j Jozef
on

 

In the original publication by the FDA (which should be NORMATIVE), the rule definition and error message of FDA rule SE2306 conflict with each other.
The rule definition states: "At least one of the these variables or sets of variables should be populated: (DM.RFSTDTC and --DTC) or --STDY, or --VISITDY".
The error message states: "Missing values for all required set(s) of timing variables [DM.RFSTDTC with --DTC] , --DY and VISITDY".

First of all, there is nothing such as a "--VISITDY" variable. May I presume it must be "VISITDY" in the rule definition?
Secondly, the rule speaks about "--STDY" whereas the error message speaks "--DY".

So, what is this rule now about? Is it about --STDY, or is it about --DY?

And when then I look up the rule on the P21 website, the rule is suddenly something completely else:
definition: "At least one of the these variables or sets of variables should be populated: VISITDY, --DY, or --NOMDY"
error message: "Missing values for all required set(s) of timing variables: VISITDY, --DY or --NOMDY".

What has happened here? Are we talking about two rather different versions of the same rule?

 

Forums: SEND

Sergiy
on June 25, 2020

Hi Jozef, 

Please see our recent webinar https://www.pinnacle21.com/blog/how-we-improved-send-validation-rules

Slide #13 or recorded webinar https://www.youtube.com/watch?v=o-qjjaeHoqw&feature=youtu.be&t=682

Kind Regards,
Sergiy

 

j Jozef
on June 26, 2020

Thanks Sergiy, I appreciate your fast response!

But ... this is a mess ... If the rule as published by the FDA is faulty, it is up to the FDA to correct it and to publish an update.
Such "corrections" should not be done by a private company.

Whoever developed this rule at the FDA, this is not good quality work. And I wonder whether any QC is done at all at the FDA.

Luckily, I also asked one of the top leading SEND experts in the world, and she explained me very well what the rule is about and why it is there. Her detailed explanation however deviates from what both FDA and P21 publish.

As implementers of the standard, we need exactness and legal assurance, and no "improvements" communicated through privately owned websites and youtube videos. So FDA, do your QC work, and publish an update!

j Jozef
on June 26, 2020

I also see that there is a conflict between slide 13 of the webinar and the P21 website for rule SE2305. According to the slide, rule SE2305 only applies to DS, whereas the P21 website states that the rule applies to OM, MA, MI, TF. The rule description on the website then however then only mentions DS.
More confusion ...

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