Tuesday, August 04, 2015

A Simple Question, A Complex Answer

A colleague of mine contacted me with the following question:

 "Can you tell me real quick how to do a semen analysis?"

OK.  Where do I even start?

Semen analysis is a complex diagnostic lab test.  As such, it is a highly regulated endeavor.  To do even a basic semen analysis requires a license from both federal and state agencies.  Your lab must submit to both routine inspections and random inspections and must comply with regulations regarding quality testing, quality control (QC), and quality assurance (QA).  Accuracy testing must also be performed a constant basis. The results of all QC and QA must be maintained for 7-10 years. The lab must have detailed operating  and policy and procedure manuals.  These are very complex items to develop.  The lab must have safety manuals that meet OSHA standards.  Other regulations include data security and backup, disaster planning, staff training and CME.

Oh yeah, and then there is how do the test itself, the semen analysis.  But that description is for a different blog.