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.