Measures of Zibo Municipality on the Administration of Health Examination of Medical Personnel

Article 1 These Measures are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and other laws and regulations, combined with the actual situation of this Municipality, in order to strengthen the management of medical personnel's health examination and ensure people's drug safety and health. Article 2 These Measures shall apply to the health examination, supervision and management of medical personnel within the administrative area of this Municipality. The term "medical personnel" as mentioned in these Measures refers to the relevant post personnel of drug production, management and use units, aseptic medical device production enterprises and medical device management units, and those who are in direct contact with drug packaging materials and containers (hereinafter referred to as pharmaceutical packaging materials). Article 3 The food and drug supervision and administration departments of cities, districts and counties shall be responsible for the management of health examination of medical personnel within their respective administrative areas. Article 4 Medical personnel in the following positions shall conduct annual health examination according to regulations:

(1) Personnel who are in direct contact with the production operation, quality management and inspection, equipment maintenance, packaging and storage, acceptance and maintenance, sales and supply of drugs, sterile medical devices and packaging materials in enterprises producing drugs, sterile medical devices and packaging materials;

(two) pharmaceutical and medical device business enterprises have direct contact with the procurement, acceptance, storage, maintenance, quality management, deployment and sales of pharmaceuticals and medical devices;

(3) Drug users are in direct contact with the procurement, acceptance, storage, maintenance, preparation, preparation and inspection staff of drugs. Article 5 The institution undertaking the health examination of medical personnel shall be a medical institution at or above the second level or a disease prevention and control institution that has obtained the Practice License for Medical Institutions, and shall meet the following conditions:

(1) Having the qualification of a legal person;

(2) Having inspection and laboratory premises, facilities, equipment and sanitary conditions suitable for health examination;

(three) professional and technical personnel with intermediate or above technical titles that are suitable for health examination projects;

(4) Having a sound health examination system. Article 6 An institution with the conditions for health examination of medical personnel may submit an application for health examination of medical personnel to the district and county food and drug supervision and management departments, which shall be determined by the municipal food and drug supervision department in accordance with the principle of reasonable layout and convenient inspection. Article 7 An institution undertaking the health examination of medical personnel shall implement the following provisions:

(1) Conduct inspection according to the inspection items specified in these Measures, issue true inspection results, and inform the unit where the medical personnel work and the local food and drug supervision and administration department in writing within 10 days after the inspection results are made;

(two) unified use of the health checklist and health certificate prescribed by the municipal food and drug supervision and management department;

(three) to collect health examination fees according to the charging standards stipulated by the price department;

(four) the establishment of medical personnel health examination files, by the person in charge;

(five) accept and cooperate with the supervision and inspection of the food and drug supervision and administration department;

(6) Where laws and regulations provide otherwise, such provisions shall prevail. Eighth medical staff health examination items include:

(a) liver function and hepatitis B;

(2) Routine stool (stool culture for abnormal persons);

(3) chest x-ray;

(4) Skin signs;

(five) the inspection, acceptance and maintenance of the quality of drugs, sterile medical devices and packaging materials, and the vision and color discrimination ability of the staff. Article 9 The municipal food and drug supervision and administration department shall, according to the needs of emergency control of infectious diseases and public health emergencies announced by the state, and in combination with the actual situation of this Municipality, timely adjust the health examination items of medical personnel, and report them to the municipal government for approval before publication. Article 10 Persons suffering from infectious diseases such as tuberculosis, viral hepatitis, typhoid fever, paratyphoid fever, bacterial and amebic dysentery, and exudative, suppurative or desquamation skin diseases shall not engage in direct contact with drugs, sterile medical devices and packaging materials.

Those who fail the color discrimination test or whose corrected vision is below 5.0 shall not engage in the quality inspection, acceptance and maintenance of drugs, sterile medical devices and packaging materials. Article 11 Medical personnel who have objections to the health examination results may apply to the original health examination institution for re-examination within 7 days from the date of receiving the health examination results. The original medical examination institution shall accept it in time and make a review conclusion within 15 days. Twelfth medical personnel shall enjoy the following health examination rights:

(a) require the unit to organize health examination;

(2) Receiving education, training and health examination on the prevention and treatment of infectious diseases;

(three) to participate in the democratic management of the health examination work of the unit;

(four) to report and accuse violations of health supervision regulations. Thirteenth medical personnel units shall perform the following obligations:

(a) regularly organize the medical staff of the unit to carry out health examination;

(2) Medical personnel who fail to pass the health examination shall be transferred from their posts in time, and allowed to return to their original posts after treatment and rehabilitation;

(3) Submit the list of health inspectors this year to the local food and drug supervision and administration department on time;

(four) the establishment of medical personnel health examination files, personnel management, one file.

(five) accept and cooperate with the supervision and inspection of the food and drug supervision and administration department.