[Histonet] Techs Documenting Knowing Procedure Manual

Rene J Buesa rjbuesa <@t> yahoo.com
Fri Aug 3 07:27:36 CDT 2007

We used to have a front page in the SOP with the signatures of all the histotechs acknowledging the contents of all and each protocol.
  During the years we were inspected many times by CAP and that procedure was always accepted.
  René J.

Lee & Peggy Wenk <lpwenk <@t> sbcglobal.net> wrote:
  Need some help interpreting a CAP check list question.

ANP.06440 Does the laboratory have a system documenting that all personnel
are knowledgeable about the contents of procedure manuals relevant to the
scope of their testing activities?

I have been told as several NSH workshops, and also talking with various
histotechs who have been inspected by CAP, that techs have to sign off on
each procedure. That having one sheet in the front of the staining manual
that says "I know and understand and will follow all the procedures in this
manual" is not acceptable.

However, there is no comment either way after the CAP checklist question.
I've looked up the two NCCLS regs, and can't find it there either (but I
also fall asleep trying to read the NCCLS regs). 
REFERENCES: 1) NCCLS. A Quality Management System Model for Health Care;
Approved Guideline-Second Edition. NCCLS document HS1-A2 
2) NCCLS. Application of a Quality Management System Model for Laboratory
Services; Approved Guideline-Third Edition. NCCLS document GP26-A3 

Can someone point me in the right direction, or have I been misinformed all
these years?

I know employees don't have to sign off every year, only the director. I
know employees have to sign off on new or changed procedures.

But what do you do with a new employee, who has to read every procedure? Is
one sheet OK, or do should there be a list of all the procedures, and they
sign off on each one and date it? 

What if I'm inspecting a lab, and see that they don't have any record of
employees reading the procedures, or just have one sheet in the front? 

Thanks in advance for input.

Peggy A. Wenk, HTL(ASCP)SLS
William Beaumont Hospital
Royal Oak, MI 48073

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