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FOR IMMEDIATE RELEASEKorManagement Services Announces FDA Removal of Key Barrier to DOT Oral Fluid Drug TestingFlorence,...
10/07/2026

FOR IMMEDIATE RELEASE

KorManagement Services Announces FDA Removal of Key Barrier to DOT Oral Fluid Drug Testing

Florence, SD — October 7, 2026 — KorManagement Services (KMS) is pleased to announce a significant federal development that clears the path for long‑awaited implementation of DOT oral fluid drug testing. On Tuesday, the U.S. Food and Drug Administration (FDA) issued an order eliminating the 510(k) premarket notification requirement that has prevented laboratories from beginning the certification process for federal oral fluid testing.

This regulatory change removes the primary obstacle that has stalled progress since the U.S. Department of Transportation (DOT) approved oral fluid testing in 2023. Until now, laboratories were unable to apply for HHS certification because oral fluid test systems were still subject to FDA’s 510(k) requirements. With this requirement now lifted, laboratories can move forward immediately.

A Clear Path to Federal Implementation

Under DOT regulations, oral fluid testing cannot begin until two laboratories successfully complete the HHS certification process. The FDA’s action finally enables those laboratories to initiate validation, compliance, and certification steps—opening the door for federal oral fluid testing to become operational once the dual‑lab requirement is met.

Industry Impact

The FDA’s decision:

Allows laboratories to begin the federal certification process for oral fluid testing.

Enables manufacturers to advance device development and submission without the previous regulatory barrier.

Provides employers, collectors, and service agents with a realistic timeline toward operational readiness.

“This change marks a pivotal moment for the industry,” said KorManagement Services Founder and CEO Janet Kornmann. “For years, the field has been prepared to adopt oral fluid testing, but unable to move forward. With the FDA’s order, laboratories finally have the green light to begin certification, and the DOT’s approved testing method can progress toward full implementation.”

About KorManagement Services

KorManagement Services (KMS) is a nationally recognized leader in drug and alcohol testing compliance, training, and professional development. With more than 35 years of industry expertise, KMS provides regulatory guidance, scenario‑based training, and ADA‑compliant educational resources for employers, collectors, DERs, and industry professionals.

Get ahead now and receive your Qualified Professional Collector training for Oral Fluid at KMS Empowered Training.

https://jan-s-site-4e5a.thinkific.com/courses/qpc-of-course

Media Contact

KorManagement Services

44324 157th St Florence, SD 57235

605-758-2325

[email protected]

10/06/2026
The Shy Bladder Protocol & DER Responsibilities in Regulated TestingLeadership and Doing It RightA shy bladder situation...
09/30/2026

The Shy Bladder Protocol & DER Responsibilities in Regulated Testing
Leadership and Doing It Right
A shy bladder situation can quickly become complicated if the people involved do not understand their roles.
The key is simple: the collector follows the collection protocol, the DER manages the employer’s responsibilities, and the MRO makes the medical determination. Each professional has a defined role under DOT regulations.
The Supervisor’s Role: Transport — Not Manage the Collection
The supervisor’s role that morning was straightforward: pick up the employee from the worksite and transport him to the collection facility.
Nothing more.
The supervisor does not manage the collection, interpret Part 40 requirements, determine whether the employee has refused a test, or make medical determinations.
Once the employee arrived at the collection facility, the supervisor’s involvement in the testing process ended. The trained collector took responsibility for the collection.
The supervisor remained available only if transportation was needed later.
Where the Shy Bladder Protocol Begins
Inside the collection facility, the donor was cooperative but was unable to provide a sufficient amount of urine.
The collector recognized that the specimen was insufficient and initiated the procedures required under 49 CFR § 40.193.
The collector’s responsibilities included following the shy bladder protocol, including:
• Recognizing that the specimen was insufficient
• Providing the employee with the required opportunity to provide additional specimen
• Following the required fluid-intake provisions
• Keeping the employee at the collection site as required
• Documenting the collection attempts and applicable times
• Following the required procedures through the conclusion of the collection
The supervisor did not direct the collector, interpret the regulation, or make decisions about the testing outcome.
That distinction matters.
The collection belongs to the collector.
The Three-Hour Requirement
Under 49 CFR § 40.193, when an employee is unable to provide a sufficient specimen, the collector follows the required procedures for the insufficient specimen.
The employee must be given the opportunity to provide additional specimen within the regulatory timeframe, and the collector must document the process appropriately.
If the employee remains unable to provide a sufficient specimen after the required procedures have been completed, the collector reports the situation to the Designated Employer Representative (DER).
At that point, the DER's responsibilities begin.
When the DER Is Notified — Compliance Takes Center Stage
Once notified by the collector, the DER steps into the role assigned under Part 40.
The DER reviews the information provided by the collector and follows the regulatory requirements for an insufficient specimen.
Importantly, the DER does not make the medical determination.
The DER must consult with the Medical Review Officer (MRO) and, as required by § 40.193, direct the employee to obtain an evaluation from a licensed physician acceptable to the MRO within the required timeframe.
The DER's role is to ensure that the regulatory process is initiated and followed.
The DER does not diagnose the employee.
The DER does not determine whether a medical condition caused the inability to provide a sufficient specimen.
And the DER does not independently declare a refusal.
The MRO and Referral Physician: Where the Medical Determination Is Made
This is one of the most important distinctions in the entire process.
The MRO is responsible for evaluating the medical information and making the determination required by Part 40.
If another physician performs the medical evaluation, the MRO must provide that physician with the required information and instructions.
The referral physician evaluates whether a medical condition has, or with a high degree of probability could have, prevented the employee from providing a sufficient specimen.
The referral physician then provides a written statement of the recommendation and the basis for that recommendation to the MRO.
The MRO must seriously consider and assess the referral physician's recommendation before making the final determination.
The possible outcomes include:
Medical Condition Established
If the MRO determines that a medical condition has, or with a high degree of probability could have, precluded the employee from providing a sufficient specimen, the MRO cancels the test as required by the regulation.
No Adequate Medical Basis
If the MRO determines that there is not an adequate basis for concluding that a medical condition prevented the employee from providing a sufficient specimen, the MRO follows the regulatory requirements for reporting the result as a refusal to test.
That determination belongs to the MRO — not the supervisor, collector, or DER.
What Counts as a Medical Condition?
The regulation provides important guidance.
For purposes of § 40.193, a medical condition can include an ascertainable physiological condition, such as a urinary-system dysfunction in the case of a urine test, or a medically documented pre-existing psychological disorder.
However, the regulation specifically states that unsupported assertions of “situational anxiety” or dehydration do not, by themselves, constitute a qualifying medical condition.
This is another reason the determination cannot be made casually at the collection site.
It requires the appropriate medical evaluation and MRO determination.
The Employer’s Role After the MRO Determination
Once the MRO makes the determination, the MRO reports the determination to the DER in writing.
If the employer receives an MRO report indicating that the test is cancelled because a medical condition precluded the employee from providing a sufficient specimen, the employer takes no further action with respect to that employee regarding that test.
If the test was a random test, the employee remains in the random testing pool.
The employer follows the MRO's determination rather than attempting to make its own medical judgment.
The Responsibility Chain
A shy bladder situation demonstrates why every person involved in DOT testing must understand where their responsibility begins — and where it ends.
Collector
Manages the collection process.
The collector follows the applicable collection procedures, documents the attempts, and notifies the DER when required.
DER
Manages the employer's regulatory responsibilities.
The DER receives the collector's notification, consults with the MRO, initiates the required medical evaluation process, and ensures the employer follows the applicable requirements.
Referral Physician
Performs the medical evaluation.
The referral physician evaluates the employee and provides the required written recommendation and supporting basis to the MRO.
MRO
Makes the medical determination.
The MRO evaluates the medical information, considers the referral physician's recommendation, and determines whether the test should be cancelled or handled as a refusal under the applicable regulation.
Supervisor
Provides transportation or other employer-directed support within their assigned role.
The supervisor does not take over the collection, interpret Part 40, or make medical or refusal determinations.
Why This Matters
Shy bladder situations reveal whether an organization understands its compliance structure.
They demonstrate whether:
• Collectors understand and follow the collection protocol
• DERs understand their regulatory responsibilities
• Supervisors understand the limits of their role
• MROs and referral physicians understand the medical determination process
• Employers respect the regulatory chain of responsibility
Compliance is not about everyone doing everything.
Compliance is about the right person doing the right thing at the right time.
The Bottom Line
A shy bladder situation is not something to improvise.
It is a regulated process with defined responsibilities.
The collector follows the collection protocol.
The DER manages the employer's responsibilities and coordinates the required next steps.
The referral physician conducts the medical evaluation when required.
The MRO makes the medical determination.
And the supervisor stays within the role assigned to them.
When everyone understands those boundaries, the process becomes more defensible, more professional, and more consistent with federal requirements.
The goal is not simply to complete a test.
The goal is to follow the process correctly — from the first collection attempt through the final MRO determination.
________________________________________
Regulatory Reference
This article is based on the requirements of 49 CFR Part 40, § 40.193, concerning an employee's inability to provide a sufficient amount of urine specimen.
For the complete regulation, consult the U.S. Department of Transportation's official Part 40 regulations.
Workplace Safety Isn't Accidental — It's a Responsibility.
Jan Kornmann, BS, MBATT, CPCT-U/OF, CDERT
KorManagement Services LLC
www.kormanagementservices.com

09/29/2026

FREE -New Course Launch: BEFORE YOU LAUNCH**
**The Essential Training Every New Drug & Alcohol Testing Business Must Complete**

Starting a testing business isn’t just about supplies and clients — it’s about **credibility, compliance, and defensible practice**.
Before you invest time, money, or reputation, make sure you understand what this industry truly requires.

This foundational course from **KMS Empowered Training** gives you the clarity, confidence, and compliance insight every new entrepreneur needs to build a sustainable, respected business.

You’ll learn:
- The difference between DOT and non‑DOT expectations — and why blending them is risky
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- How to evaluate readiness, risk, and opportunity before you launch

Your clarity begins here.
👉 Enroll now at KMS Empowered Training https://jan-s-site-4e5a.thinkific.com/products/courses/testing-business-training

Discover the comprehensive solutions available for your business: designed to support workplace safety and ensure regula...
09/25/2026

Discover the comprehensive solutions available for your business: designed to support workplace safety and ensure regulatory compliance. KorManagement Services LLC offers expert consulting and training tailored to meet your organization's unique needs. Visit the website today to explore trusted resources that empower your team, strengthen operations, and promote a secure work environment. Click through to learn more and take proactive steps toward excellence.
https://kormanagementservices.com/

Training Tuesday Insight: What DOT *Actually Requires* in Drug & Alcohol Testing In the compliance world, “DOT requires…...
09/14/2026

Training Tuesday Insight: What DOT *Actually Requires* in Drug & Alcohol Testing
In the compliance world, “DOT requires…” is one of the most over‑used phrases — and one of the most misunderstood.
So, today’s Training Tuesday focuses on **what DOT truly requires**, and just as importantly, **what it does *not* require**.
**1. DOT Requires Compliance with Part 40 — Nothing More, Nothing Less**
Every DOT‑regulated test follows **49 CFR Part 40**, regardless of agency (FMCSA, FAA, FRA, FTA, PHMSA, USCG).
Part 40 is the *how* of testing:
- How collections must be performed
- How laboratories must analyze specimens
- How MROs must review results
- How employers must manage the process
- How SAPs must conduct evaluations and follow‑up testing
If it’s not in Part 40, it’s not a DOT requirement.
**2. DOT Requires Agency‑Specific Testing Programs**
Each DOT agency sets the *when* and *who*:
- FMCSA: CDL drivers
- FAA: Safety‑sensitive aviation employees
- FRA: Hours‑of‑service and maintenance‑of‑way employees
- FTA: Transit safety‑sensitive employees
- PHMSA: Pipeline operators
- USCG: Regulated mariners
These agencies define testing circumstances: pre‑employment, random, post‑accident, reasonable suspicion, return‑to‑duty, and follow‑up.
**3. DOT Requires Clear Documentation — Not Guesswork**
DOT doesn’t require fancy forms or custom templates.
DOT requires **accurate, complete, defensible documentation**:
- Proper CCF completion
- Clear Reasonable Suspicion documentation
- Accurate MIS reporting
- Correct SAP and follow‑up records
- Secure storage and confidentiality
Compliance is about precision, not paperwork volume.
**4. DOT Requires Training — But Only Certain Training**
DOT mandates training for:
- **DERs** (must understand Part 40 and agency rules)
- **Supervisors** (reasonable suspicion training)
- **Collectors** (qualification + proficiency + error‑correction)
- **BATs/STTs** (qualification + device proficiency)
- **SAPs** (credential + continuing education)
DOT does **not** require:
- “Annual DER training”
- “Collector refresher training every year”
- “Random program training”
Those are *best practices*, not DOT rules.
**5. DOT Requires Consistency — Not Creativity**
DOT compliance is built on repeatable, standardized processes.
If your program changes every time a situation arises, you’re not compliant — you’re improvising.
Consistency protects:
- The employer
- The employee
- The integrity of the testing process
- The defensibility of every result

**Training Tuesday Takeaway**
When someone says, “DOT requires…,” pause and ask:
**Is that in Part 40 or the agency regulations? **
If not, it’s a myth — and myths create liability.

DOT compliance isn’t complicated.
It’s **precise**, **structured**, and **consistent** — and when we understand what DOT *actually* requires, we build programs that are defensible, professional, and safe.

Companies don’t struggle because employees lack willingness — they struggle because employees lack training.If you work ...
09/10/2026

Companies don’t struggle because employees lack willingness — they struggle because employees lack training.

If you work with Designated Employer Representatives (DERs), Supervisor Reasonable Suspicion, or Certified Professional Collectors for Urine & Oral Fluid, this is the training that transforms your program.

NDASA’s Midyear Training & Train‑the‑Trainer Courses (Sept 22–23 • Omaha, NE) give organizations exactly what they need:

*Stronger compliance *Clearer documentation *Confident supervisors *Fewer testing errors *Better decision‑making in real situations

From shy bladder to reasonable suspicion, your team will learn what to do, how to do it, and how to teach others — confidently and correctly.

If you want a safer workplace, fewer incidents, and a more empowered staff, this is the training to send them to.

Invest in your people. Invest in your process.

Join us in Omaha — and bring your future trainers with you.

Invest in your people. Invest in your process. Join us in Omaha — and bring your future trainers with you. https://ndasa.com/midyear-training-2026/

Address

44324 157th Street
Florence, SD
57235

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Tuesday 9am - 4pm
Wednesday 9am - 4pm
Thursday 9am - 5pm
Friday 9am - 4pm

Telephone

+16057582325

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