April 26, 2022

NDASA’s Response to Proposed Guidelines for Oral Fluid Testing and Other Changes to 49 CFR Part 40

By NDASA

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 April 20, NDASA submitted remarks to the Office of Drug and Alcohol Policy and Compliance in response to the Department of Transportation, Department of the Secretary’s Notice of Proposed Rulemaking, Procedures for Transportation Workplace Drug and Alcohol Testing Program: Addition of Oral Fluid Specimen Testing for Drugs.

In its introduction, NDASA voiced its strong support for the inclusion of oral fluid testing in 49 CFR Part 40.

“NDASA strongly supports the inclusion of using oral fluid testing as an additional tool to eliminate various issues that exist with the limitation of using urinalysis only at present, such as direct observation collections, ability to subvert the test, and shy bladder, to name a few.  NDASA believes the addition of oral fluid as an alternative specimen for testing will assist those involved in the drug and alcohol testing Industry, covered employers, vendors, and service agents to diminish many current collection procedural errors that occur.”

In addition to commenting on how the inclusion of oral fluid testing will benefit those in the drug and alcohol screening industry, NDASA reviewed proposed changes in language to 49 CFR Part 40. The association:

  • Included remarks and recommendations concerning proposed language in the Oral Fluid Testing procedures that might not be clear to industry professionals and potentially cause confusion.   
  • Called for increased standardization for procedures and training for collectors and other professionals in the industry to reduce confusion and collection errors. (“standardized collector and trainer training curriculum is needed for all specimen collections…”)
  • Supported clarifying language (about collection donor identification requirements, for example) and more specific definitions of general terms like “medical personnel.”
  • Suggested opportunities to reduce in inefficiencies in procedures and documentation that cost time and money or create problems in an audit (for example, requiring collectors to record two phone numbers for a donor on the CCF and the risk involved with leaving those spaces blank.)  

NDASA’s remarks were based on expert input from the association’s Board of Directors and Governmental Committee. 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.


NDASA logo

April 20th, 2022

In Re: Docket DOT–OST–2021–0093, RIN 2105-AE94

Comments Submitted to:

Patrice Kelly, JP, Office of Drug and Alcohol Policy and Compliance
Department of Transportation
Office of the Secretary
Docket DOT-OST-2021-0093
RIN 2105-AE94
Regarding:
Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Oral Fluid Specimen Testing for Drugs 49 CFR Part 40
Notice of Proposed Rulemaking
Federal Register Vol. 87, No. 39
Tuesday, February 28, 2022

Dear Patrice,

The National Drug and Alcohol Screening Association (NDASA) respectfully submits the remarks contained in this letter in response to the Department of Transportation, Department of the Secretary’s Notice of Proposed Rulemaking, Procedures for Transportation Workplace Drug and Alcohol Testing Program: Addition of Oral Fluid Specimen Testing for Drugs, published in the in the Federal Register at Vol. 87, No. 39, Monday, February 28, 2022.  The comments are based on input from NDASA’s Governmental Affairs Committee, its members, and Board of Directors.

NDASA is a non-profit professional association representing over 3,000 private and public sector DOT-regulated employers and service agents who administer and manage workplace drug and alcohol testing programs mandated by the Omnibus Transportation Employee Testing Act (OTETA) and DOT agency regulations, 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 and 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 Department of Transportation for the opportunity to comment on the Department of Transportation, Office of the Secretary’s Notice of Proposed Rulemaking, regarding the proposed language changes to 49 CFR Part 40 to allow the addition of oral fluid specimens for use in drug testing as mandated by the Department of Transportation.  NDASA strongly supports the inclusion of using oral fluid testing as an additional tool to eliminate various issues that exist with the limitation of using urinalysis only at present, such as direct observation collections, ability to subvert the test, and shy bladder, to name a few.  NDASA believes the addition of oral fluid as an alternative specimen for testing will assist those involved in the drug and alcohol testing Industry, covered employers, vendors, and service agents to diminish many current collection procedural errors that occur.  

NDASA submits the comments below as requested in the NPRM:

Using Oral Fluid Testing as an Alternative Method Can Reduce Costs

The assertation that oral fluid testing may be less expensive than urinalysis needs further consideration. Most of the cost an employer incurs in drug or alcohol testing is the collection fee. Although the cost of oral fluid testing may appear less than urine on the surface, when you take a closer look, oral fluid may be slightly more expensive. The average cost for a DOT urine collection provided by a third-party collection site: $20 – $25 for the collection fee (more if on-site, at the employer’s location) + $12 – $20 for the laboratory testing + $3 – $6 for MRO review = $38 to $51. If an outside collector (not an employer representative) is still collecting the specimen, those costs would most likely remain the same, however, the cost of the oral fluid kit would need to be factored in, which could be approximately $3 – $8. Unlike urine specimen collection supplies, oral fluid test devices will have an expiration date that could incur further costs to replace outdated inventory.  If an employer chooses to collect in-house, their representative who acts as a collector would be required to obtain full “qualification training” (urine, oral fluid, and alcohol training with device specific manufacturer training) from a person meeting the trainer requirements of Part 40. This will incur further expense for the employer. NDASA strongly recommends oral fluid testing remain with the existing collection sites in order to keep costs minimal and to protect the integrity of the collections process. NDASA does agree there will be substantial cost savings where time is concerned for the employer, donor, collector, and MRO.

The members of NDASA agree that oral fluid is needed to protect the integrity and effectiveness of the DOT safety program. We appreciate the opportunity for enhanced flexibility in cases of insufficient urine specimen and specimens submitted with an out-of-range temperature. NDASA also values the prospect oral fluid collections offer for enhanced logistic versatility in providing and using a non-restroom-based collection area.

NDASA and its members fully agree that oral fluids testing will decrease the alarming rate of attempts to substitute or adulterate the urine specimen, thereby assuring DOT the integrity of the drug test specimen is in full alignment with safety as the highest priority.

  1. § 40.3 What do the terms used in this part mean?
    a. We agree with these changes and particularly would like to emphasize our appreciation in clarifying the term “SSN or Employee I.D. Number” as this has caused confusion in the industry.
    b. We agree with all other proposed definition changes in this section.
  2. §  40.13 (d) How do DOT drug and alcohol tests relate to non-DOT tests?
    a. We agree with these changes and appreciate the clarification regarding medical tests as non-DOT tests.
  3. §  40.26 What Form Must an Employer Use to Report Management Information System (MIS) data to a DOT agency?
    a. We agree with this proposed change.
  4. §  40.29 and similar sections
    a. We believe there are many who continue to utilize the cross referencing through manual means.  However, most people have the capability to search electronically for specific information in Part 40.  Those most affected by this change would be the owner-operators under FMCSA, many of whom do not have sufficient electronic capability or knowledge.  In those instances, they should maintain a relationship with a C/TPA as their service agent with whom they could enlist assistance.  Therefore, we agree with the proposed changes.
  5. § 40.31 Who may collect specimens for DOT drug testing?
    a. NDASA agrees with the requirement of training qualifications for all oral fluid specimen collectors.
    b. NDASA agrees with the clarification that employees, relatives, and close friends of the donor may not conduct collections consistent with existing guidelines.
  6. § 40.33 What training requirements must a collector meet for urine collection?
    a. NDASA strongly agrees with and appreciates this change. We feel that unnecessary error correction has been required for far too many circumstances that are beyond the control of the collector, costing time and cancelled tests.
  7. § 40.35 What training requirements must a collector meet for oral fluid collection?
    a. NDASA agrees with the suggested requirement of training qualifications for all oral fluid specimen collectors similar to urine collector qualifications. However, the association membership has expressed concerns that urine collection training requirements should be similar to and reflect those specified for Alcohol as noted in Subpart J 40.213 (b)(1) which outlines the DOT Model Course. Additionally, we highly recommend the oral fluid specimen collection guidelines do the same (and any further approved specimens in future). Without a standardized and structured training curriculum, training of collectors nationwide has degraded over time with regards to quality and content. We recommend the Urine Specimen Collection Guidelines be re-titled, “Specimen Collections Guidelines” that would encompass all specimen collections training with a mandated curriculum outline.
    b. NDASA does not believe 5 proficiency demonstrations should be provided for each type of oral fluid device as this is not practical or cost-effective, but the mock demonstrations can include a variety of approved devices in accordance with manufacturer’s instructions.
    c. NDASA members are requesting an updated version of the Specimen Collection Guidelines that address and bring clarity to those common situations that occur in the “real world” of performing collections, in order to provide cohesive instructions, eliminating errors and confusion that cause actions based on self-interpretation, i.e. donors who enter the facility claiming inability to provide a specimen before an attempt to provide is made, donors leaving before shy bladder is complete, the point at which the actual collection process begins, who may and may not determine a refusal to test, etc.
    d. Currently, each oral fluid device has its own instructions for how to provide the collection with that device, meaning collectors would need to be trained on the specific oral fluid collection device being used. We recommend collectors be required to obtain device-specific training for DOT devices (according to each manufacturer’s written instructions.) NDASA also is in favor of the DOT or ODAPC producing an updated and relevant specimen collector training video to include all specimen types.
    e. Pertaining to training qualifications, allowing for the same type of “qualifications” of those who monitor mock collections as urine is good in theory, however, in many cases with urine, the reality is that mock proficiency demonstrations are monitored by people who are simply signing off without thoroughly reviewing for accuracy or that they are consecutively error-free, etc.  This leads to collector qualification that is severely inadequate.  Again, the need for a standardized collector and trainer training curriculum is needed for all specimen collections, similar to the Alcohol guidelines.
    f. NDASA requests clarity that mock demonstrations may be performed virtually when the only trainer available is long-distance.
    g. Per the question regarding pre-printing DER information on the CCF, as frequently as DERs change employment, this is an impractical and potentially costly suggestion. However, a space to write DER information is acceptable.
    h. We agree with the addition of “collectors” to the title of 40.43
    i. We agree with re-numbering the sections accordingly.
    j. We agree with the clarification that the collection site address information should accurately reflect the precise location where the collection has taken place. As for a telephone number that provides access directly to the collector and/or the collector’s supervisor, we believe it may be difficult to compel all collectors to supply a personal telephone number outside of their workplace phone. The collection site business phone number should suffice.
    k. NDASA requests clarification on whether or not it is acceptable to use an expired driver’s license as proof of identification for a donor who requires a mandated drug or alcohol test.
  8. § 40.65 What does the collector check for when the employee presents a urine specimen?
    a. To be in compliance with employment law, employers should notify their employees of the inclusion of oral fluid in the DOT drug testing policies and any decision to provide a second alternative specimen should be clearly defined in the employer policy and clarified in the contract between the employer and the service agent. The C/TPAs and employers should communicate instructions ahead of time to the collector, so they understand how to proceed before they find themselves in the situation. If these items are in place, the collector should be able to proceed with a second, alternative specimen collection to satisfy the need of a directly observed test.
  9.  § 40.67 When and how is a directly observed urine collection conducted?
    a. Pertaining to an exception to the same gender requirement for a directly observed urine collection, the term “Medical Personnel” should be clearly defined at a level that carries professional medical malpractice insurance, for example P.A., N.P., M.D., D.O., or D.C. and only used at the discretion of both the donor and the observer. Otherwise, the direct observation procedure should revert to a same gender observer. It is more preferable to use oral fluid in lieu of a urine collection where direct observation is required.
    b. NDASA is in agreement with the proposed technical change.
  10. § 40.71 How does the collector prepare the urine specimens?
    a. NDASA requests the word “after the collection” be added before the words “for urine” so the collector understands these boxes are checked AFTER the collection takes place.
  11. § 40.72 – 40.74 – NDASA is in agreement with the emphasis on determination of refusal and the instructions for the collector to check the expiration date on the device and use according to the manufacturer’s instructions.
  12. § 40.72
    a. Requesting clarification that the word “employee” in 40.72 be changed to “donor”.
    b. Is rinsing the mouth with 8 oz. of fluid in 40.72(b)(1) a scientifically valid measure for creating saliva production in cases of dry mouth? We propose the collector be allowed to switch to a urine collection in cases where dry mouth prevents the collection of oral fluid.
  13. § 40.79
    a. Pertaining to Step 5 of the revised CCF, donors frequently do not have a second phone number or email address. NDASA is requesting the collector be permitted to write N/A when there is no alternative phone number or email information to be provided. Across the industry, auditors frequently require all spaces be filled in with “something” or blank spaces will be considered a finding against the subject of the audit. This is an unreasonable demand that creates confusion, is time consuming and should be easily remedied with a simple alternative.
  14. § 40.83
    a. NDASA has concerns that 90 days is far too short of a time frame for donors to challenge their results. We do not support this change and recommend the “one year” remain out of fairness to the donor and to remain consistent with common industry practice.
  15. 40.97
    a. In reference to 40.97(c)(1)(i)(I) requiring elements to include in the lab report format: “For oral fluid only, collection device expiration date”, NDASA is deeply concerned this will create an undue burden of labor upon the labs which will increase time and create exorbitant expense. This responsibility should be on the collector during the time of the collection and added to 40.73(c) in correct use per the manufacturer’s instructions, collector should verify the device is not expired. This could also be recorded on the CCF or the security seals by the collector at the time of the collection.
    b. NDASA has concerns that the indicated use of “clear” security labels for oral fluid collections will create significant cost to the industry.  At this current time, clear label materials are an untested technology, without evidence of how a clear label product could affect the collection device and its components. For the collector to verify the expiration date during the collection process and then adhere paper-based security seals which are already in use and industry standard, should suffice in the collection process.

SUBPART F & G

  1.  § 40.141 How does the MRO obtain information for the verification decision?
    a. NDASA and its members agree that the trained MRO Staff/Assistants should be permitted to verify prescriptions at the pharmacy. The MRO must be the only one that generates the final determination of the result.
  2.  § 40.191 What is a refusal to take a DOT drug test, and what are the consequences?
    a. NDASA strongly agrees with, “The proposed rule would revise § 40.191(d) and add a new paragraph (c)(1) to § 40.261 to clarify an often-misunderstood point about who has the authority to declare that conduct at the collection site constitutes a refusal to test. The Department has received many inquiries in which employers have automatically treated as a refusal any situation in which the collection site notes a refusal in the remarks section of the CCF. This is not correct.” However, per the example given, “For example, if an employee arriving for a pre-employment test, engages in disruptive or combative conduct at the collection site, a collector could report a refusal to the employer for determination” this language is confusing in real life situations. Collectors are often “reporting refusals” to the DER, who interprets this as the determination, rather than investigating the circumstances on their own. As DERs are not required to undergo mandatory training, they often rely on the collection site for guidance. We are requesting clarity in this area that collectors “notify” an employer of a donor’s actions, followed by the employer’s determination of “whether or not” this constitutes a refusal.
    b. NDASA highly recommends consideration of mandatory training for DERs.
  3. § 40.193 What happens when an employee does not provide a sufficient amount of specimen for a drug test?
    a. NDASA is in support of using one, single Chain of Custody Form to preserve supplies and maintain a single Specimen I.D. Number throughout the process, except in cases where the urine collection device and the oral fluid device are supplied by different labs. We also support a single CCF when possible, because cross-referencing forms causes difficulty and confusion for collections professionals.
    b. If the regulations state the employer has the option of requiring an oral fluid specimen, would the medical evaluation for shy bladder still need to be performed?
  4. § 40.207 Pertaining to: Can an MRO ever “uncancel” a test:
    a. An MRO is unable to cancel a test without a Chain of Custody Form. The Association would recommend that ODAPC provide guidance for an MRO to issue a report that the test is cancelled if the MRO has not received a legible Chain of Custody Form. The MRO must mark Copy 1 as cancelled in the absence of Copy 2. This can be done at the bottom of the Chain of Custody Form on Copy 1 in the blank space.
  5. § 40.210 What kinds of drug tests are permitted under the regulations?
    a. We believe the employer should make the decision, per their workplace drug and alcohol policy, which initial specimen should be collected and only in cases where an alternative is required to complete the collection, should the service agent make a determination.
  6. § 40.261 What is a refusal to take an alcohol test, and what are the consequences?
    a. We agree with this proposed change.
  7. § 40.291 What is the role of the SAP in the evaluation, referral, and treatment process of an employee who has violated DOT agency drug and alcohol testing regulations?
    a. Remote medical visits are commonplace in the U.S. and gained significant popularity during the pandemic.  It makes sense to continue to allow for remote SAP evaluations so long as they are performed under the current guidelines that were issued regarding quality of video, ability to SAP to clearly see the donor, etc.  This has also been a huge benefit to those individuals who do not live close to a qualified SAP and are typically forced to commute hundreds of miles in rural areas to meet the requirement of a face-to-face interview. While face-to-face is always the preferred method for SAP evaluations, remote should be allowed when face-to-face is not possible. NDASA also believes remote evaluations and further treatment sessions will provide a cost-savings benefit to employers and donors.
  8. § 40.311 What are the requirements concerning SAP reports?
    a. NDASA agrees with the proposed changes in this section.
  9. § 40.365 What is the Department’s policy concerning starting a PIE proceeding?
    a. NDASA agrees with this proposed change in this section.
  10. § 40.327 When must the MRO report medical information gathered in the verification process?
    a. We agree with this proposed change for MRO Comments pertaining to safety concerns.
  11. § 40.377 Who decides whether to issue a PIE?
    a. “The ODAPC Director, or his or her designee, decides whether to issue a PIE.” In recent years the position of ODAPC Director was inexplicably eliminated, with no designee appointed, leaving a void for the proper issuance of Public Interest Exclusions. The PIE process aids and assists this industry in safety compliance and protects from bad actors which is critical to the integrity of the program. NDASA requests the essential position of ODAPC Director be reinstated in order to maintain and protect the crucial Public Interest Exclusion, as well as other areas in which the Director function has provided invaluable support, guidance and leadership to the industry.

APPENDICES

NDASA agrees with renumbering and reordering of appendices per the redesignation table in support of the proposed standards.

APPENDIX B – Concerning establishing proposed standards for oral fluid collection kits:

Regarding oral fluid split-specimen collections, NDASA members support the concept that the mouth should be considered the collection container, thereby allowing the specimen to be split during the collection process. As such, we purport the current, widely used lab-based oral fluid collection devices that support immunoassay testing should be acceptable for DOT purposes.

Should the common use devices be deemed not acceptable by OTETA requirements this could perpetuate the unintended consequence of significantly delaying or prohibiting oral fluid testing from coming to fruition.

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