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Regulations of Shanghai Municipality on Blood Donation

Regulations of Shanghai Municipality on Blood Donation
 
(Adopted at the 5th Session of the Standing Committee of the 11th Shanghai Municipal People's Congress on September 22, 1998)
    
     Chapter I General Provisions
    
     Article 1
     With a view to guaranteeing blood supply and safety for medical and clinical purposes, protecting the health of blood donors and blood users, advocating the spirit of humanitarianism and promoting the socialist material and spiritual civilization, these regulations are formulated in accordance with the Laws on Blood Donation of the People's Republic of China and other laws, administrative regulations, and in the light of the actual situations of this Municipality.
     Article 2
     These regulations shall apply to the units and individuals within the administrative areas of this Municipality.
     Article 3
     This Municipality implements free blood donation system by law.
     It is advocated in this Municipality that healthy citizens from 18 to 55 years old (hereinafter referred to as citizens of right age) shall donate blood voluntarily.
     Each unit and citizen shall participate in blood donation activities on their own initiatives.
     Article 4
     The people's governments at various levels and the relevant departments shall take measures to extensively propagate the implications of blood donation, popularize the scientific knowledge on blood and blood donation, and educate the citizens to prevent and control diseases infected via blood.
     Mass media such as broadcasting stations, movies, televisions and newspapers shall engage in the propaganda on blood donation for public welfare.
     All kinds of schools shall incorporate the scientific knowledge on blood donation into the health education courses or give special lectures.
    
     Chapter II Institutions and functions
    
     Article 5
     Municipal, county, or district people's governments shall govern the blood donation work within their respective jurisdiction by drawing up and instructing the annual blood donation plan, ensuring the fund for blood donation work, unifying the programs, organizing and coordinating the relevant departments to jointly and successfully implement the blood donation work.
     Article 6
     The competent department responsible for the blood donation work in the administrative areas of this Municipality is the Municipal Public Health Administrative Department. Its main functions are as follows:
     1. To draw up the annual blood donation plan for this municipality, to supervise and to inspect the execution of the blood donation plan;
     2. To formulate the management systems and technical standards for blood donation, blood collection, blood supply and medical and clinical use of blood;
     3. To take charge of the establishment of institutions of blood collection and blood supply for medical and clinical purposes in this municipality (hereinafter referred to as institutions of blood collection and supply, which is also called blood center or blood station) as well as to review and to approve the emergent blood collection of the medical institutions;
     4. To take charge of adjusting the blood supply between this municipality and other provinces;
     5. To take charge of supervising and administering blood donation, blood collection, blood supply and medical and clinical use of blood; and
     6. To take incentive and penalty measures.
     Article 7
     District and county public health administrative departments shall be responsible for the supervision and management of blood donation within their respective jurisdiction. Their main functions are as follows:
     1. To draw up annual plan for carrying out blood donation work for their respective district and county according to the municipal annual blood donation plan, to arrange, to guide and to supervise the execution of the plan;
     2. To supervise and administer blood collection and blood supply institutions subordinate to their respective district and county;
     3. To supervise and administer blood donation and medical and clinical use of blood; and
     4. To take incentive and penalty measures.
     Article 8
     Blood management institutions set up by the municipal, district and county public health administrative department shall take charge of the routine management work on blood donation, blood collection, blood supply and medical and clinical use of blood within their respective jurisdiction.
     Article 9
     Administrative departments of finance, price, education, human resources, public security, industrial and commercial administration, labor, social protection, construction, broadcasting, film and television, news, press and culture at all levels shall coordinate the blood donation work according to their respective duties and responsibilities.
     Article 10
     Red Cross Association at all levels in this municipality shall join and facilitate the blood donation work in this municipality.
    
     Chapter III Management of Blood Donation
    
     Article 11
     The Municipal Public Health Administrative Department shall draw up annual blood donation plan for this municipality in accordance with the medical and clinical demand for blood and the number of the right age citizens for blood donation and then instruct the district and county people's government after the plan being approved by the Municipal People's Government.
     The district and county public health administrative departments shall draw up annual blood donation plan for their respective district and county according to the annual blood donation plan given by the Municipal People's Government and instruct units (including units in this municipality subordinate to central government, other provinces, cities and autonomous regions, the same below), township and town people's governments and subdistrict offices.
     Article 12
     A work unit shall mobilize and organize the right age citizens (including non-local employees) to donate blood for the purpose of completing the annual blood donation plan for the unit.
     Township and town people's governments, and subdistrict offices shall mobilize and organize the right age citizens (including provisional non-local residents) that do not belong to any units to donate blood. Village committees and neighborhood committees shall cooperate with township and town people's governments and subdistrict offices to carry out blood donation.
     Article 13
     The citizens subordinate to a unit can donate blood either under the organization by the unit or by directly registering with Identity Card to local district or county blood management institutions, and either way the blood donated shall be counted in that unit's annual amount of the blood donated.
     The citizens that do not belong to any unit can donate blood either under the organization by the local township and town people's governments or subdistrict offices or by directly registering with Identity Card to local district or county blood management institutions, and either way the blood donated shall be counted in that local district's annual amount of the blood donated.
     Producing their own Identity Cards, citizens can donate blood at blood collection stations or bloodmobiles set up by blood collection institutions, and the blood donated shall be counted in the annual amount of the blood donated by their units or districts where they belong to.
     Article 14
     It is encouraged in this municipality that government employees, personnel on active service and students of higher learning shall take the lead in donating blood so as to play an exemplary role in forming new social practice.
     Detailed measures on blood donation for personnel on active service shall be separately formulated by the Municipal People's Government together with the armed forces stationed in Shanghai in accordance with the relevant State regulations.
     Article 15
     Blood collection and supply institutions or medical institutions designated by the Municipal, district or county blood management institutions shall conduct free physical examinations for citizens that are going to donate blood and shall issue certificates to those that pass the physical examinations for blood donation.
     Blood collection and supply institutions or medical institutions shall check the citizens' Identity Cards when conducting physical examinations for blood donation.
     Article 16
     Blood collection institutions usually collect 200 milliliters of blood from the blood donor each time, the maximum amount collected each time shall not exceed 400 milliliters and the interval between 2 collections shall not be less than 6 months.
     Article 17
     Blood collection institutions shall issue Free Blood Donation Certificates made by the Public Health Administrative Department of the State Council to the blood donors.
     Article 18
     District and county blood management institutions shall issue Blood Donation Plan Completion Certificates made by the Municipal Public Health Administrative Department to those units, township and town people's governments and subdistrict offices that have completed the annual blood donation plan.
     As to those units that have not completed the annual blood donation plan, the public health administrative departments shall notify them in writing of completing the plan before a specified deadline and may impose a penalty of blood donation compensation fee that equals to 5 times the cost of the unfulfilled amount of the annual blood donation plan on the unit that exceeds the time limit.
     The blood donation fee shall be allocated for the development of blood donation cause only.
     Article 19
     It's forbidden to illegally organize other people to sell blood. It's also forbidden to employ people to donate blood under somebody else's name.
     It's forbidden to counterfeit, alter, lease, buy, sell, or borrow the Blood Donation Plan Completion Certificate or Free Blood Donation Certificate.
    
     Chapter IV Blood Collection and Blood Supply
    
     Article 20
     This municipality adopts license system on blood collection and blood supply.
     No unit or individual shall be allowed to engage in the activities of blood collection and blood supply without the approval from the Municipal Public Health Administrative Department.
     Article 21
     Blood collection and blood supply institutions are non-profit-making organizations in the interest of public welfare.
     Applications for the establishment of blood collection and blood supply institutions shall be submitted to the Municipal Public Health Administrative Department that shall review and approve the applications pursuant to the relative state provisions. License for blood collection and blood supply institution shall be issued to the qualified applicants.
     Blood collection and blood supply institutions shall be engaged in the blood collection and blood supply activities strictly within the scope verified and specified in the License for blood collection and blood supply institution and shall provide all sorts of safe, sanitary and convenient conditions for the blood donors. Blood collection and blood supply institutions shall obtain the approval from the Municipal Public Health Administrative Department if they shall set up blood collection stations outside the business premises or they shall be equipped with bloodmobiles.
     Article 22
     Blood collection and blood supply institutions shall check the blood donors' Identity Cards and certificates of passing the physical examination for blood donation before collecting blood.
     Collecting blood by blood collection and blood supply institutions shall be subject to strict operation standard and system. Blood shall be collected by medical personnel qualified for collecting blood. Disposable blood collecting instruments in conformity with the national standards shall be used and destroyed after blood collection.
     Blood collection and blood supply institutions shall guarantee the quality of blood pursuant to the national and municipal standards and shall test the quality of the blood collected. Blood collection and blood supply institutions shall not supply the medical institutions with blood that has neither been tested nor qualified. The hygiene standards and requirements set by the state must be observed in blood test, separation, package, storage and transportation.
     Blood collection and blood supply institutions shall timely supply blood to medical institutions according to the medical and clinical blood use plan approved by the Municipal Blood Management Institution.
     Article 23
     If blood collection and blood supply institutions can not supply blood for emergency use, they shall report to the Municipal Public Health Administrative Department. Upon the approval from the Municipal Public Health Administrative Department, the medical institution in emergent need may collect the blood on the temporary basis by strictly complying with operational standards and system of blood collection to ensure the safety of blood collection and blood use.
     Article 24
     The blood donated free shall be used for the medical and clinical purposes and shall not be traded. Blood collection and blood supply institutions and medical institutions shall not sell the blood donated free to plasma collection stations or blood product manufacturing units.
    
     Chapter V Medical and Clinical Blood Use
    
     Article 25
     This municipality adopts a combined system for blood use of individual citizen blood storage, mutual help of family members and among a unit, and social assistance.
     The citizens that donate blood in this municipality (hereinafter referred to as CDB) shall be given the precedence in blood use.
     Article 26
     If CDB needs blood for medical and clinical purposes, he shall produce his own Identify Card and Free Blood Donation Certificate.
     Article 27
     Citizens who are not qualified for blood donation but subordinate to a unit shall produce the Completion Certificate of Blood Donation Plan of the relevant unit if they need blood for medical and clinical purposes.
     Healthy right age citizens subordinate to a unit who are qualified for blood donation but have not donated blood shall obtain blood use certificate from the district or county blood management institutions where their unit is located and pay blood use mutual fee if they need blood for medical and clinical purposes.
     If the employees in a unit that has not fulfilled the annual blood donation plan need blood for medical and clinical purposes, such unit shall pay blood use mutual fee to the district or county blood management institutions where their unit is located.
     Article 28
     If a citizen without a unit and not qualified for blood donation needs blood for medical and clinical purposes, he/she shall bring his/her family member's Free Blood Donation Certificate, together with residence booklet or relevant certificate to the local district or county blood management institution to get a Blood Use Certificate. If such a healthy right age citizen's family members qualified for blood donation fail to help him/her in blood matters, he/she shall present the residence booklet to the local district or county blood management institution to get a Blood Use Certificate and pay blood use mutual fund.
     If a healthy right age citizen without a unit, being not a blood donor, but qualified for blood donation needs blood for medical and clinical purposes he/she shall present the residence booklet to the local district or county blood management institution to get a Blood Use Certificate and pay blood use mutual fee.
     Article 29
     If a citizen above sixty years old needs blood for medical and clinical purposes, he/she shall be exempt from blood use mutual fee by presenting his/her Identity Card.
     If a citizen without a unit, neither himself/herself nor his/her family member(s) qualified for blood donation for age or health reasons, needs blood for medical and clinical purposes, he/she shall obtain blood use certificate from the local district or county blood management institution with the residence booklet and relevant certificate.
     Article 30
     The medical institutions shall give priority in using blood to emergent patients in need of blood, and the patient, his / her family member or his / her work unit shall later go through the necessary procedures for obtaining the blood use in accordance with these Regulations.
     Article 31
     The district or county blood management institutions shall refund the blood use mutual fee handed in by the unit or the citizen if the citizen has met one of the following qualifications after using blood for medical and clinical purposes:
     1. The unit fulfills the annual blood donation plan within the specified period;
     2. The citizen or his/ her family member donates blood within the specified period; or
     3. Neither the citizen nor his / her family member is qualified for blood donation.
     Article 32
     The medical institutions shall charge the citizen expenses covering blood collection, storage, separation and test, etc. according to the standards stipulated by the state when he / she uses blood for medical and clinical purposes.
     CDB in this Municipality and their family members without work unit may be exempt from the expenses specified in the above section and the blood use mutual fee specified in the present regulations according to the following provisions:
     1. CDB in this municipality shall be entitled to use blood free for medical and clinical purposes in the amount of 5 times the blood he / she donated without paying blood use mutual fee within 5 years after the date of blood donation, and for the same purposes in the same amount of the blood he / she donated after 5 years from the date of blood donation without paying blood use mutual fund; and
     2.CDB' s family member not qualified for blood donation shall be entitled to use blood free for medical and clinical purposes, in the same amount of the blood donated within 5 years after the date of blood donation without paying blood use mutual fund.
     Article 33
     The medical institutions shall formulate blood use plan for medical and clinical purposes according to the demand for medical and clinical blood use and submit the plan to the local district or county blood management institutions for review and consent. After being approved by the municipal blood management institution the medical institutions shall arrange the use of blood for medical and clinical purposes.
     The municipal blood management institution can coordinate the blood use plans of medical institutions for medical and clinical purposes on the basis of blood supply situation in this Municipality.
     Article 34
     The medical institutions shall get blood at the blood collection and blood supply institutions designated by the municipal blood management institution and shall strictly comply with the blood storage and management regulations.
     The medical institutions shall inspect and examine the blood use for medical and clinical purposes according to the state provisions. The blood that has not been examined and inspected or fails to meet the state provisions shall not be used for medical and clinical purposes.
     The medical institutions shall check the blood use certificate and the relevant certificate pursuant to these regulations before the patient uses the blood for medical and clinical purposes.
     Article 35
     In blood use for medical and clinical purposes, the medical institutions shall observe the technical standards for blood transfusion, follow reasonable and scientific principles and actively facilitate constituent blood transfusion and self blood transfusion, and shall not waste or abuse blood.
    
     Chapter VI Reward and Penalty Measures
    
     Article 36
     Commendation and awards shall be given to the following units and individuals by municipal, district or county people's governments and Red Cross Association:
     1. Any individual who donates blood in the accumulated amount of above 1,000 milliliters;
     2. Any unit that has overfulfilled its annual blood donation plan for 3 consecutive years;
     3. Any unit or individual who has made outstanding achievements in the education and propaganda of free blood donation;
     4. Any unit or individual who has made outstanding achievements in studying and spreading new blood use technology for medical and clinical purposes; or
     5. Other unit or individual who has made outstanding achievements in the work of blood donation, blood collection, blood supply and blood use for medical and clinical purposes.
     Article 37
     The municipal, district or county public health administrative departments shall confiscate the Blood Donation Plan Completion Certificate or Free Blood Donation Certificate that is counterfeited, altered, leased, traded or borrowed, and shall impose a fine of 500 yuan to 5,000 yuan.
     As to employing other people to donate blood, the municipal, district or county public health administrative departments shall impose on the unit a fine of 10,000 yuan to 50,000 yuan, and for serious cases, a fine of 50,000 yuan to 100,000 yuan, and on an individual a fine of 1,000 yuan to 5,000 yuan, and for serious cases, a fine of 5,000 yuan to 10,000 yuan.
     Article 38
     In any one of the following cases in violation of these regulations, the municipal, district or county public health administrative department shall ban such activity, confiscate illegal gains, and may impose a fine of 10,000 yuan to 50,000 yuan, and for serious cases, a fine of 50,000 yuan to 100,000 yuan. Those whose act constitutes a crime shall be prosecuted for their criminal liability according to law:
     1. To collect blood illegally;
     2. To sell blood donated free; or
     3. To organize other people to sell blood illegally.
     Article 39
     If blood collection and blood supply institutions violate blood collection operational standards and system, the municipal, district or county public health administrative departments shall instruct such institutions to correct; if a blood donor's health is impaired, compensation shall be made according to law, and the direct responsible executive and other direct responsible persons shall be given administrative punishments according to law. Those whose act constitutes a crime shall be prosecuted for their criminal liability according to law.
     If blood collection and blood supply institutions do not comply with the hygiene standards and requirements set by the state in blood test, separation, package, storage and transportation, the municipal district or county public health administrative departments shall instruct such institutions to correct and shall give them a warning as well as a fine of 1,000 yuan to 10,000 yuan.
     If blood collection and blood supply institutions provide the medical institutions with the blood that does not meet the standards stipulated by the state and this municipality, the municipal, district or county public health administrative departments shall instruct such institutions to correct and shall order them to reform within time limit in case of serious incident that causes disease transmitted by blood or poses danger of infectious disease. The direct responsible executive and other direct responsible persons shall be given administrative punishments according to law. Those whose act constitutes a crime shall be prosecuted for their criminal liability according to law.
     Article 40
     If medical service personnel of medical institutions violate these provisions by failing to check the blood use certificate or the relevant certificates for medical and clinical blood use as specified in these provisions, the municipal, district or county public health administrative departments shall instruct them to correct and may give administrative punishments to the relevant responsible persons according to law.
     If medical service personnel of medical institutions violate these provisions by using the blood that does not meet the standards stipulated by the state for the patient, the municipal, district or county public health administrative departments shall instruct them to correct, if the patient's health is impaired, compensation shall be made according to law. The direct responsible executive and other direct responsible persons shall be given administrative punishments according to law. Those whose act constitutes a crime shall be prosecuted for their criminal liability according to law.
     Article 41
     Those who reject and hinder the public health executives' enforcement of laws, disrupt the work order of blood donation, and violate the Regulations of the People's Republic of China on Public Security Administration and Imposition of Punishment shall be penalized by the public security departments according to law. Those whose act constitutes a crime shall be prosecuted for criminal liability according to law.
     Article 42
     The public health administrative department shall produce an administrative penalty decision letter when making such a decision and shall produce a unified receipt printed exclusively by the municipal finance department when receiving a fine or confiscating properties.
     All fines shall be handed in to the state treasury.
     Article 43
     If the party concerned refuses to accept the specific administrative act, he / she can apply for reconsideration or bring legal action pursuant to the Regulations on Administrative Review or the Administrative Litigation Law of the People's Republic of China.
     If the party concerned fails to apply for reconsideration, or to bring legal action as to a specific administrative act, or to perform his / her obligation within the statutory period, the department that takes such a specific act may apply to the people's court for enforcement.
     Article 44
     If the personnel working in the public health administrative departments neglect their duties, abuse their power and engage in malpractice for personal gains, such personnel shall be given administrative punishments by their units or their superior competent departments according to law. Those whose act constitutes a crime shall be prosecuted for their criminal liability according to law.
    
     Chapter VII Supplementary Provisions
    
     Article 45
     The family members named as such in these Regulations refer to the citizen's spouse, children, parents, and parents-in-law.
     Article 46
     If non-local citizens who come to Shanghai for medical treatment need blood for medical and clinical purposes, they shall comply with the relevant provisions on the medical and clinical blood use for local citizens under these Regulations.
     Article 47
     Foreign citizens, overseas Chinese, residents in Hong Kong Special Administrative Region and in Macao and Taiwan regions living in this Municipality can donate blood or use blood for medical and clinical purposes by presenting their valid identity cards.
     Article 48
     If the citizen in this Municipality donated blood free before these regulations becoming effective, such citizen and his / her family member without a work unit can use blood for medical and clinical purposes pursuant to the provisions of these Regulations.
     If the citizen in this Municipality donated blood on voluntary basis before these Regulations becoming effective and if such citizen and his / her family member without a work unit need blood for medical and clinical purposes within 5 years after the date of blood donation, they can use equal amount of blood without paying blood use mutual fee. But they shall pay the expenses listed in Section 1 of Article 32 of these Regulations.
     Article 49
     These Regulations shall become effective on October 1, 1998. The Regulations of Shanghai Municipality on Voluntary Blood Donation adopted at the 6th Session of the Standing Committee of the 9th Shanghai Municipal People's Congress on January 28, 1989, shall be annulled on the same date.
    

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