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Administrative Measures For The Collection Of Plasma Stand

Original Language Title: 单采血浆站管理办法

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(January 4, 2008, the Ministry of Health announced as of March 1, 2008, 58th) Chapter I General provisions article in order to strengthen the supervision and management of the collection of plasma, the prevention and control of blood-transmitted diseases, protect plasma donors health, ensure the quality of raw plasma, in accordance with the regulations on the management of blood products, these measures are formulated.
    Article Apheresis plasma stand in these measures refers to blood resources, set up in accordance with the relevant standards and requirements and strict examination, acquisition supply raw materials for the production of blood products plasma units. Apheresis plasma stand set by the blood products production units, has an independent legal personality.
    No other unit or individual is allowed to engage in mining activities in plasma.
    Article plasma donors in these measures refers to provision of raw materials for the production of blood products plasma staff.
    Designated mining and pulping area of residence within healthy citizens aged 18 to 55 years old can apply to register for plasma donors.
    Fourth Ministry of health according to the raw materials for the production of plasma needs, economic development, disease prevalence, and develop national blood collection and supply institutions planning guidelines. The provinces, autonomous regions and municipalities directly under the Ministry of health in the health administrative departments under the people's Governments of the blood collection and supply institutions set the guiding principles for planning, combining administrative areas of the epidemic, for plasma, and so on the actual situation and local regional health development plan, Apheresis plasma sets can be enacted plan and implement.
    Apheresis plasma station plan shall be submitted to the Ministry of health records.
    Fifth Ministry of health responsible for apheresis plasma stations nationwide supervision and management work.
    Health administrative departments under local people's Governments at or above the county level are responsible for apheresis plasma stations within their respective administrative areas supervisory and administrative work.
    Chapter II sets blood products manufacturers for approving the sixth set shall conform to the local Apheresis plasma Apheresis plasma station station planning and approval by the health administration of provinces, autonomous regions and municipalities.
    Seventh Apheresis plasma station should be set up in County (banner), and county-level cities, not with blood banks generally set within the same County.
    Endemic disease or blood-borne infectious disease epidemic, high in areas which are planning to set a single collection of plasma stands.
    The previous year, and this year's voluntary unpaid blood donors to meet the need of blood for clinical use of municipal administrative areas not a single collection of plasma stands. Eighth health administrative departments of provinces, autonomous regions and municipalities according to the delineation of Apheresis plasma mining and pulping area. Mining slurry area of selection should ensure the number of plasma donors, to meet the raw material of plasma collected volume of not less than 30 tonnes/year.
    New Apheresis plasma stand year within 3 years of acquisition not less than 30 tons.
    Nineth article set single mining plasma station must has following conditions: (a) meet mining for blood institutions set planning, and single mining plasma station set planning and single mining plasma station basic standard requirements of conditions; (ii) has and by collection raw materials plasma phase adapted of health professional technicians; (three) has and by collection raw materials plasma phase adapted of places and the health environment; (four) has recognition for plasma who of identity recognition system; (five) has and by collection raw materials plasma phase adapted of single mining plasma mechanical and the other facilities;
    (F) with plasma on the collected raw material quality control technicians, as well as necessary equipment; (VII) compliance with the national bio-safety management requirements. Tenth Article application set single mining plasma station of blood products production units, should to single mining plasma station set to of County Government health administrative sector submitted set single mining plasma station application book, and submitted following material: (a) application set single mining plasma station of blood products production units of about situation and corporate registration certificate; (ii) intends set single mining plasma station of feasibility research report.
    Content including: 1. intends set single mining plasma station basic situation, including name, and address, and scale, and task, and function, and organization structure,; 2. intends set single mining plasma station plasma collection regional and the regional within disease popular status, and age health for plasma population situation, and institutions run and the environmental protection measures of forecast analysis; 3. intends set single mining plasma station of location and architectural design plane Figure; 4. application carried out of business project, and technology equipment conditions information; 5. sewage, and dirt real and medical waste processing programme;
    (Three) total investment and the funds of source and inspection funding proved; (four) single mining plasma station with room of housing property proved or right proved; (five) intends set single mining plasma station of statutory representative people and main head of identity proved file and professional resume; (six) single mining plasma station practitioners list and the qualification certificate; (seven) single mining plasma station of the regulations.
    11th article has following case one of of, shall not application set new of single mining plasma station: (a) intends set of single mining plasma station not meet mining for blood institutions set planning or local single mining plasma station set planning requirements of; (ii) provincial health administrative sector not agreed delineation mining pulp regional of; (three) blood products production units was revoked drug production quality management specification (GMP) certificate not full 5 years of; (four) blood products production units occurred had illegal collection plasma or unauthorized calls plasma behavior of;
    (E) the blood products production of registered units of blood products at least 6 varieties, assume control of national immunization unit of blood product production of less than 5. 12th article following personnel shall not as new single mining plasma station of statutory representative people or main head: (a) is served or not has completely civil capacity of people; (ii) occurred blood security accident not full 5 years of responsibility people; (three) was revoked single mining plasma license or blood station practice industry license not full 10 years of single mining plasma station or blood station of statutory representative people, and main head and the responsibility people; (four) was revoked drug production quality management specification (GMP)
    Certificate of production units of blood products under 5 years of age the legal representative or principal responsible; (v) by the health Administrative Department in charge shall command within a time limit of 3 months or pay a fine of 5-100,000 penalties for apheresis plasma stand under 3 years of age the legal representative, the main person in charge and responsible.
    13th all application materials are received by the Administrative Department of health under the county level after the first trial, city divided into districts, autonomous administrative departments of health under review agreement, reported to the provincial health Administrative Department for approval.
    14th provincial health Administrative Department upon receipt of the application materials for the collection of plasma, or authorize the technical bodies may organize relevant experts, in accordance with the quality management standard for apheresis plasma station technical review.
    Reviewed in accordance with the conditions, the provincial health Administrative Department issuing the license for apheresis plasma, and reported to the Ministry of health in the 10th after the set approval record reviewed do not meet the conditions, and shall notify the applicant in writing of the reasons for the rejection.
    15th, applications settings got does not comply with the Nineth Apheresis plasma, 11th and 12th articles shall not be approved.
    16th Apheresis plasma license is valid for 2 years.
    The main content license for apheresis plasma: (a) setting of plasma stood Apheresis blood products manufacturers name, (ii) Apheresis plasma station name, address, legal representative or principal responsible person; (c) operational projects and the plasma region (scope); (d) the issuing authority, date of issue, license number and expiration date.
    17th article single mining plasma license effective expires Qian 3 months, single mining plasma station should to original sent card sector application continued, and submitted following material: (a) single mining plasma license of copies; (ii) practice industry during run situation of report, including raw materials plasma collection of number, and regularly since check report,; (three) health administrative sector supervision check of views and the rectification situation,; (four) technology institutions according to single mining plasma station quality management specification issued of technology review report. 18th the health administrative departments under the people's Governments at the provincial level on the collection of plasma to practising periodic business review, technical review and supervision of, qualified, to be extended.
    Unqualified audited, order the rectification; has not qualified the rectification, cancellation of its permit for apheresis plasma.
    Without renewal application or cancellation of the license for apheresis plasma Apheresis plasma stand, do not continue to practice.
    19th Apheresis plasma station changes its name or address, legal representative, business project contents, purposes shall register the change with the original issuing authorities.
    Sets of plasma stood Apheresis blood products production unit is changed, the collection of plasma to stand again for apheresis plasma license, original Apheresis plasma license cancellation.
    20th health administrative departments under local people's Governments at or above the county level shall approve of plasma stood Apheresis procedures and deadlines, in accordance with the administrative licensing law, administrative authorization management and other relevant regulations.
    Chapter practice 21st single collection of plasma to practise shall abide by the relevant laws, rules, regulations and technical specifications.
    Apheresis plasma stand the legal representative or principal responsible should be responsible for collecting plasma quality and safety of raw materials.
    22nd single collection of plasma station shall, within the mining and pulp under regional organizations, the mobilization of plasma donors, and appropriate health education to plasma donors, providing plasma donors with safety, health, convenience and good conditions of service.
    23rd Apheresis plasma stand should be in accordance with the People's Republic of China Pharmacopoeia blood products plasma procedure plasma donors on the application of raw materials for health consultation, health checks and blood tests, and in accordance with the Ministry of Health issued notes for plasma donors fulfilled their obligation to plasma donors. Checked for health applications of plasma donors, checking ID cards, fill in the roster of plasma donors, the Administrative Department of health under the County.
    The provincial health Administrative Department in the province and adjacent provinces for plasma donors in information retrieval, verify that no other single collection of plasma stand registration, feedback on the information, the competent administrative Department of health under the certificate of plasma.
    The plasma certificate shall include at least: name, sex, blood type, nationality, identity card number, 2 years Hat ID photos, home address, date and number cards.
    24th article has following situation one of of, not to for plasma card: (a) health check, and laboratory not qualified of; (ii) had forged ID ming, holds 2 a above for plasma card of; (three) has in other single mining plasma station registration for for plasma who of; (four) local household sector failed to verified its identity information of. 25th plasma Apheresis plasma donors should be established management files, record for plasma for plasma, health inspection. Plasma donors permanently eliminated, established temporary denial for plasma certificate files and cannot be released to the roster.
    Using computer file management and the establishment of identification systems for plasma.
    Article 26th Apheresis plasma stand for plasma collection found in the blood plasma of the certificate content changes, or plasma donors failed to pass the medical examination, shall withdraw the plasma for certificate and inform the health administrative departments under local people's Governments at the county level.
    27th single collection of plasma stands shall be registered according to plasma donors for plasma realities and blood plasma products manufacturers raw material demand, adopting Grouting work plans, arranging for plasma plasma donors.
    28th plasma Apheresis plasma collecting raw material should be voluntary and informed consent principle. Require special immune plasma donors, it shall notify the special immunity of significance, functions, methods, procedures, and adverse reactions, after the written consent of plasma donors, I agree, can be carried out in accordance with the schedule prescribed by the State immunity.
    Dealing with immunization and adverse reaction should be recorded in detail.
    29th article single mining plasma station in each collection plasma Qian, must will for plasma who holds of ID or other effective ID ming, and for plasma card and computer archives management content for verified, confirmed correct of, party can according to provides program for health check and blood laboratory; on check, and laboratory qualified of, according to about technology operation standard and program collection plasma, and detailed records.
    30th single collection of plasma collected stood Apheresis plasma machine must be used in plasma, no hand-collected plasma. Each volume of plasma collected plasma donors shall not be exceed 580 ml (containing anticoagulant solution by volume than the conversion ratio of not more than 600 g).
    Excessive collecting plasma is strictly prohibited. Twice for plasma not less than 14 days.
    Frequent collecting plasma is strictly prohibited. No collection of delimitation of mining the plasma plasma plasma donors in the region.
    For plasma collection impostor and is strictly prohibited without the certificate of the plasma.
    No blood or plasma collected raw materials used in the clinic.
    31st single collection of plasma to blood-borne diseases should be established after the dangerous behavior of plasma donors for plasma reporting procedures, plasma donors screened and eliminated.
    Article 32nd Apheresis plasma plasma collection should be the implementation of total quality management, strictly abide by the People's Republic of China Pharmacopoeia blood plasma products raw materials procedures, quality management code for apheresis plasma station and other technical norms and standards.
    33rd Apheresis plasma station shall establish a personnel post responsibility system and plasma collection and supply management-related work, and periodic inspection, examination rules and regulations and the implementation and follow-up of all categories of personnel at all levels of personal responsibility.
    34th single collection of plasma key staff shall be consistent with positions practising and accept job training and the assessment blood safety and business, receive job training certificates before they can post.
    Apheresis plasma station staff should receive not less than 75 hours a year post continuing education.
    Job training and assessment organized by the people's Governments above provincial level health Administrative Department is responsible for the implementation.
    35th Apheresis plasma stand business work records should be true, project complete, well-formed, clear writing, recording, and operators and reviews are signed.
    Records when changes are required, shall keep the original record contents legible, indicate changes and dates and changing the signature.
    Plasma collection and testing and records shall be kept for at least 10 years for pulp, otherwise provided by the laws and regulations and the Ministry of health, in accordance with the relevant provisions.
    Article 36th Apheresis plasma station shall ensure the collection of plasma are rigorous testing.
    The 37th single frozen plasma collection must be saved, no mixing.
    Article 38th Apheresis plasma laboratory should be developed for internal quality control and external quality assessment system, and regularly took part in or above the provincial level of external quality assessment to ensure health equipment, reagents, apparatus and equipment used in the process to achieve the desired effect.
    Apheresis plasma Biosafety of the laboratory shall be equipped with the necessary equipment and facilities, staff should be trained in biosafety training.
    39th Apheresis plasma plasma must be retained in each bag of plasma specimens collected, retention period should be not less than 2 years after the release of blood products.
    40th Apheresis plasma disinfection and isolation management should be strengthened to prevent and control the spread of infectious diseases.
    Apheresis plasma generated medical waste should be dealt with in accordance with the provisions of the regulations on medical waste management, records and signatures to avoid cross infection.
    41st single collection of plasma stands and duty personnel found that a statutory epidemic situation of infectious diseases, shall, according to the communicable disease prevention Act and the provisions of the Ministry of Health reported to the relevant authorities.
    42nd plasma collection of raw materials, packaging, storage, transport shall conform to the requirements of the quality management code for apheresis plasma station.
    Plasma bags of raw materials must be marked on the label: (a) name of the collection of plasma (ii) plasma donors name, number or bar code; (c) the weight of plasma, plasma, plasma type, acquisition date, number, period of validity; (d) the storage conditions.
    Plasma storage, transportation of raw materials when boxed, in each case shall have the packing slip, with specimen testing qualified and plasma review.
    43rd one-only collection of plasma station to set its blood plasma products manufacturers supplying raw materials.
    Apheresis plasma material plasma issued should ensure quality in line with the relevant national standards, variety, size, number of error-free, the biological activity of the plasma intact.
    44th Apheresis plasma using drugs, in vitro diagnostic reagents and disposable sanitary equipment shall comply with the relevant provisions of the State. Article 45th must use computer management for plasma Apheresis plasma station information, collecting and supplying blood and related work processes. Establish the plasma's identity management program, ensure that all plasma can be traced back to the corresponding plasma donors and plasma processes, ensure that the item lot number as well as ownership, full inspection, transportation records. Plasma logo should use barcode technology.
    Plasma of the same bar code for at least 50 years does not repeat.
    46th Apheresis plasma should be six-monthly report to the Administrative Department of health under the County relating to material plasma collection. 47th Apheresis plasma station emergency disaster contingency plans should be developed, and from blood, management systems and technology capabilities and equipment guarantee the implementation of the plan.
    Subject to emergency disaster Department of the people's Governments above the county level health fields.
    48th single blood collection and plasma stand must strictly implement relevant State scrapped and there is blood-borne disease risk behaviors of plasma donors for plasma privacy abandoned blood processing requirements. 49th Apheresis plasma stand staff must undergo an annual medical examination, establish health files.
    Suffering from infectious diseases, serious infections of the skin and the surface wounds open, may engage in the collection, testing, disinfection and supply position in plasma.
    50th single collection of plasma per year shall entrust the technical institutions in accordance with the requirements of the quality management code for apheresis plasma station carried out not less than once in technical reviews.
    51st technology provided by Apheresis plasma technology evaluation, test results should be objective and realistic.
    Fourth chapter supervision management 52nd article County above place Government health administrative sector is responsible for this administrative within single mining plasma station supervision management work, developed annual supervision check plans, check content including: (a) implementation legal, and regulations, and regulations, and technology standard and specification situation; (ii) single mining plasma station the regulations and staff responsibility implementation situation; (three) for plasma who management, test, raw materials plasma of collection, and save, and supply,;
    (D) Apheresis plasma self-test and critical incident reports on a regular basis.
    People's Governments at the county level health Administrative Department in accordance with the provisions of the measures responsible for the administration of plasma stood Apheresis daily supervision and control.
    District municipal administrative departments of health under at least every six months for apheresis plasma stations within their respective administrative areas an inspections and unscheduled spot checks.
    Department of the provincial health organizations at least once a year for apheresis plasma stand within their respective administrative areas supervisory inspections and unscheduled spot checks.
    Superior administrative departments of public health should be regular or irregular material plasma provisional supervision and inspection administration and subordinate administrative departments of public health supervision and inspection in a timely manner.
    53rd responsible for apheresis plasma station, approving, and monitoring of the Administrative Department of public health to establish a communication system, approval, supervision and inspection information such as notices, ensure effective cohesion.
    Provincial health administrative departments to establish in Apheresis plasma station announcement system, Basic for apheresis plasma stand, practice, administrative departments of public health supervision and inspection, as well as complaints, telephone hotlines for public notification.
    54th people's Governments above provincial level health Administrative Department shall specify the relevant Blood Institute, to monitor the quality of plasma Apheresis plasma collection, monitoring results reported to the people's Government at the public health Administrative Department.
    55th for apheresis plasma station technical review report issued by the technical body shall comply with the conditions specified by the people's Governments above provincial level health administrative departments.
    56th in conducting supervision and inspection, the Administrative Department of public health has the right to obtain the information, Apheresis plasma stand shall not conceal, obstruct or refuse.
    Administrative Department of public health on plasma stood Apheresis obliged to confidentiality of information provided by the laws, administrative regulations, or except as otherwise provided in the regulations.
    57th levels of the Administrative Department of health under Apheresis plasma station supervision and management should be established to report and complaint mechanisms.
    Administrative Department of public health to informants and complainants have a duty of confidentiality.
    58th with the health Administrative Department under local people's Governments at the county level shall be in accordance with the relevant provisions of plasma collection of escalation in raw materials on a regular basis.
    The provinces, autonomous regions and municipalities public health Administrative Department shall report annually to the Ministry of health summary material plasma collected within their respective administrative areas.
    The 59th provincial health administrative departments shall establish information management systems for plasma donors, and provide search query information to the relevant authorities.
    On the 60th level administrative Department of health under the right to correct or cancel the next level does not meet the requirements of the Administrative Department of health under the Executive.
    Fifth chapter penalty is 61st article single mining plasma station has following behavior one of of, by County above place Government health administrative sector according to blood products Management Ordinance 34th article of about provides be punishment: (a) not made single mining plasma license carried out mining for plasma activities of; (ii) single mining plasma license has was cancellation or revoked still carried out mining for plasma activities of; (three) rental, and borrowed, and rental, and lending, and variable made, and forged single mining plasma license carried out mining for plasma activities of.
    62nd article single mining plasma station violation this approach about provides, has following behavior one of of, by County above place Government health administrative sector be warning, and at 30,000 yuan following of fine: (a) hide, and hinder, and refused to health administrative sector supervision check or not truthfully provides about information of; (ii) on for plasma who not perform prior told obligations, without for plasma who agreed carried out special immune of; (three) not according to provides established for plasma who archives management and the shield, and eliminated system of;
    (D) failing to establish working system or are not implemented, and (v) staff without obtaining the relevant post qualification or without the work of registered practitioners engaged in the collection and supply of blood plasma (vi) in accordance with the provisions of record or save the record, (VII) failing to save blood plasma specimens. 63rd article single mining plasma station has following case one of of, according to blood products Management Ordinance 35th article provides be punishment: (a) collection plasma Qian, not according to about health check requirements on for plasma who for health check, and blood laboratory of; (ii) collection non-delineation regional within of for plasma who or other personnel plasma of; or not for plasma who for identity recognition, collection impostor who, and health check not qualified who or no for plasma card who of plasma of; (three) excess, and frequently collection plasma of ; (Four) to medical institutions directly supply raw materials plasma or unauthorized collection blood of; (five) not using single mining plasma mechanical for plasma collection of; (six) not using has products approved paper, and by national drug biological products verification institutions by batch verification qualified of body outside diagnosis reagents and qualified of one-time blood pulp equipment of; (seven) not according to national provides of health standard and requirements packaging, and store, and transport raw materials plasma of; (eight) not according to provides on pollution of syringe, and mining plasma equipment, and
    Unqualified and scrapping of plasma processing, without dumping, polluting the environment, causing social harm; (IX) repeated use of disposable blood plasma devices; (j) Apheresis plasma stands to set up production units of blood products plasma units other than the supply of raw materials.
    Has following case one of of, according to plot serious be punishment, and revoked single mining plasma license: (a) on national provides detection project detection results is positive of plasma not clear does not timely reported of; (ii) 12 months within 2 times occurred blood products Management Ordinance 35th article by column violations of; (three) while has blood products Management Ordinance 35th article 3 items above violations of; (four) health administrative sector ordered deadline corrected and refused to corrected of;
    (V) cause blood-transmitted disease or other serious consequences.
    64th station known for its collection of plasma Apheresis plasma test result is positive, to supply blood products manufacturers, in accordance with the regulations on the management of blood products the 36th penalty shall be imposed.
    65th, forged, altered, transferred to the plasma certificate, in accordance with the regulations on the management of blood products article 37th will be punished.
    66th article in violation of the regulations on the management of blood products, and these measures, plasma exports raw materials without authorization, in accordance with the regulations on the management of blood products 42nd penalty shall be imposed.
    67th article Apheresis plasma technology assessment, testing of technology issued a false certificate, by the Administrative Department of public health ordered corrective action and give a warning, and to a fine of less than 20,000 yuan; directly responsible in charge and other direct liable persons shall be given sanctions in serious cases, constitute a crime, criminal responsibility shall be investigated according to law.
                                      Sixth chapter supplementary articles article 68th the measures come into effect on March 1, 2008.