Quality Improvement Programme:- Gujarat (NABH / NABL) Steps for NABL Accreditation of Laboratory Service in Gujarat Dr J L Meena State Quality Assurance Officer Commissionerate of Health, MS & ME Government of Gujarat Phone No. 09099075162 Email:- drjlmeena@gmail.com

I Heartily Thankful to Shri Chakrapani sir, NABH & NABL for initiate 1st Video Conference on Quality Healthcare Service (NABH / NABL) in India

Quality Improvement Programme:- Gujarat (NABH / NABL) Gujarat is the first state in India which initiated for actively pursuing Quality Improvements (NABH / NABL) in the public healthcare facilities through the network of Primary Health Centers (PHCs), Community Health Centers (CHCs), District Hospitals, Blood banks, Laboratories, Food and drug laboratories & Medical Colleges.

Quality Improvement Programme:- Gujarat (NABL) To provide The right test result, at the Right time, on the Right specimen, from the Right patient, with result interpretation based on Correct reference data, and at the Right price (Cost of the community / country afford.)

Quality Improvement Programme:- Gujarat (PROJECT STRATEGY FOR- NABL) Internal Audit (By Internal Auditors) and Closures of Non Conformances raised Defining, monitoring & evaluating the Quality Indicators Development of Quality Management System as per ISO 15189:2007(Monitoring quality indicators etc ) Development, Review and Implementation of policies and procedures for implementation of Quality Management system as per ISO 15189:2007 Involvement of staff (Skill Mapping & Motivation ) Cont….

Quality Improvement Programme:- Gujarat (PROJECT STRATEGY FOR- NABL) Final Assessment and Reassessment – Continual Improvement Pre-assessment Visit by the Lead Assessor Application for NABL Accreditation Meeting with the clinicians for feedback of Laboratory Services Management Review Committee Meeting

A Case Study JOURNEY TOWARDS QUALITY Year 2007 Events 29 May -07 Meeting on Quality improvement programme by Health & Family Welfare Department, Gujarat. 20-21July 07 1st visit of the Laboratory Services as per ISO 15189, B . J. Medical College& Civil Hospital, Ahmedabad, by Consultant & our Team 30 Aug–1 Sep 07 Sensitization workshop for faculty members to implement ISO 15189 21 Sep 07 2nd visit of the Laboratory Services as per ISO 15189, 20 Oct 07 Discussion on progress report of Laboratory Services with QA team at Commissionerate office Gandhinagar Cont….

A Case Study JOURNEY TOWARDS QUALITY Year 2008 Events 7-12 Feb 08 1st Internal Audit by QA Team 27 Feb -08 1st Management Review Committee meeting, Organaogram of the Laboratory services formulated comprising of chairman, co chairman , key laboratory personnel & their deputies March – Oct 08 Preparation of the Apex document of Laboratory Services –Quality Manual as per ISO 15189:2007 10 Oct 08 Issue Date of Quality Manual 3 Dec 08 2nd Management Review Committee Cont….

A Case Study JOURNEY TOWARDS QUALITY Year 2009 Events 8 Jan 09 1st Clinical Meeting 2 Feb 09 Issue Date of Quality System Procedure & Primary Sample Collection Manual 31 March 09 Application for NABL Accreditation of Laboratory Services, B . J. Medical College& Civil Hospital, Ahmedabad. 9 April 09 2nd Clinical Meeting & Issue Date of Safety Manual 6-16 July 09 2nd Internal audit by QA Team 30 July 09 Pre assessment by NABL Assessor 6 Aug & 10 Dec 09 3rd & 4th Clinical Meeting 25 Aug & 3 Dec 09 3rd & 4th Management Review Committee for Closure of Non Conformances of Final Assessment 28-31 Dec 09 3rd Internal audit by QA Team & closure report of pre assessment sent to NABL Cont….

A Case Study JOURNEY TOWARDS QUALITY Year 2010 Events 1-8 Jan 10 3rd Internal Audit on going by QA team 12 Jan 10 5th Management Review Committee for preparation of laboratory to Final assessment 6-7 March 10 NABL Final Assessment by NABL Assessor 9 March 10 6th Management Review Committee for Closure of Non Conformances of Final Assessment 24 April 10 Closure of the Non conformances with documentary evidence send to NABL July 10 Recommendation Letter from NABL & India’s 2nd Govt. Medical College Lab Accredited as per NABL Cont….

A Case Study JOURNEY TOWARDS QUALITY Year 2011 Events 31st January 2011 5th Internal Audit 23-24th July 2011 NABL 1st Surveillance inspection 17th August 2011 8th Management Review Committee meeting 22 Nov 2011 Continuation of Accreditation 12 December 2011 Change in the organogram Cont….

A Case Study JOURNEY TOWARDS QUALITY Year 2012 Events 10-11th March 12 NABL 1st Renewal Assessment 5th April 2012 6th Internal Audit 8th July 2012 Certificate of Renewal of Accreditation – Valid up to 7th July 2014

A Case Study COMPARISON OF NON CONFORMANCE DURING ASSESSMENT SR No Year 2010 Year 2011 Year 2012 Quality Management System 04 09 02 Heamatology and Immunohaematology 03 Cytopathology and Histopathology 05 06 Microbiology and Serology 01 Clinical Biochemistry 10 Total 32 33 12

A Case Study COMPARISON OF SCOPE OF ACCREDITATION Name of Department Year 2010 Year 2012 Pathology 26 33 Microbiology 16 Biochemistry Total 58 65

Pre analytical Variables Physician Test Knowledge Appropriateness of Test Selection Physician Test Ordering Patient Preparation Patient Identification Specimen Labelling/ Identification Adequacy of specimen information Specimen Collection/Complication of phlebotomy Sample rejection rate Specimen Delivery Processing and Preparation

Analytical Variables Specimen Analysis Critical value reporting Housekeeping record ( Incidence of sample spillage) Report Review or Verification Results Review Incidence of needle stick & other injuries Quality control (IQC & EQAS)

Post analytical Variables Turnaround Time Notification of Critical Values Report Accuracy and Completeness Incidence of Typographical error Report Delivery Physician Follow-up Interpretive Consultation Customer Satisfaction

Quality Improvement Programme:- Gujarat (NABL) Outcomes…..

Comparison of Past and Present Scenario Lack of standards ISO 15189:2007 & NABL- 112 for lab in place No Gap analysis report in standard format. Gaps identified and addressed as per standards Lack of Statutory requirements (e.g. Licenses, Acts, Rules & Certificates). Statutory requirements fulfilled Absence of written policies, procedures, forms & formats. Written policies, procedures, forms & formats. available. Poor sanitation and cleanliness. Hygienic Hospital environment Staff shortage. Recruitment of staff as per workload through RKS. Lack of trained health care staffs Staff trained and its on ongoing No concept of internal audit Staff trained as internal auditors, audits conducted to find out non conformances, corrective & preventive measures taken to rectify it No Management meeting9 & Meeting with clinicians conducted Regular Management meeting & clinical meetings conducted which facilitates the important decisions affecting the quality of care, hence achieving the total quality management. Cont….

Comparison of Past and Present Scenario Inadequate infrastructure for handling biomedical waste and infection control safety practices All required practices in place Damaged and poor condition of building Repairing & renovation done No Calibration system of Instruments for Quality check & Regular AMC Calibration system of Instruments for Quality check are available. Shortage of equipments and proper ambulances . Sufficient equipments and ambulances. Lack of accountability & planning. Policy and processes for care of the patients in place Absence of quality standards. Quality standards e.g. medical audit, management of medication, care of patients etc practiced No participation in EQAS/ inter laboratory comparisons Participation in EQAS / inter laboratory comparison and achieving good scores in it. No feedbacks from patients & clinicians Feedback of patients & clinician is used to monitor the continual improvement2 Cont….

Comparison of Past and Present Scenario Poor signage system. Well developed signage and displays for patient information Only some Major Equipments covered under AMC AMC for all sophisticated equipments is done with their respective companies& others are maintained by biomedical workshop CHA Absence of Patient & Employees’ satisfaction. Established No measurable parameter for patient safety. Measurable parameters for patient safety are available. No realization of problems and weaknesses A clear understanding of what is lacking and what needs to be done No monitoring or reporting of adverse events, needle stick injury, Sentinel events etc. These are being reported and are monitored. Practically non-existent security arrangement Availability of well trained security guards Non Implementation of Different Codes in the facilities. RED for FIRE, YELLOW for EXTERNAL CALAMITIES, BLUE for CARDIAC ARREST, BLACK for BOMB THREAT, PINK for CHILD ABDUCTION

Sample rejection-2010-2012 Microbiology Dept- Ahmedabad

Turn Around Time Outliers-2010-2012 Microbiology Dept- Ahmedabad

Sir T Bhavnagar Laboratory (Total No. of Lab Investigations)

B J Medical College Laboratory Ahmedabad (Total No B J Medical College Laboratory Ahmedabad (Total No. of Lab Investigations)

Govt. Medical Laboratory Surat (Total No. of Lab Investigations)

SSG Medical College Laboratory Vadodara (Total No SSG Medical College Laboratory Vadodara (Total No. of Lab Investigations)

Quality Improvement Programme:- Gujarat (NABL) Bhavnagar

Quality Improvement Programme:- Gujarat (NABL) Bhavnagar

Quality Improvement Programme:- Gujarat (NABL) Bhavnagar

Quality Improvement Programme:- Gujarat (NABL) Bhavnagar

Quality Improvement Programme:- Gujarat (NABL) Bhavnagar

Quality Improvement Programme:- Gujarat (NABL) Bhavnagar

Quality Improvement Programme:- Gujarat A Success Story Quality Improvement Programme:- Gujarat S. N. Name of the Facility Total Facility Under NABH /NABL Total Accredited facilities Final Assessment done Pre Assessment done Facilities under Process for NABH/ NABL 1 District Hospitals 23 2 3 4 14 Medical college Hospitals 6 Medical college, Blood banks 5 Medical college, Laboratories Mental Hospitals Dental Hospitals 7 Paraplegia Hospital, Ahmedabad 8 Primary Health Centers (PHCs) 29 12 17 9 Community Health Centers (CHCs) 26 25 10 NABL Food & Drug Laboratories Total 103 28 66

Award received by Government of Gujarat for Quality Improvement Appreciation awarded by QCI to Ministry of Health and Family Welfare Government of Gujarat for establishing Quality Assurance framework in providing quality healthcare to the people of Gujarat in 5th National Quality Conclave, New Delhi. Appreciation awarded to Department of Health and Family Welfare Government of Gujarat for their pioneering effort to spearhead the Quality and Accreditation Programme in health care organization. In 3rd International Health Care Quality Conclave FICCI Health care Excellence Award to Dist Hospital Gandhinagar & PHC Gadboriad, Govt of Gujarat in FICCI Heal 2010, New Delhi Date: 6th Sept 2010 FICCI Health care Excellence Award to Dist Hospital Gandhinagar, Govt of Gujarat in FICCI Heal 2011, New Delhi Date: 8th Sept 2011

Strategies Adopted for sustainability & Capacity building: Appointment of Quality Assurance officers at State level, District level, Assistant Hospital Administrator (AHA) at facility level. We are designated NABH Coordinators & NABL Directors at Facility level. NABH lead assessor training (Total 290) & NABL Internal audit training (Total 238). Quality Improvement Programme (NABH, BMW, Kaizen, HOPE, fire & Non fire emergency, Radiation Safety, Cleanliness) Training (Total 114). Post Graduation Certificate Course in Quality Management and Accreditation of Health care Organization (PGQM & AHO) to (Total trained persons194) . Training regarding Various Codes like code blue, red, orange, pink; disaster management training (Fire & Non Fire emergencies), sentinel events, Bio Medical Waste Management, Infection control practices, new born care training end of life care. New posts of clinicians, paramedical and other are sanction by Government of Gujarat as per requirement. Extra budgets from 13th finance commission, Government of Gujarat and NRHM. Formation of the state level review committee under the Chairmanship of Commissioner of Health, Medical Service & Medical Education and Member secretary is State Quality Assurance Officer.

Road Ahead To create a Quality culture based on various standards which is sustainable, affordable, equitable & reliable having state of art technology and which can be easy to follow and replicate.

The woods are lovely dark and deep And we have promises to keep Quality Improvement Programme:- Gujarat The woods are lovely dark and deep And we have promises to keep And miles to go before we sleep….. And miles to go before we sleep…..

www.gujhealth.gov.in Quality Improvement Programme Email:- drjlmeena@gmail.com Mobile No:- 09099075162