step by step procedure for medical laboratory accreditation
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Step by Step procedure forMedical Laboratory Accreditation
by NABL in India
By KKV Yasas
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ISO 15189:2003 and NABL 112 requirement
Quality & Competencein Medical Testing Laboratories
a stepwise approach
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The Indian Scenario
Over 100,000 medical testing laboratories providediagnostic services
Over 80% are small, 18% medium and less than
2% are large in number
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Lab size in India
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Accreditation status of large andmedium labs :- as they
can afford to meet the accreditation cost
are able to maintain quality requirement
are under the supervision of seniorconsultants
are having state of art technology with them
are able to get external contracts
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Future of small labs
Do not have adequate financial or the manpower
Eventually will become part of medium/large labs
Get converted in to collection centers
Might close down if not accredited
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Medical labs need to get accredited
By whom?
How?When?
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Ten steps towards accreditation
STEP 1
Get a copy of the IS/ISO 15189Indian Standard
MEDICAL LABORATORIES PARTICULAR REQUIREMENTS FORQUALITY AND COMPETENCE
Details can be obtained from
Bureau of Indian Standards
Manak Bhavan, 9 Bahadur Shah Zafar Marg New delhi 110002Telephones 2323 0131, 2323 3375, 2323 9402 website :
www.bis.org.in
Do not use Xerox copies
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Ten steps towards accreditation
STEP 2
Download a copy of the NABL documentNABL-112
from the NABL website
www.nabl-india.orgThis is free of cost
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Ten steps towards accreditation
STEP 3
From Google.com download SAMPLE modelquality manual ISO 15189 of a section
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Ten steps towards accreditation
STEP 4
Understand terms and definitions undersection 3 on page 1 of IS/ISO 15189
There are 17 terms with foot notes provided.You need to refer to and stick to these
internationally accepted terminologies allthrough your documentation
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Terms and definitions
Provided on pages 1 and 3 of the IS/ISO 15189 : 2003 ofthe August 2005 issue. Total of 17 are listed
Example: 3.13 referral laboratory refers to other laboratory towhich a sampleis submitted for a supplementary or
confirmatory examination procedure and report.3.14 Sampleis one or more parts taken from a system and
intended to provide information on the system, often toserve as a basis of decision on the system or its product. Avolume of serum taken from a larger volume of serum
3.11 Primary sampleSpecimen set of one or more partsinitially taken from a system
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Ten steps towards accreditation
STEP 5
Understand carefully all 15 Clauses under theMANAGEMENT REQUIREMENT
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Management requirement(15)
4.1 Organization and Management (4.1 to 4.1.4 a to j)4.2 Quality Management System (4.2 to 4.2.3 a to f, 4.2.4 a to
w & 4.2.5)4.3 Document Control4.4 Review of Contracts4.5 Examination by Referral Laboratories4.6 External services and supplies4.7 Advisory Services4.8 Resolution of Complaints4.9 Identification and Control of Non Conformities
4.10 Corrective Action4.11 Preventive Action4.12 Continual improvement4.13 Quality and Technical Records4.14 Internal Audit
4.15 Management ReviewMedical Lab Accreditation in India - stepwise
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4.1
4.1 ORGANISATION AND MANAGEMENT 4.1.1 Legal identity : 4.1.2 Laboratory design appropriate to meet the needs : 4.1.3 Conformity with relevant requirements for permanent facilities, Decentralized facilities : 4.1.5a appropriate authority for all personnel, resources to carry out their duties:
4.1.4 Possible conflict of interest, financial or political considerations: 4.1.5b 4.1.5c Confidentiality, impartiality and operational integrity 4.1.5d 4.1.5e Organizational structure, relation with other organizations 4.1.5f Function descriptions and interrelationships 4.1.5g Staff training (to be considered along with NABL-112) 4.1.5h Technical management 4.1.5i Quality manager (authority and responsibilities) 4.1.5j Deputies for all key functions
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4.2
4.2.1 Documentation, communication andimplementation
4.2.2 IQC and EQA
4.2.3 Quality policy statement : content andavailability
4.2.4 Content of the quality manual4.2.5 Calibration, monitoring and preventive
maintenance of instruments
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4.3
4.3.1 Procedures for documentmanagement
4.3.2
4.3.3 Identification of documents
4.3.2 a-d, g Availability, release, review,amendments
4.3.2. h Changes4.3.2 e-f Archives and removing of invalid
documentsMedical Lab Accreditation in India - stepwise
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Ten steps towards accreditation
STEP 5 continued
Understand carefully all 8 Claus under theTECHNICAL REQUIREMENT
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Technical requirement (8)
5.1 Personnel
5.2 Accommodation and EnvironmentalConditions
5.3 Examination Procedures
5.4 Laboratory Equipment
5.6 Assuring the Quality of Examination
Procedures
5.7 Pre-examination Procedures
5.8 Reporting of ResultsMedical Lab Accreditation in India - stepwise
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5.1
5.1.1 Organizational plan, personnel policies, job descriptions 5.1.2 Records of education and qualification 5.1.3 Supervision and competency 5.1.4 Responsibilities of the laboratory director
5.1.5 Adequate staff resources 5.1.6 Training of personnel in quality assurance 5.1.7 Authorization to perform specific tasks 5.1.8 Use of and access to computers 5.1.9 Continuing education program
5.1.10 Training to prevent or contain the effects of adverse incidents 5.1.11 Assessment of competency after training and re-evaluation 5.1.12 Qualification for professional judgements 5.1.13 Confidentiality of information regarding patients
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5.2
5.2 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS 5.2.1 Adequacy and suitability of the lab space (including other sites) 5.2.4 5.2.2 Risk of injury and protection from hazards 5.2.3 Accommodation for sample collection
5.2.4 5.2.5 Control and registration of environmental conditions 5.2.6 Separation of incompatible activities 5.2.7 Access control 5.2.8 Adequate communication system within the facilities
5.2.9 Storage of samples and documents assuring integrity 5.2.10 Housekeeping
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Ten steps towards accreditation
STEP 7
Study in detail all clauses (scope wise)referred in NABL-112
This is the Regional /National requirement
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NABL - 112
Provides description and type of laboratory
Covers all 23 elements from the angle oflocal/regional regulatory requirement
Annexure I describes routine and specialtests under each discipline
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Ten steps towards accreditation
STEP 8
Prepare your Quality System Manualcovering both requirements under
IS/ISO 15189 and NABL-112 requirement
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Check and re check your system
STEP 9
Conduct at least one Internal Audit followedby the management review meeting anddocument the action taken and provide theevidence for the effectiveness of the actiontaken and document the proceedings priorto your pre assessment.
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Example : under requirements
Storage and retention of samples andspecimens
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Ten steps towards accreditation
STEP 9
Now obtain application form from :The Director NABL
Fill it out carefully annex all details and submit
along with the prescribed fee
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Three stages ofNABL Accreditation Process
Stage 1 Quality System Manual adequacystudy by NABL lead Assessor
Stage II Pre-assessment visit by the LeadAssessor (One day)
Stage III Final Assessment by the NABL team(two days or more)
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After final assessment
Report will reach NABL with total knowledgeof the laboratory
NABL technical committee will review thereport and recommendations
Will communicate to the laboratory aboutthe accreditation status
Accredited labs need to go in for periodicsurveillance with annual fee
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Take home message
Irrespective of Laboratory size, Quality needs to be validated by ThirdParty
Documentation is easy under ISO 15189
NABL guide lines provide local/ regional requirements
Laboratory can be accredited by any authorized Third Party
Quality Control and PT requirements are the integral components ofaccreditation
Focus should be continual improvement
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