[ASCLS Molecular SA] FW: [ASCLS Region V General Membership] Fw: Prosposed Genetic TestingMMWR

[Pat Tille]

ascls-molecular-sa_ascls-lists.org 

 
Pat Tille

________________________________

From: ascls-region-v-general-membership-bounces at ascls-lists.org on behalf of Lezlee Koch
Sent: Sat 12/29/2007 7:55 PM
To: ASCLS Mail List Admin; 2007-08 RegV Memb ML
Subject: [ASCLS Region V General Membership] Fw: Prosposed Genetic TestingMMWR


 
----- Original Message ----- 
From: Elissa Passiment <mailto:elissap at ascls.org>  


Hi Everyone,

 

The CDC is asking for our comments about an MMWR that they would like to publish about genetic testing.  Please circulate this to any one of our members who have expertise in genetic testing.  Please get comments back to me by Jan 4th so I can compose our response by their deadline.  Thanks

 

Elissa Passiment

ASCLS

6701 Democracy Blvd, #300

Bethesda, MD 20817

301.657.2768 (voice)

301.657.2909

elissap at ascls.org

 

-----Original Message-----
From: Boone, D. Joe (CDC/CCID/NCPDCID) [mailto:djb2 at CDC.GOV] 
Sent: Saturday, December 22, 2007 11:55 AM
To: Yost, Judith A. (CMS/CMSO); Gutman, Steven I. (FDA); Carr, Sarah (NIH); Khoury, Muin (CDC/CCHP/NOPHG); Hooper, Craig (CDC/CCHP/NCBDDD); Moore, Cynthia (CDC/CCHP/NCBDDD); Bradley, Linda (CDC/CCHP/NOPHG); Hannon, Harry (CDC/CCEHIP/NCEH); Unger, Elizabeth (CDC/CCID/NCZVED); Carol Greene; David Smalley; Dina Mody; Elissa Passiment; Ellen Jo Baron; Emily Winn-Deen; Gary Overturf; Geraldine Hall; James Nichols; Jared Schwartz; Joeline Davidson; Kevin McNeill; Lee Hilborne; Lou Turner; Luann Ochs; Merilyn Francis; Nancy Elder; Norman "Chip" Harbaugh; Stephen Raab; Tom Williams; Andrea Ferreira-Gonzalez; emccabe at mednet.ucla.edu; jlfrias at comcast.net; jamoswilson at sequenom.com; katherine.klinger at genzyme.com; kap03 at health.state.ny.us; lms7r at virginia.edu; margaret.mcgovern at stonybrook.edu; mark.rothstein at louisville.edu; nancy.fisher at hca.wa.gov; Pcharach at jhmi.edu; rvaldes at louisville.edu
Cc: Chen, Bin (CDC/CCID/NCPDCID); Anderson, Nancy L. (CDC/CCID/NCPDCID); Granade, Sharon E. (CDC/CCID/NCPDCID); Howerton, Devery (CDC/CCID/NCPDCID); Hearn, Thomas L. (CDC/CCID/NCPDCID); Khabbaz, Rima (CDC/CCID/NCPDCID); Malone, Kevin M. (CDC/OCOO/OD)
Subject: Prosposed Genetic Testing MMWR

 

 

Dear Colleagues, 

The topic of how much genetic testing oversight is needed to assure reliable and accurate testing in the U.S. has generated much attention over the last decade.  Both advisory committees to the Secretary of Health and Human Services (Clinical Laboratory Improvement Advisory Committee (CLIAC) and Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS)) have provided recommendations on what should be done at the federal level to address concerns about this rapidly evolving field.

Attached for your review and comment is a proposed Recommendations and Reports (RR) Morbidity and Mortality Weekly Report (MMWR) entitled:

 "Good Laboratory Practices for Ensuring the Quality of Genetic Testing." 
   <<GT MMWR 122207draft.doc>> 
This MMWR was recommended by the CLIAC during its February 2007 meeting.  They felt that a MMWR report highlighting the CLIAC's previous recommendations, the CDC's Notice of Intent (NOI) and public comments to that document, and the changes that have been incorporated within CLIA and into CMS and state oversight processes since the CLIAC first began addressing this topic in 1997 was needed.  

We would greatly appreciate your review and comments on the RR MMWR.  In order to meet our MMWR publication date, we need to receive your comments by COB January 7, 2008.  We will address these comments in the revised version sent to the MMWR Editorial Office.  I regret that this comes during the holiday season, but this conflict was unavoidable.   

Thank you for all of your past and continued support.   We look forward to your comments. 

Note to Sarah Carr:  While not the focus of this MMWR,  the fine work of the SACGHS in developing a Task Force and a report on the U.S. System of Oversight of Genetic Testing http://www4.od.nih.gov/oba/SACGHS/public_comments.htm <http://www4.od.nih.gov/oba/SACGHS/public_comments.htm>  is recognized as an important parallel effort to address this important topic.  Sarah - Please feel free to seek comments from anyone involved in the SACGHS on the MMWR.  We just need their comments by COB January 7.

With regards, 

Joe 

D. Joe Boone, Ph.D. 
Acting Director 
Division of Laboratory Systems 
National Center for Preparedness, Detection and Control of Infectious Diseases 
CDC 
Phone: 404-718-1046 
Fax 404-718-1095 
e-mail: dboone at cdc.gov  
  

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