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DOT Public Interest Exclusion - PIE Part 3

22 Apr 2016

Who is Subject to a Public Interest Exclusion and What Are Some Major Causative Factors? Part 3

This article will address the Substance Abuse and Mental Health Services Administration (SAMHSA) accredited laboratories, Medical Review Officers (MROs) and Substance Abuse Professionals (SAPs) and how they could potentially face a possible Public Interest Exclusion (PIE) scenario.

LABORATORIES

The SAMHSA accredited laboratories are a service agent per Department of Transportation (DOT) and can be subject to receiving a Notice of Public Exclusion (NOPE). In reality, that probably will not happen.  The few major areas where a NOPE could be issued would be:

  • Sending out of erroneous test results to a MRO without the report being corrected
  • Sending results directly to an employer;
  • Sending results to a Non-DOT qualified MRO;
  • A non-DOT (SAMHSA) qualified laboratory doing analysis on regulated specimens.

The above scenarios are highly unlikely to happen largely because of the very strict checks and double checks that occur before a test result is sent from the laboratory to the MRO and the only laboratories that can legally issue a Federal CCF are only the SAMHSA accredited laboratories.

A laboratory, when establishing a new account, should check and ensure that the name of the MRO on the account is indeed a DOT qualified MRO.  A check could be made to ensure that the listed address for the MRO is also not the address for the employer.  In this Internet age and the use of databases, that check would not be that difficult to perform.

If there is a laboratory internal problem with the receipt of the specimens, doing the analysis, or review of the test results those are all areas that will fall within the domain of the SAMHSA laboratory inspectors. 

The laboratories are inspected two times a year by qualified forensic toxicologists to review all procedures are being following as stated in the Standard Operating Procedures (SOP).  The SOP is usually 2,000 pages in length.  The SOP has to be approved by the National Laboratory Certification Program (NLCP).  There are other challenges besides the on-site inspections, the laboratories are challenged 4 times a year with proficiency specimens. The laboratories have to identify if there is an analyte present and if present, the quantity of the analyte within a range of ± 20%.  Failure to do that correctly is cause for further inspections and review which could potentially lead to a laboratory being removed from the SAMHSA accredited laboratory listing.  That removal has happened twice since the inception of NLCP in 1988.  It should be noted when a Consortium/Third Party Administrator (C/TPA) or an employer with 2,000 or more covered employees submit proficiency specimens, these specimens are considered double blind specimens.  This was a practice that started with the establishment of the military drug test laboratories in 1982.

A laboratory stands a better chance of having the accreditation revoked by NLCP versus receiving a NOPE issued by a DOT Modal Agency for any uncorrected problems.

MEDICAL REVIEW OFFICERS

Medical Review Officers (MROs) are subject to receiving a NOPE for doing consistently uncorrected errors.  The first one is not being a DOT qualified MRO and receiving test results for a regulated employer.  This has happened with a pseudo MRO receiving a PIE.  In the last PIE the individual had to serve jail time person for fraud in accordance with the state law.

There other conditions for which a NOPE could be issued.  They are:

  • Not doing an interview of the employee with a non-negative test result;
  • Not informing the employee of their right to have the split specimen tested;
  • Making the employee pay the split specimen analysis costs;
  • Not sending the verified test results to the DER for the regulated employer, or to the C/TPA, if the C/TPA is allowed to receive test results;
  • Sending test results to a non-secure recipient, i.e., FAX, E-Mail, regular mail:

The above list is not inclusive but serves as an example of the precautions that a MRO should take when conducting business with a regulated employer.

SUBSTANCE ABUSE PROFESSIONAL (SAP)

SAPs can receive a NOPE for actions that do not follow or meet the regulatory requirements.  Because of the role that SAPs play in having an individual who has a test violation in returning to work it is equally important that what they do is above reproach and meets what is required.

Some of the areas that a SAP or an individual could receive a NOPE for are:

  • Not being a DOT qualified SAP;
  • Not having a license or be certified to practice as a Substance Abuse Professional;
  • Not ensuring that the individual fulfilled all of the recommendations as stated;
  • Not ensuring the Return to Duty (RTD) test was done as required.
  • Not ensuring that the follow-up (F/U) tests were done as required;
  • Failure to do a Follow-Up testing plan and to give it to the DER.

The above list is not inclusive but will cover must of the areas of concern that SAP must comply with.

One point should be made:  A single instance of not following the regulatory requirements will usually not cause a NOPE but consistent reports of wrong doing could lead to a NOPE.

The next article will discuss the NOPE and PIE Processes and how this particular process evolved along with how the individual DOT Modal Agency Program Managers are involved.  Additionally, the article will discuss how the policy that DOT uses today evolved for doing a NOPE and PIE. The article will also address areas that I encountered where I could have done a NOPE that could have led to a service agent receiving a NOPE.