Whatever the specimen type, the collector does the same six things:

• Verifies who the donor is
• Prepares the site and the supplies
• Explains the procedure before starting it
• Takes custody of the specimen and checks it
• Keeps the chain of custody intact and documented
• Seals, packages, and moves it on

Notice what is not on the list: deciding what the result means, and deciding whether anything the donor did counts as a refusal.

There is no federal qualification standard for non-DOT collection. There is still a defensibility standard, and it comes down to the appearance of bias. Do not serve as collector for:

• The donor’s direct supervisor
• A close relative or close friend
• Yourself — never collect your own specimen

Use judgment about co-workers in a small workplace, where the appearance of bias is high even when none exists.

Borrowed from DOT practice. Part 40 has its own exclusions for DOT tests; they do not by themselves bind a non-DOT collection, but a program that ignores this entirely is hard to defend.

Nobody issues a federal non-DOT collector credential. What protects a program when a result is challenged is a documented, repeatable training record:

• Knowledge of how non-DOT differs from DOT — section 1 of this course
• A walkthrough of the instructions for use for every lab and device you work with
• Supervised practice collections, including problem scenarios — not only the ones that go smoothly
• A refresher at a set interval, with the date recorded
• Per-collector, per-method records kept on file

Beware of anyone selling a “certified non-DOT collector” credential as though a government or standards body recognized it. No such federal recognition exists.

Recommended DOT-like site controls. No federal rule imposes these on an ordinary private-sector collection — use them unless your program, the laboratory or state law says otherwise. Three things matter whatever the method:

• Privacy — no observers, no foot traffic through the collection
• A clean, clear work surface for the form, the kit, and the device
• Control of what the donor can reach — the specifics depend on the specimen

Urine and instant-urine collections add

• Single-stall restroom, or a multi-stall secured so only one is usable
• Bluing agent in the bowl and the tank
• Water sources shut off or taped; soap, cleaners, and other liquids removed

Hair and breath collections do not need a secured restroom — but they still need privacy and a clean surface.

• Maintain control of the donor and the process. In a normal urine collection the donor enters the restroom alone — observation of urination only where the program requires and authorizes it
• Ask only for outer garments that could conceal tampering items (coat, jacket, hat, coveralls), and for bags to be left with you. Never ordinary clothing; the donor keeps their wallet
• The specimen never leaves your sight from the moment you receive it until it is sealed
• Seals go on in the donor’s view; the donor initials them
• Sealed specimens stay somewhere access-restricted until they ship

A gap in the documented chain of custody can undermine a challenged collection. Adopted practice, not universal law — follow what your program specifies.

DOT testing uses one federal Custody and Control Form. Non-DOT testing has no single equivalent. The form you use depends on the laboratory, the employer, or the program — and they differ.

Common fields may include (breath, lab urine, hair and instant forms differ materially):

Read the instructions for use for each lab before your first collection with them. Copy routing, seal placement, and packaging order all vary.

Confirm all of this before the donor is in front of you:

• Donor name and identifier
• Employer name and the contact who receives results
• Reason for the test
• What is being tested for — panel, or threshold for alcohol
• Where it goes — laboratory name and shipping address
• Who reviews a non-negative result, and how to reach them
• Whether the program calls for an observed collection

The last two are the ones people skip. A non-negative with no review pathway in place leaves you holding a result nobody is authorized to act on.

Follow the governing program’s requirements. A common DOT-derived approach (§40.61(c)):

• Photo ID issued by the employer, or by a federal, state or local government
• Or positive ID by an employer representative — not a co-worker, not another employee being tested
• Not faxes or photocopies

Stop and check with the employer if

• No identification, and nobody present who can vouch for the donor
• The donor appears unable to understand or consent
• The donor will not sign the chain of custody
• The donor will not empty pockets where the method requires it

Do not evaluate or record medications unless the governing form or procedure specifically tells you to.

Where the program uses a medical review officer or another authorized reviewer, medical explanations belong in that review — after a non-negative, not at the collection site. Not every private program uses one.

If the donor raises it anyway

• Do not speculate about whether something will show up
• Do not write it on the form unless the form asks for it
• Tell them who handles medical questions under your program

Collecting medication information you were not asked to collect creates a record nobody wanted, and invites the argument that the collection was biased.

When something goes wrong, you do two things: write down exactly what happened, and hand the decision to whoever has authority for it under the program governing that test.

You do not decide whether it was a refusal. You do not decide what the result means. You record facts and pass them on.

Depending on the program, the decider may be the employer, a third-party administrator, a medical review officer, or a contracting authority. Know which one before you need them.

It is not timidity — it is how the mature version of this system is built.

Under Part 40, a service agent “must not make a determination that an employee has refused a drug or alcohol test. This is a non-delegable duty of the actual employer” (§40.355(i)). The collector may provide facts and advice; the employer decides.

§40.355(j) carves out two narrow exceptions: a self-employed individual or owner-operator who fails to appear without a legitimate reason, and a medical review officer determining refusal on the basis of adulteration or substitution.

That is the DOT rule and it binds DOT tests. It does not automatically bind your non-DOT program — but the division of labor it describes is sound, and copying it keeps you out of a decision you are not positioned to defend.

Common across all four methods. Record what happened, in the donor’s words where possible, and refer it:

• Declining to provide the specimen or take the test
• Leaving before the collection is complete
• Declining to sign the chain of custody
• Apparent tampering — adulterating, substituting, or manipulating the specimen
• Declining an observed collection where the program calls for one
• Conduct that obstructs the collection

Write “the donor left the site at 10:42 without providing a specimen”. Do not write “the donor refused”. The first is a fact you observed. The second is a determination somebody else makes.

Retention for non-DOT testing is set by employer policy, state law, and contract — there is no single federal schedule. Programs commonly land somewhere near:

Typical practice, not a legal schedule. Get the real periods from your program — and if nobody can tell you, flag that.

Every figure below is an approximate range. What moves it: the specimen, the substance, the cutoff level the lab uses, the donor’s pattern of use, and the laboratory’s methodology.

Never quote a single number to an employer or a donor as though it were fixed. “Roughly this range, depending on the substance and the lab’s cutoff” is both more accurate and more useful.

Hair has a lag at the other end too: a substance used in the last several days has not yet grown above the scalp to be cut. Separately, do not confuse availability: DOT-regulated oral fluid testing cannot begin until two HHS-certified oral fluid laboratories exist, but that condition does not gate non-DOT oral fluid testing, which employers use today.

Use what your laboratory supplies. Contents vary, but expect:

Before you start

• Kit in date, seals intact, nothing pre-opened
• Form matches the laboratory the program actually uses
• Lot number recorded

1. (DOT-derived sequence — your program and the lab instructions control.) Prepare the site — bluing in, water secured
2. Verify identity against the form
3. Explain the procedure and show the donor the form
4. Complete your section of the form
5. Outer clothing off, pockets emptied and displayed
6. Donor washes hands, under observation
7. Sealed cup opened in the donor’s view; donor enters alone with the cup only
8. Donor provides the specimen and returns promptly, without flushing
9. Check the temperature within four minutes
10. Check volume and appearance
11. You pour into the bottles — not the donor
12. Seals on, dated, donor initials each one
13. Record checks and anything unusual in Remarks
14. Donor signs
15. Bag, seal, distribute copies, ship

DOT-derived. §40.65(b) has the collector check temperature no later than four minutes after the specimen is handed over, against 90–100°F. On a non-DOT collection it applies because your program, the lab instructions, state law or the contract adopted it.

An out-of-range reading is not proof of anything. Record the actual number. Under current DOT procedure it requires an immediate new collection — either a urine collection under direct observation or an oral fluid collection — and both specimens are processed and sent to their respective laboratories (§40.65(b)(5)–(6)).

Do not tell a donor the four-minute window is federally required on a non-DOT test.

Insufficient volume is common and is not, by itself, anything sinister. The widely used approach, borrowed from DOT:

1. Stop the first attempt and note the time
2. Offer fluids over a set period — a capped amount over a few hours
3. If there is still not enough, stop, document, and refer it

The employer may then arrange a medical evaluation. That is their call, not yours.

Do not top up a short specimen from a second void unless the laboratory’s instructions specifically allow it. Combining voids invalidates the collection for most labs.

In ordinary private-sector testing, an observed collection happens because the program provides for it. Common triggers written into policy:

• Temperature out of range
• Signs of tampering — appearance, odor, a suspected device
• Return-to-duty or follow-up testing, where the employer’s lawful written policy or another governing program expressly requires it

Note the third one carefully. A preliminary non-negative screen is not a verified positive, and by itself it does not create a return-to-duty situation. Federally regulated non-DOT programs (HHS, NRC) set their own observed-collection rules and are outside this course.

Observation is intrusive and carries real legal exposure if done outside policy or by the wrong person. Confirm it is authorized in writing, and confirm who is permitted to observe, before you proceed.

Everything rests on the evidential breath testing device being right and being current.

• Devices on the NHTSA Conforming Products List are widely preferred, including for non-DOT use, because their results are easier to defend
• Fuel-cell sensors are generally more specific than semiconductor sensors
• Calibration current per the manufacturer’s schedule — and logged every time
• A fresh, sealed mouthpiece for every blow, opened in the donor’s view
• Instructions for use printed and on site

A result from a device used outside its calibration interval is very hard to defend. The calibration log is not paperwork — it is the evidence that the number meant something.

This is the most commonly misstated rule in alcohol testing, so be precise about which wait you mean.

What Part 40 actually says

§40.251(a)(1) requires a wait before the confirmation test — at least 15 minutes from completion of the screening test, with confirmation begun no more than 30 minutes after. Part 40 requires no wait before the initial screening test.

What applies to your non-DOT test

Your employer’s policy and the device IFU. Many programs adopt a pre-test observation period; that comes from the policy and the IFU, not Part 40.

Do not tell a donor a wait is “federally required” on a non-DOT test. Tell them it is what the program and the device call for.

Alcohol still in the mouth — a recent drink, mouthwash, some medications, a belch — sits on the sensor and reads far higher than what is in the bloodstream.

During an observation period, the donor should not:

• Eat or drink anything
• Smoke or vape
• Put anything in their mouth — gum, mints, tobacco, dental products
• Belch or regurgitate into the mouth

A materially lower confirmation may be consistent with mouth alcohol dissipating — but do not assign a cause from two numbers. Where the program uses screening plus confirmation, the confirmation is the result acted upon. Record both readings and report per the governing procedure.

1. Greet the donor, verify identity, explain the procedure
2. Donor reads and signs the affirmation on the form
3. Observation period per your policy and the device IFU
4. Power up the device; confirm it completes its self-test
5. Open a fresh sealed mouthpiece in the donor’s view
6. Donor provides one continuous breath until the device signals
7. Record the reading and show it to the donor
8. Below the program’s threshold — done. At or above — go to confirmation.

DOT-derived sequence; on a non-DOT test the operative procedure comes from your program, the device IFU and any service protocol. The applicable threshold comes from the governing law, program, contract or policy — some private programs voluntarily adopt the DOT 0.02 / 0.04 framework, which is a choice, not an inherited rule.

1. Continue observation through the waiting period
2. In the donor’s presence, run an air blank on the EBT you are using; show them the reading
3. 0.00 — proceed. Above 0.00 — run a second air blank
4. Second reads 0.00 — proceed. Still above — that EBT comes out of service; continue on another EBT if available
5. Fresh sealed mouthpiece, opened in the donor’s view
6. Donor provides the confirmation breath
7. Record the result — the test of record; donor signs; notify per policy

DOT-derived (§40.253) — on a non-DOT test your program and the device IFU control. One high air blank does not condemn the device: run a second.

The donor cannot produce an adequate sample

• Coach technique — one continuous exhalation, not a series of puffs
• Allow another attempt; document each one
• Still unable — stop, document, refer. A medical evaluation is the employer’s call.

The device will not cooperate

• Air blank above 0.00: run a second. Only if that also fails does the EBT come out of service — then continue on another EBT if available.
• Any other device error — follow the manufacturer’s instructions and your program’s procedure, and write down exactly what the device did

A device problem is not a refusal and not a positive. Record what happened and let the program decide.

Substances circulating in the blood are incorporated into the hair shaft as it grows. Cutting close to the scalp gives a historical record rather than a snapshot.

• Head hair grows at roughly half an inch a month, so a sample of about an inch and a half covers approximately the last three months — an average, not a measurement
• Very recent use may not yet be detectable in the portion of hair available above the scalp
• There is no instant version — hair is always laboratory-analyzed
• Hair is not an authorized methodology for DOT testing. It is a non-DOT method only

Because it is poor at recent use, hair is a weak choice for post-incident or reasonable-suspicion testing. It is strongest where a pattern over time is what the employer is asking about.

Length and volume minimums, body-hair sites, foil handling and treated-hair documentation are all set by the laboratory and differ between them. Take every number and every handling step from the collection instructions in front of you, not from memory.

1. Part the hair at the vertex posterior — back of the crown. Growth is most consistent there.
2. Section a bundle to the volume the laboratory specifies
3. Cut as close to the scalp as practical, without nicking skin. One decisive cut.
4. Keep the root end aligned. The cut end is the newest growth; the lab reads from it.
5. Mark the root end — most kits include an arrow or marker for this
6. Fold the foil around the hair without creasing the shaft
7. Into the specimen envelope, sealed per the IFU, seal number on the form
8. Donor initials the seals in your view

Root-end orientation matters and is easy to lose. If you are unsure which end is which, stop before you package it and check the laboratory’s instructions.

Not enough head hair

Follow the laboratory’s instructions on whether body hair is acceptable, which sites, how much, and how to document it. Density is lower, so expect several passes, and body hair is not segmented the same way — the timeline is less precise.

Treated hair

Bleach, perms and relaxers can affect what the lab detects. Handle and document any disclosure the way that laboratory directs.

Not enough of either

Stop, document, refer. An alternative method is the employer’s decision.

A shaved head is not evidence of anything on its own. Record what you observed and let the program decide what it means.

This is the single most misunderstood point in instant testing, so learn it in this order.

CLIA applicability principally turns on the purpose or use of the testing — not merely on whether the device says “CLIA-waived”. CMS puts it as the determining factor being not the test itself but the purpose for which it is conducted. Device labeling, the IFU, and state laboratory law remain separate requirements you still have to meet.

• Testing purely for employment purposes is treated as forensic, and CLIA certification is generally not required for it
• Testing where an individual is offered diagnosis or treatment based on the result is clinical, and CLIA applies

Two different layers of authority. The forensic exemption itself is regulation — 42 CFR §493.3(b)(1) exempts a facility that only performs testing for forensic purposes. The position that employment testing counts as forensic comes from CMS guidance interpreting that rule, not from the text of the regulation.

For purposes of CLIA applicability only — device labeling and the IFU still govern whether a given product is appropriate for the use you are putting it to.

Buying a CLIA-waived device does not by itself put your employment testing under CLIA, and choosing a forensic-use-only device does not by itself keep a clinical program out of it. Start from what the result will be used for.

Confirm your own state’s rules. This course does not substitute for a determination about your specific program.

Retain the specimen. Where the program sends non-negatives for laboratory confirmation, you cannot send what you already discarded.

For common competitive lateral-flow devices that use C and T lines, the following pattern is typical:

The IFU controls interpretation, always. Cups, cassettes, dip cards, oral kits and digital readers do not all work this way. Read inside the window the IFU specifies; note the start time when you activate the device.

On these devices a faint test line is still a test line — confirm against the IFU in your hand. If repeated invalids occur, follow the IFU and QC procedure and notify the program or supplier.

An instant device screens; it does not confirm. A preliminary non-negative is never a confirmed positive. What follows depends on state law, employer policy and the device or lab procedure.

What to say

“Your screening result is non-negative. That is not a positive — here is what happens next under our procedure.”

Where the program uses lab confirmation

1. Follow the device and program procedure for getting a specimen to the laboratory; where the retained specimen is used, seal and ship it per the lab’s instructions, donor initialing the seals
2. The lab confirms by a second, different analytical method
3. The reviewer takes any medical explanation and reports the verified result — not you

• Part 40 does not automatically apply. Know what actually does — policy, state law, the lab or device IFU, the contract. And remember non-DOT does not mean unregulated.
• Document facts; refer decisions. Whether something is a refusal is not your call.
• CLIA turns mainly on purpose, not the label on the device.
• A non-negative is not a positive. Ever.
• Detection windows are ranges. Say what they depend on.

When you are unsure, the safe move is almost always the same one: write down exactly what you observed, and ask the person who has authority to decide.