Difference between revisions of "Add Waivered Methodology"
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Waivered tests (methodologies) are much less strictly managed as of the date of this writing. Unfortunately waivered labs are so widely misused and so poorly maintained by offices that use waivered labs (Low Complexity Labs) | Waivered tests (methodologies) are much less strictly managed as of the date of this writing. Unfortunately waivered labs are so widely misused and so poorly maintained by offices that the use of waivered labs (Low Complexity Labs) may be monitored similar to Medium Complexity and High Complexity Labs in the future. | ||
On | On receipt of a new kit. | ||
Record procedure in laboratory procedure manual | Record procedure in laboratory procedure manual. | ||
Record test kit name and lot number | Record test kit name and lot number | ||
| Line 9: | Line 9: | ||
*Expiration date | *Expiration date | ||
*cost per kit | *cost per kit | ||
*Number of effective tests per kit (number of tests less number needed to run controls). | *Number of effective tests per kit (number of tests less number tests needed to run controls). | ||
Medium Complexity and High Complexity Labs are held to a higher standard than Low complexity Laboratories and these control materials need to be logged in a similar fashion to the Medium and High Complexity methodologies. The results of the positive and negative controls are recorded in the waivered lab control log. The frequency of controls is according to the manufacturers recommendations. Usually this is when opening a new box of test kits. | |||
In our laboratory the test result is recorded on a waivered lab form with the testing technician's initials, date:time of the test, | |||
The results are recorded in the result log. | The results are recorded in the result log. | ||
Revision as of 07:45, 26 August 2011
Waivered tests (methodologies) are much less strictly managed as of the date of this writing. Unfortunately waivered labs are so widely misused and so poorly maintained by offices that the use of waivered labs (Low Complexity Labs) may be monitored similar to Medium Complexity and High Complexity Labs in the future.
On receipt of a new kit.
Record procedure in laboratory procedure manual.
Record test kit name and lot number
- date received
- Expiration date
- cost per kit
- Number of effective tests per kit (number of tests less number tests needed to run controls).
Medium Complexity and High Complexity Labs are held to a higher standard than Low complexity Laboratories and these control materials need to be logged in a similar fashion to the Medium and High Complexity methodologies. The results of the positive and negative controls are recorded in the waivered lab control log. The frequency of controls is according to the manufacturers recommendations. Usually this is when opening a new box of test kits.
In our laboratory the test result is recorded on a waivered lab form with the testing technician's initials, date:time of the test,
The results are recorded in the result log.
If there are panic values associated with the kit then these panic values are recorded in the panic value log per the Panic Value Policy.
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