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"Pathology of medical quality management procedures," the draft
"Pathology of medical quality management procedures," the draft
 

To strengthen the management of medical pathology and improve pathologic diagnosis to ensure the quality of medical care and medical safety, facilitate clinical work, under the "Medical Practitioners", "medical institution regulations", "Construction and Management Guide for Pathology" and "clinical technology operation - pathology volumes" and other relevant laws, regulations and professional standards, formulated rules. All work carried out clinical and pathological diagnosis of the medical institutions apply the rules of Pathology.

 

First, the basic pathology of the settings and conditions

(A) the setting of Pathology

Pathology is a professional, high-tech and business requirements of departments, and the basic conditions set should have strict requirements.

1 level and two types of hospital medicine, dental, infectious diseases, skin diseases, plastic surgery and other hospital principle, calling for the establishment of Pathology

(2) three types of hospitals and two comprehensive, integrative medicine, cancer, children's and maternity hospital who may be established with the conditions of Pathology

3 the level of hospital corporations, but in pathological cases less than 2000 cases (not including cytology) are, in principle, should establish Pathology

4 Department of Pathology of the hospital has not established, the pathological diagnosis of two or more tasks by a nearby hospital pathology bear, or according to geographical conditions, the actual situation, the use of the adjacent hospital co-founded a number of pathological diagnosis center solution, specifically by the Provincial Pathology quality control center and local-level health administrative departments to coordinate

5 hospitals such as the newly established Department of Pathology, Pathology quality control center by the provincial Department of Pathology, according to the local level and development, the application of Pathology, Hospital personnel, equipment and other conditions to evaluate and assess the results back to the health administrative department as a basis for decision making

6 routine histopathologic diagnosis, three-level general hospitals ≥ 8000 cases (times) / year, three B General Hospital ≥ 4000 cases (times) / year, two hospitals should be ≥ 2000 cases (times) / year

7 Department of Pathology, the Hospital opened its medical institution treatment programs must have a "pathology" of the registration;

8 of Pathology departments should be independent establishment, a medical institution can set up a Department of Pathology. In order to meet hospital demand for the development and clinical disciplines, to promote the development of sub-specialty of pathology, including cellular pathology, digestive pathology, kidney disease management, blood pathology, nerve pathology, eye pathology, dermatology and other pathology. Pathology other than its subordinate departments shall not engage in pathology and laboratory diagnostic work

 

(B) the number of pathology staff

Pathology services personnel is to ensure the quality and quantity of the quality of basic pathology condition, all hospitals must be in strict accordance with specifications, selected personnel engaged in the pathology of good quality work.

1 Department of Pathology, the number of persons, all hospitals should be based on the actual number of pathological examination, combined with the number of hospital beds and hospital level and to determine the

(2) the number of pathologists in accordance with 100 beds with 1 2, while the ratio of 1:1 with technicians and related support staff

3 three or more hospitals for teaching, research, pathology specialization and new business needs, pathologist and technicians should increase the number of the establishment

4 physicians and technical staff shall not be greater than 1:1, the division of labor must be clear, each part-time technicians and physicians may not, nor serve as non-pathological professional work, such as endoscopy, surgery, etc.

5 two hospital doctors with at least two qualifications issued by pathology report; three hospitals with at least five doctors with qualifications issued by pathology report, issued at least two doctors have reported intraoperative rapid pathological diagnosis of qualifications

 

(C) the requirements of the pathologist's office

1 clinical pathologist should have a qualified medical practitioner, physician registration and appropriate professional and technical qualifications

(2) pathology report issued by a physician shall be subject to pathology specialist training or expertise to learn more than 3 years, and passing the examination

3 separate signed pathology report, in addition to meeting the above requirements, but also in the histopathological diagnosis for four years. Physician in any hospital pathologist during the biopsy of the small cases, newly diagnosed malignancies, borderline lesions, the diagnosis of difficult and rare cases, in principle, shall be subject to higher physician review before issuing the report

4 to carry out specialized pathology (such as renal biopsy, ophthalmic pathology, bone marrow smears), should be specialist training for 3-6 months pathological

5 quick intraoperative frozen section pathology consultation work required by the principle title of deputy chief physician staff to take over, who is also an unconditional commitment by the attending physician of high qualification, subject to rapid freezing and above the pathological diagnosis of professional training. Do not have the conditions of medical institutions, not forcing the Department of Pathology, to carry out this work, where necessary, by a higher hospital pathologist appropriate consultation

6 Department of Pathology Medical Director should have a college degree or above and pathology professional and technical positions above the intermediate level qualifications, clinical and pathological diagnosis in more than 10 years, three of Pathology Director, Deputy High above should have technical qualifications of professional pathology

 

(D) the business scope of Pathology

Pathological examination and diagnosis should be able to meet the needs of hospital clinical work, should be able to carry out

1 Histopathological diagnosis of biopsy specimens, including cut, bite biopsy, endoscopic biopsy and biopsy forceps

(2) the pathological diagnosis of surgical specimens

3 diagnostic cytopathology, including fine needle aspiration cytology and diagnostic

4 to carry out the types of immunohistochemical staining should be more than 60, two hospitals in more than 30, have been carried out immunohistochemical staining of the project should have good internal quality control records

5 tertiary hospitals should be able to carry out surgery in the rapid diagnosis

6 tertiary hospitals to carry out staining in more than 10 species, two hospitals in more than 5

7 Participation in hospital internal medicine grand rounds and clinical pathological conference will

8 tertiary hospitals should be able to carry out consultation work pathological

9 three hospitals conditional, molecular pathology testing should be carried out

10 qualified persons to carry out research and teaching

11 autopsy (Department of Pathology qualified to carry out)

 

(E) the space of Pathology

1 Department of Pathology, should have adapted to their functions and tasks of the working space

(2) two of Pathology specimens should be equipped to receive room, drawing room specimen examination, routine pathological technical rooms, room immunohistochemistry, cytology production room, pathology room, pathology archives and specimen storage room, two hospital beds Science of the total area of ​​not less than 200M2 space

3 hospitals of Pathology, space area of ​​not less than 500M2, three B of Pathology space area of ​​not less than 300M2

4 Department of Pathology, in addition to two tertiary hospitals in the requirements of the hospital, the frozen section room should be located, staining chamber, molecular pathology room, consultation room, computer room management, resource center, academic activities room, a small warehouse, etc.; teaching base should have an independent studio training physicians to learn

 

(F) Department of Pathology, basic equipment

Diagnostic equipment

1 binocular microscope with a light source units 1 / 2 physicians, 1-room for each technology

2 Department of Pathology, tertiary hospitals should be equipped with more than a total of view microscope, photomicrography and projection equipment, such as fluorescence microscopy

3 with the operating room between the need for fax machines, fax frozen section report. Between conditional and operating room equipment installation video intercom, convenient communication between surgeon and pathologist

4 general photographic equipment

 

Technology room equipment

1 programmable automatic dehydration machine

(2) paraffin-embedded machine

3 automatic dyeing machine

4 paraffin slicing machine

5 spread sheet machine

6 baking sheet machine

7 fume hood

8 Refrigerator

9 disposable blades or Grinder

10 incubator

11 air-conditioned

12 ventilation equipment

13 cells in the centrifuge

14 tertiary hospitals should have the liquid-based cell production equipment, PCR instrument

15 can be configured conditionally by electron microscopy, thin slicer, slice of digital scanners, remote automatic microscope

 

Department of Pathology, special equipment

1 drawing room: sample units should be drawn straight exhaust devices, special sewer, grinder, air conditioning

(2) Production room: ventilation equipment, special sewer, air conditioning

3 specimen storage room: ventilation equipment

4 conditional, set up special transmission channels specimen

5 Department of Pathology, the layout should be reasonable and consistent with the requirements of biological safety, contaminated, contaminated and clean areas into semi-clear

6 should have a separate shower and shower facilities

7 specimen reception room, drawing room should be UV light disinfection equipment and other

8 conditional units, should be an independent autopsy rooms and facilities

9.

 

Professional Reference Books

Clinical Pathology business involves various disciplines, the required books and access to a wide range of high frequency of use. Department of Pathology, Hospital shall provide special books and materials

 

(G) Department of Pathology, rules and regulations

1 Director, Deputy Director, pathologist, Branch Secretary, hospitalization, head of technical rooms, technicians and other staff positions at all levels of responsibility system

2 there Ke Neiqie film review and consultation within the Section to implement the system and the corresponding record

3 Pathological standard technical specifications and pathological diagnosis

4 of infectious diseases and waste management systems

5 Data management and loan system

 

Second, the quality control procedures Pathology

(A) fixed tissue samples for inspection and specification

1 taken from the body's need for diagnostic tissue, cells and other pathological inspection requirements of the project should be, complete and timely sent to pathology examination. For those specimens were taken without permission, there should be criticism, education and punitive measures

(2) pathological specimens and corresponding pathological examination application form forwarded to the Department of Pathology, the links need to have checked and signed, to ensure the traceability of samples; to ensure the timely and adequate pathological specimens fixed

3 have the time of specimen collection, specimen sent to pathology time, a written record of specimens fixed time, the time to the minute

4 applications for single specimens and check people, mark specimens, specimen transfer and pathology specimens recipient should sign the registration and related personnel

5 hospitals should convene the relevant departments to establish a sample check, the transfer of registration and inspection system for each signature

6 In addition there are special requirements, samples must be used in 10% neutral buffered formalin-fixed, the amount of fixative to tissue volume should be 5-10 times

7 specimens from in vitro to a fixed time should not exceed half an hour

8 large cavity substantive organ specimens and specimens must be promptly cut, fixed overnight, the next drawing. Sufficient time should be fixed specimens in more than six hours.

 

(B) pathological complete standard application form

1 application form must be completed clearly on the patient's name, gender, age, hospital number, date of inspection departments and

(2) application form should be completed in patients with clinical history and other (test image) results, surgical findings and clinical diagnosis

3 application form shall specify the drawing area, number of specimens.

4 previous pathology who has done must be marked with numbers and pathological diagnosis pathology

5 shall specify whether the infectious specimens, such as hepatitis B, hepatitis C serology, HIV, etc.

6 application form writing clear, tidy, without body fluids and blood contamination

7 Pathology application form must be signed by the doctor to apply (stamp), doctor's name easily identified

 

(C) the examination of pathological specimens and specifications drawn

Pathologist carefully observed by the naked eye specimens, to determine the lesion location, size, depth of invasion and margins and surrounding tissue with the relationship, then the selection of representative parts of the drawing, do biopsy. Drawn must comply with certain specifications, to ensure the accuracy of diagnosis and provide accurate information and TNM staging and prognosis and treatment of other related information. Derived specification can be found in "clinical technology operation - pathology volumes", monograph, or other pathological drawn

 

1 specimen inspection and drawn by the pathologist must be borne

2 drawn in the application form carefully before reading the content, the initial judge the nature of disease, be aware of the disease

3 check the application form number and specimen number, specimen copies are consistent with the application form and specimens should be double-marked and double-check

4 samples shall be drawn in accordance with the inspection and operation specifications

5 It should be carried out on specimens of careful observation, and the corresponding transcripts

6 work sheets should be drawn, drawn to check the tissue after

7 the number of tissue blocks should each separately numbered, one to one

8 drawn after specimens, a small biopsy specimen containers should be properly preserved, save to the pathology report was issued 2 weeks

9 The remaining specimens are pathological medical waste shall be in accordance with special regulations, not to be thrown away

 

(D) routine pathological production specifications

Conventional biopsy is a tissue fixation, dehydration, dipping wax, embedding, sectioning, staining the whole process, as many links, prone to errors, special attention should be quality control and verification. Producers should refer to the corresponding technical specifications to ensure the quality of slices

1-embedded, sliced, to the wax block, slice, single-phase derived work records check to ensure that no mistakes

(2) have different organizations (such as small biopsies, bone, lymph nodes, etc.) to optimize the production, dyeing processes, to ensure the quality of slices

3 production process, such as abnormal should immediately contact with the pathologist and director of the report, find out the facts, take appropriate remedial measures

4 small endoscopic biopsy, puncture, etc. need more than eight consecutive slices

5 conventional producers should be drawn after 1 working days

 

(E) regulate the pathological diagnosis, review of systems, system consultation within the Section

Pathological diagnosis is based on the pathologist under a microscope, histopathological changes, combined with the history and laboratory examinations, and immunohistochemistry, special stains and molecular pathology results, the integrated use of the understanding of disease pathology doctor to arrive at the final diagnosis. Physicians need for long-term pathological diagnosis and systematic training, and the diagnosis of different situations that arise during the trade-off, only to make sure the diagnosis of disease, are not familiar with the disease, should be submitted to Division of consultation or inter-hospital consultation, in order to avoid misdiagnosis.

 

1 pathologist for diagnosis, they must check the application form and slices are matched;

(2) read the application form must be filled out all the content, the content is not clear in time for submission of physician contact

3 refer to films must be comprehensive, not to missed lesions

4 have higher physician consultation system, and a corresponding written records

5 can not be issued promptly report, the report should be delayed, delayed to explain the reasons for clinicians

6 difficult cases should be higher physician review and sign the full name

7 pathologist shall be responsible for the pathological diagnosis report issued by an explanation

8 consultation with the Branch system for difficult cases, and the corresponding records and signatures

 

(F) should be standardized pathology report, the text is accurate, legible

Pathology report is an important medical files, pathology reports not only the basis for diagnosis and treatment of disease, but also the legal instrument, the contents of the report should be complete and accurate, legible, the application of computer printing conditions, without any report on altered form. Pathology report by the pathologist chapter names, or I personally signed cover

1 pathology report should have basic information, including number of pathological examination and specimen sections, patient name, gender, age, specimen drawn parts, patient number, and / or hospital number

2 samples of the general description of the pathological diagnosis

3 other required reports or recommendations of the content

4 The report physician signature (seal), the report time

5 diagnostic pathology report should be used in the internationally accepted standard Chinese term or

6 pathology report should be issued within 5 working days, difficult cases, special specimens, further immunohistochemical staining, except in cases of molecular pathology, but should promptly report issued late, reasons

7 non-pathological diagnosis of issuing false reports, not to clinicians and patients provided a signed blank pathologist pathology report

8 pathology report (late report) should be promptly distributed to the appropriate department or outpatient clinical call center, the relevant sections of the report should be signed by the recipient record

 

(Vii) specification cytology

1 cytopathology diagnosis must be a qualified physician pathologist, and received specialized training

2 needle aspiration specimen collection, should have the medical procedures by the pathologist or qualified clinicians perform, and strict aseptic

3 for cytological diagnosis, one should carefully check the applications are consistent with the smear

4 cell pathology report should be issued within 2 working days, difficult cases, special cases and need to make further special staining and immunohistochemistry, except

5 cell pathology report should be issued by the signature of the report of the pathologist

 

(Viii) rapid intraoperative frozen section (including rapid paraffin) diagnosis of specification

Rapid intraoperative pathological diagnosis of clinicians in the implementation of surgical procedures on program-related diseases and surgery request pathologists to diagnose problems quickly in an emergency consultation, clinicians and pathologists need for close cooperation between. Rapid section diagnosis have greater limitations and the possibility of misdiagnosis

1 should have a system to ensure the use of intraoperative rapid diagnostic indications, to prevent the rapid diagnosis of abuse

(2) shall not prohibit the appropriate system to carry out surgery for rapid diagnosis of the situation

3-piece drawn specimens, frozen sections producer should be completed within 15 minutes, from specimens sent to the diagnosis should be made within 30 minutes.

4 intraoperative rapid diagnosis in surgical treatment only as a reference, not the final diagnosis

5 should be in the preoperative patients or family members of patients to introduce the limitations of frozen section diagnosis, frozen quickly diagnose signed informed consent

6 for the diagnosis difficult, borderline lesions, such as inspection organization appropriate to the situation, the pathologist can not make a definite diagnosis, waiting for report on paraffin sections

7 frozen section diagnosis report must be in writing (by fax), in order to prevent misuse and misrepresentation listening, verbal or telephone report is strictly prohibited by the way

8 issued a report received from the sample time should be indicated on the application form in the pathological

9 frozen section diagnosis report signed by the full name of pathologist

 

(I) autopsy pathology specification

Post-mortem lesions by organs and procuratorial organs cut open, and drawing production, with a special pathological examination, the process of making a final pathological diagnosis. Autopsy confirmed deaths is an important means of clinical pathology at the seminar is a prerequisite for clinical subjects physicians understand the disease, differential diagnosis, improved treatment options have significant value. Autopsy must comply with relevant state regulations.

1 to participate in the autopsy pathologists and technical staff must have appropriate qualifications

2 clinicians must be identified and signed the death certificate death

3 requires the prior consent of the patient's family's consent, by the hospital authorities (Medical Services / Division) responsible for the autopsy consent form signed

4 autopsy needs to be all or part of the patient's organs removed, and can not yet satisfied, to the family of the deceased to be and / or people responsible for instructions and to be recognized at the autopsy consent form

5 autopsy cases involving criminal, should be provided to the judiciary or to the designated medical institutions, hospitals or forensic department

6 units to carry out an autopsy should establish a complete autopsy files

7 autopsy report should be issued within 3 months

8 autopsy specimens from the autopsy report should be kept for at least 1 year after the issue involving disputes and criminal cases, except

 

(J) Special dyeing operations specifications

Special staining, also known as staining is the use of different organizations on the chemical characteristics of different dye affinity to dye a different effect, as the basis for the diagnosis and differential diagnosis. Must ensure that the special staining of the normative and accuracy, thus ensuring the correct pathological diagnosis

1 technician for special staining, special training must be

(2) Each batch of special stains to set a positive control, can be used within the control of the organization

3 for each special stain must have the laboratory practices and technical regulations

4 replacement of the staining reagents, you must use positive and negative tissue staining to verify, and record and the corresponding stained sections of text files, related files retained 2 years

5 generated by the special staining liquid toxic pollution should be devoted to recycling, dumping is prohibited everywhere

6 results of special stains as a final diagnosis can not be integrated by a pathologist to determine the combination of morphology and staining into the pathology report

 

(K) immunohistochemical staining of the specification

Immunohistochemical staining has become indispensable in modern pathology tools, accurate immunohistochemical staining greatly help the pathological diagnosis, or treatment provided accurate molecular target; not accurate immunohistochemical staining but misleading, resulting in misdiagnosed. It must affect the immunohistochemical staining of all aspects of strict quality control, technical staff and pathologists for training, to ensure accurate results of staining results and correct interpretation

1 Immunohistochemical staining is a special technique, the relevant operator must go through specialized training

(2) Each batch of immunohistochemical staining of positive control must be located, can be used within the control of the organization

3 The laboratory must be established for each immunohistochemical staining procedures, and update

4 Replace the antibody, positive and negative need to be useful to validate the organization, and the corresponding stained sections of text records and files, related files retained 2 years

5 Immunohistochemical staining of the process of toxic liquids (such as DAB) should be devoted to recycling, dumping is prohibited everywhere

6 pathologists must be familiar with a variety of antibody staining, positive signals to express parts of their range of diagnostic applications, in order to achieve the correct interpretation of results

7 simple immunohistochemical staining results as the final diagnosis can not be integrated by a pathologist to determine the combination of morphology and staining results integrated into the pathology report

 

(Xii) the molecular pathology testing

Other molecular diagnostic techniques such as PCR, FISH, flow and other laboratory tests for the pathological diagnosis, the laboratory should be certified by the provincial pathology quality control center, staff training and assessment should be qualified to work.

 

(Xiii) pathology records management system

Pathological application form, biopsy, wax block, positive cytology smears, etc., is an important medical records, pathology must strengthen the management of these files to ensure data integrity, meet the medical needs of patients and medical research need

1 Department of Pathology, tertiary hospitals, the report should be equipped with a computer graphics system, and pathological data in computer management

(2) All files must be locked pathological and expert management

3 has a comprehensive section, the hospital staff access to pathology files, sliced ​​loan system, and strictly enforced

4 biopsy, and positive cytology smear wax block shelf life of 15 years, negative cytology smears for 1 year

5 should be managed according to medical records management and consultation with the relevant provisions, establish and improve the patient (or family) of the slice, smears and other loan information and consultation system

 

(N) inter-hospital pathology consultation system

    
Intercollegiate slice consultation refers to patients or their family with biopsy, paraffin and other consultation to the hospital, carrying a small number of slices for the pathological counterparts to come to consultation. Inter-hospital patient consultation is clear pathological diagnosis of the disease an important way, but because the master physician consultation less clinical data, history is not comprehensive and other reasons, there is a big limitation, it must follow certain standards, and inform the patient of the limitations of consultation nature, the views only of the original pathology consultation physician reference.

1 establish a sound system of consultation, inform the patient of the Court's consultation processes and the expected time of consultation

(2) consultation fees must strictly enforce the provisions of the local prices

3 generally with senior pathologist should be accepted outside the hospital pathology consultation

4 times longer in the diagnosis of cases, the disease should be taken into account that the awareness level, the technical conditions and the diagnostic criteria, the interpretation of certain diseases

5 must have a consultation diagnostic pathologist views the signing

6 are in principle not to receive any other hospital would have been attending pathologist outside the hospital cases of

7 need to do immunohistochemistry, special stains and molecular pathological examination to confirm the diagnosis, it should explain to the risk of side fees, check the time required, and obtain the consent of the risk of side

8 telephone consultation is only responsible for this consultation report has been checked out, shall not disclose the contents of the report to protect patient privacy

 

 

(Xv) the pathology lab should have instruments, reagents, quality control management system and a complete record

Pathology laboratory all the instruments should be in normal operation, the reagent must be valid, and has perfect quality control management measures

1 Department of Pathology, the use of instruments, reagents and consumables must conform to the relevant provisions of the relevant technical standards to achieve

(2) should have equipment operation, maintenance of files

3 reagents should complete the registration, validity and use of archives

4 to establish the pathological diagnosis of error identification, reporting, investigation and treatment procedures

5 establishment of the Branch refrigerator operating temperature record

6 participated in various industry organizations, activities, laboratory quality control

 

(Xvi) Biosafety

Pathology should strictly implement the "Fire Control Law," "People's Republic of Occupational Disease Prevention Law," "Dangerous Chemicals Regulations", "Laboratory Biosafety General Requirements" and "Microbiological and Biomedical Laboratories Biosafety General Guidelines "and other regulations make dangerous chemicals and bio-safety management

1 drawing room on a regular basis, slice room to formaldehyde, xylene concentrations of test reports and to ensure the concentration of harmful gases to the extent permitted in regulations

2 Pathology Division of the waste generated in xylene, formaldehyde and other liquids, must be unified recovery, non-random dumping into the sewer

3 is not fixed pathology specimens drawn at the P2 level laboratory should be carried out strictly distinguish between contaminated and non-contaminated areas, there should be a separate splash pool and eye wash spray equipment

4 have a well-flammable, highly toxic chemicals registration and management practices

5 Department of Pathology staff should be exposed to hazardous materials job subsidies, and regular medical examination of occupational diseases

 

Third, the supervision and management

1. Provincial health authorities to set "Pathology Quality Control Center" on the area of ​​quality medical pathology to assess the quality and safety management and inspection guidance.

2. Medical institutions should be undertaken by the Centre for pathology quality control inspection of Pathology and guidance be with, and may not refuse and obstruct, or provide false materials. Pathological examination failed quality control center shall rectification, and rectification.

3. Health administrative departments shall timely medical pathology of the quality, safety management, conduct notification or notice.

4. Provincial Quality Control Center Pathology Department of Pathology, according to the local level and development needs, develop no less than this "order" quality control standards for quality control monitoring

5. The order by the "Ministry of Health, the National Pathology Quality Control Center," explained that since the release date of implementation.
Source:Media      AddTime:2011-7-5 16:30:40
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