NDASA responds to SAMHSA proposed rules for Oral Fluid Testing in federal workplaces

In its role as the voice for the drug and alcohol testing industry, one of the National Drug and Alcohol Screening Association’s priorities is to provide input representing members’ interests concerning drug and alcohol testing regulations.

On June 1, NDASA submitted remarks to the Substance Abuse and Mental Health Services Administration in response to the agency’s Notice of Proposed Rulemaking, for Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG).

In its introduction, NDASA voiced its strong support for the use of oral fluid testing as another tool in federal drug testing as well as additional steps that will help with the detection of drug test tampering.

“NDASA strongly supports the inclusion of using oral fluid testing as an additional tool to eliminate various issues that exist with the limitations of urinalysis. NDASA also values the efforts to add new testing panels and the requirements for biomarkers that would detect testing substitution.”

However, NDASA voices some concerns on behalf of the drug and alcohol screening industry. Regarding the following:

• The importance of inviting public comment, especially input from industry experts, SAMSHA makes changes to testing panels or practices and procedures.
• Making changes annually to testing panels and associated practices and procedures would “produce an impossible implementation timeframe” and an immense burden on all parts of the industry in terms of cost, preparation, and training.
• Standardization of regulatory language, training requirements, device and testing rules and collection procedures wherever possible between SAMHSA, and the Department of Transportation.
• Specific sections of the proposed guidelines that, according to NDASA members, would make processes more difficult, time-consuming or costly for MROs, collectors, employers and others working within the system. (See below for details.)

NDASA’s remarks were based on expert input from the association’s members and Board of Directors. Below is the full text of the letter submitted to ODAPC. If you have any questions, concerning NDASA’s remarks, please contact Executive Director Jo McGuire.

June 1^st, 2022

In Re: SAMHSA 2022-001

Comments Submitted to:
Ron Flegel, Director
SAMHSA
Center for Substance Abuse Prevention (CSAP)
Division of Workplace Programs (DWP)
5600 Fishers Lane, Room 16N02
Rockville, MD 20857

Regarding:
Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG)
Notice of Proposed Rulemaking
Federal Register Vol. 87, No. 67
Thursday, April 7, 2022

Director Flegel,

The National Drug and Alcohol Screening Association (NDASA) respectfully submits the remarks contained in this letter in response to the SAMHSA Notice of Proposed Rulemaking, Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG), published in the Federal Register at Vol. 87, No. 67, Thursday, April 7, 2022. The comments are based on input from NDASA’s members, and Board of Directors.

NDASA is a non-profit professional association representing over 3,000 private and public sector employers and service agents who administer and manage workplace drug and alcohol testing programs mandated by the Omnibus Transportation Employee Testing Act (OTETA), DOT agency regulations, Federal HHS Drug-Free Workplace Program testing, as well as non-Federal/non-mandated drug-free workplace programs.  NDASA’s membership includes employers’ substance abuse program administrators, Consortia/Third Party Administrators (C/TPA), specimen collection facilities, Collectors, Breath Alcohol Technicians, Screening Test Technicians, laboratories, medical review officers (MRO) and substance abuse professionals (SAP) who support employers in their Drug-Free Workplace Program initiatives. NDASA is a member-owned organization that has led the way for industry education, training, and consultation expertise in the drug-free workplace arena through the NDASA University courses, industry-specific certifications, annual conferences, pertinent webinars and NDASA publications. 

NDASA appreciates and thanks the Substance Abuse and Mental Health Services Administration for the opportunity to comment on the Director’s Notice of Proposed Rulemaking, regarding the proposed changes to oral fluid specimens for use in drug testing as mandated by the HHS Guidelines. NDASA strongly supports the inclusion of using oral fluid testing as an additional tool to eliminate various issues that exist with the limitations of urinalysis. NDASA also values the efforts to add new testing panels and the requirements for biomarkers that would detect testing substitution. However, NDASA members are in strong opposition to changes being made without public comment and believe that annual changes would present an undue burden upon the industry as these proposed changes cannot be completed with such short timelines.

NDASA submits the comments below as requested in the NPRM:

• While the NDASA Membership fully supports the ability to maintain flexibility in adding and removing drug panels as needed, industry participants believe it is vital that public comment remains as a necessary, critical component in the process. The decisions made by SAMHSA have far-reaching impact across the industry, particularly to the laboratories, the Medical Review Officers, and in the long-term to the U.S. Department of Transportation program that will follow suit. Creating annual changes without public comment is not an appropriate precedent to set and has the potential to create unrealistic expectations and deadlines.

• NDASA is concerned that the proposal of annual changes to the drug test panel will produce an impossible implementation timeframe that places a costly and cumbersome burden upon the laboratories. Additionally, industry experts believe that there will be associated costs passed to the end-user if the drug panels become extensive. Annual changes will also require employers to update their workplace drug and alcohol testing policies and provide notification to their employees, which will also incur time and expense. NDASA respectfully requests a more realistic, flexible and adequate schedule for changes to the HHS drug testing panels.

• NDASA requests clarity on what established method(s) or system(s) will be used to collect data and whether there has been a cost impact study to determine the effect on employers and industry participants who must collect the data that will determine future drug test panels. Will the baseline data and significant quantifications be made public information when the notices of changes are published, whether a panel is added or removed?

• In reference to the outlined need for biomarkers, NDASA members are requesting standardized biomarker panels across the industry that will aid in the detection of specimen substitution. While the intent to prevent substitution of any specimen is applauded and needed, NDASA requests that all industry stakeholders be consulted to determine satisfactory biomarker standards. While it is admirable that attempts are being made to produce standard nomenclature between urine and oral fluid testing, it is simply not practical when differentiating between the two, where uniquely identified analytes occur in the separate specimens. We ask for consideration in allowing industry consensus to determine how the analytes should be identified.

• NDASA does not believe the cost analysis provided was sufficient in considering the real costs to Medical Review Officers for mandated bi-annual reporting, nor was training and education considered for bringing MROs and MRO Staff up to date with newly added drug panels and reporting methods. We request the MRO community be given input into these matters in order to permit the MROs to be adequately staffed and prepared for these changes.

• Regarding the determination of refusals to test during a pre-employment scenario, NDASA encourages SAMHSA to reconsider this departure from decades long established protocol. As donors in a pre-employment situation are typically not yet hired and not a current employee, reporting a refusal to test could damage the individual’s ability to seek further employment in a safety-sensitive position. For example, if a donor finds out they were hired by another preferable employer just as they are entering the collection area and the donor chooses to forego the current drug test so as to not waste time or expense, this should not be marked as a refusal to test.

• NDASA requests clarity in the HHS Guidelines that it is the employer and not the collector who makes a refusal to test determination. To maintain consistency and clear up confusion across urine collections, oral fluid collections, and collector training that impacts both DOT and HHS safety sensitive employees, collectors may document and notate the circumstances, but it is up to the employer representative to make the determination.

• In light of the ability for oral fluid devices to be used without the need for a restroom facility, which may include no availability of a sink, NDASA requests the option for the donor and collector to wear gloves, rather than mandatory handwashing. Additionally, the requirement that the donor must refrain from touching any surfaces post-handwashing is an unnecessary and unreasonable expectation.

• Device manufacturers should have the option to use acceptable opaque vials, not simply transparent, due to cost considerations, supply availability, and currently approved manufacturing specifications.

• To prevent placing an undue labor and time burden upon the labs, it is imperative that the laboratory not be required to double-check the expiration date on the devices. It is sufficient for the collector to do so and to note this on the Chain of Custody Form.

• Under Subpart D – Collectors: Section 4.1 Who may collect a specimen, NDASA requests the word “each” replace the word “the” before “manufacturer’s procedures”

• Under Subpart D – Collectors: Section 4.3 What are the requirements to be a collector? Under a) 4) i): NDASA requests the 5 mock demonstrations consist of: 2 uneventful, 1 device appears to be tampered with, 1 insufficient quantity and 1 donor is uncooperative/refuses to test. Donors refusing to sign has not been an issue in the industry for many years and collectors need to train on commonly occurring, real life scenarios.

• Under Subpart D – Collectors: Section 4.4 What are the requirements to be a trainer for collectors? NDASA requests a uniform list of training components required before an individual may be considered a trainer. Trainers should also be required to understand the manufacturer’s specific device use for each device for which they are providing training. NDASA would like to understand if trainers will be grandfathered into the first year of oral fluids implementation as trainers, if they have not performed 1 year of oral fluid collections.

• Under Subpart E – Collection Sites: Section 5.2 What are the requirements for a collection site? Under b) “A suitable and clean surface area that is not accessible to the donor for handling the specimens and completing the required paperwork.” This requirement is not consistent with how collections are performed, in which the donor and the collector BOTH access the Chain of Custody Form and the specimen tubes for signature. The words “that is not accessible to the donor” may be removed.

• Under Subpart G – Oral Fluid Specimen Collection Devices: NDASA requests that current commonly used and approved oral fluid devices be deemed satisfactory for HHS use in oral fluid collections. These requirements should be standardized in alignment with those approved by the U.S. DOT program in order to ensure the industry does not have separate requirements for separately approved devices.

• Under Subpart H – Oral Fluid Specimen Collection Procedure: Section 8.4 What steps does the collector take in the collection procedure before the donor provides an oral fluid specimen? Under b) 1) Please add “Collector will verify and note the device expiration date” to “The collector will open the package in view of the donor.”

• Under Subpart H – Oral Fluid Specimen Collection Procedure: Section 8.9 How does the collector report a donor’s refusal to test? Under c) “Sending all copies of the Federal CCF to the federal agency’s designated representative” should be more specific to include the collector keeps the Collector Copy and the Donor is given the Donor Copy.

• Providing excellence in training of collectors is one of NDASA’s highest priorities. For maintaining consistency across industry practices, we request that the collection guidelines be standardized and duplicative with the U.S. DOT guidelines to every extent possible in order to alleviate collector confusion, prevent errors, and alleviate the costs of duplicative training where collectors participate in both HHS and DOT programs.