By Todd Simo, MD, President, American Association of Medical Review Officers (AAMRO); Chief Medical Officer, International Association of Medical Review Officers (IAMRO)
More than 24 years ago, I began my Medical Review Officer (MRO) practice after being certified by the American Association of Medical Review Officers (AAMRO). At that time, 49 CFR 40 only had one safety concern provision under 40.327. That regulation essentially stated MROs must immediately relay any safety concern to the Designated Employer Representative (DER) at the time of interview based upon that MRO’s belief the donor may not be able to perform safety-sensitive duties safely.
This regulation is straightforward. In my MRO practice, I voiced a safety concern on any donor who had verifiable proof of ongoing opiate use (whether daily or sporadically). I informed the DER that medical clearance was recommended, and that the donor be removed from safety-sensitive duties until clearance was obtained from his/her treating physician (or a physician knowledgeable of the safety-sensitive duties and prescription drug usage) to perform those duties. Beyond ongoing opiate use, I also voiced safety concerns for other classes of drugs on donors covered by medical fitness standards under DOT agency rule (FMCSA, FAA pilots, and mariners covered by USCG).
In 2018, the safety concern process landscape changed because ODAPC introduced 40.135 into its rule. 40.135 specifies that no safety concern can be relayed until you (the MRO) provide the donor five business days to attempt to receive medical clearance from his/her treating physician. However, 40.327 remains, and the question is, “Which regulation do I follow?” I hope the forthcoming guidance helps you in your MRO practice.
§ 40.327 (Immediate Safety Concern)
“As the MRO, you must report drug test results and medical information you learned as part of the verification process to employers without the donor’s consent if you determine, in your reasonable medical judgment, that:
The information is likely to result in the donor being determined to be medically unqualified under an applicable DOT agency regulation; or
The information indicates that continued performance by the donor of his or her safety-sensitive function is likely to pose a significant safety risk.”
I lever the “Immediate Safety Concern” process for any DOT donor who has a medical safety standard in place. The three DOT drug testing entities that have a medical standard are:
- Federal Motor Carrier Safety Administration
- Federal Aviation Administration for pilots
- United States Coast Guard
Every drug class tested for on the DOT panel is potentially medically disqualifying for donors covered under the above DOT agencies. This includes amphetamine; therefore, I follow the following safety concern process:
Medical Qualification Agency Safety Concern Process
ONLY if the prescription verification happens immediately after the interview, do I notify the DER of the safety concern after the verification.
My reasoning is to notify the DER immediately of the safety issue under the agency medical standard to assure the safety sensitive employee has been appropriately vetted by the medical examiner, and if he/she has not been medically cleared, recommend removal from safety sensitive duties to ensure safety and compliance as well as mitigate risk for that employer. In relaying the safety concern, I use a separate letter from the drug test report since in some instances, I am relaying the safety concern prior to my ultimate drug test verification.
§ 40.135 (Latent Safety Concern)
Before informing any third party (the employer) about any medication the donor is using pursuant to a legally valid prescription, you will allow five business days for the donor to have the prescribing physician provide medical clearance. If, in your reasonable medical judgment, a medical qualification issue or a significant safety risk remains after you communicate with the employee’s prescribing physician or after 5 business days.
If, in your reasonable medical judgment, a medical qualification issue exists after you communicate with the donor, you must follow §40.327.
The “Latent Safety Concern” rule was put into place when DOT added opioids to its drug testing panel. The reasoning given for this rule is that during the notice of proposed rulemaking, ODAPC received multiple comments from safety-sensitive employees saying that they believe they would be fired if their employers knew of their prescription drug usage.
The 40.135 process is pertinent for DOT employees who are managed under the following agencies:
- Federal Aviation Administration – non-pilots
- Federal Transit Administration
- Federal Rail Administration
- Pipeline and Hazardous Material Safety Administration
No medical qualification agency safety concern basic process
How I functionally handle the 40.135 process is to provide the donor a checklist that he/she can share with his/her physician. The checklist provides the treating physician the following option:
- Safe to perform safety-sensitive duties with the medication usage
- Unsafe to perform safety-sensitive duties with the medication usage
- Changing the medication
- Then specifying what the new medication is
I verify that letter on receipt, and I tether together the safety concern process with the prescription verification since I do not want to report a negative drug test to then report a safety concern several days later.
My overall 40.135 process
Please note it does have an “escape hatch.” If you believe a donor without a medical standard is unsafe based on your interview, you must immediately relay that to the DER. However, functionally doing this on every case opens yourself and the employer up to scrutiny due to ADA and EEOC issue.
In conclusion, the handling of safety concerns is a core responsibility of the MRO. Knowing the DOT agency regulations and knowing how to navigate between the two safety concern rules is critically important to assure not only your compliance, but also to mitigate the client’s risk and improve safety.