The Change of Blood Donation Modes from Paid and Mobilized Unpaid to Voluntary Unpaid Blood Donation
In 1998, the Blood Donation Law became the symbol of the VNRBD system in China. VNRBD, family replacement/mutual blood donation (FRMBD), and employer-organized blood donation were the three types of blood donation programs permitted by the Blood Donation Law (see Figure1).
Employer-organized blood donation is an interim policy from paid blood donation to voluntary unpaid blood donation. Employer-organized blood donation, workers blood donation as pre-arranged by the employer and local blood stations, a semi-obligatory and mobilized unpaid mode, was banned by the Chinese government in 2005[19, 20]. The reason for the ban was that those who donate blood, as required by their employer, were exposed to undue pressures and had higher rates of infectious disease markers compared to volunteer donors[21-24]. In fact, the cancellation of employer-organized blood donation meant that China implemented a voluntary unpaid donation system nationwide, thereby eliminating paid donation by 2005. Of course, group voluntary blood donation, as a mode of VNRBD, is allowed in China, accounting for a large percentage of blood donation. Group blood donation has the advantage of being arranged in advance, making up for seasonal shortage of street blood collection and emergency mobilization[25].
There were three identified types of blood donors in the WHO Blood Safety and Availability Report, such as the voluntary unpaid, family or replacement, and paid[12]. FRMBD, which was concerned with the patients’ family members, relatives, and friends, the unit to which he or she belongs in the community, with regard to blood donation for mutual aid, thereby ensuring the supply of blood for citizens' clinical first-aid treatment[26]. FRMBD was widely used for more than 20 years in China. Since 2009, the government of China has been paying much attention to the proportion of FRMBD in blood collection. According to the NHC, the policy of FRMBD was cancelled to improve blood quality and safety in 2018 in most regions[27].
Roles of Government, Blood Centers, and Medical Institutions in the Management of Blood Collection and Transfusion
Blood must be used for official clinical activities. Any form of blood trade has been banned by the Chinese government to assure the quality and safety of blood collected, which were listed in accordance with blood-related laws and regulations (see Table 1,From 1996 to 2013 the national health administration department of China is The Ministry of Health, and it was revoked and replaced by The National Health and Family Planning Commission from 2013 to 2018. Since March 2018, it was replaced by The National Health Commission). Even the importation and exportation of blood was forbidden in 2017[28]. To encourage donation, the government provides voluntary blood donors with a holiday, a nutrition allowance, and priority access to blood transfusion during emergencies[29].
Table 1
The Outline of Laws and regulations related to Blood Donation and Safety in China
Type | Act | Legal sources | Implementation Years | Legislature | Main points |
Specific Legislations | Regulations on Blood Collection and Supply Institution and Blood Administration | Regulation | 1993 (1998 Expired) | The Ministry of Healtha | Permission of The Blood Centre Blood Donor Registration Promotion of VNBD |
Detailed Rules for the National Verification of External Immunodiagnostic Reagent for Blood Use | Regulation | 1994 | The Ministry of Health | Test of HIV, HBV, HCV, Syphilis |
Regulations on Administration of Blood Products | Regulation | 1996(2016 Revision) | Instrumentalities of the State Council | Blood Product Administration |
Blood Donation Law | Law | 1998 | Standing Committee of the National People's Congress | VNBD System; Blood Only for Clinical Use |
Measures for the Administration of Blood Centres (for Trial Implementation) | Regulation | 1998 (2006 Expired) | The Ministry of Health | Blood Centre Administration |
regulations on Clinical Use of Blood in Medical Institutions (for Trial Implementation) | Regulation | 1999 (2012 Expired) | The Ministry of Health | Clinical Blood Use |
Technical Standards for the Clinical Blood Transfusion | Regulation | 2000 | The Ministry of Health | Corss-Match Test Blood Transfusion Record |
Measures for the Administration of Blood Centres | Regulation | 2006 (2009,2016༌2017 Amendment) | The National Health and Family Planning Commissiona | Classification and Management Of Blood Centre Blood Specimen Restoration 2017 Cancellation of Blood Imports and Exports |
Provisions on Clinical Use of Blood in Medical Institution | Regulation | 2012 | The National Health and Family Planning Commission | Clinical Blood Use Emergency Blood Use |
Technical Operating Procedures for Blood Centres (2019 Edition) | Regulation | 2019 Edition (2005, 2012, 2015 Edition Expired) | The National Health Commissiona | NAT in clinical use |
Other Relative Legislations | Regulation on the Handling of Medical Accidents | Regulation | 2002 | Instrumentalities of the State Council | Fault Compensation Liability |
Tort Law | Law | 2010 | Standing Committee of the National People's Congress | Principle of No-Fault Liability in Blood Transfusion Tort |
Pharmaceutical Administration Law | Law | 1984 (2001, 2002, 2004, 2016, 2017, 2019 Revision) (2013 Amendment) | Standing Committee of the National People's Congress | Blood Products Blood Products Cannot Be Commissioned Production and Sell Online |
Prevention and Treatment Of Infectious Diseases Law | Law | 1989 (2004 Revision) (2013 Amendment) | Standing Committee of the National People's Congress | Ensure the Quality Of Blood And Blood Products To Prevent Transfusion-Transmitted Diseases |
Local Legislation | Regulations on Voluntary Blood Donation By Citizens Of Beijing | Regulation | 1992 (1998 Expired) | Beijing’s Standing Committee of the National People's Congress | Promotion of voluntary blood donors |
Regulations on Shenzhen Special Economic Zone on Citizen's Gratis of Blood Donation and Blood Management | Regulation | 1995 (2015 Expired) | Shenzhen’s Standing Committee of the National People's Congress | Reimbursement of VNBD |
Regulations of Beijing Municipality on Mobilizing and Arranging for Citizens to Donate Blood | Regulation | 1998 (2006 Expired) | Beijing’s Standing Committee of the National People's Congress | VNBD system |
Rules of Guangzhou Municipality on Donation of Blood | Rules | 2004 (2015 Amendment) | Guangzhou Municipal People's Government | Mutual Blood Donation |
Regulations of Nanning Municipality on Blood Donation | Regulation | 2004 (2012 Revision) | Nanning’s Standing Committee of the National People's Congress | VNBD system |
Measures of Beijing Municipality for Administration of Blood Donation | Rules | 2009 | Beijing Municipal People's Government | VNBD publicity and the service |
Regulations on Shenzhen Special Economic Zone Blood Donation | Regulation | 2015 (2019 Amendment) | Shenzhen’s Standing Committee of the National People's Congress | VNBD incentives |
Measures of Nanning for rewarding blood donation | Rules | 2017 | Standing Committee of Nanning Municipal People's Government | VNBD incentives and rewarding |
aFrom 1996 to 2013 the national health administration department of China is The Ministry of Health, and it was revoked and replaced by The National Health and Family Planning Commission from 2013 to 2018. Since March 2018, it was replaced by The National Health Commission. |
Blood centers serve as the main institution in the collection and restoration of blood. From 1993 to 1998, the establishment of blood centers have been constantly approved by the Red Cross Society in China[30]. After the Measures for the Administration of Blood Centre (for Trial Implementation) were implemented in 1998, the blood center was defined as a non-profit, public welfare organization, and its establishment was thereafter managed by the health administration department of the provincial government[31]. Blood centers provide the necessary health examination and blood collection service for voluntary unpaid blood donors, maintain blood supply for clinical use, and are responsible for restoration and transportation[32]. The blood collected from donors will be tested to avoid quality problems[33].
The medical institution is the only legal institution for the clinical use of blood. The Blood Donation Law stipulated that all blood and blood products must be tested before transfusion in medical institutions to ensure safety[34]. Other regulations and technical standards regarding blood centers and medical institutions are listed in Table 1. These guidelines and regulations have the effect of strengthening the management of blood collected and enhancing the level of blood safe.
Huge Increase in Blood Collection and Supply
Before 1998, the recruitment of blood donor volunteers was a very challenging endeavor in China. Traditional Chinese medicine holds that the loss of even a small amount of blood was harmful on the health, and it was also why paid blood donation was common at that time[3].
Since 1998, the implementation of the Blood Donation Law and encouragement of unpaid blood donation by laws and policies[35], the number of unpaid blood donors and the amount of blood collected in China have been continuously increasing for 20 years (see Figure 2,Data on 1998, 2010, 2011, 2014, 2015, 2016, 2017, 2018 from National Health Commission of the People’s Republic of China (NHC)Data on 2012, 2013 from Global database on blood safety (GDBS). The steady increase in the number of unpaid blood donors and the amount of blood collected has ensured the safe supply of blood from the source[11].
The proportion of unpaid blood donation was only 8% in 1998, which increased to 95.5% in 2005. After 2009, it was realized that all clinical blood came from unpaid donation[36]. In response to the call of The Melbourne Declaration on 100% Voluntary Non‐Remunerated Donation of Blood and Blood Components, the Chinese government engaged in efforts to popularize VNRBD donors and entered the list of countries which reported almost 100% blood collection in 2011[37].
Through the establishment of a multi-level alarm mechanism when blood is in short supply and the deployment of resources in different blood centers, seasonal, regional, and partial blood tension problems have been solved to a great extent. In 2015, 1.19 million units of blood were allocated across the country, and it reached 1.54 million in 2017[38]. In 2018, a total of 1.84 million units of blood were allocated across the country, of which 1.585 million units (86.1%) were allocated among the province and 255 thousand units (13.9%) were allocated between provinces. The policy of alarming and deployment of blood effectively ensured the clinical blood demand in blood intensive areas and major public health events[11].
The Rise and Fall of Family Replacement/Mutual Blood Donation in VNRBD
Since 1998, according to Article 15 of the Blood Donation Law, patients’ family members, relatives, friends, and their colleagues have been allowed to donate blood for mutual aid in emergency situations. FRMBD is a double-edged sword for blood safety. On the one hand, it can solve the shortage of blood. On the other hand, the risk of blood trade exists in mutual blood donation. The WHO has stressed that when mutual blood donation accounts for more than 5% of unpaid blood donation, there would be a risk of illegal blood trade.
As a specific mode of donation, it was able to relieve the tension and shortage in the clinical blood in China. FRMBD accounted for 0.41% of the national blood collection in 2009 [39]. In 2015, it increased to 4.2% (see Figure 3) nationwide. In some provinces, it was significantly higher, such as in Hainan (35.6%), Guangxi (25.9%), Xinjiang (11.7%), Gansu (9.5%), and Guangdong (9.3%)[40]. Even in the Xinning City of Guangxi Province, it was up to more than 50%[41], while it was 21% in Beijing in 2017[42].
However, the rules on mutual blood donation in the Blood Donation Law are too wide in scope for FRMBD to leave room for criminals to sell blood illegally, thereby increasing the people’s distrust regarding voluntary blood donation and lowering the quality and safety of donated blood[43]. Private transactions between donors and recipients cannot be supervised by medical institutions or blood centers.
To ensure the quality and safety of blood collection, NHC issued a government order to cancel FRMBD nationwide, except for some remote areas, by March 2018[27]. At present, most areas have completely stopped FRMBD. It is no doubt that the cancellation of blood donation imposes a burden on the clinical blood shortage in hospitals[44]. In response thereto, VNRBD should be promoted and inter-provincial transfers of blood should be well-allocated to maintain the balance of blood supply and demand.
Development of Blood Safety in China
Blood safety depends on whether the source of blood is safe to a large extent. Ensuring the safety of blood collected is the first step in the whole process. It took the Chinese government 4 years to establish and strictly implement the testing procedures, and continuously improve it over the past two decades.
China’s commercial plasma-selling emerged in the early 1980s[45]. Since 1993, blood donors have been required to be tested for HIV, hepatitis B, hepatitis C, and syphilis in order to reduce the infections through transfusion according to Health Examination Standards for Blood Donors[32]. But these regulations was not be fully implemented,HIV-positive individuals could enter the blood plasma collection process without HIV testing. From the end of 1994 to the beginning of 1995, when local outbreaks of the infection occurred first in provinces including Hebei, Anhui, and Henan provinces, the HIV epidemic was subsequently found among plasma donors[45].It was reported that 326 cases from who had donated blood at plasmapheresis centres in Hebei Province were identified as HIV-positive during 1995-2013. These HIV infections were proved to emerge in October 1994 initially[2].
Finally, the Technical Operation Procedures in Blood Stations standardized donor screening has become an essential testing step at blood collection centres since 1997[46]. From then on, each unit of blood must be tested for blood grouping, hemoglobin, alanine aminotransferase(ALT), HBV surface antigen(HBsAg) before collection. Then, donated blood (post-collection) would undergo comprehensive donor testing twice, using different equipment and/or different personnel, including HIV, HBV, hepatitis C virus, ALT, and syphilis[47].
In the next two decades, testing is strictly implemented. Equipment and technology are updated continuously. For blood group, the RhD type were forced to appraise since 2012[48]. For serum markers, colloidal gold strip method was used to detect the markers of HBV in early 1990s. Since 1997, serum markers were tested through enzyme-linked immunosorbent assay (ELISA) reagent[46]. Since 2010, Chinese government has established NAT system in several regions, such as Beijing and Shanghai, covering all types of donations and achieving great progress in improving blood safety[49]. Due to huge operating costs and the shortage of qualified staff of blood centre, NATs were mainly implemented at the provincial level of blood centre in 2013[15]. In 2014, the blood test completed by NAT nationwide approached 4.7 million units, which accounted for 36% of the annual blood donation[16]. About 129 million dollars was invested on the nationwide expansion of NAT in 2015[50]. Eventually, nucleic acid test (NAT) and chemiluminescent immunoassay (CLIA) were formally added to this procedure according to Technical Operating Procedures for Blood Centres (2015 Edition)[51]. In order to simplify the procedure and improve the efficiency, serum markers only need to be detected once by ELISA or CLIA except NAT since 2019[52]. (As showed in Figure4) The window period of HIV, HBV, HCV are shortened by NAT from 50, 72 and 22 days to 25, 59 and 11 days respectively[53].
Through analyzing the litigation cases related to transfusion from 1981 to 2020, we found that the numbers of cases experiences a huge reduction, since the HCV was required to be tested in 1994 (Figure5). Blood transfusion reactions accounted for 5.6% of all documents, HBV infection accounted for 5.3%, HIV infection accounted for 11.0%, HCV infection accounted for 76.7%, syphilis infection accounted for 2.3%. HCV infection took the largest share, of which 55.8% occurred before 1994.
Transformation of Liability in Blood Transfusion Malpractice
Process optimization and technology updates improved blood safety directly but the risk of blood transfusion cannot be eliminated completely for some unpredictable reasons, infections, venous thromboembolism[54], transfusion-related lung injury and transfusion-associated graft-versus-host disease[55]. So it is crucial that who takes this liability.
Before 1993, there was no regulations related to adverse events caused by transfusion. For instance, medical institutions or blood stations would not be held accountable for HIV infection caused by blood transfusion because the antibody of HIV was not required to test until 1993[46]. Between 1993 to 2002, there were no laws or regulations to compensate for the adverse events caused by blood transfusion, leaving the issue to be addressed by civil law. The result of judgements often depended on the opinions of judges and juries.
Between 2002 and 2010, according to Article 33 of the Regulation on the Handling of Medical Accidents, the fault liability principle was deemed applicable in transfusion. It was found that hospitals were not responsible for no-fault transfusion[56]. It means that the hospital will not bear legal responsibility if the whole process met the inspection standards and technical index, even though the unfavorable consequences caused by infections resulting from the quality of blood. What’s more, in case of emergency, infections caused by blood transfusion were exempted due to the thought that life extension was more important than long-term quality of life. Then obviously, it was not fair for the patient who get HIV or HBV infectious in transfusion. So in judicial practice, to any cases that the hospital was ordered to pay compensation for patients even no error in transfusion for fairness[57]. Of the 301 cases, 236 hospitals or blood stations in China paid compensation for the infection related to transfusion from 1981 to 2018.
After 2010, according to the Article 59 of the Tort Law of China, damage of transfusion was classified as a special no-fault liability tort. It was the first time to clearly point out that patients could claim compensation. This principle shows the protection of the rights and interests of patients. Although the hospital may not be at fault in whole process, they should assume the tort liability for infringing upon a civil right or interest of patient and pay compensation. As showed in Figure5, the numbers of decisions reached its peak in 2015, which has a great deal to do with the Tort Law of China. Generally speaking, the trial practice takes three to four years after the prosecution. In one word, the patient has the right to claim for compensation from the blood centre or the hospital, if only he or she suffered any adverse event due to transfusion or infected blood.