Circular 01/2013/tt-Byt: A Guide To Implementing Quality Management Tests At The Medical Facility, Healing

Original Language Title: Thông tư 01/2013/TT-BYT: Hướng dẫn thực hiện quản lý chất lượng xét nghiệm tại cơ sở khám bệnh, chữa bệnh

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MINISTRY OF HEALTH
Number: 01 /2013/TT-BYT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, January 11, 2013

IT ' S SMART

Guidelines for performing laboratory quality management at the clinic, cure for disease.

________________________________

Base of Protocol 63 /2012/NĐ-CP August 31, 2012 of the Government stipulated the function, mandate, jurisdiction and organizational structure of the Ministry of Health;

On the recommendation of the Director of the Bureau of Management, cure;

The Minister of Health for the Department of Health issued a Guide to the Management of Experimental Quality at the facility of the disease, healing.

Chapter I

GENERAL REGULATION

What? 1. The adjustment range

This information instructs the content and responsibility to carry out the management of the laboratory quality at the clinic, treating the disease with the laboratory.

What? 2. Explain the word

In this Information, the words below are understood as follows:

1. The test room is the faculties, rooms or unit tests at the facility of the disease, healing the test sample taken from people and other relevant sources to carry out the test, provide direct information that serves to the disease examination, cure. Disease, scientific research and training.

2. The quality of testing quality is the coordination activities for the orientation and control of the laboratory quality of testing, including planning, control, assurance and improvement of the quality of testing.

3. Evaluation of internal testing quality is self-examination and evaluation of organized testing quality, planning in the laboratory with the purpose of consideration of the leader to assess the quality of performing tests, find out problems that do n' t work out. conform to the prevention of preventable, remedied and improved measures.

4. The standard practice process (SOP) testing is the set of mandatory detailed guidelines to take steps of a process.

5. The interviewer program is a quality test system within a laboratory that monitors and monitors every aspect of the test execution process at the laboratory, ensuring that the test results have sufficient reliability before paying for the test results. customer and offer a timely recovery if errors are made; aim for evaluation of the laboratory system (measurement method, trial medication, and chemicals, equipment, skill level of the technician).

6. The exposition program is quality control, the reference and comparison of the test results of a test room with the test results of many other test rooms on the same sample, compared to the results of the reference labs in the lab. Water or international aims not to stop raising the quality of the test and contribute to the certification of the laboratory recognition of national standards or international standards.

7. The pre-test process is steps from when receiving a request for testing and ending when starting to implement the test process, including the patient ' s preparation, test designation, sample collection, or sampling of the original test, preserved storage and maintenance. Shipping the sample to the lab.

8. The test process is the test sample analysis steps.

9. The following procedure is the starting steps from when the test process ends, including system testing, recording or interpretation of the test results, the decision to publish the results of the test, store results and samples that have been analyzed.

10. Customers are the organization or individual who receives the test results or service of the test room, which may be a customer in or out of an examination facility, healing.

Chapter II

TEST QUALITY MANAGEMENT

What? 3. Test Quality Management System

1. The medical examination facility, which has a test room performing tests on test samples; coordination of the work, plans with the test-testing center to be decided by the Ministry of Health, allows the establishment of operations to ensure the quality of the disease. Medical tests at the clinic, healing.

2. The reference test room is a laboratory laboratory of the medical or other laboratory that is recognized by the Ministry of Health, which is responsible for carrying out reference tests and providing the results of the reference test at the request of the patient. The Ministry of Health, the Department of Health, at the suggestion of the test-testing center in the work-scale control of the mission size and competence of the reference laboratory. While serving as a reference laboratory, the laboratory will be subject to the quality supervision of the Ministry of Health and the test control center. Periodically, the Ministry of Health evaluated the reference to the reference laboratory.

3. The test test center serves as the unit to perform professional activities in order to ensure the quality of the testing in the labs of the clinic, treating the disease (including the reference laboratory). The functional base, the assignment to be delivered, the test-testing center implemented: extras; monitoring the quality of the laboratory; the expert consultation on quality control and management; using the results of the test results. The reference test room is based on the test test.

4. The Ministry of Health, the Department of Health of the Provinces, the central city health, medical practice of state management, direction, guidance, inspection, inspection of the implementation of regulations on the facilities of the disease, the treatment of laboratory testing and laboratory testing. references in the management quality management; directing the specialized activity of test testing centers. The Ministry of Health evaluated and recognized the laboratory as a reference laboratory for one or more types of tests.

What? 4. The content management content of the medical examination facility, healing.

1. The basis of the disease, the treatment of experimental quality management in accordance with the law policy, stated (committed) quality, quality target, scale, condition of the examination facility, the treatment and of the laboratory.

2. The basis of the disease, the construction of planning and roadmap implementation of the test quality reached and maintained by the regulation of the national technical regulation of the laboratory after being enacted by the Ministry of Health, which encourages to achieve the requirements of the criteria. country ' s national and international standards for the lab.

3. The facility of the disease, healing has to publicly test the test of the unit for the agency ' s management, customer, community to know and monitor.

What? 5. The quality management content of the laboratory

1. There is a five-year test quality management plan and a five-year plan on the implementation of a test quality management that is given the basis of an examination facility, curing the approx, the incubator with the annual plan and the five-year plan of the disease facility, healing.

2. There is a statement (commitment) quality, quality target, quality plan, quality control, quality assurance and quality of testing quality.

3. Compact, build, perform on a quality manual, including standard practice processes (SOP) for all the technical expertise of the laboratory. Search, adjust, and improve (if necessary) quality handbook once a year.

4. Build and implement the interagency program due to the leadership of the medical examination facility, curing the approx, which has a record system, storage, incident detection and remedied measure, the prevention of the incident.

5. Participate in foreign exchange programs, according to the Allocation Procedure of the Ministry of Health's operational testing expertise and is encouraged to participate in international diplomatic programs that have been recognized.

6. Build the test quality index in accordance with the condition of the laboratory and of the medical examination facility, cure:

a) The index of the unit ' s test quality for striving to be achieved, to evaluate the maintenance and improvement of the continuous quality built by regulation at the Appendix issued by this Information;

b) periodically at least every year to adjust the quality indicators.

What? 6. Content assurance implementation of the quality management of the laboratory

1. Make the organization requirements:

a) There is an organizational scheme, the description of the work, the recognition of the role and function, the task of each medical staff;

b) The laboratory contains the personnel records of all medical personnel (copy);

c) The medical staff of the laboratory has a responsibility for deployment, performing well the management of the laboratory quality management.

2. Set up the document system, test quality management profile:

a) Set up the document management system, records, which encourages application of information technology in document management, laboratory records;

b) Perform the process of controlling the document, the filing to help the document system, the filing of scientific archives, favorable for the control, tracking, lookup and use;

c) The quality manual is easy to access and use, store all the technical records.

3. Training:

a) There is a plan and implementation of quality management training for the annual periodic health worker;

b) The laboratory involved training activities on quality management of the specialized field of the room.

4. Monitor and review:

a) There is a plan and implementation of the monitoring, assessment of internal testing quality, daily professional activities;

b) There are plans and execution of oversight, post-training evaluation for all health workers;

c) Planning and execution of monitoring, evaluation, contingation of possible incidents;

d) Monitoring, evaluating the use, preservation, maintenance of the equipment and chemicals in the test;

Participating in the construction of the plan and execution, the monitoring, the contact assessment or the laboratory (if any).

Chapter III

RESPONSIBILITY FOR EXPERIMENTAL QUALITY MANAGEMENT

What? 7. The responsibility of the head of the facility to examine the disease, cure has a laboratory

1. The direction of the implementation and organization performs the correct quality management content of the examination facility, the treatment and of the laboratory.

2. Set up the organizational system to build and enact texts on quality management in accordance with the actual conditions of its unit; construction of the structural system structure of the quality of testing parallel to the structure of the administrative and technical systems of the company. The clinic, the treatment.

3. Approvate the unit ' s test quality management plan.

4. Secure the appropriate resources for the management quality management, including: manpower, facilities, equipment, funding to deploy plans that have been approved and the regular funding includes:

a) To implement, maintain and improve the quality of testing;

b) Training laboratory personnel;

c) Secure the quality of the laboratory;

d) Build and approve the regulations, guidelines process, training organization for the relevant staff; and the following:

The organization evaluated the implementation of the test quality management plan.

5. The division of at least one health worker manages the quality of the test quality at the laboratory, depending on the scale, the actual condition of the examination facility, the treatment and the laboratory.

What? 8. The responsibility of the chief of the lab

1. The organization that performs laboratory quality management, fulfills the tasks, plans of the laboratory quality management laboratory, coordination with the room (or nest) of hospital quality management, plots for the head of the disease to examine the disease, It ' s a medical treatment for the entire laboratory quality management.

2. Build a yearly and 5-year plan on the quality of the quality of testing to lead the facility to examine the disease, cure the disease, approve.

3. Direct Direct, the organization that performs the approved quality management plan contents. A six-month term periodically review the implementation of the year plan on the management of the test quality, actively proposing appropriate adjustments.

4. Directed and Direct to monitor, test and monitor the quality of the test; detect, propose solutions, and manage the errors or risk cases of errors in the process of laboratory quality testing.

5. Directed and build the quality manual of the laboratory, the standard practice processes (SOP) for the leadership of the medical examination facility, the treatment of the review, issued.

6. The organization of scientific research, construction and management of the pathology facility, curing the disease that approx the training plan at the site or sending the medical staff of the laboratory and other related rooms to the training of the quality of the test quality.

7. The incubation of laboratory quality management with the activities of the department or other relevant department in scientific research, training for the medical staff of the laboratory.

8. Take on the information, process, and staff with the head of the medical examination facility, heal the appropriate response and promptly with the customer using the test service.

What? 9. The responsibility of the quality management staff at the lab

1. General, the staff of the laboratory chief in the deployment of content management content.

2. Build a plan and content management content of the room, the director of the review laboratory, the decision to lead the facility to examine the disease, cure the disease, approve.

3. The organization performs the interagency program and joins the outlaw program to monitor, monitor, assess the quality of the test work and detect, propose a timely intervention solution in order to manage the errors of errors, which are at risk of error. in the test processes.

4. Gather, aggregate, analyze data, manage and secure information related to laboratory operations.

5. Coordinate and support other faculties or other relevant departments in the deployment of the quality of the test quality.

6. General, monthly recurring report, quarter and year of activity and results management outcomes with the chief of the laboratory, chief of the chamber (or organization) of the quality of the hospital and the leadership of the disease, healing.

7. As the lead of a joint venture to carry out relevant work with the assessment organizations, the certification department certification of national standards or international standards.

What? 10. Clinical Accountability

1. Head of the General Responde, nursing director of the sampling technique. Each faculty is responsible for the work: sampling, preserving, transporting samples, and receiving test results.

2. The responsibility of the members at the relevant department:

a) Help leadership implement the full implementation of the quality management quality of the faculty;

b) Join the work and training classes on the management quality management involved.

Chapter IV

EXECUTION CLAUSE

What? 11. Effect of execution

This announcement came into effect on 15 March 2013.

What? 12. organizational responsibility

1. Bureau of Management, which is responsible for responsibility

a) As the first unit of organizational implementation, the evaluation of this information evaluation at the facility of the disease, the treatment of the disease, and the localities.

b) Perform other tasks related to quality management testing at the clinic, treating the disease according to the Minister of Health's assignment.

2. Department of Health in the Province of Central, Central City, Health Services, which is responsible for disseminalization, direction, inspection and evaluation of the implementation of the practice at the facilities of the disease, treating the disease directly, and reporting on the Ministry of Health periodically 6 January.

In the course of execution, if there is difficulty, entangrium, recommended units, individuals reflect on the Ministry of Health (Bureau of Management) to be guided, reviewed, resolved.

Minister.

(signed)

Nguyen Thi Kim