MINISTRY OF HEALTH AND MEDICAL INDUSTRY OF THE RUSSIAN FEDERATION ORDER of May 31, 1996 N 222 ON IMPROVING ENDOSCOPY SERVICE IN HEALTH INSTITUTIONS OF THE RUSSIAN FEDERATION
The development of endoscopic technology in recent decades, based on the use of fiber optics, has significantly expanded the use of minimally invasive instrumental methods research in medical practice. Currently, endoscopy has become quite widespread in both diagnosis and treatment. various diseases. A new direction has appeared in medical practice - surgical endoscopy, which makes it possible to achieve a pronounced economic effect while maintaining the therapeutic result by significantly reducing the length of hospitalization and the cost of treating patients.
The advantages of endoscopic methods ensure the rapid development of this service in the Russian Federation. Over the past 5 years, the number of endoscopy departments and rooms in medical institutions has increased by 1.7 times, and their equipment with endoscopic equipment has increased by 2.5 times. From 1991 to 1995, the number of endoscopists increased 1.4 times; 35% of specialists have qualification categories (1991 - 20%). The scope of performed research and treatment procedures is constantly expanding. Compared to 1991, their number increased by 1.5 and 2 times, respectively. In 1995, 142.7 thousand operations were performed using endoscopic technology. In a number of areas of the country, a 24-hour emergency endoscopic care service has been created, which can significantly improve performance indicators. emergency surgery, traumatology and gynecology. Computer programs have been developed and are being actively implemented to evaluate the results of endoscopic studies.
At the same time, there are serious shortcomings in the organization of the endoscopy service and unresolved problems. Only 38.5 percent of hospitals in rural areas, 21.7 percent of dispensaries (including 8 percent for tuberculosis), and 3.6 percent of outpatient clinics have endoscopy units. Only 17 percent of the total number of endoscopy specialists work in health care facilities located in rural areas. In the staffing structure of endoscopists, there is a high proportion of part-time doctors from other specialties. The capabilities of endoscopy are underutilized due to unclear organization of the work of existing departments and the slow introduction into practice of new forms of management and labor organization medical personnel, spraying specialists involved in endoscopy among others specialized services, lack of highly effective endoscopic diagnostic and treatment programs and algorithms. In some cases, expensive endoscopic equipment is used extremely irrationally due to poor training of specialists, especially in surgical endoscopy, and lack of proper continuity in work with doctors of other specialties. The load on one endoscope with fiber optics is 2 times lower than the standard. Certain difficulties in organizing the service are due to the lack of the necessary regulatory framework, recommendations for optimizing the structure and staffing, and the range of studies in endoscopy units of various capacities. The quality of endoscopic equipment produced by domestic enterprises does not fully meet modern technical requirements
In order to improve the organization of the endoscopy service and increase the efficiency of its work, the rapid introduction of new diagnostic and treatment methods, including surgical endoscopy, as well as improving personnel training and technical equipment of departments with modern endoscopic equipment, I affirm:
1. Regulations on the chief freelance specialist in endoscopy of the Ministry of Health and Medical Industry of the Russian Federation and health authorities of the constituent entities of the Russian Federation ( Annex 1).
2. Regulations on the department, unit, endoscopy room ( Appendix 2).
3. Regulations on the head of the department, department, endoscopy room ( Appendix 3).
4. Regulations on the doctor - endoscopist of the department, department, endoscopy room ( Appendix 4).
5. Regulations on the senior nurse of the department, endoscopy department ( Appendix 5).
6. Regulations on the nurse of the department, department, endoscopy room ( Appendix 6).
7. Estimated time standards for endoscopic examinations, therapeutic and diagnostic procedures, operations ( Appendix 7).
8. Instructions for the use of estimated time standards for endoscopic examinations ( Appendix 8).
9. Instructions for the development of estimated time standards when introducing new equipment or new types of research and treatment ( Appendix 9).
10. Qualification characteristics endoscopist ( Appendix 10).
12. Methodology for calculating prices for endoscopic examinations ( Appendix 12).
13. Journal of registration of studies performed in the department, unit, endoscopy room - form N 157/u-96 ( Appendix 13).
14. Instructions for filling out the Register of studies performed in the department, unit, endoscopy room - form N 157/u-96 ( Appendix 14).
15. Addition to the list of forms of primary medical documentation ( Appendix 15).
I order:
1. To the Ministers of Health of the republics within the Russian Federation, heads of health authorities and institutions of territories, regions, autonomous entities, the cities of Moscow and St. Petersburg:
1.1. During 1996, develop and implement the necessary measures to form a unified endoscopy service in the territory, including diagnostic, therapeutic and surgical endoscopy, taking into account the profile of medical institutions and local conditions.
1.2. When planning a network of endoscopy units, pay attention to Special attention to organize them in institutions primary care, including rural health care.
1.3. Appoint the main freelance endoscopy specialists and organize work in accordance with the Regulations approved by this Order.
1.4. Involve departments of research institutes, educational universities and postgraduate educational institutions in organizational, methodological and advisory work on endoscopy.
1.5. Organize the work of departments, departments, endoscopy rooms in accordance with this Order.
1.6. Establish the number of personnel in departments, departments and endoscopy rooms in accordance with the volume of work based on the estimated time standards for endoscopic examinations.
1.7. Take the necessary measures to maximize the use of endoscopic equipment with fiber optics, ensuring the load on the device is at least 700 studies per year.
1.8. Ensure regular training of doctors of the medical network on topical issues endoscopy.
2. The Department of Organization of Medical Care to the Population (A.A. Karpeev) to provide organizational and methodological assistance to health authorities on the organization and functioning of endoscopy services in the territories of the Russian Federation.
3. The Department of Educational Institutions (Volodin N.N.) to supplement the training programs for training specialists in endoscopy in educational institutions of postgraduate training, taking into account the introduction into practice of modern equipment and new research methods.
4. The Department of Scientific Institutions (Nifantev O.E.) to continue work on creating new endoscopic equipment that meets modern technical requirements.
5. Rectors of institutes for advanced training of doctors must ensure in full the applications of health care institutions for the training of endoscopists in accordance with the approved standard programs.
6. Consider as invalid for institutions of the Russian Ministry of Health and Medical Industry the Order of the USSR Ministry of Health N 1164 of December 10, 1976 “On the organization of endoscopy departments (rooms) in medical institutions”, appendices N 8, 9 to the Order of the USSR Ministry of Health N 590 of April 25, 1986 "On measures to further improve the prevention, early diagnosis and treatment of malignant neoplasms" and Order of the USSR Ministry of Health N 134 of February 23, 1988 "On approval of estimated time standards for endoscopic examinations and therapeutic and diagnostic procedures."
7. Entrust control over the execution of the Order to Deputy Minister A.N. Demenkov.
Minister of Health and Medical Industry of the Russian Federation A.D. TSAREGORODTSEV
The procedure for applying the order of the Ministry of Health of the Russian Federation dated May 31, 1996 No. 222 when determining the staff of medical personnel in the endoscopy department
The issued order of the Ministry of Health of Russia dated May 31, 1996 No. 222 “On improving the endoscopy service in healthcare institutions of the Russian Federation” is aimed at improving the organization of the service, training and use of personnel, and the further development of endoscopic surgery.
However, when applying this order in healthcare institutions, certain difficulties may arise due to insufficient clarity, and in some cases, contradictory presentation of individual positions related, in particular, to economic justification application of the normative indicators presented in the order. This requires some clarification and comment.
1. The order abolished all previously existing regulatory documents on endoscopy, including the order of the USSR Ministry of Health dated December 10, 1976 No. 1164, which defined staffing standards medical personnel of the endoscopy department (office). At the same time, Appendix No. 2, clause 8 states that the staffing of medical and technical personnel is established in accordance with recommended staffing standards or the planned volume of work and depending on local conditions based on the estimated time standards for endoscopic examinations. Subsequently, there are no indications of new staffing standards, and the heads of healthcare institutions naturally have a question: what staffing standards should they focus on when forming the number of department positions?
In our opinion, the positions of endoscopists should be established based on the volume of work and the estimated time standards specified in Order No. 222. When establishing the positions of heads of departments, nursing and junior medical personnel, it is advisable to use the Provision of Order No. 1164, according to which:
The head of the department is installed if there are at least 4 positions of endoscopists on the staff, instead of one of them;
The positions of nurses are established according to the positions of endoscopists, including the position of the head of the endoscopy department, and the head nurse - according to the position of the head of the department instead of one of the positions of nurses;
The positions of nurses are established at the rate of 0.5 positions per 1 position of endoscopist, the position of head of the endoscopy department, but not less than 1 position.
This procedure for establishing positions with a focus on the volume of work and the rational ratio of nursing and junior medical personnel to medical personnel is fully consistent with modern ideas about the rights of chief physicians when establishing staff.
2. B ^ Appendix No. 7 of Order No. 222 presents the estimated time standards for endoscopic examinations and endoscopic operations, and in Appendix No. 8- Instructions for the use of estimated time standards for endoscopic examinations. The time spent on 14 main types of research (out of 22 given in the order) corresponds to the order of the USSR Ministry of Health dated February 23, 1988 No. 134, the development of which was carried out on the basis of scientific research by the Research Institute named after. N. A. Semashko with the reduction of timing measurements. When designing the standard indicator, it was decided to include in the calculated time standards for endoscopic examinations all the time spent by the endoscopist, including the necessary personal time, that is, the coefficient of use of working time for procedures in the total working time budget is 1.0 (Calculation Methodology cost and tariff for the provision of medical care. M., Research Institute named after N. A. Semashko, 1994.
Order of the Federal Compulsory Medical Insurance Fund dated 10.95 No. 72 “On methodological recommendations for calculating tariffs for the provision of outpatient care”).
The order in question states that the calculated time standards include main and auxiliary activities and work with documentation, which amounts to 85% of working time.
Consequently, a change in the working time utilization factor from 1.0 to 0.85 while the time standards for endoscopic examinations remain unchanged leads to an actual increase in personnel when using the order by 115% with the same amount of work.
3. Estimated time standards for endoscopic examinations, procedures and endoscopic operations are expressed in minutes, and the annual volume of work is recommended to be determined in conventional units. The discrepancy between the meters of these indicators, as well as negligence in decoding the symbols, and even the absence in some cases of such decoding in the presented formulas can cause difficulties in the economic analysis of the activities of medical personnel.
In labor standardization, it is traditional to express the estimated time standards and the annual volume of work in the same units: either in minutes or in conventional units.
4. B Appendix No. 12 a methodology for calculating prices for endoscopic examinations is presented. At the same time, it is not indicated that when calculating the average salary of medical personnel directly involved in research, one should take into account the standard ratio of the positions of 1 medical personnel with middle and junior personnel, that is, the methodological approach that is currently adopted when calculating the cost of medical help.
Thus, taking into account the specified clarifications and comments on individual provisions of Order No. 222, it is advisable to calculate the number of positions of medical personnel in endoscopy departments (offices) in the following order:
ORDER of the Ministry of Health and Medical Industry of the Russian Federation dated May 31, 1996 N 222 “ON IMPROVING ENDOSCOPY SERVICE IN HEALTHCARE INSTITUTIONS OF THE RUSSIAN FEDERATION”
The development of endoscopic technology in recent decades, based on the use of fiber optics, has significantly expanded the use of minimally invasive instrumental research methods in medical practice.
Currently, endoscopy has become quite widespread both in the diagnosis and treatment of various diseases. A new direction has appeared in medical practice - surgical endoscopy, which makes it possible to achieve a pronounced economic effect while maintaining the therapeutic result by significantly reducing the length of hospitalization and the cost of treating patients.
The advantages of endoscopic methods ensure the rapid development of this service in the Russian Federation.
Over the past 5 years, the number of endoscopy departments and rooms in medical institutions has increased by 1.7 times, and their equipment with endoscopic equipment has increased by 2.5 times.
From 1991 to 1995, the number of endoscopists increased 1.4 times; 35% of specialists have qualification categories (1991 - 20%).
The scope of performed research and treatment procedures is constantly expanding. Compared to 1991, their number increased by 1.5 and 2 times, respectively. In 1995, 142.7 thousand operations were performed using endoscopic technology.
In a number of areas of the country, a 24-hour emergency endoscopic care service has been created, which can significantly improve performance in emergency surgery, traumatology and gynecology. Computer programs have been developed and are being actively implemented to evaluate the results of endoscopic studies.
At the same time, there are serious shortcomings and unresolved problems in organizing the activities of the endoscopy service.
Only 38.5 percent of hospitals in rural areas, 21.7 percent of dispensaries (including 8 percent for tuberculosis), and 3.6 percent of outpatient clinics have endoscopy units.
Only 17 percent of the total number of endoscopy specialists work in health care facilities located in rural areas.
In the staffing structure of endoscopists, there is a high proportion of part-time doctors from other specialties.
The capabilities of endoscopy are underutilized due to the unclear organization of work of existing departments, the slow introduction into practice of new forms of management and labor organization of medical personnel, the scattering of specialists involved in endoscopy among other specialized services, and the lack of highly effective endoscopic diagnostic and treatment programs and algorithms.
In some cases, expensive endoscopic equipment is used extremely irrationally due to poor training of specialists, especially in surgical endoscopy, and lack of proper continuity in work with doctors of other specialties. The load on one endoscope with fiber optics is 2 times lower than the standard.
Certain difficulties in organizing the service are due to the lack of the necessary regulatory framework, recommendations for optimizing the structure and staffing, and the range of studies in endoscopy units of various capacities.
The quality of endoscopic equipment produced by domestic enterprises does not fully meet modern technical requirements.
In order to improve the organization of the endoscopy service and increase the efficiency of its work, the rapid introduction of new diagnostic and treatment methods, including surgical endoscopy, as well as improving personnel training and technical equipment of departments with modern endoscopic equipment, I affirm:
1. Regulations on the chief freelance specialist in endoscopy of the Ministry of Health and Medical Industry of the Russian Federation and health authorities of the constituent entities of the Russian Federation (Appendix 1).
2. Regulations on the department, department, endoscopy room (Appendix 2).
3. Regulations on the head of the department, department, endoscopy room (Appendix 3).
4. Regulations on the doctor - endoscopist of the department, department, endoscopy room (Appendix 4).
5. Regulations on the head nurse of the department, endoscopy department (Appendix 5).
6. Regulations on the nurse of the department, department, endoscopy room (Appendix 6).
7. Estimated time standards for endoscopic examinations, therapeutic and diagnostic procedures, operations (Appendix 7).
8. Instructions for the use of estimated time standards for endoscopic examinations (Appendix 8).
9. Instructions for the development of estimated time standards for the introduction of new equipment or new types of research and treatment (Appendix 9).
10. Qualification characteristics of the endoscopist (Appendix 10).
12. Methodology for calculating prices for endoscopic examinations (Appendix 12).
13. Journal of registration of studies performed in the department, department, endoscopy room - form N 157/u-96 (Appendix 13).
14. Instructions for filling out the Register of studies performed in the department, unit, endoscopy room - form N 157/u-96 (Appendix 14).
15. Addition to the list of forms of primary medical documentation (Appendix 15).
1. To the Ministers of Health of the republics within the Russian Federation, heads of health authorities and institutions of territories, regions, autonomous entities, the cities of Moscow and St. Petersburg:
1.1. During 1996, develop and implement the necessary measures to form a unified endoscopy service in the territory, including diagnostic, therapeutic and surgical endoscopy, taking into account the profile of medical institutions and local conditions.
1.2. When planning a network of endoscopy units, pay special attention to their organization in primary care institutions, including rural healthcare.
1.3. Appoint the main freelance endoscopy specialists and organize work in accordance with the Regulations approved by this Order.
1.4. Involve departments of scientific research institutes, educational universities and postgraduate educational institutions in organizational, methodological and advisory work on endoscopy.
1.5. Organize the work of departments, departments, endoscopy rooms in accordance with this Order.
1.6. Establish the number of personnel in departments, departments and endoscopy rooms in accordance with the volume of work based on the estimated time standards for endoscopic examinations.
1.7. Take the necessary measures to maximize the use of endoscopic equipment with fiber optics, ensuring the load on the device is at least 700 studies per year.
1.8. Provide regular training to medical doctors on current issues of endoscopy.
2. The Department of Organization of Medical Care to the Population (A.A. Karpeev) to provide organizational and methodological assistance to health authorities on the organization and functioning of endoscopy services in the territories of the Russian Federation.
3. The Department of Educational Institutions (Volodin N.N.) to supplement the training programs for training specialists in endoscopy in educational institutions of postgraduate training, taking into account the introduction into practice of modern equipment and new research methods.
4. The Department of Scientific Institutions (Nifantev O.E.) to continue work on creating new endoscopic equipment that meets modern technical requirements.
5. Rectors of institutes for advanced training of doctors must ensure in full the applications of health care institutions for the training of endoscopists in accordance with the approved standard programs.
6. Consider as invalid for institutions of the Russian Ministry of Health and Medical Industry Order of the USSR Ministry of Health N 1164 of December 10, 1976 “On the organization of endoscopy departments (rooms) in medical institutions”, appendices N 8, 9 to Order of the USSR Ministry of Health N 590 of April 25, 1986 “On measures to further improve the prevention, early diagnosis and treatment of malignant neoplasms” and Order of the USSR Ministry of Health N 134 of February 23, 1988 “On approval of estimated time standards for endoscopic examinations and therapeutic and diagnostic procedures.”
7. Entrust control over the execution of the Order to Deputy Minister A.N. Demenkov.
Minister of Health and
medical industry
Russian Federation
A.D.TSAREGORODTSEV
Annex 1
to the Order of the Ministry of Health and Medical Industry of the Russian Federation
dated May 31, 1996 N 222
Order of the Ministry of Health of Russia N 974 n: new rules for endoscopy
Articles on the topic
The requirements for endoscopic procedures changed on July 1, 2018 after Order 974 n on endoscopy came into force.
We will tell you what has changed in the work of endoscopy rooms and departments, how to plan and record studies conducted in a medical institution.
The main thing in the article:
Major changes in the order on endoscopy
Order 974 n on endoscopy changed the rules for conducting research in the “endoscopy” profile. The requirements of the order and its annexes are mandatory in work from July 1, 2018.
Order N 974n on endoscopic examinations: with appendices (2018)
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Area of premises of endoscopic units
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Order 974n on endoscopy established new rules for the operation of endoscopy departments and offices. In particular:
Mechanics: how to organize the work of an endoscopy department or office
Rules for conducting endoscopic examinations since 2018
The new order on endoscopy defines a list of medical interventions that are classified as endoscopic:
Endoscopic examinations are carried out for the purpose of:
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The procedure for conducting endoscopic examinations
Order 974 n on endoscopy determined the procedure for referring patients to an endoscopist. Thus, a doctor, as well as a paramedic or midwife, if they are assigned separate medical responsibilities, can refer a patient to the endoscopy department or office.
Order on endoscopy 974n establishes that it is important to take into account the legal right to choose a suitable medical institution.
How to organize the work of an endoscopy department or office
The organization of the work of endoscopy departments and offices was described in detail in the recommendation of the “Chief Physician” Help System.
Referrals for endoscopy
In accordance with the new rules, the following information must be indicated on the patient referral form for endoscopy:
If the patient is sent to the endoscopy office or department of another medical institution, two additional details are included in the referral:
The new order on endoscopy in 2018 allows you to issue a referral for endoscopic examination in the clinic in different forms:
- in the form of a paper document;
- in the form of an electronic document signed with the digital signature of a doctor;
- if the patient receives medical care in a hospital (day hospital), the new endoscopy order allows you to make an entry about the referral on the appointment sheet.
- for an endoscopist – higher medical education, as well as compliance with the requirements for the specialty “Endoscopy”;
- for a nurse – secondary vocational education, as well as compliance with the requirements for the specialty “Nursing”.
Order 974 n on endoscopy provides a list of requirements for health workers who conduct endoscopic examinations:
Logging
One of the features of endoscopic examinations, which is established by the order on endoscopy 2018 974 n, is the preparation of an examination protocol.
The order on endoscopy establishes the requirements for its preparation and content:
Order 974 n on endoscopy provides for difficult and complex cases of examinations when the endoscopist finds it difficult to interpret the results obtained. In such a situation, he can consult with colleagues, including if telemedicine capabilities are used for this.
The protocol based on the results of the examination is prepared in 2 copies, one of which is placed in the patient’s medical documents, the second copy is intended for the patient himself.
If the patient was referred for examination by another medical institution, then a copy of the endoscopic examination protocol is sent to her address.
The patient has the right at any time to request a copy of the completed protocol from the medical institution; the request can be sent, including in paper form.
New requirements
To organize the work of the endoscopy department or office, use the staffing standards and equipment standards recommended by the Ministry of Health
Rules for organizing endoscopy in medical institutions
The new order 974 n on endoscopy determined the main rules for organizing the activities of medical institutions whose work is related to endoscopic examinations.
An endoscopy room or department can be organized in a medical institution. The order discusses detailed standards for equipping these units, as well as standards for their standard equipment. medical specialists depending on the planned load.
Thus, in accordance with Appendix No. 2 to the Rules for Conducting Endoscopic Research, one doctor and one nurse must work in the endoscopy room in one shift.
General requirements
The new order on endoscopy of 2018 establishes a list of general requirements for departments for endoscopic examinations:
SanPiN 2.1.3.2630-10 and order 974 n on endoscopy establish a standard for equipping the endoscopy department, which will allow it to comply with the anti-epidemic regime:
- There should not be a shortage of endoscopes in the department. If these are insufficient, the required sterilization, disinfection and cleaning cycles for endoscopes will not be maintained between different patient visits.
- Cleanliness class B is established in the treatment rooms of the endoscopy department.
- Standards have been established for the area of premises of the endoscopy department. Thus, the operating room must have an area of at least 36 sq.m., and the treatment room must have an area of at least 18 sq.m.
Medical institutions are required to comply sanitary standards and rules. Due to the fact that in the endoscopy department there is a high risk of developing dangerous infections, the head of the department must appoint those responsible for carrying out and organizing anti-epidemic measures.
The quality of processing of endoscopic equipment is subject to careful checking.
New endoscopy order
CHIEF STATE SANITARY DOCTOR OF THE RUSSIAN FEDERATION
On approval of SP 3.1.3263-15 “Prevention infectious diseases for endoscopic interventions"
In accordance with the Federal Law of March 30, 1999 N 52-FZ “On the sanitary and epidemiological welfare of the population” (Collected Legislation of the Russian Federation, 1999, N 14, Art. 1650; 2002, N 1 (part 1), Art. 2 ; 2003, N 2, art. 167; 2004, N 35, art. 3607; 2006, N 1, art. 10; 52 (Part 1), Article 5498; 2007, No. 1 (Part 1), Article 21, 29; No. 3213; No. 49, Article 6070; N 24, art. 2801; N 29, art. 3418; N 30 (part 2), art. 3616; N 52 (part 1), art. 6223; Article 17; 2010, N 40, Article 4969; 2011, No. 1, Article 6, N 30 (part 1), Article 4563, N 30 (part 1), Article 4590, N 30 (part .1), Art. 4591, No. 30 (part 1), Art. 4596, No. 50, Art. 7359; 2012, No. 24, Art. 3069, No. 26, Art. 3446; 2013, No. 27, Art. 3477, N 30 (part 1), art. 4079; 2014, N 26 (part 1), art. 3366, art. 3377; .11) and Decree of the Government of the Russian Federation of July 24, 2000 N 554 “On approval of the Regulations on the State Sanitary and Epidemiological Service of the Russian Federation and the Regulations on State Sanitary and Epidemiological Standardization” (Collected Legislation of the Russian Federation, 2000, N 31, Art. 3295 ; 2004, N 8, art. 663, N 47, art. 4666; 2005, N 39, art. 3953)
1. Approve the sanitary and epidemiological rules SP 3.1.3263-15 “Prevention of infectious diseases during endoscopic interventions” (Appendix).
Registered
at the Ministry of Justice
Russian Federation
registration N 38110
Application. SP 3.1.3263-15 “Prevention of infectious diseases during endoscopic interventions”
APPROVED
resolution
Chief State
sanitary doctor
Russian Federation
dated June 8, 2015 N 20
Sanitary and epidemiological rules
SP 3.1.3263-15
I. Scope of application
1.1. These sanitary rules establish requirements for sanitary and anti-epidemic (preventive) measures aimed at preventing the occurrence and spread of infectious diseases during endoscopic interventions.
1.2. These sanitary rules are intended for medical organizations performing endoscopic interventions, as well as bodies exercising federal state sanitary and epidemiological supervision, educational and scientific organizations implementing educational programs additional professional education for medical workers performing endoscopic interventions.
1.3. Compliance with sanitary rules is mandatory for medical organizations.
1.4. Control over the implementation of these sanitary rules is carried out in accordance with the legislation of the Russian Federation by bodies authorized to carry out federal state sanitary and epidemiological supervision.
II. General provisions
2.1. Endoscopic interventions are minimally invasive, highly informative and effective medical services aimed at diagnosis (endoscopic examination) and treatment (endoscopic manipulation, including endoscopic surgery) of various diseases. Endoscopic interventions are performed using endoscopic equipment.
2.2. Endoscopic equipment, including endoscopes and instruments for them, alone or as part of endoscopic and endosurgical complexes (systems), refers to medical products intended for endoscopic interventions.
2.3. During use, endoscopes come into contact with mucous membranes and (or) penetrate into sterile organs, tissues and cavities of the body. According to their purpose, they are divided into endoscopes for non-sterile and sterile endoscopic interventions.
2.4. Interventions in which the endoscope is inserted through natural ways into organs that normally contain their own microflora (gastrointestinal tract, respiratory tract).
2.5. Interventions in which the endoscope is inserted through punctures, cuts in the skin and mucous membranes into the bloodstream, cavities or tissues of the body, as well as into normally sterile organs (uterus, bladder) through natural routes are considered sterile.
2.6. The use of endoscopes in clinical practice for diagnostic and therapeutic interventions is accompanied by the risk of infection of patients and personnel with pathogens of infectious diseases.
2.7. High-level disinfection (hereinafter referred to as HLD) ensures the death of vegetative forms of bacteria (including mycobacteria), fungi, enveloped and non-enveloped viruses and a certain amount of bacterial spores. DLD of endoscopes is carried out manually or mechanized in a washing-disinfecting machine (hereinafter referred to as MDM).
III. Organization and control of measures for the prevention of infectious diseases associated with endoscopic interventions
3.1. Sanitary and anti-epidemic (preventive) measures in structural units of medical organizations performing endoscopic interventions and (or) processing and storing endoscopic equipment are aimed at preventing the transmission of infection to patients and staff.
3.2. In structural divisions medical organization performing endoscopic interventions, the administrative document of the head of the organization must determine the persons responsible for organizing and carrying out anti-epidemic measures, including the quality of processing of endoscopic equipment.
3.3. The head (doctor) of the structural unit (office) performing endoscopic interventions must develop work instructions for processing endoscopes available in the equipment of the structural unit (office), which is approved by the head of the medical organization. The specified instructions should be developed on the basis of the provisions of these sanitary rules, taking into account the type, brand (model) of endoscopes, operational documentation for them and for equipment intended for their processing and storage, instructions for the use of chemical cleaning, disinfection and sterilization agents used.
3.4. Medical workers directly involved in performing endoscopic interventions and processing endoscopic equipment (doctors and nurses) must undergo advanced training at least once every 5 years on the basis of organizations licensed to educational activities on programs of additional professional education, including issues of ensuring the epidemiological safety of endoscopic interventions.
3.5. Measures to monitor compliance with the requirements of these sanitary rules, including laboratory quality control of the processing of endoscopic equipment, are included in the Program (plan) of production control of a medical organization.
3.6. Each endoscope equipped at a structural unit in which endoscopic interventions are performed is assigned an identification code (number), which includes information about its type (model) and serial number. Identification code used during medical intervention The endoscope must be indicated in the endoscopic intervention protocol, in the special notes column of the journal for recording studies performed in the department, unit, endoscopy room or in the journal for recording surgical interventions in a hospital.
3.7. Each endoscope reprocessing cycle must be recorded in logs.
3.7.1. In the Journal of control over the processing of endoscopes for non-sterile interventions (Appendix No. 1 to these sanitary rules) must be indicated:
— date of processing of the endoscope;
— identification code (number) of the endoscope;
— results of the leak test;
— name of the final cleaning product;
— start and end times of the final cleaning process;
— results of quality control of cleaning carried out in accordance with the requirements of paragraph 10.2 of these sanitary rules;
— two-way endoscope method (manual or mechanized). For the manual processing method, the following must be indicated: the name of the product and the controlled parameters of the mode of its use (temperature of the solution, concentration of the solution and the results of express control of the level of active substance (AI), start/end time of disinfection exposure). For a mechanized processing method, the following must be indicated: serial number or brand of MDM (if the department has several pieces of equipment for processing endoscopes), number of the processing mode used, name of the TLD product, solution concentration and results of express monitoring of the level of active substance content, cycle completion time processing in MDM;
3.7.2. The quality of cleaning of endoscopes intended for sterile interventions, instruments for endoscopes and auxiliary equipment should be noted in the logbook for recording the quality of pre-sterilization treatment of medical products.
In the Logbook for monitoring the sterilization of endoscopic equipment manually (Appendix No. 2 to these sanitary rules), which is filled out in the sterilization room of the operating unit or specialized surgical department, must indicate:
— name of the products being sterilized, including the endoscope;
— identification code (number) of the endoscope (if there are several endoscopes);
— name of the sterilizing agent and controlled parameters of the mode of its use (temperature of the solution, concentration of the solution and results of express monitoring of the level of active substances in the working solution, exposure);
— time to complete sterilization and packaging of the endoscope;
- last name, first name, patronymic and signature of the medical worker who carried out the treatment.
When sterilizing endoscopic equipment in the sterilization room of the operating unit using sterilization equipment, the sterilization parameters are recorded in the sterilizer operation control log.
3.7.3. When processing instruments and endoscopes for sterile interventions in the central sterilization department (hereinafter referred to as the CSD), the stages of processing must be recorded in the quality log of pre-sterilization processing of medical products and logs for monitoring the operation of sterilizers.
3.8. Transportation of endoscopes and instruments for them along the corridors between the premises of the endoscopy department and the operating unit, as well as to other departments and central treatment centers of a medical organization, should be carried out in rigid containers or on closed trays.
3.9. Containers and trays for transporting endoscopes must be disinfected after each use.
IV. Requirements for the processing cycle of endoscopes and instruments for them
4.1. Endoscopes for non-sterile endoscopic interventions and their accessories (valves, plugs, caps), immediately after use, are subject to the following:
— final cleaning (final cleaning combined with disinfection);
— high-level disinfection;
— storage under conditions that exclude secondary contamination.
4.2. Endoscopic equipment, including endoscopes, for sterile endoscopic interventions, all types of instruments for sterile and non-sterile interventions immediately after use are subject to the following:
— pre-sterilization cleaning combined with disinfection;
4.3. Immediately after each use of an endoscope intended for non-sterile interventions, all stages of its reprocessing must be completed in full. All channels of the endoscope are processed, regardless of whether they were involved in endoscopic intervention or not.
4.4. The process of sterilization of endoscopes and instruments for them can be transferred to the next work shift, provided that they are effectively disinfected and pre-sterilized cleaned immediately after use.
V. Requirements for the layout, equipment and sanitary maintenance of premises of structural units of medical organizations performing non-sterile endoscopic interventions
5.1. The endoscopy department (office) must have the following premises:
5.1.1. Doctor's office(s);
5.1.2. Separate endoscopic manipulations (depending on the types of interventions performed) for:
- studies of the upper gastrointestinal tract,
— studies of the lower gastrointestinal tract;
5.1.3. Washing and disinfection room;
5.1.4. Auxiliary premises.
5.2. Retrograde cholangiopancreatography is carried out in an endoscopic manipulation room or in an x-ray medical organization that meets the requirements of radiation safety standards.
5.3. When manipulative for conducting studies of the lower parts of the digestive tract, the presence of a sanitary unit is provided.
5.4. The manipulation room for bronchoscopy (cleanliness class “B”) is equipped with a supply and exhaust ventilation system with a predominance of air flow. The supplied air must be cleaned and disinfected with an efficiency of at least 95%.
5.5. The room in which endoscopic interventions are performed must be equipped with a sink for washing the hands of medical workers.
5.6. Preliminary cleaning of used endoscopes and instruments for them is carried out in the same room where the intervention was performed.
5.7. Final cleaning (final cleaning combined with disinfection) and high-level disinfection of endoscopes intended for non-sterile endoscopic interventions are carried out in a specially equipped washing and disinfection room (endoscope processing room).
5.8. The room for processing endoscopes is equipped with general supply and exhaust ventilation and local exhaust ventilation with removal of solution vapors at the level of the washing baths.
5.9. If the quality of tap water does not meet hygienic requirements, as well as when using MDM, the operating instructions of which indicate the requirements for the quality of water supplied to the machine, additional means of purifying tap water are installed.
5.10. The location of technological equipment in the room for processing endoscopes must ensure the flow of all stages of processing endoscopes in accordance with the requirements of these sanitary rules. In newly designed medical organizations, planning solutions are provided that eliminate the cross-flow of clean and dirty endoscopes.
5.11. The room for processing endoscopes is functionally divided into a conditionally dirty area, intended for final cleaning, and a conditionally clean area, where high-level disinfection, drying and storage of endoscopes is carried out.
5.12. A sink is installed in the endoscope processing room for washing the hands of medical personnel. It is not allowed to be used for other purposes.
5.13. The final cleaning area for endoscopes should be equipped with:
— a table (trolley) for containers (trays) with used endoscopes;
— washing baths with a capacity of at least 10 liters, connected to sewerage and water supply; the number of washing baths is determined based on the maximum workload in the endoscopy department (office);
— racks (cabinets) for storing non-sterile consumables (sheets, diapers, gloves, napkins, detergents and disinfectants).
5.14. The TLD and endoscope storage area should be equipped with:
— a container for carrying out HLD in a solution of a chemical agent with a volume of at least 10 liters and (or) MDM;
— washing baths to remove residues of TLD from/from endoscopes for gastrointestinal studies;
— containers for rinsing bronchoscopes (when using sterile water- sterile, in other cases - disinfected);
— tables for drying and packaging processed endoscopes;
— cabinets for storing endoscopes or cabinets for drying and storing endoscopes in an aseptic environment;
— racks (cabinets) for storing sterile materials (sheets, diapers, gloves, covers for endoscopes).
5.15. All types of cabinets for storing processed endoscopes must be cleaned and disinfected with a chemical solution in a bactericidal mode at least once a week, unless otherwise provided in the operating instructions.
5.16. Cleaning and preventive disinfection in manipulation rooms for non-sterile endoscopic interventions and in the washing and disinfection room should be carried out as they become dirty, but at least once per shift or 2 times a day. After each patient, the surface of the examination couch (table) with which he was in contact must be disinfected. spring-cleaning should be carried out once a week.
VI. Requirements for premises of structural units of medical organizations intended for carrying out sterile endoscopic interventions, processing endoscopes for sterile interventions and instruments
6.1. Sterile endoscopic interventions should be carried out in operating rooms, small operating rooms of medical organizations or in endoscopic manipulation specialized surgical departments.
6.2. Preliminary cleaning of endoscopic equipment (rigid endoscope, video camera head, light guide, suction (flushing) pump, insufflation device, set of silicone tubes, instruments) after completion of surgery should be carried out in the area in which preliminary cleaning of surgical instruments is carried out.
6.3. Preliminary cleaning of flexible endoscopes and instruments for them should be carried out immediately after completion of the intervention in the endoscopic manipulation room.
6.4. Pre-sterilization cleaning, combined with disinfection, of endoscopes for sterile manipulations and instruments should be carried out in the instrument disassembly and washing room of the operating unit, in the washing and disinfection room of the surgical department, in the central surgical department.
6.5. Sterilization of endoscopes for sterile interventions and instruments for them is carried out:
— manually in a sterilization room (cleanliness class “B”) of the operating unit or surgical department;
— in a mechanized way using sterilization equipment in a sterilization room (cleanliness class “B”) of the operating unit, surgical department, central surgical center.
6.6. Endoscopes and instruments that have been sterilized must be stored under aseptic conditions.
6.7. Cleaning and disinfection of areas where sterile endoscopic procedures are performed should be carried out after each procedure. General cleaning - once a week.
VII. Requirements for equipment, tools and materials for processing endoscopic equipment
7.1. When processing endoscopes and other medical products as part of endoscopic and endosurgical complexes (systems), as well as instruments for endoscopes, medical equipment products (sterilizers, washing machines, MDMs, ultrasonic cleaners and others), detergents and disinfectants approved for use must be used. these goals in the Russian Federation.
7.2. When choosing means of cleaning, disinfection (including HLD), as well as means and methods of sterilization, the recommendations of manufacturers of endoscopes and instruments for them regarding the impact of a specific product (sterilizing agent) on the materials of these medical devices should be taken into account.
7.3. It is not allowed to use disinfectants for cleaning or cleaning combined with disinfection, which in the recommended modes have a fixing effect on organic contaminants, including those containing alcohols and aldehydes.
7.4. Detergent solutions for cleaning endoscopes based on enzymes and (or) surfactants are used once. Disinfectant solutions in the cleaning mode combined with disinfection are applied until changed appearance, but not more than one work shift.
7.5. For HLD endoscopes, solutions of aldehyde-containing, oxygen-active and some chlorine-containing agents in sporicidal concentrations are used.
7.6. To sterilize endoscopes and instruments, the following are used:
— steam, gas and plasma methods;
- solutions of aldehyde-containing, oxygen-active and some chlorine-containing agents in sporicidal concentrations.
7.7. It is prohibited to use ozone sterilizers and steam-formalin chambers to sterilize endoscopes and their instruments.
7.8. With repeated use (within the expiration date) of working solutions of sterilization agents and HLDs:
— medical devices must be dried before immersion in the solution (manual processing method);
— the level of active substance content in the working solution must be monitored with express indicators (if they are developed for the product) at least once per shift (manual and mechanized processing methods);
— when the level of active substance in the working solution decreases below the standard value or the first visual signs of contamination appear, the solution is replaced.
7.9. Containers with working solutions of sterilization agents and HLDs must be equipped with lids and labeled with the name of the product, its concentration, purpose, preparation date, and expiration date.
For ready-to-use products, the name and purpose, and the start date of its use must be indicated.
VIII. Requirements for processing technology and storage of endoscopic equipment
8.1. Reprocessing of flexible endoscopes for non-sterile endoscopic procedures after use should be carried out in the following sequence:
8.1.1. Pre-cleaning external surfaces insertion tube, flushing of channels; for a video endoscope - sealing using a protective cap.
8.1.2. Visual inspection of the endoscope and checking for leaks. A leaking endoscope cannot be further processed or used.
8.1.3. The process of final cleaning or final cleaning combined with disinfection includes the following steps:
— immersion of the endoscope in a solution of detergent or detergent; disinfectant with filling of all channels through the irrigator, adapters and flushing tubes for the time specified in the instructions for the product;
— cleaning the external surfaces of the endoscope with napkins, cleaning valves, valve seats, end optics and open channels with brushes;
— washing with a detergent or detergent-disinfectant solution all channels of the endoscope through the irrigator, adapters and flushing tubes;
— rinsing the external surfaces and channels of the endoscope with drinking water using the same devices as for cleaning;
— drying of external surfaces with clean material and channels by blowing (aspiration) with air.
Wash water after the stages of cleaning and rinsing endoscopes should be drained into a centralized sewer system without prior disinfection.
8.1.4. The quality of cleaning of the endoscope is checked in accordance with paragraph 10.2 of these sanitary rules.
8.1.5. The manual endoscope TLD process includes the following steps:
— disinfection exposure when the endoscope is completely immersed in a solution of one of the products specified in paragraph 7.5 of these sanitary rules. All channels must be forcibly filled with solution, air bubbles from the outer surfaces must be removed with a napkin;
— rinsing the endoscope according to the instructions for use of a specific product intended for HLD. Endoscopes for gastrointestinal examinations must be rinsed tap water drinking quality, bronchoscopes - sterile water, boiled or purified with antibacterial filters. A portion of water for rinsing the endoscope is used once.
8.1.6. Removing moisture from the external surfaces of the endoscope using sterile material; from the channels - by blowing air or active aspiration of air. To more completely remove moisture from the endoscope channels, treatment ends with rinsing 70-95% ethyl alcohol, meeting the requirements of the pharmacopoeial monograph, and blowing with air.
8.1.7. Processing of endoscopes using a mechanized method is carried out in accordance with the operational documentation for the equipment. Before each cycle of processing of endoscopes for non-sterile interventions in the MDM, their final cleaning is carried out manually (including using brushes for all accessible channels), unless otherwise indicated in the instructions for the MDM.
8.1.9. After completion of processing, the endoscope must be reused or stored under conditions that prevent secondary contamination.
8.1.10. During a work shift, the processed endoscope, assembled and packaged in sterile material, can be stored until the next use for no more than 3 hours. An endoscope not used within the specified period is re-subjected to TLD.
8.1.11. Between work shifts, the endoscope should be stored unassembled, packaged in sterile material or unpackaged in a drying cabinet and storing endoscopes in an aseptic environment.
The shelf life of endoscopes in a cabinet for drying and storage in an aseptic environment is indicated in the cabinet’s operating instructions. The shelf life of endoscopes packed in sterile fabric covers should not exceed 72 hours. After the expiration of the specified storage period, the endoscope is subject to TLD again.
8.1.12. Endoscopes must not be stored in cabinets exposed to direct ultraviolet rays.
8.1.13. The container (container, tank) for water intended for cleaning lenses, the lid and connecting hoses to it must be cleaned, dried and sterilized at the end of the work shift. Before use, the container is filled with sterile water.
8.1.14. During operation, the suction jar is filled to no more than 3/4 of its volume. After each emptying, it must be disinfected by immersion and cleaned. At least two cans are provided for each suction suction.
8.2. Reprocessing of flexible endoscopes for sterile endoscopic interventions after use should be carried out in the following sequence:
8.2.1. Preliminary cleaning is carried out in the manner established by subclause 8.1.1 of these sanitary rules.
8.2.2. The process of pre-sterilization cleaning combined with disinfection is carried out similarly to the process of final cleaning combined with disinfection (subclause 8.1.4 of these sanitary rules).
8.2.3. Sterilization of flexible endoscopes is carried out in chemical solutions manually or mechanically in low-temperature sterilizers, which have no restrictions on use for a specific endoscope model (in terms of materials, number, length and diameter of channels).
8.2.4. The process of manually sterilizing endoscopes includes the following steps:
- sterilization exposure in a solution of one of the products specified in paragraph 7.6 of these sanitary rules, with the endoscope completely immersed and the channels forcedly filled through adapters (flushing tubes), as well as air bubbles being removed from the outer surfaces;
— rinsing the endoscope with sterile water in accordance with the instructions for use of the specific sterilant. Internal channels are rinsed through adapters and flushing tubes.
Sterile water and sterile water containers are for single use only.
8.2.5. The outer surfaces of the endoscope are dried with sterile wipes, the channels are dried with pressurized air or air aspiration. Additional drying of the channels with alcohol is not carried out. The products, washed from the remnants of the sterilizing agent and dried, are transferred to a sterile sterilization box lined with a sterile cloth. The permissible shelf life of sterilized products is no more than 72 hours.
8.3. Processing of rigid endoscopes for sterile surgical interventions includes the following processes: pre-cleaning, pre-sterilization cleaning combined with disinfection, sterilization.
8.3.1. Pre-sterilization cleaning, combined with disinfection, of rigid endoscopes and their accessories is carried out manually or mechanically in a MDM.
8.3.2. The process of pre-sterilization cleaning combined with disinfection when manually processing an endoscope includes the following steps:
— disinfection exposure in a washing-disinfecting solution with the endoscope completely immersed in the solution and forced filling of the channels;
— mechanical cleaning of internal channels and removable parts of the endoscope using brushes and wire cleaners of the appropriate size;
— flushing internal channels using special devices (syringe tubes, flushing syringes or a washing gun with nozzles);
— rinsing the endoscope with drinking water and distilled water, including channels using special devices.
The outer surfaces of the endoscope are dried with a soft cloth, and the channels are dried with air using air guns. Additionally, optical surfaces are dried with 70% alcohol if this is specified in the manufacturer's instructions.
8.3.3. Pre-sterilization cleaning, combined with disinfection, is performed mechanically in MDM using chemical agents or chemical agents and thermal methods, which are permitted by the manufacturer of endoscopic equipment.
8.3.4. After completion of pre-sterilization cleaning combined with disinfection, the quality of cleaning is checked in accordance with paragraph 10.2 of these sanitary rules; in accordance with the operating instructions, functional tests are carried out, image quality is checked, taps and hinge mechanisms of the moving parts of the endoscope are lubricated.
8.3.5. Before the automatic sterilization cycle, the endoscope is thoroughly dried and placed in the sterilization container recommended for the selected sterilization method.
8.3.6. The process of manually sterilizing an endoscope must be carried out in accordance with subclause 8.2.4 of these sanitary rules.
8.3.7. Processing of the camera control unit and video head unit (video head unit with integrated optical adapter (lens), video head with screw connection and with or without optical adapter, as well as the optical adapter itself) begins immediately after disconnecting the mains plug.
8.3.7.1. The video camera control unit is wiped with a disposable cloth soaked in a disinfectant that does not contain aldehydes, alcohols or other components that fix biological contaminants.
8.3.7.2. After visual inspection for breaks and cracks, the video head, lens and video head cable are pre-cleaned in a neutral detergent solution.
8.3.7.3. The process of pre-sterilization cleaning, combined with disinfection, of endoscopic equipment specified in subclause 8.3.7.2 of these sanitary rules includes the following steps:
— immersion in a washing-disinfecting solution for the duration of disinfection;
- removing dirt from the video head and lens soft brush(cloth);
- rinsing with distilled water.
8.3.7.4. Sterilization of endoscopic equipment specified in subclause 8.3.7.2 of these sanitary rules must be carried out in accordance with the manufacturer's recommendations using steam, gas or plasma methods. Before sterilization, the optics and camera plug are checked for cleanliness, glass surfaces are dried with 70% alcohol, and inspected for damage.
8.3.7.5. Before using disposable sterile covers to increase the safety of the video head and cable during surgery, these medical devices must undergo all processing processes in accordance with the manufacturer's instructions.
8.3.8. Pre-sterilization cleaning, combined with disinfection, of fiberglass (liquid) light guides is carried out manually or mechanized. Before sterilization, glass surfaces are additionally dried with 70% alcohol, and a functional test is carried out. Fiberglass light guides are sterilized using the methods specified in paragraph 7.6 of these sanitary rules. Liquid optical fibers are sterilized using the gas method or in chemical solutions.
8.3.9. Pre-sterilization cleaning, combined with disinfection, of a suction jar and a set of reusable silicone tubes, which are accessories to the suction (flushing pump or pump), after each endoscopic operation is carried out manually or mechanically, sterilization is carried out using the steam method according to the regime recommended by the manufacturer.
Manual processing of silicone tubes must be carried out in accordance with subclause 8.3.10.2 of these sanitary rules.
After disconnecting the pump from the network, wipe it with a cloth soaked in a solution of a disinfectant that does not contain alcohol.
8.3.10. The insufflation device and accessories are processed in the following sequence:
8.3.10.2. The reusable silicone tube set is subjected to:
— pre-cleaning in a detergent solution;
— pre-sterilization cleaning combined with disinfection, manually or mechanized using special devices for unhindered washing of the internal cavities of the tubes with a stream of detergent and disinfectant; with the manual processing method, mechanical cleaning of hollow spaces with brushes is required;
- rinsing with distilled water;
— drying internal cavities with air and external surfaces with cloth;
— inspection and testing for leaks;
- steam sterilization.
8.3.10.3. The arthroscopy tube set is a one-time use and cannot be reprocessed.
8.5. The shelf life of sterilized endoscopes and instruments for them is determined by the chosen sterilization method, the type and expiration date of the packaging material.
IX. Requirements for the technology of processing instruments for endoscopes
9.1. Instruments for endoscopes should be processed separately from endoscopes.
9.2. For pre-cleaning, instruments are immersed in a detergent solution immediately after use. Working parts of instruments for complex endosurgical complexes, including those related to robots, immediately after use are immersed in special tubes with a washing solution before pre-sterilization cleaning and disinfection begins.
9.3. Pre-sterilization cleaning, combined with disinfection, of instruments for endoscopes is carried out manually or mechanized.
9.3.1. Pre-sterilization cleaning, combined with disinfection, is performed mechanically in ultrasonic cleaners (UZO) or in MDM. The use of RCDs for cleaning instruments with glass optical parts is not allowed.
9.3.2. The process of pre-sterilization cleaning combined with disinfection in the manual processing method includes the following steps:
— disinfection exposure in a solution of detergent-disinfectant with complete immersion of the instrument and forced filling of the internal channels;
— cleaning the outer surfaces of the instrument using napkins and brushes; flushing narrow internal channels using special devices (syringe tubes, flushing syringes or washing guns with appropriate nozzles);
— mechanical cleaning of internal channels using brushes and wire cleaners;
— repeated washing of the internal channels with a solution of detergent and disinfectant using special devices;
— rinsing the external surfaces with distilled water and washing the internal channels of the instrument using special devices.
The outer surfaces of the instruments are dried with a cloth, the internal cavities are dried with air using an air gun.
9.4. After pre-sterilization cleaning of instruments for endoscopes, quality control is carried out in accordance with paragraph 10.2 of these sanitary rules, functional tests are carried out in accordance with the manufacturer’s instructions, and moving parts are lubricated.
9.5. When choosing sterilization methods, the recommendations of the instrument manufacturer are taken into account. The process of sterilizing instruments for endoscopes manually must be carried out in the manner established by subclause 8.2.4 of these sanitary rules.
X. Quality control of cleaning, high-level disinfection and sterilization of endoscopes and instruments for endoscopes
10.1. A medical organization must monitor the quality of cleaning, TLD and sterilization of endoscopes and instruments for them.
10.2. To assess the quality of cleaning of endoscopes and instruments, an azopyram or other test regulated for this purpose is administered. To assess the quality of rinsing products from alkaline solutions, a phenolphthalein test is performed.
10.3. When validating the process of final cleaning of endoscopes, MDM uses tests approved for use for these purposes in the Russian Federation.
10.4. Planned bacteriological quality control of the processing of each endoscope for non-sterile manipulations is carried out in accordance with the production control plan on a quarterly basis. The criterion for the effectiveness of TLD is the absence of growth of bacteria from the group of Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, mold and yeast fungi, as well as other opportunistic and pathogenic microorganisms. Under this condition, the indicator of total microbial contamination of the endoscope channels under study should be less than 100 CFU/ml.
10.5. Unscheduled bacteriological studies of endoscope swabs for non-sterile interventions should be carried out if there is a suspicion of a violation of the tightness of the device, after its repair or for epidemic indications.
10.6. When conducting scheduled and unscheduled bacteriological monitoring of the effectiveness of the TLD, sterile distilled water or swabs soaked in sterile distilled water are used to collect swabs. The swabs are taken from the treated and dried endoscope in the HLD area of the washing and disinfection room before work begins. Samples of swabs from the surfaces of the insertion part of the endoscope, valves, valve seats, control unit, and from the biopsy channel are subject to microbiological examination.
10.7. The criterion for the effectiveness of sterilization of endoscopes, video camera heads, light guides, sets of silicone tubes and instruments is the absence of microflora growth in swabs taken from sterilized medical devices under aseptic conditions.
10.8. The quality of self-disinfection of MDM is subject to scheduled (at least 2 times a year) microbiological control. Flushes from various areas of the machine are collected immediately after the completion of the self-disinfection cycle. The criterion for effectiveness is the absence of growth of vegetative forms of microorganisms in the studied swab samples.
XI. The procedure for conducting epidemiological investigations of cases of infectious diseases allegedly associated with endoscopic interventions
11.1. If a case of infectious disease suspected of being associated with an endoscopic procedure occurs, an epidemiological investigation should be carried out.
11.2. When investigating a case of infection caused by pathogenic bacteria:
11.2.1. The following information about the patient is established: date of illness, results of bacteriological examination of clinical material with characteristics of the isolated microorganism strain, serological and other laboratory research methods; date (or dates) of endoscopic intervention within incubation period diseases.
11.2.2. An examination of the units of a medical organization performing endoscopic interventions is carried out, during which the following is assessed: compliance of the actual processing of endoscopes with the requirements of these sanitary rules and work instructions approved by a medical organization; cleaning agents and TLDs used; ensuring control of TLD cycle parameters; quality of pre-sterilization cleaning and sterilization of instruments; knowledge of the personnel who processed endoscopes, their availability of certificates of advanced training in the prevention of infections associated with endoscopic interventions.
11.2.3. The results of planned bacteriological monitoring of the effectiveness of endoscope processing for the year preceding the epidemiological investigation are analyzed.
11.2.4. To establish the suspected source of infection and identify patients who were at the same risk of infection as the victim, the following measures are taken:
- based on the data from the Logbook for monitoring the processing of endoscopes for non-sterile interventions, the logbook for recording studies performed in the department, department, endoscopy room, the logbook for recording surgical interventions in the hospital, a list of patients who were examined (operated on) before and after the injured patient with the same endoscope is compiled, within the period determined by the epidemiologist in accordance with the etiology of the disease;
— the infectious status of patients included in the above list is established according to medical documentation and additional laboratory tests;
— examination and laboratory examination of medical workers directly involved in the endoscopic intervention of the injured patient and in the processing of equipment;
- a direct connection of the victim(s) with the alleged source of infection (if identified) is revealed by proving the identity of bacteria of the same species isolated from clinical material using cultural (species identification with determination of antibiogram), and, if possible, molecular genetic methods laboratory research.
11.2.5. The endoscope, instruments for the endoscope, MDM, and the hands of medical personnel are considered as probable factors of transmission of the infectious agent. To identify the transmission factor of the infectious agent, the following measures are taken:
— assessment of the tightness of the endoscope with which the victim was examined, and extraordinary bacteriological control of the effectiveness of its processing with identification of the type of microorganisms isolated. Isolation from swabs taken from the canals and (or) from the external surfaces of the endoscope of a microorganism identical to the causative agent of an infectious disease in the victim will indicate that this endoscope was a factor in the transmission of infection;
— the type of instrument used is determined according to the endoscopic examination protocol; compliance with processing technology, including sterilization method, is assessed; previous results of routine microbiological control of instruments for sterility are analyzed; unscheduled bacteriological control is carried out;
— the MDM is identified (using a mechanized processing method) in which the endoscope was processed, using the Logbook for monitoring the processing of endoscopes for non-sterile interventions, and a bacteriological study of washes from various areas of the machine and samples of the working solution of the disinfectant (with repeated use) is carried out for secondary contamination. Isolation from the selected samples of a microorganism identical to the causative agent of the infectious disease in the victim will give grounds to consider MDM as a factor in the transmission of infection.
11.3. Investigation of cases of infections caused by opportunistic bacteria (hereinafter referred to as OPB) and associated with diagnostic endoscopic examinations or surgical interventions performed through endoscopic access, is carried out by analogy with infections caused by pathogenic bacteria. Additionally, data on the epidemic situation and the results of microbiological monitoring for the medical organization as a whole are assessed. Infections caused by UPB are subject to registration if they occur within the period from 48 hours to 30 days from the date of endoscopic intervention.
To determine the identity of cultures of bacteria of the same species isolated from clinical material from infected patients, as well as in swabs from suspected infection transmission factors, their cultural properties, antibiograms are compared, and, if possible, molecular genetic research methods are additionally used.
11.4. When conducting an epidemiological investigation of a case of infection of a patient with hepatitis B virus (HBV) or hepatitis C virus (HCV), presumably associated with endoscopic intervention, it is necessary to collect the following data about the patient: date of illness, date of the last preceding illness, blood serum tests for markers viral hepatitis and (or) detection of deoxyribonucleic acid (hereinafter referred to as DNA) and (or) ribonucleic acid (hereinafter referred to as RNA) with a documented negative result; availability of vaccination against hepatitis B (dates of vaccine administration and drug); date(s) of endoscopic intervention within the maximum incubation period.
11.4.1. When considering an endoscope as a possible source of pathogen transmission, the following measures should be taken:
— all aspects of processing endoscopes are studied in accordance with subclause 11.2.2 and subclause 11.2.3 of these sanitary rules;
— a map of endoscopic interventions is compiled (the order of various types of interventions performed) and using the Logbook for monitoring the processing of endoscopes for non-sterile interventions, a logbook for recording studies performed in a department, unit, endoscopy room or a logbook for recording surgical interventions in a hospital, patients are identified who, within a 3-month period, (for HBV) or 2 weeks (for HCV) before the date of endoscopic intervention, the infected patient was examined (operated on) with the same endoscope;
— medical documentation of identified patients is studied to obtain data on the presence (absence) of hepatitis B (C) before hospitalization in a medical organization; persons who do not have such information are additional research for HBV (HCV) markers, if necessary, detection of DNA (RNA) and genotype of the virus.
A patient whose hepatitis virus of the same genotype as the victim was identified before the date of endoscopic examination can be considered as the suspected source of infection. To prove its direct connection with the victim, it is necessary to conduct molecular genetic studies of the viruses to determine their identity.
Patients who have not detected markers of viral hepatitis within the above period (seronegative patients) are considered as persons at risk of infection along with the victim. Detection of HBV (HCV) markers within the maximum incubation period after endoscopic examination is the basis for conducting an in-depth clinical and laboratory examination using molecular genetic methods for virus verification to confirm (exclude) a connection with the source of infection and the infected patient.
11.4.2. If the endoscopic examination was carried out using sedatives, the name of the drugs and their packaging (single-dose, multi-dose) is determined. When using one bottle of the drug for the sick person and other patients (regardless of the type of endoscopic examination performed), their blood is examined for markers of HBV (HCV), and in seropositive individuals, DNA (RNA) viruses are isolated. To prove the connection between patients infected with a virus of the same genotype, molecular genetic research methods are additionally used.
XII. Requirements for the health of medical personnel of structural units of a medical organization performing endoscopic interventions
12.1. Medical workers in structural units of a medical organization performing endoscopic interventions must undergo preliminary (upon entry to work) and periodic medical examinations.
12.2. Medical personnel of structural units of a medical organization performing endoscopic interventions must be vaccinated against infectious diseases in accordance with national calendar preventive vaccinations.
12.3. Before being allowed to work related to performing endoscopic interventions or processing endoscopic equipment, medical workers are required to undergo special primary training on the rules for processing endoscopes and workplace health instruction.
12.4. Medical workers of structural units performing endoscopic interventions must be provided with medical clothing (robes, pajamas, caps) in accordance with the equipment sheet (at least three sets per worker) and equipment personal protection(waterproof aprons, sleeves, goggles or shields, masks or respirators, disposable gloves) in sufficient quantities. The head of the medical organization is responsible for providing medical workers with medical clothing and personal protective equipment.
12.5. A change of medical clothing (gown or pajamas, cap) of the staff of the department (office) inside the lumen endoscopy should be carried out as it gets dirty, but at least 2 times a week; personnel of surgical (endoscopic) departments (offices) performing surgical endoscopic interventions - as necessary, but at least once a day.
12.6. Before carrying out each non-sterile endoscopic intervention, the personnel involved in it carry out hand hygiene in accordance with the requirements of SanPiN 2.1.3.2630-10 “Sanitary and epidemiological requirements for organizations engaged in medical activities” (approved by the resolution of the Chief State Sanitary Doctor of the Russian Federation dated May 18. 2010 N 58, registered with the Ministry of Justice of Russia on 08/09/2010, registration number 18094) and puts on personal protective equipment (disposable mask, goggles, disposable medical gloves, waterproof gown or disposable apron).
12.7. Before carrying out each sterile endoscopic intervention, the personnel involved in it disinfect their hands according to the method of treating the hands of surgeons in accordance with the requirements of SanPiN 2.1.3.2630-10 “Sanitary and epidemiological requirements for organizations engaged in medical activities”, put on a cap, mask, sterile gown and gloves.
12.8. Personnel cleaning endoscopes must wear personal protective equipment, including: disposable gloves made of chemically resistant material; safety glasses, mask or face shield; a robe or cape (with long sleeves, waterproof) or a disposable waterproof apron with sleeves (oversleeves).
12.9. To prevent the formation and spraying of microbial aerosols when processing endoscopes and canal instruments, manual cleaning procedures are carried out with the products completely immersed in the solution, including when using washing guns, the liquid pressure in which is set at a minimum sufficient level. Drying of endoscope channels for non-sterile interventions after final cleaning is carried out by aspiration of air or blowing with air after covering the exit points of the channels with napkins.
12.10. To reduce the risk of infection of personnel and ensure the reliability of processing flexible endoscopes for non-sterile interventions, a mechanized method using MDM is used. With a large turnover of endoscopes (simultaneous processing of three or more endoscopes of the same type), a mechanized method of processing endoscopes is mandatory.
12.11. To prevent injuries from instruments to endoscopes with piercing surfaces, it is necessary to minimize personnel contact with untreated instruments using containers with perforated inserts, MDMs and ultrasonic cleaners.
It is prohibited to use injection needles to collect pathological material from biopsy forceps.
12.12. Cases of injury to medical personnel at all stages of preparation for sterilization of instruments for endoscopes with piercing-cutting surfaces must be recorded in the “Register of Injuries and Emergency Situations.”
12.13. Medical personnel in the presence of wounds on the hands, exudative skin lesions or weeping dermatitis for the duration of the disease are excluded from performing endoscopic manipulations, processing endoscopes and contact with them.
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Russian Federation
ORDER of the Ministry of Health and Medical Industry of the Russian Federation dated May 31, 1996 N 222 (as amended on June 16, 1997) “ON IMPROVEMENT OF ENDOSCOPY SERVICE IN HEALTH CARE INSTITUTIONS OF THE RUSSIAN FEDERATION”
(as amended by Order of the Ministry of Health of the Russian Federation dated June 16, 1997 N 184)
The development of endoscopic technology in recent decades, based on the use of fiber optics, has significantly expanded the use of minimally invasive instrumental research methods in medical practice.
Currently, endoscopy has become quite widespread both in the diagnosis and treatment of various diseases. A new direction has appeared in medical practice - surgical endoscopy, which makes it possible to achieve a pronounced economic effect while maintaining the therapeutic result by significantly reducing the length of hospitalization and the cost of treating patients.
The advantages of endoscopic methods ensure the rapid development of this service in the Russian Federation.
Over the past 5 years, the number of endoscopy departments and rooms in medical institutions has increased 1.7 times, and their equipment with endoscopic equipment has increased 2.5 times.
From 1991 to 1995, the number of endoscopists increased 1.4 times; 35% of specialists have qualification categories (1991 - 20%).
The scope of performed research and treatment procedures is constantly expanding. Compared to 1991, their number increased by 1.5 and 2 times, respectively. In 1995, 142.7 thousand operations were performed using endoscopic technology.
In a number of areas of the country, a 24-hour emergency endoscopic care service has been created, which can significantly improve performance in emergency surgery, traumatology and gynecology. Computer programs have been developed and are being actively implemented to evaluate the results of endoscopic studies.
At the same time, there are serious shortcomings and unresolved problems in organizing the activities of the endoscopy service.
Only 38.5 percent of hospitals in rural areas, 21.7 percent of dispensaries (including 8 percent for tuberculosis), and 3.6 percent of outpatient clinics have endoscopy units.
Only 17 percent of the total number of endoscopy specialists work in health care facilities located in rural areas.
In the staffing structure of endoscopists, there is a high proportion of part-time doctors from other specialties.
The capabilities of endoscopy are underutilized due to the unclear organization of work of existing departments, the slow introduction into practice of new forms of management and labor organization of medical personnel, the scattering of specialists involved in endoscopy among other specialized services, and the lack of highly effective endoscopic diagnostic and treatment programs and algorithms.
In some cases, expensive endoscopic equipment is used extremely irrationally due to poor training of specialists, especially in surgical endoscopy, and lack of proper continuity in work with doctors of other specialties. The load on one endoscope with fiber optics is 2 times lower than the standard.
Certain difficulties in organizing the service are due to the lack of the necessary regulatory framework, recommendations for optimizing the structure and staffing, and the range of studies in endoscopy units of various capacities.
The quality of endoscopic equipment produced by domestic enterprises does not fully meet modern technical requirements.
In order to improve the organization of the endoscopy service and increase the efficiency of its work, the rapid introduction of new diagnostic and treatment methods, including surgical endoscopy, as well as improving personnel training and technical equipment of departments with modern endoscopic equipment, I affirm:
1. Regulations on the chief freelance specialist in endoscopy of the Ministry of Health and Medical Industry of the Russian Federation and health authorities of the constituent entities of the Russian Federation (Appendix 1).
2. Regulations on the department, department, endoscopy room (Appendix 2).
3. Regulations on the head of the department, department, endoscopy room (Appendix 3).
4. Regulations on the doctor - endoscopist of the department, department, endoscopy room (Appendix 4).
5. Regulations on the head nurse of the department, endoscopy department (Appendix 5).
6. Regulations on the nurse of the department, department, endoscopy room (Appendix 6).
7. Estimated time standards for endoscopic examinations, therapeutic and diagnostic procedures, operations (Appendix 7).
8. Instructions for the use of estimated time standards for endoscopic examinations (Appendix 8).
9. Instructions for the development of estimated time standards for the introduction of new equipment or new types of research and treatment (Appendix 9).
10. Qualification characteristics of the endoscopist (Appendix 10).
12. Methodology for calculating prices for endoscopic examinations (Appendix 12).
13. Journal of registration of studies performed in the department, department, endoscopy room - form N 157/u-96 (Appendix 13).
14. Instructions for filling out the Register of studies performed in the department, unit, endoscopy room - form N 157/u-96 (Appendix 14).
15. Addition to the list of forms of primary medical documentation (Appendix 15).
I order:
1. To the Ministers of Health of the republics within the Russian Federation, heads of health authorities and institutions of territories, regions, autonomous entities, the cities of Moscow and St. Petersburg:
1.1. During 1996, develop and implement the necessary measures to form a unified endoscopy service in the territory, including diagnostic, therapeutic and surgical endoscopy, taking into account the profile of medical institutions and local conditions.
1.2. When planning a network of endoscopy units, pay special attention to their organization in primary care institutions, including rural healthcare.
1.3. Appoint the main freelance endoscopy specialists and organize work in accordance with the Regulations approved by this Order.
1.4. Involve departments of research institutes, educational universities and postgraduate educational institutions in organizational, methodological and advisory work on endoscopy.
1.5. Organize the work of departments, departments, endoscopy rooms in accordance with this Order.
1.6. Establish the number of personnel in departments, departments and endoscopy rooms in accordance with the volume of work based on the estimated time standards for endoscopic examinations.
1.7. Take the necessary measures to maximize the use of endoscopic equipment with fiber optics, ensuring the load on the device is at least 700 studies per year.
1.8. Provide regular training to medical doctors on current issues of endoscopy.
2. The Department of Organization of Medical Care to the Population (A.A. Karpeev) to provide organizational and methodological assistance to health authorities on the organization and functioning of endoscopy services in the territories of the Russian Federation.
3. The Department of Educational Institutions (Volodin N.N.) to supplement the training programs for training specialists in endoscopy in educational institutions of postgraduate training, taking into account the introduction into practice of modern equipment and new research methods.
4. The Department of Scientific Institutions (Nifantiev O.E.) to continue work on creating a new endoscopic
ORDER of May 31, 1996 N 222 ON IMPROVING ENDOSCOPY SERVICES IN HEALTH CARE INSTITUTIONS OF THE RUSSIAN FEDERATION
The development of endoscopic technology in recent decades, based on the use of fiber optics, has significantly expanded the use of minimally invasive instrumental research methods in medical practice. Currently, endoscopy has become quite widespread both in the diagnosis and treatment of various diseases. A new direction has appeared in medical practice - surgical endoscopy, which makes it possible to achieve a pronounced economic effect while maintaining the therapeutic result by significantly reducing the length of hospitalization and the cost of treating patients.
The advantages of endoscopic methods ensure the rapid development of this service in the Russian Federation. Over the past 5 years, the number of endoscopy departments and rooms in medical institutions has increased by 1.7 times, and their equipment with endoscopic equipment has increased by 2.5 times. From 1991 to 1995, the number of endoscopists increased 1.4 times; 35% of specialists have qualification categories (1991 - 20%). The scope of performed research and treatment procedures is constantly expanding. Compared to 1991, their number increased by 1.5 and 2 times, respectively. In 1995, 142.7 thousand operations were performed using endoscopic technology. In a number of areas of the country, a 24-hour emergency endoscopic care service has been created, which can significantly improve performance in emergency surgery, traumatology and gynecology. Computer programs have been developed and are being actively implemented to evaluate the results of endoscopic studies.
At the same time, there are serious shortcomings and unresolved problems in organizing the activities of the endoscopy service. Only 38.5 percent of hospitals in rural areas, 21.7 percent of dispensaries (including 8 percent for tuberculosis), and 3.6 percent of outpatient clinics have endoscopy units. Only 17 percent of the total number of endoscopy specialists work in health care facilities located in rural areas. In the staffing structure of endoscopists, there is a high proportion of part-time doctors from other specialties. The capabilities of endoscopy are underutilized due to the unclear organization of work of existing departments, the slow introduction into practice of new forms of management and organization of work of medical personnel, the scattering of specialists involved in endoscopy among other specialized services, and the lack of highly effective endoscopic diagnostic and treatment programs and algorithms. In some cases, expensive endoscopic equipment is used extremely irrationally due to poor training of specialists, especially in surgical endoscopy, and lack of proper continuity in work with doctors of other specialties. The load on one endoscope with fiber optics is 2 times lower than the standard. Certain difficulties in organizing the service are due to the lack of the necessary regulatory framework, recommendations for optimizing the structure and staffing, and the range of studies in endoscopy units of various capacities. The quality of endoscopic equipment produced by domestic enterprises does not fully meet modern technical requirements
1. Regulations on the chief freelance specialist in endoscopy of the Ministry of Health and Medical Industry of the Russian Federation and health authorities of the constituent entities of the Russian Federation (Appendix 1).
2. Regulations on the department, department, endoscopy room (Appendix 2).
4. Regulations on the doctor - endoscopist of the department, department, endoscopy room (Appendix 4).
5. Regulations on the head nurse of the department, endoscopy department (Appendix 5).
6. Regulations on the nurse of the department, department, endoscopy room (Appendix 6).
13. Journal of registration of studies performed in the department, department, endoscopy room - form N 157/u-96 (Appendix 13).
1.1. During 1996, develop and implement the necessary measures to form a unified endoscopy service in the territory, including diagnostic, therapeutic and surgical endoscopy, taking into account the profile of medical institutions and local conditions.
1.7. Take the necessary measures to maximize the use of endoscopic equipment with fiber optics, ensuring the load on the device is at least 700 studies per year.
2. The Department of Organization of Medical Care to the Population (A.A. Karpeev) to provide organizational and methodological assistance to health authorities on the organization and functioning of endoscopy services in the territories of the Russian Federation.
5. Rectors of institutes for advanced training of doctors must ensure in full the applications of health care institutions for the training of endoscopists in accordance with the approved standard programs.
6. Consider as invalid for institutions of the Russian Ministry of Health and Medical Industry Order of the USSR Ministry of Health N 1164 of December 10, 1976 “On the organization of endoscopy departments (rooms) in medical institutions”, appendices N 8, 9 to Order of the USSR Ministry of Health N 590 of April 25, 1986 “On measures to further improve the prevention, early diagnosis and treatment of malignant neoplasms” and Order of the USSR Ministry of Health N 134 of February 23, 1988 “On approval of estimated time standards for endoscopic examinations and therapeutic and diagnostic procedures.”
Minister of Health and Medical Industry of the Russian Federation A.D. TSAREGORODTSEV
www.endoscopy.ru
Order 222 from 29021984
MINISTRY OF HEALTH AND MEDICAL INDUSTRY OF THE RUSSIAN FEDERATION
ORDER of May 31, 1996 N 222
ON IMPROVING ENDOSCOPY SERVICE IN HEALTH CARE INSTITUTIONS OF THE RUSSIAN FEDERATION
INSTRUCTIONS FOR DEVELOPING ESTIMATED TIME STANDARDS FOR IMPLEMENTING NEW EQUIPMENT OR NEW TYPES OF RESEARCH AND TREATMENT
When introducing new diagnostic methods and technical means for their implementation, which are based on different research methodology and technology, new labor content of medical personnel, and the absence of estimated time standards approved by the Ministry of Health and Medical Industry of Russia, they can be developed on the spot and agreed upon with the trade union committee in those institutions where they are being introduced new techniques. The development of new calculation standards includes taking time measurements of the actual time spent on individual elements of labor, processing this data (according to the methodology outlined below), and calculating the time spent on the study as a whole. Before timing, a list of technological operations (main and additional) for each method is compiled. For these purposes, it is recommended to use the methodology applied in compiling a universal list of labor elements for technological operations. In this case, it is possible to use the “List” itself. “, adapting each technological operation to the technology of a specific new diagnostic or treatment method.
Timing is carried out using sheets of timing measurements, which consistently set out the names of technological operations and the time of their implementation. Processing the results of timing measurements includes calculating the average time spent, determining the actual and expert repeatability coefficient for each technological operation and the estimated time to complete the study under study.
UNIVERSAL LIST OF LABOR ELEMENTS FOR TECHNOLOGICAL OPERATIONS, RECOMMENDED WHEN DEVELOPING ESTIMATED TIME STANDARDS
1. Conversation with the patient
2. Study of medical documentation
3. Preparation for the study
4. Hand washing
5. Consultation with your doctor
6. Conducting research
7. Advice and recommendations for the patient
8. Consultation with the manager. department
9. Processing of the apparatus and instruments
10. Registration of honey. documentation
11. Registration of biopsy material
12. Entry in the log book
The average time spent on an individual technological operation is determined as the arithmetic average of all measurements. The actual repeatability factor of technological operations in each study is calculated using the formula:
where K is the actual repeatability coefficient of the technological operation; P is the number of timed studies using a specific research method in which this technological operation took place; N is the total number of the same timed studies. The expert coefficient of repeatability of a technological operation is determined by the most qualified doctor- an endoscopist who is proficient in this technique, based on the existing experience in using the method and a professional understanding of the proper repeatability of the technological operation. The estimated time for each technological operation is determined by multiplying the average actual time spent on this operation by timing, by the expert coefficient of its repeatability. The estimated time to complete the study as a whole is determined separately for the doctor and the nurse as the sum of the estimated time to complete all technological operations for this method. After approval by the order of the head of the medical institution, it is the estimated time limit for performing this type of research in this institution. To ensure the reliability of local time standards and their correspondence to the true time spent, not dependent on random causes, the number of studies subject to time measurements should be as large as possible, but not less than 20 - 25.
It is possible to develop local time standards only when the personnel of the department, department, office have mastered the methods well enough, when they have developed a certain automatism and professional stereotypes in performing diagnostic and therapeutic manipulations. Before this, research is carried out in the order of mastering new methods, within the time spent on other types of activities.
QUALIFICATIONS OF AN ENDOSCOPIST DOCTOR
The level of an endoscopist is determined taking into account the volume and quality of the work performed, the availability of theoretical training in the field of basic and related specialties, and the regularity of training in specialized educational institutions that have a special certificate. The assessment of the practical training of an endoscopist is carried out under the guidance of the endoscopic unit and the institution at the specialist’s place of work. The general opinion is reflected in the performance characteristics from the place of work. Theoretical knowledge and compliance of practical skills with the current level of development of endoscopy are assessed during certification cycles conducted by endoscopy departments.
In accordance with the requirements of the specialty, the endoscopist must know, be able to, and master:
prospects for the development of endoscopy;
fundamentals of healthcare legislation and policy documents defining the activities of healthcare authorities and institutions in the field of endoscopy;
general issues of organizing planned and emergency endoscopic care in the country for adults and children, ways to improve endoscopic services;
organization of medical care in military field conditions during mass casualties and disasters;
etiology and ways of spreading highly infectious diseases and their prevention;
work of an endoscopist in the conditions of insurance medicine;
topographic anatomy of the bronchopulmonary apparatus, digestive tract, abdominal and pelvic organs, anatomical and physiological characteristics childhood;
reasons for occurrence pathological processes, which the endoscopist usually encounters;
diagnostic and therapeutic capabilities of various endoscopic methods;
indications and contraindications for diagnostic, therapeutic and surgical esophagogastroduodenoscopy, colonoscopy, laparoscopy, bronchoscopy;
methods of processing, disinfection and sterilization of endoscopes and instruments;
principles, techniques and methods of pain relief in endoscopy;
clinical symptoms of major surgical and therapeutic diseases;
principles of examination and preparation of patients for endoscopic methods research and management of patients after research;
equipment for endoscopy rooms and operating rooms, safety precautions when working with equipment;
design and principle of operation of endoscopic equipment and auxiliary instruments used in various endoscopic studies.
collect anamnesis and compare the information obtained with the data of the available medical documentation for the patient in order to select the desired type of endoscopic examination;
independently carry out simple examination methods: digital examination of the rectum during bleeding, palpation of the abdomen, percussion and auscultation of the abdomen and lungs;
identify the patient’s allergic predisposition to anesthetics in order to correctly determine the type of anesthesia under which endoscopic examination will be performed;
determine indications and contraindications for performing a particular endoscopic examination; — teach the patient how to behave correctly during an endoscopic examination;
choose the optimal type and type of endoscope (rigid, flexible, with end, end-side or just side optics) depending on the nature of the planned endoscopy;
master the methods of local infiltration anesthesia, local anesthesia pharyngeal ring and tracheobronchial tree;
knowledge of biopsy methods and the ability to perform them is required;
knowledge of medical documentation and research protocols;
ability to compile a report on the work done and analyze endoscopic activities.
3. Special knowledge and skills:
A specialist endoscopist must know prevention, clinical presentation and treatment, be able to diagnose and provide necessary help under the following conditions:
intraorgan or intra-abdominal bleeding that occurred during an endoscopic examination;
perforation of a hollow organ;
acute cardiac and respiratory failure;
arrest of breathing and cardiac activity.
A specialist endoscopist must know:
clinic, diagnosis, prevention and principles of treatment of major lung diseases (acute and chronic bronchitis, bronchial asthma, acute and chronic pneumonia, lung cancer, benign tumors lungs, disseminated lung diseases);
clinic, diagnosis, prevention and treatment of major diseases of the gastrointestinal tract (esophagitis, gastritis, ulcerative lesions of the stomach and duodenum, cancer and benign tumors of the stomach, duodenum and colon, diseases of the operated stomach, chronic colitis, hepatitis and liver cirrhosis, pancreatitis and cholecystitis, tumors of the hepato-pancreatoduodenal zone, acute appendicitis);
master the technique of esophagogastroduodenoscopy, colonoscopy, bronchoscopy, laparoscopy, using all techniques for a detailed examination of the mucous membrane of the esophagus, stomach, duodenum during esophagogastroduodenoscopy, all parts of the colon and terminal section ileum- during colonoscopy;
tracheobronchial tree, up to the bronchi of the 5th order - during bronchoscopy, serous integument, as well as the abdominal organs of the abdominal cavity - during laparoscopy;
visually clearly determine the anatomical boundaries of physiological narrowings and sections of the organs being studied;
correctly assess the responses of the sphincter apparatus of the organs being studied in response to the introduction of an endoscope and air;
under conditions of artificial lighting and some magnification, correctly distinguish macroscopic signs normal structure mucous, serous and parenchymal organs from pathological manifestations in them;
perform targeted biopsy from pathological foci of the mucous membranes of the serous integument and abdominal organs;
orient and fix the biopsy material for histological examination;
correctly make smears - prints for cytological examination;
remove and take ascitic fluid, effusion from the abdominal cavity for cytological examination and culture;
based on the identified microscopic signs of changes in the mucous, serous covers or tissues of parenchymal organs, determine the nosological form of the disease;
clinic, diagnosis, prevention and treatment of major diseases of the pelvic organs (benign and malignant tumors uterus and appendages, inflammatory diseases appendages, ectopic pregnancy).
4. Research and manipulation:
bronchofibroscopy and rigid bronchoscopy;
targeted biopsy from mucous membranes, serous tissues and abdominal organs;
removal of foreign bodies from the tracheobronchial tree, upper gastrointestinal tract and colon during endoscopic examination;
local hemostasis during esophagogastroduodenoscopy;
endoscopic removal of benign tumors from the esophagus and stomach; - expansion and dissection of scar and postoperative narrowing of the esophagus;
papillosphincterotomy and virsungotomy and removal of stones from the ducts;
installation of a feeding tube;
drainage of the abdominal cavity, gall bladder, retroperitoneal space;
removal of pelvic organs during laparoscopy according to indications;
removal of abdominal organs during laparoscopy according to indications;
removal of retroperitoneal organs under endoscopic control according to indications.
Depending on the level of knowledge, as well as on the basis of work experience, quantity, quality and type of work performed diagnostic studies, medical interventions, the certification commission decides on assigning the appropriate qualification category to the endoscopist.
Head of the Department of Organization of Medical Care to the Population
A.A.KARPEEV
www.laparoscopy.ru
Legislative framework of the Russian Federation
Free consultation
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ORDER of the Ministry of Health and Medical Industry of the Russian Federation dated May 31, 1996 N 222 “ON IMPROVING ENDOSCOPY SERVICE IN HEALTHCARE INSTITUTIONS OF THE RUSSIAN FEDERATION”
The development of endoscopic technology in recent decades, based on the use of fiber optics, has significantly expanded the use of minimally invasive instrumental research methods in medical practice.
Currently, endoscopy has become quite widespread both in the diagnosis and treatment of various diseases. A new direction has appeared in medical practice - surgical endoscopy, which makes it possible to achieve a pronounced economic effect while maintaining the therapeutic result by significantly reducing the length of hospitalization and the cost of treating patients.
The advantages of endoscopic methods ensure the rapid development of this service in the Russian Federation.
Over the past 5 years, the number of endoscopy departments and rooms in medical institutions has increased by 1.7 times, and their equipment with endoscopic equipment has increased by 2.5 times.
From 1991 to 1995, the number of endoscopists increased 1.4 times; 35% of specialists have qualification categories (1991 - 20%).
The scope of performed research and treatment procedures is constantly expanding. Compared to 1991, their number increased by 1.5 and 2 times, respectively. In 1995, 142.7 thousand operations were performed using endoscopic technology.
In a number of areas of the country, a 24-hour emergency endoscopic care service has been created, which can significantly improve performance in emergency surgery, traumatology and gynecology. Computer programs have been developed and are being actively implemented to evaluate the results of endoscopic studies.
At the same time, there are serious shortcomings and unresolved problems in organizing the activities of the endoscopy service.
Only 38.5 percent of hospitals in rural areas, 21.7 percent of dispensaries (including 8 percent for tuberculosis), and 3.6 percent of outpatient clinics have endoscopy units.
Only 17 percent of the total number of endoscopy specialists work in health care facilities located in rural areas.
In the staffing structure of endoscopists, there is a high proportion of part-time doctors from other specialties.
The capabilities of endoscopy are underutilized due to the unclear organization of work of existing departments, the slow introduction into practice of new forms of management and labor organization of medical personnel, the scattering of specialists involved in endoscopy among other specialized services, and the lack of highly effective endoscopic diagnostic and treatment programs and algorithms.
In some cases, expensive endoscopic equipment is used extremely irrationally due to poor training of specialists, especially in surgical endoscopy, and lack of proper continuity in work with doctors of other specialties. The load on one endoscope with fiber optics is 2 times lower than the standard.
Certain difficulties in organizing the service are due to the lack of the necessary regulatory framework, recommendations for optimizing the structure and staffing, and the range of studies in endoscopy units of various capacities.
The quality of endoscopic equipment produced by domestic enterprises does not fully meet modern technical requirements.
In order to improve the organization of the endoscopy service and increase the efficiency of its work, the rapid introduction of new diagnostic and treatment methods, including surgical endoscopy, as well as improving personnel training and technical equipment of departments with modern endoscopic equipment, I affirm:
3. Regulations on the head of the department, department, endoscopy room (Appendix 3).
7. Estimated time standards for endoscopic examinations, therapeutic and diagnostic procedures, operations (Appendix 7).
8. Instructions for the use of estimated time standards for endoscopic examinations (Appendix 8).
9. Instructions for the development of estimated time standards for the introduction of new equipment or new types of research and treatment (Appendix 9).
10. Qualification characteristics of the endoscopist (Appendix 10).
12. Methodology for calculating prices for endoscopic examinations (Appendix 12).
14. Instructions for filling out the Register of studies performed in the department, unit, endoscopy room - form N 157/u-96 (Appendix 14).
15. Addition to the list of forms of primary medical documentation (Appendix 15).
1. To the Ministers of Health of the republics within the Russian Federation, heads of health authorities and institutions of territories, regions, autonomous entities, the cities of Moscow and St. Petersburg:
1.2. When planning a network of endoscopy units, pay special attention to their organization in primary care institutions, including rural healthcare.
1.3. Appoint the main freelance endoscopy specialists and organize work in accordance with the Regulations approved by this Order.
1.4. Involve departments of scientific research institutes, educational universities and postgraduate educational institutions in organizational, methodological and advisory work on endoscopy.
1.5. Organize the work of departments, departments, endoscopy rooms in accordance with this Order.
1.6. Establish the number of personnel in departments, departments and endoscopy rooms in accordance with the volume of work based on the estimated time standards for endoscopic examinations.
1.8. Provide regular training to medical doctors on current issues of endoscopy.
3. The Department of Educational Institutions (Volodin N.N.) to supplement the training programs for training specialists in endoscopy in educational institutions of postgraduate training, taking into account the introduction into practice of modern equipment and new research methods.
4. The Department of Scientific Institutions (Nifantev O.E.) to continue work on creating new endoscopic equipment that meets modern technical requirements.
7. Entrust control over the execution of the Order to Deputy Minister A.N. Demenkov.
Minister of Health and
medical industry
Russian Federation
A.D.TSAREGORODTSEV
Annex 1
dated May 31, 1996 N 222
1. General Provisions
1.1. The chief freelance specialist in endoscopy is appointed an endoscopist with the highest or first qualification category or academic degree and has organizational skills.
1.2. The chief freelance specialist organizes his work on the basis of a contract with the healthcare authority.
1.3. The chief freelance specialist works according to a plan approved by the leadership of the relevant healthcare authority and reports annually on its implementation.
1.4. The chief freelance specialist reports to the leadership of the relevant healthcare authority.
1.5. The chief freelance endoscopy specialist in his work is guided by these Regulations, orders and instructions of the relevant health authorities, and current legislation.
1.6. The appointment and dismissal of the chief freelance specialist is carried out in accordance with the established procedure and in accordance with the terms of the contract.
2. The main tasks of the chief freelance endoscopy specialist are to develop and carry out activities aimed at improving the organization and increasing the efficiency of diagnostic, therapeutic and surgical endoscopy in outpatient and inpatient settings, introducing new research and treatment methods into the practice of medical institutions, organizational forms and working methods, diagnostic and treatment algorithms, rational and effective use of material and human resources in healthcare.
3. The chief freelance specialist, in accordance with the tasks assigned to him, is obliged to:
3.1. Participate in the development of comprehensive plans for the development and improvement of the supervised service.
3.2. Analyze the state and quality of services in the territory, make the necessary decisions to provide practical assistance.
3.3. Take part in the preparation of regulatory and administrative documents, proposals to higher health authorities and other authorities for the development and improvement of the supervised service, as well as in the preparation and implementation of scientific and practical conferences, seminars, symposia, classes in schools of excellence.
3.4. Ensure close interaction with other diagnostic services and clinical departments in order to expand capabilities and improve the level of treatment and diagnostic process.
3.5. To promote the introduction into the work of medical institutions of the achievements of science and practice in the field of diagnosis and treatment, effective organizational forms and methods of work, best practices, and scientific organization of work.
3.6. Determine the need for modern equipment and consumables, take part in the distribution of local budget funds allocated for the purchase of medical equipment and equipment.
3.7. Take part in the expert assessment of proposals for the production of medical equipment and instruments coming from enterprises and organizations with various forms property.
3.8. Participate in the certification of doctors and paramedical workers involved in endoscopy, in the certification of the activities of medical personnel, in the development of medical and economic standards and price tariffs.
3.9. Participate in the development of long-term plans to improve the qualifications of doctors and nursing staff involved in endoscopy.
3.10. Interact with the specialized association of specialists on current issues of improving the service.
4. The chief freelance specialist has the right:
4.1. Request and receive all the necessary information to study the work of medical institutions in the specialty.
4.2. Coordinate the activities of chief endoscopy specialists of subordinate health care authorities.
5. The chief freelance specialist, in order to improve the quality of medical care to the population in his specialty, in the prescribed manner organizes meetings of specialists from subordinate bodies and healthcare institutions with the involvement of the scientific and medical community to discuss scientific, organizational and methodological issues.
Head of Department
medical organization
assistance to the population
A.A.KARPEEV
Appendix 2
to the Order of the Ministry of Health and Medical Industry of the Russian Federation
dated May 31, 1996 N 222
1. The department, department, endoscopy room is a structural unit of a medical institution.
2. The management of the department, department, endoscopy room is carried out by the head, appointed and dismissed in the prescribed manner by the head of the healthcare institution.
3. The activities of the department, department, endoscopy room are regulated by relevant regulatory documents and these Regulations.
4. The main tasks of the department, department, endoscopy room are:
— the most complete satisfaction of the population’s needs for all main types of therapeutic and diagnostic endoscopy, provided for by specialization and the list of methods and techniques recommended for medical institutions at various levels;
— use in practice of new, modern, most informative methods of diagnosis and treatment, rational expansion of the list of research methods;
— rational and effective use of expensive medical equipment.
5. In accordance with the specified tasks, the department, department, endoscopy room carries out:
— development and implementation in the practice of their work of methods of therapeutic and diagnostic endoscopy corresponding to the profile and level of the medical institution, new devices and devices, progressive research technology;
— carrying out endoscopic examinations and issuing medical reports based on their results.
6. The department, department, endoscopy room is located in specially equipped premises that fully meet the requirements of the rules for design, operation and safety.
7. The equipment of the department, department, endoscopy room is carried out in accordance with the level and profile of the medical institution.
8. The staffing of medical and technical personnel is established in accordance with the recommended staffing standards, the volume of work being performed or planned and, depending on local conditions, based on the estimated time standards for endoscopic examinations.
9. The workload of specialists is determined by the tasks of the department, department, endoscopy room, regulations on their functional responsibilities, as well as estimated time standards for conducting various studies.
10. In the department, department, endoscopy room, all necessary accounting and reporting documentation is maintained in accordance with approved forms and an archive of medical documents in compliance with the storage periods established by regulatory documents.
Appendix 3
to the Order of the Ministry of Health and Medical Industry of the Russian Federation
dated May 31, 1996 N 222
In the following text - “head of department”.
1. A qualified endoscopist with at least 3 years of experience in the specialty and organizational skills is appointed to the position of head of the department.
2. The appointment and dismissal of the head of the department is carried out by the chief physician of the medical institution in the prescribed manner.
3. The head of the department reports directly to the chief physician of the institution or his deputy for medical issues.
4. In his work, the head of the department is guided by the regulations on the medical institution, department, department, endoscopy room, these Regulations, job descriptions, orders and other applicable regulatory documents.
5. In accordance with the tasks of the department, department, endoscopy room, the head carries out:
— organization of the unit’s activities, management and control over the work of its personnel;
— advisory assistance doctors - endoscopists;
— analysis of complex cases and diagnostic errors;
— development and implementation of new modern endoscopy methods and technical means;
— measures for coordination and continuity of work between departments of a medical institution;
— assistance in systematic improvement of personnel qualifications;
— control over the maintenance of medical records and archives;
— registration and submission in the prescribed manner of applications for the purchase of new equipment and consumables;
— development of measures to ensure the accuracy and reliability of the research carried out, providing for timely and competent maintenance of medical equipment products and regular metrological control of measuring instruments used in the department;
— systematic analysis of qualitative and quantitative performance indicators, preparation and submission of work reports in a timely manner and the development, on their basis, of measures to improve the activities of the unit.
6. The head of the department is obliged to:
— ensure accurate and timely performance by staff of official duties and internal regulations;
— promptly communicate to employees orders and directives from the administration, as well as instructional, methodological and other documents;
— monitor compliance with labor protection and fire safety rules;
- improve your qualifications in the prescribed manner.
7. The head of the department has the right:
— take direct part in the selection of personnel for the department;
— carry out personnel placement in the department and distribute responsibilities between employees;
— give orders and instructions to employees in accordance with the level of their competence, qualifications and the nature of the functions assigned to them;
— participate in meetings and conferences where issues related to the work of the unit are discussed;
- represent employees subordinate to him for incentives or penalties;
— make proposals to the administration of the institution on issues of improving the work of the unit, conditions and remuneration.
8. The manager’s orders are binding on all department personnel.
9. The head of a department, department, or endoscopy room bears full responsibility for the level of organization and quality of work of the department.
Appendix 4
to the Order of the Ministry of Health and Medical Industry of the Russian Federation
dated May 31, 1996 N 222
In the following text - “doctor - endoscopist”.
1. A specialist with a higher medical education who has received the specialty “general medicine” or “pediatrics” and has completed the training program in endoscopy in accordance with qualification requirements and received a specialist certificate.
2. The training of an endoscopist is carried out on the basis of institutes and faculties for advanced training of doctors from among specialists in general medicine and pediatrics.
3. In his work, the endoscopist doctor is guided by the regulations on the medical institution, department, department, endoscopy room, these Regulations, job descriptions, orders and other current regulatory documents.
4. The endoscopist is directly subordinate to the head of the department, and in his absence, to the head of the medical institution.
5. The orders of the endoscopist are mandatory for middle and junior medical personnel of the endoscopy department.
6. In accordance with the tasks of the department, department, endoscopy room, the doctor carries out:
— carrying out research and issuing conclusions based on their results;
— participation in the analysis of complex cases and errors in diagnosis and treatment, identification and analysis of the reasons for the discrepancy between the conclusions on endoscopy methods and the results of other methods diagnostic methods;
— development and implementation of diagnostic and therapeutic methods and equipment;
— high-quality maintenance of medical records and records, archives, analysis of qualitative and quantitative performance indicators;
— control over the work of nursing and junior medical personnel within their competence;
— control over the safety and rational use of equipment and equipment, their technically competent operation;
— participation in advanced training of nursing and junior medical personnel.
7. The endoscopist is obliged to:
— ensure accurate and timely fulfillment of their official duties and internal labor regulations;
- monitor compliance by nursing and junior medical staff with sanitation rules, economic and technical condition of the unit;
- submit work reports to the head of the endoscopy department, and in his absence, to the chief physician;
— comply with labor protection and fire safety rules.
8. An endoscopist has the right:
— make proposals to the administration on issues of improving the activities of the unit, organization and working conditions;
— participate in meetings and conferences where issues related to the work of the endoscopy department are discussed;
9. The appointment and dismissal of an endoscopist is carried out by the chief physician of the institution in the prescribed manner.
Head of Department
medical organization
assistance to the population
A.A.KARPEEV
Appendix 5
to the Order of the Ministry of Health and Medical Industry of the Russian Federation
dated May 31, 1996 N 222
1. A qualified nurse with a secondary medical education, who has undergone special training in endoscopy and has organizational skills, is appointed to the position of senior nurse of the department, endoscopy department.
2. In her work, the senior nurse of a department or department is guided by the regulations on the medical institution, department, endoscopy department, these Regulations, job descriptions, orders and instructions of the head of the department or department.
3. The senior nurse reports directly to the head of the department, endoscopy department.
4. Subordinate to the senior nurse are the middle and junior medical staff of the department or department.
5. The main tasks of the head nurse of the department, endoscopy department are:
— rational placement and organization of work of mid-level and junior medical personnel;
— monitoring the work of mid-level and junior medical personnel of the department, department, compliance by the above-mentioned personnel with internal regulations, sanitary and anti-epidemic regimes, the condition and safety of equipment and equipment;
— timely processing of requests for medications, Consumables, equipment repair, etc.;
— maintaining the necessary accounting and reporting documentation of the department, department;
— implementation of measures to improve the qualifications of nursing staff of the department, department;
— compliance with labor protection rules, fire safety and internal labor regulations.
6. The senior nurse of the department, endoscopy department is obliged to:
— improve your qualifications in the prescribed manner;
- inform the head of the department, department about the state of affairs in the department, department and the work of nursing and junior medical personnel.
7. The senior nurse of the department, endoscopy department has the right:
- give orders and instructions to the middle and junior medical personnel of the department, department within their boundaries job responsibilities and monitor their implementation;
— make proposals to the head of the department or department to improve the organization and working conditions of mid-level and junior medical personnel of the department or department;
- take part in meetings held in the department or department when considering issues within its competence.
8. The order of the senior nurse is mandatory for execution by the middle and junior staff of the department or department.
9. The senior nurse of the department, endoscopy department is responsible for the timely and high-quality implementation of the tasks and responsibilities provided for by these Regulations.
10. The appointment and dismissal of a senior nurse of a department or department is carried out by the chief physician of the institution in the prescribed manner.
Head of Department
medical organization
assistance to the population
A.A.KARPEEV
Appendix 6
to the Order of the Ministry of Health and Medical Industry of the Russian Federation
dated May 31, 1996 N 222
In the following text - “nurse”.
1. A medical worker who has a secondary medical education and has undergone special training in endoscopy is appointed to the position of nurse.
2. In her work, the nurse is guided by the regulations on the department, department, endoscopy room, these Regulations and job descriptions.
3. The nurse works under the direct supervision of the endoscopist and the head nurse of the department.
4. The nurse carries out:
- calling patients for examination, preparing them and participating in diagnostic, therapeutic and surgical interventions within the framework of performing assigned technological operations;
— registration of patients and studies in the accounting documentation in the prescribed form;
— regulation of the flow of visitors, the order of research and pre-registration for research;
— general preparatory work to ensure the functioning of diagnostic and auxiliary equipment, ongoing monitoring of its operation, timely registration of faults, creation necessary conditions labor in diagnostic and treatment rooms and at your workplace;
— control over the safety and consumption of necessary materials (medicines, dressings, tools, etc.) and their timely replenishment;
- daily activities to maintain the proper sanitary condition of the premises of the department, department, office and your workplace, as well as to comply with hygiene requirements and sanitary and anti-epidemic regime;
— high-quality maintenance of medical records.
5. The nurse is obliged to:
— improve your skills;
— comply with labor protection, fire safety and internal labor regulations.
6. The nurse has the right:
- make proposals to the head nurse or doctor of the department, office on the organization of the work of the department and their working conditions;
— take part in meetings held in the department on issues within its competence.
7. The nurse is responsible for the timely and high-quality performance of her duties provided for by these Regulations and internal labor regulations.
8. The appointment and dismissal of a nurse is made by the chief physician of the institution in the prescribed manner.
Appendix 7
to the Order of the Ministry of Health and Medical Industry of the Russian Federation
dated May 31, 1996 N 222
1. Estimated time standards for endoscopic operations are intended for endoscopists performing these surgical interventions.
2. Estimated time standards for endoscopic surgery increase by the corresponding number of endoscopists performing it.
Appendix 8
to the Order of the Ministry of Health and Medical Industry of the Russian Federation
dated May 31, 1996 N 222
Estimated time standards for endoscopic examinations are determined taking into account the necessary relationship between the optimal labor productivity of medical staff and the high quality and completeness of diagnostic and therapeutic endoscopic examinations.
This Instruction is intended for heads of departments and doctors of endoscopy departments to use it for the purpose of rational application of the calculated time standards approved by this Order of the Ministry of Health and Medical Industry of Russia.
The main purpose of the estimated time standards for endoscopic examinations is their use when:
— addressing issues of improving the organization of activities of departments, departments, endoscopy rooms;
— planning and organizing the work of medical personnel of these units;
— analysis of labor costs of medical staff;
— formation of staffing standards for medical staff of relevant medical institutions.
The share of work of medical staff in directly conducting endoscopic examinations (main and auxiliary activities, work with documentation) is 85% of the working time for doctors and nurses. This time is included in the estimated time standards. Time for other necessary work and personal necessary time is not taken into account in the standards.
For doctors, this means a joint discussion with attending physicians of clinical and instrumental data, participation in medical conferences, reviews, rounds, training and monitoring the work of staff, mastering techniques and new technology, work with archives and documentation, administrative and economic work.
For nurses, this is preparatory work at the beginning of the working day, caring for equipment, obtaining the necessary materials and medications, issuing reports, putting the workplace in order after the shift.
Time required for endoscopic examinations, procedures or surgeries emergency indications, as well as the time of transitions (moving) for their implementation outside the department, department, endoscopy room is taken into account according to actual costs.
For heads of departments, divisions, and endoscopy rooms, a differentiated amount of work can be established for the direct implementation of research and operations, depending on local conditions - the profile of the institution, the actual or planned annual volume of work of the department, the number of medical personnel, etc.
When determining the estimated workload standards for doctors and nursing staff, it is recommended to be guided by the methodology for rationing the work of medical personnel (M., 1987, approved by the USSR Ministry of Health). In this case, the ratio of the above-mentioned working time costs is taken as a basis.
To account for the work of personnel in departments, departments, endoscopy rooms, the possibility of comparing their workload, etc., the calculated time standards and the determined workload standards for doctors and nursing staff are reduced to a common unit of measurement - conventional units. One conventional unit is 10 minutes of working time. Thus, the shift workload norm is determined based on the duration of the work shift established for the personnel.
In accordance with the clarification of the Ministry of Labor of the Russian Federation dated December 29, 1992 N 5, approved by Resolution dated December 29, 1992 N 65, the transfer of days off coinciding with holidays, is carried out at enterprises, institutions and organizations that apply various work and rest regimes, in which work is not carried out on holidays.
The standard working time for certain periods of time is calculated according to the estimated schedule of a five-day work week with two days off, Saturday and Sunday, based on the following duration of daily work (shift):
- with a 40-hour work week - 8 hours, on holidays - 7 hours;
- if the length of the working week is less than 40 hours - the number of hours obtained by dividing the established length of the working week by five days, on the eve of holidays, in this case, no reduction in working hours is made (Article 47 of the Labor Code of the Russian Federation).
Based on an analysis of the work done by an individual employee and the department as a whole, management decisions are made aimed at improving the work of personnel, introducing more effective methods research to improve the quality and information content of the studies performed in order to most fully satisfy the need for this type of diagnosis.
Issues of use, rational placement and formation of the number of medical personnel are resolved on the basis of the objectively established or planned volume of work of the unit using recommended labor standards.
The actual or planned annual volume of activity for conducting endoscopic studies, expressed in conventional units, is determined by the formula:
T - actual or planned annual volume of activity for conducting endoscopic studies, expressed in conventional units; t1, t2, ti — time in conventional units in accordance with the approved estimated time standards for research (main and additional); n1, n2, ni - actual or planned number of studies during the year using individual diagnostic methods.
Comparison of the actual annual volume of activity with the planned one allows for an integral assessment of the unit’s activities, to get an idea of the labor productivity of its personnel and the efficiency of the unit as a whole.
Carrying out research on a larger scale throughout the year can be achieved by intensifying the work of medical staff or by increasing the amount of time used for core activities by significantly reducing the share of other necessary types of labor. If this is not the result of the use of automation tools for research and calculation of physiological parameters, methods for more rational organization of the work of doctors and nurses, then such intensification of work inevitably leads to a decrease in the quality, information content and reliability of conclusions. Failure to fulfill the plan for the volume of activity may be the result of improper planning, a consequence of defects in the organization of work and in the management of the department. Therefore, both failure to fulfill the plan and its excessive overfulfillment should be equally carefully analyzed by both the head of the office (department) and the management of the medical institution in order to identify their causes and take appropriate measures. Deviations of the actual volume of activity from the annual planned volume within +20% can be considered acceptable. -10%.
Along with the general indicators of the work performed, the structure of the studies performed and the number of studies on individual endoscopic methods are traditionally analyzed to assess the balance and adequacy of the structure, the sufficiency of the number of studies of the actual need for them.
The average time spent on one study is determined by:
The organizational and staffing structure of the endoscopy department is regulated by Appendix No. 2 of the order of the Ministry of Health of the Ministry of Health of the Russian Federation No. 222 dated May 31, 1996.
The preamble of Order No. 222 of May 31, 1996, “On improving the endoscopy service and healthcare institutions of the Russian Federation,” clearly states the advantages of endoscopy and its role in clinical medicine.
In Appendix No. 2 of this order everything organizational issues are given briefly. Thus, clause 7 states that “the equipment of a department, department, office is carried out in accordance with the level and profile of the medical institution”, and in clause 8 - “the staff of medical and technical personnel is established in accordance with the recommended staffing standards, carried out or the planned amount of work and, depending on local conditions, based on the estimated time standards for conducting various studies.” The phrase “depending on local conditions” can be interpreted quite broadly, both in favor of endoscopy and against it.
In the canceled appendices No. 8 and 9 of the order of the USSR Ministry of Health No. 590 of 1986 “On measures to further improve the prevention, early diagnosis and treatment of malignant neoplasms”, the issues of equipment and composition of the endoscopy department were covered in detail and the ratio of the rates of middle and junior staff in relation to to the staff of an endoscopist. Also, staffing standards for medical personnel in the endoscopy department (office) of a medical institution were established and the time frame for all endoscopic examinations was regulated, both in minutes and in conventional units.
All subsequent orders, having canceled the effect of Appendices No. 8 and 9 of Order No. 590, created a certain confusion in the organization of the endoscopic service, allowing healthcare organizers to freely interpret the number of staff rates for endoscopic services, especially in the number of rates for middle and junior staff. This concerns, first of all, Order No. 134 of the USSR Ministry of Health dated February 23, 1988 “On approval of estimated time standards for endoscopic examinations and therapeutic and diagnostic procedures,” as well as the currently valid Order No. 222 of the Ministry of Health of the Ministry of Health of the Russian Federation dated May 31. 96 “On improving the endoscopy service in healthcare institutions of the Russian Federation.”
222 order on endoscopy new
Endoscopic service in Russia began to emerge in the 70s of the 20th century. At the first stages, it was represented by scattered diagnostic rooms on the basis of large medical clinics and research centers. In those years, completely unsuitable premises were allocated for endoscopy rooms, since the presence of the latter was not provided for when designing the buildings. In most health care facilities, to this day, the premises of endoscopy rooms and departments do not meet sanitary and epidemiological standards.
The personnel potential of endoscopy was initially formed by part-time workers, often surgeons and therapists.
The first documents regulating the work of the new direction in medicine were: order of the USSR Ministry of Health No. 1164 dated December 10, 1976 “On the organization of endoscopic departments (rooms) in medical institutions”, appendices No. 8, 9 to the order of the USSR Ministry of Health No. 590 dated 25 April 1986 “On measures to further improve the prevention, early diagnosis and treatment of malignant neoplasms” and order of the USSR Ministry of Health No. 134 of February 23, 1988 “On approval of estimated time standards for endoscopic examinations and therapeutic and diagnostic procedures.” At that time, few people realized that these first steps in the development of endoscopy would entail titanic shifts in the entire medical industry.
On the one hand, the information content of visual observation, with the accumulation of experience, radically changed scientific views on the etiology, pathogenesis, pathological anatomy diseases, which, in turn, entailed a complete revision of the methodological aspects of diagnosis and treatment of most of the most common diseases. On the other hand, thanks to scientific and technological progress in the 90s, endoscopy began to leave the field of diagnostics and displace traditional surgery, radically changing and improving the very technique of surgical interventions. As it seemed to us then, a new section called “minimally invasive surgery” was emerging in surgery. Today we can confidently state the fact that then a whole era of modern surgery called “endoscopic surgery” was born. In parallel with the practical priority, the geography expanded. Endoscopic methods of diagnosis and treatment spread more and more widely to regional treatment and preventive institutions.
The understanding began to come that endoscopy is an independent direction in medicine, it is advisable to organize separate endoscopic departments in medical institutions, and train endoscopists from surgeons. It is at this time that issues of organization and regulations for the work of this service are raised. On May 31, 1996, the Ministry of Health of the Russian Federation issues order No. 222 “On improving the endoscopy service in healthcare institutions of the Russian Federation.” The order emphasizes that due to shortcomings in the organization of work of existing endoscopic units, the slow introduction into practice of new forms of management and organization of work of medical personnel, the scattering of specialists involved in endoscopy among other specialized services, the lack of highly effective endoscopic diagnostic and treatment programs and algorithms, This medical area is not receiving proper development. The order reflected the provisions on the chief freelance specialist; about the department, division, endoscopy room; about the head, endoscopist, senior nurse, nurse of the endoscopy department. Calculated time standards for endoscopic examinations, therapeutic and diagnostic procedures, and operations were also introduced; an approximate list of the minimum volume of endoscopic examinations for medical institutions is recommended; a methodology for calculating prices for endoscopic examinations, primary medical documentation and processing of endoscopes has been approved. The order had a lot of shortcomings, however, at that stage of the development of endoscopy, its publication ensured further progress in the development of endoscopy.
Over the past 20 years, endoscopy has undergone revolutionary changes in both qualitative and quantitative aspects. Modern digital video endoscope systems provide highly accurate images with varying degrees magnification and color range. It became possible to perform endoscopic microscopy. Endoscopic surgery is present in almost all branches of medicine. But there are still a lot of unresolved issues that, directly or indirectly, hinder the development of endoscopy in our country.
The first open question is logistics and financing. Unfortunately, the years of perestroika caused enormous damage to the country's healthcare system in general and endoscopy in particular. Enterprises involved in the production of domestic fiber endoscopes were bankrupt and liquidated, and foreign analogues turned out to be prohibitively expensive both in terms of acquisition and in terms of operation and repair. In this regard, compared to the West, where the share of modern digital endoscopes is 96%, in the Russian Federation it does not exceed 39%. In such a huge country as Russia, there are 31,237 units of endoscopic equipment, of which 16,842 gastroscopes, 6,061 colonoscopes, 5,618 bronchoscopes, 2,531 duodenoscopes and 185 ultrasound endoscopes. Most of them have been repaired several times and have long been technically obsolete. According to the Ministry of Health of the Russian Federation, wear and tear of the endoscope fleet is 67%. There are no regulations on the use of endoscopic technology in our country. In recent years, thanks to stricter sanitary requirements, old models of “non-submersible” endoscopes have begun to be withdrawn from practice. But even this has not been done everywhere. The monopoly of foreign manufacturers on the repair of endoscopes allows tens, or even hundreds of times, to exceed the real cost of eliminating technical faults. Until domestic production of endoscopic equipment is established in the country, these abuses will continue to occur.
The same monopoly system is thriving in the market for high-level endoscope disinfectants. When entering into technical support contracts, endoscope manufacturers reserve the right to recommend, and indeed dictate, the chemistries suitable for their devices. Of course, there are no domestic analogues on this list. If the recommendations are not followed, manufacturers will remove the warranty from endoscopes.
Another exorbitant cost is the purchase of endoscopic instruments. According to the new sanitary rules SP 3.1.3263-15, only sterile instruments are allowed for use in endoscopy, regardless of sterile or non-sterile examination. If you carefully study the catalogs of endoscopic instruments for fiber-fiber devices, then almost all of them are disposable and cannot be subsequently sterilized. None medical institution in Russia cannot afford such luxury. Most often, either a disposable instrument is used as a reusable one and subjected to various methods of sterilization, or they are limited to high-level disinfection, turning a blind eye to sanitary requirements. Positive dynamics in the last two years have begun to be observed in import substitution, unfortunately, so far only for certain types of endoscopic instruments. But even these first steps are very encouraging.
The second, pressing issue in the organization of endoscopy is the attraction and training of personnel. There are about 6 thousand endoscopists and the same number of endoscopic nurses in the Russian Federation. New requirements for admission to primary specialization in endoscopy require that the specialist have a certificate in surgery. This is completely justified, since even the most technically basic endoscopic examination is accompanied by penetration into the patient’s internal organs, carries the risk of damage to organs and tissues, is fraught with the development of various complications and, accordingly, should be equated with the level of complexity and risks surgical intervention. Over the past 15 years, the increase in operational activity in endoscopy has been more than 400%. No other area of modern medicine is developing as rapidly as endoscopy. This is one of the main ways to modernize healthcare in the Russian Federation. However, most medical universities still do not provide endoscopy courses to students. This is a huge gap at the current stage of development of medicine. Endoscopy has won the right to be taught as a separate course, along with radiology, radiation diagnostics, etc.
For many years, the issue of remuneration for endoscopists and nursing staff in endoscopy departments and the issue of providing this category of workers with a preferential pension remained open. A big drawback of the still valid order of the Ministry of Health of the Russian Federation No. 222 of May 31, 1996 is the absence of a clearly stated provision in it that endoscopy is a surgical profile, endoscopists enjoy all the benefits, like surgeons. This gap has widely allowed pension fund workers to interpret endoscopists' rights "at their own discretion." Plus, a lot of organizational mistakes in past years made locally by chief doctors did not allow many specialists in this field to take advantage of preferential pensions. In judicial practice, many contradictions and disagreements have accumulated on these issues, which also need to be taken into account and prevented in the future. The most typical organizational errors that did not allow endoscopic personnel to take advantage of the preferential pension:
1. According to the order of the Ministry of Health of the Russian Federation No. 222 of May 31, 1996, the endoscopy room or department is a structural unit of a medical institution with direct subordination to the chief physician or his deputy for medical work. Often, the chief physicians of clinics assigned the endoscopic department to the structure of the clinic with direct subordination to the deputy chief physician for the clinic. On the one hand, this created convenience for examinations of outpatients, excluding their flow to the hospital, and on the other hand, it deprived endoscopists of the status of inpatient doctors, which affected the level of wages and gave rise to the refusal to provide a preferential pension. If you look at it more broadly, the nature of the work of the staff of the endoscopy department in the clinic and in the hospital is no different, so this should not in any way affect the provision of preferential pensions to employees.
2. Heads of endoscopy departments, by order of the Ministry of Health of the Russian Federation No. 222 of May 31, 1996, are not exempt; they are required to perform the same number of manipulations as a resident doctor. However, the pension fund does not take this into account and the heads of departments refuse to provide a preferential pension.
3. Order of the Ministry of Health of the Russian Federation No. 222 of May 31, 1996 provides for maintaining a log of endoscopic manipulations. When assigning preferential pensions to endoscopists, the pension fund often requests a so-called operating log, which is not provided in endoscopy departments. Its absence becomes the basis for refusal to receive a preferential pension for endoscopists.
In recent years, the sanitary and epidemiological requirements for the work of the endoscopic department in medical institutions have also increased. The new sanitary and epidemiological rules SP 3.1.3263-15 “Prevention of infectious diseases during endoscopic interventions” differentiated endoscopic interventions into sterile and non-sterile, radically changing the requirements for the processing of endoscopes, their instruments, equipment and premises. The processing process itself, maintaining a lot of additional documentation (up to 7 journals per office) require additional time expenditure from middle and junior medical personnel, not provided for by Order of the Ministry of Health of the Russian Federation No. 222 of May 31, 1996. In this regard, many contradictions arose in the organizational issues of the endoscopy department. Let's list some of them.
1. According to SP 3.1.3263-15, only the process of processing one endoscope, taking into account the use of the most expensive and fastest existing funds, takes the nurse 47 minutes, instead of 17 minutes according to the order of the Ministry of Health of the Russian Federation No. 222 of May 31, 1996. This makes compliance with the old standards for the operating time of the endoscopy department impossible.
2. All actions related to the processing of endoscopes, instruments, the workplace, the operation of bactericidal lamps, oxygen supply devices, testing the quality of cleaning, etc. the nurse records in the appropriate journals. This is also not provided for by Order of the Ministry of Health of the Russian Federation No. 222 dated May 31, 1996 and forces you to waste additional time.
3. The universal list of labor elements for technological operations, recommended when developing estimated time standards for an endoscopist, has also expanded. Additional time is spent on drawing up a contract for the provision of services and the patient’s informed consent, registering data in digital format, and printing photos and videos of the study.
In connection with the above, it has matured urgency revision of the universal list of labor elements in endoscopy and estimated time standards. This will undoubtedly improve the quality of endoscopy-related medical care.
A separate issue is the organization and development of combined types of research in endoscopic departments: X-ray endoscopy, ultrasound endoscopy, confocal endoscopy, etc., which require additional material resources, attraction and training of qualified personnel, and again, increased time costs.
All these questions are even more painful for endoscopy in pediatrics. Thinner children's endoscopes are distinguished, on the one hand, by their high cost, and on the other, by increased fragility. Endoscopic manipulations in children themselves require anesthesia, which significantly increases their cost. That is why this type of endoscopy has not yet received proper distribution. But it is children who often experience emergency situations requiring endoscopic intervention.
From our analysis, we can identify the following main directions in solving the problems of further development of endoscopy:
1. Improving the regulatory framework in endoscopy. Order of the Ministry of Health of the Russian Federation dated May 31, 1996 No. 222 “On improving the endoscopy service in healthcare institutions of the Russian Federation” has long been outdated and does not meet modern requirements. There is an urgent need to develop and implement a new “Procedure for providing endoscopic care to adults and children in the Russian Federation,” taking into account all of the above contradictions.
2. Implementation of the import substitution program in endoscopy. Creation of domestic endoscopic equipment complexes with subsequent service support, reusable endoscopic instruments, detergents and disinfectants.
3. Optimization personnel policy. A clear definition of endoscopy as a surgical specialty, with the provision of providing employees with all relevant benefits, including on the basis of the Federal Law of December 17, 2001 No. 173 (as amended on December 31, 2002) Art. 28 clause 11 “On labor pensions in the Russian Federation” and Russian Government Decree No. 781 of October 29, 2002. . Isolation of endoscopy as a separate direction in the course of teaching to students of medical universities.
www.science-education.ru
ORDER of May 31, 1996 N 222 ON IMPROVING ENDOSCOPY SERVICES IN HEALTH CARE INSTITUTIONS OF THE RUSSIAN FEDERATION
The development of endoscopic technology in recent decades, based on the use of fiber optics, has significantly expanded the use of minimally invasive instrumental research methods in medical practice. Currently, endoscopy has become quite widespread both in the diagnosis and treatment of various diseases. A new direction has appeared in medical practice - surgical endoscopy, which makes it possible to achieve a pronounced economic effect while maintaining the therapeutic result by significantly reducing the length of hospitalization and the cost of treating patients.
The advantages of endoscopic methods ensure the rapid development of this service in the Russian Federation. Over the past 5 years, the number of endoscopy departments and rooms in medical institutions has increased by 1.7 times, and their equipment with endoscopic equipment has increased by 2.5 times. From 1991 to 1995, the number of endoscopists increased 1.4 times; 35% of specialists have qualification categories (1991 - 20%). The scope of performed research and treatment procedures is constantly expanding. Compared to 1991, their number increased by 1.5 and 2 times, respectively. In 1995, 142.7 thousand operations were performed using endoscopic technology. In a number of areas of the country, a 24-hour emergency endoscopic care service has been created, which can significantly improve performance in emergency surgery, traumatology and gynecology. Computer programs have been developed and are being actively implemented to evaluate the results of endoscopic studies.
At the same time, there are serious shortcomings and unresolved problems in organizing the activities of the endoscopy service. Only 38.5 percent of hospitals in rural areas, 21.7 percent of dispensaries (including 8 percent for tuberculosis), and 3.6 percent of outpatient clinics have endoscopy units. Only 17 percent of the total number of endoscopy specialists work in health care facilities located in rural areas. In the staffing structure of endoscopists, there is a high proportion of part-time doctors from other specialties. The capabilities of endoscopy are underutilized due to the unclear organization of work of existing departments, the slow introduction into practice of new forms of management and organization of work of medical personnel, the scattering of specialists involved in endoscopy among other specialized services, and the lack of highly effective endoscopic diagnostic and treatment programs and algorithms. In some cases, expensive endoscopic equipment is used extremely irrationally due to poor training of specialists, especially in surgical endoscopy, and lack of proper continuity in work with doctors of other specialties. The load on one endoscope with fiber optics is 2 times lower than the standard. Certain difficulties in organizing the service are due to the lack of the necessary regulatory framework, recommendations for optimizing the structure and staffing, and the range of studies in endoscopy units of various capacities. The quality of endoscopic equipment produced by domestic enterprises does not fully meet modern technical requirements
In order to improve the organization of the endoscopy service and increase the efficiency of its work, the rapid introduction of new diagnostic and treatment methods, including surgical endoscopy, as well as improving personnel training and technical equipment of departments with modern endoscopic equipment, I affirm:
1. Regulations on the chief freelance specialist in endoscopy of the Ministry of Health and Medical Industry of the Russian Federation and health authorities of the constituent entities of the Russian Federation (Appendix 1).
2. Regulations on the department, department, endoscopy room (Appendix 2).
3. Regulations on the head of the department, department, endoscopy room (Appendix 3).
4. Regulations on the doctor - endoscopist of the department, department, endoscopy room (Appendix 4).
5. Regulations on the head nurse of the department, endoscopy department (Appendix 5).
6. Regulations on the nurse of the department, department, endoscopy room (Appendix 6).
7. Estimated time standards for endoscopic examinations, therapeutic and diagnostic procedures, operations (Appendix 7).
8. Instructions for the use of estimated time standards for endoscopic examinations (Appendix 8).
9. Instructions for the development of estimated time standards for the introduction of new equipment or new types of research and treatment (Appendix 9).
10. Qualification characteristics of the endoscopist (Appendix 10).
12. Methodology for calculating prices for endoscopic examinations (Appendix 12).
13. Journal of registration of studies performed in the department, department, endoscopy room - form N 157/u-96 (Appendix 13).
14. Instructions for filling out the Register of studies performed in the department, unit, endoscopy room - form N 157/u-96 (Appendix 14).
15. Addition to the list of forms of primary medical documentation (Appendix 15).
1. To the Ministers of Health of the republics within the Russian Federation, heads of health authorities and institutions of territories, regions, autonomous entities, the cities of Moscow and St. Petersburg:
1.1. During 1996, develop and implement the necessary measures to form a unified endoscopy service in the territory, including diagnostic, therapeutic and surgical endoscopy, taking into account the profile of medical institutions and local conditions.
1.2. When planning a network of endoscopy units, pay special attention to their organization in primary care institutions, including rural healthcare.
1.3. Appoint the main freelance endoscopy specialists and organize work in accordance with the Regulations approved by this Order.
1.4. Involve departments of scientific research institutes, educational universities and postgraduate educational institutions in organizational, methodological and advisory work on endoscopy.
1.5. Organize the work of departments, departments, endoscopy rooms in accordance with this Order.
1.6. Establish the number of personnel in departments, departments and endoscopy rooms in accordance with the volume of work based on the estimated time standards for endoscopic examinations.
1.7. Take the necessary measures to maximize the use of endoscopic equipment with fiber optics, ensuring the load on the device is at least 700 studies per year.
1.8. Provide regular training to medical doctors on current issues of endoscopy.
2. The Department of Organization of Medical Care to the Population (A.A. Karpeev) to provide organizational and methodological assistance to health authorities on the organization and functioning of endoscopy services in the territories of the Russian Federation.
3. The Department of Educational Institutions (Volodin N.N.) to supplement the training programs for training specialists in endoscopy in educational institutions of postgraduate training, taking into account the introduction into practice of modern equipment and new research methods.
4. The Department of Scientific Institutions (Nifantev O.E.) to continue work on creating new endoscopic equipment that meets modern technical requirements.
5. Rectors of institutes for advanced training of doctors must ensure in full the applications of health care institutions for the training of endoscopists in accordance with the approved standard programs.
6. Consider as invalid for institutions of the Russian Ministry of Health and Medical Industry Order of the USSR Ministry of Health N 1164 of December 10, 1976 “On the organization of endoscopy departments (rooms) in medical institutions”, appendices N 8, 9 to Order of the USSR Ministry of Health N 590 of April 25, 1986 “On measures to further improve the prevention, early diagnosis and treatment of malignant neoplasms” and Order of the USSR Ministry of Health N 134 of February 23, 1988 “On approval of estimated time standards for endoscopic examinations and therapeutic and diagnostic procedures.”
7. Entrust control over the execution of the Order to Deputy Minister A.N. Demenkov.
Minister of Health and Medical Industry of the Russian Federation A.D. TSAREGORODTSEV
www.endoscopy.ru
MINISTRY OF HEALTH AND MEDICAL INDUSTRY OF THE RUSSIAN FEDERATION
ORDER of May 31, 1996 N 222
ON IMPROVING ENDOSCOPY SERVICE IN HEALTH CARE INSTITUTIONS OF THE RUSSIAN FEDERATION
INSTRUCTIONS FOR DEVELOPING ESTIMATED TIME STANDARDS FOR IMPLEMENTING NEW EQUIPMENT OR NEW TYPES OF RESEARCH AND TREATMENT
When introducing new diagnostic methods and technical means for their implementation, which are based on different research methodology and technology, new labor content of medical personnel, and the absence of estimated time standards approved by the Ministry of Health and Medical Industry of Russia, they can be developed on the spot and agreed upon with the trade union committee in those institutions where they are being introduced new techniques. The development of new calculation standards includes taking time measurements of the actual time spent on individual elements of labor, processing this data (according to the methodology outlined below), and calculating the time spent on the study as a whole. Before timing, a list of technological operations (main and additional) for each method is compiled. For these purposes, it is recommended to use the methodology applied in compiling a universal list of labor elements for technological operations. In this case, it is possible to use the “List” itself. “, adapting each technological operation to the technology of a specific new diagnostic or treatment method.
Timing is carried out using sheets of timing measurements, which consistently set out the names of technological operations and the time of their implementation. Processing the results of timing measurements includes calculating the average time spent, determining the actual and expert repeatability coefficient for each technological operation and the estimated time to complete the study under study.
UNIVERSAL LIST OF LABOR ELEMENTS FOR TECHNOLOGICAL OPERATIONS, RECOMMENDED WHEN DEVELOPING ESTIMATED TIME STANDARDS
1. Conversation with the patient
2. Study of medical documentation
3. Preparation for the study
4. Hand washing
5. Consultation with your doctor
6. Conducting research
7. Advice and recommendations for the patient
8. Consultation with the manager. department
9. Processing of the apparatus and instruments
10. Registration of honey. documentation
11. Registration of biopsy material
12. Entry in the log book
The average time spent on an individual technological operation is determined as the arithmetic average of all measurements. The actual repeatability factor of technological operations in each study is calculated using the formula:
where K is the actual repeatability coefficient of the technological operation; P is the number of timed studies using a specific research method in which this technological operation took place; N is the total number of the same timed studies. The expert coefficient of repeatability of a technological operation is determined by the most qualified doctor - an endoscopist who knows this technique, based on the existing experience in using the method and professional understanding of the proper repeatability of the technological operation. The estimated time for each technological operation is determined by multiplying the average actual time spent on a given timing operation by the expert coefficient of its repeatability. The estimated time to complete the study as a whole is determined separately for the doctor and the nurse as the sum of the estimated time to complete all technological operations using this method. After approval by the order of the head of the medical institution, it is the estimated time limit for performing this type of research in this institution. To ensure the reliability of local time standards and their correspondence to the true time spent, not dependent on random causes, the number of studies subject to time measurements should be as large as possible, but not less than 20 - 25.
It is possible to develop local time standards only when the personnel of the department, department, office have mastered the methods well enough, when they have developed a certain automatism and professional stereotypes in performing diagnostic and therapeutic manipulations. Before this, research is carried out in the order of mastering new methods, within the time spent on other types of activities.
Head of the Department of Organization of Medical Care to the Population
A.A.KARPEEV
QUALIFICATIONS OF AN ENDOSCOPIST DOCTOR
The level of an endoscopist is determined taking into account the volume and quality of the work performed, the availability of theoretical training in the field of basic and related specialties, and the regularity of training in specialized educational institutions that have a special certificate. The assessment of the practical training of an endoscopist is carried out under the guidance of the endoscopic unit and the institution at the specialist’s place of work. The general opinion is reflected in the performance characteristics from the place of work. Theoretical knowledge and compliance of practical skills with the current level of development of endoscopy are assessed during certification cycles conducted by endoscopy departments.
In accordance with the requirements of the specialty, the endoscopist must know, be able to, and master:
prospects for the development of endoscopy;
fundamentals of healthcare legislation and policy documents defining the activities of healthcare authorities and institutions in the field of endoscopy;
general issues of organizing planned and emergency endoscopic care in the country for adults and children, ways to improve endoscopic services;
organization of medical care in military field conditions during mass casualties and disasters;
etiology and ways of spreading highly infectious diseases and their prevention;
work of an endoscopist in the conditions of insurance medicine;
topographic anatomy of the bronchopulmonary apparatus, digestive tract, abdominal and pelvic organs, anatomical and physiological features of childhood;
the causes of pathological processes that an endoscopist usually encounters;
diagnostic and therapeutic capabilities of various endoscopic methods;
indications and contraindications for diagnostic, therapeutic and surgical esophagogastroduodenoscopy, colonoscopy, laparoscopy, bronchoscopy;
methods of processing, disinfection and sterilization of endoscopes and instruments;
principles, techniques and methods of pain relief in endoscopy;
clinical symptoms of major surgical and therapeutic diseases;
principles of examination and preparation of patients for endoscopic methods of examination and management of patients after examinations;
equipment for endoscopy rooms and operating rooms, safety precautions when working with equipment;
design and principle of operation of endoscopic equipment and auxiliary instruments used in various endoscopic studies.
collect anamnesis and compare the information obtained with the data of the available medical documentation for the patient in order to select the desired type of endoscopic examination;
independently carry out simple examination methods: digital examination of the rectum during bleeding, palpation of the abdomen, percussion and auscultation of the abdomen and lungs;
identify the patient’s allergic predisposition to anesthetics in order to correctly determine the type of anesthesia under which endoscopic examination will be performed;
determine indications and contraindications for performing a particular endoscopic examination; — teach the patient how to behave correctly during an endoscopic examination;
choose the optimal type and type of endoscope (rigid, flexible, with end, end-side or just side optics) depending on the nature of the planned endoscopy;
master the methods of local infiltration anesthesia, local anesthesia of the pharyngeal ring and tracheobronchial tree;
knowledge of biopsy methods and the ability to perform them is required;
knowledge of medical documentation and research protocols;
ability to compile a report on the work done and analyze endoscopic activities.
3. Special knowledge and skills:
A specialist endoscopist must know prevention, clinical presentation and treatment, be able to diagnose and provide the necessary assistance for the following conditions:
intraorgan or intra-abdominal bleeding that occurred during an endoscopic examination;
perforation of a hollow organ;
acute cardiac and respiratory failure;
arrest of breathing and cardiac activity.
A specialist endoscopist must know:
clinic, diagnosis, prevention and principles of treatment of major lung diseases (acute and chronic bronchitis, bronchial asthma, acute and chronic pneumonia, lung cancer, benign lung tumors, disseminated lung diseases);
clinic, diagnosis, prevention and treatment of major diseases of the gastrointestinal tract (esophagitis, gastritis, ulcerative lesions of the stomach and duodenum, cancer and benign tumors of the stomach, duodenum and colon, diseases of the operated stomach, chronic colitis, hepatitis and liver cirrhosis, pancreatitis and cholecystitis, tumors of the hepato-pancreatoduodenal zone, acute appendicitis);
master the technique of esophagogastroduodenoscopy, colonoscopy, bronchoscopy, laparoscopy, using all techniques for a detailed examination of the mucous membrane of the esophagus, stomach, duodenum during esophagogastroduodenoscopy, all parts of the colon and terminal ileum during colonoscopy;
tracheobronchial tree, up to the bronchi of the 5th order - during bronchoscopy, serous integument, as well as the abdominal organs of the abdominal cavity - during laparoscopy;
visually clearly determine the anatomical boundaries of physiological narrowings and sections of the organs being studied;
correctly assess the responses of the sphincter apparatus of the organs being studied in response to the introduction of an endoscope and air;
under conditions of artificial lighting and some magnification, it is correct to distinguish macroscopic signs of the normal structure of the mucous membranes, serous tissues and parenchymal organs from pathological manifestations in them;
perform targeted biopsy from pathological foci of the mucous membranes of the serous integument and abdominal organs;
orient and fix the biopsy material for histological examination;
correctly make smears - prints for cytological examination;
remove and take ascitic fluid, effusion from the abdominal cavity for cytological examination and culture;
based on the identified microscopic signs of changes in the mucous, serous covers or tissues of parenchymal organs, determine the nosological form of the disease;
clinic, diagnosis, prevention and treatment of major diseases of the pelvic organs (benign and malignant tumors of the uterus and appendages, inflammatory diseases of the appendages, ectopic pregnancy).
4. Research and manipulation:
bronchofibroscopy and rigid bronchoscopy;
targeted biopsy from mucous membranes, serous tissues and abdominal organs;
removal of foreign bodies from the tracheobronchial tree, upper gastrointestinal tract and colon during endoscopic examination;
local hemostasis during esophagogastroduodenoscopy;
endoscopic removal of benign tumors from the esophagus and stomach; - expansion and dissection of scar and postoperative narrowing of the esophagus;
papillosphincterotomy and virsungotomy and removal of stones from the ducts;
installation of a feeding tube;
drainage of the abdominal cavity, gall bladder, retroperitoneal space;
removal of pelvic organs during laparoscopy according to indications;
removal of abdominal organs during laparoscopy according to indications;
removal of retroperitoneal organs under endoscopic control according to indications.
Depending on the level of knowledge, as well as on the basis of work experience, quantity, quality and type of diagnostic tests performed and therapeutic interventions, the certification commission decides on assigning the appropriate qualification category to the endoscopist.
www.laparoscopy.ru
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