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

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

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

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

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

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

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

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

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.

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

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

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

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

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 (143-165 pts) 1 Lab 2 Stars (166-191 pts) 3 Stars (192-217 pts) 4 Stars (218-243 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

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 (143-165 pts) 1 Lab 2 Stars (166-191 pts) 3 Stars (192-217 pts) 4 Stars (218-243 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

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% - 39.09% 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

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

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

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

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

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

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

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

Activity Divide into 4 groups & each group will: review their Assessment Reports Present a 10 - 15 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

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