STEPS TO NABL Medical Laboratory Accreditation in India Dr Thuppil Venkatesh Lead Assessor & TC member NABL Venkatesh.thuppil@gmail.com Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

“Quality & Competence” in Medical Testing Laboratories ISO 15189:2003 and NABL – 112 requirement a stepwise approach Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

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

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

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

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

Medical labs need to get accredited By whom? How? When? Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

Ten steps towards accreditation Get a copy of the IS/ISO 15189 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 110002 Telephones 2323 0131, 2323 3375, 2323 9402 website : www.bis.org.in Do not use Xerox copies Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

Ten steps towards accreditation Download a copy of the NABL document NABL-112 from the NABL website www.nabl-india.org This is free of cost Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

Ten steps towards accreditation From Google.com download SAMPLE model quality manual ISO 15189 of a section Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

Ten steps towards accreditation Understand terms and definitions under section 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 all through your documentation Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

Terms and definitions Provided on pages 1 and 3 of the IS/ISO 15189 : 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. 3.14 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 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

Ten steps towards accreditation Understand carefully all 15 Clauses under the MANAGEMENT REQUIREMENT Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

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 Control 4.4 Review of Contracts 4.5 Examination by Referral Laboratories 4.6 External services and supplies 4.7 Advisory Services 4.8 Resolution of Complaints 4.9 Identification and Control of Non Conformities 4.10 Corrective Action 4.11 Preventive Action 4.12 Continual improvement 4.13 Quality and Technical Records 4.14 Internal Audit 4.15 Management Review Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

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

4.2 4.2.1 Documentation, communication and implementation 4.2.2 IQC and EQA 4.2.3 Quality policy statement : content and availability 4.2.4 Content of the quality manual 4.2.5 Calibration, monitoring and preventive maintenance of instruments Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

4.3 4.3.1 Procedures for document management 4.3.2 4.3.3 Identification of documents 4.3.2 a-d, g Availability, release, review, amendments 4.3.2. h Changes 4.3.2 e-f Archives and removing of invalid documents Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

Ten steps towards accreditation STEP 5 continued Understand carefully all 8 Claus under the TECHNICAL REQUIREMENT Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

Technical requirement (8) 5.1 Personnel 5.2 Accommodation and Environmental Conditions 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 Results Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

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

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

Ten steps towards accreditation Study in detail all clauses (scope wise) referred in NABL-112 This is the Regional /National requirement Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

NABL - 112 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 Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

Ten steps towards accreditation Prepare your Quality System Manual covering both requirements under IS/ISO 15189 and NABL-112 requirement Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

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

Example : under requirements Storage and retention of samples and specimens Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

Ten steps towards accreditation Now obtain application form from : The Director NABL Fill it out carefully annex all details and submit along with the prescribed fee Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

Three stages of NABL Accreditation Process Stage 1 Quality System Manual adequacy study by NABL lead Assessor Stage II Pre-assessment visit by the Lead Assessor (One day) Stage III Final Assessment by the NABL team (two days or more) Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

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

Take home message Irrespective of Laboratory size, Quality needs to be validated by Third Party 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 of accreditation Focus should be continual improvement Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006