Article 2 The term "plasma collection station" as mentioned in these Measures refers to the unit that collects and supplies raw plasma for the production of blood products after strict examination and approval according to the regional blood source resources and relevant standards and requirements. Plasma collection stations are established by blood products production units and have independent legal personality. No other unit or individual may engage in plasma collection activities.
Article 3 The term "plasma donors" as mentioned in these Measures refers to those who provide raw plasma for the production of blood products. Healthy citizens aged 18 to 55 who have local household registration in the designated plasma collection area may apply for registration as plasma donors.
Article 4 The Ministry of Health shall, according to the national demand for raw plasma for production, economic development and epidemic situation of diseases, formulate the guiding principles for the establishment planning of blood collection and supply institutions nationwide.
The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, according to the Guiding Principles for the Establishment Planning of Blood Collection and Supply Institutions of the Ministry of Health, and in combination with the actual situation of the disease epidemic situation and plasma supply capacity in their respective administrative regions and the local regional health development plan, formulate the planning for the establishment of plasma collection stations in their respective regions, and organize their implementation. The planning of apheresis plasma station should be reported to the Ministry of Health for the record.
Article 5 The Ministry of Health shall be responsible for the supervision and management of plasma collection stations nationwide.
The administrative department of health of the local people's government at or above the county level shall be responsible for the supervision and management of plasma collection stations within their respective administrative areas. Article 6 The establishment of plasma collection stations by blood product production units shall conform to the local planning for the establishment of plasma collection stations and be approved by the health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
Article 7 Plasma apheresis stations shall be set up in counties (banners) and county-level cities, and shall not be set up in the same county-level administrative area as general blood stations.
In areas where endemic diseases or blood-borne infectious diseases are prevalent and high-incidence, plasma collection stations shall not be planned.
In the municipal administrative area where the unpaid blood donation in the previous year and this year failed to meet the clinical use of blood, no new plasma collection station shall be built.
Article 8 The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, according to the actual situation, delimit the plasma collection areas of plasma collection stations. The selection of plasma collection area should ensure the number of plasma donors and meet the requirements of collecting raw plasma of not less than 30 tons per year. The newly-built plasma collection station will achieve an annual collection of not less than 30 tons within three years.
Article 9 The following conditions must be met for setting up a plasma collection station:
(a) in line with the planning of blood collection and supply institutions, the planning of plasma collection stations and the basic standards of plasma collection stations;
(2) Having health professionals suitable for the collected raw plasma;
(3) Having a place and sanitary environment suitable for collecting raw plasma;
(4) Having an identification system to identify the plasma donors;
(5) Having plasma collection machinery and other facilities suitable for the collected raw plasma;
(6) Having technicians and necessary instruments and equipment for quality inspection of the collected raw plasma;
(seven) in accordance with the relevant provisions of the national biosafety management.
Article 10 A blood product production unit applying for the establishment of apheresis plasma station shall submit an application for the establishment of apheresis plasma station to the health administrative department of the people's government at the county level where apheresis plasma station is located, and submit the following materials:
(a) the relevant information and legal person registration certificate of the blood products production unit applying for the establishment of the apheresis plasma station;
(two) the feasibility study report of the proposed plasma collection station. The contents include:
1. Basic information of the plasma collection station to be established, including name, address, scale, task, function and organizational structure;
2. Forecast and analyze the disease epidemic situation, healthy plasma donors of school age, institutional operation and environmental protection measures in the plasma collection area and the area where the plasma collection station is to be established;
3. The site selection and architectural design scheme of the proposed apheresis plasma station;
4 business projects and technical equipment applied for;
5 sewage, sewage and medical waste treatment plan;
(three) the certificate of property rights or the certificate of the right to use the place for the plasma collection station;
(four) the identity documents and professional resumes of the legal representative and principal responsible person of the plasma collection station to be established;
(five) the list of employees and qualification certificates of apheresis plasma station;
(six) the rules and regulations of the plasma collection station.
Eleventh any of the following circumstances, shall not apply for the establishment of a new plasma collection station:
(a) the plasma collection station to be set up does not conform to the planning of blood collection and supply institutions or the planning of local plasma collection stations;
(two) the provincial health administrative department does not agree to delimit the pulp mining area;
(three) the blood products production unit has been revoked the good manufacturing practice (GMP) certificate for less than 5 years;
(four) the production unit of blood products illegally collects plasma or calls plasma without authorization;
(five) the blood products production units registered less than six varieties of blood products, and the blood products production units undertaking the task of national immunization are less than five varieties.
Twelfth the following persons shall not serve as the legal representative or the main person in charge of the newly built plasma collection station:
(1) A person who is serving a sentence or does not have full capacity for civil conduct;
(two) the person responsible for the blood safety accident is less than 5 years;
(3) The legal representative, principal responsible person and responsible person of the apheresis plasma station or blood station whose apheresis plasma license has been revoked or whose practice license of blood station has not expired for 10 years;
(four) the legal representative or principal responsible person of the blood products production unit has been revoked the good manufacturing practice (GMP) certificate for less than five years;
(5) The legal representative, principal responsible person and responsible person of the apheresis plasma station ordered by the administrative department of health to make corrections within a time limit of more than 3 months or fined 5-65438+ 10,000 yuan for less than 3 years.
Article 13 The health administrative department of the people's government at the county level shall conduct a preliminary examination after receiving all the application materials, and report to the health administrative department of the people's government at the provincial level for examination and approval after being examined and approved by the health administrative department of the people's government of the city or autonomous prefecture divided into districts.
Article 14 After receiving the application materials for apheresis plasma stations, the health administrative department of the provincial people's government may organize relevant experts or entrust technical institutions to conduct technical review in accordance with the quality management standards for apheresis plasma stations.
Upon examination, if it meets the requirements, the administrative department of health of the provincial people's government shall issue a license for plasma apheresis, and report it to the Ministry of Health for the record within 10 days after examination and approval; If it does not meet the requirements after examination, it shall notify the applicant in writing of the reasons for disapproval.
Fifteenth applications for the establishment of apheresis plasma stations do not conform to the provisions of Article 9, Article 11 and Article 12 of these measures, and shall not be approved.
Sixteenth "plasma apheresis license" is valid for 2 years.
The main contents of "plasma apheresis license" are:
(a) the name of the blood product production unit that set up the plasma collection station;
(two) the name, address, legal representative or principal responsible person of the plasma collection station;
(three) business projects and pulp mining areas (scope);
(4) Issuing authority, issuing date, license number and validity period.
Seventeenth "plasma collection permit" three months before the expiration, the plasma collection station shall apply to the original issuing department for extension, and submit the following materials:
(a) a copy of the simplex collection license;
(two) the operation report during the practice, including the number of raw plasma collection, periodic self-inspection report, etc.;
(three) the supervision and inspection opinions and rectification of the administrative department of health;
(four) the technical review report issued by the technical organization according to the "quality management standard for apheresis plasma stations".
Article 18 The health administrative department of the provincial people's government shall conduct an audit according to the business development, technical review, supervision and inspection of the apheresis plasma station in the last practice cycle, and if it passes the audit, it shall be continued. If the examination fails, it shall be ordered to make rectification within a time limit; If it is still unqualified after rectification, its "plasma apheresis license" shall be cancelled.
Plasma collection stations that have not applied for renewal or cancellation of the plasma collection permit shall not continue to practice.
Article 19 Name, address, legal representative and business items. If there is any change in the plasma collection station, it shall go through the registration formalities with the original issuing department.
If the production unit of blood products that set up the apheresis plasma station changes, the apheresis plasma station shall re-apply for the apheresis plasma license, and the original apheresis plasma license shall be cancelled.
Twentieth health administrative departments of local people's governments at or above the county level shall examine and approve the procedures and time limit for the establishment of plasma collection stations, in accordance with the relevant provisions of the Administrative Licensing Law and the Administrative Measures for Health Administrative Licensing. Article 21 The practice of apheresis plasma stations shall comply with relevant laws, regulations, rules and technical specifications.
The legal representative or principal responsible person of the plasma collection station shall be responsible for the quality and safety of the collected raw plasma.
Article 22 A plasma collection station shall organize and mobilize plasma collectors within the prescribed plasma collection area, and provide corresponding health education for plasma collectors, so as to provide safe, hygienic and convenient conditions and good services for plasma collectors.
Article 23 Plasma collection stations shall conduct health consultation, health examination and blood sample testing for plasma donors in accordance with the Pharmacopoeia of People's Republic of China (PRC), and fulfill the obligation of informing plasma donors in accordance with the information for plasma donors issued by the Ministry of Health.
Those who have passed the health examination and applied for plasmapheresis, after checking their ID cards, fill in the list of plasmapheresis recipients and report it to the health administrative department of the local people's government at the county level. The health administrative department of the people's government at the provincial level shall retrieve the information of plasma donors in this province and neighboring provinces, confirm that they are not registered in other plasma collection stations, and feed back relevant information. The health administrative department of the people's government at the county level shall issue a certificate of plasma donors.
The contents of the plasma donor certificate should at least include: name, gender, blood type, nationality, ID number, bareheaded photos within 2 years, home address, date and number of card establishment.
Twenty-fourth in any of the following circumstances, the "plasma supply certificate" shall not be issued:
(1) Failing the health examination and test;
(2) Having forged identity certificates and holding more than two plasma apheresis certificates;
(3) Those who have registered as plasma apheresis in other plasma apheresis stations;
(four) the local household registration department failed to verify its identity information.
Twenty-fifth plasma collection stations shall establish management files for plasma collection, and record the blood supply and health examination of plasma collection. Establish a permanent elimination, temporary refusal and refusal to issue the "plasma donor certificate" of the plasma donor file list. At the same time, the files were managed by computer, and the identification system of plasma donors was established.
Article 26 In the process of collecting plasma, a plasma collection station finds that the contents of the plasma donor certificate have changed, or the plasma donor's health examination is unqualified, it shall withdraw the plasma donor certificate and promptly inform the health administrative department of the local people's government at the county level.
Twenty-seventh plasma collection stations shall, according to the actual situation of registered plasma collectors and the demand of blood products production units for raw plasma, formulate a work plan for plasma collection, and reasonably arrange plasma supply for plasma collectors.
Article 28 The principle of voluntary and informed consent shall be followed when collecting raw plasma at a plasma collection station.
Plasma donors who need special immunity should be informed of the significance, function, methods, steps and adverse reactions of special immunity. After obtaining the written consent of the plasma donor, immunization can be carried out in accordance with the immunization procedures prescribed by the state. Immunization and handling of adverse reactions should be recorded in detail.
Article 29 Before each plasma collection, the plasma collection station must verify the identity card or other valid identity certificate held by the plasma collection person, the plasma collection person's card and the contents of computer file management, and can carry out health examination and blood sample testing according to the prescribed procedures; For those who pass the inspection and test, plasma should be collected in accordance with relevant technical operating standards and procedures, and detailed records should be made.
Thirtieth plasma collection stations must use plasma collection machinery to collect plasma, and manual collection of plasma is strictly prohibited.
The plasma volume of the plasma donor shall not exceed 580ml at a time (including anticoagulant, the mass ratio by volume ratio shall not exceed 600g). Excessive collection of plasma is strictly prohibited.
The time interval between two plasma donors shall not be less than 14 days. Frequent collection of plasma is strictly prohibited.
It is forbidden to collect plasma from plasma donors in non-designated plasma collection areas. It is strictly forbidden to collect the plasma of imposters and those who have no "plasma supply certificate".
It is forbidden to collect blood or use the collected raw plasma in clinic.
Thirty-first plasma collection stations shall establish reporting procedures for plasma donors who are prone to blood-borne diseases, as well as screening and elimination systems for plasma donors.
Thirty-second plasma collection stations shall implement total quality management of plasma collection, and strictly abide by the technical specifications and standards such as the Regulations of People's Republic of China (PRC) on the Administration of Raw Plasma for Blood Products and the Quality Management Standard for Plasma Collection Stations.
Thirty-third plasma collection stations shall establish the post responsibility system for personnel and the relevant work system for the management of single collection and supply, and regularly check and assess the implementation and implementation of various rules and regulations and the post responsibility system for personnel at all levels and types.
Thirty-fourth key post staff of apheresis plasma station should meet the requirements of post practice, and accept blood safety and business training and assessment, and receive post training certificate before taking up their posts.
The staff of apheresis plasma station should receive at least 75 hours of post continuing education every year.
On-the-job training and assessment shall be organized and implemented by the health administrative department of the people's government at or above the provincial level.
Article 35 The work records of each business post of apheresis plasma station shall be true in content, complete in project, standardized in format, clear in handwriting, recorded in time, and signed by the operator and the auditor.
When the recorded contents need to be changed, the original recorded contents should be kept clear and easy to read, the changed contents and date should be indicated, and the changed places should be signed.
The original records of plasma collection, detection and plasma supply shall be kept for at least 10 years. Where laws, regulations and the Ministry of Health provide otherwise, the relevant provisions shall prevail.
Thirty-sixth plasma collection stations should ensure that the collected plasma is strictly tested.
Thirty-seventh collected plasma must be stored in single freezing, and it is forbidden to mix plasma.
Thirty-eighth plasma collection stations shall formulate laboratory indoor quality control and inter-room quality evaluation system, and regularly participate in inter-room quality evaluation at or above the provincial level to ensure that reagents, sanitary equipment, instruments and equipment can achieve the expected results in the use process.
The laboratory of apheresis plasma station shall be equipped with necessary biosafety equipment and facilities, and the staff shall be trained in biosafety knowledge.
Thirty-ninth plasma samples must be stored in each bag of plasma collected by the plasma collection station, and the storage period should be not less than 2 years after the production of blood products.
Fortieth plasma collection stations should strengthen disinfection and isolation management to prevent and control the spread of infectious diseases.
Medical wastes generated by plasma collection stations should be treated in accordance with the Regulations on the Management of Medical Wastes, and recorded and signed to avoid cross-infection.
Forty-first plasma collection stations and their personnel performing their duties shall report to the relevant departments in accordance with the Law on the Prevention and Control of Infectious Diseases and the provisions of the Ministry of Health when they find the epidemic situation of legal infectious diseases.
Article 42 The collection, packaging, storage and transportation of raw plasma shall conform to the requirements of the quality management standards of plasma collection stations.
The label of raw plasma packaging bag must indicate:
(a) the name of the plasma collection station;
(2) The name, serial number or bar code of the plasma donor;
(3) plasma weight, plasma type, collection date, plasma number and expiration date;
(4) storage conditions.
When raw plasma is stored, transported and packed, each box should have a packing list, with inspection certificate and plasma re-inspection samples attached.
Forty-third plasma collection stations can only supply raw plasma to their blood products production units.
The plasma collection station shall ensure that the quality of the raw plasma distributed conforms to the relevant national standards, the variety, specifications and quantity are correct, and the biological activity of the plasma is well preserved.
Forty-fourth drugs, in vitro diagnostic reagents and disposable sanitary equipment used in plasma collection stations shall comply with the relevant provisions of the state.
Forty-fifth plasma collection stations must use computer systems to manage the information of plasma collectors, plasma collection and related workflows. Establish a management procedure for plasma labeling to ensure that all plasma can be traced back to the corresponding plasma donor and plasma donor process, and ensure that the batch number of materials used and all preparation, inspection and transportation records are complete. The plasma label should adopt bar code technology. The same plasma barcode will not be repeated for at least 50 years.
Forty-sixth plasma collection stations shall report the collection of raw plasma to the health administrative department of the local people's government at the county level every six months.
Forty-seventh plasma collection stations should formulate emergency plans for sudden disasters, and ensure the implementation of the plans from the aspects of blood sources, management systems, technical capabilities and equipment conditions. In case of emergency, obey the dispatch of the health administrative department of the people's government at or above the county level.
Forty-eighth plasma collection stations must strictly implement the provisions of the state on the disposal of abandoned blood, and treat the abandoned blood of plasma collection people who are at risk of being infected with blood-borne diseases in a confidential manner.
Forty-ninth staff of apheresis plasma stations must have a health examination once a year, and establish health records for employees. Those suffering from infectious diseases, serious skin infections and unhealed wounds on the body surface shall not be engaged in plasma collection, inspection, disinfection and supply.
Fiftieth plasma collection stations shall, in accordance with the requirements of the "Quality Management Standards for Plasma Collection Stations", entrust technical institutions to conduct technical review at least once a year.
Article 51 The technical evaluation and test results of apheresis stations provided by technical institutions shall be objective and true. Article 52 The health administrative department of the local people's government at or above the county level shall be responsible for the supervision and management of plasma collection stations within their respective administrative areas, and formulate annual supervision and inspection plans, including:
(a) the implementation of laws, regulations, rules, technical standards and norms;
(two) the implementation of the rules and regulations of the plasma collection station and the post responsibility system of the staff;
(3) Management and inspection of plasma suppliers, collection, preservation and supply of raw plasma, etc. ;
(four) regular self-examination and major accident report of apheresis plasma station.
The health administrative department of the people's government at the county level shall, in accordance with the provisions of these measures, be responsible for the daily supervision and management of plasma collection stations within their respective administrative areas.
The health administrative department of the municipal people's government with districts shall conduct an inspection and irregular spot checks on the apheresis plasma stations within their respective administrative areas at least once every six months.
The administrative department of health of the people's government at the provincial level shall organize at least once a year the supervision and inspection and irregular spot checks of the apheresis stations within their respective administrative areas.
The health administrative department at a higher level shall regularly or irregularly supervise and inspect the management of raw plasma within its jurisdiction, and timely notify the health administrative department at a lower level of the supervision and inspection.
Fifty-third health administrative departments responsible for the examination and approval and supervision of apheresis plasma stations shall establish an information communication system to inform each other of the examination and approval, supervision and inspection, and ensure the effective convergence of work.
The health administrative department of the provincial people's government shall establish a publicity system in the apheresis plasma station, and announce the basic situation, practice, supervision and inspection and complaints and reports of apheresis plasma station.
Article 54 The administrative department of health of the people's government at or above the provincial level shall designate relevant blood testing institutions to monitor the quality of plasma collected by plasma collection stations, and report the monitoring results to the administrative department of health of the people's government at the same level.
Fifty-fifth technical institutions that issue technical review reports for apheresis plasma stations shall meet the requirements and be designated by the health administrative department of the people's government at or above the provincial level.
Fifty-sixth health administrative departments have the right to obtain relevant information when conducting supervision and inspection, and plasma collection stations shall not conceal, hinder or refuse.
The administrative department of health has the obligation to keep confidential the information provided by the plasma collection station, except as otherwise provided by laws, administrative regulations or departmental rules.
Fifty-seventh health administrative departments of the people's governments at all levels shall establish a reporting and complaint mechanism for the supervision and management of apheresis plasma stations.
The administrative department of health has the obligation to keep confidential the informants and complainants.
Article 58 The health administrative department of the local people's government at or above the county level shall, in accordance with relevant regulations, report the collection of raw plasma step by step on a regular basis.
The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall report to the Ministry of Health on the collection of raw plasma within their respective administrative areas every year.
Article 59 The health administrative department of the people's government at the provincial level shall establish an information management system for plasma apheresis patients, and provide retrieval and inquiry information to relevant departments.
Article 60 The administrative department of health of the people's government at a higher level has the right to correct or revoke the administrative acts that are not in conformity with the provisions made by the administrative department of health of the people's government at a lower level. Article 61 A plasma collection station that commits one of the following acts shall be punished by the health administrative department of the local people's government at or above the county level in accordance with the relevant provisions of Article 34 of the Regulations on the Administration of Blood Products:
(a) did not obtain the "plasma collection permit" to carry out plasma collection activities;
(two) the "plasma collection permit" has been cancelled or revoked, and plasma collection activities are still carried out;
(3) Renting, lending, lending, altering or forging the Permit for Plasma Collection to carry out blood collection and supply activities.
Sixty-second plasma collection stations in violation of the relevant provisions of these measures, one of the following acts, the health administrative department of the local people's government at or above the county level shall give a warning and impose a fine of 30 thousand yuan:
(1) Concealing, obstructing or refusing the supervision and inspection by the administrative department of health or failing to provide relevant information truthfully;
(2) Failing to fulfill the obligation of informing the plasma donors in advance and carrying out special immunization without the consent of the plasma donors;
(3) Failing to establish the system of file management, screening and elimination of plasma donors in accordance with regulations;
(four) not in accordance with the provisions of the work system or not implemented;
(five) the staff has not obtained the relevant post qualifications or engaged in blood collection and supply work without practicing registration;
(6) Failing to record or keep work records in accordance with regulations;
(seven) failing to keep the plasma samples in accordance with the provisions.
Sixty-third plasma collection stations in any of the following circumstances shall be punished in accordance with the provisions of Article 35 of the Regulations on the Administration of Blood Products:
(a) before collecting plasma, failing to conduct health examination and blood test for plasma donors in accordance with the relevant health examination requirements;
(2) Collecting plasma from plasma donors or other personnel in non-designated areas; Or collect the plasma of an impostor, a person who fails the health examination or a person who has no "plasma donor certificate" and no identity certificate;
(three) excessive and frequent collection of plasma;
(4) directly providing raw plasma to medical institutions or collecting blood without authorization;
(five) without the use of plasma collection machinery for plasma collection;
(six) did not use the product approval number and the national drug and biological products testing institutions batch by batch inspection of qualified in vitro diagnostic reagents and qualified disposable plasma collection equipment;
(seven) failing to package, store or transport raw plasma in accordance with the hygienic standards and requirements stipulated by the state;
(eight) failing to dispose of contaminated syringes, plasma collection equipment, unqualified or abandoned plasma in accordance with the regulations, and dumping it without authorization, polluting the environment and causing social harm;
(9) Reusing disposable plasma collection equipment;
(ten) the supply of raw plasma to other units other than the production units of blood products that set up plasma collection stations.
In any of the following circumstances, it shall be punished according to the seriousness of the case, and the license for plasma collection shall be revoked:
(a) the plasma that is positive for the inspection items specified by the state is not cleared and reported in time;
(2) The illegal acts listed in Article 35 of the Regulations on the Administration of Blood Products have occurred twice within 12 months;
(three) at the same time, there are three or more illegal acts as stipulated in Article 35 of the Regulations on the Administration of Blood Products;
(four) the administrative department of health ordered to make corrections within a time limit and refused to make corrections;
(5) Causing the spread of blood-borne diseases or other serious injury consequences.
Article 64 If a plasma collection station knowingly supplies the plasma it collects to the production unit of blood products, it shall be punished in accordance with the provisions of Article 36 of the Regulations on the Administration of Blood Products.
Article 65 Whoever alters, forges or transfers the Plasmapheresis Certificate shall be punished in accordance with Article 37 of the Regulations on the Administration of Blood Products.
Article 66 Whoever, in violation of the Regulations on the Administration of Blood Products and these Measures, exports raw plasma without authorization shall be punished in accordance with the provisions of Article 42 of the Regulations on the Administration of Blood Products.
Sixty-seventh technical institutions that undertake the technical evaluation and testing of apheresis plasma stations issue false certification documents, and the health administrative department shall order them to make corrections, give them a warning and may impose a fine of not more than 20,000 yuan; The directly responsible person in charge and other directly responsible personnel shall be punished according to law; If the circumstances are serious enough to constitute a crime, criminal responsibility shall be investigated according to law. Decision of the National Health and Family Planning Commission on Amending the Measures for the Administration of Plasmapheresis Stations (Order No.6 of the National Health and Family Planning Commission)
The Decision of the National Health and Family Planning Commission on Revision was discussed and passed at the meeting of directors of the National Health and Family Planning Commission on May 20 12, 2005. It is hereby promulgated and shall come into force as of the date of promulgation.
Director Li Bin.
2065438+May 27, 2005
Decision of the National Health and Family Planning Commission on Amending the Measures for the Administration of Plasmapheresis Stations
In order to implement the Notice of the State Council on Printing and Distributing the Reform Plan of the Registered Capital Registration System (Guo Fa [2014] No.7) and the Notice of the General Office of the State Council on Accelerating the Reform of the Registered Capital Registration System (Guo Ban Han [20 15] 14), it is decided to "Administrative Measures for Plasma Collection Stations".