1. 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 -

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

3. 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.

4. 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.)

5. 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….

6. 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

7. 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….

8. 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….

9. 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….

10. 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….

11. 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….

12. 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

13. 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

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

15. 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

16. 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)

17. 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

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

19. 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….

20. 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….

21. 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

22. Sample rejection-2010-2012 Microbiology Dept- Ahmedabad

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

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

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

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

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

28. Quality Improvement Programme:- Gujarat (NABL) Bhavnagar

29. Quality Improvement Programme:- Gujarat (NABL) Bhavnagar

30. Quality Improvement Programme:- Gujarat (NABL) Bhavnagar

31. Quality Improvement Programme:- Gujarat (NABL) Bhavnagar

32. Quality Improvement Programme:- Gujarat (NABL) Bhavnagar

33. Quality Improvement Programme:- Gujarat (NABL) Bhavnagar

34. 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

35. 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

36. 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.

37. 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.

38. 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…..

39. Quality Improvement Programme - Mobile No: