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

Medical Lab Accreditation in India - stepwiseprocess QCI Bio-Rad Feb 2006 5


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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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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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STEP 3

From Google.com download SAMPLE modelquality manual ISO 15189 of a section



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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

Medical Lab Accreditation in India - stepwise

process QCI Bio-Rad Feb 2006

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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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STEP 5

Understand carefully all 15 Clauses under theMANAGEMENT REQUIREMENT



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M i


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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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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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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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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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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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Documents

Step by Step Procedure for Medical Laboratory Accreditation