1 summary of assessment reports and gap analysis module 3 1

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Summary of Assessment Reports and Gap Analysis

Module 3

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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

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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

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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

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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

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

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Gap Analysis Includes:

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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)

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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

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• 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.

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Assessment Scoring

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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

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Profile of Laboratory

Contains information:Name of AssessorsName of Head of LabPhysical address of laboratoryLaboratory level and affiliationSummary of staff qualificationsDays / hours of laboratory serviceReferral networkAvailable lab tests

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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

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Summary of assessment and recommendations

• Summary• Challenges noted• Recommendations by assessors• Action Plan (if needed)• Sources consulted

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Cohort I Baseline Assessment # 1

Performed in August 2011 at all 12 labs

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Ratings/ Stars: # Labs Earning Stars

Range of Points Earned

0 Stars (1-142 pts) 5 Labs points

1 Star (143-165 pts) 1 Lab points


3 Stars (192-217 pts) 1 Lab points


5 Stars (244 – 258 pts) 0 Labs points

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Cohort I Baseline Assessment # 2

Performed in (Insert date range) at all labsAugust 2011 at all 12 labs

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Ratings/ Stars: # Labs Earning Stars

Range of Points Earned


1 Star (143-165 pts) 1 Lab points


3 Stars (192-217 pts) 1 Lab points


5 Stars (244 – 258 pts) 0 Labs points

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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%

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General Strengths of Labs

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• 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

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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

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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

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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.

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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

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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 andresponsible persons are established and can beused to document progress • Can evolve into an Improvement Plan when the GAP involves improvement

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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

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1001

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Baseline June 2010

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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

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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

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