1. Summary of Assessment Reports and Gap Analysis
Module 3
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

2. Objectives After this presentation, you will be able to:
Define Gap Analysis
Discuss the organization of the ISO 15189:2012 standards, the sections and information contained in each
Discuss the importance of reviewing a Gap Analysis Report
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

3. Objectives After this presentation, you will be able to:
Interpret your own Lab’s Gap Analysis report
Implement Improvement Projects and International Best Laboratory Practices into their daily laboratory activities based on the Gap Analysis Report
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

4. Gap Analysis
A technique for determining the steps to be taken in moving from a current state to a desired future-state. Also called need-gap analysis, needs analysis, and needs assessment
Begins by asking yourself two basic questions:
Where are you now?
Where do you want to be?
You need to be as detailed as possible so it is easier to develop realistic plans of action
Study your current situation and determine how you are presently performing. Afterward, write down your desired outcome or goal. Doing so will give you a clear view of how far you actually are from your objectives.
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

5. Gap Analysis Includes:
(1) A listing of characteristic factors (attributes, competencies, performance levels) of the present situation (“what is”)
* ISO 15189:2012 Standards document
(2) A cross listing of factors required to achieve the future objectives ("what should be“)
* ISO 15189:2012 Standards document

6. Gap Analysis Includes:
(3)Highlighting gaps that exist and need to be filled * Reviewing the Standards and implementing Improvement Projects to fill identified gaps

7. Cohort I Assessments
X number of laboratories invited to form Cohort (x) in country xxx
x Regional Laboratories
x District Laboratories
Baseline Assessments – (Insert date of assessment)
Post –Assessments – (Insert date of assessment)
This slide will need to be tailored to the country and group attending the workshop- the information is left here as an example
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

8. Why Ukraine Chose ISO 15189:2012
Accreditation gives formal recognition that Laboratory services meet ISO 15189:2012 requirements for quality management and quality in medical laboratories and personnel
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

9. Assessment Scoring
NOTE: items that include “tick lists” must receive all “yes” and/or “n/a” responses to be marked “yes” for the overarching item.
Items marked “partial” receive 1 point.
Items marked “no” receive 0 points.
When marking “partial” or “no”, notes should be written in the comments field explaining why the laboratory did not fulfill this item. Comments assist the laboratory with addressing these areas of identified need following the assessment.

10. Worksheet to determine and record current Laboratory performance
Records laboratory performance over previous 12 months
This part measures how well the lab has (or has not) met criteria 1-3
Criteria 1: Are internal quality control procedures routinely conducted for all test methods?
2.1 Monitoring of control values
2.2 Monitoring with internal standards
2.3 Monitoring quality of each new batch of kits
2.4 Documentation of internal controls and kits validation
Criteria 2: Has the laboratory achieved acceptable PT results of at least 80% on the two most recent PT challenges?
Criteria for (5 star certification and accreditation of international standards
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

11. Profile of Laboratory Contains information: Name of Assessors
Name of Head of Lab
Physical address of laboratory
Laboratory level and affiliation
Summary of staff qualifications
Days / hours of laboratory service
Referral network
Available lab tests
Lab floorplan
Organizational structure
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

12. Assessment checklist for evaluation of laboratory operations procedures
Laboratory assessments are an effective means to determine whether a laboratory is providing accurate and reliable results and is well-managed and adhering to good laboratory practices.
Begins on page 7
Includes all 12 sections and an assessment scoring summary page
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

13. Summary of assessment and recommendations
Challenges noted
Recommendations by assessors
Action Plan (if needed)
Sources consulted

14. Cohort I Baseline Assessment # 1
Performed in August 2011 at all 12 labs
Ratings/ Stars:
# Labs Earning Stars
Range of Points Earned
0 Stars (1-142 pts)
5 Labs
points
1 Star ( pts)
1 Lab
2 Stars ( pts)
3 Stars ( pts)
4 Stars ( pts)
0 Labs
5 Stars (244 – 258 pts)
This slide needs to be updated for the country and the labs within the country going through SLMTA (or some other process of earning international accreditation). These numbers are an example only – the information would come from the assessment reports
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

15. Cohort I Baseline Assessment # 2
Performed in (Insert date range) at all labs August 2011 at all 12 labs
Ratings/ Stars:
# Labs Earning Stars
Range of Points Earned
0 Stars (1-142 pts)
5 Labs
points
1 Star ( pts)
1 Lab
2 Stars ( pts)
3 Stars ( pts)
4 Stars ( pts)
0 Labs
5 Stars (244 – 258 pts)
This slide needs to be updated for the country and the labs within the country going through SLMTA (or some other process of earning international accreditation). These numbers are an example only – the information would come from the assessment reports
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

16. Comparison of Assessment Results
Average points score increased from Baseline to 2nd Assessment by 4.61%
6 labs improved their scores
Improvements ranged from 1.68% %
6 labs decreased their scores
Decreases ranged from (-)0.60% -(-)19.08%
This slide will need to be updated with the country-specific comparison data
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

17. General Strengths of Labs
Section 12: Facilities and Safety
All labs scored between 49% - 77%
Section 3: Organization and Personnel
All labs scored 55% or higher
Available Qualified Lab Personnel
Good Managerial coordination between Ministry of Health, Regional and District Hospital Laboratories
Awareness of Laboratory professionals on Quality Management system
This slide will need to be updated for the country this workshop is presented in.
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

18. General Challenges Faced by Labs
Quality Manuals are still in draft as seen during assessments in some labs
Lack of enough knowledge and skills in purchasing and inventory management
Incompleteness of Laboratory request forms and log books
Lack of commitment in implementation of Quality Management System to some laboratory staff
Inconsistence of Laboratory supplies and reagents
No Service contracts for all Laboratory equipment
Update information on this slide based on the assessment reports
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

19. General Recommendations
Advocate commitment of all laboratory staff and practice professionalism
Maintain number of qualified Laboratory personnel in line with MOHSW recommendation and provide motivation
Train all staff and equip them with knowledge and skill on Laboratory Management System(On job training to be imposed)
Documentation of all incidences/occurrence and action taken need to be enforced
Update information on this slide based on the assessment reports
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

20. General Recommendations
Advocate proper use and filling of Laboratory request forms and different logs
Ensure constant laboratory supplies and reagents to avoid interruption of service due to stock out.
Facilitation of provisional of all Laboratory equipment service contracts and adherence to PPM schedules as per manufacturer’s instructions
Conduct regular assessments to draw attention and recognition of staff implementing Quality Management System in their day to day activities.
Update information on this slide based on the assessment reports
The main challenge ahead these Laboratories is not being able to integrate Quality Management into an everyday’s activities and lack of commitment. This includes importance of sensitizing Laboratory staff to understand their roles in the Implementation of Laboratory Quality Management System.
The goal of Quality Management Systems is to deliver service for better care to patients: Laboratories need to implement Quality Management Systems at large and make it the way of daily practice
With continued top Management support, Close supervision, Mentoring and Regular Assessments Laboratories can address the gaps identified in assessments; it is possible for visible and measurable progressive changes and hence increase acceleration towards accreditation.
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

21. Back to Gap Analysis
Why is a Gap Analysis Report useful to you and your lab?
Gives you an objective evaluation of your lab’s ability to provide accurate and reliable test results
How can you use the information in the report?
The information is baseline level ability to provide accurate & reliable results, and from this point you can develop a Plan of Action or Improvement Project to increase the lab’s ability to meet this goal
What is the best way to share the information with your staff?
At a staff meeting
At a general interdepartmental or administration meeting
Designate a bulletin board to showcase your labs successes and improvements
to build and continue staff motivation
to showcase your lab’s professionalism and impact on patient healthcare
Recognize staff for following Best Lab Practices on a daily basis
with verbal recognition, written thank you, or sticker
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation

22. GAP ANALYSIS: Shows areas of compliance MINUS areas of non-compliance
Is a TOOL that assists in project management
Is a road map to follow when making improvements
Can evolve into an Action Plan when timelines and
responsible persons are established and can be
used to document progress
Can evolve into an Improvement Plan when the GAP involves improvement

23. Spider Graph Visual of GAP Analysis
Sections
1 - Documents and Records
2 - Management Reviews
3 - Organization and Personnel
4 - Client Management and Customer Service
5 - Laboratory Equipments
6 - Internal Audits
7 - Purchasing and Inventory
8 – Information Management
9 - Process Control and Internal / External Quality Assessment
10 - Corrective Action
11 - Occurrence / Incident Management and Process Improvement
12 - Facilities and Safety

24. Activity Divide into 4 groups & each group will:
review their Assessment Reports
Present a minute summary of their lab’s strengths, challenges, and recommendations to the large group (can be a general small group summary)
Each lab must write their own Gap Analysis to present at workshop and use as basis for their Plan of Action or Improvement Project

25. Summary After this presentation participants can now:
Define Gap Analysis
Discuss the organization of the ISO 15189:2012 Standards document, the sections and information
Discuss the importance of reviewing a Gap Analysis Report
Interpret their own Lab’s Gap Analysis report
Implement Improvement Projects and International Best Laboratory Practices into their daily laboratory activities based on the Gap Analysis Report
Module 4: Demonstrations, Practicals and Clinical Teaching, and Performance Evaluation