Thông tư 01/2013/TT-BYT quản lý chất lượng xét nghiệm tại cơ sở khám bệnh, chữa bệnh

 THE MINISTRY OF HEALTH

Circular No. 01/2013/TT-BYT dated January 11, 2013 of the Ministry of Finance guiding the laboratory quality control at medical examination and treatment places

Pursuant to the Decree No. 63/2012/ND-CP dated August 31, 2012 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of Director of Medical Examination and Treatment Management Department;

The Minister of Health issues the Circular guiding the laboratory quality control at medical examination and treatment places.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular guides the content of and responsibility for laboratory quality control at medical examination and treatment places possessing laboratory.

Article 2. Interpretation of terms

In this Circular, the following terms are construed as follows:

1. Laboratory includes testing departments, divisions or units at medical examination and treatment places that receive the testing sample taken from people and other relevant sources for the testing and information supply that directly serve for the medical examination and treatment, science study and education.

2. Testing quality control means the coordinative activities of laboratory in order to orient and control on testing quality, including formulation of plans, control, assurance and improvement on testing quality.

3. Internal testing quality assessment mean activities of self-examination and assessment on testing quality that are organized and planned in laboratory with purpose of consideration by leaders for testing quality assessment, finding out unsuitable matters in order to set out measures for prevention, remedy and improvement.

4. The standard operating procedure (SOP) of testing means collection of compulsory and detailed guides in order to perform steps of a process.

5. The internal examination program means the system of quality examination in scope of a laboratory aiming to monitor and supervise all aspects of testing process in laboratory, ensuring for testing result to be enough reliability before returning them to customers and timely give out remedial measures if detecting errors; aiming to assess system of laboratory (method of measurement, reagent and chemicals, equipment, skill qualification of technicians).

6. The outer examination program means the quality control, collation and comparison of the testing result of a laboratory with testing result of various laboratories on a same sample, compared with results of international or domestic reference laboratories aiming to unceasingly raise the testing quality and contribute on supplying evidences to recognize a laboratory s obtaining national standard or international standard.

7. The process prior to testing means steps which are begun upon receipt of testing request and ended upon beginning the testing process, including step of patient preparation, testing appointment, collection of samples or taking the initial testing sample, preservation and transport to bring sample to laboratory.

8. The testing process means steps of analyzing the testing sample.

9. The process after testing means steps which are begun upon ending the testing process, including the system examination, recording or explaination on testing result, decision on announcement of testing result, preservation for result and the analyzed sample.

10. Customers mean organizations or individuals receiving the testing result or service of laboratory, may be customers inside or outside of the medical examination and treatment facility.

Chapter II

LABORATORY QUALITY CONTROL’S CONTENTS

Article 3. The system of laboratory quality control

1. The medical examination and treatment facility possessing laboratory shall implement test for testing samples; coordinate to implement affairs, plans with center of testing calibration that is decided and allowed for establishment and operation by the Ministry of Health in order to ensure the testing quality at its laboratory.

2. The reference laboratory means laboratory of other medical examination and treatment facility or laboratory recognized by decision of the Ministry of Health, take responsibility for implementation of reference testing and supplying result of reference testing at the requests of the Ministry of Health, the provincial Health Department, center of testing calibration in affairs of calibration, based on scale, task and capacity of reference laboratory. During taking role of a reference laboratory, the laboratory shall be supervised on quality by the Ministry of Health and center of testing calibration. Every three years, the Ministry of Health shall make assessment to re-recognize the reference laboratories.

3. Testing calibration center keeps role as unit performing professional activities aiming to ensure the testing quality at laboratories of medical examination and treatment places (including reference laboratories). Based on the designed functions and tasks, the center of testing calibration shall perform: outer examination programs; quality control for laboratories; consult with specialists on calibration and quality control; use of reference testing results of reference laboratory as the basis for testing calibration.

4. The Ministry of Health, the Health Departments of provinces and centrally-run cities, health sectors shall implement state management, direct, guide, examine, inspect implementation of regulation applicable to the medical examination and treatment places possessing laboratories and reference laboratories in the laboratory quality control; direct specialized activities of centers of testing calibration. The Ministry of Health shall assess and recognize a laboratory as a reference laboratory in respect of many types of testing.

Article 4. Laboratory quality control’s contents at medical examination and treatment places

1. The medical examination and treatment places implement the laboratory quality control in conformity possessing law policies, statements (commitments) of quality, quality target, scale, condition of medical examination and treatment places and of laboratories.

2. The medical examination and treatment places formulate plan and roadmap to implement the laboratory quality control to attain and maintain as prescribed by National technical regulation on laboratory after being promulgated by the Ministry of Health, encourage attaining requirements of national and international standards on laboratory.

3. The medical examination and treatment places must publicize the testing calibration work of units to management agencies, customers, community for information and supervision.

Article 5. The content of laboratory quality control

1. Having annual and 5-year plans on management of the testing quality approved by heads of medical examination and treatment places, that integrate with annual and 5-year plans of medical examination and treatment places.

2. Having statement (commitment) of quality, quality target, quality plan, quality control, assurance of quality and improvement of testing quality.

3. Conducting compilation, formulation of and complying with the quality handbook, including standard operating procedure (SOP) for all technical professional processes of laboratory. Reviewing, adjusting and improving (if necessary) the quality handbook once every year.

4. Formulating and implementing the internal examination program approved by heads of medical examination and treatment places, having system of recording, preservation, detecting breakdowns and measures to remedy, prevent breakdowns.

5. Participating in outer examination programs under specialized sector, regulation on assigning to undertake specialized activities of testing calibration of the Ministry of Health and being encouraged to participate in international outer examination programs that have been recognized.

6. Formulating the testing quality index set in conformity with conditions of laboratory and medical examination and treatment places:

a) The testing quality index set of unit that is used for striving to attain, assessment on continuously maintaining and improving quality is formulated in accordance with regulation in the Appendix issued with this Circular;

b) At least once every year, conducting adjustment on quality indexes.

Article 6. The content of assurance of laboratory quality control

1. To implement the organizational requirements:

a) Having organizational chart, work’s descriptions, clearly stating roles, functions and tasks of each health officer;

b) Laboratory saves personnel files of all health officers (copies);

c) Health officers of laboratory are responsible for the implementation of laboratory quality control.

2. To set up documents system, laboratory quality control’s files:

a) To set up documents management system, files and encourage information technology application in documents management and laboratory files;

b) To implement process on controlling documents and records aiming to make system of documents and records to be archived in scientific and convenient way for control, monitor, searching and use;

c) To ensure the quality handbook which must be easy for accessing and use, store all technical records.

3. Training:

a) To have plan on and implement annual training on quality control for health staff;

b) Laboratory participates in training activities on quality control in specialized fields of laboratory.

4. Supervision and assessment:

a) To have plans on and implement supervision, assessment of internal testing quality, daily specialized activities;

b) To have plans on and implement the supervision and assessment for all health staff after training;

c) To have plans on and implement supervision, provision against breakdowns that may occur;

d) To supervise, assess use, management, maintenance of equipment and chemicals in testing;

e) To participate in formulation of plans and conduct inter-department or laboratory supervision and assessment (if any).

Chapter III

LABORATORY QUALITY CONTROL’S RESPONSIBILITIES

Article 7. Responsibilities of medical examination and treatment place’s heads

1. To direct the implementation and organization in accordance with content of the laboratory quality control at medical examination and treatment facility and laboratory.

2. To set up organization system to formulate and issue documents on quality control in conformity with actual conditions of their unit; to build the structural chart of laboratory quality control system to be parallel with structure of administration and technical system of the medical examination and treatment facility.

3. To approve plan on laboratory quality control of their units.

4. To ensure suitable sources for laboratory quality control, including: human resources, material places, equipment, funding for implementation of approved plan and regular funding including:

a) To implement, maintain and improve testing quality;

b) To train laboratory’s human resources;

c) To ensure laboratory’s quality;

d) To formulate and approve regulations, guidance process, hold training courses for relevant officers;

e) To take assessment on implementation of plan on laboratory quality control.

5. To assign at least one health officer in laboratory quality control at laboratory, depend on scale, actual conditions of medical examination and treatment places and laboratories.

Article 8. The responsibilities of laboratory’s heads

1. To organize quality control of laboratory, implement fully tasks and plans of laboratory on laboratory quality control, to coordinate with office (or team) of quality control of hospital in advise leaders of medical examination and treatment facility on entire quality control work of laboratory.

2. To formulate annual and 5-year plans on content of laboratory quality control in order to submit to leaders of medical examination and treatment facility for consideration, approval.

3. To personally direct, organize implementation of contents of the approved plan on laboratory quality control. Every 6-month, to consider implementation of annual plan on laboratory quality control, proactively proposes suitable adjustments.

4. To direct and personally implement monitoring, inspection and supervision of testing quality; to detect, propose solutions and manage cases with errors or risks of occurring errors during the laboratory quality control at laboratory.

5. To direct and formulate the quality handbook of laboratory, standard operating procedures (SOP) in order to submit to leaders of medical examination and treatment facility for consideration, issuance.

6. To organize scientific study, formulate and submit to leaders of medical examination and treatment facility for approval of plans on training on the spot or by sending health officers of laboratory and other relevant divisions to be trained on testing quality management.

7. To integrate quality control of laboratory with activities of other relevant departments or divisions in science study, training for health officer of laboratory.

8. To receive information, handle and advise heads of medical examination and treatment places for timely and suitable feedbacks to customers using laboratory services.

Article 9. Quality control officer’s responsibilities at laboratory

1. To summarize, advise for chief of laboratory in carrying out contents content of laboratory quality control.

2. To formulate plans on and contents of laboratory quality control in order to submit to heads of laboratory to consider and decide for submission to leaders of medical examination and treatment facility for consideration, approval.

3. To organize implementation of the internal examination program and participate in the outer examination program in order to monitor, supervise, assess quality of testing work and detect, propose solutions to interfere timely aiming to manage cases with errors or risks of errors in the laboratory procedures.

4. To collect, summarize, analyze data, manage and keep in secret information related to operation of laboratory.

5. To coordinate and support other relevant departments, divisions in carrying out laboratory quality control.

6. To make final reviews, month, quarter and annual reports on activities and results of laboratory quality control to chief of laboratory, chief of division (or team) of quality control of hospital and leaders of medical examination and treatment facility.

7. To be focal advisory in order to implement relevant affairs with organizations of assessment and granting certify of laboratory qualified national or international standard.

Article 10. Clinical department’s responsibilities

1. The department’s heads takes general responsibilities; chief of nurses shall technically direct taking samples. Each department appoints a person in charge of affairs: taking samples, preservation and transport of samples and receipt of testing results.

2. Member’s responsibilities at relevant departments:

a) To assist deans to implement fully content of laboratory quality control of departments;

b) To participate in affairs and training courses on laboratory quality control related to them.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 11. Effect

This Circular takes effect on March 15, 2013.

Article 12. Implementation responsibilities

1. The Medical Examination and Treatment Department shall:

a) Be focal unit to implement, inspect, assess implementation of this Circular at the attached and local medical examination and treatment places.

b) Implement other missions related to laboratory quality control at medical examination and treatment places under assignment of the Minister of Health.

2. The Health Departments in provinces and centrally-run cities, medical sector agencies shall popularize, direct, inspect and assess implementation of the Circular at attached medical examination and treatment places and report the Ministry of Health every 6 months.

Any arising problems in the course of implementation should be reported to the Ministry of Health (Medical Examination and Treatment Department) for guide, consideration and settlement.

The Minister of Health

Nguyen Thi Kim Tien

APPENDIX

GUIDING ON ESTABLISHING LABORATORY QUALITY INDEX SET

(Promulgated together with the Circular No. 01/2013/TT-BYT, of January 11, 2013 of the Minister of Health)

I. Requirements and contents of laboratory quality index set

1. To formulate the index set, including:

- Group 1: Organization and personnel, material places, equipment, procurement of supplies, safety (including biological safety);

- Group 2: Specialized activities (control of procedures, documents, records, information management);

- Group 3: Assessment and supervision (management of breakdowns, control, customer services and continuous quality improvement).

2. The laboratory quality index set ensures for assessment of three procedures: Prior to testing, testing, after testing.

3. The laboratory quality index set must be suitable with laboratory in implementation of routine tests

II. Laboratory quality index’s reference list