre-inspection process

5.4.3 In addition to the general requirements, the pathological examination application form should also include the following:

e) Relevant clinical data of the patient, including: what they saw during surgery (including endoscopy), previous pathological examination (including original pathology number and diagnosis), laboratory test / imaging results (when applicable) Obstetric pathological examination, history of menstruation and pregnancy;

f) Sample separation time, sample fixing time, and number of samples. 5.4.5 c) The pathological samples should be sent to the laboratory for inspection after collection. If there is a special need for materials, the pathologist should be notified and operated by the pathologist.

5.4.6 It should be ensured that the pathological number is always used as the unique identification of the original sample, sample (embedding box), wax block or section during the examination.

5.5 Inspection process

5.5.1.1 The pathological examination procedures shall be established in accordance with recognized procedures, such as the Clinical Technical Practices and Pathology Volume and international authoritative monographs, which shall include the process from examination of general samples, collection of materials, to the issuance of pathological reports. Where applicable, previous cytological and / or histological material from the same patient should be examined with materials currently undergoing pathological examination.

5.5.1.2 For new antibodies, the laboratory shall evaluate the staining conditions for positive and negative target antigens. These evaluation tests should determine the optimal conditions for antibody response, such as antibody titer, antigen retrieval, and the type and concentration of other reagents.

5.5.3 Pathological examination procedures should include:

(a) General inspection and sampling of samples: After the samples are collected, physicians and technicians should carry out inventory counting, handover and receipt;

(b) Tissue processing and preparation: dehydration, wax impregnation, embedding, sectioning, staining and mounting of tissue;

(c) Histological diagnosis: set the diagnostic authority of physicians at all levels, establish a secondary or tertiary physician review system and a department consultation system for difficult cases. When necessary, use special staining, immunohistochemical staining, electron microscope technology, molecular biology technology, flow cytometry and other related technical inspections. Each time the flow cytometer is turned on to detect clinical samples, the optical path of the instrument should be calibrated or verified with a fluorescent standard and recorded. If calibration or verification fails, find the cause and take appropriate measures until the calibration passes.

Flow cytometry should establish standards for detecting cell viable specimens.

Flow cytometry should establish a cell counting procedure to adjust the cell concentration to ensure optimal antibody staining.

Flow cytometry should establish procedures for immunoglobulin staining to ensure that only endogenous immunoglobulins are detected.

Flow cytometry should use appropriate gating methods in data analysis to distinguish different cell populations, especially abnormal cell populations.

5.6 Quality assurance of inspection results

5.6.1 The compliance rate with previous pathological diagnosis, intraoperative freezing and paraffin section diagnosis should be monitored, and pathological reports should be randomly selected periodically for internal peer review.

5.6.2.2 Immunohistochemical staining or fluorescent staining shall establish appropriate positive and negative controls; flow cytometry shall establish corresponding controls for each fluorescent antibody and labeling method.

5.6.3.1 Should participate in the corresponding proficiency testing / room quality assessment in accordance with the requirements of CNAS-RL02 "Proficiency Testing Rules". The results and certificates of participation in the proficiency testing / room quality assessment shall be retained. The laboratory manager or designated person shall monitor the results of the inter-room quality assessment activities and sign the results report.

5.6.3.2 When determining the acceptability of the test results by comparison with other laboratories, the laboratory shall specify the selection principles of the comparison laboratories (such as accredited laboratories, laboratories using the same test method), Number of samples, frequency, judgment criteria, etc.

5.7 Post-inspection process

5.7.1 When requested by the clinician, the results of pathological diagnosis should be reviewed and confirmed. The discussion of difficult cases in the department should be organized at least once a month, or participate in the reading sessions of provinces, cities or regions, and record.

5.7.2 The remaining samples after collection should be placed in appropriate containers, and an appropriate amount of 10% neutral buffered formalin should be added for storage, and the relevant pathological numbers and patient names should be attached. The remaining samples should be stored at least 2 weeks after the pathological examination report is issued, and the sample container without the remaining tissue after taking the materials should be stored at least 2 weeks after the report is issued. The preservation of pathological archives should meet the requirements of the "Guidelines for the Construction and Management of Pathology (Trial)". Provisions should be made for the lending of original sections / wax blocks for consultation or legal procedures, and there should be records of use, lending, and lending.

5.8 Results report

5.8.1 The pathology examination cycle should meet the requirements of the "Guidelines for the Construction and Management of Pathology (Trial)".

5.8.3 In addition to the general requirements, the pathology report should also include the following:

-A general description;

-Description under the microscope, when applicable;

-Final diagnosis;

-Explanations that are inconsistent with previous cell, needle aspirate and / or frozen section results;

-Results of special examinations (eg immunohistochemistry, electron microscopy, molecular pathology), if applicable.

The terms used in the report, tumor staging, etc. should conform to industry norms.

The results of the consultation in the department should be included in the patient's final diagnosis report and the corresponding requirements should be formulated.

The flow cytometry / diagnosis report should include the percentage of abnormal cell populations (if identified), immunophenotypic information, and provide a possible diagnosis.

5.9 Results Release

5.9.1 The pathological examination report should be released in accordance with the clinical information of the patient. When the pathological examination result is obviously inconsistent with the clinical diagnosis, especially when the lesion site or the nature of the lesion is involved, there should be a document specifying how to publish the results. The laboratory shall authorize a special person to send the pathological examination report, and there shall be procedures to specify the method for sending the report. The receiving personnel shall sign and record the time when receiving the report. The report issuing receipt should be kept for at least 2 months.

5.10 Laboratory Information Management

Appendix A (Normative Appendix)

Assessment requirements for histopathology and special pathology

A.1 Histopathological assessment requirements

A.1.1 Review items

(1) Covering all projects applying for accreditation and all systems applying for accreditation projects;

(2) Small biopsy specimens, including puncture biopsies and endoscopic biopsy specimens, at least 20 cases;

(3) 20 cases of surgical resection specimens, 5 of which were lymph node specimens;

(4) Frozen sections, at least 10 cases.

A.1. 2 Review content

A.1.2.1 Pathologist

(1) Selection and description specifications;

(2) It should be able to make pathological diagnosis or differential diagnosis based on morphological characteristics;

(3) It should be able to choose appropriate auxiliary examination methods, such as immunohistochemistry, special staining, molecular pathological examination, flow cytology, etc .;

(4) It should be able to correctly judge the results of special staining, immunohistochemistry and molecular testing, and give accurate pathological diagnosis based on the above results, and grasp the relevant differential diagnosis; the content and format of the pathological report should conform to the specifications;

(5) Familiar with the indoor quality control and inter-room quality evaluation of pathological diagnosis.

A.1.2.2 Pathologist

(1) Master the processing methods of different types of specimens, such as embedding direction;

(2) Should be able to produce qualified pathological sections;

(3) It should be able to find and correct the problems in the production of slices;

(4) Should master the routine equipment of the technical room, such as automatic dehydration machine, paraffin embedding machine, tissue microtome, automatic staining machine, routine maintenance and maintenance;

(5) Familiar with and apply conventional pathological techniques to indoor quality control and quality evaluation.

A.1.3 Evaluation criteria for the quality of pathological sections

The eligibility criterion is to be able to make a pathological diagnosis based on the slice, evaluate the following aspects respectively, and finally make a judgement of unqualified, qualified, excellent, etc. on the whole slice; the slice pass rate should be above 95%.

(1) Contrast: Clear contrast between nucleus and cytoplasm staining, suitable for red and blue

(2) Transparency: high transparency, clean and clear

(3) Thickness: thin slice (usually 4m), uniform thickness

(4) Integrity: complete tissue sections, complete endoscopic bite and puncture specimen sections

(5) Cracks: knife marks, cracks, chatter marks

(6) Creases: wrinkles, folds

(7) Pollution: No other tissue pollution

(8) Sealing sheet: no bubbles, no glue overflow

(9) Location: The mounting position is appropriate

(10) Label: straight and firm, clear numbering

A.2 Assessment requirements for special pathological examinations

A.2.1 Review items

(1) Special pathological examinations include immunohistochemistry, special staining, molecular pathology, flow cytology, and electron microscopy;

(2) Matching detection based on the evaluation items of histopathology applications;

(3) The application review items should be covered, including the system for applying for recognized projects.

A.2.2 Review content

A.2.2.1 Pathologist

(1) It should be able to correctly interpret the test results;

(2) Master indoor quality control and inter-room quality evaluation.

A.2.2.2 Pathologist

(1) The basic principles of special pathological examinations should be mastered;

(2) It should be able to identify and judge the detection effect;

(3) Master indoor quality control and quality assessment, such as the selection of positive control tissues.

Appendix B (normative)

Histopathological examination field recognized project requirements

B.1 The histopathological examination shall be approved simultaneously with the corresponding histochemical, immunohistochemical / flow cytometric and / or molecular pathological testing items.

B.2 The histopathological examination involving individualized treatment should be recognized in combination with relevant immunohistochemical and / or molecular pathology testing items: such as ER, PR, HER2, CD20, EGFR, KRAS, etc.

B.3 The approval scope of the histopathological examination project should be clear: respiratory system, digestive system, nervous system, breast and female reproductive system, bones and joints and soft tissues, urinary and male reproductive systems, endocrine system and hematopoietic system.