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THE MINISTRY
OF HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
01/2013/TT-BYT
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Hanoi, January
11, 2013
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CIRCULAR
GUIDING THE LABORATORY QUALITY CONTROL AT
MEDICAL EXAMINATION AND TREATMENT FACILITIES
Pursuant to the Government’s
Decree No. 63/2012/ND-CP, of August 31, 2012, defining the functions, tasks,
powers and organizational structure of the the Ministry of Health;
At the proposal of Director of
medical examination and treatment Management Department;
The Minister of Health
promulgates the Circular guiding the laboratory quality control at medical
examination and treatment facilities.
Chapter I
GENERAL
PROVISIONS
Article 1.
Scope of regulation
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Article 2.
Interpretation of terms
In this Circular, the following terms
are construed as follows:
1. Laboratory means testing
departments, divisions or units at medical examination and treatment facilities
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. The laboratory 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,
comparison 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.
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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
THE CONTENT OF
LABORATORY QUALITY CONTROL
Article 3. The
sytem 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 Departments of
Health, 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. Center of testing calibration
keeps role as unit performing professional activities aiming to ensure the
testing quality at laboratories of medical examination and treatment facilities
(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
Departments of Health 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 facilities 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 a or many types of testing.
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1. The medical examination and
treatment facilities implement the laboratory quality control in conformity
possessing law policies, statements (commitments) of quality, quality target,
scale, condition of medical examination and treatment facilities and of laboratories.
2. The medical examination and
treatment facilities 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 facilities 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 facilities, that integrate with annual and 5-year plans of
medical examination and treatment facilities.
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
handbool once every year.
4. Formulating and implementing
the internal examination program approved by heads of medical examination and
treatment facilities, 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.
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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 Annex promulgated together with this Circular;
b) At least once every year,
conducting adjustment of the quality indexes.
Article 6. The
content of assurance of laboratory quality control
1. To implement the organizational
requirements:
a) Having organizational chart,
descriptions of affairs, clearly stating the role, functions and tasks of each
health officer;
b) Laboratory conducts preservation
of personnel records of all health officers (copies);
c) Health officers of laboratory
are responsible for well implementing quality control of laboratory.
2. To set up system of documents,
records of laboratory quality control:
a) To set up the management system
of documents, records, application of information technology in management of
documents and records of laboratory is encouraged;
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c) To ensure the quality handbook
which must be easy for accessing and use, store all technical records.
3. Training:
To have plan on and implement
annual training on quality control for health staff;
b) Laboratory participates in training activities on quality control falling 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;
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Chapter III
THE RESPONSIBILITIES
FOR LABORATORY QUALITY CONTROL
Article 7. The
responsibilities of heads of medical examination and treatment facilities
possessing laboratory
1. To direct implementation and
organization in accordance with content of the laboratory quality control at
medical examination and treatment facility and laboratory.
2. To set up the system of
organization to formulate and issue of 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 resource, material facilities,
equipment, funding for implementation of approved plan and regular funding
including:
a) To implement, maintain and
improve testing quality;
b) To train personnel for
laboratory;
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d) To formulate and approve
regulations, guiding process, hold training courses for relevant officers;
e) To hold 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 facilities and laboratories.
Article 8. The
responsibilities of chief of laboratory
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 oder 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 propose 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 occuring errors
during the laboratory quality control at laboratory.
5. To direct and formulate the
quality handbook of laboratory, standard operating procedures (SOP) in oder to
submit to leaders of medical examination and treatment facility for
consideration, issuance.
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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 leaders of medical
examination and treatment facilities for timely and suitable
feedbacks to customers using laboratory services.
Article 9. The
responsibilities of quality control officers 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 oder to submit to leaders 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 annnual 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.
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Article 10.
The responsibilities of clinical department
1. The dean 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. The responsibilities of members
at relevant departments:
a) To assist deans to implement
fully content of laboratory quality control of departments;
b) To participate 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.
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1. The Administration of medical
examination and treatment shall
a) Be focal unit to implement,
inspect, assess implementation of this Circular at the attached and local
medical examination and treatment facilities.
b) Implement other missions
related to laboratory quality control at medical examination and treatment
facilities under assignment of the Minister of Health.
2. The Departments of Health 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 facilities and report the Ministry of Health every 6
months.
In the course of implementation,
any arising problems should be reported to the Ministry of Health
(Administration of medical examination and treatment) for guide, consideration
and settlement.
THE MINISTER
OF HEALTH
Nguyen Thi Kim Tien
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GUDING THE SETTING UP LABORATORY
QUALITY INDEX SET
(Promulgated together with the Circular No. 01/2013/TT-BYT,
of January 11, 2013 of the Minister of Health)
I. The requirement and content
of laboratory quality index set
1. To formulate the index set, including
3 groups:
- Group 1: organization and
personnel, material facilities, 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. The reference list of
laboratory quality indexes
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The
laboratory quality index
The Procedure prior to
testing
1
Full and exact information of
patient
2
The request of testing performed
with full information and correctness.
3
Label of testing sample recorded
full and exact information
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The samples are presereved and transported
in accordance with regulation.
5
The testing samples are
contained in utensils in conformity with regulation
6
Duration of taking the testing
sample
7
Status and external form of
utensil containing the testing sample
8
The quality of testing sample
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The infection rate of urine
culture
10
The infection rate of blood
culture
11
The refused testing samples
12
The rate of being injured due to
injection needle of laboratory officer
The Procedure of testing
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To implement internal
examination properly as scheduled duration and have reasonable measures to
settle
14
To implement outer examination
15
To compare accuracy of fast testing
and testing results performed in laboratory.
16
To monitor and assess capability
of officers
17
Duration to finish the testing
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Number of times which medical
equipment is corrupted
19
Empty, lack of biologicals,
reagents
The Procedure after testing
20
Right and exact result
21
Returning results of cases of
which values exceeded critical threshold is available
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Satisfaction of customers
23
Duration of returning the
testing result
24
The returning of testing result
is exact, not mistake
25
Service is interrupted due to
personnel problems