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Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 11

STEPS TO NABL MedicalSTEPS TO NABL MedicalLaboratory AccreditationLaboratory Accreditation

in Indiain IndiaDr Thuppil Venkateshr Thuppil VenkateshLead Assessor & TC memberead Assessor & TC [email protected]@gmail.com
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Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 2

Quality & CompetenceQuality & Competence

in Medical Testing Laboratoriesin Medical Testing Laboratories

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

a stepwise approacha stepwise approach
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Indian ScenarioIndian Scenario

Over 100,000 medical testing laboratoriesOver 100,000 medical testing laboratories

provide diagnostic servicesprovide diagnostic services

Over 80% are small, 18% medium and lessOver 80% are small, 18% medium and less

than 2% are large in numberthan 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%

small

medium

large
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Accreditation status of large andAccreditation status of large and

medium labs :- as theymedium 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 seniorare under the supervision of seniorconsultantsconsultants

are having state of art technology withare having state of art technology with

themthemare 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 manpowerDo not have adequate financial or the manpower

Eventually will become part of medium/large labsEventually will become part of medium/large labs

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 accreditedMedical labs need to get accredited

By whom?By whom?

How?How?When?When?
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Ten steps towards accreditationTen steps towards accreditation

STEP 1STEP 1

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

MEDICAL LABORATORIES PARTICULAR REQUIREMENTS FOREDICAL LABORATORIES PARTICULAR REQUIREMENTS FORQUALITY AND COMPETENCEUALITY AND COMPETENCEDetai ls can be obtained frometai ls can be obtained from Bureau of Indian Standardsureau of Indian StandardsManak Bhavan, 9 Bahadur Shah Zafar Marg New delhi 110002anak Bhavan, 9 Bahadur Shah Zafar Marg New delhi 110002Telephones 2323 0131, 2323 3375, 2323 9402 website :elephones 2323 0131, 2323 3375, 2323 9402 website :www.bis.org.inww.bis.org.in

Do not use Xerox copieso not use Xerox copies
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STEP 2STEP 2

Download a copy of the NABL documentDownload a copy of the NABL documentNABL-112ABL-112from the NABL websitefrom the NABL website

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

This is free of costThis is free of cost

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STEP 3STEP 3

FromFrom Google.comoogle.com download SAMPLEdownload SAMPLEmodel quality manual ISO 15189 of amodel quality manual ISO 15189 of a

sectionsection

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STEP 4STEP 4

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

There are 17 terms with foot notes provided.There are 17 terms with foot notes provided.You need to refer to and stick to theseYou need to refer to and stick to these

internationally accepted terminologies allinternationally accepted terminologies allthrough your documentationthrough your documentation
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Terms and definitionsTerms and definitions

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

ExampleExample: 3.13: 3.13 referral laboratoryreferral laboratory refers to other laboratory torefers to other laboratory towhich awhich a samplesampleis submitted for a supplementary oris submitted for a supplementary or

confirmatory examination procedure and report.confirmatory examination procedure and report.3.14 Sample3.14 Sampleis one or more parts taken from a system andis one or more parts taken from a system and

intended to provide information on the system, often tointended to provide information on the system, often toserve as a basis of decision on the system or its product.serve as a basis of decision on the system or its product. AAvolume of serum taken from a larger volume of serumvolume of serum taken from a larger volume of serum

3.11 Primary sample3.11 Primary sampleSpecimen set of one or more partsSpecimen set of one or more partsinitially taken from a systeminitially taken from a system
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Management requirementManagement requirement

(15)(15)

4.14.1 Organization and ManagementOrganization 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 SystemQuality Management System (4.2 to 4.2.3 a to f, 4.2.4 a to(4.2 to 4.2.3 a to f, 4.2.4 a tow & 4.2.5)w & 4.2.5)

4.34.3 Document ControlDocument Control

4.44.4 Review of ContractsReview of Contracts

4.54.5 Examination by Referral LaboratoriesExamination by Referral Laboratories

4.64.6 External services and suppliesExternal services and supplies

4.74.7 Advisory ServicesAdvisory Services

4.84.8 Resolution of ComplaintsResolution of Complaints

4.94.9 Identification and Control of Non ConformitiesIdentification and Control of Non Conformities

4.104.10 Corrective ActionCorrective Action4.114.11 Preventive ActionPreventive Action

4.124.12 Continual improvementContinual improvement

4.134.13 Quality and Technical RecordsQuality and Technical Records

4.144.14 Internal AuditInternal Audit

4.154.15 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 duties: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:4.1.4 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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4.24.2

4.2.1 Documentation, communication and4.2.1 Documentation, communication and

implementationimplementation

4.2.2 IQC and EQA4.2.2 IQC and EQA

4.2.3 Quality policy statement : content and4.2.3 Quality policy statement : content and

availabilityavailability

4.2.4 Content of the quality manual4.2.4 Content of the quality manual4.2.5 Calibration, monitoring and preventive4.2.5 Calibration, monitoring and preventive

maintenance of instrumentsmaintenance of instruments
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4.34.3

4.3.1 Procedures for document4.3.1 Procedures for documentmanagementmanagement

4.3.24.3.2

4.3.3 Identification of documents4.3.3 Identification of documents4.3.2 a-d, g Availability, release, review,4.3.2 a-d, g Availability, release, review,

amendmentsamendments

4.3.2. h Changes4.3.2. h Changes4.3.2 e-f Archives and removing of invalid4.3.2 e-f Archives and removing of invalid

documentsdocuments
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STEP 5 continuedSTEP 5 continued

Understand carefully all 8 Claus under theUnderstand carefully all 8 Claus under theTECHNICAL REQUIREMENTTECHNICAL REQUIREMENT
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Technical requirement (8)Technical requirement (8)

5.15.1 PersonnelPersonnel

5.25.2Accommodation and EnvironmentalAccommodation and Environmental

ConditionsConditions

5.35.3 Examination ProceduresExamination Procedures

5.45.4 Laboratory EquipmentLaboratory Equipment

5.65.6Assuring the Quality of ExaminationAssuring 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 incidents5.1.10 Training to prevent or contain the effects of adverse incidents 5.1.11 Assessment of competency after training and re-evaluation5.1.11 Assessment of competency after training and re-evaluation 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 other sites)5.2.1 Adequacy and suitability of the lab space (including 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-112referred in NABL-112

This is the Regional /National requirementThis is the Regional /National requirement
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NABL - 112NABL - 112

Provides description and type of laboratoryProvides description and type of laboratory

Covers all 23 elements from the angle ofCovers all 23 elements from the angle of

local/regional regulatory requirementlocal/regional regulatory requirement

Annexure I describes routine and specialAnnexure I describes routine and special

tests under each disciplinetests under each discipline
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STEP 8STEP 8

Prepare your Quality System ManualPrepare your Quality System Manualcovering 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 systemCheck and re check your system

STEP 9STEP 9

Conduct at least one Internal Audit followedConduct at least one Internal Audit followedby the management review meeting andby the management review meeting and

document the action taken and provide thedocument the action taken and provide the

evidence for the effectiveness of the actionevidence for the effectiveness of the action

taken and document the proceedings priortaken and document the proceedings prior

to your pre assessment.to your pre assessment.
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Example : under requirementsExample : under requirements

Storage and retention of samples andStorage and retention of samples and

specimensspecimens
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STEP 9STEP 9

Now obtain application form from :Now obtain application form from :The Director NABLThe Director NABL

Fill it out carefully annex all details and submitFill it out carefully annex all details and submit

along with the prescribed feealong with the prescribed fee

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Three stages ofhree stages ofNABL Accreditation ProcessABL Accreditation ProcessStage 1Stage 1 Quality System Manual adequacyQuality System Manual adequacy

study by NABL lead Assessorstudy by NABL lead Assessor

Stage IIStage II Pre-assessment visit by the LeadPre-assessment visit by the Lead

Assessor (One day)Assessor (One day)

Stage IIIStage III Final Assessment by the NABL teamFinal Assessment by the NABL team

(two days or more)(two days or more)
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After final assessmentAfter final assessment

Report will reach NABL with total knowledgeReport will reach NABL with total knowledge

of the laboratoryof the laboratory

NABL technical committee will review theNABL technical committee will review the

report and recommendationsreport and recommendations

Will communicate to the laboratory aboutWill communicate to the laboratory about

the accreditation statusthe accreditation status

Accredited labs need to go in for periodicAccredited labs need to go in for periodic

surveillance with annual feesurveillance with annual fee
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Take home messageTake home message

Irrespective of Laboratory size, Quality needs to be validated by ThirdIrrespective of Laboratory size, Quality needs to be validated by ThirdPartyParty

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 components ofQuality Control and PT requirements are the integral components ofaccreditationaccreditation

Focus should be continual improvementFocus should be continual improvement
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Documents

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