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PIE - DOT Public Interest Exclusion

07 Apr 2016

Part 2 - Who is Subject to a Public Interest Exclusion and What Are Some Major Causative Factors?

A Must Read for TPA's and C/TPA's

The last article addressed collection facilities and some possible Public Interest Exclusion (PIE) scenarios. Collection facilities are not the only service agent group subject to a Notice of Public Exclusion (NOPE). 

Another major group that can be subject to a NOPE are Consortiums/Third Party Administrators (C/TPAs).  This is a very large complex compliance issue, not only for the C/TPA but for their regulated clients and other service agents that they may use in providing compliance services to regulated employers.  Not to be excluded but this is also an issue for each of the Modal Agency Program Managers on addressing compliance within their respective industries when a C/TPA is involved.

When the drug test programs for Department of Transportation (DOT) regulated employers first started back in 1988, the formation of consortiums took DOT unawares.  A phone conversation that this author had with a senior attorney in DOT in 1991 confirmed this.  The question was asked of how were they going to address the consortiums issue with the response that they were examining the issue but were not sure.  It took from 1992 to the major rule change in 2001 to address that issue.  Part of the answer was the development and use of PIE for errant service agents.

A C/TPA that functions as a full service C/TPA has many regulatory requirements that will confront them but yet C/TPAs are not regulated.  It is recognized that there are some C/TPAs that provide limited compliance service, for instance provide random test selection only.  My view is that type of C/TPA will have a difficult time in having their clients in compliance and providing compliance services.

A full service C/TPA, in general, provides that following services:

  • Drug test services can include the following:
    • Develop a policy for drug and alcohol testing for each client;
    • Collection site arrangements;
    • Laboratory Analysis at a SAMHSA accredited laboratory:
    • Medical Review Officer (MRO) Services;
    • Arrangements for alcohol testing;
    • Receipt and transmission of drug test results (If employer so designates);
    • Arrange for pre-employment testing services;
    • Ensure that the 49 CFR part 40.25 requirements are done for all new hires;
    • Do random test selections;
    • Arrange for these random tests to be conducted;
    • Ensure that clients are aware or know when and how to do Post-Accident testing;
    • Advise clients on regulatory issues when requested;
    • Provide for Substance Abuse Professional services for each client;
    • Provide required educational materials that meet regulatory requirements for each client;
    • Provide blind proficiency specimens as required;
    • Provide audit records as required for each individual client upon request;
    • Data management and if required provide a consolidated Management Information System (MIS) report to be submitted as required or requested;

While the above list may not include all of the items that C/TPA is or is not responsible for, one point needs to be made clear.

A C/TPA cannot stand in the shoes of the employer.

When there is a review of the above list, it quickly becomes very apparent that a C/TPA has a great many responsibilities to keep clients in compliance.  A C/TPA with many regulated employers has to contract with many other service agents to provide compliant services.  According to 49 CFR part 40 the contract can be verbal or written but a contract needs to be in place.  It is strongly advised that all contracts be in writing with all contract terms clearly spelled out.  A contract between a C/TPA and a regulated employer should clearly identify what, how and when compliance services will be provided.

With above list in mind the following areas are where a C/TPA can be exposed and held accountable for in the event of a NOPE:

Area of Concern

Rationale for a NOPE

Collection site arrangements

Not ensuring that the collection facility has qualified collectors.

Laboratory Analysis

Not using a SAMHSA accredited laboratory for analysis.

Medical Review Officer (MRO) Services

Not having specimen results reviewed by a qualified MRO.

Transmission of test result

Test results received at the C/TPA then retransmitted to the MRO.

Transmission of non-negative test results

Failure to inform employers when there has been a test violation thereby letting the individual who had the test violation continue to work in a safety-sensitive position.

Alcohol testing arrangements

Not ensuring that the facility has alcohol testing equipment listed on the current Conforming Products List (CPL.

Not ensuring the testing facility has qualified personnel do conduct the alcohol testing.

Receipt and transmission of drug test results from the MRO to the C/TPA (If employer so designates)

No documentation that the employer has elected to have the C/TPA receive the test results to be retransmitted to the employer by the C/TPA.  NOTE: This can be included as part of the contract between the employer and the C/TPA.

Arrange for pre-employment testing services

Failure to arrange for or instruct the client on pre-employment testing or exemptions before placing an employee in a safety-sensitive position.

Ensure that the 49 CFR part 40.25 requirements are completed for all new hires

This is a requirement that is placed on the employer but a C/TPA can arrange to assist in completing this process by contract.  If contracted for and failure to complete this contract term, could lead to a NOPE.

Random test selections

Failure to do random test selections at the minimum required rate for both drug and alcohol.

Failure to ensure that all safety-sensitive personnel are in the random selection pool when doing the selections.

Arrange for these random tests to be conducted

Failure to have employees that have been selected for testing report to a testing site with qualified collectors.

Ensure that clients are aware or know when and how to do Post-Accident testing

Failure to inform clients of collection site facilities where post-accident drug and alcohol tests can be conducted.

Failure to inform clients of their modal agency post-accident testing requirements.

Provide for Substance Abuse Professional services for each client

A C/TPA can provide a list of qualified Substance Abuse Professionals (SAP) as a referral in the event of a test violation, however if the C/TPA refers a nonqualified SAP, that could be considered a violation that could lead to a NOPE.

Provide required educational materials that meet regulatory requirements for each client

If contracted for, then educational materials should be provided that meet the requirements of the modal agency.

Provide blind proficiency specimens as required

Failure to submit qualified blind proficiency specimens as required in 49 CFR part 40.103.

Provide audit records as required for each individual client upon request

Audit records are to be provided for upon request within two business days.  Reference:  49 CFR 40.333.

Data management and if required provide a consolidated Management Information System (MIS) report to be submitted as required or requested

This is applicable to all modal agencies and should be provided for upon request of the employer and if an auditor requests, provide same to the auditor. See above question and response.

For USCG provide a listing of marine employers that the C/TPA is submitting the MIS on behalf of enrolled marine employers.

Advice clients on regulatory issues when requested

Consistently give out advice that does not address what is stated in the regulations.  If unsure, contact the agency program manager to get the correct response. 

This above list is not complete but the astute C/TPA should be aware of what actions that can lead to non-compliance and can lead to a NOPE being issued to the C/TPA.

On a personal note I have seen many of these violations throughout my years as a Program Manager.  Some of the most egregious ones were:

  1. Transmission of test results where the test results were walked down the street to the MRO, if they were even taken there.
  2. Failure to inform the employer of non-negative test results allowing the individuals to work in a safety-sensitive position.  (One audit revealed over 80 unreported non-negative test results.)
  3. Submission of blind proficiency specimens with specimens obtained from a street user of drugs then shipped to the laboratory as blind proficiency specimens.

The above items were just the tip of the iceberg with further investigations revealing a whole plateful of regulatory transgressions by these C/TPAs.

How effective the PE process will be as a deterrent for to curb service agents doing activities that are not in correspondence with the regulatory requirements cannot be addressed.  Hopefully it will serve as a deterrent to curb non-regulatory activities with service agents when providing compliance service to regulated employers.

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.