DOT Public Interest Exclusion – PIE

… 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.

Labs, MRO’s and SAP’s and the PIE

This section 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.

PUBLIC INTEREST EXCLUSION: HISTORICAL, DEVELOPMENTAL AND IMPLEMENTATION ASPECTS

This section article will address the history along with the process and procedures to be taken for a Public Interest Exclusion (PIE) and the process and timeline for a Notice of Public Exclusion (NOPE).

It should be noted that there is no specific Congressional legislation that allows for a PIE and NOPE procedures or process to take place. However there is an Executive Order 12549 (3 CFR 1986 Comp., p. 189), issued on February 18, 1986.  The purpose of this Executive Order was to establish a government-wide debarment and suspension system for government contractors that failed to fulfill the scope of their contract with a US Government Agency or failed to comply with all government requirements. One of the requirements is to be incompliance with the Drug-Free Workplace Act of 1988.

Just to be clear on one point that is oftentimes confusing, the Drug-Free Workplace Act of 1988 did not have any requirement for drug testing but was largely an educational program that Federal Contractors were required to be in compliance with.  The program requires a commitment to a drug free workplace so a best practice interpretation would be to include drug testing although not required.

As identified in a previous article, the development of Consortiums/Third Party Administrators (C/TPAs) was not anticipated by DOT. For a lengthy period of time, DOT was unsure on how to deal with C/TPAs and service agents that were not operating within the regulatory boundaries.

It was not until December 9, 1999 when the proposed changes to 49 CFR part 40 were published was the PIE was first identified as a process for dealing with “bad actors”.  These proposed changes to 49 CFR part 40 including the PIE were finalized on December 19, 2000.

There have been 3 PIEs issued since that date. It is unknown how many NOPEs have been issued that the issuance of a NOPE is not a public record but part of a process.  This point will be explained later in this article.

It should be noted that to date, there have not been any legal challenges regarding the authority of DOT to issue a PIE.

A question is who can initiate a PIE?  The only parties that can initiate a PIE are each of the modal agency Program Managers, an official of Office of Drug and Alcohol Policy and Compliance (ODAPC) except for the Director or a designee of these officials.  A designee should be identified in writing.

It should be noted that an initiating official have broad discretion in making the decision of whether or not to pursue a PIE action.  A Modal Agency Program Manager can work with a Senior Policy Analyst within ODAPC.  Each of the three Senior Policy Analysts will have as a practice two modal agencies that they will work closely.  At all times and in accordance with internal policy, the decision maker, normally the Director, will be kept in the dark and not aware that a PIE is being proposed until shortly before the actual hearing.

Before a PIE is initiated, the initiating official will informally contact the service agent whose conduct is in question. It is after that communication that a Notice of Public Exclusion (NOPE) will be issued to the service agent being charged.

The NOPE is to give the service agent an opportunity to make corrective changes in those areas that are outlined in the NOPE. These changes must be in writing and submitted to the initiating official within 60 days of receipt of the NOPE.  All correspondence should be writing and with the use of certified mail.

The initiating official has the authority to conduct fact finding to ensure that the listed corrective changes have been made.  If satisfied that all corrective compliance action has been taken, the initiating official will send to the service agent that the matter in question has been satisfied and concluded.

If the conditions of the NOPE are not successfully brought to a conclusion, then the process continues to a PIE hearing.  The hearing will take place before the decision maker, who has been kept in the dark up to this point.  The parties that will be present at the hearing will be the Initiating Official, Modal Agency legal representation (if needed), the named party in the NOPE and PIE and their legal representation.  An attorney from DOT General Counsel may also be present.

The evidence of non-compliance will be presented along with the NOPE.  The NOPE will be accompanied with the dates of sending to the service agent and then the receipt by the service agent.

The decision maker will hear the case and review the case.  The decision maker will render a judgment based on the evidence and relevant testimony.

There have been three PIEs issued.  How many NOPES have been issued is largely unknown.

A question for discussion is can a PIE action be initiated even if there is a NOPE and corrective action has been taken?  The answer is yes; a PIE action can be initiated.  The rationale is that the PIE action can be initiated for past actions that a service agent has taken, even though corrective action has been taken.

On a personal note, I could have issued NOPEs while I was a Program Manager but in all of the cases, the violations were mostly resolved.

The first instance was a Doctor of Chiropractor posing as an MRO and managing a C/TPA.  When called about it, they closed their doors and go out of the drug test business immediately. A review a week later revealed that they were no longer in business.

Another instance with over 80 non-negative tests not reported to marine employers or to the Coast Guard, that C/TPA is no longer in business.

As a follow-on to the above, A Vice-President of a major marine transport company called me one afternoon about a compliance issue with this C/TPA.  My response was that this C/TPA was not in compliance. The Vice-President was also a Vice-President of a major waterways association with the majority of the association members having their program managed by this C/TPA.  I swear that I could hear the emails and phone calls going up and down the Eastern Seaboard as the word was passed about the non-compliance.  Later that afternoon, I received a phone call from the C/TPA asking what they could do to get back in compliance.  I told him that there was no way as all the reports were not only two months past due but more than three years past due. A month later I myself and some Coast Guard Investigating Officers performed an audit on this C/TPA where we discovered all of those non-negative tests that had not been reported.  They shuttered their doors soon after that audit.  I was informed that it took that particular marine safety office almost five years to clean up that mess.

On the other potential NOPE and PIE action and the C/TPA where they were using a street person to donate his urine to use as proficiency specimens, I retired before I could complete that action. That was just one of several charges that I was preparing against this C/TPA.

Again, 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.

Public Interest Exclusion: Legal Standing and Can a PIE Be Challenged? 

This is a special article that will discuss a challenge to a Public Interest Exclusion (PIE) and the process for a Notice of Public Exclusion (NOPE). At the same time, it will examine the regulatory process in years 1996, 1999 and 2000 when the PIE was being formulated.

Again, it should be noted that there is no specific Congressional legislation that allows for a PIE and NOPE procedures or process to take place.  There is an Executive Order 12549 (3 CFR 1986 Comp., p. 189), issued on February 18, 1986 by then President Ronald Reagan. The purpose of this Executive Order was to establish a government-wide debarment and suspension system for government contractors that failed to fulfill the scope of their contract with a US Government Agency or failed to comply with all government requirements.  It is that Executive Order that the PIE process is based upon.

It was not until December 9, 1999 when the proposed changes to 49 CFR part 40 were published was the PIE first PUBLICLY identified as a process for dealing with “bad actors”.  These proposed changes to 49 CFR part 40 including the PIE were finalized on December 19, 2000.  While an Advance Notice of Proposed Rulemaking (ANPRM) was published in the Federal Register on April 29, 1996, wording from that ANPRM does state: “The Department conceives this ANPRM, then, not as an occasion for suggesting major substantive changes to how we test for drugs and alcohol, but rather as an opportunity to clarify the myriad details of Part 40. We want to make the rule as easy to understand and apply as we can, reduce burdens where feasible, take “lessons learned” during the several years of operating the program under Part 40 into account, correct problems that have been identified, clarify areas of uncertainty or ambiguity, and incorporate, where appropriate, the Department’s interpretations of Part 40 into the regulatory text. We also anticipate reordering provisions of the rule so that the material flows more smoothly and is easier for readers to follow.”

There is no mention or identification of a proposal to initiate the PIE Process.

Department of Transportation(DOT) stated in the Preamble on December 9, 1999 (Federal Register page 69086) is the following: “This process is analogous to the procedure for imposing suspension and debarment in non-procurement situations (see 49 CFR part 29). It should be noted that this proposed provision is not a sweeping new assertion of regulatory authority over entities who were previously untouched by DOT regulations. Provisions of both part 40 and DOT agency drug and alcohol testing regulations already govern in detail the activities conducted by laboratories, MROs, collectors, substance abuse professionals, and other service agents. The proposed provision adds no new substantive requirements. Rather, it uses the Department’s existing regulatory authority over transportation employers to direct the employers, in the public interest and in the interest of their own compliance with our regulations, not to use service agents whose conduct violates part 40. The General Counsel of the Department of Transportation has determined that the Department has sufficient legal authority to implement these proposed requirements.”

A question that should come to mind did DOT have sufficient legal authority to implement the PIE process.  Until there is a court challenge to the PIE process that question will remain unanswered.

The Office of Management Budget (OMB) for the publication of the NPRM and the Final Rule made the determination the changes to 49 CFR part 40 were not significant.  I have to question what the ruling of OMB would be today if those Proposed and Final Regulations were presented to them for review.  I have to believe that there would be a Significance Determination by OMB.  I say that based upon my own experience in the rulemaking process.

As a further note DOT sought comment on three alternative methods for the implementation of the PIE. As stated in the Preamble on December 9, 1999 (Federal Register page 69086) is stated the following: “We believe that all these alternative approaches could use due process procedures like those outlined above: (1) The process would work as described above, but instead of issuing a PIE, the Department would issue an advisory notice to employers telling them that the service agent was not providing services as required by part 40, placing employers using the agent at peril of enforcement action. (2) As a condition of participation, all service agents would be required to self-certify that they provide all services as required by Part 40. Instead of issuing a PIE, the Department would decertify service agents that failed to carry out requirements properly. (3) A contract provision in all agreements between service agents and regulated employers (see §40.11(d)) would bind service agents to providing services in compliance with Part 40. Noncompliance would breach this provision, leading to termination of the contract.”

The DOT did not directly adopt any of the above three alternative approaches in lieu of the PIE.  Why they did not adopt but my assumptions are for each one not being adopted are:

1. Approach (1): The PIE process is a modification of this approach.
2. Approach (2): Self-certification on paper looks great but in practice is not a viable option as that would leave self-certification wide open to a number of both good and bad players.  Potentially this would not happen as in order to decertify an inspection or audit would have to be done on each service agent that was being decertified.  Then the question arises would one minor flaw be cause to decertify or how many flaws would it take to decertify?  That could vary from service agent to service agent and upon the type of service being provided.  The scenarios or combination of scenarios are far too numerous to count and would render that certification process unworkable.  Another minus factor is how much manpower and expense could potentially be involved in this particular process.
3. Approach (3) is one that was proposed and is in place as stated in 49 CFR part 40.11(c) which states: “(c) All agreements and arrangements, written or unwritten, between and among employers and service agents concerning the implementation of DOT drug and alcohol testing requirements are deemed, as a matter of law, to require compliance with all applicable provisions of this part and DOT agency drug and alcohol testing regulations. Compliance with these provisions is a material term of all such agreements and arrangements.”

On March 2, 2000, a petition was received by DOT/ODAPC to sever the Proposed PIE from the proposed Part 40 rulemaking process and enter into negotiated rulemaking in accordance with the provisions and procedures of the Negotiated Rulemaking Act of 1990 (NRA), 5 U.S.C. ”561 – 570.

A response to the above petition dated March 9, 2000 in which the petition was denied.  There were several reason given for the denial but in the response letter from DOT it is stated: “However, we do not believe that that negotiated rulemaking is necessary or appropriate in this case.”

It should further be noted in the response letter, a meeting between DOT/ODAPC and certain SELECT representatives from Substance Abuse Program Administrators Association (SAPAA) is identified.  This meeting was titled the “First SAPAA Invitational Conversation” was held at a hotel in downtown Washington, DC.  Representatives of ODAPC were invited and accepted the invitation including the ODAPC Director.  Included in the meeting agenda (unpublished) the PIE was discussed, apparently at length.  This meeting was held shortly before the Notice of Proposed Rulemaking (NPRM) was published on December 9, 1999.  A transcript of those proceedings was promised but was not distributed nor made public.

The letter of request to sever out the PIE process from the rulemaking and the response letter are part of the public docket and can be located in www.regulations.gov.  The Docket Number for the petition is DOT-OST-1999-6578-0032.  The Docket Number for DOT Response is DOT-OST-1999-6578-0037.

The question still remains about DOT authority to have a PIE process.  Will a court challenge ever be mounted is hard to say but in my opinion, no.  Why, is because of the expense in bringing this to a legal review through a court process.  It will take very deep pockets with DOT prepared to defend the PIE process.

This concludes for the present time, the discussion about the PIE and NOPE processes.  If there are any questions about the PIE and NOPE processes, please let me know by contacting National Drug Screening as they will pass on any questions to me.