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Ministry of Justice of Ukraine

October 3, 2016

No. 1311/29441

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of July 28, 2016 No. 786

About approval of the Regulations on quality management system of researches in the laboratories performing microbiological diagnosis of tuberculosis

According to the subitem 15 of Item 1 of appendix 2 to the Nation-wide target social program of counteraction to disease of tuberculosis for 2012-2016 approved by the Law of Ukraine of October 16, 2012 No. 5451-VI and for the purpose of effective diagnostics of cases of tuberculosis, I order:

1. Approve Regulations on quality management system of researches in the laboratories performing microbiological diagnosis of tuberculosis (further - the Provision) which are applied.

2. To the Minister of Health of the Autonomous Republic of Crimea, heads of structural divisions concerning health care of the regional, Kiev and Sevastopol city public administrations, to heads of the healthcare institutions performing microbiological diagnosis of tuberculosis to provide execution of this order.

3. In accordance with the established procedure to provide to management of public health submission of this order on state registration in the Ministry of Justice of Ukraine.

4. To impose control of execution of this order on the deputy minister Ilik R. R.

5. This order becomes effective from the date of its official publication.

Minister

V. Shafransky

Approved by the Order of the Ministry of Health of Ukraine of July 28, 2016 No. 786

Regulations on quality management system of researches in the laboratories performing microbiological diagnosis of tuberculosis

I. General provisions

1. This Provision establishes the main approaches to creation and functioning of quality management system of researches in the laboratories performing microbiological diagnosis of tuberculosis, the efficiency of medical and diagnostic process directed to increase, reduction of unjustified expenses and risks for patients, decrease in incidence and death rate, increase in life expectancy of the population of Ukraine.

2. Action of this provision extends to the healthcare institutions of the state and municipal patterns of ownership providing fence, transportation of material and carrying out microbiological researches for the purpose of diagnosis of tuberculosis.

3. The provision is based on the general requirements stated in state standards of quality management system and recommendations of the international organizations.

4. In this Provision terms are used in the following values:

internal control of quality of bacteriological researches - effective and systematic monitoring and ensuring compliance of all laboratory processes to the approved standard operational procedures (further - SOP) and to the established standards;

external control (or external assessment) qualities of researches - system of objective assessment of the organization and results of work of laboratory network;

quality management system (quality management) - the coordinated actions of all concerned parties on quality which direct and control activities of the healthcare institutions and laboratories performing microbiological diagnosis of tuberculosis;

quality of laboratory researches - the accuracy, reliability and timeliness of results which are carried out;

II. System of actions for quality management of microbiological researches

1. The main objective of the laboratories performing microbiological diagnosis of tuberculosis is providing reliable laboratory diagnostic information of healthcare institutions.

The system of actions for quality management shall guarantee reliability and reproducibility of results of microbiological researches.

2. The quality management system of microbiological researches provides: planning, providing, control and compliance to modern requirements.

3. Quality planning of microbiological researches consists in determination of accuracy which is reached using available technical means of laboratory, nutrient mediums, other reagents and consumable materials, in case of the minimum costs of working hours and laboratory materials, taking into account medical reasonable requests.

4. Planning of actions for quality assurance of laboratory researches is obligation of the head of the laboratory.

5. Quality assurance of microbiological researches consists in implementation of the actions creating necessary conditions for receipt of guaranteed reliable laboratory information which adequately reflects absence/availability of the causative agent of tuberculosis, its antitubercular medicines resistance / sensitivity, extent of infection. Actions for quality assurance are performed:

at the central level;

at the regional level;

at the level of separate healthcare institution;

at the level of separate laboratory.

6. Quality assurance of microbiological researches at the national level of health care system of Ukraine consists in development of regulatory legal acts, examination of quality and safety of medical products: means of the measuring equipment, nutrient mediums, reagents, test systems, standard samples, the service equipment and other equipment, held for use in healthcare institutions of the country, their introduction in turnover and operation.

7. Quality assurance of microbiological researches at the level of separate healthcare institution consists in:

providing laboratory with the room which conforms to requirements of biological safety;

proper material and metrological support of laboratory process, including diagnostic medicines of guaranteed quality;

assistance to effective functioning of system of increase in professional training of specialists;

development and implementation by personnel of clinical divisions of healthcare institution of the measures warning negative impact of factors of preanalitichesky stage (abuse of regulations of fence, marking, preprocessing, storage, transportation of samples of biological material, execution of the accompanying documentation, incoming and systematic inspection of diagnostic medicines), analytical and post-analytical stages (inadequate interpretation of results of research) on quality of results of microbiological researches.

Development and implementation of measures for quality assurance of microbiological researches at the level of separate healthcare institution is obligation of the head of this organization.

8. Quality assurance of laboratory researches at the level of separate laboratory consists in development and implementation of the measures interfering receipt of unreliable laboratory information and warning negative impact of factors:

preanalitichesky stage (abuse of regulations of marking, registration, storage, preprocessing of biological material, maintaining accounting and reporting medical documentation, etc.);

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