[Histonet] RE: ThinPrep

[Yang, Mari]

Lisa,



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



CYP.05257


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

REFERENCES

1)


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


2)


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


3)


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!

Mari


Mari Yang, MHA, CT(ASCP)CMHTLCM
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



423-979-3567



423-979-3401 fax







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Thank You





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