[Foreword] As early as 2015, General Secretary Xi Jinping clearly pointed out: We must strengthen the supervision of food and drug safety, and accelerate the establishment of scientific and perfect with the most stringent standards, the strictest supervision, the most severe punishment, and the most serious accountability. The food and drug safety management system strictly controls every line of defense from farmland to table, from laboratory to hospital. Vaccines are related to the health of the people and to public health and national security. After the case of the illegal vaccine series in Jinan, Shandong Province in 2016, the State Council revised the Regulations on the Administration of Vaccine Circulation and Vaccination. On July 15, 2018, the State Food and Drug Administration said that it had recently seized a batch of rabies vaccines for production and fraud, and had requested the Jilin Food and Drug Administration to take back the pharmaceutical GMP of the Changchun Changsheng Biotechnology Co., Ltd. The Certificate is ordered to stop the production of rabies vaccine and to investigate the relevant violations. On August 16, 2018, the Standing Committee of the Political Bureau of the CPC Central Committee held a meeting to hear reports on the investigation of vaccine cases and related accountability of Jilin Changchun Changsheng Company, and to hold serious accountability. General Secretary Xi Jinping presided over the meeting. This fully demonstrates that the Party Central Committee with Comrade Xi Jinping as the core is highly responsible for the vital interests of the people, attaches great importance to the supervision of drug safety and quality, and has a strong responsibility for strictly administering the party and resolutely removing defects.

 

The Party Committee and the Disciplinary Committee of the Municipal Women's and Children's Medical Center attached great importance to it, seriously recognizing that the vaccine is related to life and health, and that quality and safety are not allowed to be a little bit embarrassing. We must not be lucky enough to require relevant functional departments and party organizations at all levels to implement the "one post and two responsibilities". In the actual situation of the hospital, special supervision work was carried out on the use and management of hepatitis B vaccine, BCG and hepatitis B immunoglobulin.

 

First, the leadership attaches importance to active deployment

The leaders of the center deeply realized that the problem of the vaccine was serious and the nature was bad, causing serious adverse effects, exposing many loopholes such as inadequate supervision, and also reflecting the institutional defects in the production and use of vaccines.

On July 25th, the Discipline Inspection and Supervision Audit Office formulated the “Work Plan for the Special Supervision of Hepatitis B Vaccine, BCG, and Hepatitis B Immunoglobulin Use and Management” and submitted it to the Party Committee for consideration and approval.

On the morning of July 30th, Feng Qiong, secretary of the Central Commission for Discipline Inspection, presided over the joint meeting of the relevant functional departments of the special self-inspection work for hepatitis B vaccine, BCG, hepatitis B immunoglobulin use and management, requiring the Ministry of Health and nursing before August 5th. The Ministry of Health, the Ministry of Children's Health and the Ministry of Pharmacy have carried out self-examination and self-correction of hepatitis B vaccine, BCG and hepatitis B immunoglobulin, and implemented the "Nine Mistakes" and Honest and Self-discipline Commitment Letters. Party organizations at all levels supervise and implement the Central Disciplinary Committee. Re-supervise and re-examine the implementation of this work management and supervision duties by the above functional departments.

 

Second, find out the bottom, comprehensive inspection

(1) Self-examination of the purchase, management and use of vaccines

1. The Pharmacy Department conducted a self-examination of the hepatitis B vaccine and BCG vaccine collection or purchase, and found three problems: 1 unable to monitor the use of vaccines in the ward; 2 vaccine refrigerator temperature maintenance; 3 maternal and child hospitals have difficulty in placing vaccine refrigerators .

Put forward rectification opinions or suggestions 3 points: 1 Strengthen monitoring by the preventive health department; 2 Logistics management department to carry out maintenance and repair in time; 3 Keep the drug storehouse of the maternal and child hospital area.

2. The Ministry of Children's Health conducted a self-examination of the procurement bidding and management use of hepatitis B human immunoglobulin. Since 2016, the Guangzhou Municipal Health and Family Planning Commission has entrusted the Municipal Women and Children Medical Center to purchase the necessary materials for the city's midwifery institutions. Hepatitis B human immunoglobulin (including syringe) is used for passive immuno-implantation of newborns born to women with hepatitis B virus infection. Found that there are two difficulties: 1 the use of funds is more difficult to complete more than 95% of the requirements of the higher authorities; 2 hepatitis B human immunoglobulin tendering and use departments are more difficult to control.

Recommendations: 1 The hepatitis B human immunoglobulin funds are not included in the progress assessment of the Health Planning Commission, or the funds for the next year are not included in the total assessment. 2 The relevant quality inspection departments of the state increase the frequency of quality inspections.

3. The Nursing Department conducted a self-examination of the vaccine management and use situation and the implementation of the process by the nurses. It found that there are 6 problems: 1 department store vaccine, refrigerator management, cold chain equipment, monthly rotation, mechanical refueling, no one to perform; 2 Saturday , Japanese and holiday pharmacies did not give the vaccine transport record to the department; 3 departments have no vaccine scrap records and suspected adverse reactions register; 4 departments did not set up a separate vaccination room; 5 can only try to inject hepatitis B immunity within 24 hours The main reason for globulin is that hepatitis B immunoglobulin is also zero stock and that the pediatrician did not open the doctor's prescription at night and signed the informed consent form to the family member; 6CDC issued BCG vaccine for 5 people/support, and could not implement one vaccination for one person.

Put forward rectification opinions or suggestions 10 points: 1 Communicate with the Pharmacy Department in time to solve the problem of no vaccine transportation record on Saturday, Sunday and holidays. 2 Communicate timely with the logistics management department to strengthen the maintenance of the vaccine refrigerator in the department. 3 Require the head nurse to strictly train and check the situation, and put an end to the situation that the registration of the warehousing has been altered or missed. At the same time, please feel the hospital and CDC and other relevant departments: It is recommended to consider informatizing the vaccination registration form. The 4 Department Vaccine Scrap Record and the suspected adverse reaction register are currently temporarily used for registration in the remarks of various vaccine registration forms. The hospital and CDC and other relevant departments are required to issue the scrap record book and the suspected adverse reaction register. Registration information management. 5 It is recommended that the hospital set up separate vaccination rooms in 15 relevant departments. 6 It is recommended that the hospital communicate with the CDC to strengthen the qualification training and retraining of vaccinators in our hospital. 7 The optimal injection time of hepatitis B immunoglobulin is within 6 hours after birth. It is recommended to consider the agreement or the designated pediatrician to serve the delivery room. The pharmacy will issue the vaccine in time. The “small train” will be delivered to the delivery room in time, and the immunoglobulin injection will be completed by the delivery room. 8 It is recommended that the hospital propose to the higher authorities to return the hepatitis B vaccine replanting work to the community to avoid management inconsistency. 9 It is recommended to apply to the CDC for BCG to use one vaccine and complete a closed-loop management. 10 Communicate with the Department of Science, Education and Data Management. It is recommended to provide information needs to the medical system. Mobile care can also be used to import vaccination information into the nursing records to ensure consistency and homogeneity with the nursing records of the critical system.

4. On August 8, 2018, the Medical Department (Prevention and Health Care Department) placed a signboard at the nurse station and set up a consultation point and a NICU in the obstetrics group, the obstetric group 2, the obstetrics group, the obstetric special needs ward, and the outpatient injection room. The consultation point is placed at the door or in the conversation room to make "the first needle hepatitis B vaccine, BCG vaccine vaccination and hepatitis B mother-to-child blocking counseling guidelines": The hospital's vaccination does not involve the manufacturers and problem vaccines of the National Food and Drug Administration! For inquiries about other vaccines such as DTP, rabies vaccine, etc., please call the Yuexiu District Disease Control and Prevention Department telephone number 83833792 or 12320 health hotline for consultation. The Ministry of Medical Affairs has proposed to the higher authorities to provide "one person one" for BCG vaccination. On August 13, 2018, Guangzhou Yuexiu District Center for Disease Control and Prevention issued the "Response to the Consultation on the Vaccination of BCG Vaccination in Guangzhou Women and Children Medical Center": After the request from the Department of Immunization of the Guangzhou Municipal Center for Disease Control and Prevention, the reply: According to the national vaccination The standard of work, BCG is 5, the maximum loss factor can not exceed 2.5, the "one person one" approach will lead to a serious shortage of BCG vaccine caused by vaccine shortage, resulting in some inoculation objects without seedlings, do not agree with the proposal and request.

 

(2) Supervising the implementation of honesty and self-discipline

Party organizations at all levels and relevant functional departments fully understand the importance and necessity of carrying out special supervision work for hepatitis B vaccine, BCG and hepatitis B immunoglobulin, and the nursing department, pharmacy department, child health department and medical department cooperate well and manage The department and the staff signed a "Nine Mistakes" and a commitment to integrity and self-discipline; the relevant party general branch and party branch secretary urged the implementation of relevant management, use of the department and the party branch, the party general branch signed "nine is not allowed" and integrity and self-discipline commitment book. According to statistics, 12 departments have been signed, and 471 staff members have been signed. No violations have been found.

 

Third, the next step is to work

On the basis of this special supervision, the Central Party Committee and the Disciplinary Committee will firstly do a good job in propaganda and education. Party organizations at all levels must stand on the heights of politics and overall situation, and unify thoughts and actions into the Party Central Committee. The deployment will effectively enhance the awareness of medical staff and the sense of legal practice; second, the Ministry of Nursing, the Pharmacy, the Ministry of Health, and the Ministry of Health will immediately implement the problems of self-examination and self-examination, and focus on the prevention and treatment of medical personnel. The behavior is to ensure the health and safety of the vaccinated objects; the third is that the discipline inspection and supervision department will further strengthen the re-supervisory efforts, and earnestly do a good job in the investigation and accountability of the responsibility investigation of the transfer of relevant functional departments.