Notice of the general office of the Ministry of Health on printing and distributing the "Quality Management Specification for the Operating Procedures for Centralized Allocation of Intravenous Drugs".

A, intravenous drug dispensing center (room) workflow

Clinicians issue intravenous infusion prescriptions or medication orders → information transmission of medication orders → pharmacists review → printing labels → labeling and dispensing → checking → mixing and dispensing → checking finished infusion products → packaging finished infusion products → placing them in closed containers in different wards, locking or sealing them → sending them to wards by staff → unlocking (or unsealing) and checking and signing them by drug nurses in wards → Before giving drugs to patients, nurses should check with medical records and medication orders again → passing intravenous infusion.

Second, clinicians prescribe prescriptions or medicines.

Doctors should follow the principle of safe, effective and economical rational drug use according to the diagnosis or treatment needs of patients, and make prescriptions or medication orders, and their information should be complete and clear.

The ward will send the long-term doctor's advice that the patient needs intravenous infusion the next day to the intravenous drug dispensing center (room) according to the specified time. The deployment method of temporary intravenous medication orders shall be stipulated by medical institutions according to the actual situation.

Three, review the prescription or medication orders operating procedures

Pharmacists responsible for reviewing prescriptions or medication orders review patients' intravenous infusion prescriptions or orders one by one to confirm their correctness, rationality and completeness. Mainly includes the following contents.

(1) Formal review: the contents of prescriptions or medication orders shall conform to the relevant provisions of the Prescription Management Measures and the Basic Specification for Case Writing, and the writing shall be correct, complete, clear and without omission.

(two) analysis and identification of clinical diagnosis and the consistency of the selected drugs.

(three) to confirm the correctness and suitability of the selected drug varieties, specifications, routes of administration, usage and dosage, and to prevent repeated administration.

(4) Confirm the compatibility of intravenous drugs, and analyze the compatibility and stability of drugs.

(5) Confirm the suitability of solvent selection.

(six) to confirm the suitability of intravenous drugs and their packaging materials.

(seven) to confirm the results of drug skin test and serious or special adverse drug reactions and other important information.

(eight) any questions or uncertain contents that need to be further verified with the doctor.

If there is any mistake in the prescription or medication order, you should communicate with the prescription doctor in time and ask him to adjust and sign it. For special drugs such as overdose due to illness, the doctor should sign again for confirmation. Prescriptions or doctor's orders that are wrong or cannot guarantee the quality of finished infusion should be rejected.

Four, print labels and label management procedures

(1) After the data of prescriptions or medication orders reviewed by pharmacists are summarized, they are printed into infusion prescription labels (hereinafter referred to as infusion labels) in units of wards. Check the patient's name, ward, bed number, medical record number, date, deployment date, time and expiration date on the infusion labels, arrange the infusion labels according to the prescription nature and administration time, and put them in containers with different colors (different batches) to facilitate deployment operation.

(two) infusion labels are automatically generated by the computer system, and the numbering method is determined by each medical institution.

(3) Printing infusion labels shall be carried out by cpoe operation or synchronous printing of spare infusion labels in accordance with the relevant provisions of the Quality Management Specification for Centralized Configuration of Intravenous Drugs. The infusion label shall be affixed to the infusion bag (bottle), and the spare infusion label shall be kept for 65,438+0 years for future reference together with the deployment process, and shall be signed or sealed by the operators in each post.

(four) the contents of the infusion label should not only comply with the relevant regulations, but also indicate the following items that need special tips:

1. Allergy test should be carried out according to regulations, or the infusion label of some special drugs should be clearly marked;

2. Pharmacists should pay special attention and suggestive attention when preparing or dispensing drugs, such as the conversion of drug concentration, the actual dosage of non-bottle (branch) drugs, etc.

3. Matters needing special attention in the process of clinical medication, such as special dropping speed, dark drip, special medication monitoring, etc.

Five, labeling and inspection procedures

(a) pharmacists should carefully read and check whether the infusion label is accurate and complete before dispensing. If there is any error or incompleteness, they should inform the reviewing pharmacists to proofread and correct it.

(2) Put the drugs in the order listed in the infusion label, and put them in containers of different colors in batches according to the nature of the drugs and different medication time; According to the disease area and different drug properties, they are placed in different mixed areas.

(3) When placing drugs, it is necessary to check whether the name, dosage and specifications of the drugs are consistent with the contents on the label, and at the same time, it is necessary to pay attention to the integrity and expiration date of the drugs, and sign or seal them.

(4) Precautions for dispensing:

1. When dispensing, make sure that the batch number of the same drug used by the same patient is the same;

2. The drugs should be wiped clean before entering the clean room, but the bottle cap of penicillin for injection should not be removed;

3. The used containers should be cleaned, scrubbed and disinfected according to the regulations every day for the next use.

(5) Supplementary drugs in the drug preparation room:

1. After dispensing medicine every day, the medicines in short supply in the dispensing preparation room should be replenished and checked in time;

2. Auxiliary drugs should be removed from the outer packaging in special areas. At the same time, it is necessary to check the validity period and production batch number of drugs to prevent dislocation. If there is dust, it should be wiped clean before it can be put on the shelf.

3. Pay attention to the validity period of drugs when supplementing drugs, and use them first in advance and first in the near future;

4. High-risk drugs such as potassium chloride injection should have special marks and fixed positions.

(6) pendulum medicine inspection procedures:

1. Stick the infusion label neatly on the infusion bag (bottle), but don't cover the original label;

2 pharmacists should review and sign or seal;

3. Send the containers containing injections and labeled infusion bags (bottles) into the operation room of clean area through the transfer window, and put them on the medicine rack (car) according to the ward code.

Six, intravenous drug mixed deployment program

(1) Preparation before deployment:

1. 30 minutes before the start of operation, start the clean room and laminar flow workbench purification system according to the operating procedures, and confirm that they are in normal working condition. The room temperature in the operation room is controlled at 18℃ ~ 26℃, and the humidity is 40% ~ 65%. The indoor and outdoor pressure difference meets the requirements, and the operator shall record and sign it.

2. Successors should read the handover records first and deal with related problems in time;

3. Enter the operation room in the clean area according to the changed operation rules. First, wipe all the parts in the laminar flow cleaning table from top to bottom and from inside to outside with a non-woven fabric soaked with 75% ethanol.

(2) Push the medicine cart with the medicine container to the corresponding position near the laminar clean operating table.

(3) Proofreading before blending: the blending pharmaceutical technicians check the accuracy and completeness of the drug name, specification, quantity and expiration date according to the infusion label, and enter the mixed blending operation procedure after confirmation.

(4) Deployment procedures:

1. Select a suitable disposable syringe, remove the outer packaging, connect the syringe with the rotating needle, ensure that the bevel of the needle tip is consistent with the calibration direction of the syringe, and place the syringe vertically in the laminar flow cleaning table;

2. Disinfect the dosing place of infusion bag (bottle) with 75% ethanol and place it in the central area of laminar flow cleaning table;

3. Remove the cap of the penicillin bottle, disinfect the bottleneck or rubber stopper of the penicillin bottle with 75% ethanol, and open the ampoule bottle on the side wall of the laminar flow cleaning table. The ampoule bottle should avoid opening towards the high-efficiency filter to prevent the liquid from splashing on the high-efficiency filter;

4. When extracting the liquid medicine, the inclined plane of the needle tip of the syringe should face upwards, extract the liquid medicine close to the bottleneck of the ampoule, and then inject it into the infusion bag (bottle) and gently shake it;

5. Dissolved powder injection: use a syringe to extract an appropriate amount of solvent for intravenous injection and inject it into a penicillin bottle for injection. If necessary, gently shake (or put it on the oscillator) to help dissolve. After all the solutions are dissolved and mixed, use the same syringe to extract the liquid medicine, inject it into the infusion bag (bottle) and shake it gently;

6. After deployment, check the infusion label and the name, specification and dosage of the drugs used again. After it is accurate, the deployment operator shall sign or seal the infusion label, mark the deployment time, and put the prepared finished infusion, empty penicillin bottles and ampoules, spare infusion labels and other related information into the basket for inspection by inspectors;

7. Send the finished product infusion to the finished product inspection area through the transfer window, and enter the finished product inspection and packaging procedure;

8. After completing a group of infusion deployment operations, immediately clean up the site, wipe the table with a non-woven fabric soaked with 75% ethanol to remove the residual liquid medicine, and do not leave drugs, residual liquid, used syringes and other items irrelevant to the next batch of infusion deployment.

(five) after the deployment work every day, clean and disinfect in accordance with the cleaning and disinfection procedures and operating procedures of this specification.

(6) Matters needing attention in mixing intravenous drugs:

1. Cross-deployment processes are not allowed;

2. If the dosage of intravenous drug preparation is not the whole bottle (branch), the actual dosage must be clearly marked on the infusion label for proofreading;

3. If more than two kinds of powder injections or injections need to be added in the same infusion, they should be added in strict accordance with the requirements of the drug instructions and the order of drug properties; For the preparation of parenteral nutrition solution, high-risk drugs and some special drugs, the relevant operating procedures for the preparation and administration sequence should be formulated;

4. In the process of deployment, when the infusion is abnormal or there are doubts about drug compatibility and operating procedures, the deployment should be stopped, and the reason should be found out by reporting to the pharmacist on duty, or the medication order should be adjusted through consultation with the prescriber; Deployment errors should be corrected in time, redeployed and recorded;

5. Matters needing attention in handling dangerous drugs:

(1) Pay attention to the occupational protection of operators when preparing dangerous drugs. When preparing, the protective glass of the biosafety cabinet should be pulled down, and the front glass should not be higher than the safety warning line to ensure negative pressure;

(2) After the preparation of dangerous drugs is completed, the penicillin bottles and ampoules containing dangerous drugs must be placed separately in appropriate packages and sent out together with the finished infusion and spare infusion labels for verification;

(3) Disposable syringes, gloves, masks, penicillin bottles, ampoules and other wastes used for the preparation of dangerous drugs shall be uniformly treated by this medical institution in accordance with regulations;

(4) Handling of leakage of dangerous drugs shall be carried out in accordance with relevant regulations.

Seven, finished infusion inspection, packaging and distribution procedures

(a) finished infusion inspection and verification procedures:

1. Check the infusion bag (bottle) for cracks, and the infusion should be free of precipitation, discoloration and foreign bodies.

2. Carry out extrusion test to observe whether the infusion bag leaks, especially at the dosing place;

3. Check whether the name, specification and dosage of the used infusion and empty penicillin bottles and ampoules are consistent one by one according to the contents of the infusion label;

4. Check whether the dose of patients who have not used the whole bottle (branch) is consistent with the label;

5. Whether the signatures of the operators in each position are complete, and the checker shall sign or seal them after confirmation;

6. After verification is completed, waste such as empty ampoules should be disposed of in accordance with regulations.

(2) Qualified finished infusion products are packed in suitable plastic bags, neatly placed in sealed containers marked with wards according to wards, and the delivery time and quantity are recorded in the delivery register. There should be eye-catching marks on the outer packaging of dangerous drugs.

(3) Lock or seal the closed container. Keys are kept by the deployment center and wards, and delivered to each ward by the food delivery staff in time. After unlocking or unsealing, the nurses in the ward should check them one by one and indicate the handover time. Sign the distribution register after it is correct.

Eight, intravenous drug deployment required drugs and materials recipients management procedures.

(1) The collection, storage and maintenance of drugs and materials shall be the responsibility of special personnel.

(2) Drug demand:

1. The application for drugs in the intravenous drug distribution center (room) should be based on the daily dosage, fill in the drug application form, and apply to the pharmacy regularly. The drug application form shall be signed by the person in charge or the designated person;

2. The intravenous drug allocation center (room) shall not allocate prescriptions other than intravenous drug allocation;

3. The intravenous drug allocation center (room) shall not directly purchase drugs, and all the drugs needed shall be purchased and supplied by the pharmacy department (library).

(3) drug acceptance:

1. Pharmacists responsible for the management of secondary drug warehouses should check the drug quality standards, application forms, drug delivery vouchers and physical objects one by one, including whether the product name, specifications, quantity and expiration date are correct, whether the drug labels and packaging are clean and intact, and put them in the corresponding fixed storage space after passing the inspection, and sign the drug delivery vouchers;

2. There are doubts about the quality of drugs, the specifications and quantity of drugs are inconsistent, expired or damaged. , should communicate with the pharmaceutical department (library) in time, return drugs or replace drugs, and make records.

(four) the storage management and maintenance of drugs:

1. The drug warehouse should be clean, the ground should be flat and dry, and the width of doors and passages should be convenient for carrying drugs and meet the fire safety requirements; Drug storage should be located and stored according to the method of "partition classification and location number", and stored centrally according to the nature of drugs; Clear warning signs should be set for high-risk drugs; And should do a good job in monitoring and recording the temperature and humidity of the drug storehouse;

2. The drug storehouse has the temperature and humidity conditions to ensure the storage requirements of drugs and materials: 10℃ ~ 30℃ in the normal temperature area, not higher than 20℃ in the cool area, 2℃ ~ 8℃ in the cold storage area, and the relative humidity in the storehouse is 40% ~ 65%;

3. The distance between drug stacking and heat dissipation or heating facilities shall not be less than 30cm, the distance between walls shall not be less than 20cm, and the distance between the roof and the ground shall not be less than10cm;

4. Standardize the stacking and handling of drugs, comply with the requirements of graphic identification on drug packaging, and do not store them upside down;

5. Each drug should be stacked in sequence or separately according to the batch number and expiration date, and clearly marked, following the principles of "first production and first use", "first use in advance", "first use in the near future" and drug use according to batch number;

6. There should be standardized systems and records for the confirmation, loss reporting and destruction of unqualified drugs.

(5) Medical institutions that have established hospital information systems should establish an electronic drug information management system, and the drug inventory should establish electronic network transmission links with the first-class library, and strengthen the drug cost accounting and accounting management system.

(six) the drugs used in the intravenous drug allocation center (room) should be counted on a monthly basis, and the accounts are consistent. If there is any discrepancy, the reasons shall be found out in time.

(7) The collection and management of materials such as syringes and injection needles shall be carried out in accordance with the relevant provisions of this specification and with reference to the Measures for the Administration of Drug Collection and Acceptance, and shall be stored separately from drugs.

Nine, the electronic information system deployment of intravenous drug use program

(a) electronic information system intravenous drug dispensing process:

1. The doctor is responsible for inputting patients' prescriptions or medication orders into the computer in groups according to the Prescription Management Measures and the Basic Specification for Electronic Medical Records (Trial);

2. Give the intravenous infusion orders directly to the intravenous drug dispensing center (room);

3. Pharmacists will automatically generate infusion labels and back up infusion labels or use electronic prescription information system records after reviewing the suitability of prescriptions or medication orders. The labels or records should have the information of operators in each process.

(two) the establishment of electronic drug information management system. Prescriptions or medication orders are printed into infusion labels, and after the deployment operation process is completed, the number of drugs stored in the secondary library of prescription drugs is automatically subtracted, so that the accounts are consistent with the contents, and the monthly balance report of drugs is automatically formed.

Ten, intravenous drug allocation center (room) personnel change clothes operation procedures

(a) in and out of the intravenous drug allocation center (room) dressing change procedures. In and out of the intravenous drug allocation center (room) should change the center (room) work clothes, work shoes and wear a hair cap. Personnel who are not in the center (room) shall not enter without the consent of the person in charge of the center (room).

(2) Rules for entering 1 00000 clean zone (1):

1. Replace ordinary work clothes and work shoes, and disinfect your hands and dry them according to the six-step hand cleaning and disinfection method;

2. Wear designated clothes, hair bands and masks.

(3) Rules for entering the 10,000-level clean zone (2):

1. Replace special shoes and clean isolation suits in the clean area;

2. Disinfect your hands and put on disposable gloves.

(4) Procedures for leaving the clean area:

1. Temporary outing: Take off clean isolation suits, hats and masks in the second shift room and put them in order, and throw disposable gloves into the dirt bucket; Work clothes and work shoes should be replaced in the shift room;

2. Re-entering the cleaning area, you must change clothes in the cleaning area according to the above procedures;

3. After one-day deployment, take off special shoes and clean isolation suits in the clean area for routine disinfection, and clean them at least twice a week; Disposable masks and gloves are thrown into the dirt bucket together.

Eleven, intravenous drug allocation center (room) cleaning and disinfection procedures.

(1) Selection and preparation of ground disinfectant;

1. Sodium hypochlorite is 5% strongly alkaline solution, and 1% solution is used for ground disinfection. The solution must be freshly prepared before use, and thick masks and protective gloves must be worn when handling/repackaging high-concentration 5% sodium hypochlorite solution;

2. Corrosive quaternary ammonium cationic surfactant; It is forbidden to mix with soapy water and anionic surfactant, and it should be freshly prepared before use;

3. Cresol soap solution is corrosive and used for ground disinfection. It is a 5% solution and should be freshly prepared before use.

(2) Other provisions on the cleaning and hygiene management of the intravenous drug dispensing center (room):

1. Items unrelated to the nature of the operation room shall not be stored in each operating room, and meals shall not be placed in the intravenous drug dispensing center (room);

2. After the daily work, the site should be cleaned in time, and all kinds of wastes must be disposed of in time every day.

(3) Cleaning and disinfection procedures for non-clean areas:

1. After daily work, scrub the floor with a special mop, and wipe the workbench, stool chair, door frame, door handle, plastic basket, etc. Use normal water;

2. Disinfect the floor and dirt bucket once a week: first clean it with ordinary water, then scrub the floor and dirt bucket with disinfectant after drying, and wipe off the disinfectant with ordinary water after 15 minutes;

3. Wipe the disinfection workbench, closed container for finished product delivery, medicine cart, stainless steel equipment, stools and chairs, door frames and door handles once a week with 75% ethanol.

(4) Cleaning and disinfection procedures for ten thousand clean areas:

1. Daily cleaning and disinfection: After mixing, clean the stainless steel equipment, the laminar operating table and the inner walls on both sides, the top of the transmission window, the inner walls on both sides, the handle and the table, the chair and the lighting switch. Wipe and disinfect with 75% ethanol;

2. Clean and disinfect the ground in accordance with the prescribed operating procedures every day;

3. The walls and ceilings shall be cleaned and disinfected once a month, and the operation procedures are the same as above.

(5) Precautions for cleaning and disinfection:

1. Disinfectant should be used in rotation regularly;

2. The cleaning tools in the cleaning area and the general auxiliary work area must be strictly separated and shall not be mixed;

3. In the process of cleaning and disinfection, ordinary water or disinfectant shall not be sprayed on the high efficiency filter;

4. When cleaning and disinfecting, wipe from top to bottom and from inside to outside, leaving no dead ends;

5. When cleaning with ordinary water, only after drying can it be wiped with disinfectant to ensure the cleaning and disinfection effect.

Twelve, biological safety cabinet operation procedures

Biosafety cabinet belongs to vertical laminar flow platform. Through the high-efficiency filter at the top of the laminar flow table, 99.99% of particles above 0.3μm can be filtered, so that the operating table space forms a local clean environment of 100, and the return air around the table forms a relative negative pressure. Therefore, there should be no object blocking the divergent hole, including the arm. Biosafety cabinets used to prepare dangerous drugs should be equipped with activated carbon filters to filter harmful gases.

(1) cleaning and disinfection:

1. Before the operation starts every day, 75% ethanol should be used to wipe the top, sides and countertops of the work area in the order from top to bottom and from inside to outside;

2. During the preparation process, after each infusion preparation, normal water should be used to clean and wipe the waste on the operating table, and 75% ethanol should be used to disinfect the table when necessary;

3. Every day after the operation, it should be thoroughly cleaned, washed with ordinary water first, and then wiped and disinfected with 75% ethanol;

4. Open the cover of the return air channel after operation every day, first clean the return air channel with distilled water, and then wipe it with 75% ethanol for disinfection.

(II) Operation and precautions of biosafety cabinet:

1. There are 1 2 deployment personnel who start the circulating fan and ultraviolet lamp of the biological cabinet half an hour in advance, close the front window to the safety line, turn off the ultraviolet lamp 30 minutes later, then wipe the top, side and countertop of the biological safety cabinet with 75% ethanol, disinfect it from top to bottom and from inside to outside in turn, and then turn on the lighting before deployment;

2. During the start of the ultraviolet lamp, it shall not be unfolded, and the staff shall leave the operation room;

3. The ultraviolet lamp should be tested regularly. If the sterilization effect cannot be achieved, the lamp tube should be replaced in time;

4. All intravenous drug dispensing must be carried out in an area 20 cm away from the outer edge of the workbench, 8 ~ 10 cm away from the workbench and at least 10 cm away from the workbench;

5. When deploying, the front window should not be higher than the safety warning line, otherwise the negative pressure in the operation area cannot be guaranteed, which may lead to the diffusion of drug aerosol, injury to staff or pollution of the clean room;

6. The air return pipe of biosafety cabinet should be cleaned with distilled water regularly, and then disinfected with 75% ethanol;

7. Biosafety cabinets should monitor settling bacteria once a month. Methods: Open the Petri dish, put it on the operating table for half an hour, cover it, and then carry out bacterial culture and colony count.

8. The biological safety cabinet should replace the activated carbon of the filter in time according to the automatic monitoring instruction.

(3) Test the parameters of the biosafety cabinet every year to ensure the operation quality of the biosafety cabinet, and save the test report.

Thirteen, horizontal laminar flow clean workbench operation procedures

(1) The correct placement and operation of articles on the horizontal laminar flow clean table is an important factor to ensure the working quality of the clean table. The air blown from the horizontal laminar flow clean table is filtered by a high-efficiency filter, which can remove 99.99% particles with a diameter greater than 0.3 mm and ensure the flow direction and speed of the air. The air inlet of the horizontal laminar flow table used for intravenous drug dispensing operation should be at the top of the workbench, so that the cleanest air can enter the workbench first, and the lower support part of the workbench can ensure air circulation. This laminar flow cleaning table can only be used to prepare drugs that are harmless to workers, such as electrolyte drugs and parenteral nutrition drugs.

(2) cleaning and disinfection:

1. Every day before the operation, 1 2 deploys personnel to start the circulating fan and ultraviolet lamp of the horizontal laminar flow table in advance, turn off the ultraviolet lamp after 30 minutes, then wipe the top, sides and table top of the laminar flow cleaning table with 75% ethanol, and disinfect it from top to bottom and from inside to outside; Then turn on the lighting lamp before deployment;

2. In the deployment process, after each infusion deployment, normal water should be used to clean the waste on the operating table, and 75% ethanol should be used to disinfect the table when necessary;

3. After daily deployment, it should be thoroughly cleaned, washed with ordinary water first, and then wiped and disinfected with 75% ethanol.

(3) Operation and precautions of horizontal laminar clean workbench:

1. The horizontal laminar flow cleaning table can be started half an hour before intravenous drug deployment;

2. Too many items should be avoided on the operating table, and the distance between larger items is about15 cm; The placement distance between small items is about 5 cm;

3. The sterile articles on the clean workbench should ensure that clean air flows in the first time, that is, there should be no objects between the articles and the high-efficiency filter, which is also called "window opening";

4. Avoid any liquid substance splashing into the high-efficiency filter, which is easy to break and breed mold once it is wet;

5. Avoid placing objects too close to the HEPA filter. All operations should be carried out in the work area. Don't put your wrist or elbow on a clean workbench, and keep an "open window" at all times;

6. Avoid strenuous exercise and loud noise in the clean room, and strictly abide by the aseptic operation procedures;

7. The horizontal laminar clean workbench can be divided into three areas:

(1) inner area, the area closest to the high-efficiency filter, is about 10 ~ 15 cm away from the high-efficiency filter, and is suitable for placing unpacked sterile articles such as opened ampoules.

(2) The working area, that is, the central part of the workbench, is 10 ~ 15 cm away from the edge of the clean workbench, and all deployments should be completed in this area;

(3) The outer area, from the edge of the table to the area of 15 ~ 20cm, can be used for placing syringes with outer packaging and other articles with outer packaging (it should be put as little as possible).

8. After cutting the ampoule with a grinding wheel and opening the injection hole cover of the penicillin bottle, carefully wipe and disinfect it with 75% ethanol to remove particles, and the direction of opening the ampoule should be far away from the high-efficiency filter;

9. The horizontal laminar clean workbench should be dynamically monitored once a week. Methods: Open the Petri dish, put it on the operating table for half an hour, cover it, and then carry out bacterial culture and colony count.

(4) Each parameter of the horizontal laminar clean workbench shall be tested every year to ensure the running quality of the clean workbench, and the test report shall be kept.

Fourteen others

Medical institutions to carry out other centralized or decentralized clinical intravenous drug deployment, with reference to the above-mentioned relevant operating procedures, the specific implementation procedures are formulated by medical institutions.