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DOT Public Interest Exclusion - PIE

02 Apr 2016

… What is the Public Interest Exclusion and Some Major Causative Factors?

A topic that is not clearly understood but can be a discussion with many parties is what can cause a service agent is to be faced with a charge of Public Interest Exclusion (PIE).  Many service agents do not know what their options are or how to handle a potential PIE charge when confronted with a Notice of Public Exclusion (NOPE).  This complex subject is outlined in a 49 CFR Part 40 (Subpart R)

First who can be confronted with a NOPE that can lead to a PIE.  This applies to all service agents as defined in 49 CFR Part 40.3.  The definition as given below states that any party that provides compliance services to a regulated company is a service agent.

Service agent. Any person or entity, other than an employee of the employer, who provides services specified under this part to employers and/or employees in connection with DOT drug and alcohol testing requirements. This includes, but is not limited to, collectors, BATs and STTs, laboratories, MROs, substance abuse professionals, and C/TPAs. To act as service agents, persons and organizations must meet the qualifications set forth in applicable sections of this part. Service agents are not employers for purposes of this part.

The key part of the definition is that service agents “must meet the qualifications as set forth in applicable sections of this part.”  It should be noted that even if personnel are indeed qualified it would behoove the astute manager/owner to perform quality control checks to ensure there was compliance 100 percent of the time.

What are some instances of where and when a NOPE could be instituted?  These instances can vary with who and the role of the service agent.

To start, collection sites will be discussed as that is where the donor meets the drug test program by providing a specimen for analysis.  I purport that all drug tests have to be collected as a potential legal bomb as you never know when a drug test could “blow up” and cause a headache and financial ruin for the collection facility. 

For instance, a collection facility that fails to have qualified personnel collect regulated specimens While a single instance of this might not be detected it is still a symptom that all is not right and that there are problems within the collection facility.  However, if this single instance led to a test result with a non-negative test result, it could pose to be a legal nightmare for the collection facility. If the employee was terminated and had a grievance, this employee could contest this result in court where it potentially could be revealed that the collector was not qualified.  The call now is to determine if this was a minor procedural flaw or a major procedural flaw.  That is a determination that would be made in court.

As a side note, I personally have seen this determination go either way in a hearing before an Administrative Law Judge (ALJ).  Normally when such instances were brought to my attention I would recommend that the Investigating Officer (IO) do a Letter of Warning (LOW) to the facility.

There are other areas of where a NOPE could be instituted.  Another such scenario could be when a Medical Review Officer (MRO) steps in and advises what the collection facility should do when there has been a collection problem when that is a determination to be made by the employer’s Designated (Employer Representative (DER). As a reminder, the role of the MRO does not start until the test result is received from the laboratory, the MRO has no part in any collection issues.  This is particularly applicable with “Doc in the Box” facilities where the medical facility collects drug test specimens and has a MRO.  The collector will then go to the MRO with adverse situations instead of going to the DER.

If proper collector training is done, the above situation could be addressed as a reminder of the role and responsibilities of all the parties.

Most of the collection site errors can be easily solved with remedial action following the written recommendation(s) of the official investigating the errors.  The letter will specify what regulation(s) that the collection facility was not in compliance with. In addition, a review of the regulations governing the error should be reviewed and measures instituted to ensure that those errors are not repeated. If those errors are not corrected after being informed, then yes the collection site facility could potentially receive a NOPE. 

It is highly recommended that the all correspondence be in writing.  If a requirement is not understood or needs clarity, the facility should correspond in writing to the Investigating Official and ask for clarification.  When correspondence is in writing there can be no mistake or error in judgement.

When a facility determines that corrective action has been taken on all the listed errors, a letter should be prepared that lists all of the recommendations (errors) and what the remedial measures that were taken by each identified recommendation.  If a recommendation cannot be corrected, then the facility should identify and list specifically why that recommendation could not be corrected.

All of the above is absolutely necessary in order to not receive a NOPE.

Collection facilities are not the only service agents that are subject to a PIE determination.  Medical Review Officers (MROs), Substance Abuse Professionals (SAPs) along with Consortium/Third Party Administrators (C/TPAs) have exposure and liability that can lead to a PIE finding.  These will be discussed in a future article.

A future article will explore further the PIE and the NOPE processes and consequences along with the different service agent’s non-compliant behavior that can lead to receiving a PIE. 

Future articles will discuss how is a PIE evolved along with the process and role of the Department of Transportation Modal Agency Program Manager.

By: Robert C. Schoening