Remember CLIA 1988?  And the many versions of “final” rules that have been issued since then??

CMS-2226F, the FINAL Rule, was issued Jan 24, 2003. Sifting through the verbiage one comes down to the nitty gritty, Director qualifications and Frequency of QC tests.

Full text of the law is available at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-1230.htm

Additional information from CMS at  www.cms.hhs.gov/clia/cms2226ffs.asp and http://www.cms.hhs.gov/clia/cms2226fqa.pdf

The Final Rule confirms Board Certification as a requirement to direct a High Complexity lab, with the caveat that certain current directors who are not Board Certified can be grandfathered.

Regarding QC, moderate and high complexity tests are grouped together and differentiated only from Waived tests. Two levels of control is the standard for the moderate/high group, frequency of the two levels varies by specialty and test but generally, daily when test is run. What will substitute for “wet” external controls (internal and electronic, for instance) remains for discussion, a process ongoing at present and undoubtedly continuing for some time into the future. There is significant language in the Rule about not increasing the cost of testing, and this will probably impact these discussions.

The above URL’s are available on our website www.clsaonline.org with a couple of samples of information about ‘alternative’ controls.

Other news:

*Sometimes things don’t seem to make sense. At least to us peons. If you use an I-STAT, you may have wondered about this, too.  In July 2002 I-STAT announced that it would be severing its relationship with Abbott, which was its distributor, as of Dec 31, 2003. I-STAT would pay Abbott rather well to resume its own distribution rights. Then, surprise! on Dec 15, 2003, Abbott announced its plan to purchase I-STAT. Hmmm!!!

*Wampole (Inverness) has legal action against it by Trinity Biotech (see Dec 10, 2003 Press release on Trinity’s website) over a test change that has potentially serious consequences to patient care.  This is an interesting action and makes me wonder how often this sort of thing happens.

*The Roche CoaguChek strip recall is apparently winding down, with new lot numbers not affected by the packaging problem now shipping.

*On a local (and happier note!) Alaska Scientific celebrated its 14^th birthday in December. We very much appreciate the support we’ve had from Alaska’s laboratorians over the years… we know lots of companies that have come and gone in that time!