This Week Online at www.DATIA.org
October 28, 2004

New Specimen Validity Testing Guidelines Take Effect November 1, 2004

In addition to the much discussed proposed Department of Health and Human Services (HHS) rules on alternative specimen testing, the department has new mandatory guidelines about specimen validity testing conducted on all urine specimens collected under mandatory guidelines. These guidelines are effective November 1, 2004.

The guidelines include new definitions associated with the federal CCF, adulterated specimen, confirmatory validity test, dilute specimen, initial validity test, invalid result, and substituted specimen.

The revisions grant donors the right to request that a split (Bottle B) specimen be tested to confirm an adulteration or substitution result that was reported by the primary laboratory on the primary (Bottle A) specimen. Validity testing must be done by a laboratory and the revision establishes the criteria that must be used by a laboratory to report a specimen as adulterated, substituted, invalid, or dilute. Updated drug test cutoff levels are also part of the revisions, namely 2,000 ng/mL for opiates and specific gravity tests to validate specimens with creatinine levels of less than 2 mg/dL.

Click here for a full summary of changes.
Click here to download the entire Federal Register notice


Reminder: Deadline for Submitting MRO Assistant Training Course RFP is Fast Approaching

The deadline for submitting MRO Assistant Training Course proposals is November 5, 2004. We are looking for proposals from members on education that you feel is needed for the industry. Specifically, we would like to see proposals to develop new curriculum to be presented in a seminar for MRO assistants.

Winning proposals will be awarded by DATIA. View the complete RFP for details.


Question & Answer From DATIA's Forum:

Question: I am a Certified Professional Collector through DATIA and I was curious to see what the protocol and guidelines are for a collection site in regards to getting or speaking with a donor about prescriptions he/she may be taking. Does it say anywhere that you cannot invade the donor's privacy by writing down the specific prescriptions that he/she may be taking? If so, I would like to know where I can find that information.

Answer:
Section 40.61(g) of the 49 CFR Part 40 states that "You must instruct the employee not to list medications that he or she is currently taking on the CCF. (The employee may take notes of medications on the back of the employee copy of the form for his or her own convenience, but these notes must not be transmitted to anyone else)."


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