[Histonet] RE: ThinPrep

Yang, Mari MYang <@t> emc.org
Mon Sep 16 11:30:52 CDT 2013


If the ThinPrep processor is new to your organization, then the requirements below may apply.


Implementation/Verification Protocol

Phase II

There is documentation of adherence to the manufacturer's recommended protocol(s) for implementation and verification of new instruments.

NOTE:  Before implementing use of new gynecologic liquid-based methods and instruments, automated preparations, and automated screening instruments, the laboratory must verify and document the functioning of the instrument in its own specific laboratory environment, including the capability of the instrument to replace existing procedure(s), if applicable.  If the manufacturer does not provide verification and instrument monitoring recommendations, the laboratory must document the specific verification procedure used.

Evidence of Compliance:

✓        Records of completed instrument/method verification consistent with manufacturer's recommendations OR records of an alternative documented verification procedure approved by the section director



Chang AR, et al. Can technology expedite the cervical cancer screening process? A Hong Kong experience using the AutoPap Primary Screening System with location-guided screening capability. Am J Clin Pathol. 2002; 117:399-437-443


Wilbur DC, et al. Location-guided screening of liquid-based cervical cytology specimens. A potential improvement in accuracy and productivity is demonstrated in a preclinical feasibility trial. Am J Clin Pathol. 2002; 118:399-407


Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):3707 [42 CFR493.1253, 493.1255, and 493.1274(g)]

Good Luck!


Cytology Supervisor
Eisenhower Medical Center
Tel: 760.773.2009

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Joe W. Walker, Jr.
Sent: Saturday, September 14, 2013 11:45 AM
To: White, Lisa M.; histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] RE: ThinPrep

Hi Lisa,

I am not aware of a specific CAP regulation/question related to the validation of the ThinPrep processor.  However, there are general questions related to ensuring your devices are functioning as intended prior to using them on patient specimens.  This should have been done when the device was initially setup in the lab and with the help of the manufacturer.  They should help you verify that the instrument is working as designed.

Joe W. Walker, Jr. MS, SCT(ASCP)CM

Anatomical Pathology Manager

Rutland Regional Medical Center

160 Allen Street, Rutland, VT 05701

P: 802.747.1790  F: 802.747.6525

Email joewalker <@t> rrmc.org    www.rrmc.org

Our Vision:

To be the Best Community Healthcare System in New England

Rutland Regional...Vermont's 1st Hospital to Achieve Both ANCC Magnet Recognition® and the Governor's Award for Performance Excellence

-----Original Message-----

From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of White, Lisa M.

Sent: Thursday, September 12, 2013 9:16 AM

To: histonet <@t> lists.utsouthwestern.edu

Subject: [Histonet] ThinPrep

Does anyone know a CAP regulation for validation of ThinPrep?

Lisa White HT(ASCP)

Supervisory HT

James H. Quillen VAMC

Corner of Veterans Way and Lamont

VAMC Warehouse BLDG. 205

PO Box 4000

PLMS 113

Mountain Home, TN 37684


423-979-3401 fax


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