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From: Dr. K
Password: orange
Date: 01 Sep 2009
Time: 05:26:48 -0700
Remote Name: 12.40.33.118
When the MRO discovers a collection should have been observed but was not, what should the MRO do at that point? Obviously if the specimen was adulterated/substituted or positive the result stands. But, if the result is negative, is the test cancelled and the donor sent back immediately for an observed recollection? I am confused about this because it seems that it should be recollected, but according to 49 CFR 40.209(b)(6) it appears that it should not. The regulations state however that if a collector learns a specimen should have been observed, an immediate observed recollection should take place. Whether it is follow-up, RTD or simply a recollection after a cold specimen, when an observed collection was required but was omitted by mistake, what should the MRO do?
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