Quality assessment

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<ul>
 
<ul>
 
<li>N = number of differnent sperms</li>
 
<li>N = number of differnent sperms</li>
−
<li>P1 = <span id="result_box" class="short_text" lang="en"><span class="hps">Percentage of the</span> <span class="hps">first</span> <span class="hps">count</span></span></li>
+
<li>P1 = <span id="result_box" class="short_text" lang="en"><span class="hps">percentage of the</span> <span class="hps">first</span> <span class="hps">count</span></span></li>
−
<li>P2 = <span id="result_box" class="short_text" lang="en"><span class="hps">Percentage of the</span> second <span class="hps">count</span></span></li>
+
<li>P2 = <span id="result_box" class="short_text" lang="en"><span class="hps">percentage of the</span> second <span class="hps">count</span></span></li>
 
<li>AVG = average = (N1 + N2):2</li>
 
<li>AVG = average = (N1 + N2):2</li>
 
<li>d = difference (absolut) = |N1 - N2|</li>
 
<li>d = difference (absolut) = |N1 - N2|</li>
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<p><strong><span style="text-decoration: underline;">Assessment</span>: d &le; 1,96 * sqrt( 2 * MW * (100-MW) : N )</strong></p>
 
<p><strong><span style="text-decoration: underline;">Assessment</span>: d &le; 1,96 * sqrt( 2 * MW * (100-MW) : N )</strong></p>
 
</td>
 
</td>
 +
</tr>
 +
<tr>
 +
<td><img style="display: block; margin-left: auto; margin-right: auto;" src="/images/Q15.png" alt="" width="119" height="88" /></td>
 +
<td>If the difference is greater than the formula value,<br />the release can not be effected. The count have to carried out again.</td>
 +
</tr>
 +
</tbody>
 +
</table>
 +
<h3>Result of the motility</h3>
 +
<div id="gt-res-content" class="almost_half_cell">
 +
<div style="zoom: 1;" dir="ltr"><span id="result_box" lang="en"><strong><span class="hps">Parameters:</span> <span class="hps">percentage</span> </strong><span class="hps">P1 and P2</span> <span class="hps">of the normal</span> <span class="hps">sperm.</span></span></div>
 +
</div>
 +
<table border="0">
 +
<tbody>
 +
<tr>
 +
<td colspan="2">[[Image:QM17.png|none|740px|thumb|left|link=http://wiki.meditex-software.com/images/QM17.png| ]]</td>
 +
</tr>
 +
<tr>
 +
<td colspan="2">
 +
<ul>
 +
<li>N = number of differnent sperms</li>
 +
<li>P1 = <span id="result_box" class="short_text" lang="en"><span class="hps">percentage of the</span> <span class="hps">first</span> <span class="hps">count</span></span></li>
 +
<li>P2 = <span id="result_box" class="short_text" lang="en"><span class="hps">percentage of the</span> second <span class="hps">count</span></span></li>
 +
<li>AVG = average = (N1 + N2):2</li>
 +
<li>d = difference (absolut) = |N1 - N2|</li>
 +
</ul>
 +
<p><strong><span style="text-decoration: underline;">Assessment</span>: d &le; 1,96 * sqrt( 2 * MW * (100-MW) : N )</strong></p>
 +
<br /></td>
 
</tr>
 
</tr>
 
<tr>
 
<tr>
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</table>
 
</table>
 
<p>&nbsp;</p>
 
<p>&nbsp;</p>
 +
<h2>Semen analysis quality assessment</h2>
 +
<p>Exist more than <strong>50 shared value pairs</strong>, after a <strong>control period</strong> (= 1 calendar month), or - if this number is not reached - <strong>when 50 pairs be achieved</strong>, a <strong>long-term validation </strong>by calculating and evaluating the mean (including standard deviation) have to be made of the d<strong>uplicate determinations</strong>.</p>
 +
<p><span id="result_box" lang="en"><span class="hps">To do</span> <span class="hps">this, click</span> <span class="hps"><strong>Reports -&gt;</strong></span><strong> <span class="hps">Semen analysis quality assessment<br /></span></strong></span></p>
 +
<table border="0">
 +
<tbody>
 +
<tr>
 +
<td><img src="/images/QM18.png" alt="" width="456" height="258" /></td>
 +
</tr>
 +
</tbody>
 +
</table>
 +
<h3>Long-term validation preparation</h3>
 +
<p>All results of the internal quality assurance are documented separately by <strong>paramenter </strong>and <strong>workplace</strong>.</p>
 +
<table border="0">
 +
<tbody>
 +
<tr>
 +
<td>[[Image:QM20.png|none|740px|thumb|left|link=http://wiki.meditex-software.com/images/QM20.png| ]]</td>
 +
</tr>
 +
<tr>
 +
<td>
 +
<p><strong>First Step: Select parameter and workplace</strong></p>
 +
<p>Parameters:</p>
 +
<ul>
 +
<li>concentration</li>
 +
<li>motility WHO AB</li>
 +
<li>motility WHO C</li>
 +
<li>motility WHO D</li>
 +
<li>morphology</li>
 +
</ul>
 +
<p><strong>It can be displayed only a single quantity!</strong></p>
 +
</td>
 +
</tr>
 +
</tbody>
 +
</table>
 
<p>&nbsp;</p>
 
<p>&nbsp;</p>
 +
<p>All <strong>results </strong>of internal quality assessment have to be <strong>documented separately</strong> by <strong>parameter </strong>and <strong>workplace</strong>.</p>
 +
<table border="0">
 +
<tbody>
 +
<tr>
 +
<td>[[Image:QM21.png|none|740px|thumb|left|link=http://wiki.meditex-software.com/images/QM21.png| ]]</td>
 +
</tr>
 +
<tr>
 +
<td><strong>Second Step: evaluation of all duplicate determinations</strong><br /><br />
 +
<ul>
 +
<li>per parameter</li>
 +
<li>per workplace</li>
 +
</ul>
 +
</td>
 +
</tr>
 +
</tbody>
 +
</table>
 
<p>&nbsp;</p>
 
<p>&nbsp;</p>
 +
<p>All <strong>results </strong>of internal quality assessment have to be <strong>documented separately</strong> by <strong>parameter </strong>and <strong>workplace</strong>.</p>
 +
<table border="0">
 +
<tbody>
 +
<tr>
 +
<td>[[Image:QM22.png|none|740px|thumb|left|link=http://wiki.meditex-software.com/images/QM22.png| ]]</td>
 +
</tr>
 +
<tr>
 +
<td><strong><span style="text-decoration: underline;">Third Step:</span> flowing assessment/ current assessment</strong><br /><br />&nbsp;&nbsp;&nbsp;&nbsp; n = number of pairs of values ​​(immediately reviews)<br />&nbsp;&nbsp;&nbsp;&nbsp; d = difference of the value pairs<br />&nbsp;&nbsp;&nbsp;&nbsp; MWd = mean deviation = 1: n * Sum (d)<br />&nbsp;&nbsp;&nbsp;&nbsp; Sd = standard deviation of the difference = sqrt (1: (n-1) * Sum ([d MWd] 2))<br /><br /><strong><span style="text-decoration: underline;">Assessment:</span> MWd &le; 1.96 * sd: sqrt (n)</strong></td>
 +
</tr>
 +
</tbody>
 +
</table>
 
<p>&nbsp;</p>
 
<p>&nbsp;</p>
−
<table style="float: left;" border="0">
+
<table border="0">
 
<tbody>
 
<tbody>
 +
<tr>
 +
<td>[[Image:QM23.png|none|740px|thumb|left|link=http://wiki.meditex-software.com/images/QM23.png| ]]</td>
 +
</tr>
 +
<tr>
 +
<td>
 +
<p><strong><span style="text-decoration: underline;">Fourth Step:</span> control period / 50 value pairs</strong><br /><br />After reaching the 50 value pair or the control period, a information window remind you of the long-term assessment.</p>
 +
<p>&nbsp;</p>
 +
</td>
 +
</tr>
 
</tbody>
 
</tbody>
 
</table>
 
</table>
 +
<p>&nbsp;</p>
 +
<p>All <strong>results </strong>of internal quality assessment have to be <strong>documented separately</strong> by <strong>parameter </strong>and <strong>workplace</strong>.</p>
 +
<table border="0" width="662" height="74">
 +
<tbody>
 +
<tr>
 +
<td><br /></td>
 +
</tr>
 +
<tr>
 +
<td><strong><span style="text-decoration: underline;">Fifth Step: </span>Long-term validation</strong> (for the period evaluated single results)<br /><br /><strong>The long-term validation is to be performed individually for each parameter!</strong></td>
 +
</tr>
 +
</tbody>
 +
</table>
 +
<p>&nbsp;</p>
 +
<p>Is the <strong>mean value of the difference greater than the formula value</strong>, may no results be issued, <strong>until the cause is cleared and removed</strong>. The process must be <strong>documented</strong>. The fields <strong>cause, corrective action, eliminated</strong> and <strong>person (correction)</strong> need to be completed. Is this not the case, <strong>"information messages"</strong> remember on it.</p>
 +
<table border="0">
 +
<tbody>
 +
<tr>
 +
<td>&nbsp;</td>
 +
</tr>
 +
<tr>
 +
<td>In the upper half of the window you see <strong>per line</strong> the <strong>results </strong>of the long-term validation of <strong>one parameter </strong>or a <strong>workplace</strong>.<br /><br />Below there is a list of the <strong>single duplicate determinations</strong>. The associated semen analysis can be viewed by <strong>"double-click"</strong> or <strong>"right-click"</strong>.</td>
 +
</tr>
 +
</tbody>
 +
</table>
 +
<p>&nbsp;</p>
 +
<h2>Documentation of long-time validation</h2>
 +
<table border="0">
 +
<tbody>
 +
<tr>
 +
<td>&nbsp;</td>
 +
</tr>
 +
<tr>
 +
<td><strong>The content of the documentation is required:</strong><br />
 +
<ul>
 +
<li>name of the laboratory</li>
 +
<li>workplace</li>
 +
<li>evaluation period</li>
 +
<li>investigation, samples, unit</li>
 +
<li>method</li>
 +
<li>results (= individual values ​​of duplicates)</li>
 +
<li>reviews (immediate and long-term)</li>
 +
<li>release</li>
 +
<li>corrections</li>
 +
<li>examiner</li>
 +
</ul>
 +
</td>
 +
</tr>
 +
</tbody>
 +
</table>
 +
<p>&nbsp;</p>
 +
<p>&nbsp;</p>
 +
<p>&nbsp;</p>
 +
<p>&nbsp;</p>

Revision as of 10:49, 8 January 2013

This link leads you to the German version "<a href="/index.php?title=RiliB%C3%84K%20zu%20Ejakulatuntersuchungen">RiliBÄK</a>".

 

Contents

Quality assessment settings

Before using Quality assessment, check the basic parameters in the settings of MedITEX IVF and adjust if needed.

<tbody> </tbody>
<img src="/images/QM1.png" alt="" width="508" height="119" />
  • You access settings via the menu System -> Configuration / administration -> Settings on the top of the window.
  • In the settings you go to System -> Functions -> Semen analysis to Quality assessment-default settings and check "Activate / deactivate Qualitiy assessment".
<tbody> </tbody>
File:QM2.png

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, you use at the menu item "Laboratory diagnosis" of the male patients in which you create a new semen analysis by using the button "New sample".

<tbody> </tbody>
<img src="/images/QM3.png" alt="" width="279" height="329" /> <img src="/images/QM4.png" alt="" width="255" height="262" />

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

The examination of the spermatozoa in a counting chamber is separated according to

  1. Concentration (number),
  2. Morphology (normal or abnormal in percent)
  3. Motility (movement in 3 stages: progressive movement, locally movable immotil in percent)

performed in duplicate determinations, evaluated and documented.

<tbody> </tbody>
QM5.png

This form is no direct data entry in fields

Concentration
Motility and
Morphology

possible, because a duplicate determination is required.

<tbody> </tbody>
QM6.png

The examintaions are independent according to the quantity mass and can be evaluated separately.

 

Execution - investigation concentration

To add a count with duplicate determination go to the tab Quality assessment-> Sperm counts.

The duplicate determination of the concentration is carried out as follows:

  1. A counting chamber is filled with the sample.
  2. Subsequently, the two halves of counting chambers are evaluated separately. Each counting chamber is one of the duplicate determinations!
<tbody> </tbody>
QM7.png
  • Concentration: 1. counting chamber, 2. counting chamber
  • Concentration calculator

 

Execution - investigation motility & morphology

In the duplicate determinations at least 2x200 sperm have to be evaluated. If the number of sperm less than 200/visulal field after enrichment, the requirement is not relevant and a smaller number has to be evaluated.

<tbody> </tbody>
QM8.png

Investigation motility

The examination of the sperm is to perform with motility (movement in 3 stages: progressive movement, locally movable and immotil in percent) in duplicate determinations.

<tbody> </tbody>
QM9.png

In Germany entering the values ​​of WHO A and WHO B must be separated because DIR interface!

 

<tbody> </tbody>
Mo5.png

There is a "WHO sperm calculator", that converts the numbers in percent. New is the "Motility counter" that counts the respective sperm about the keyboard, or via an external number pad touch screen monitor. (freely configurable).

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

Investigation morphology

<tbody> </tbody>
QM11.png

Morphology (normal forms)

  • 1. Counting
  • 2. Counting

The investigation of sperm morphology is to be carried out (normal in percent) in a duplicate determination.

 

Documentation

<tbody> </tbody>
QM12.png

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.

 

<tbody> </tbody>
Q14.png
  • N1 = number, 1. Counting
  • N2 = number, 2. Counting
  • AVG = average = (N1 + N2):2
  • d = difference (absolut) = |N1 - N2|
<img style="display: block; margin-left: auto; margin-right: auto;" src="/images/Q15.png" alt="" width="119" height="88" /> 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.

<tbody> </tbody>
QM16.png
  • 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 )
<img style="display: block; margin-left: auto; margin-right: auto;" src="/images/Q15.png" alt="" width="119" height="88" /> 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.
<tbody> </tbody>
QM17.png
  • 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 )
<img style="display: block; margin-left: auto; margin-right: auto;" src="/images/Q15.png" alt="" width="119" height="88" /> 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

<tbody> </tbody>
<img src="/images/QM18.png" alt="" width="456" height="258" />

Long-term validation preparation

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

<tbody> </tbody>
QM20.png

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.

<tbody> </tbody>
QM21.png
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.

<tbody> </tbody>
QM22.png
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)

 

<tbody> </tbody>
QM23.png

Fourth Step: control period / 50 value pairs

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

 

 

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

<tbody> </tbody>

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.

<tbody> </tbody>
 
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".

 

Documentation of long-time validation

<tbody> </tbody>
 
The content of the documentation is required:
  • name of the laboratory
  • workplace
  • evaluation period
  • investigation, samples, unit
  • method
  • results (= individual values ​​of duplicates)
  • reviews (immediate and long-term)
  • release
  • corrections
  • examiner