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TCVN ISO 15189

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Tiêu chuẩn quốc gia TCVN ISO 15189:2014 (ISO 15189:2012) về Phòng thí nghiệm y tế - Yêu cầu về chất lượng và năng lực (vanbanphapluat.co)⁠

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Full text of the national standard TCVN ISO 15189:2014 (ISO 15189:2012) Medical laboratories - Quality and competence requirements

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NATIONAL STANDARDS

TCVN ISO 15189:2014

ISO 15189:2012

Medical laboratories - Requirements for quality and competence

Preface

TCVN ISO 15189:2014ISO 15189:2014 is completely equivalent to ISO 15189:2012;

TCVN ISO 15189:2014 replaces TCVN 7782:2008;

TCVN ISO 15189:2014 is compiled by the Technical Committee for standards TCVN/TC 176, Quality management and quality assurance , proposed by the General Department of Standards, Metrology and Quality, and published by the Ministry of Science and Technology.

Introduction

This standard is built on two standards TCVN ISO/IEC 17025 and TCVN ISO 9001. This standard specifies competence and quality requirements specific to medical laboratories. Each country may have its own regulations or requirements that apply to some or all of the professional personnel and their activities and responsibilities in this area.

The services of a medical laboratory are essential to patient care and therefore should be available to meet the needs of all patients and medical professionals alike . responsible for patient care. These services include placement of test orders, patient preparation, patient identification, sampling, transportation, storage, handling, and testing of patient samples, along with interpretations, reports and follow-up advice, in addition to safety and regulatory considerations in medical laboratory work.

Where permitted by national , regional or local regulations or requirements, medical laboratory services should include testing of patients during consultations and these services should be subject to consultation. Actively involved in disease prevention in addition to patient diagnosis and management. Each laboratory should also provide appropriate educational and technical opportunities for specialized personnel working for it .

Although this International Standard is intended for use across all currently recognized areas of medical laboratory services, it may also be useful and relevant to organizations engaged in the services and fields of medicine. other areas such as clinical physiology, imaging, and medical physics. In addition, organizations involved in the accreditation of medical laboratory competence can also use this International Standard as a basis for their operations . If the laboratory wishes to be accredited, an accreditation body operating in accordance with TCVN ISO/IEC 17011 should be selected taking into account the specific requirements for the medical laboratory.

This International Standard is not intended to be used for accreditation purposes, however meeting the requirements of this standard by a medical laboratory means that the laboratory meets both the energy requirements and the requirements . technical and management system requirements necessary to provide technically valid results . The management system requirements in clause 4 are written in a language appropriate to the operation of the medical laboratory, in accordance with the principles of TCVN ISO 9001:2008 , Quality management systems - Requirements , and be happy a with appropriate laboratory requirements (IAF-ILAC-ISO Joint Communiqué issued in 2009).

The correlation between the clauses of this standard and the clauses of TCVN ISO 9001:2008 and TCVN ISO/IEC 17025:2007 is given in Annex A of the standard.

Environmental issues related to the operation of medical laboratories are covered in general throughout the standard, specific requirements are mentioned in 5.2.2, 5.2.6, 5.3, 5.4, 5.5 .1.4 and 5.7.

MEDICAL LABOR - QUALITY AND CAPACITY REQUIREMENTS _ _

Medical laboratories - Requirements for quality and competence

1. Scope of application

This standard specifies requirements for the quality and competence of medical laboratories.

This International Standard is intended for use by medical laboratories in the development of quality management systems and for assessment of competence. This International Standard can also be used by laboratory customers, regulatory authorities and accreditation bodies in certifying or acknowledging the competence of medical laboratories.

NOTE : International , national or regional regulations or requirements may also apply to specific provisions of this standard .

2. References

The documents cited below are essential for the application of this standard. For dated documents, the mentioned version applies. For unpublished documents, the latest version , including any amendments, applies .

TCVN ISO/IEC 17000 (ISO/IEC 17000), Conformity assessment - Vocabulary and general principles;

TCVN ISO/IEC 17025:2007 (ISO/IEC 17025:2005), General requirements for the competence of testing and calibration laboratories;

TCVN ISO /IEC Guide 2 , Standardization and related activities - General terms and definitions

TCVN 6165 (ISO/IEC Guide 99), International dictionary of metrology - General and basic concepts and terms (VIM) .

3. Terms and definitions

For the purposes of this International Standard, the terms and definitions given in TCVN ISO/IEC 17000 (ISO/IEC 17000), TCVN 6450 (ISO/IEC Guide 2), TCVN 6165 (ISO/IEC Guide 99) and the following terms apply.

3.1 . Accreditation

Procedure by which an authorized organization gives formal recognition that an organization is competent to perform specific tasks.

3.2 . Alert interval

critical interval

The laboratory test results range of a warning (danger) trial indicates an immediate risk of injury or death to the patient .

NOTE 1: The warning interval can be a one- way open panic , where only one person is defined.

NOTE 2: The laboratory will determine the appropriate category of diagnostic tests for the patient and the user.

3.3. Automated selection and reporting of results

The process by which a patient's test results are submitted to a laboratory's information system, which is compared with the laboratory 's defined acceptance criteria and the results fall within the specified criteria . The determination is automatically included in the patient report format without any other intervention.

3.4 . Biological reference interval

Reference interval

Defined range of the distribution of values taken from a population of biological standards.

EXAMPLE The biological circadian interval that concentrates 95 % of serum sodium ion concentration values from a population of healthy male and female adults is 135 mmol/l to 145 mmol / l .

Note 1 to entry : An inventory of standards is usually defined as the 95 % concentration range. In particular cases , a reference interval of a different width or a non -symmetrical interval may be more appropriate.

NOTE 2 The standard interval may depend on the type of priming sample and the test procedure used.

NOTE 3: In some cases, only one biological standard limit is important , for example , the upper limit, x , for which the corresponding biological standard interval would be less than or equal to x .

NOTE 4: Terms such as “ normal range ” , “ normal value ” and “ clinical range ” are ambiguous and therefore are not recommended . encourage.

3.5 . Competence

Demonstrated ability to apply knowledge and skills .

NOTE : The concept of competence is defined in the general sense in this standard . The use of the wording may be more specific in other ISO documents.

[TCVN ISO 9000:2007, definition 3.1.6].

3.6 . Documented procedure

A defined way to perform an activity or process is documented, implemented, and maintained.

Note 1 to entry : Requirements for documented procedures can be addressed in a single document or across multiple documents.

Note 2 to entry : Corresponding to TCVN ISO 9000:2007, definition 3.4.5.

3.7. Examination

A set of operations intended to determine the value or characteristic of an attribute.

Note 1 to entry: In some specialties ( e.g. microbiology), testing is the whole activity of some test , observation or measurement.

Note 2 to entry: Laboratory tests that determine the value of an attribute are called quantitative tests; The tests used to characterize an attribute are called qualitative tests .

Note 3 to entry: Laboratory tests are also often referred to as analyzes or tests.

3.8. Interlaboratory comparisons

The organization , performance , and evaluation of measurements or tests on the same or similar specimens b in two or more laboratories under predetermined conditions.

[TCVN ISO/IEC 17043:2011, definition 3.4].

3.9. Laboratory director

Person (s ) with general responsibility and authority for the laboratory.

NOTE 1: For the purposes of this standard, the person(s) referred to are collectively designated as "laboratory director " .

Note 2 to entry : National, regional and local regulations may apply to qualifications and training .

3.10 . Laboratory management

The person(s) who run and manage the operation of the laboratory.

NOTE The term “laboratory leadership” is synonymous with the term “top management” in TCVN ISO 9000:2007.

3.11 . Medical laboratory /clinical laboratory

Laboratories for biological, microbiological, immunological , chemical, immunohematological, hematologic, biophysical, cytological , pathological, genetic or other testing of samples from the human body for the purpose of providing information for the diagnosis, management, prevention and treatment of disease or for the assessment of human health, and may provide consulting services on all The research aspect of the laboratory includes both the interpretation of the results and advice on appropriate further studies.

NOTE : These tests also include procedures for the identification , measurement or other description of the presence or absence of various substances or microorganisms.

3.12 .Nonconformity

Non-compliance with a request.

[TCVN ISO 9000:2007, definition 3.6.2].

3.13 . Point-of-care testing

POCT

Near - patient testing

Testing done near or at the patient's location with results can lead to changes in patient care.

[ISO 22870:2006, definition 3.1].

3.14 . Post-examination processes

Postanalytical phase

The follow-up process includes reviewing results, storing and preserving clinical samples, disposal of samples ( and waste), formatting, release, reporting, and retention of test results. .

3.15 . Pre - examination processes

The preanalytical phase

The process begins, chronologically, from the clinician's request , including the laboratory order , preparation, and identification of the patient; primary sample(s), transport to and within the laboratory, and end when analytical testing begins.

3.16 . Primary sample

Sample (specimen)

A portion of body fluid, breathing air, hair, or tissue taken for testing, investigation, or analysis of one or more quantities or properties assumed to apply to the whole.

Note 1 to entry: The Global Harmonization Task Force ( GHTF) uses the term sample in its guidance documents to mean a sample of biological origin for medical laboratory testing .

NOTE 2: In some ISO and CEN documents, sample is defined as " a biological sample of human origin".

NOTE 3: In some countries, the term "sample " is used instead of an initial sample ( or part of a sample) that is prepared for submission to a laboratory, or accepted by the laboratory for testing purposes.

3.17 . Process

A set of interrelated or interacting activities that transforms inputs into outputs.

NOTE 1 : The input to one process is often the output of other processes . _ _

Note 2 to entry: Corresponding to TCVN ISO 9000:2007, definition 3.4.1.

3.18 . Quality

The degree to which a set of inherent characteristics fulfills requirements.

Note 1 to entry: The term "quality" can be used with adjectives such as poor , good, excellent.

NOTE 2: "Inherent " , as opposed to "assigned", means existing in something , especially as a permanent or permanent characteristic .

[TCVN ISO 9000:2007, definition 3.1.1]

3.19 . Quality indicator

A measure of how well a set of inherent characteristics meets requirements.

NOTE 1: The measure can be expressed , for example % of results (% within specified requirement ) , % k defect (% outside of specified requirement) , defects per million chances (DPMO) or in the range of 6 sigma.

Note 2 to entry : Quality indicators can measure how well an organization is meeting user needs and requirements and the quality of all operational processes .

EXAMPLE If it is requested to receive all laboratory urine samples uncontaminated , the number of contaminated urine samples received is expressed as a percentage of all samples . Urine received ( inherent characteristic of the process ) is a measure of the quality of that process .

3.20 . Quality management system

Management system to direct and control an organization in terms of quality.

NOTE 1: The term " quality management " referred to in this definition relates to management in general, the provision and management of resources, prior processes , during and after testing and review evaluation, continuous improvement.

NOTE 2 : Corresponding to TCVN ISO 9000:2007 , definition 3.2.3

3.21 . Quality policy

The overall intentions and direction of an organization with regard to quality are formally announced by top management .

Note 1 to entry: In general, the quality policy should be consistent with the overall policy of the organization and be the basis for setting quality objectives .

Note 2 to entry : Corresponding to TCVN ISO 9000:2007, definition 3.2.4.

3.22 . Quality objective

What to look for or aim for is related to quality.

NOTE 1 Quality objectives should generally be based on the organization's quality policy .

Note 2 to entry: Quality objectives are generally defined for respective departments and levels within the organization.

Note 3 to entry: Corresponding to TCVN ISO 9000:2007 , definition a 3.2.5

3.23 . Referral laboratory

The external laboratory where the sample is sent for testing.

NOTE An external laboratory is the laboratory chosen by the leadership to send a sample or portion of a sample for testing or when routine tests are not possible . This external laboratory is different from a laboratory where it may include a public health service, forensics, cancer screening, or a central (headquarters) facility where the work is done . Sample submission is according to structural or regulatory requirements .

3.24. Sample

One or more sections taken from the original sample.

EXAMPLE A quantity of serum taken from a larger volume of serum .

3.25. Turnaround time

The time elapsed between two defined time points during pre-test, test, and post- test .

3.26. Validation

Confirmation , through the provision of objective evidence, that the requirements for the intended use have been fulfilled.

Note 1 to entry: The term " validated " is used to refer to a corresponding condition .

NOTE 2 : Corresponding to TCVN ISO 9000:2007, definition 3.8.5 .

3.27 . Verification

The assertion, through the provision of objective evidence, that the specified requirements have been fulfilled.

Note 1 to entry: The term "verified" is used for a corresponding condition

Note 2 : Verification may include activities such as:

- calculation by other method ;

- comparing a new design specification with a similar verified design specification ;

- conduct testing and demonstration; and

- review of documents prior to issuance.

[TCVN ISO 9000:2007, definition a 3.8.4]

4. Management requirements

4.1. Organization and management responsibilities

4.1.1 . Organization

4.1.1.1 . General

Medical laboratories (hereinafter referred to as " laboratory") shall meet the requirements of this standard when performing work at permanent facilities or at associated or mobile facilities .

4.1.1.2 . Legal

A laboratory or organization that has a laboratory must be a legal entity that can be legally responsible for its activities.

4.1.1.3 . Code of Ethics

Laboratory management shall make arrangements to ensure :

a) not engage in any activity that undermines confidence in the competence , objectivity, judgment or integrity of the laboratory 's operations ;

b) management and employees are not subject to any commercial, financial or other pressures and influences that could negatively affect the quality of their work;

c) where there are potential conflicts of competitive interest, such conflicts should be disclosed in a broad and appropriate manner;

d) have appropriate procedures in place to ensure that personnel handle samples, tissues taken from humans or corpses in accordance with applicable legal requirements;

e) maintain confidentiality of information .

4.1.1.4 . Laboratory manager

The laboratory must be operated by i(s) of competent person(s) and assigned responsibility for the services provided.

The responsibilities of the laboratory director shall include professional, scientific, consulting or advisory, organizational, administrative and educational matters relating to the services provided by the laboratory. .

The laboratory director may delegate selected duties and/or responsibilities to qualified personnel ; however, the laboratory director is ultimately responsible for the overall operation and administration of the laboratory.

The duties and responsibilities of the laboratory director should be documented.

The laboratory director (or designee on assigned duties) shall have the necessary competence, authority and resources to fulfill the requirements of this International Standard.

The laboratory director (or designee) must:

a) effective administration of medical laboratory services, including budgeting and financial management, as assigned by the organization;

b) effectively liaise and operate with accrediting and regulatory bodies, administrative authorities, health care facilities and the patient communities served and providers of formal consent , upon request;

c) ensure that an appropriate number of staff members are educated and trained as required and capable of providing medical laboratory services that meet the needs and requirements of users;

d) ensuring the implementation of the quality policy;

e) implement a safe laboratory environment in accordance with good practices and appropriate requirements;

f) act as a contributing member of the medical staff for the facilities served, when possible and appropriate;

g) ensure that clinical advice is provided regarding the selection of tests, use of services, and interpretation of test results;

h) selection and monitoring of laboratory suppliers;

i) select external laboratories and monitor the quality of their services (see also 4.5);

j ) offer professional development programs for laboratory staff and the opportunity to participate in scientific and other activities of professional laboratory organisations ;

k) defining , applying and monitoring standards for the performance and quality improvement of medical laboratory services ;

NOTE Where appropriate and applicable, this can be done within the context of the various quality improvement committees of the parent organization.

I) monitor laboratory work performance to determine that clinically relevant information is generated ;

m) deal with any complaints, requests or suggestions from staff and /or users of the laboratory's services (see also 4.8, 4.14.3 and 4.14.4 ) ;

n) design and implement a contingency plan to ensure that essential services are available during emergencies or other conditions where laboratory services are limited or not available;

NOTE Contingency plans should be checked periodically.

o) plan and conduct research and development, as appropriate.

4.1.2 . Leadership Responsibilities

4.1.2.1. Leadership commitment

Laboratory management shall provide evidence of its commitment to the development and implementation of the quality management system and to continually improve its effectiveness by:

a) communicate to laboratory personnel the importance of meeting user needs and requirements (see 4.1.2.2) as well as regulatory and accreditation requirements;

b) establishing the quality policy (see 4.1.2.3);

c) ensure that quality objectives and plans are established (see 4.1.2.4 ) ;

d) defining the responsibilities, authorities and interrelationships of all personnel (see 4.1.2.5);

e) establish a communication process ( see 4.1.2.6);

f) designate a quality manager, by any name ( see 4.1.2.7);

g) conduct a management review (see 4.15);

h) ensuring that all personnel are competent to perform assigned activities ( see 5.1.6 ) ;

i) ensure that appropriate resources are available (see 5.1, 5.2 and 5.3) so that pre-test, intra- and post-test activities can be carried out ( see 5.4, 5.5 and 5.7).

4.1.2.1. User needs

Laboratory management shall ensure that the laboratory's services, including counseling and answering services, meet the needs of patients and users of the laboratory's services, ( see also 4.4 and 4.14.3).

4.1.2.3. Quality Policy

The laboratory leader shall define the purpose of the quality management system in the quality policy . Laboratory management shall ensure that the quality policy:

a) fit for the purpose of the organization;

b) includes a commitment to good professional practice, tests of fitness for use, compliance with the requirements of this International Standard, and continual improvement of laboratory service quality;

c) provide a framework for setting and reviewing quality objectives;

d) is communicated and understood within the organization;

e) are reviewed for continuity of conformity.

4.1.2.4. Quality objectives and quality planning

Laboratory management shall establish quality objectives, including those necessary to meet the needs and requirements of users, at appropriate functions and levels within the organization . c. Quality objectives must be measurable and consistent with the quality policy .

Laboratory management shall ensure that planning for the quality management system is carried out to meet requirements (see 4.2) and quality objectives.

Laboratory management shall ensure that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

4.1.2.5. Responsibilities, Authority and Relationships

Laboratory management shall ensure that responsibilities, authorities and relationships are defined, documented and communicated within the laboratory organization. This should include the appointment of the person(s) responsible for each laboratory function and the appointment of a deputy to key technical and managerial personnel .

NOTE In small laboratories , individuals may be responsible for more than one task and it is impractical to appoint deputies for all functions .

4.1.2.6. Information exchange

Laboratory management shall have an effective means of communicating with staff (see also 4.14.4). Records should be kept of matters discussed in communications and meetings.

Laboratory management shall ensure that appropriate communication processes are established between the laboratory and interested parties and that communication regarding the effectiveness of pre-examination processes is established. testing, during and after testing and the laboratory's quality management system.

4.1.2.7. Quality manager

Laboratory management shall appoint a quality manager who, in addition to other responsibilities, has the following delegated responsibilities and authorities :

a) ensure that the processes necessary for the quality management system to be established, implemented and maintained;

b) reporting to laboratory management making decisions about the laboratory's policy, objectives and resources, the performance of the quality management system and any need for improvement ;

c) ensure increased awareness of user needs and requirements throughout the laboratory organization .

4.2. Quality management system

4.2.1. General requirements

The laboratory shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

The quality management system must integrate all the processes necessary to implement the quality policy and quality objectives and to meet the needs and requirements of the users.

The laboratory must:

a) determine the processes required for the quality management system and ensure the application of the processes throughout the laboratory;

b) determine the sequence and interactions between these processes;

c) defining the criteria and methods needed to ensure that the operation and control of these processes are effective ;

d) ensure the availability of the resources and information necessary to support the operation and monitoring of these processes ;

e) monitoring and evaluation of processes;

f) take the actions necessary to achieve the planned results and continually improve these processes.

4.2.2. Requirements for the documentation system

4.2.2.1. General

The quality management documentation system must include:

a) a statement of the quality policy (see 4.1.2.3) and quality objectives (see 4.1.2.4);

b) the quality manual (see A.2.2.2) ;

c) the procedures and records required by this standard;

d) documents and records (see 4.13) defined by the laboratory to ensure effective planning , operation and control of system processes;

e) copies of applicable regulations, standards and other regulatory documents.

NOTE Documentation can be in any form or type of media, as long as it is easily accessible and protected from unauthorized changes and excessive quality degradation.

4.2.2.2. Quality Handbook

The laboratory shall establish and maintain a quality manual that includes :

a) quality policy (4.1.2.3) or reference to the quality policy;

b) describe the scope of the quality management system;

c) an introduction to the organization and management of the laboratory and its position within the parent organization ;

d) describe the roles and responsibilities of laboratory management (including laboratory directors and quality managers) to ensure compliance with this standard;

e) describe the structure and relationships of the documentation used in the quality management system ;

f) documented policies for the quality management system and lead to technical and managerial activities that support the policy.

All laboratory personnel should have access to and instruction in the use and application of the quality manual and the documents referenced in the manuals .