(5) in order to ensure the examination reagent supply, to achieve a smooth transition, the pilot medical institutions to make out an invoice of purchased testing reagent, according to the original provisions sales. Inspection detection reagent management enterprise purchase before May 1, 2017 test reagent, can continue to sell to the medical and health institutions as stipulated (provide a company sales notes and documents). Set the transition period of a month, after the transition period, medical and health institutions shall strictly carry out the examination reagent procurement of two votes.
, the medical institution for the examination reagent selection
Inspection detection reagent can be delivered directly by the production enterprise, or entrust inspection detection reagent management enterprise distribution, medical institutions can be selected to the business enterprise.
(a) medical institutions choose accord with qualification examination reagent management enterprises, medical institutions to develop test reagent management enterprise selection system and process of the selection process and the selection results to foreign public, open and transparent. Family planning department will report according to the medical institutions at all levels of health inspection detection reagent management enterprise information audit and spot check, for the false information, is testified, disqualified from shortlisted, prohibited in this province and related business.
(2) the examination reagent management enterprise entry qualifications, valid for five years. Should reorganize after the expiration of the qualification.
(3) the selection of reagent management enterprise by medical institutions shall comply with the following basic conditions:
1, registered in the territory of the People's Republic of China, with independent legal person qualification, and in the business of in vitro diagnostic reagents in heilongjiang province have entity test detection reagent management enterprise, has the good records shall pay taxes according to law and social security funds.
2, shall obtain the valid business license of enterprise legal person, the medical equipment business license (including in vitro diagnostic reagents) and the pharmaceutical trade license (including in vitro diagnostic reagents) and GSP certification.
3, nearly 3 years business activities in the no criminal record.
4, in this province has a wide range of business and cooperative medical institutions quantity is more, can satisfy the cold storage, warehousing and distribution business need ability, cold chain transportation ability and financial strength, and so on, has covered the examination reagent for the purchase, storage, sales, as well as management and quality control the traceability of all the network information system.
5. In this province has a separate cold-chain logistics center and cold storage (area of over 500 cubic meters), the vehicle can meet the needs of the distribution chain. Inspection detection reagent production enterprises or enterprise can have more qualifications entrusted by the strong comprehensive strength, transportation, high standard, with qualification of drug, vaccine cold-chain transportation, professional delivery of business enterprises to carry out the entire cold chain transportation.
6, the provincial quality control system construction ability and medical clinical laboratory (ISO15189) consulting service ability.
7, state-level new registered enterprises and meet the requirements of the mutual recognition of test results of quality control, information platform construction, process optimization and other comprehensive ability enterprises is preferred.
Eight, third rate of medical institutions and made of medical institution to the selection of test detection reagent management enterprise were submitted to the provincial health and family planning commission and provincial administration of traditional Chinese medicine medical administration area to the medical administration for the record, and other medical institutions at the local health administrative departments of family planning for the record. Record filing materials mainly include:
(a) document regulations of all kinds of licenses and qualification certificates.
(2) enterprise purchased invoice and cold-chain car driving license.
(3) enterprise in heilongjiang province tax certificate.
(4) business cooperation with medical institutions in our province.
(5) of cold storage management enterprises have relevant certificates.
Nine, work requirements
(a) all about the family planning department of health and medical institutions are to seriously implement the provincial party committee, the provincial government, making important decisions about health care reform deployment, fully recognize the significance of deepening the comprehensive reform of medical health system, standing about politics, the height of the overall situation, the people's livelihood, highlight the focus, carefully organize the implementation, strengthen communication and coordination, clear division of work, completes the regulatory cohesion, do every negative its duty and does its work force, vigorously promote the examination reagent purchasing two votes, to ensure that the entire province inspection results mutual recognition project smooth implementation.
(2) the implementation of the medical and health institutions examination reagent purchasing two votes, involving the interests of all parties adjust, a difficult task, responsibility is significant. Health family planning departments to strengthen the relevant policy of publicity, actively respond to the masses concerned, correctly guide social expectations, create a good social and public opinion atmosphere, ensure that all work of the reform smoothly. The family planning administrative department of public health, medical and health institutions at various levels in the process of execution, the new problems and new situation, should report to the provincial family planning of health talk things over solve, actively yet prudently proceed with our province inspection detection reagent purchasing two votes smooth implementation and mutual recognition of test results.
(3) in the process of two votes pilot programs, to strengthen the system of examination, to implement responsibility. Don't carry out of two votes for medical institutions and other relevant provisions of this document, in bad record, and cancel the hospital level evaluation qualification.
(4) the family planning administrative department of public health at various levels shall strengthen the region test reagent trading enterprises and medical institutions supervision and management, establishing and perfecting the assessment mechanism, to promote the tube, benign competition. Carry out inspection detection reagent management enterprise work specification. For the assessment work for two consecutive years failed to meet the demand of medical institutions the examination reagent clinical related measures for the management of business enterprise, puts forward a written application by the relevant units, after the approval of the provincial health and family planning commission, cancel the enterprises in our province inspection detection reagent business qualification.
We will deepen reform of the medical and health system in heilongjiang province leading group office
Heilongjiang province health and family planning commission
Heilongjiang province administration of traditional Chinese medicine
On March 20, 2017
Attachment 2: list of 118 hospitals of heilongjiang perform two votes
Back [ 1] [2] the next page
|
