Quality assessment

Revision as of 12:10, 11 January 2013

<a href="/index.php?title=RiliB%C3%84K%20zu%20Ejakulatuntersuchungen">Click here</a> to read the German version of "RiliBÄK".

Quality assessment settings

Before using Quality assessment, check the basic parameters in the <a href="/index.php?title=MedITEX_IVF_Settings#Semen_analysis">settings</a> of MedITEX IVF.

You can access the settings from the menu System -> Configuration / administration -> Settings on the top of the window.
Go to System -> Functions -> Semen analysis and check "Activate / deactivate Quality assessment".

As number of differentiating cells for motility and morphology by default 200 sperm are set. This number is the minimum value that is to be counted according to the directive per sperm count.

Also the specification of the workplace, the examination and the method should be entered here. The data will be automatically transferred to your Quality assessment entry screen.

The dilution or enrichment of the ejaculate and / or the number of the counting fields must be selected in accordance with an orienting preliminary examination. If the sperm concentration is less than 1-2 sperm per high power field (objective magnification 40-fold), the sample should be enriched. Finds then less than 200 sperm per counting grid of the counting chamber, eliminates the requirement of at least 2 x 200 to be counted spermatozoa.

These settings will be loaded on every Quality assessment calculation as default values and can be edited in addition, depending on the special case.

Using Quality assessment

The Quality assessment functionality is used when conducting a Semen analysis. From a male patient window, select Lab. diagnosis. From the new window, click on New sample and choose Semen analysis.

Examinations can be conducted either manually or automatically (CASA = Sperm class analyzer).

The examination of sperms in a counting chamber is separated according to

Concentration (number),
Morphology (normal or abnormal percentage)
Motility (movement in 3 stages: progressive movement, locally movable immotile percentage)

These are performed in duplicate determinations then evaluated and documented.

If you check the box Use quality assessment, the Concentration, Motility and Morphology fields will not be able to be entered on this window. This method requires a new way for the calculation.

Switch to the Quality assessment tab to input the data.

The examinations are independent and may change according to the parameters. They can also be evaluated separately.

Examining the concentration

Switch to the tab Quality assessment -> Sperm counts.

In order to calculate the concentration, folow these steps:

Fill the counting chamber with the sample;
The two halves of counting chambers are examined separately. Each one accounts for a separate analysis: number 1 and number 2.

Concentration: 1st counting chamber, 2nd counting chamber
Concentration calculator

Exemaning the motility and morphology

When using quality assessment, at least 400 sperms need to be counted. 200 from the first chamber and another 200 for the second. If the number of sperms are less than 200, the counting may proceed with a smaller quantity.

Motility

The examination carried on the sperm, identifies its motility: progressive motile, locally motile and immotile .

Note: for Germany, the values of WHO A and WHO B must be calculated separately according to the DIR regulations!

In order to make this process faster, MedITEX IVF offers the WHO sperm calculator and the Motility counter.

To learn more about the Motility counter, click <a href="/index.php?title=Motility_counter">here</a>.

Morphology

The examination of sperm morphology is to be carried out for both analysis.

Documentation

The content of the documentation provided (excerpt):

...
Workplace /Examination
Sample material
Unit / method (counting chamber, coloring)
...
Examiner
...

Result

For each duplicate determination the evaluation of results have to be made immediately after the completion of investigations.

Please open the second tab "Result", which is located right next to the tab "Sperm counts".

Result of the sperm concentration

Parameters: number of sperm in the two count chambers of the duplicate determination.

N1 = number, 1. Counting
N2 = number, 2. Counting

AVG = average = (N1 + N2):2
d = difference (absolut) = |N1 - N2|

If the difference is greater than the formula value,
the release can not be effected. The count have to carried out again.

Result of the sperm motility

Each type of sperm (WHO AB, C WHO, WHO D) has to be evaluated.
Parameters: percentage P1 and P2 of one type, first and second counting.

N = number of different sperms
P1 = percentage of the first count
P2 = percentage of the second count
AVG = average = (N1 + N2):2
d = difference (absolute) = |N1 - N2|

Assessment: d ≤ 1,96 * sqrt( 2 * MW * (100-MW) : N )

If the difference is greater than the formula value,
the release can not be effected. The count have to carried out again.

Result of the motility

Parameters: percentage P1 and P2 of the normal sperm.

N = number of differnent sperms
P1 = percentage of the first count
P2 = percentage of the second count
AVG = average = (N1 + N2):2
d = difference (absolut) = |N1 - N2|

Assessment: d ≤ 1,96 * sqrt( 2 * MW * (100-MW) : N )

If the difference is greater than the formula value,
the release can not be effected. The count have to carried out again.

Semen analysis quality assessment

Exist more than 50 shared value pairs, after a control period (= 1 calendar month), or - if this number is not reached - when 50 pairs be achieved, a long-term validation by calculating and evaluating the mean (including standard deviation) have to be made of the duplicate determinations.

To do this, click Reports -> Semen analysis quality assessment

Long-term validation preparation

All results of the internal quality assurance are documented separately by parameter and workplace.

First Step: Select parameter and workplace

Parameters:

concentration
motility WHO AB
motility WHO C
motility WHO D
morphology

It can be displayed only a single quantity!

All results of internal quality assessment have to be documented separately by parameter and workplace.

Second Step: evaluation of all duplicate determinations

per parameter
per workplace

All results of internal quality assessment have to be documented separately by parameter and workplace.

Third Step: flowing assessment/ current assessment

     n = number of pairs of values (immediately reviews)
     d = difference of the value pairs
     MWd = mean deviation = 1: n * Sum (d)
     Sd = standard deviation of the difference = sqrt (1: (n-1) * Sum ([d MWd] 2))

Assessment: MWd ≤ 1.96 * sd: sqrt (n)

Fourth Step: control period / 50 value pairs

After reaching the 50 value pair or the control period, an information window remind you of the long-term assessment.

All results of internal quality assessment have to be documented separately by parameter and workplace.

Fifth Step: Long-term validation (for the period evaluated single results)

The long-term validation is to be performed individually for each parameter!

Is the mean value of the difference greater than the formula value, may no results be issued, until the cause is cleared and removed. The process must be documented. The fields cause, corrective action, eliminated and person (correction) need to be completed. Is this not the case, "information messages" remember on it.

In the upper half of the window you see per line the results of the long-term validation of one parameter or a workplace.

Below there is a list of the single duplicate determinations. The associated semen analysis can be viewed by "double-click" or "right-click".

<a href="/index.php?title=MedITEX_IVF_manual">Back to the MedITEX IVF menu </a>

@@ Line 70: / Line 70: @@
 <ol>
 <li>Fill the counting chamber with the sample;</li>
-<li>The two halves of counting chambers are examined separately. <strong>Each counting chamber is one of the duplicate determinations!</strong></li>
+<li>The two halves of counting chambers are examined separately. Each one accounts for a separate analysis: <strong>number 1 </strong>and <strong>number 2.</strong></li>
 </ol>
 <table style="margin-left: auto; margin-right: auto;" border="0" width="525" height="496">
@@ Line 80: / Line 80: @@
 <td>
 <ul>
-<li>Concentration: 1. counting chamber, 2. counting chamber</li>
+<li>Concentration: 1st counting chamber, 2nd counting chamber</li>
 <li>Concentration calculator</li>
 </ul>
@@ Line 88: / Line 88: @@
 </table>
 <p>&nbsp;</p>
-<h2>Execution - investigation motility &amp; morphology</h2>
+<h2>Exemaning the motility and morphology</h2>
-<p>In the <strong>duplicate determinations</strong> at least <strong>2x200 sperm</strong> have to be evaluated. If the number of sperm less than 200/visual field <strong>after enrichment</strong>, the requirement is not relevant and a <strong>smaller number</strong> has to be evaluated.</p>
+<p>When using quality assessment, at least <strong>400 </strong>sperms need to be counted. 200 from the <strong>first </strong>chamber and another 200 for the <strong>second</strong>. If the number of sperms are less than 200, the counting may proceed with a <strong>smaller </strong>quantity.</p>
 <table style="margin-left: auto; margin-right: auto;" border="0">
 <tbody>
@@ Line 98: / Line 98: @@
 </table>
 <p>&nbsp;</p>
-<h3>Investigation motility</h3>
+<h3>Motility</h3>
-<p>The <strong>examination </strong>of the sperm is to perform with <strong>motility </strong>(movement in 3 stages:<strong> progressive movement</strong>, <strong>locally movable</strong> and <strong>immotile </strong>in percent) in <strong>duplicate determinations</strong>.</p>
+<p>The <strong>examination </strong>carried on the sperm, identifies its <strong>motility</strong>: <strong>progressive motile</strong>, <strong>locally motile</strong> and <strong>immotile</strong><strong>&nbsp;</strong>.</p>
 <table style="margin-left: auto; margin-right: auto;" border="0">
 <tbody>
@@ Line 108: / Line 108: @@
 </table>
 <p>&nbsp;</p>
-<p>In Germany entering the values of WHO A and WHO B must be separated because DIR interface!</p>
+<p><em>Note: for <strong>Germany</strong>, the values of <strong>WHO A</strong> and <strong>WHO B</strong> must be calculated separately according to the <strong>DIR</strong> regulations!</em></p>
 <table style="margin-left: auto; margin-right: auto;" border="0">
 <tbody>
 <tr>
-<td>[[Image:Mo5.png|none|740px|thumb|left|link=http://wiki.meditex-software.com/images/Mo5.png| ]]</td>
+<td><img src="/images/Mo5.png" alt="" width="740" height="508" /></td>
 </tr>
 </tbody>
 </table>
 <p>&nbsp;</p>
-<p>There is a "<strong>WHO sperm calculator</strong>", that converts the numbers in percent. New is the "<strong>Motility counter</strong>"  that counts the respective sperm about the keyboard, or via an external  number pad touch screen monitor. (freely configurable).</p>
+<p>In order to make this process faster, MedITEX IVF offers the <strong>WHO sperm calculator</strong> and the <strong>Motility counter</strong>.</p>
-<p><span id="result_box" lang="en"><span class="hps">To</span> <span class="hps">learn more about</span> <span class="hps">the</span> <span class="hps atn">"Motility counter</span><span>"</span><span>, click <a href="/index.php?title=Motility_counter">here</a></span><span>.</span></span></p>
+<p><span id="result_box" lang="en"><span class="hps">To</span> <span class="hps">learn more about</span> <span class="hps">the</span>&nbsp;<span class="hps atn"><strong>Motility counter</strong></span><span></span><span>, click <a href="/index.php?title=Motility_counter">here</a></span><span>.</span></span></p>
 <p><span lang="en"><span><br /></span></span></p>
-<h3>Investigation morphology</h3>
+<h3>Morphology</h3>
+<p>The <strong>examination </strong>of sperm <strong>morphology </strong>is to be carried out for<strong> both analysis</strong>.</p>
 <table style="margin-left: auto; margin-right: auto;" border="0">
 <tbody>
 <tr>
 <td><img src="/images/QM11.png" alt="" width="558" height="442" /></td>
-</tr>
-<tr>
-<td>
-<p>Morphology (normal forms)</p>
-<ul>
-<li>1. Counting</li>
-<li>2. Counting</li>
-</ul>
-</td>
 </tr>
 </tbody>
 </table>
-<p>&nbsp;</p>
-<p>The <strong>investigation </strong>of sperm <strong>morphology </strong>is to be carried out (normal in percent) in a <strong>duplicate determination</strong>.</p>
 <p>&nbsp;</p>
 <h2>Documentation</h2>

Quality assessment

From MedITEX - Wiki

Revision as of 12:10, 11 January 2013

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