Office of the national health and family planning commission about seeking "blood safety supervision specification (draft)" opinion letter

The national health and family planning commission of the People's Republic of China

The 2016-12-07

Countries who do supervision letter [2016] no. 1309

Provinces, autonomous regions and municipalities directly under the central government health and family planning commission, the xinjiang production and construction corps health bureau:

To regulate blood safety supervision, in accordance with the "blood", the relevant provisions of the regulations on the management of blood products, etc, by organization drafted the blood safety supervision specification (draft) ", is now open for advice. On January 6, 2017, please feedback form by fax or E-mail. Draft and prepare the instructions are available from by commission official website (www.nhfpc.gov.cn) to download the "comment" section.

Fax: 010-68791896

E-mail: fswsjdc@163.com

General office of national health and family planning commission

On December 2, 2016

Blood safety supervision norms

(draft)

The first chapter the general

Article 1 in order to protect the public health, regulating the blood safety supervision, according to the blood of the People's Republic of China, the "regulations on the administration of blood products", "blood stations management method", "single plasma stand management method", "measures for the management of clinical blood use of medical institution" and other laws, regulations and rules, make this specification.

Blood safety surveillance referred to in article 2 of this specification refers to the local family planning administrative department of health at or above the county level on the basis of blood safety related laws, regulations and rules, the blood stations, single plasma stations, medical institutions violation behavior in clinical use and illegal CaiGongXie behavior supervise law enforcement activities.

Article 3 the local family planning administrative department of health at or above the county level shall actively organize and coordinate relevant departments to establish and improve the blood safety supervision and law enforcement in the basic construction, equipment purchase of security, such as work and personnel expenditure, expenditure enriched with supervision and law enforcement personnel.

Article 4 the local family planning administrative department of health at or above the county level in the blood safety supervision, this specification shall apply.

The second chapter supervision responsibilities and requirements

Article 5 of the family planning administrative department of public health under the state council shall be responsible for blood safety supervision work throughout the country, the local family planning administrative department of health at or above the county level responsible for blood safety supervision work within their respective jurisdictions, local family planning of health supervision and law enforcement agencies, under the leadership of the family planning administrative department of public health at the same level the concrete implementation of blood safety supervision work within their respective jurisdictions.

The family planning administrative department of health at or above the county level in the blood safety supervision to undertake the following tasks:

(a) blood safety supervision planning and planning;

(2) is responsible for blood safety supervision organization and coordination;

(3) to organize the implementation of blood safety supervision work to evaluate;

(4) supervision division blood safety major cases;

(5) to carry out other duties assigned by the superior blood safety surveillance task.

Article 6 the state family planning of health supervision and law enforcement agencies in the blood safety supervision work to undertake the following tasks:

(a) to assist the organization to carry out the blood safety supervision work;

(2) to organize the formulation of blood safety supervision and relevant technical specifications and guidelines, regulating the behavior of supervision;

(3) responsible for blood safety supervision information construction and management;

(4) to assume the national blood safety supervision and personnel training and management work;

(5) to carry out other duties assigned by the family planning administrative department of public health under the state council.

Article 7 of the provinces, autonomous regions and municipalities directly under the central government family planning of health supervision and law enforcement agencies in the blood safety supervision work to undertake the following tasks:

(a) the implementation of the province (autonomous region or municipality directly under the central government) blood safety supervision work plans and annual plans;

(2) to lower blood safety supervision work for guidance and supervision and inspection;

(3) the guiding and supervisory, investigation of blood safety within their respective jurisdictions illegal cases;

(4) is responsible for the province (autonomous region or municipality directly under the central government) blood safety supervision information management and data summary, verification, analysis and reporting work;

(5) the organization carries out blood safety supervision training work within their respective administrative areas;

(6) to carry out blood safety supervision duties assigned by the superior department designated or task.

Article 8 the city divided into districts, autonomous prefectures and counties, autonomous counties and health supervision and law enforcement agencies in the blood safety supervision and family planning in to undertake the following tasks:

(a) the implementation of blood safety within their respective jurisdiction supervision work plans and annual plans;

(2) the implementation of blood stations within their respective jurisdictions, single plasma stations, medical institutions such as clinical use of blood safety regulation and supervision and inspection;

(3) the illegal blood safety within their respective jurisdictions cases;

(4) is responsible for the jurisdiction of blood safety supervision information summary, verification, analysis and reporting work;

(5) city divided into districts, autonomous prefectures of counties, autonomous counties blood safety supervision work guidance and supervision and inspection supervision;

(6) to carry out blood safety supervision duties assigned by the superior department designated or task.

Article 9 the state council, provinces, autonomous regions and municipalities directly under the central government and city divided into districts, autonomous prefecture of family planning of health supervision and law enforcement agencies shall be responsible for specific division (room) blood safety supervision work; Counties and autonomous counties shall be responsible for family planning of health supervision and law enforcement agencies blood safety supervision department or appoint someone in the blood safety supervision work.

Article 10 the local family planning of health supervision and law enforcement agencies at or above the county level shall establish a blood safety supervision archives, master blood stations within their respective jurisdictions, single plasma stand basic and clinical use of medical institutions.

The third chapter supervision contents and methods

The first section of the blood stations supervision

Article 11 the general blood stations to supervise and inspect the main contents include:

(a) general blood stations and blood testing laboratory qualification, professional qualifications CaiGongXie project, content, scope, and other business activities legitimacy;

(2) medical personnel practicing qualification and registration, assessment of staff training;

(3) the identity verification and registration of blood donors, blood donors health consultation, health check and told that the duration between blood and blood, and so on and so forth.

Blood tests (4) according to regulations;

(5) logo, packaging, storage and transportation of blood, blood specimens preserved;

(6) blood activity and blood mix;

(7) to detect unqualified or scrap processing situation of blood;

(eight) drugs, in vitro diagnostic reagents, one-time health equipment usage;

(9), testing and supply of blood blood donation original record and save the situation;

(10) of other administrative penalties shall be illegal.

Article 12 for the average blood stations while conducting supervision and inspection mainly adopts the following method:

(a) refer to the "practice license of blood stations and blood testing laboratory qualification, relevant verification information on the development of its business;

(2) random medical personnel and professional qualification certificate, the staff on-the-job training and examination of blood safety and business records and related materials;

(3) access to archives, informed consent and health blood donors blood donors consult table, before donating blood examination and blood work record, register and other related information;

(4) check blood records and inspection records, check the blood test; Check the inspection instruments and equipment configuration, verification; Reagent usage; Can be random inspection part of the whole blood weighing;

(5) check blood identification, packing; See the blood and blood specimen storage conditions, temperature records, retention time; See the different varieties and different type of blood stored separately; See the blood transport, temperature control, etc.;

(6) refer to outbound records, financial transaction documents, etc., to check blood supply, the remaining ingredients plasma, blood mix, and so on and so forth;

(7) refer to unqualified or discarded blood processing records;

(eight) random use of drugs, in vitro diagnostic reagent, disposable sanitary equipment is in accordance with the provisions of the state, check whether there is a repeated use of disposable sanitary equipment situation;

(9) donate blood sampling, testing and supply of blood original records and their retention time.

(10) of other administrative penalties shall be illegal.

Article 13 the special blood stations to supervise and inspect the main contents include:

(a) special blood stations and blood testing laboratory qualification, CaiGongXie project, content, scope, and other business activities legitimacy;

(2) staff on-the-job training assessment;

(3) of umbilical cord blood collected before informed consent;

(4) the issuance of umbilical cord blood stem cells and whereabouts;

(5) scrap on the progress of the umbilical cord blood;

(6) drugs, in vitro diagnostic reagents, one-time health equipment usage;

(7) the cord blood collection, detection, and save the situation;

(8) other administrative penalties shall be illegal.

Article 14 the supervision over and inspection of special blood stations mainly adopts the following method:

(a) refer to the "practice license of blood stations and blood testing laboratory qualification, relevant verification project, the content and scope of the actual practice is consistent with the license;

(2) sampling staff on-the-job training and examination of records and related materials;

(3) refer to the cord blood provider (mother before delivery) informed consent, blood work record, register and other related information;

(4) refer to scrap the cord blood treatment records;

(5) refer to transplant organization by the relevant documents for the record;

(6) random use of drugs, in vitro diagnostic reagent, disposable sanitary equipment is in accordance with the provisions of the state, check whether there is a repeated use of disposable sanitary equipment situation;

(7) spot check blood sampling, testing and issuing of work records and shelf life.

In the second quarter supervision stations of sole collection of plasma

Article 15 the supervision and inspection of the main content:

(a) single plasma stand qualification and its status in the laboratory qualification, conducting CaiGongXie pulp project legitimacy, area (range), and other business activities;

(2) medical personnel practicing qualification and registration, assessment of staff training;

(3) for plasma management files and shielding, elimination system set up; The key work system formulation and implementation;

(4) to collect raw material plasma following the voluntary and informed consent; Immune to special for plasma prior informed and consent to the circumstances; For plasma health consultation, health examination, blood test;

(5) for plasma identification and verification;

(6) using single plasma machine collection of plasma, blood plasma and mining slurry interval;

(7) the raw material of plasma packaging, identification, storage, plasma specimen storage condition;

(8) the supply of raw materials for the plasma;

(9) to detect unqualified or discarded plasma processing of materials;

(10) in vitro diagnostic reagents and one-time plasma equipment usage;

(11) for plasma management, testing and work record and preservation conditions for plasma;

(12) other illegal circumstances should be punished.

Article 16 when conducting supervision and inspection of single plasma station USES the following methods:

(a) access to the single plasma license, check the business project and collecting the plasma region (scope);

(2) random medical personnel and professional qualification certificate, the staff of blood safety and business post training, examination of records and related materials;

(3) check for the plasma shielding, elimination system, control system to verify the implementation; Check for plasma management files, the inspection qualified, permanent elimination, temporarily refused to set up the list of players in a plasma condition; Check the files for the plasma voluntary books, special for immune immunization record of the plasma or the plasma is a special immune agreement, for the plasma certificate, as well as for plasma physical examination, inspection and plasma record whether such information is complete; Refer to the key work system, control system of spot check the implementation.

(4) check for plasma archives, check follow voluntary, informed consent; On the need for special immune for plasma to inform and written consent of himself, can carry out special immune; Consult for plasma health examination, blood test and plasma record, verification for plasma health examination, blood tests, inspections, anti - HIV screening positive specimens were confirmed;

(5) check for plasma identification system and the running situation, will be used for plasma prior verification collection plasma id card or other valid identity certificate, the certificate for the plasma and the computer file management content check and confirm the situation; Spot check when necessary for plasma identity information and public security household registration information are consistent; When necessary to collect blood samples for plasma, and inventory plasma samples together to send qualified lab for biology characteristic homology comparisons;

(6) check the plasma sampling site single plasma mechanical plasma condition; Random spot check several times for plasma, check for plasma interval is in line with the requirements; Random sample single plasma weighing ingredients;

Plasma packaging, logo (7) to check the raw material; Plasma quick-frozen check raw material, storage equipment; Check the storage conditions of plasma and serum specimens of raw material, temperature control, and shelf life;

(8) to check the outbound records, financial transaction vouchers, checklists of plasma stand have to set its raw materials production units of blood products outside of the unit of the plasma condition;

(9) refer to unqualified or scrap raw materials of the plasma treatment records;

(10) random use of in vitro diagnostic reagents and related qualification, the period of validity of one-off plasma, check whether there is a repeated use of disposable sanitary equipment situation;

(11) check the business working records, check the plasma collection, detection and original records retention time for pulp.

The third section medical institutions supervision and clinical use

Article 17 the supervision and inspection of the main content:

(1) set of clinical blood use management committee (management group) for clinical use to formulate related plans and clinical use to implementing evaluation and examination of plan implementation, establish medical staff and unpaid blood donation knowledge training system, clinical use of blood transfusion branch (blood) Settings and whether the economic income for their work in the blood transfusion branch (blood) assessment indicator;

(2) the source of blood, blood swap between medical institutions and emergency blood;

(3) when receiving, issuing, before blood transfusion and transfusion blood check;

(4) the blood storage facilities and environment temperature records and disinfection, air train.

(5) apply for blood transfusion, blood transfusion blood tests before;

(6) other administrative penalties shall be illegal.

Article 18 for clinical use of medical institutions while conducting supervision and inspection mainly adopts the following method:

(a) refer to set up clinical use management committee (clinical use management working group) files, and access to blood and issue check and clinical use for blood transfusion management, medical staff and unpaid blood donation knowledge training, clinical use and physician clinical blood use evaluation and the public department system; View the blood transfusion division (blood bank) set; Refer to clinical use plan and a year of planning implementation evaluation and examination of the data;

(2) through the spot check (blood) storage of blood, blood transfusion can also spot check blood transfusion medical record, such as blood transfusion patients expenses listing trace the legitimacy of the source; There are emergency blood condition, verification report after emergency blood conditions and emergency blood;

(3) access to records for ins and outs of blood and blood transfusion record data, receiving a blood transfusion is check blood (blood) staff, outbound when taking blood, hair, blood transfusion and transfusion medical staff before to check the situation of blood; See if blood make personnel for medical personnel;

(4) to check the blood storage conditions of medical institutions, ChuXie facilities and its running status; Check to see different varieties and different type of blood stored separately; Check the validity of blood; For ChuXie facilities temperature, refer to the temperature monitoring, disinfection and air training materials;

Part (5) random inspection records, blood transfusion back transfusion application, check for doctors' qualifications, application amount of blood transfusion, blood examine and approve; Spot check related inspection records, verification test before blood transfusion, cross matching and records, inspection personnel qualification.

The fourth chapter to supervise and inspect the case processing

Article 19 the local family planning administrative department of health at or above the county level and after the implementation of blood safety supervision and inspection, supervision and law enforcement agencies should be timely feedback will supervise and inspect the units under inspection. For problems, shall issue a certificate of health supervision opinions; The existence of illegal ACTS, shall be investigated according to law; Suspected of a crime, transferred to public security organs in accordance with the law.

Article 20 the family planning administrative department of public health and the supervision and law enforcement agencies at all levels after the implementation of blood safety supervision and inspection, supervision and inspection shall be information in accordance with the regulations on the health supervision information report required procedures, time limit, report to health supervision information system or health supervision daily business report.

The fifth chapter is attached

Article 21 for blood stations, stations of sole collection of plasma, medical institutions, infectious disease prevention and control of clinical blood use supervision and inspection in accordance with the code for the infectious disease prevention and control of health supervision is carried out.

Article 22 of this code shall be the responsibility of the national health and family planning commission, shall come into force as of the date of release.

Regarding the compilation of "standard of blood safety supervision"

To regulate blood safety supervision, to better guide the local family planning administrative departments for public health supervision and law enforcement agencies at all levels and monitors started in place in accordance with the law, raise the level of supervision and law enforcement, protect public health, I entrust management of blood center in anhui province and anhui provincial health supervision organization compiled by the "guidelines for blood safety supervision" (hereinafter referred to as the "specification"), is proposed to appoint issued by post form.

A, compilation background

The blood of the People's Republic of China, our country CaiGongXie career and blood safety supervision work performance significantly, effectively ensure the quality and safety of blood, plasma collection work is unpaid blood donation and materials to get fast development, the remarkable achievement in the CaiGongXie management, the unpaid blood donation visitors increased from 1998 in 328000 to 2015 in 13.2 million. Clinical science reasonable use level also has a certain degree. But along with our country social economy and the rapid development of medical and health undertakings, the deepening of the reform of social management, the rapid increase of medical service quality, the demand for blood and its products is growing, blood supply and security, profound changes have taken place in the situation, to blood safety supervision put forward new challenges and higher requirements. Blood safety supervision includes CaiGongXie and clinical use supervision and professional stronger, and the blood safety supervision and law enforcement in the lack of unified norms and standards, supervision and law enforcement practice there exist significant differences in capability and level of law enforcement, supervision and law enforcement efficiency and level. Make blood safety supervision rules, therefore, necessary and urgent.

Second, the establishment process

To regulate blood safety supervision, I commissioned in 2014 blood center in anhui and anhui provincial health supervision by analyzing the relevant laws and regulations, standards and normative documents, on the investigation of some province blood safety supervision work, organization expert argumentation, combined with functional shift work requirements, compiled the "specification", further made clear in the blood safety supervision work, the family planning administrative department of public health as well as the supervision and law enforcement agencies at all levels of responsibility. In December 2015 and May 2016, our bureau held two expert seminar, to the discussion of "specification", the participating experts agree that the "specification" to increase the intensity of illegal CaiGongXie blow, clear administrative department and the supervision and law enforcement authority, regulating the blood safety supervision work has a guiding significance, hope to come as soon as possible, through the summary and analysis of the experts put forward amendments and finishing, actively adopt and part adopted reasonable opinions and Suggestions, to form the "standard (draft)".

Third, the main content

"Specification" five chapter 22, including:

(a) general rules. Illustrates the establishment of "specification" basis, applicable scope and the law enforcement main body.

(2) supervision responsibilities and requirements. The family planning administrative department of public health and supervision agencies at all levels of responsibility for the broken down, and put forward the specific job requirements.

(3) the supervision contents and methods. Three sections of blood stations (general blood stations and special blood stations), single plasma station, the main contents of supervision and examination of the clinical use of medical institutions and monitoring methods.

(4) to supervise and inspect the processing condition. Rules for processing, the result of the supervision and administrative penalty and criminal case of suspected criminal cases. And demand in accordance with the procedures and time limit to blood safety hygiene supervision information.

(5) supplementary provisions. Illustrates the involved in the prevention and treatment of infectious diseases work content of supervision, the authority for the interpretation of this specification and implementation date.

Fourth, main basis

(a) the laws and regulations and the state council issued by the file. Oct.1.1998, the "regulations on the administration of blood products", "the supreme people's court, the supreme people's procuratorate of deal with illegal CaiGongXie liquid such as" the explanation of the concrete application of law in criminal case, the administrative punishment law of the People's Republic of China, the compulsory administrative law of the People's Republic of China, the health administrative punishment procedures, "blood stations management method", "single plasma stand management method", "measures for the management of clinical blood use of medical institution".

(2) normative documents. The national health and family planning commission on strengthen the guidance of comprehensive supervision and law enforcement supervision who (countries hair [2013] no. 40), the crack down on illegal medical and illegal CaiGongXie work to strengthen cohesion with the interim provisions on (who supervise is sent [2009] no. 29), the supreme people's procuratorate, the national leading group office, rectify and standardize market economic order of the ministry of public security, ministry of supervision about in the administrative law enforcement in a timely manner to the opinions of the alleged crimes "([2006] no. 2) widely).

(3) the standards and specifications. Blood stations technology operating rules 2015 edition (countries who medical hair [2015] no. 95) and "technical specification for clinical blood transfusion (who is sent [2000] 2000)," blood stations and the quality control standard "(who is sent [2006] 2006)," blood stations laboratory quality management norms "(who is sent [2006] 2006), the blood donor health inspection requirements (GB18467-2011)," the quality of whole blood and component blood "(GB18469-2012)," the blood transfusion medicine commonly used term "thiophosphate (WS/T203-2001), the blood storage (WS399-2012), the blood transport requirement (WS/T400-2012), the requirements on the configuration of the blood donation site (WS/T401-2012).

(4) the relevant approval. The ministry of health on illegal CaiGongXie fluid and single plasma, the rectification of illegal medical practice work on the problem of applicable law "(who is sent [2004] 2004) of political science and law, the ministry of health on strengthening the management of the" blood therapy "notice" (medical hair [2005] no. 92), the ministry of health of the deadline to stop machine adopt platelet notification (who is sent [2006] 2006), the ministry of health on measures for the management of blood stations article 31 of the revised notice (who d [2009] no. 28) of political science and law, the general office of the ministry of health, about clear single plasma interval about the problem (who medical office administration letter [2011] no. 255).