Quyết định 1099/QĐ-BYT của Bộ Y tế về việc ban hành Quy định điều kiện thực hiện và quản lý chất lượng xét nghiệm đếm tế bào T-CD4

THE MINISTRY OF HEALTH

Decision No.  1099/QD-BYT dated April 04, 2013 of the Ministry of Health promulgating conditions for implementation and quality management of T-CD4 cytometry tests

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 the Director of the Vietnam Administration of HIV/AIDS Control,

DECIDES:

Article 1.To promulgate together with this Decision “Conditions for implementation and quality management of the T-CD4 cytometry tests”.

Article 2.This Decision takes effect on the signing date and replaces the Decision No. 3781/QD-BYT, of October 04, 2007 of the Minister of Health, on “Management and use of CD4-cytometry machine in serve for HIV/AIDS prevention and combating in Vietnam”.

Article 3. Mr., Mrs.: Chief of Ministerial Office, directors, general directors of departments, bureaus, general departments, heads of units affiliated the Ministry of Health, Directors of the provincial Departments of Health and heads of relevant units shall implement this Decision.

For the Minister of Health

Deputy Minister

Nguyen Thanh Long 

REGULATION

CONDITIONS FOR IMPLEMENTATION AND QUALITY MANAGEMENT OF THE T-CD4 CYTOMETRY TESTS

(Issued with the Decision No.1099/QD-BYT dated April 04, 2013 of the Ministry of Health)

Chapter 1.

CONDITIONS FOR IMPLEMENTATION OF THE T-CD4 CYTOMETRY TESTS

Article 1. Implementation of the T-CD4 cytometry tests using fixed machine

T-CD4 testing establishments must satisfy all criteria after carrying out the T-CD4 cytometry tests:

1. Personnel

There are at least 02 officers meeting the following conditions:

a. Officer taking main responsibility graduated from University or higher specialized in medical or biological sector. Officer conducting the testing activities graduated from professional high school or higher specialized in medical or biological sector;

b. Experienced for at least 01 year about conducting the activities of Serological tests or concerned tests;

c. Being trained on techniques and quality assurance for the T-CD4 cytometry tests and possessing certificates of training issued by units that are permitted by the Ministry of Health or certificates of training issued by the conformity international organizations that are recognized by the Ministry of Health;

d. Being assessed capability under periodical basis of 01 year/once about theory and practice by units that are appointed by the Ministry of Health.

2. Material facilities

a. T-CD4 cytometry machine must be placed on desk in the testing area in laboratory and be ensured for airiness, cleanness, anti-dust, anti-wetness and adequate light for implementation of the testing techniques in accordance with regulation, not placed together with other equipment that can cause vibration. Temperature in room always is maintained in about 18 – 25oC, humidity of 20 – 80 %. Walls are made by dado or painted by materials in conformity with laboratory, bright colors, easy for cleaning, with height of 160 cm or more;

b. The testing desk must be flat, firm, waterproof, heat resistant, resistant to chemical corrosion and resistant to electricity;

c. Having 02 sinks: One for washing the testing instruments and one for washing hands for staff;

d. Having the waste treatment system in accordance with the existing regulations;

d. The power source is stable and conformable with equipment, prioritized or replaced when necessary.

3. Equipment

a. T-CD4 cytometry machine in conformity with the testing technique;

b. Device for printing out results;

c. Having at least 01 pipette set in conformity with the testing technique and be calibrated annually;

d. Sample vortex in conformity with the testing technique;

dd. Having cool preservation device for separately preserving biological and other specimens, cool preservation device must be monitored and supervised about temperature daily;

e. Clock to measure time.

Article 2. Implementation of the T-CD4 cytometry tests using the movable testing machine

1. Personnel

a. Graduating from high school or higher specialized in medical or biological sector.

b. Being trained on techniques in testing on use device and assessed capability under periodical basis for one year once about theory and practice by units that are appointed by the Ministry of Health.

2. Material facilities and equipment

a. Movable T-CD4 cytometry machine;

b. Device for printing out results;

c. The power source is stable and conformable with equipment, prioritized or replaced when necessary.

dd. Having cool preservation device for preserving biological and other specimens when necessary;

e. When making tests, T-CD4 cytometry machine must be placed on a flat and firm surface, prevented from vibration, dust and direct sun lights as well as not be placed together with other equipment that can cause vibration.

Article 3. Laboratory of T-CD4 cytometry by areas

Laboratory of T-CD4 cytometry referenced under areas must satisfy at least criteria specified in Article 2 of this Decision, meet the standard of ISO 15189 and ISO 17043 in case of producing the internal and external control specimens, and the following requirements:

1. Having at least 05 officers, of which:

a. Officer taking main responsibility of laboratory must graduate from university specialized in medical or biological sector and experienced for 05 years or more about tests of immune phenotype, CD(s) on white blood cell related to HIV. Experienced about performing tests for over 02 years involving method of immune classification of which at least there is a method that zoning under the populations of white blood cells;

b. Officer conducting activities of tests must have qualification at intermediate level of medical or biological sector or higher and experienced about performing T-CD4 tests for 01 year or more than.

2. Having capacity to perform and meet the receipt of T-CD4 cytometry testing samples of not less than 200 samples /day.

3. Having capacity to carry out the T-CD4 cytometry internal control program.

4. Participating and achieving results of the international external control program.

5. Experienced about carrying out the national external control program involving HIV Serological tests or T-CD4 cytometry tests.

6. Experienced about producing the external control samples involving HIV Serological tests or T-CD4 cytometry tests.

7. Having experience and capacity in training, evaluation on laboratory.

8. Experienced about standardization, evaluation and appraisal of the testing modalities.

9. Having kinds of T-CD4 cytometry machines being used in Vietnam to solve results that are not compatible and to serve for study and training.

Chapter 2.

MANAGEMENT AND USE OF T-CD4 CYTOMETRY MACHINES

Article 4. Management

1. T-CD4 cytometry machines must be managed in accordance with regulations in the Circular No. 112/2006/TT-BTC dated December 27, 2006 of the Ministry of Finance, on “Guiding implementation of Regulation on management of state property at public non-business units that is promulgated together with the Decision No. 202/2006/QD-TTg dated August 31, 2006 of the Prime Minister.

2. Establishments engaged in T-CD4 cytometry test activities must have record of equipment including at least the following items:

a. The record of equipment installment made by suppliers;

b. Information of equipment made according to the Annex 1;

c. Operational instruction and the process of conducting tests in Vietnamese made by suppliers;

d. The use diary of machine.

Article 5. Usage

1. Establishments using T-CD4 cytometry machine must use and operate machine in accordance with instructions of producers.

2. Machine must be perform periodical maintenance and calibration under instruction of producers and must be recorded fully in the equipment information book under the Annex 1.

3. When T-CD4 cytometry machine is faulted or faced with technical problems, within 05 days, it must send a written notice to unit in charge of machine maintenance/provision to request for repair or remedy shortcomings in the earliest time.

4. The machine-using establishments must have plan on budget with the aim to ensure the maintenance, repair or replacement of parts of machine timely.

5. Establishments engaged in T-CD4 cytometry test activities must ensure adequate biological and testing instruments to supply the uninterrupted testing service and use biological in ensuring quality as permitted for use in Vietnam by the Ministry of Health.

Chapter 3.

QUALITY CONTROL OF T-CD4 CYTOMETRY TESTS

Article 6. Taking blood, transport, receipt and processing the T-CD4 cytometry tests

1. Taking blood, transporting, receiving blood must comply with regulation in the Circular No. 43/2011/TT-BYT dated December 05, 2011 of the Minister of Health, on providing the regulation on management of infectious specimens.

2. Taking blood must preserve blood in tube containing anticoagulant by EDTA (ethylene diamine tetra acetic acid) at temperature of 18° - 25°C after collecting and transferring to laboratory in prescribed time by producers together with slip of blood delivery and receipt.

3. Establishments engaged in the T-CD4 cytometry test activities shall receive blood in accordance with regulation.

4. Establishments engaged in T-CD4 cytometry test activities shall conduct testing techniques in accordance with instructions of producers and return the test results within 03 days for establishments that sent samples as from receiving blood in accordance with regulations.

5. Establishments engaged in T-CD4 cytometry test activities shall implement specimen destruction in accordance with the Decision No. 43/2007/QD-BYT, of November 30, 2007, of the Ministry of Health, on promulgating the regulation on management of medical wastes and other relevant laws.

6. In case where T-CD4 cytometry testing machine happens malfunction:

a. The testing establishments must be responsible for receiving specimens of the specimen-sending establishments in provinces and sending specimen to other testing establishments under the zoning and level transfer guidance;

b. Notifying the specimen-sending establishments that are outside of their provinces/cities of the testing suspension and reporting to the Vietnam Administration of HIV/AIDS Control for coordination in operation;

c. If a laboratory has received specimen, it must preserve and transport such specimen by manner in accordance with regulation to other laboratory under the zoning and level transfer guidance.

Article 7. Quality control

1. Internal control must be implemented before performing tests on specimen.

2. Participating in the periodical external control program of at least 6 months/ once.

3. T-CD4 cytometry testing establishments shall be allowed to continue conducting T-CD4 cytometry tests when satisfying the following conditions:

a. The result of internal control sample is eligible before each testing phase;

b. Two-thirds of results of analyzing external control sample must be eligible in number of participation times of one year;

c. Reason of external control fail has been remedied.

Article 8. Material and record’s management

1. The testing establishments shall have adequate Standard Operation Procedure –SOP of:

a. T-CD4 cytometry testing techniques;

b. The specimen management;

c. Management of biological and consumed supplies;

d. The equipment management;

e. Handling malfunction.

2. Establishments shall implement storage of books, forms, reports involving repair and replacement of components of machine in accordance with the existing regulation and store the testing results for 02 years.

Article 9. Laboratory’s safety

1. Ensuring to satisfy biological safety level in conformity with testing techniques.

2. Officers who directly conduct testing must have certificate of training in safety of practicing in laboratory.

3. Using tools containing wastes that meet standard stipulated for each type of wastes; classifying, transporting and handling wastes under the Decision No. 43/2007/QD-BYT, of November 30, 2007, on promulgating the regulation on management of medical wastes.

4. Managing specimens in accordance with the Circular No. 43/2011/TT-BYT, dated December 05, 2011 of the Minister of Health, on providing the regulation on management of infectious specimens.

5. Having a first-aid box at position favorable for use.

6. Ensuring about the fire and explosion prevention for laboratory.

Chapter 4.

IMPLEMENTATION ORGANIZATION

Article 10. Implementation responsibilities

1. The Vietnam Administration of HIV/AIDS Control – the Ministry of Health shall:

a. Manage, provide directions and guide on carrying out the T-CD4 cytometry testing activities nationwide;

b. Coordinate with relevant units to advise the Ministry of Health in appointing laboratories of T-CD4 cytometry referenced under areas;

c. Organize inspection, supervision and assessment on management and use of T-CD4 cytometry machines nationwide;

d. Analyze report data of T-CD4 cytometry test activities nationwide.

2. Laboratories of T-CD4 cell enumeration referenced under areas shall:

a. Coordinate and organize implementation of management on the quality assurance including production, distribution and organization of internal and external control activities;

b. Coordinate with relevant units in study, appraisal of modalities of testing, training, inspection, supervision and professional support for establishments carrying out the T-CD4 cytometry test activities nationwide;

c. Providing courses of training, re-training for establishments carrying out the T-CD4 cytometry test activities;

d. Inspect, supervise the T-CD4 cytometry test activities annually and upon arising irregular problems; provide technical supports when establishments conducting the T-CD4 cytometry tests had the failed external control results and report to the Vietnam Administration of HIV/AIDS Control for coordination in settlement.

3. The provincial Departments of Health shall:

a. Base on actual situations in localities and conditions for implementation of the testing techniques to ensure investment in equipment with the aim to implementation of the economical, reasonable and effective T-CD4 cytometry;

b. Manage and coordinate the utilization of equipment and provision of T-CD4 cytometry tests that are quality, timely and easy for access;

c. Organize inspection and supervision over the T-CD4 cytometry test activities in localities in accordance with this Decision.

4. The provincial HIV/AIDS Control centers shall:

a. Providing advices for the provincial Departments of Health about organization and implementation of this Decision at the health establishments related to the T-CD4 cytometry test activities in their localities;

b. Organize implementation and provision of T-CD4 cytometry tests during monitoring and treating for HIV-AIDS infected persons in localities of their provinces, cities;

c. Coordinate with relevant units in provision of training for officers who take blood and conduct the T-CD4 cytometry tests;

d. Sum up, analyse data of the T-CD4 cytometry tests in their localities and send reports to the provincial Departments of Health and the Vietnam Administration of HIV/AIDS Control before fifth date of each month according to the form set in the Annex 2;

e. Make and send annual reports according to the form set in Annex 3 to the Vietnam Administration of HIV/AIDS Control before January 30 of each year.