Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 1 STEPS TO NABL Medical Laboratory Accreditation in India Dr Thuppil Venkatesh

Medical Lab Accreditation in India - stepwiMedical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 se process QCI Bio-Rad Feb 2006

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STEPS TO NABL STEPS TO NABL Medical Laboratory Medical Laboratory

Accreditation in IndiaAccreditation in IndiaDr Thuppil VenkateshDr Thuppil Venkatesh

Lead Assessor & TC member Lead Assessor & TC member NABLNABL

[email protected]@gmail.com

Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

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““Quality & Competence”Quality & Competence”in Medical Testing Laboratoriesin Medical Testing Laboratories

ISO 15189:2003 and NABL – 112 ISO 15189:2003 and NABL – 112 requirementrequirement

a stepwise approacha stepwise approach


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Indian ScenarioIndian Scenario

►Over 100,000 medical testing Over 100,000 medical testing laboratories provide diagnostic laboratories provide diagnostic services services

►Over 80% are small, 18% medium and Over 80% are small, 18% medium and less than 2% are large in numberless than 2% are large in number


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Lab size in IndiaLab size in India

0%

10%

20%

30%

40%

50%

60%

70%

80%

smallmediumlarge


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Accreditation status of large and Accreditation status of large and medium labs :- as they medium labs :- as they

►can afford to meet the accreditation costcan afford to meet the accreditation cost►are able to maintain quality requirementare able to maintain quality requirement►are under the supervision of senior are under the supervision of senior

consultantsconsultants►are having state of art technology with are having state of art technology with

themthem►are able to get external contractsare able to get external contracts


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Future of small labsFuture of small labs

► Do not have adequate financial or the Do not have adequate financial or the manpower manpower

► Eventually will become part of medium/large Eventually will become part of medium/large labslabs

► Get converted in to collection centersGet converted in to collection centers► Might close down if not accreditedMight close down if not accredited


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Medical labs need to get Medical labs need to get accreditedaccredited

►By whom?By whom?►How?How?►When?When?


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Ten steps towards Ten steps towards accreditationaccreditation

STEP 1STEP 1

Get a copy of the IS/ISO 15189 Get a copy of the IS/ISO 15189 Indian Standard Indian Standard

MEDICAL LABORATORIES – PARTICULAR REQUIREMENTS MEDICAL LABORATORIES – PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCEFOR QUALITY AND COMPETENCE

Details can be obtained fromDetails can be obtained from

Bureau of Indian StandardsBureau of Indian Standards

Manak Bhavan, 9 Bahadur Shah Zafar Marg New delhi Manak Bhavan, 9 Bahadur Shah Zafar Marg New delhi 110002 110002

Telephones 2323 0131, 2323 3375, 2323 9402 website : Telephones 2323 0131, 2323 3375, 2323 9402 website : www.bis.org.inwww.bis.org.in

Do not use Xerox copiesDo not use Xerox copies


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STEP 2STEP 2

Download a copy of the NABL document Download a copy of the NABL document

NABL-112 NABL-112 from the NABL website from the NABL website

www.nabl-india.org www.nabl-india.org

This is free of cost This is free of cost


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STEP 3STEP 3

From From Google.com Google.com download SAMPLE download SAMPLE model quality manual ISO 15189 of a model quality manual ISO 15189 of a

sectionsection


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STEP 4STEP 4

Understand terms and definitions under Understand terms and definitions under section 3 on page 1 of IS/ISO 15189 section 3 on page 1 of IS/ISO 15189

There are 17 terms with foot notes There are 17 terms with foot notes provided. You need to refer to and provided. You need to refer to and stick to these internationally stick to these internationally accepted terminologies all through accepted terminologies all through your documentation your documentation


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Terms and definitionsTerms and definitions

► Provided on pages 1 and 3 of the IS/ISO 15189 : 2003 Provided on pages 1 and 3 of the IS/ISO 15189 : 2003 of the August 2005 issue. Total of 17 are listedof the August 2005 issue. Total of 17 are listed

ExampleExample: 3.13 : 3.13 referral laboratory referral laboratory refers to other refers to other laboratory to which a laboratory to which a samplesample is submitted for a is submitted for a supplementary or confirmatory examination supplementary or confirmatory examination procedure and report.procedure and report.

3.14 Sample 3.14 Sample is one or more parts taken from a system is one or more parts taken from a system and intended to provide information on the system, and intended to provide information on the system, often to serve as a basis of decision on the system or often to serve as a basis of decision on the system or its product. its product. A volume of serum taken from a larger volume of serumA volume of serum taken from a larger volume of serum

3.11 Primary sample 3.11 Primary sample Specimen set of one or more parts Specimen set of one or more parts initially taken from a systeminitially taken from a system


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STEP 5STEP 5

Understand carefully all 15 Clauses Understand carefully all 15 Clauses under the MANAGEMENT under the MANAGEMENT

REQUIREMENT REQUIREMENT


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Management requirement Management requirement (15)(15)

4.14.1 Organization and Management Organization and Management (4.1 to 4.1.4 a to j)(4.1 to 4.1.4 a to j)4.24.2 Quality Management System Quality Management System (4.2 to 4.2.3 a to f, (4.2 to 4.2.3 a to f,

4.2.4 a to w & 4.2.5)4.2.4 a to w & 4.2.5)4.34.3 Document Control Document Control 4.44.4 Review of ContractsReview of Contracts4.54.5 Examination by Referral LaboratoriesExamination by Referral Laboratories4.64.6 External services and suppliesExternal services and supplies4.74.7 Advisory ServicesAdvisory Services4.84.8 Resolution of ComplaintsResolution of Complaints4.94.9 Identification and Control of Non ConformitiesIdentification and Control of Non Conformities4.104.10 Corrective ActionCorrective Action4.114.11 Preventive ActionPreventive Action4.124.12 Continual improvementContinual improvement4.134.13 Quality and Technical RecordsQuality and Technical Records4.144.14 Internal AuditInternal Audit4.154.15 Management ReviewManagement Review


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4.14.1► 4.1 ORGANISATION AND MANAGEMENT4.1 ORGANISATION AND MANAGEMENT► 4.1.1 Legal identity : 4.1.1 Legal identity : ► 4.1.2 Laboratory design appropriate to meet the needs : 4.1.2 Laboratory design appropriate to meet the needs : ► 4.1.3 Conformity with relevant requirements for permanent facilities,4.1.3 Conformity with relevant requirements for permanent facilities,► Decentralized facilities : Decentralized facilities : ► 4.1.5a appropriate authority for all personnel, resources to carry out their 4.1.5a appropriate authority for all personnel, resources to carry out their

duties: duties: ► 4.1.4 Possible conflict of interest, financial or political considerations: 4.1.4 Possible conflict of interest, financial or political considerations: ► 4.1.5b4.1.5b► 4.1.5c Confidentiality, impartiality and operational integrity4.1.5c Confidentiality, impartiality and operational integrity► 4.1.5d4.1.5d► 4.1.5e Organizational structure, relation with other organizations4.1.5e Organizational structure, relation with other organizations► 4.1.5f Function descriptions and interrelationships4.1.5f Function descriptions and interrelationships► 4.1.5g Staff training (to be considered along with NABL-112)4.1.5g Staff training (to be considered along with NABL-112)► 4.1.5h Technical management4.1.5h Technical management► 4.1.5i Quality manager (authority and responsibilities)4.1.5i Quality manager (authority and responsibilities)► 4.1.5j Deputies for all key functions4.1.5j Deputies for all key functions


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4.2 4.2

►4.2.1 Documentation, communication 4.2.1 Documentation, communication and implementationand implementation

►4.2.2 IQC and EQA4.2.2 IQC and EQA►4.2.3 Quality policy statement : 4.2.3 Quality policy statement :

content and availabilitycontent and availability►4.2.4 Content of the quality manual4.2.4 Content of the quality manual►4.2.5 Calibration, monitoring and 4.2.5 Calibration, monitoring and

preventive maintenance of instrumentspreventive maintenance of instruments


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4.34.3

►4.3.1 Procedures for document 4.3.1 Procedures for document managementmanagement

►4.3.24.3.2►4.3.3 Identification of documents4.3.3 Identification of documents►4.3.2 a-d, g Availability, release, 4.3.2 a-d, g Availability, release,

review, amendmentsreview, amendments►4.3.2. h Changes4.3.2. h Changes►4.3.2 e-f Archives and removing of 4.3.2 e-f Archives and removing of

invalid documentsinvalid documents


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Ten steps towards Ten steps towards accreditationaccreditationSTEP 5 continuedSTEP 5 continued

Understand carefully all 8 Claus under Understand carefully all 8 Claus under the TECHNICAL REQUIREMENT the TECHNICAL REQUIREMENT


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Technical requirement (8)Technical requirement (8)

5.15.1 PersonnelPersonnel

5.25.2 Accommodation and Environmental Accommodation and Environmental ConditionsConditions

5.35.3 Examination ProceduresExamination Procedures

5.45.4 Laboratory EquipmentLaboratory Equipment

5.65.6 Assuring the Quality of Examination Assuring the Quality of Examination ProceduresProcedures

5.75.7 Pre-examination ProceduresPre-examination Procedures

5.85.8 Reporting of ResultsReporting of Results


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5.15.1

► 5.1.1 Organizational plan, personnel policies, job descriptions5.1.1 Organizational plan, personnel policies, job descriptions► 5.1.2 Records of education and qualification5.1.2 Records of education and qualification► 5.1.3 Supervision and competency5.1.3 Supervision and competency► 5.1.4 Responsibilities of the laboratory director5.1.4 Responsibilities of the laboratory director► 5.1.5 Adequate staff resources5.1.5 Adequate staff resources► 5.1.6 Training of personnel in quality assurance5.1.6 Training of personnel in quality assurance► 5.1.7 Authorization to perform specific tasks5.1.7 Authorization to perform specific tasks► 5.1.8 Use of and access to computers5.1.8 Use of and access to computers► 5.1.9 Continuing education program5.1.9 Continuing education program► 5.1.10 Training to prevent or contain the effects of adverse 5.1.10 Training to prevent or contain the effects of adverse

incidentsincidents► 5.1.11 Assessment of competency after training and re-5.1.11 Assessment of competency after training and re-

evaluationevaluation► 5.1.12 Qualification for professional judgements5.1.12 Qualification for professional judgements► 5.1.13 Confidentiality of information regarding patients5.1.13 Confidentiality of information regarding patients


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5.25.2► 5.2 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS5.2 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS► 5.2.1 Adequacy and suitability of the lab space (including 5.2.1 Adequacy and suitability of the lab space (including

other sites)other sites)► 5.2.45.2.4► 5.2.2 Risk of injury and protection from hazards5.2.2 Risk of injury and protection from hazards► 5.2.3 Accommodation for sample collection5.2.3 Accommodation for sample collection► 5.2.45.2.4► 5.2.5 Control and registration of environmental conditions5.2.5 Control and registration of environmental conditions► 5.2.6 Separation of incompatible activities5.2.6 Separation of incompatible activities► 5.2.7 Access control5.2.7 Access control► 5.2.8 Adequate communication system within the facilities5.2.8 Adequate communication system within the facilities► 5.2.9 Storage of samples and documents assuring integrity5.2.9 Storage of samples and documents assuring integrity► 5.2.10 Housekeeping5.2.10 Housekeeping


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STEP 7STEP 7

Study in detail all clauses (scope wise) Study in detail all clauses (scope wise)

referred in NABL-112 referred in NABL-112

This is the Regional /National This is the Regional /National requirementrequirement


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NABL - 112NABL - 112

►Provides description and type of Provides description and type of laboratorylaboratory

►Covers all 23 elements from the angle Covers all 23 elements from the angle of local/regional regulatory of local/regional regulatory requirement requirement

►Annexure – I describes routine and Annexure – I describes routine and special tests under each discipline special tests under each discipline


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STEP 8STEP 8

Prepare your Quality System Manual Prepare your Quality System Manual covering both requirements undercovering both requirements under

IS/ISO 15189 and NABL-112 requirementIS/ISO 15189 and NABL-112 requirement


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Check and re check your Check and re check your system system

STEP 9STEP 9

Conduct at least one Internal Audit Conduct at least one Internal Audit followed by the management review followed by the management review meeting and document the action meeting and document the action taken and provide the evidence for the taken and provide the evidence for the effectiveness of the action taken and effectiveness of the action taken and document the proceedings prior to your document the proceedings prior to your pre assessment.pre assessment.


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Example : under Example : under requirementsrequirements

►Storage and retention of samples and Storage and retention of samples and specimens specimens


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STEP 9STEP 9

Now obtain application form from :Now obtain application form from :

The Director NABL The Director NABL

Fill it out carefully annex all details and Fill it out carefully annex all details and submit along with the prescribed feesubmit along with the prescribed fee


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Three stages of Three stages of NABL Accreditation ProcessNABL Accreditation Process

Stage 1Stage 1 Quality System Manual Quality System Manual adequacy study by NABL lead Assessoradequacy study by NABL lead Assessor

Stage IIStage II Pre-assessment visit by the Pre-assessment visit by the Lead Assessor (One day)Lead Assessor (One day)

Stage IIIStage III Final Assessment by the NABL Final Assessment by the NABL team (two days or more)team (two days or more)


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After final assessmentAfter final assessment

►Report will reach NABL with total Report will reach NABL with total knowledge of the laboratoryknowledge of the laboratory

►NABL technical committee will review NABL technical committee will review the report and recommendationsthe report and recommendations

►Will communicate to the laboratory Will communicate to the laboratory about the accreditation status about the accreditation status

►Accredited labs need to go in for Accredited labs need to go in for periodic surveillance with annual feeperiodic surveillance with annual fee


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Take home messageTake home message► Irrespective of Laboratory size, Quality needs to be validated Irrespective of Laboratory size, Quality needs to be validated

by Third Partyby Third Party

► Documentation is easy under ISO 15189Documentation is easy under ISO 15189

► NABL guide lines provide local/ regional requirementsNABL guide lines provide local/ regional requirements

►

Laboratory can be accredited by any authorized Third PartyLaboratory can be accredited by any authorized Third Party

► Quality Control and PT requirements are the integral Quality Control and PT requirements are the integral components of accreditationcomponents of accreditation

► Focus should be continual improvementFocus should be continual improvement

Documents

Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 1 STEPS TO NABL Medical Laboratory Accreditation in India Dr Thuppil Venkatesh