(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 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 medical staff in writing within 10 days after the inspection results are made;
(two) the establishment of medical personnel health examination files, by the person in charge;
(3) Accepting and cooperating with the supervision and inspection of the food and drug supervision and administration department;
(4) Where laws and regulations provide otherwise, such provisions shall prevail. Seventh medical staff health examination items include:
(1) liver function;
(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 8 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 9 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 are not allowed to come into 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 10 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. Eleventh 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. Article 12 The units where medical personnel work 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;
(three) the establishment of medical personnel health examination files, personnel management, one file;
(four) accept and cooperate with the supervision and inspection of the food and drug supervision and administration department. Article 13 The food and drug supervision and administration department shall supervise and inspect the health examination of the institutions undertaking the health examination of medical personnel and the units where medical personnel work according to law. The inspected entity shall provide true and complete information and documents, and shall not refuse or conceal them. Article 14 Citizens, legal persons or other organizations may report to the food and drug supervision and administration department if they find that the health examination institution for medical personnel and the unit where medical personnel work violate the provisions of these measures, and the food and drug supervision and administration department shall promptly accept it, investigate and verify it, and deal with it according to law. Fifteenth in violation of the provisions of these measures, the unit where the medical staff work has not established a true and complete medical staff health examination file, and the food and drug supervision and administration department shall order it to make corrections and impose a fine of 1000 yuan.