Control Phase

Following the move to Biochemistry or test names were renamed TMA became Anti TPO and TGA became Anti Tg.

Review Levey Jennings Graphs:

The graphs below represent the Internal Quality Control of Anti Tg  and Anti TPO using the automated system, before patient samples are analysed, these graphs are checked any points that break the rules of Control Charts are investigated and remedied.

Graph 1: Internal QC ( Anti- Tg)

Graph 2: Internal QC ( Anti- TPO)

FMEA Review:

At our most recent meeting, the team not only discussed Quality Control measures of the new process but we also agreed on an FMEA for the Automated Anti- Tg and Anti-TPO process.The team were generally impressed with the  RPN figures which  were significantly decreased. The number of Process Step Input Variables where also greatly reduced.

Histology Test Numbers:

Even though it is early days Anti Nuclear Antibodies (ANA's) test numbers have decreased by approximately 25%, this is primarily as a result of ANA's not being processed as an "Add on" test to Thyroid Antibody request as was previously the case before this Six Sigma project was started.


TAT's Anti Tg and Anti TPO

There is very little systematic research done on TAT's for specialised laboratory test such as Thyroid Antibodies. Data does exist for routine laboratory tests which I have supplied a link to:- (TAT's) The pathology User Manual for Anti Tg and Anti TPO specifies a TAT of 2 days. The following graphs shows a 75% and an 83% compliance to this for Anti Tg and Anti TPO respectively.

Lessons Learned:

Summary
The image above summaries our final meeting on "Lessons Learned". This has been a very successful Six Sigma project with all parties of our cross functional team delighted with the results. This project has achieved its measurable goals with cost savings exceeding €30,000 annually.

Improve Phase

 Gannt Chart

Our team met in early August to plan and organise the Change of Control from Histology to Biochemistry of the Thyroid Antibodies. We designed a schedule for implementation of our new process using a Gannt Chart. This chart clearly defines the remaining timescale of our project.

Process Map 


Review of the new improved Process map demonstrates a considerable reduction in  manual input, thus reducing process variability.

 

Validation 

Test method validation is a critical part of any test method change, we are required to meet the requirements of ISO 15189. Samples were supplied by External Quality Assurance - RIQAS (www.riqas.com). Accuracy, within and between run precision were calculated. A-TPO is to replace TMA. Accuracy was established against samples with specific target values from RIQAS. Regression analysis was performed and r=0.998486 for Anti -TPO

Regression analysis performed on Anti-TG which will replace TGA in Histology was r= 0.995474

 Precision analysis is also detailed below.

This project remains on schedule and is projected to produce significant cost savings within the laboratory with minimal disruption to staff or customers.

Analyse Phase

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Analysing Sources of Variation

During this phase of our project our team met to discuss the various sources of variation associated with our current process. The cause and effect diagram below demonstrates these.

We also decided that an FMEA chart would be useful to help pin point  high risk elements of our current process to make sure whatever process improvements we may implement at a later date will be sufficient.

We found the FMEA extremely useful as most "Potential Causes" were as a result of human error, therefore implementation of an automated system should correct most of these variables.

The following Control chart represents further analysis of data collected in the Measure Phase illustrating the number of Thyroid Antibody samples processed daily in Histology. This number of samples should be easily incorporated into such an automated laboratory as Biochemistry. This figure may even be overestimated as the point on the graph on Day 2 is outside 2SD so this needs to be investigated.

Critical to Schedule (CTS) factors or Turn around Times (TAT) from receipt of specimen to authorisation are a vital aspect of this project. At present our user manual states that our TAT for these tests is 2 days. The following Histogram illustrates recent TAT's recorded. This demonstrates excellent compliance of TAT's.

 Analyse Phase Summary

Through Brainstorming sessions and FMEA, we can conclude that much of our possible sources of variation are directly related to the fact that the current method is so "manual" resulting in many opportunities for human error. An move to an automated platform in the remaining phases of this project should correct this. Daily sample numbers are encouraging, these sample numbers should easily be incorporated into the current Biochemistry workload.

The project in on schedule and the team are looking forward to the Improve Stage next week.

Measure Phase

Data Collection:

Our team met to decide on what relevant data we needed to collect and how it needed to be collected.We found brainstorming to be a very useful tool for this. It allowed us to  extensively examine all the area's of this project where cost saving and efficiencies could be achieved. We agreed that the following data types were required.

• Current Processing time within the Histology department where Medical Scientists could fill in the following quick time sheet.

 

 This will allow us to not only estimate a baseline processing time but also very importantly help us estimate a baseline cost of a Medical Scientist processing the current manual method. We asked Medical Scientists if they would be willing to fill in this time sheet and they were very agreeable, as if would not take much time to complete daily. To date the following chart represents current processing times.

                                                                                                                              

• Reduction in Antinuclear Antibody (ANA) Test on completion of project .      

Historically within the Histology Department  ANA's are performed on every Thyroid Antibody request. Following discussion with Head of the Histology Department, it appears that this is unnecessary and was only originally done to make the requesting of tests easier for worksheets. The following Pie Chart estimates that if 15% of the total number of requests from clinicians that is covered in the scope of project relates to Anti Thyroid Antibodies then, therefore there will be 15% ANA's performed annually.

This Pie chart also shows the percentage of Auto immune Antibody screens requested. Currently this screen includes Thyroid Antibodies also but it is proposed this will no longer be the case and that Thyroid Antibodies will have to be specifically requested following the move to Biochemistry.

• Data Base Query was set up with the help of  IT to cross link patient that would have had one serum tube sent to Biochemistry for routine tests and one sent to Histology for Thyroid Antibodies. This Data Base Query is to be fed into excel and analysed. So far this process is  proving  to be time consuming.

Our Project is on schedule  and we are very hopeful that we can make significant savings for the Pathology department.

Define Phase

Introduction

My name is Carmel Erett. I work as a Medical Scientist in a large hospital Pathology Department. I am currently undertaking a Six Sigma Project as part of a Six Sigma Green Belt Certificate at Sligo Institute of Technology. This blog will be divided in to five individual sections of DMAIC (Figure1 with the first blog dealing with the Define Phase.

Figure1- http://icpartnership.com/sixsigma.html

Background

This project is based in a Pathology Department of a large hospital. There is an ongoing drive to improve efficiencies within the department. The Pathology Department is divided into five individual departments (laboratories), Biochemistry, Blood Transfusion, Haematology, Histology and Microbiology, each analysing different patient tests.

Project Charter

A project charter has been developed which has been very helpful to our team in defining our problem statement and refining our scope which is critical when there are two separate departments involved.

Project Description

Currently the differential diagnosis of thyroid diseases as described in Figure 2 is segregated into two departments.  Thyroid Stimulating Hormone (TSH) and Free Triiodothyronine (fT3) and Free Thyroxine (f T4) are analysed in Biochemistry and antibodies against thyroglobulin ( Anti-Tg) and thyroid peroxidase (Anti- TPO) [Thyroid Microsomal Antibody] are tested in the Histology department using a completely manual, labour intensive method with potential for significant variation in the process, processing time and process output (Figure 3).Designing the Define Phase Top level Process Definition helped highlight to all involved how manual our current process is.

 In 2011 the Biochemistry department installed an automated new generation analyser not only with the capability to analyse the then extensive Biochemistry test workload but with the additional capacity to encompass additional tests from other departments within pathology if deemed cost effective.

Figure 2: Supplied by Roche Diagnostics Limited

To date we have established that these tests (Anti-TPO and Anti Tg) are available on the Biochemistry analyser.


Scope

To evaluate and examine the inefficiencies of the current manual testing method for these antibody tests against the efficiencies that can be gained using an automated system. In addition to this the requesting protocol of these tests will be examined. Current protocol in Histology is to perform an additional test Anti Nuclear Antibodies that may not be required as part of a Thyroid disease work up. Thyroid Antibodies are also performed as part of a general Autoimmune screen in Histology and this protocol will be examined.

Figure 3: Define Stage Top Level Process Definition.

Metrics

These metrics are a moderate estimate and our team would expect savings to be greater than the estimation below when the review of Histology Test Requesting procedure is thoroughly examined.

To date we are on schedule and we hope to have this project completed by the end of August 2013, our team are working well together and communication is good between all the departments which should ensure a smooth transition into the Measure phase of this project.