[Histonet] CAP Question regarding procedure manual

[WILLIAM DESALVO]

You will need a signature for the manual and for each procedure that is implemented or amended during your cycle year. If your manual is very stable, a yearly signature page for the entire manual may suffice, but the inspector will note the date everyone signed the manual review page and then go through the manual to see if there are any implementation dates or procedure change dates after the manual review date. Each occurrence found one can be a deficiency.

In my lab, it is not uncommon for new procedures to be written and implemented or existing procedures implemented during a cycle year and all these events require a signature by System Medical Director, Site Medical Director, Site Lab Director, System Technical Specialist (responsible for physically writing) and all employees affected. You must prove to CAP that all personnel know where the procedure manual is located, that they have reviewed the manual as a whole and that they have reviewed all additions implemented. We have employees sign each technical alert, procedure update/change and new procedures, along with a once a year review of all manuals.

This type of signature trail is part of and right in line with quality management and document control. This process alone can be a daunting task and requires a lot or forethought. To better manage this process, we are moving to an electronic on-line, web based procedure manual with document control functions that tracks usage by employee and captures electronic signatures for each step of the creation, review and implementation process. Thankfully, this process is the responsibility of our Technical Specialist for Anatomic Pathology and our System Quality Department.


William DeSalvo, B.S., HTL(ASCP)





> Date: Wed, 22 Dec 2010 15:16:37 -0800
> From: victor <@t> pathology.washington.edu
> To: Histonet <@t> lists.utsouthwestern.edu
> CC: 
> Subject: [Histonet] CAP Question regarding procedure manual
> 
> Is there a requirement to have a signature of every staff member on a 
> procedure if they perform that procedure in a manual? Wouldn't one 
> signature on a cover page suffice that you have read and understand what 
> is in the manual?
> 
> Victor
> 
> -- 
> Victor Tobias
> Clinical Applications Analyst
> University of Washington Medical Center
> Dept of Pathology Room BB220
> 1959 NE Pacific
> Seattle, WA 98195
> victor <@t> pathology.washington.edu
> 206-598-2792
> 206-598-7659 Fax
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