I. Hemodialysis is one of the renal replacement therapies on which chronic renal failure patients rely, and it also creates conditions for patients with acute renal failure to completely or partially restore renal function. Hemodialysis requires the patient's blood to be drawn out of the body, and the blood is exchanged with the dialysis fluid in the dialyzer for the purpose of removing metabolic wastes from the body, discharging excess water from the body, and correcting electrolyte and acid-base balance. In recent years, it is also an important means of rescue for poisoning and other acute and critical diseases. Second, the establishment of the provincial hemodialysis quality control department, mainly on the province's hemodialysis diagnosis and treatment activities to carry out comprehensive quality control, and commissioned by the provincial health department to check the medical institutions hemodialysis work carried out. It carries out technical training and relevant technical evaluation and assessment. Medical institutions carrying out hemodialysis technology should be equipped with at least 4 dialysis machines and have access to the technology and personnel by the Provincial Department of Health. Fourth, medical institutions carrying out hemodialysis technology shall meet the requirements of this specification, establish and improve the quality control system, and strictly abide by the provisions of hospital infection management and disinfection and isolation, so as to prevent the resulting medical infections; the reuse of dialyzers shall be carried out in strict accordance with the Code of Practice for the Reuse of Hemodialyzers formulated by the Ministry of Health, so as to ensure the safety of the patients. V. The medical and nursing personnel engaged in hemodialysis treatment shall accept the training organized by the provincial health administrative department, and shall be allowed to be on duty only after passing the examination. Chapter II Basic Requirements for Hospital Qualification
I. The foundation of internal medicine work A good foundation of internal medicine work, able to independently complete the basic diagnosis and treatment programs, with the ability to independently deal with common diseases in internal medicine. II. Setting up an independent nephrology department (or nephrology group of internal medicine) Possessing a good working foundation of nephrology and being able to complete basic diagnostic and treatment programs independently. Renal internal medicine wards (or internal medicine wards set up nephrology beds): there is a team of physicians specializing in renal internal medicine, with the ability to independently deal with common diseases in renal internal medicine. Third, hemodialysis room (center) Hemodialysis room (center) (referred to as hemodialysis room) shall have dialysis area, water treatment area, treatment room, waiting room and other basic functional areas; there shall be dialysis machine, water treatment device and basic equipment for rescue in accordance with regulations; establish and implement disinfection and isolation system, quality testing system for dialysis solution and dialysis water and water treatment equipment, technical operation specification, and equipment checking and maintenance system; There is a complete file management system for medical records: including the informed consent of dialysis treatment patients, the record of the first disease course, the record sheet of dialysis treatment, and the laboratory test sheet. To establish a sound register of dialysis patients, with ordinary patients, isolated patients and emergency patients registered separately. IV. Ability to deal with acute and chronic dialysis complications and comprehensive resuscitation Have medical technical support from anesthesiology, intensive care unit, radiology, laboratory and major internal medicine. V. Medical institutions carrying out hemodialysis technology must obtain the local environmental protection department's sewage discharge license.
Chapter III Hemodialysis Room (Center) staffing and responsibilities
I. Physician (a) Director of the hemodialysis room: should have extensive clinical experience, skilled in nephrology diagnosis and treatment of operational techniques and overall management capabilities of the nephrology specialist physician as. The director of the hemodialysis room with less than 10 dialysis machines shall be a person with the technical title of attending physician or above, and the director of the hemodialysis room with more than 10 dialysis machines shall be a person with the technical title of deputy chief physician or above. Duties of the director of the hemodialysis unit: responsible for the overall management and quality control of the hemodialysis unit, conducting regular checkups and solving difficult clinical problems; supervising and evaluating the quality of dialysis and preventing and controlling hospital infection; formulating and implementing the management system, routine and operation procedures of the dialysis center in accordance with the requirements of the standardization of dialysis, arranging for the medical treatment, teaching and scientific research, and organizing the business study and technical examination. (b) Physicians shall be specialized physicians who have undergone specialized training in nephrology and mastered comprehensive nephrology diagnosis and treatment techniques. Duties of hemodialysis room physician: responsible for patient dialysis arrangements, dialysis program development, adjustment; treatment of acute and chronic complications; room visits; monitoring and evaluation of the quality of patient dialysis; record and keep dialysis patient data; fill in the quality report form every three months (including the unit of hemodialysis room environmental hygiene monitoring results; dialysis water, dialysis fluid bacterial counts, endotoxin measurement results, etc.); strict implementation of the relevant systems of hospital infection management, if any. Infection management and other related systems, if there are difficult problems, they should report to the superior physician in time. (c) The ratio of nephrologists and dialysis machines in the hemodialysis unit shall not be less than 1:5. Nurses (a) The hemodialysis unit shall be equipped with a head nurse and nurses; for the hemodialysis unit with less than 10 dialysis machines, the head nurse shall be the person with the technical title of chief nurse or above in renal specialties, and for the hemodialysis unit with more than 10 machines, the head nurse shall be the nurse with the ability to manage the unit with comprehensive management, who has rich clinical experience and has been working in the unit for more than 5 years. (ii) Nurse manager: Responsible for the management of dialysis unit. (ii) Duties of the head nurse: responsible for the implementation of rules and regulations on nursing and hospital infection; the organization, implementation and supervision of technical training and operation procedures; the management of medical supplies; assisting the director of the dialysis room to carry out daily management work; and completing the summary of various reports such as patients' bills, workload, and all kinds of nursing records. (C) Nurses' duties: strictly implement the rules and regulations; strictly implement the operation according to the hospital infection management system; implement the dialysis medical instructions; skillfully master the operation of various hemodialysis machines and various vascular access; closely observe the condition during the dialysis process, observe the operation of the machines, carefully make records, and carefully check and check, so as to prevent the occurrence of errors. (d) Configuration of nurses in hemodialysis room: The configuration of nurses in hemodialysis room should be set up according to the number of dialysis machines and patients and dialysis environment, so as to ensure the normal progress of hemodialysis and patient safety. In principle, the ratio of nurses and dialysis machines should not be less than 1:2 at least. iii. Technician: The hemodialysis room with more than 10 dialysis machines should be equipped with one full-time technician. Units with less than 10 dialysis machines can be assigned a part-time technician. The technician should have relevant professional knowledge and be trained accordingly, be familiar with the performance, structure, working principle and maintenance technology of dialysis machine and water treatment equipment, and be responsible for their daily maintenance to ensure normal operation; be responsible for the implementation of quality monitoring of dialysis water and dialysate to ensure that it meets the relevant quality requirements; and be responsible for the registration of the operation of all the equipments. (i) Maintenance and upkeep of dialysis machines. Daily inspect the working condition of dialysis machine and water treatment machine; supervise the disinfection and de-calcification of the machine; regularly check and correct the conductivity, blood pump speed, dialysate temperature, flow rate, ultrafiltration volume, arterial pressure, venous pressure, trans-membrane pressure, etc., and regularly change the filters and cartridges of the on-line hemofiltration machine. Discover problems and make records in time to ensure the normal operation of dialysis machine. (ii) Maintenance of water treatment system. Monitor the working condition of each component of the water treatment system, and regularly flush, disinfect and register the water treatment system according to the requirements of the equipment. Problems should be dealt with in time and records should be made to ensure the normal operation of the water treatment system and to ensure that the water quality meets the requirements. Fourth, continuing education physicians, nurses and technicians should participate in relevant continuing education each year, according to the provisions of the corresponding credits.
Chapter IV hemodialysis room (center) layout and basic requirements
hemodialysis room according to the actual need for reasonable layout, must have dialysis area, water treatment area, treatment room, waiting area and other basic functional areas, distinguish between clean and polluted areas.
I. Dialysis treatment room
(a) dialysis treatment room should reach the hospital disinfection health standards (GB15982-1995) in the provisions of the Class III environment, and keep quiet, light enough. Equipped with air sterilization devices, air conditioning, etc.. Keeping the air fresh, ventilation fans should be used when necessary. The floor of dialysis treatment room should use acid-proof material and set up floor drain.
(B) a dialysis machine and a bed (or chair) called a dialysis unit, dialysis unit spacing according to the bed spacing can not be less than 0.8 meters, the actual occupied area of not less than 3.2 square meters. Each dialysis unit should have a power outlet group, reverse osmosis water supply interface and waste dialysate drainage interface (the central liquid supply system should have dialysate interface), and the dialysis room should be equipped with oxygen supply device, central negative pressure interface or movable negative pressure suction device. According to the environmental conditions, it can be equipped with network interface, headset or call system.
(c) Dialysis treatment rooms should have a dual circuit power supply. If there is no two-way power supply, in the event of a power failure, the hemodialysis machine should be equipped with appropriate safety devices to ensure that the extracorporeal circulation of blood back to the patient's body.
(d) The nursing station is located in a place where it is easy to observe and handle patients and equipment operation. There are treatment carts (containing the necessary items and drugs for hemodialysis operation), rescue carts (containing the necessary rescue items and drugs) and rescue equipment (such as cardiac monitoring, defibrillator, simple respirator, etc.).
(e) special dialysis room should be set up for infectious diseases isolation treatment room or isolation area (for AIDS and infectious hepatitis B, hepatitis C patients should be isolated dialysis); the conditions of the unit should be set up in the rescue room for critically ill patients.
Treatment room
The treatment room should meet the requirements of Class III environment stipulated in Hospital Disinfection Health Standard (GB15982-1995). The medicines that need to be used in dialysis such as erythropoietin, heparin saline, ichthyoglobin, antibiotics, etc. should be prepared in the treatment room and used now; the spare disinfected items (suture kit, phlebotomy kit, sterile gauze, etc.) should be stored in the treatment room for spare.
Third, storage
Dialyzers, tubing, puncture needles and dialysis powder and other consumables should be stored in the storage room, which should be in line with the Hospital Disinfection Hygiene Standards (GB15982-1995) stipulated in the Class III environment.
Four, water treatment room
The area of the water treatment room should be more than 1.5 times of the floor area of the water treatment machine; the ground bearing should meet the requirements of the equipment; the ground should be waterproof and set up floor drains. Water treatment room should maintain a suitable room temperature, and have good sound insulation and ventilation conditions. Water treatment equipment should avoid direct sunlight to prevent algae growth in the light-permeable part. Water treatment equipment should have a sink where it is placed to prevent water leakage. Water treatment machine should meet the requirements of the tap water supply, the entrance to the installation of pressure gauges, inlet pressure should meet the requirements of the equipment.
V. Staff and patient changing area
Staff and patient changing area should be separated, the size of the patient changing area should be decided according to the actual number of patients in the hemodialysis room, in order not to be crowded, comfortable to the extent. Staff in the changing area to change the work clothes, work cap and work shoes before entering the dialysis treatment room and treatment room. Chairs (sofas) and lockers are set up in the patients' changing area, and patients can enter the dialysis treatment rooms only after changing the slippers prepared by the hemodialysis room. Slippers are used exclusively by each patient and cleaned regularly, and should be sterilized according to the standard requirements when contaminated. Change the bed sheet at each dialysis.
Sixth, receiving area
After changing slippers, patients are weighed and measured in the receiving area, blood pressure and pulse rate are measured, etc. (serious patients are completed on the dialysis bed), and the medical staff determines the treatment plan of the patient for this dialysis, and prescribes medicines and laboratory tests.
Seven, the medical staff office and living room
can be configured according to the actual situation (such as office, dining room, bathroom, case file room, duty room, etc.).
VIII. Polluted area
The polluted area is used for temporary storage of domestic garbage and medical waste, which should be stored separately and handled separately. Medical waste includes used dialyzers, tubing, puncture needles, gauze, syringes, medical gloves and so on.
Chapter V Basic Requirements for Equipment in Hemodialysis Rooms (Centers)
The water treatment system used in hemodialysis rooms, hemodialysis machines, hollow fiber dialyzers, hollow fiber filters, adsorbents, plasma separators, dialysis lines, arterial and venous needles, etc., should be used in accordance with the State Food and Drug Administration, the Ministry of Health announced Class III medical devices (blood purification equipment and blood purification). Apparatus, No. 6845-04) for management.
I. Dialysis machine
Dialysis machine must have the registration certificate issued by the State Food and Drug Administration can be put into clinical use. Dialysis machine should be used in the environment specified in the equipment (including temperature, humidity, voltage, water supply pressure), and operated according to the requirements to ensure the normal operation of the machine and patient safety. Maintenance should be carried out according to the instructions of the equipment.
The hemodialysis laboratory should establish a file for each dialysis machine, including the dialysis machine factory information (technical information and operation information) operation running and maintenance records.
Second, the water treatment equipment
Water treatment equipment must have the registration certificate issued by the State Food and Drug Administration can be put into clinical use. Water treatment equipment should be used in the equipment specified environment (including temperature, humidity, voltage, water supply pressure) to ensure the normal operation of the machine, the supply of adequate reverse osmosis water.
The water treatment equipment includes a pre-treatment system, a reverse osmosis machine and a reverse osmosis water supply system. The pre-treatment system should be configured accordingly to the water quality. Reverse osmosis water supply line should not have open water storage devices to prevent secondary pollution. Reverse osmosis water supply lines should be made of non-toxic materials and set up with circulation loops, avoiding blind ends and dead chambers as much as possible to prevent bacterial growth and biofilm formation. If the water supply pressure is insufficient or often interrupted, you can set up raw water storage water device in front of the reverse osmosis machine.
Third, the maintenance and disinfection of the water treatment system:
The water treatment system must be maintained on a daily basis, the frequency of maintenance should be based on the results of water quality testing.
The maintenance of the water treatment system mainly includes reverse osmosis machine and reverse osmosis water supply pipeline cleaning, disinfection, pre-treatment system in the regeneration of water softener resin, activated carbon and sand filter backwash, filter replacement and reverse osmosis membrane pickling and replacement.
The cleaning and disinfection of the water treatment system should be carried out in strict accordance with the operating instructions or with the assistance of the manufacturer. The frequency of cleaning and disinfection should be determined by reference to bacterial culture results or according to the manufacturer's recommendations.
The hemodialysis laboratory should establish a file for the water treatment equipment, including water treatment equipment factory information (technical information and operational information), disinfection and flushing records, malfunction and maintenance records.
Fourth, dialysis equipment
All kinds of dialysis equipment should be stored in a qualified warehouse, and should be carefully examined before use for the period of use, and whether there is any packaging damage. Record the possible adverse reactions associated with them and the measures taken to deal with them.
Chapter 6: Basic Requirements for Dialysis Water and Dialysis Solution
I. Dialysis Water
Dialysis water should meet the requirements of Table-2 and Table-4, and be tested regularly according to the requirements of Table-1.
(I) The water quality monitoring of dialysis water shall be carried out on time, see Table-1:
Table-1: Monitoring requirements of dialysis water
Monitoring items Monitoring content Monitoring frequency Standard Water supply line near the end Endotoxin Quarterly Endotoxin < 1 EU/ml Reverse osmosis machine Conductivity, water yield Daily According to the data of the manufacturer of reverse osmosis machine Activated carbon tank Free chlorine Weekly Chlorine < 0.1mg/ml Reverse osmosis machine lt; 0.1mg/l Water softener Hardness Weekly < 17 PPM (ii) The quality of water used for dialysis is measured at least once a year and the criteria are given in Table-2 (refer to AAMI standards). Bacterial culture of dialysis water should be carried out monthly and endotoxin test of dialysis water should be carried out every 3 months. The results of the above tests and laboratory slips should be registered and retained so that any problems found can be resolved in a timely manner. The frequency of testing should be increased for newly installed water treatment systems or when problems with the water treatment system are suspected; if it is determined that there is a problem with the water treatment equipment that cannot be corrected in a timely manner, it should be discontinued. Table-2 Maximum Allowable Concentrations of Chemical Contaminants in Hemodialysis Water (AAMI Standards, 2004) Contaminant Maximum Allowable Concentration of Chemical Contaminants (mg/L) Calcium 2 (0.1 mEq/L) Magnesium 4 (0.3 mEq/L) Sodium 70 (3.0 mEq/L) Potassium 8 (0.2 mEq/L) Fluorine 0.2 Chlorine (free state) 0.5 Chloramines 0.1 Nitrates 2.0 Sulfate 100.0 Copper, barium, zinc 0.1 each Aluminum 0.01 Arsenic, lead, silver 0.005 each Cadmium 0.001 Chromium 0.014 Selenium 0.09 Mercury 0.0002 Antimony 0.006 Beryllium 0.0004 Thallium 0.002 II. Dialysate The dialysis solution concentrates and dialysate powders that are purchased must have a certificate of registration issued by the State Food and Drug Administration. Concentrates can be purchased directly from manufacturers or prepared by hospital preparation rooms qualified to prepare concentrates (with a "preparation license" issued by the State Food and Drug Administration and an approval number for the preparation of dialysis solutions, and the concentrated dialysis solutions prepared are for internal use only in this hospital). If the dialysis powder is purchased from the manufacturer, the dialysis center will dissolve and configure it by itself, and the preparation of the concentrated dialysis solution B (mainly containing bicarbonate) should be used now, and there must be a person in charge of it, and there is a person to verify it and sign the registration. The solute concentration of dialysate should be measured at least once a month (Table-3 shows the solute concentration of bicarbonate dialysate formulation), and bacterial culture should be measured at least once a month. Endotoxin testing is performed every 3 months. Table-3 Solute concentration of bicarbonate dialysate formulation Sodium (mmol/L) 135 to 145 Potassium (mmol/L) 0 to 4.0 Calcium (mmol/L) 0 to 1.75 Magnesium (mmol/L) 0.25 to 0.5 Chlorine (mmol/L) 102 to 106 Acetate (mmol/L) 2 to 4 Bicarbonate (mmol/L) 30 to 39 Glucose ( mmol/L) 0～11 pH value 7.1～7.3 Chapter VII Indications and contraindications for hemodialysis Hemodialysis room in the implementation of dialysis treatment should be based on the patient's condition, grasp the emergency dialysis and chronic renal failure patients with routine dialysis indications, dialysis should be strictly enforced in a variety of operating procedures to improve the efficacy of the treatment and prevention of complications. I. Indications for hemodialysis in chronic renal failure Even if there are no clinical symptoms, patients with chronic renal failure should undergo hemodialysis when the glomerular filtration rate (eGFR) drops to about 10ml/min, but patients with diabetes mellitus should start dialysis when the eGFR is less than 15ml/min. The alternative reference indexes of Ccr mainly include the following indexes: 1. Blood urea nitrogen ≥28.6mmol/L (80mg/dl). 2. blood creatinine ≥707.2umol/L (8mg/dl). 3. hyperkalemia:blood potassium ≥6.5mmol/L. 4. metabolic acidosis that is difficult to be corrected by drug therapy. 5. Signs of significant water retention (severe edema, elevated blood pressure and congestive heart failure). 6. Significant uremia manifestations such as anorexia, nausea and vomiting. The clinical manifestations and complications of different uremic patients vary greatly. For patients who do not reach the above indexes, but have severe clinical symptoms and ineffective internal medicine conservative treatment, dialysis physicians can decide the timing of dialysis according to their conditions. B. Indications of hemodialysis for acute renal failure Hemodialysis should be carried out if one of the following conditions occurs: (1) Diagnosis of acute renal failure is established, and volume-loaded hypertension and left heart failure occur; (2) Hyperkalemia: blood potassium ≥6.5mmol/L; (3) Blood creatinine ≥442mmol/L (5mg/dl); (4) Gastrointestinal tract or neuropsychiatric symptoms appear; (5) High catabolism (daily blood urea nitrogen rises more than 14.3mmol/L, blood creatinine rises more than 177umol/L or blood potassium rises more than 1mmol/L); (6) metabolic acidosis that is difficult to be corrected by drug treatment. Other indications (1) All kinds of drugs and poisonous substances are suitable for hemodialysis treatment; (2) Other diseases with hemodialysis indications. Relative contraindications to hemodialysis (1) Shock or systolic blood pressure lower than 10.7kPa (80mmHg). (B) Those with serious bleeding or bleeding tendency. (C) Serious cardiopulmonary insufficiency including arrhythmia, cardiac insufficiency or serious coronary heart disease. (D) Those with severe infections such as sepsis, or those with blood-borne infectious diseases. (v) Uncooperative patients.
Chapter VIII Hemodialysis treatment procedures and monitoring
I. Preparation of new patients for hemodialysis
(a) Before the new patient receives the first dialysis, the dialysis physician should communicate with the patient and the family, inform the patient's condition, dialysis precautions and so on, so that the patient fully understands the purpose of hemodialysis and the risks that may occur in the process of dialysis, and sign the informed consent for medical risk of hemodialysis, the informed consent for medical risk of hemodialysis, the informed consent for medical risk of hemodialysis, the informed consent for medical risk of hemodialysis, the informed consent for medical risk of hemodialysis, and the signed consent for medical risk of hemodialysis. The patient or relatives should sign the informed consent and power of attorney for the medical risks of hemodialysis, and the patients who need to reuse the dialyzer should also sign the application for reuse.
(2) For patients with chronic renal failure, it is recommended to establish a permanent arteriovenous fistula in advance, and for patients with acute renal failure and chronic renal failure requiring emergency dialysis, it is recommended to place a central venous catheter to establish a temporary vascular access, and it is not advocated to use arterial puncture for dialysis directly.
(3) Patients should be checked for hepatitis B, hepatitis C, AIDS, syphilis and other infectious disease markers before dialysis. Second, the dialysis program