On June 26, June 26, the health and family planning commission of guangdong province issued the guidance (trial) on the internal management of medical consumables procurement of medical institutions in guangdong province, which has been piloted since the date of promulgate.
The health and family planning commission of guangdong province has finally stepped in to make public medical institutions "self-reform", starting with strengthening internal management and standardizing the procurement of medical consumables. This new document focuses on the prevention of corruption of medical consumables, and puts forward many measures, such as the establishment of medical consumables management committee.
The new document contains a lot of information. The following is the full text of the document:
Guidance on internal management of medical consumables purchasing in guangdong medical institution (trial)
The general
Article 1 with a view to regulating the behavior of medical consumables purchase of medical institutions, improve the management level of medical institutions for medical consumables procurement, to prevent corruption, according to the regulations on the supervision and administration of medical devices (state council order no. 680), the medical instrument clinical use safety management standard (trial) "(who d tube hair [2010] no. 4), the medical equipment using the measures for the administration of quality supervision, state administration of drug safety for the 18th), medical consumable transaction way of medical institutions in guangdong province (trial)" (yue who [2016] no. 53), and other rules, formulates this work instructions.
Referred to in article 2 of this work instruction medical consumables is refers to the national or provincial food and drug regulatory or health family planning department certification, belonging to medical consumables management of medical equipment, disinfection products product or drug management of diagnostic reagents.
Article 3 the medical consumables purchase of medical institutions is refers to the medical institutions to determine product, supplier (including the production and distribution enterprises) and the process of purchasing price, shall strictly follow the relevant management regulations of the state, ensure that procurement specification, unified entrance, legal and complete formalities.
Article 4 the medical consumables purchase management of medical institutions is to show medical institutions internal is the selection of medical consumables, access, procurement, warehousing, budget, settlement and supervision and so on each link's management work, including the process used by various means of informationization, adhere to the "quality first, price reasonable" principle, conform to the public "process, program specification, clear responsibility, checks and balances, easily traced" requirements.
Article 5 of the medical institutions should be based on the work guidance to develop and improve the system of medical consumables purchase management of the unit, according to apanage the family planning administrative department of public health at the same level for the record, and provincial, affiliated medical institutions at the provincial family planning administrative department of public health for the record.
Institutions and responsibilities
Article 6 the public medical institutions of the secondary and above shall set up the relevant committees for the management of medical consumables and undertake the management responsibilities of the medical consumables of the unit; We will encourage qualified community-level medical and health institutions to set up relevant committees to improve management levels and prevent corruption.
Medical institutions should specify the specific internal department overall management of medical consumable purchase, and the general duties of a commission, the main responsibilities include medical consumables management, daily variety and supplier selection, organization, bidding procurement, procurement price adjustment or inquiry, purchasing data statistical analysis, etc. Secondary and tertiary medical institutions in principle to set up a relatively independent medical consumables management department (or deliberation and coordination mechanisms, similarly hereinafter), grassroots medical institutions can be based on the existing unit to the corresponding management department to carry out the purchasing management of medical consumables.
Article 7 medical consumables management committee in principle by the medical institutions in charge of the leadership and management of medical consumables, auditing, finance, price control, medical care, medical, information, hospital, nursing and other relevant departments, and medical, clinical, (department) of experts and other professionals, by, director of the committee in charge of the leadership. Number of specific personnel is relatively fixed, the committee should be adapted to scale and level medical institutions, triple the number of medical institutions in principle at least 11 people, were not less than 7 secondary medical institutions, medical consumable management related with commission of grassroots medical institutions do not make the number of requirements, the committee in principle for odd in number.
Article 8 the committee duties include formulated and supervise the implementation of medical consumables management system, set up and management expert, authorized medical consumables procurement directory, guidance and supervision of medical consumables management department daily work, the major problems in the process of disposal of procurement, etc. The committee held meetings for no less than two times a year, and special circumstances could be convened to insist on "scientific argumentation and democratic decision-making".
Article 9 of the medical consumables expert database by the medical establishment medical consumables procurement management experts and clinical experts, management experts from medical consumables, auditing, finance, price control, health care, medical, information, such as hospital, nursing department head; In principle, the clinical experts of higher or higher vocational titles are included in the expert database, and secondary medical institutions may increase the number of intermediate titles into expert libraries. The number of expert database of primary medical and health institutions is determined according to the actual situation. The expert database is adjusted every two years, and the special situation can be adjusted temporarily after the research of the relevant committee of medical consumables management.
Article 10 the department of medical consumables management in principle should be set up purchasing, quality control, warehouse management, file management, accounting, such as jobs, specific posts with relevant personnel should be after appropriate training, and organize regular training business, laws and regulations, establish training files, check regularly. Participating in the procurement of medical consumables management, warehouse management, accounting and other incompatible positions to ensure the separation of posts; A rotation mechanism should be established for sensitive posts, which in principle will rotate through 3-5 years.
The business section shall set up full-time or part-time personnel to manage the medical consumables used in the undergraduate room, and shall be responsible for the formulation of purchase plans, the requirements for purchasing, the use of management and statistics, etc.
Directory selection
Article 11 medical institutions at all levels to gradually establish a national family planning department of public health medical consumables standardized classification and coding (otherwise required, the state from his request) on the basis of medical consumables and system information management system.
Article 12 varieties of medical consumables catalogue to be used for medical institutions, medical consumables management committee to organize concentration to evaluate the hospital experts, evaluation experts challenge system to practice the interest relations, the interest relationship of experts, in principle, shall not participate in relevant review and negotiation of pricing. The clinical experts participating in the review shall in principle not be less than a third of the time of the evaluation expert. The evaluation expert's extraction should meet the following principles:
(a) according to the principle of random extraction, experts from the expert database of medical consumables in this unit will be selected, and the number of experts participating in the review shall be singular;
(2) for different types of medical consumables, management experts and clinical experts should set a reasonable proportion, while taking into account the professional background of clinical experts;
(3) in principle, the interval between the extraction of experts and the selection of medical consumables should not exceed 24 hours.
Article 13 varieties directory selection should be carried out in accordance with the principle of evidence-based medicine, health economics technology assessment, and according to the various varieties of quality and technical and price information (including brand, quality, price, effect, adverse reaction and economics) to choose after comprehensive evaluation, on the premise of quality assurance, preferred varieties of cost-effective.
For directory varieties, medical institutions at all levels according to the service people, comprehensive strength and the actual situation such as the introduction of new technology in accordance with the high value of low risk, low safety principle of the classic high sexual price to choose the appropriate origin, brand, etc., to encourage favoring domestic varieties.
Article 14 the selection of category catalogue adopts a real-name voting system, which can be used in either system or paper. The results shall be archived for reference.
Article 15 the medical establishment shall establish strict system for the admission of medical consumables, and conduct dynamic maintenance of the catalogue to improve the catalogue management.
Product purchasing condition management
Article 16 medical establishment condition of medical consumables procurement management refers to the medical institutions to ensure that in clinical use of medical consumables legal, safe, economic and effective, and management and technical measures. The medical establishment should establish the verification, evaluation and management of medical consumables procurement conditions to ensure that the medical consumables purchased are in line with the clinical requirements and the actual unit.
Article 17 medical institutions shall not purchase medical consumables that have not been registered or filed in accordance with the law, unqualified certificates, expired or expired or are technically obsolete in accordance with state regulations. The clinical trial or trial of medical consumables new products shall be carried out in accordance with the relevant regulations.
Article 18 in case the medical institution to establish the medical consumables supplier qualification and evaluation system, from has the qualification of medical consumables buy medical consumables production and operation enterprises, by the medical consumables for procurement management departments and strict inspection qualification of the supplier (including the medical device manufacturing enterprise license or medical equipment business license, the business license, etc.), product qualification (including the medical device registration certificate and its attachments "medical device registration form, registration certificate, product quality inspection report, import product authorization, etc.), and sales staff identity documents, etc. By means of centralized procurement, the medical consumables of the joint venture can be checked and the medical institution can not audit its supplier qualification.
Article 19 medical institutions in medical device project procurement, to the medical consumables purchase management departments in advance for supporting the use of medical consumables, special special materials can occur in the whole life cycle of equipment cost and other factors, a comprehensive evaluation on evaluating the corresponding charging items of special special consumable cost rate, reference for review.
Article 20 the use of medical consumables should be included in the management category of medical consumables purchasing conditions, and the trial rules shall be established accordingly, and the rationality, legality and safety of the trial shall be fully considered.
Article 21 in accordance with the "insurance for, concentrated, moderate" principle, in principle, each product can only choose a distributors, encourage group procurement and distribution of medical institutions at all levels, improve the distribution concentration, reduce procurement costs, ensure supply. The selection of distribution enterprises, according to the enterprise operation qualification, scale, service and other related factors, by the medical establishment consumables management department to make the selection system, the material management committee for approval, the hospital medical consumables purchasing management department is responsible for the implementation.
Procurement management
Article 22 the medical institutions shall formulate the actual purchasing rules in conformity with the actual conditions of the unit and shall be implemented after the approval of the relevant committees of the medical consumables management. Medical institutions shall exercise unified management for the procurement of medical consumables, and the medical consumables management departments shall uniformly purchase medical consumables, and other departments or personnel shall not purchase them themselves.
Article 23 all medical institutions shall purchase from the centralized purchasing platform of municipal medical consumables through the electronic trading platform of the third party or approved by the province.
The tendering or inquiry procurement may be subject to the relevant provisions of the government tendering or inquiry procurement.
For the purpose of carrying out new technology, clinical urgent (snatch) rescue, and no substitute products in the centralized procurement (or transaction) of the provincial and municipal level, it can be purchased for filing. The filing of the record purchase shall be subject to quota management, and the record purchase amount of medical institutions at all levels shall not exceed 20% of the total purchase amount of medical consumables this year. The relevant committee of medical consumables management shall make the filing of the purchase method as the key management content.
Article 24 when purchasing, first put forward by clinical departments use requirements, after summarizing audit by the department of medical consumables management, procurement department to implement, strictly control the "material proportion", medical institutions shall purchase plan implementation, as an important factor of department for examination and assessment.
The purchasing department of the medical institution shall be responsible for the approval of the departments responsible for the management of the products, prices, quantities, production enterprises and corresponding distribution enterprises. The medical consumables management department shall notify the departments of finance, health insurance and prices.
Article 25 medical institutions to arrange all kinds of varieties of medical consumables purchase frequency, the low value medical consumables for heavy usage, general class of high value medical consumables and in vitro diagnostic reagent, secondary and tertiary medical institutions can take many times the frequency of purchasing in January, grassroots medical institutions should be relatively long-term procurement plan to reduce the distribution cost of distribution enterprises, in principle, the procurement; once a month For the high-value medical consumables, which are run by the zero inventory management, the purchasing frequency is determined by the medical establishment according to the requirements of the clinical department.
Article 26 the contract for electronic purchase and sale of medical consumables shall be signed by means of centralized procurement of electronic trading platform for third-party pharmaceutical products. The supply and demand of medical consumables should be signed by the buyer and the supplier of medical consumables through the record of the purchase of medical consumables.
Article 27 the selection procedures, selection results and procurement results of medical supplies for medical institutions shall be made public and subject to social and public supervision through the website and the public information boards.
Acceptance into warehouse
Article 28 the medical institutions to establish medical consumables acceptance, storage, storage custody system, such as true, complete and accurate records of inspection, and gradually using informatization technology to store and record management. The medical institution shall make regular inventory of the medical consumables in the stock every quarter, and make the account match and account the account. The medical institutions shall supervise the delivery of the facilities within the institution and ensure the quality and safety of medical consumables.
Article 29 the acceptance of medical consumables to the medical consumable management department designated medical institutions designed duty of personnel or their authorized with the third party organization and implementation of the corresponding qualifications and evaluate clinical acceptance with the clinical departments related to the results of the trial. When acceptance by medical consumables management department should be united operation, required to purchase a check-for-acceptance medical consumables of the quality documents, there is a requirement for special storage and transportation of the medical consumables shall also supplier of storage and transportation conditions to verify whether meet the requirements of the product data sheet and label inspection personnel must be familiar with medical consumables acceptance standard, within the range of specified acceptance according to the acceptance procedure. The medical consumables need to be accepted by the medical consumables, the medical consumables that the medical consumptive material that the medical consumptive material should not be examined and approved by the relevant committee of medical consumables is not allowed.
Medical institutions for medical consumables in the process of purchasing, evaluation, inspection and acceptance of the report, contract and evaluation records and other documents for inputting and properly kept, implantable medical consumables inspection records should be kept permanently.
Article 30 medical institutions should be in accordance with the requirements of the national family planning departments for public health classification and coding, the uniqueness of medical consumable, into the information management system, and keep the third class medical consumables purchase of packaging, labels, manuals, qualification, such as raw materials, to ensure that information has the traceability.
Article 31 the medical institutions shall set up the premises that meet the requirements for the storage standards of medical consumables. The medical consumables warehouse is relatively independent, and the storage area is suitable for storage, and it has the corresponding storage conditions and facilities, which can fire, moisture-proof and insect-proof.
Article 32 medical institutions shall regularly inspect and record the medical consumables stored in storage according to the storage conditions and the expiry date of medical devices. Products with control requirements for temperature and humidity shall conform to the requirements of their specifications or labelling requirements, and shall record the necessary temperature and hygrometer; To implement zoning or classification management; The term management products shall be kept in accordance with the order of validity. Conduct regular inspection and maintenance of the infrastructure and related equipment of the warehouse, and check the records regularly.
Budget and settlement
Article 33 of the medical institutions to prepare the medical consumables purchase budget, combined with its practical and financial management requirements, budget quota or flexible budget can be used, such as the zero-base budget or incremental budget establishment method.
Article 34 medical institutions should be compiled in accordance with the procedures prescribed by the relevant financial management system of medical consumables procurement budget, clinical departments use budget department, after approved by the department of medical consumables management summary, unified to medical consumables management committee for examination and approval. The medical establishment may, on the basis of the compilation of the annual budget, select the monthly or quarterly budget, and the annual budget shall be submitted to the competent authority for the record by the hospital decision-making body.
Article 35 a medical institution shall pay the payment of goods strictly in accordance with the purchase contract signed by both parties.
Supervisory control
Article 36 the medical institutions shall cooperate with the competent departments in supervising the work, formulate effective rules for the supervision of rewards and punishments, standardize the procurement of medical consumables, and ensure that the policies are in place.
Article 37 medical institutions shall make full use of information technology means to realize informatization, automation and intelligence of supervision. Through the whole life cycle of medical consumables records management, building including expert management system, transaction system, storage system, settlement system, supervision system, such as safety, perfect integrated information network system, so as to realize the whole process of medical consumables procurement and comprehensive regulation.
Article 38 medical institutions to implement the family planning administrative department of health job requirement about material purchasing management, take the initiative to report our medical consumables purchasing management situation, actively cooperate with related inspection work.
Supplementary provisions
Article 39 the guidance of this work shall apply to all kinds of public medical institutions at all levels, and encourage other medical institutions to combine actual reference execution.
Article 40 the guidance of this work shall be piloted from the date of promulgate.
|
