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

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Presentation on theme: "Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 1 STEPS TO NABL Medical Laboratory Accreditation in India Dr Thuppil Venkatesh."— Presentation transcript:

1 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb STEPS TO NABL Medical Laboratory Accreditation in India Dr Thuppil Venkatesh Lead Assessor & TC member NABL

2 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb “Quality & Competence” in Medical Testing Laboratories ISO 15189:2003 and NABL – 112 requirement a stepwise approach

3 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Indian Scenario ► Over 100,000 medical testing laboratories provide diagnostic services ► Over 80% are small, 18% medium and less than 2% are large in number

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

5 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Accreditation status of large and medium labs :- as they ► can afford to meet the accreditation cost ► are able to maintain quality requirement ► are under the supervision of senior consultants ► are having state of art technology with them ► are able to get external contracts

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

7 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Medical labs need to get accredited ► By whom? ► How? ► When?

8 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Ten steps towards accreditation STEP 1 Get a copy of the IS/ISO Indian Standard MEDICAL LABORATORIES – PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE Details can be obtained from Bureau of Indian Standards Manak Bhavan, 9 Bahadur Shah Zafar Marg New delhi Telephones , , website : Do not use Xerox copies

9 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Ten steps towards accreditation STEP 2 Download a copy of the NABL document NABL-112 from the NABL website This is free of cost

10 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Ten steps towards accreditation STEP 3 From Google.com download SAMPLE model quality manual ISO of a section

11 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Ten steps towards accreditation STEP 4 Understand terms and definitions under section 3 on page 1 of IS/ISO There are 17 terms with foot notes provided. You need to refer to and stick to these internationally accepted terminologies all through your documentation

12 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Terms and definitions ► Provided on pages 1 and 3 of the IS/ISO : 2003 of the August 2005 issue. Total of 17 are listed Example : 3.13 referral laboratory refers to other laboratory to which a sample is submitted for a supplementary or confirmatory examination procedure and report Sample is one or more parts taken from a system and intended to provide information on the system, often to serve as a basis of decision on the system or its product. A volume of serum taken from a larger volume of serum 3.11 Primary sample Specimen set of one or more parts initially taken from a system

13 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Ten steps towards accreditation STEP 5 Understand carefully all 15 Clauses under the MANAGEMENT REQUIREMENT

14 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Management requirement (15) Management requirement (15) 4.1Organization and Management (4.1 to a to j) 4.2Quality Management System (4.2 to a to f, a to w & 4.2.5) 4.3Document Control 4.4Review of Contracts 4.5Examination by Referral Laboratories 4.6External services and supplies 4.7Advisory Services 4.8Resolution of Complaints 4.9Identification and Control of Non Conformities 4.10Corrective Action 4.11Preventive Action 4.12Continual improvement 4.13Quality and Technical Records 4.14Internal Audit 4.15Management Review

15 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb ► 4.1 ORGANISATION AND MANAGEMENT ► Legal identity : ► Laboratory design appropriate to meet the needs : ► Conformity with relevant requirements for permanent facilities, ► Decentralized facilities : ► 4.1.5a appropriate authority for all personnel, resources to carry out their duties: ► 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

16 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb ► Documentation, communication and implementation ► IQC and EQA ► Quality policy statement : content and availability ► Content of the quality manual ► Calibration, monitoring and preventive maintenance of instruments

17 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb ► Procedures for document management ► ► Identification of documents ► a-d, g Availability, release, review, amendments ► h Changes ► e-f Archives and removing of invalid documents

18 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Ten steps towards accreditation STEP 5 continued Understand carefully all 8 Claus under the TECHNICAL REQUIREMENT

19 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Technical requirement (8) Technical requirement (8) 5.1Personnel 5.2Accommodation and Environmental Conditions 5.3Examination Procedures 5.4Laboratory Equipment 5.6Assuring the Quality of Examination Procedures 5.7Pre-examination Procedures 5.8Reporting of Results

20 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb ► Organizational plan, personnel policies, job descriptions ► Records of education and qualification ► Supervision and competency ► Responsibilities of the laboratory director ► Adequate staff resources ► Training of personnel in quality assurance ► Authorization to perform specific tasks ► Use of and access to computers ► Continuing education program ► Training to prevent or contain the effects of adverse incidents ► Assessment of competency after training and re-evaluation ► Qualification for professional judgements ► Confidentiality of information regarding patients

21 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb ► 5.2 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS ► Adequacy and suitability of the lab space (including other sites) ► ► Risk of injury and protection from hazards ► Accommodation for sample collection ► ► Control and registration of environmental conditions ► Separation of incompatible activities ► Access control ► Adequate communication system within the facilities ► Storage of samples and documents assuring integrity ► Housekeeping

22 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Ten steps towards accreditation STEP 7 Study in detail all clauses (scope wise) referred in NABL-112 This is the Regional /National requirement

23 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb NABL ► Provides description and type of laboratory ► Covers all 23 elements from the angle of local/regional regulatory requirement ► Annexure – I describes routine and special tests under each discipline

24 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Ten steps towards accreditation STEP 8 Prepare your Quality System Manual covering both requirements under IS/ISO and NABL-112 requirement

25 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Check and re check your system STEP 9 Conduct at least one Internal Audit followed by the management review meeting and document the action taken and provide the evidence for the effectiveness of the action taken and document the proceedings prior to your pre assessment.

26 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Example : under requirements ► Storage and retention of samples and specimens

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

28 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Three stages of NABL Accreditation Process Stage 1Quality System Manual adequacy study by NABL lead Assessor Stage IIPre-assessment visit by the Lead Assessor (One day) Stage IIIFinal Assessment by the NABL team (two days or more)

29 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb After final assessment ► Report will reach NABL with total knowledge of the laboratory ► NABL technical committee will review the report and recommendations ► Will communicate to the laboratory about the accreditation status ► Accredited labs need to go in for periodic surveillance with annual fee

30 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb Take home message ► Irrespective of Laboratory size, Quality needs to be validated by Third Party ► Documentation is easy under ISO ► 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 of accreditation ► Focus should be continual improvement


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