Copied below is a question from the CAP website. Note in the last 2 lines of the "Note" paragraph where it talks about signatures. One signature is not sufficient on a main page, but if you list each procedure on one page, you can initial each procedure on that one page. It wants multiple signatures.
The intent seems to make sure each document is reviewed, but how does allowing a main page where you can sign your name 50 times ensure that you have read the manual? We have gone to signing each individual procedure, we feel that this is what will be required in the future.
ANP.03776 Phase II N/A YES NO
Is there documentation of at least annual review of all policies and procedures in the anatomic pathology section by the current laboratory director or designee?
NOTE: The director must ensure that the collection of policies and procedures is complete, current, and has been thoroughly reviewed by a knowledgeable person. Technical approaches must be scientifically valid and clinically relevant. To minimize the burden on the laboratory and reviewer(s), it is suggested that a schedule be developed whereby roughly 1/12 of all procedures are reviewed monthly. Paper/electronic signature review must be at the level of each procedure, or as multiple signatures on a listing of named procedures. A single signature on a Title Page or Index of all procedures is not sufficient documentation that each procedure has been carefully reviewed. Signature or initials on each page of a procedure is not required.
From: email@example.com on behalf of Lee & Peggy Wenk
Sent: Fri 8/3/2007 5:59 AM
Subject: [Histonet] Techs Documenting Knowing Procedure Manual
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
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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